02012R0528 — EN — 10.06.2021 — 005.001
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
|
REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167 27.6.2012, p. 1) |
Amended by:
Corrected by:
REGULATION (EU) No 528/2012 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 22 May 2012
concerning the making available on the market and use of biocidal products
(Text with EEA relevance)
CHAPTER I
SCOPE AND DEFINITIONS
Article 1
Purpose and subject matter
This Regulation lays down rules for:
the establishment at Union level of a list of active substances which may be used in biocidal products;
the authorisation of biocidal products;
the mutual recognition of authorisations within the Union;
the making available on the market and the use of biocidal products within one or more Member States or the Union;
the placing on the market of treated articles.
Article 2
Scope
Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall not apply to biocidal products or treated articles that are within the scope of the following instruments:
Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community ( 1 );
Directive 90/385/EEC, Directive 93/42/EEC and Directive 98/79/EC;
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products ( 2 ), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( 3 ) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency ( 4 );
Regulation (EC) No 1831/2003;
Regulation (EC) No 1333/2008;
Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods ( 7 );
Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed ( 8 );
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market ( 9 );
Regulation (EC) No 1223/2009;
Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys ( 10 ).
Notwithstanding the first subparagraph, when a biocidal product falls within the scope of one of the abovementioned instruments and is intended to be used for purposes not covered by those instruments, this Regulation shall also apply to that biocidal product insofar as those purposes are not addressed by those instruments.
Subject to any explicit provision to the contrary in this Regulation or other Union legislation, this Regulation shall be without prejudice to the following instruments:
Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 11 );
Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work ( 12 );
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work ( 13 );
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption ( 14 );
Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations ( 15 );
Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work ( 16 );
Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy ( 17 );
Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work ( 18 );
Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants ( 19 );
Regulation (EC) No 1907/2006;
Directive 2006/114/EC of the European Parliament and of the Council of 12 December 2006 concerning misleading and comparative advertising ( 20 );
Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals ( 21 );
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures ( 22 );
Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides ( 23 );
Regulation (EC) No 1005/2009 of the European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer ( 24 );
Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes ( 25 );
Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions ( 26 ).
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
‘biocidal product’ means
A treated article that has a primary biocidal function shall be considered a biocidal product.
‘micro-organism’ means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, algae, protozoa and microscopic parasitic helminths;
‘active substance’ means a substance or a micro-organism that has an action on or against harmful organisms;
‘existing active substance’ means a substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;
‘new active substance’ means a substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development;
‘substance of concern’ means any substance, other than the active substance, which has an inherent capacity to cause an adverse effect, immediately or in the more distant future, on humans, in particular vulnerable groups, animals or the environment and is present or is produced in a biocidal product in sufficient concentration to present risks of such an effect.
Such a substance would, unless there are other grounds for concern, normally be:
‘harmful organism’ means an organism, including pathogenic agents, which has an unwanted presence or a detrimental effect on humans, their activities or the products they use or produce, on animals or the environment;
‘residue’ means a substance present in or on products of plant or animal origin, water resources, drinking water, food, feed or elsewhere in the environment and resulting from the use of a biocidal product, including such a substance’s metabolites, breakdown or reaction products;
‘making available on the market’ means any supply of a biocidal product or of a treated article for distribution or use in the course of a commercial activity, whether in return for payment or free of charge;
‘placing on the market’ means the first making available on the market of a biocidal product or of a treated article;
‘use’ means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union;
‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;
‘national authorisation’ means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product or a biocidal product family in its territory or in a part thereof;
‘Union authorisation’ means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof;
‘authorisation’ means national authorisation, Union authorisation or authorisation in accordance with Article 26;
‘authorisation holder’ means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation;
‘product-type’ means one of the product-types specified in Annex V;
‘single biocidal product’ means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;
‘biocidal product family’ means a group of biocidal products having:
similar uses;
the same active substances;
similar composition with specified variations; and
similar levels of risk and efficacy;
‘letter of access’ means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation;
‘food’ and ‘feed’ mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation;
▼M3 —————
‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;
‘Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;
‘advertisement’ means a means of promoting the sale or use of biocidal products by printed, electronic or other media;
‘nanomaterial’ means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100 nm.
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
‘administrative change’ means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family;
‘minor change’ means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;
‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change;
‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products. These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents;
‘small and medium-sized enterprises’ or ‘SMEs’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises ( 27 ).
For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:
‘substance’;
‘mixture’;
‘article’;
‘product and process-orientated research and development’;
‘scientific research and development’.
CHAPTER II
APPROVAL OF ACTIVE SUBSTANCES
Article 4
Conditions for approval
The approval shall specify the following conditions, as appropriate:
the minimum degree of purity of the active substance;
the nature and maximum content of certain impurities;
the product-type;
manner and area of use including, where relevant, use in treated articles;
designation of categories of users;
where relevant, characterisation of the chemical identity with regard to stereoisomers;
other particular conditions based on the evaluation of the information related to that active substance;
the date of approval and the expiry date of the approval of the active substance.
Article 5
Exclusion criteria
Subject to paragraph 2, the following active substances shall not be approved:
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;
active substances which, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of paragraph 3, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;
active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.
Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:
the risk to humans, animals or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or under other conditions which aim at excluding contact with humans and release into the environment;
it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.
When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall be a key consideration.
The use of a biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk-mitigation measures to ensure that exposure of humans, animals and the environment to those active substances is minimised. The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met.
Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties.
Article 6
Data requirements for an application
An application for approval of an active substance shall contain at least the following elements:
a dossier for the active substance satisfying the requirements set out in Annex II;
a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and
if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:
the data are not necessary owing to the exposure associated with the proposed uses;
it is not scientifically necessary to supply the data; or
it is not technically possible to generate the data.
However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or Article 10(1), if required by the evaluating competent authority under Article 8(2).
Article 7
Submission and validation of applications
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance of the application and its unique identification code.
In the context of the validation referred to in the first subparagraph, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant and the Agency accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) shall be reimbursed.
Article 8
Evaluation of applications
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.
Article 9
Approval of an active substance
The Commission shall, on receipt of the opinion of the Agency referred to in Article 8(4), either:
adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; or
in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, adopt an implementing decision that an active substance is not approved.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Article 10
Active substances which are candidates for substitution
An active substance shall be considered a candidate for substitution if any of the following conditions are met:
it meets at least one of the exclusion criteria listed in Article 5(1) but may be approved in accordance with Article 5(2);
it meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as a respiratory sensitiser;
its acceptable daily intake, acute reference dose or acceptable operator exposure level, as appropriate, is significantly lower than those of the majority of approved active substances for the same product-type and use scenario;
it meets two of the criteria for being PBT in accordance with Annex XIII to Regulation (EC) No 1907/2006;
there are reasons for concern linked to the nature of the critical effects which, in combination with the use patterns, amount to use that could still cause concern, such as high potential of risk to groundwater, even with very restrictive risk management measures;
it contains a significant proportion of non-active isomers or impurities.
Article 11
Technical guidance notes
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter, in particular Article 5(2) and Article 10(1).
CHAPTER III
RENEWAL AND REVIEW OF APPROVAL OF AN ACTIVE SUBSTANCE
Article 12
Conditions for renewal
Article 13
Submission and acceptance of applications
When applying for the renewal of the approval of the active substance, the applicant shall submit:
without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial approval or, as appropriate, previous renewal; and
its assessment of whether the conclusions of the initial or previous assessment of the active substance remain valid and any supporting information.
The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of the acceptance.
Article 14
Evaluation of applications for renewal
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application in accordance with Article 13(3), prepare and submit to the Agency a recommendation on the renewal of the approval of the active substance. It shall provide the applicant with a copy of its recommendation.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, notify the applicant of the fees payable under Article 80(2). The evaluating competent authority shall reject the application if the applicant fails to pay the fees within 30 days of the notification and shall inform the applicant accordingly.
The Commission shall, on receipt of the opinion of the Agency, adopt:
an implementing regulation providing that the approval of an active substance is renewed for one or more product-types, and under which conditions; or
an implementing decision that the approval of an active substance is not renewed.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Article 9(2) shall apply.
Article 15
Review of approval of an active substance
Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). Article 9(2) shall apply. The Commission shall inform the initial applicants for the approval accordingly.
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4).
Article 16
Implementing measures
The Commission may adopt, by means of implementing acts, detailed measures for the implementation of Articles 12 to 15, further specifying the procedures for the renewal and review of the approval of an active substance. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
CHAPTER IV
GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
Article 17
Making available on the market and use of biocidal products
Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’).
Applications for Union authorisation shall be submitted to the Agency.
Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.
Member States shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.
Article 18
Measures geared to the sustainable use of biocidal products
By 18 July 2015 the Commission shall, on the basis of experience gained with the application of this Regulation, submit to the European Parliament and the Council a report on how this Regulation is contributing to the sustainable use of biocidal products, including on the need to introduce additional measures, in particular for professional users, to reduce the risks posed to human health, animal health and the environment by biocidal products. That report shall, inter alia, examine:
the promotion of best practices as a means of reducing the use of biocidal products to a minimum;
the most effective approaches for monitoring the use of biocidal products;
the development and application of integrated pest management principles with respect to the use of biocidal products;
the risks posed by the use of biocidal products in specific areas such as schools, workplaces, kindergartens, public spaces, geriatric care centres or in the vicinity of surface water or groundwater and whether additional measures are needed to address those risks;
the role that improved performance of the equipment used for applying biocidal products could play in sustainable use.
On basis of that report, the Commission shall, if appropriate, submit a proposal for adoption in accordance with the ordinary legislative procedure.
Article 19
Conditions for granting an authorisation
A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:
the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;
it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:
the biocidal product is sufficiently effective;
the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;
the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:
the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;
where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 ( 29 ), Regulation (EC) No 396/2005 of the European Parliament and of the Council ( 30 ), Regulation (EC) No 470/2009 of the European Parliament and of the Council ( 31 ) or Directive 2002/32/EC of the European Parliament and of the Council ( 32 ), or specific migration limits or limits for the residual content in food contact materials have been established with respect to such active substances in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council ( 33 );
where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.
The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:
realistic worst case conditions under which the biocidal product may be used;
the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;
the consequences of use and disposal of the biocidal product;
cumulative effects;
synergistic effects.
A biocidal product shall not be authorised for making available on the market for use by the general public where:
it meets the criteria according to Directive 1999/45/EC for classification as:
it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:
it consists of, contains or generates, a substance that meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;
it has endocrine-disrupting properties; or
it has developmental neurotoxic or immunotoxic effects.
The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised. The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met.
A biocidal product family shall be authorised only if:
the application explicitly identifies the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the assessment is based, as well as the permitted variations in composition and uses referred to in point (s) of Article 3(1) together with their respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and
it can be established based on the assessment referred to in the first subparagraph of this paragraph that all the biocidal products within the family comply with the conditions set out in paragraph 1.
Article 20
Requirements for applications for authorisation
The applicant for an authorisation shall submit the following documents together with the application:
for biocidal products other than biocidal products meeting the conditions laid down in Article 25:
a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;
a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;
a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;
for biocidal products that the applicant considers meet the conditions laid down in Article 25:
a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;
efficacy data; and
any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
Article 21
Waiving of data requirements
By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:
the data are not necessary owing to the exposure associated with the proposed uses;
it is not scientifically necessary to supply the data; or
it is not technically possible to generate the data.
Article 22
Content of authorisation
Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:
trade name of the biocidal product;
name and address of the authorisation holder;
date of the authorisation and its date of expiry;
authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;
qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;
manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
manufacturers of the active substances (names and addresses including location of manufacturing sites);
type of formulation of the biocidal product;
hazard and precautionary statements;
product-type and, where relevant, an exact description of the authorised use;
target harmful organisms;
application doses and instructions for use;
categories of users;
particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;
instructions for safe disposal of the product and its packaging;
conditions of storage and shelf-life of the biocidal product under normal conditions of storage;
where relevant, other information about the biocidal product.
Article 23
Comparative assessment of biocidal products
The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission, shall prohibit or restrict the making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where a comparative assessment, performed in accordance with the technical guidance notes referred to in Article 24, demonstrates that both of the following criteria are met:
for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;
the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying the criteria for determining when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments.
Article 24
Technical guidance notes
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Article 22(2) and Article 23(3).
CHAPTER V
SIMPLIFIED AUTHORISATION PROCEDURE
Article 25
Eligibility for the simplified authorisation procedure
For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure. A biocidal product shall be eligible if all the following conditions are met:
all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex;
the biocidal product does not contain any substance of concern;
the biocidal product does not contain any nanomaterials;
the biocidal product is sufficiently effective; and
the handling of the biocidal product and its intended use do not require personal protective equipment.
Article 26
Applicable procedure
Upon receipt of the fees payable under Article 80(2), the evaluating competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
The evaluating competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, where fees have been paid, part of the fees paid in accordance with Article 80(2) shall be reimbursed.
Article 27
Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
Where a Member State has valid reasons to consider that a biocidal product authorised in accordance with Article 26 does not meet the criteria laid down in Article 25 and a decision pursuant to Articles 35 and 36 has not yet been taken, that Member State may provisionally restrict or prohibit making available on the market or use of that product on its territory.
Article 28
Amendment of Annex I
Active substances give rise to concern where:
they meet the criteria for classification according to Regulation (EC) No 1272/2008 as:
they fulfil any of the substitution criteria set out in Article 10(1); or
they have neurotoxic or immunotoxic properties.
Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance.
CHAPTER VI
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
Article 29
Submission and validation of applications
Within 30 days of acceptance, the receiving competent authority shall validate the application if it complies with the following requirements:
the relevant information referred to in Article 20 has been submitted; and
the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).
In the context of the validation referred to in the first subparagraph, the receiving competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
The receiving competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in paragraph 2.
The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
Article 30
Evaluation of applications
The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
Within the 365-day period referred to in paragraph 1, the receiving competent authority shall:
draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);
send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and
take due account of those comments when finalising its assessment.
Article 31
Renewal of a national authorisation
When applying for renewal, the applicant shall submit:
without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and
its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
Upon receipt of the fees payable under Article 80(2), the receiving competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
Where the receiving competent authority decides that a full evaluation of the application is not necessary, it shall decide on the renewal of the authorisation within 180 days of accepting the application in accordance with paragraph 4 of this Article.
CHAPTER VII
MUTUAL RECOGNITION PROCEDURES
Article 32
Authorisation through mutual recognition
Article 33
Mutual recognition in sequence
The competent authorities of the Member States concerned shall inform the applicant of the fees payable under Article 80 and shall reject the application if the applicant fails to pay the fees within 30 days. They shall inform the applicant and the other competent authorities accordingly. Upon receipt of the fees payable under Article 80, the competent authorities of the Member States concerned shall accept the application and inform the applicant indicating the date of acceptance.
Within 90 days of validating the application, and subject to Articles 35, 36 and 37, the Member States concerned shall agree on the summary of biocidal product characteristics referred to in Article 22(2) and shall record their agreement in the Register for Biocidal Products.
Article 34
Mutual recognition in parallel
Applicants wishing to seek the mutual recognition in parallel of a biocidal product which has not yet been authorised in accordance with Article 17 in any Member State shall submit to the competent authority of the Member State of its choice (‘the reference Member State’) an application containing:
the information referred to in Article 20;
a list of all other Member States where a national authorisation is sought (‘the Member States concerned’).
The reference Member State shall be responsible for the evaluation of the application.
The applicant shall, at the same time as submitting the application to the reference Member State in accordance with paragraph 1, submit to the competent authorities of each of the Member States concerned an application for mutual recognition of the authorisation for which it has applied to the reference Member State. This application shall contain:
the names of the reference Member State and of the Member States concerned;
the summary of biocidal product characteristics referred to in Article 20(1)(a)(ii) in such official languages of the Member States concerned as they may require.
Within 365 days of validating an application, the reference Member State shall evaluate the application and draft an assessment report in accordance with Article 30 and shall send its assessment report and the summary of biocidal product characteristics to the Member States concerned and to the applicant.
Article 35
Referral of objections to the coordination group
All Member States and the Commission shall be entitled to participate in the work of the coordination group. The Agency shall provide the secretariat of the coordination group.
The coordination group shall establish its rules of procedure.
Article 36
Referral of unresolved objections to the Commission
Article 37
Derogations from mutual recognition
By way of derogation from Article 32(2), any of the Member States concerned may propose to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted, provided that such a measure can be justified on grounds of:
the protection of the environment;
public policy or public security;
the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants;
the protection of national treasures possessing artistic, historic or archaeological value; or
the target organisms not being present in harmful quantities.
Any of the Member States concerned may, in particular, propose in accordance with the first subparagraph to refuse to grant an authorisation or to adjust the terms and conditions of the authorisation to be granted for a biocidal product containing an active substance to which Article 5(2) or Article 10(1) applies.
If the Member State concerned is unable to reach agreement with the applicant or receives no reply from the applicant within 60 days of that communication it shall inform the Commission. In that case, the Commission:
may ask the Agency for an opinion on scientific or technical questions raised by the applicant or the Member State concerned;
shall adopt a decision on the derogation in accordance with the examination procedure referred to in Article 82(3).
The Commission’s decision shall be addressed to the Member State concerned and the Commission shall inform the applicant thereof.
The Member State concerned shall take necessary measures to comply with the Commission’s decision within 30 days of its notification.
‘While the procedure under this Article is ongoing, the Member States’ obligation to authorise a biocidal product within three years of the date of approval, referred to in the first subparagraph of Article 89(3), shall be temporarily suspended.
Article 38
Opinion of the Agency
The Agency may suspend the time limit referred to in paragraph 1 to allow the applicant or the authorisation holder to prepare the comments.
Article 39
Application for mutual recognition by official or scientific bodies
The applicant shall demonstrate that the use of such a biocidal product is of general interest for that Member State.
The application shall be accompanied by the fees payable under Article 80.
Article 40
Supplementary rules and technical guidance notes
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 laying down supplementary rules for the renewal of authorisations subject to mutual recognition.
The Commission shall also draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 37 and 39.
CHAPTER VIII
UNION AUTHORISATIONS OF BIOCIDAL PRODUCTS
SECTION 1
Granting of Union authorisations
Article 41
Union authorisation
A Union authorisation issued by the Commission in accordance with this Section shall be valid throughout the Union unless otherwise specified. It shall confer the same rights and obligations in each Member State as a national authorisation. For those categories of biocidal products referred to in Article 42(1), the applicant may apply for Union authorisation as an alternative to applying for a national authorisation and mutual recognition.
Article 42
Biocidal products for which Union authorisation may be granted
Applicants may apply for Union authorisation for biocidal products which have similar conditions of use across the Union with the exception of biocidal products that contain active substances that fall under Article 5 and those of product-types 14, 15, 17, 20 and 21. The Union authorisation may be granted:
from 1 September 2013, to biocidal products containing one or more new active substances and biocidal products of product-types 1, 3, 4, 5, 18 and 19;
from 1 January 2017, to biocidal products of product-types 2, 6 and 13; and
from 1 January 2020, to biocidal products of all remaining product-types.
The report shall, if appropriate, be accompanied by relevant proposals for adoption in accordance with the ordinary legislative procedure.
Article 43
Submission and validation of applications
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of acceptance.
In the context of the validation referred to in the first subparagraph, the evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
The evaluating competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirement laid down in paragraph 3.
The evaluating competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly. In such cases, part of the fees paid in accordance with Article 80(1) and (2) shall be reimbursed.
Article 44
Evaluation of applications
Prior to submitting its conclusions to the Agency, the evaluating competent authority shall provide the applicant with the opportunity to provide written comments on the conclusions of the evaluation within 30 days. The evaluating competent authority shall take due account of those comments when finalising its evaluation.
If the Agency recommends the authorisation of the biocidal product, the opinion shall contain at least the following elements:
a statement on whether the conditions laid down in Article 19(1) are fulfilled, and a draft summary of biocidal product characteristics, as referred to in Article 22(2);
where relevant, details of any terms or conditions which should be imposed on the making available on the market or use of the biocidal product;
the final assessment report on the biocidal product.
The Commission shall, at the request of a Member State, decide to adjust certain conditions of a Union authorisation specifically for the territory of that Member State or decide that a Union authorisation shall not apply in the territory of that Member State, provided that such a request can be justified on one or more of the grounds referred to in Article 37(1).
SECTION 2
Renewal of Union authorisations
Article 45
Submission and acceptance of applications
▼M3 —————
When applying for renewal, the applicant shall submit:
without prejudice to Article 21(1), all relevant data required under Article 20 that it has generated since the initial authorisation or, as appropriate, previous renewal; and
its assessment of whether the conclusions of the initial or previous assessment of the biocidal product remain valid and any supporting information.
The Agency shall inform the applicant of the fees payable to it under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant and the evaluating competent authority accordingly.
Upon receipt of the fees payable to it under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the date of acceptance.
Article 46
Evaluation of applications for renewal
Where the evaluating competent authority decides that a full evaluation of the application is not necessary, it shall, within 180 days of the Agency accepting the application, prepare and submit to the Agency a recommendation on the renewal of the authorisation. It shall provide the applicant with a copy of its recommendation.
The evaluating competent authority shall, as soon as possible after the Agency has accepted the application, inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days. It shall inform the applicant accordingly.
The Commission shall renew a Union authorisation, provided that the conditions set out in Article 19 are still satisfied.
CHAPTER IX
CANCELLATION, REVIEW AND AMENDMENT OF AUTHORISATIONS
Article 47
Obligation for notification of unexpected or adverse effects
On becoming aware of information concerning the authorised biocidal product, or the active substance(s) it contains, that may affect the authorisation, the holder of an authorisation shall without delay notify the competent authority that granted the national authorisation and the Agency or, in the case of a Union authorisation, the Commission and the Agency. In particular, the following shall be notified:
new data or information on the adverse effects of the active substance or biocidal product for humans, in particular vulnerable groups, animals or the environment;
any data indicating the potential of the active substance for the development of resistance;
new data or information indicating that the biocidal product is not sufficiently effective.
Competent authorities of Member States that have issued a national authorisation for the same biocidal product under the mutual recognition procedure shall examine whether the authorisation needs to be amended or cancelled in accordance with Article 48.
Article 48
Cancellation or amendment of an authorisation
Without prejudice to Article 23, the competent authority of a Member State or, in the case of a Union authorisation, the Commission shall at any time cancel or amend an authorisation it has granted where it considers that:
the conditions referred to in Article 19 or, where relevant, in Article 25 are not satisfied;
the authorisation was granted on the basis of false or misleading information; or
the authorisation holder has failed to comply with its obligations under the authorisation or this Regulation.
Competent authorities that have issued authorisations under the mutual recognition procedure for biocidal products for which the authorisation has been cancelled or amended shall, within 120 days of the notification, cancel or amend the authorisations and shall notify the Commission accordingly.
In the case of disagreement between competent authorities of certain Member States concerning national authorisations subject to mutual recognition the procedures laid down in Articles 35 and 36 shall apply mutatis mutandis.
Article 49
Cancellation of an authorisation at the request of the authorisation holder
At the reasoned request of an authorisation holder, the competent authority that granted the national authorisation or, in the case of Union authorisation, the Commission shall cancel the authorisation. Where such a request concerns a Union authorisation, it shall be submitted to the Agency.
Article 50
Amendment of an authorisation at the request of the authorisation holder
The application shall be accompanied by the fees payable under Article 80(1) and (2).
An amendment to an existing authorisation shall fall under one of the following categories of changes:
administrative change;
minor change; or
major change.
Article 51
Detailed rules
In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall lay down detailed rules for the application of Articles 47 to 50 by means of implementing acts. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
The rules referred to in the first paragraph of this Article shall be based, inter alia, on the following principles:
a simplified notification procedure shall be applied for administrative changes;
a reduced evaluation period shall be established for minor changes;
in the case of major changes, the evaluation period shall be proportionate to the extent of the proposed change.
Article 52
Period of grace
Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health, animal health or the environment.
The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the use of existing stocks of the biocidal products concerned.
CHAPTER X
PARALLEL TRADE
Article 53
Parallel trade
The applicant who intends to place the biocidal product on the market in the Member State of introduction shall submit the application for a parallel trade permit to the competent authority of the Member State of introduction.
The application shall be accompanied by the information referred to in paragraph 4 and all other information necessary to demonstrate that the biocidal product is identical to the reference product as defined in paragraph 3.
A biocidal product shall be considered as identical to the reference product only if all the following conditions are met:
they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;
they are identical in specification and content in respect of the active substances and the type of formulation;
they are the same in respect of the non-active substances present; and
they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.
An application for a parallel trade permit shall include the following information and items:
name and authorisation number of the biocidal product in the Member State of origin;
name and address of the competent authority of the Member State of origin;
name and address of the authorisation holder in the Member State of origin;
original label and instructions for use with which the biocidal product is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction;
name and address of the applicant;
name to be given to the biocidal product to be distributed in the Member State of introduction;
a draft label for the biocidal product intended to be made available on the market in the Member State of introduction in the official language or languages of the Member State of introduction, unless that Member State provides otherwise;
a sample of the biocidal product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
name and authorisation number of the reference product in the Member State of introduction.
The competent authority of the Member State of introduction may require a translation of the relevant parts of the original instructions for the use referred to in point (d).
If the authorisation holder of the reference product applies for cancellation of authorisation in accordance with Article 49 and the requirements of Article 19 are still fulfilled, the validity of the parallel trade permit shall expire on the date on which the authorisation of the reference product would normally have expired.
CHAPTER XI
TECHNICAL EQUIVALENCE
Article 54
Assessment of technical equivalence
CHAPTER XII
DEROGATIONS
Article 55
Derogation from the requirements
The competent authority referred to in the first subparagraph shall, without delay, inform the other competent authorities and the Commission of its action and the justification for it. The competent authority shall, without delay, inform the other competent authorities and the Commission of the revocation of such action.
On receipt of a reasoned request from the competent authority, the Commission shall, without delay and by means of implementing acts, decide whether, and under what conditions, the action taken by that competent authority may be extended, for a period not exceeding 550 days. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).
If the Commission decides not to approve the new active substance, the competent authorities which granted the provisional authorisation or the Commission shall cancel that authorisation.
Where a decision on the approval of the new active substance has not yet been adopted by the Commission when the period of three years expires, the competent authorities which granted the provisional authorisation, or the Commission, may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2). Competent authorities which extend the provisional authorisation shall inform the other competent authorities and the Commission of such action.
Article 56
Research and development
Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment. They shall make this information available to the competent authority on request.
In the absence of an opinion from the competent authority within 45 days of the notification referred to in the first subparagraph, the notified experiment or test may take place.
Article 57
Exemption from registration under Regulation (EC) No 1907/2006
In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in biocidal products authorised for placing on the market in accordance with Article 27, 55 or 56 shall be regarded as being registered and the registration as completed for manufacture or import for use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5, Title II of Regulation (EC) No 1907/2006.
CHAPTER XIII
TREATED ARTICLES
Article 58
Placing on the market of treated articles
The person responsible for the placing on the market of a treated article shall ensure that the label provides the information listed in the second subparagraph, where:
The label referred to in the first subparagraph shall provide the following information:
a statement that the treated article incorporates biocidal products;
where substantiated, the biocidal property attributed to the treated article;
without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;
the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;
any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
This paragraph shall not apply where at least equivalent labelling requirements already exist under sector-specific legislation for biocidal products in treated articles to meet information requirements concerning those active substances.
CHAPTER XIV
DATA PROTECTION AND DATA-SHARING
Article 59
Protection of data held by competent authorities or the Agency
Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
the subsequent applicant submits a letter of access; or
the relevant time limit for data protection has expired.
Article 60
Data protection periods
Data protected under this Article or for which the protection period under this Article has expired shall not be protected again.
The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.
The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review.
The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5).
The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.
Article 61
Letter of access
A letter of access shall contain at least the following information:
the name and contact details of the data owner and the beneficiary;
the name of the active substance or biocidal product for which access to the data is authorised;
the date on which the letter of access takes effect;
a list of the submitted data to which the letter of access grants citation rights.
Article 62
Data sharing
Any person intending to perform tests or studies (‘the prospective applicant’)
shall, in the case of data involving tests on vertebrates; and
may, in the case of data not involving tests on vertebrates,
submit a written request to the Agency to determine whether such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application under this Regulation or Directive 98/8/EC. The Agency shall verify whether such tests or studies have already been submitted.
Where such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application, under this Regulation or Directive 98/8/EC, the Agency shall, without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant.
The data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner.
Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:
shall, in the case of data involving tests on vertebrates; and
may, in the case of data not involving tests on vertebrates,
request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications under this Regulation.
Article 63
Compensation for data sharing
Within 60 days of being informed, the Agency shall give the prospective applicant permission to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs incurred. Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant is to pay to the data owner.
The data owner shall not refuse to accept any payment offered pursuant to the second subparagraph. Any acceptance is without prejudice, however, to his right to have the proportionate share of the cost determined by a national court, in accordance with the second subparagraph.
Article 64
Use of data for subsequent applications
Where the relevant data protection period according to Article 60 has expired in relation to a biocidal product, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is the same as the one already authorised, or the differences between them are not significant in relation to the risk assessment and the active substance(s) in the biocidal product are technically equivalent to those in the biocidal product already authorised, including the degree of purity and the nature of any impurities.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under the first and second subparagraphs of this paragraph.
Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the receiving competent authority or the Agency, as applicable:
all necessary data for the identification of the biocidal product, including its composition;
the data needed to identify the active substance and to establish technical equivalence of the active substance;
the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.
CHAPTER XV
INFORMATION AND COMMUNICATION
SECTION 1
Monitoring and reporting
Article 65
Compliance with requirements
In order to facilitate such enforcement, manufacturers of biocidal products placed on the Union market shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market and shall store production batch samples. The documentation shall include as a minimum:
safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;
records of the various manufacturing operations performed;
results of internal quality controls;
identification of production batches.
Where necessary in order to ensure uniform application of this paragraph, the Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3).
Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and Member States.
Every five years, from 1 September 2015, Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories. The report shall include in particular:
information on the results of official controls carried out in accordance with paragraph 2;
information on any poisonings and, where available, occupational diseases involving biocidal products, especially regarding vulnerable groups, and any specific measures taken to mitigate the risk of future cases;
any available information on adverse environmental effects experienced through using biocidal products;
information on the use of nanomaterials in biocidal products and the potential risks thereof.
Reports shall be submitted by 30 June of the relevant year and shall cover the period until 31 December of the year preceding their submission.
The reports shall be published on the relevant website of the Commission.
Article 66
Confidentiality
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:
details of the full composition of a biocidal product;
the precise tonnage of the active substance or biocidal product manufactured or made available on the market;
links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;
names and addresses of persons involved in testing on vertebrates.
However, where urgent action is essential to protect human health, animal health, safety or the environment or for other reasons of overriding public interest, the Agency or the competent authorities shall disclose the information referred to in this paragraph.
Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:
the name and address of the authorisation holder;
the name and address of the biocidal product manufacturer;
the name and address of the active substance manufacturer;
the content of the active substance or substances in the biocidal product and the name of the biocidal product;
physical and chemical data concerning the biocidal product;
any methods for rendering the active substance or biocidal product harmless;
a summary of the results of the tests required pursuant to Article 20 to establish the product’s efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;
recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;
safety data sheets;
methods of analysis referred to in Article 19(1)(c);
methods of disposal of the product and of its packaging;
procedures to be followed and measures to be taken in the case of spillage or leakage;
first aid and medical advice to be given in the case of injury to persons.
Article 67
Electronic public access
From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the following up-to-date information held by the Agency or the Commission on that active substance shall be made publicly and easily available free of charge:
where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
physicochemical endpoints and data on pathways and environmental fate and behaviour;
the result of each toxicological and ecotoxicological study;
acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
the guidance on safe use provided in accordance with Annexes II and III;
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information:
the terms and conditions of the authorisation;
the summary of the biocidal product characteristics; and
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
From the date on which the Commission adopts an implementing Regulation providing that an active substance is approved, as referred to in point (a) of Article 9(1), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on that active substance:
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
the trade name(s) of the substance;
the assessment report.
From the date on which a biocidal product is authorised, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information:
study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
the assessment report.
Article 68
Record-keeping and reporting
SECTION 2
Information about biocidal products
Article 69
Classification, packaging and labelling of biocidal products
In addition, products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made. If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.
In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health, animal health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications. In addition, the label must show clearly and indelibly the following information:
the identity of every active substance and its concentration in metric units;
the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;
the authorisation number allocated to the biocidal product by the competent authority or the Commission;
the name and address of the authorisation holder;
the type of formulation;
the uses for which the biocidal product is authorised;
directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
particulars of likely direct or indirect adverse side effects and any directions for first aid;
if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;
directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;
the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by humans or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;
where applicable, the categories of users to which the biocidal product is restricted;
where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;
for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
By way of derogation from the first subparagraph, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
Member States may require:
the provision of models or drafts of the packaging, labelling and leaflets;
that biocidal products made available on the market in their territories be labelled in their official language or languages.
Article 70
Safety data sheets
Safety data sheets for active substances and biocidal products shall be prepared and made available in accordance with Article 31 of Regulation (EC) No 1907/2006, where applicable.
Article 71
Register for Biocidal Products
Where the Agency decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.
The information to be introduced into the Register for Biocidal Products shall include, as appropriate:
the terms and conditions of the authorisation;
the summary of the biocidal product characteristics referred to in Article 22(2);
the assessment report of the biocidal product.
The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.
Article 72
Advertising
Article 73
Poison control
Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.
CHAPTER XVI
THE AGENCY
Article 74
Role of the Agency
Article 75
Biocidal Products Committee
The Biocidal Products Committee shall be responsible for preparing the opinion of the Agency on the following issues:
applications for approval and renewal of approval of active substances;
review of approval of active substances;
applications for inclusion in Annex I of active substances meeting the conditions laid down in Article 28 and review of the inclusion of such active substances in Annex I;
identification of active substances which are candidates for substitution;
applications for Union authorisation of biocidal products and for renewal, cancellation and amendments of Union authorisations, except where the applications are for administrative changes;
scientific and technical matters concerning mutual recognition in accordance with Article 38;
at the request of the Commission or of Member States’ competent authorities, any other questions that arise from the operation of this Regulation relating to technical guidance or risks to human health, animal health or the environment.
In order to facilitate its work, the Committee may, by a decision of the Management Board of the Agency in agreement with the Commission, be divided into two or more parallel committees. Each parallel committee shall be responsible for the tasks of the Biocidal Products Committee assigned to it. Each Member State shall be entitled to appoint one Member for each of the parallel committees. The same person may be appointed to more than one parallel committee.
Article 76
Secretariat of the Agency
The Secretariat of the Agency referred to in point (g) of Article 76(1) of Regulation (EC) No 1907/2006 shall undertake the following tasks:
establishing and maintaining the Register for Biocidal Products;
performing the tasks relating to the acceptance of the applications covered by this Regulation;
establishing technical equivalence;
providing technical and scientific guidance and tools for the application of this Regulation by the Commission and Member States’ competent authorities and providing support to national helpdesks;
providing advice and assistance to applicants, in particular to SMEs, for the approval of an active substance or its inclusion in Annex I to this Regulation or for a Union authorisation;
preparing explanatory information on this Regulation;
establishing and maintaining database(s) with information on active substances and biocidal products;
at the request of the Commission, providing technical and scientific support to improve cooperation between the Union competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products;
notification of decisions taken by the Agency;
specification of formats and software packages for the submission of information to the Agency;
providing support and assistance to Member States in order to avoid the parallel assessment of applications relating to the same or similar biocidal products referred to in Article 29(4);
providing support and assistance to Member States with regard to control and enforcement activities.
Article 77
Appeal
Article 92(1) and (2) and Articles 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation.
Fees may be payable, in accordance with Article 80(1) of this Regulation, by the person bringing an appeal.
Article 78
The budget of the Agency
For the purposes of this Regulation, the revenues of the Agency shall consist of:
a subsidy from the Union, entered in the general budget of the European Union (Commission Section);
the fees paid to the Agency in accordance with this Regulation;
any charges paid to the Agency for services that it provides under this Regulation;
any voluntary contributions from Member States.
Revenues of the Agency as referred to in Article 96(1) of Regulation (EC) No 1907/2006 shall not be used for carrying out tasks under this Regulation, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency. Revenues of the Agency as referred to in paragraph 1 of this Article shall not be used for carrying out tasks under Regulation (EC) No 1907/2006, unless for a joint purpose or a temporary transfer to ensure the proper functioning of the Agency.
Article 79
Formats and software for submission of information to the Agency
The Agency shall specify formats and software packages and make them available free of charge on its website for submissions to the Agency. The competent authorities and applicants shall use these formats and packages in their submissions pursuant to this Regulation.
The technical dossier referred to in Article 6(1) and Article 20 shall be submitted using the IUCLID software package.
CHAPTER XVII
FINAL PROVISIONS
Article 80
Fees and charges
The Commission shall adopt, on the basis of the principles set out in paragraph 3, an implementing Regulation specifying:
the fees payable to the Agency, including an annual fee for products granted a Union authorisation in accordance with Chapter VIII and a fee for applications for mutual recognition in accordance with Chapter VII;
the rules defining conditions for reduced fees, fee waivers and the reimbursement of the member of the Biocidal Products Committee who acts as a rapporteur; and
conditions of payment.
That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3). It shall apply only with respect to fees paid to the Agency.
The Agency may collect charges for other services it provides.
The fees payable to the Agency shall be set at such a level as to ensure that the revenue derived from the fees, when combined with other sources of the Agency’s revenue pursuant to this Regulation, is sufficient to cover the cost of the services delivered. The fees payable shall be published by the Agency.
Based on the principles set out in paragraph 3, the Commission shall issue guidance concerning a harmonised structure of fees.
Member States may levy annual fees with respect to biocidal products made available on their markets.
Member States may collect charges for other services they provide.
Member States shall set and publish the amount of fees payable to their competent authorities.
Both the implementing Regulation referred to in paragraph 1 and Member States’ own rules concerning fees shall respect the following principles:
fees shall be set at such a level as to ensure that the revenue derived from the fees is, in principle, sufficient to cover the cost of the services delivered and shall not exceed what is necessary to cover those costs;
partial reimbursement of the fee if the applicant fails to submit the information requested within the specified time limit;
the specific needs of SMEs shall be taken into account, as appropriate, including the possibility of splitting payments into several instalments and phases;
the structure and amount of fees shall take into account whether information has been submitted jointly or separately;
in duly justified circumstances, and where it is accepted by the Agency or the competent authority, the whole fee or a part of it may be waived; and
the deadlines for the payment of fees shall be fixed taking due account of the deadlines of the procedures provided for in this Regulation.
Article 81
Competent authorities
Member States shall ensure that competent authorities have a sufficient number of suitably qualified and experienced staff so that the obligations laid down in this Regulation can be carried out efficiently and effectively.
Competent authorities may in particular provide advice by establishing helpdesks. Helpdesks already established under Regulation (EC) No 1907/2006 may act as helpdesks under this Regulation.
The Commission shall make publicly available a list of competent authorities and helpdesks.
Article 82
Committee procedure
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.
Article 83
Exercise of the delegation
Article 84
Urgency procedure
Article 85
Adaptation to scientific and technical progress
In order to allow the provisions of this Regulation to be adapted to scientific and technical progress, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the adaptation of Annexes II, III and IV to such scientific and technical progress.
Article 86
Active substances included in Annex I to Directive 98/8/EC
Active substances for which the Commission has adopted directives including them in Annex I to Directive 98/8/EC shall be deemed to have been approved under this Regulation on the date of inclusion and shall be included in the list referred to in Article 9(2). Approval shall be subject to the conditions set out in those Commission directives.
Article 87
Penalties
Member States shall lay down the provisions on penalties applicable to infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission no later than 1 September 2013 and shall notify the Commission without delay of any subsequent amendment affecting them.
Article 88
Safeguard clause
Where, on the basis of new evidence, a Member State has justifiable grounds to consider that a biocidal product, although authorised in accordance with this Regulation, constitutes a serious immediate or long-term risk to the health of humans, particularly of vulnerable groups, or animals, or to the environment, it may take appropriate provisional measures. The Member State shall, without delay, inform the Commission and the other Member States accordingly and give reasons for its decision based on the new evidence.
The Commission shall, by means of implementing acts, either permit the provisional measure for a time period defined in the decision or require the Member State to revoke the provisional measure. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Article 89
Transitional measures
Depending upon the progress of the work programme, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 concerning the extension of the duration of the work programme for a determined period.
In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Commission shall adopt either implementing regulations providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, implementing decisions stating that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). Regulations approving an active substance shall specify the date of approval. Article 9(2) shall apply.
By way of derogation from Articles 17(1), 19(1) and 20(1) of this Regulation, and without prejudice to paragraphs 1 and 3 of this Article, a Member State may continue to apply its current system or practice of making available on the market or using a given biocidal product for up to three years after the date of approval of the last of the active substances to be approved in that biocidal product. The Member State concerned may, in accordance with its national rules, authorise the making available on the market or use in its territory only of a biocidal product containing only:
existing active substances which:
have been evaluated under Commission Regulation (EC) No 1451/2007 ( 38 ), but which have not yet been approved for that product-type; or
are being evaluated, under Regulation (EC) No 1451/2007, but which have not yet been approved for that product-type;
or
a combination of active substances referred to in point (a) and active substances approved in accordance with this Regulation.
By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to 12 months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1, and may continue to apply its current system or practice of using biocidal products for up to 18 months after that decision.
To that effect, those wishing to apply for the authorisation or mutual recognition in parallel of biocidal products of that product-type containing no active substances other than existing active substances shall submit applications for authorisation or mutual recognition in parallel no later than the date of approval of the active substance(s). In the case of biocidal products containing more than one active substance, applications shall be submitted no later than the date of approval of the last active substance for that product-type.
Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph:
the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
use of existing stocks of the biocidal product may continue for up to 365 days after the date of approval of the active substance(s).
Where a Member State’s competent authority, or where relevant, the Commission, decides to reject an application submitted in accordance with paragraph 3 for authorisation of a biocidal product already made available on the market, or decides not to grant an authorisation or to impose conditions for the authorisation making it necessary to change such a product, the following shall apply:
a biocidal product which has not been authorised or, where relevant, which does not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the authority; and
use of existing stocks of the biocidal product may continue for up to 365 days after the date of the decision of the authority.
Article 90
Transitional measures concerning active substances evaluated under Directive 98/8/EC
That evaluation shall be carried out on the basis of the information provided in the dossier submitted under Directive 98/8/EC.
Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.
Every effort shall be made to avoid additional testing on vertebrates and to avoid causing delays to the review programme laid down in Regulation (EC) No 1451/2007 as a result of these transitional arrangements.
Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission from 1 January 2014.
Article 91
Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 September 2013 shall be evaluated by the competent authorities in accordance with that Directive.
Notwithstanding the first paragraph, the following shall apply:
Where the evaluation identifies concerns arising from the application of provisions of this Regulation which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.
Article 92
Transitional measures concerning biocidal products authorised/registered under Directive 98/8/EC
Biocidal products authorised in accordance with Article 3 or 4 of Directive 98/8/EC shall be considered as authorised in accordance with Article 17 of this Regulation.
Article 93
Transitional measures concerning biocidal products not covered by the scope of Directive 98/8/EC
By way of derogation from Article 17(1), a Member State may continue to apply its current system or practice of making available on the market and using a biocidal product not covered by the scope of Directive 98/8/EC, but falling within the scope of this Regulation, and consisting of, containing or generating only active substances that were available on the market, or used in biocidal products, on 1 September 2013. The derogation shall apply until one of the following dates:
where applications for approval of all those active substances, which the biocidal product consists of, contains or generates, are submitted for the relevant product-type by 1 September 2016, the deadlines provided for in the second subparagraph of Article 89(2), in Article 89(3) and in Article 89(4); or
where an application is not submitted in accordance with point (a) for one of the active substances, until 1 September 2017.
Article 94
Transitional measures concerning treated articles
By way of derogation from Article 58(2), a treated article treated with or intentionally incorporating one or more biocidal products containing only active substances that are under examination for the relevant product-type in the work programme referred to in Article 89(1) on 1 September 2016 or for which an application for approval for the relevant product-type is submitted by that date, or containing only a combination of such substances and active substances included in the list drawn up in accordance with Article 9(2) for the relevant product-type and use or included in Annex I, may be placed on the market until one of the following dates:
in the case of a decision adopted after 1 September 2016 to reject the application for approval of, or not to approve, one of the active substances for the relevant use, the date falling 180 days after such a decision;
in other cases, the date of approval for the relevant product-type and use of the last active substance to be approved and contained in the biocidal product.
Article 95
Transitional measures concerning access to the active substance dossier
A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the Agency either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).
The Agency shall inform the submitting supplier of the fees payable under Article 80(1). It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.
Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.
Article 96
Repeal
Without prejudice to Articles 86, 89 to 93 and 95 of this Regulation, Directive 98/8/EC is hereby repealed with effect from 1 September 2013.
References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.
Article 97
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 September 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25(a)
|
EC number |
Name/group |
Restriction |
Comment |
|
Category 1 — Substances authorised as food additives according to Regulation (EC) No 1333/2008 |
|||
|
200-018-0 |
Lactic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 270 |
|
204-823-8 |
Sodium acetate |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 262 |
|
208-534-8 |
Sodium benzoate |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 211 |
|
201-766-0 |
(+)-Tartaric acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 334 |
|
200-580-7 |
Acetic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 260 |
|
201-176-3 |
Propionic acid |
Concentration to be limited so that each biocidal product does not require classification according to either Directive 1999/45/EC or Regulation (EC) No 1272/2008 |
E 280 |
|
Category 2 — Substances included in Annex IV to Regulation (EC) No 1907/2006 |
|||
|
200-066-2 |
Ascorbic acid |
|
|
|
232-278-6 |
Linseed oil |
|
|
|
Category 3 — Weak acids |
|||
|
Category 4 — Traditionally used substances of natural origin |
|||
|
Natural oil |
Lavender oil |
|
CAS 8000-28-0 |
|
Natural oil |
Peppermint oil |
|
CAS 8006-90-4 |
|
Not available |
Vinegar (1) |
Excluding vinegar that is not food and excluding vinegar that contains more than 10 % acetic acid (whether or not it is food). |
CAS No 8028-52-2 |
|
Not available |
Saccharomyces cerevisiae (yeast) (2) |
Excluding Saccharomyces cerevisiae that is not food or feed. |
CAS No 68876-77-7 |
|
Not available |
Powdered egg (3) |
Excluding powdered egg that is not food or feed. |
|
|
Not available |
Honey (4) |
Excluding honey that is not food or feed. |
CAS No 8028-66-8 |
|
200-333-3 |
D-Fructose (5) |
Excluding D-fructose that is not food or feed. |
CAS No 57-48-7 |
|
Not available |
Cheese (6) |
Excluding cheese that is not food or feed. |
|
|
Not available |
Concentrated apple juice (7) |
Excluding concentrated apple juice that does not fall within the definition in point (2) of Part I of Annex I to Council Directive 2001/112/EC (8). |
|
|
Category 5 — Pheromones |
|||
|
222-226-0 |
Oct-1-en-3-ol |
|
|
|
Mixture |
Webbing clothes moths pheromone |
|
|
|
Category 6 — Substances for which a Member State has validated an active substance dossier in accordance with Article 7(3) of this Regulation or accepted such a dossier in accordance with Article 11(1) of Directive 98/8/EC |
|||
|
204-696-9 |
Carbon dioxide |
Only for use in ready-for-use gas canisters functioning together with a trapping device |
|
|
204-696-9 |
Carbon dioxide generated from propane, butane or a mixture of both by combustion (10) |
|
CAS No 124-38-9 |
|
201-069-1 |
Citric acid |
Minimum degree of purity of the active substance (9): 995 g/kg |
CAS No 77-92-9 |
|
231-783-9 |
Nitrogen |
Only for use in limited quantities in ready-for-use canisters |
|
|
246-376-1 |
Potassium (E,E)-hexa-2,4-dienoate (potassium sorbate) (11) |
Minimum degree of purity of the active substance (12): 990 g/kg |
CAS No 24634-61-5 |
|
Not available |
(9Z,12E)-tetradeca-9,12-dien-1-yl acetate |
|
CAS 30507-70-1 |
|
Category 7 — Other |
|||
|
|
Baculovirus |
|
|
|
215-108-5 |
Bentonite |
|
|
|
203-376-6 |
Citronellal |
|
|
|
231-753-5 |
Iron sulphate |
|
|
|
►M4
(1)
The date of approval of vinegar for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M5
(2)
The date of approval of Saccharomyces cerevisiae for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M6
(3)
The date of approval of powdered egg for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M7
(4)
The date of approval of honey for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M8
(5)
The date of approval of D-fructose for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M9
(6)
The date of approval of cheese for product-type 19 for the purposes of Article 89(3) is 1 June 2021. ◄
►M10
(7)
The date of approval of concentrated apple juice for product-type 19 for the purposes of Article 89(3) is 1 June 2021.
(8)
Council Directive 2001/112/EC of 20 December 2001 relating to fruit juices and certain similar products intended for human consumption (OJ L 10, 12.1.2002, p. 58). ◄
(9)
The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated activesubstance.
(10)
The date of approval of carbon dioxide generated from propane, butane or a mixture of both by combustion for product-type 19 for the purposes of Article 89(3) is 1 July 2022.
(11)
The date of approval of potassium sorbate for product-type 6 for the purposes of Article 89(3) is 1 February 2023.
(12)
The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance. |
|||
ANNEX II
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
1. This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(1).
2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances. However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.
With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table. The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates. The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6(1), which is available on the website of the Agency.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set down in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).
3. A detailed and full description of the studies conducted or referred to and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements. Evidence should also be provided to demonstrate that the active substance upon which the tests have been carried out is the same as the substance for which the application has been submitted.
4. The formats made available by the Agency must be used for submission of the dossiers. In addition, IUCLID must be used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and dossier preparation are available on the website of the Agency.
5. Tests submitted for the purpose of the approval of an active substance shall be conducted according to the methods described in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ( 39 ). However, if a method is inappropriate or not described, other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, and their appropriateness must be justified in the application. When test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
6. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes ( 40 ) and in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances ( 41 ) or other international standards recognised as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.
7. Where testing is done, a detailed description (specification) of the active substance used and its impurities must be provided. Testing should be performed with the active substance as manufactured or, in the case of some of the physical and chemical properties (see indications given in column I of the table), with a purified form of the active substance.
8. Where test data exist that have been generated before 1 September 2013 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State concerned, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrates.
9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In-vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
TITLE 1
CHEMICAL SUBSTANCES
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in the Regulation (EC) No 440/2008 and are not repeated in column 3, also apply.
|
Column 1 Information required |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
|
1. APPLICANT |
||
|
1.1. Name and address |
|
|
|
1.2. Contact person |
|
|
|
1.3. Active substance manufacturer (name, address and location of manufacturing plant(s)) |
|
|
|
2. IDENTITY OF THE ACTIVE SUBSTANCE |
||
|
For the active substance, the information given in this Section shall be sufficient to enable the active substance to be identified. If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated |
|
|
|
2.1. Common name proposed or accepted by ISO and synonyms (usual name, trade name, abbreviation) |
|
|
|
2.2. Chemical name (IUPAC and CA nomenclature or other international chemical name(s)) |
|
|
|
2.3. Manufacturer’s development code number(s) |
|
|
|
2.4. CAS number plus EC, INDEX and CIPAC numbers |
|
|
|
2.5. Molecular and structural formula (including SMILES notation, if available and appropriate) |
|
|
|
2.6. Information on optical activity and full details of any isomeric composition (if applicable and appropriate) |
|
|
|
2.7. Molar mass |
|
|
|
2.8. Method of manufacture (syntheses pathway) of active substance including information on starting materials and solvents including suppliers, specifications and commercial availability |
|
|
|
2.9. Specification of purity of the active substance as manufactured in g/kg, g/l or %w/w (v/v) as appropriate, providing inclusively the upper and lower limit |
|
|
|
2.10. The identity of any impurities and additives including by-products of synthesis, optical isomers, degradation products (if the substance is unstable) un-reacted and end-groups etc. of polymers and un-reacted starting materials of UVC-substances |
|
|
|
2.11. Analytical profile of at least five representative batches (g/kg active substance) including information on content of the impurities referred to in 2.10. |
|
|
|
2.12. The origin of the natural active substance or the precursor(s) of the active substance, e.g. an extract of a flower |
|
|
|
3. PHYSICAL AND CHEMICAL PROPERTIES OF THE ACTIVE SUBSTANCE |
||
|
3.1. Appearance (1) |
||
|
3.1.1. Aggregate state (at 20 °C and 101,3 kPa) |
|
|
|
3.1.2. Physical state (i.e. viscous, crystalline, powder) (at 20 °C and 101,3 kPa) |
|
|
|
3.1.3. Colour (at 20 °C and 101,3 kPa) |
|
|
|
3.1.4. Odour (at 20 °C and 101,3 kPa) |
|
|
|
3.2. Melting/freezing point (2) |
|
|
|
3.3. Acidity, alkalinity |
|
|
|
3.4. Boiling point (2) |
|
|
|
3.5. Relative Density (2) |
|
|
|
3.6. Absorption spectra data (UV/VIS, IR, NMR) and a mass spectrum, molar extinction coefficient at relevant wavelengths, where relevant (2) |
|
|
|
3.7. Vapour pressure (2) |
||
|
3.7.1. Henry’s law constant must always be stated for solids and liquids if it can be calculated |
|
|
|
3.8. Surface tension (2) |
|
|
|
3.9. Water solubility (2) |
|
|
|
3.10. Partition coefficient (n-octanol/water) and its pH dependency (2) |
|
|
|
3.11. Thermal stability, identity of breakdown products (2) |
|
|
|
3.12. Reactivity towards container material |
|
|
|
3.13. Dissociation constant |
ADS |
|
|
3.14. Granulometry |
|
|
|
3.15. Viscosity |
ADS |
|
|
3.16. Solubility in organic solvents, including effect of temperature on solubility (2) |
ADS |
|
|
3.17. Stability in organic solvents used in biocidal products and identity of relevant breakdown products (1) |
ADS |
|
|
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS |
||
|
4.1. Explosives |
|
|
|
4.2. Flammable gases |
|
|
|
4.3. Flammable aerosols |
|
|
|
4.4. Oxidising gases |
|
|
|
4.5. Gases under pressure |
|
|
|
4.6. Flammable liquids |
|
|
|
4.7. Flammable solids |
|
|
|
4.8. Self-reactive substances and mixtures |
|
|
|
4.9. Pyrophoric liquids |
|
|
|
4.10. Pyrophoric solids |
|
|
|
4.11. Self-heating substances and mixtures |
|
|
|
4.12. Substances and mixtures which in contact with water emit flammable gases |
|
|
|
4.13. Oxidising liquids |
|
|
|
4.14. Oxidising solids |
|
|
|
4.15. Organic peroxides |
|
|
|
4.16. Corrosive to metals |
|
|
|
4.17. Additional physical indicators for hazards |
||
|
4.17.1. Auto-ignition temperature (liquids and gases) |
|
|
|
4.17.2. Relative self ignition temperature for solids |
|
|
|
4.17.3. Dust explosion hazard |
|
|
|
5. METHODS OF DETECTION AND IDENTIFICATION |
||
|
5.1. Analytical methods including validation parameters for the determination of active substance as manufactured and where appropriate, for relevant residues, isomers and impurities of the active substance and additives (e.g. stabilisers) For impurities other than relevant impurities this only applies if they are present at ≥ 1 g/kg |
|
|
|
5.2. Analytical methods for monitoring purposes including recovery rates and the limits of quantification and detection for the active substance, and for residues thereof in/on the following where relevant |
||
|
5.2.1. Soil |
|
|
|
5.2.2. Air |
|
|
|
5.2.3. Water (surface, drinking etc.) and sediment |
|
|
|
5.2.4. Animal and human body fluids and tissues |
|
|
|
5.3. Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor articles treated with it come into contact with food-producing animals, food of plant or animal origin or feeding stuffs) |
ADS |
|
|
6. EFFECTIVENESS AGAINST TARGET ORGANISMS |
||
|
6.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide and mode of control e.g. attracting, killing, inhibiting |
|
|
|
6.2. Representative organism(s) to be controlled and products, organisms or objects to be protected |
|
|
|
6.3. Effects on representative target organism(s) |
|
|
|
6.4. Likely concentration at which the active substance will be used in products and, where appropriate, in treated articles |
|
|
|
6.5. Mode of action (including time delay) |
|
|
|
6.6. Efficacy data to support these claims on biocidal products and, where label claims are made, on treated articles, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate |
|
|
|
6.7. Any known limitations on efficacy |
||
|
6.7.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
|
|
|
6.7.2. Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms |
|
|
|
7. INTENDED USES AND EXPOSURE |
||
|
7.1. Field of use(s) envisaged for biocidal products and, where appropriate, treated articles |
|
|
|
7.2. Product-type(s) |
|
|
|
7.3. Detailed description of the intended use pattern(s) including in treated articles |
|
|
|
7.4. Users e.g. industrial, trained professional, professional or general public (non-professional) |
|
|
|
7.5. Likely tonnage to be placed on the market per year and, where relevant, for the envisaged major use categories |
|
|
|
7.6. Exposure data in conformity with Annex VI to this Regulation |
||
|
7.6.1. Information on human exposure associated with the intended uses and disposal of the active substance |
|
|
|
7.6.2. Information on environmental exposure associated with the intended uses and disposal of the active substance |
|
|
|
7.6.3. Information on exposure of food- producing animals and food and feeding stuffs associated with the intended uses of the active substance |
|
|
|
7.6.4. Information on exposure from treated articles including leaching data (either laboratory studies or model data) |
|
|
|
8. TOXICOLOGICAL PROFILE FOR HUMAN AND ANIMAL INCLUDING METABOLISM |
||
|
8.1. Skin irritation or skin corrosion The assessment of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4. Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008) |
|
|
|
8.2. Eye irritation The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008) |
|
|
|
8.3. Skin sensitisation The assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided |
|
Step 2 does not need to be conducted if: — the available information indicates that the substance should be classified for skin sensitisation or corrosivity, or — the substance is a strong acid (pH < 2,0) or base (pH > 11,5) |
|
8.4. Respiratory sensitisation |
ADS |
|
|
8.5. Mutagenicity |
||
|
The assessment of this endpoint shall comprise the following consecutive steps: — an assessment of the available in vivo genotoxicity data — an in vitro test for gene mutations in bacteria, an in vitro cytogenicity test in mammalian cells and an in vitro gene mutation test in mammalian cells are required — appropriate in vivo genotoxicity studies shall be considered in case of a positive result in any of the in vitro genotoxicity studies |
|
|
|
8.5.1. In vitro gene mutation study in bacteria |
|
|
|
8.5.2. In vitro cytogenicity study in mammalian cells |
|
|
|
8.5.3. In vitro gene mutation study in mammalian cells |
|
|
|
8.6. In vivo genotoxicity study The assessment of this endpoint shall comprise the following consecutive steps: — If there is a positive result in any of the in vitro genotoxicity studies and there are no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study shall be proposed/conducted by the applicant — If either of the in vitro gene mutation tests is positive, an in vivo test to investigate unscheduled DNA synthesis shall be conducted — A second in vivo somatic cell test may be necessary, depending on the results, quality and relevance of all the available data — If there is a positive result from an in vivo somatic cell study available, the potential for germ cell mutagenicity should be considered on the basis of all available data, including toxicokinetic evidence to demonstrate that the substance reached the tested organ. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered |
ADS |
The study/ies do(es) not generally need to be conducted if: — the results are negative for the three in vitro tests and if no metabolites of concern are formed in mammals or — valid in vivo micronucleus data is generated within a repeat dose study and the in vivo micronucleus test is the appropriate test to be conducted to address this information requirement — the substance is known to be carcinogenic category 1A or 1B or mutagenic category 1A, 1B or 2. |
|
8.7. Acute toxicity In addition to the oral route of administration (8.7.1), for substances other than gases, the information mentioned under 8.7.2 to 8.7.3 shall be provided for at least one other route of administration — The choice for the second route will depend on the nature of the substance and the likely route of human exposure — Gases and volatile liquids should be administered by the inhalation route — If the only route of exposure is the oral route, then information for only that route need be provided. If either the dermal or inhalation route is the only route of exposure to humans then an oral test may be considered. Before a new dermal acute toxicity study is carried out, an in vitro dermal penetration study (OECD 428) should be conducted to assess the likely magnitude and rate of dermal bioavailability — There may be exceptional circumstances where all routes of administration are deemed necessary |
|
The study/ies do(es) not generally need to be conducted if: — the substance is classified as corrosive to the skin |
|
8.7.1. By oral route The Acute Toxic Class Method is the preferred method for the determination of this endpoint |
|
The study need not be conducted if: — the substance is a gas or a highly volatile substance |
|
8.7.2. By inhalation Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account: — the vapour pressure of the substance (a volatile substance has vapour pressure > 1 × 10–2 Pa at 20 °C) and/or — the active substance is a powder containing a significant proportion (e.g. 1 % on a weight basis) of particles with particle size MMAD < 50 micrometers or — the active substance is included in products that are powders or are applied in a manner that generates exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers) — the Acute Toxic Class Method is the preferred method for the determination of this endpoint |
|
|
|
8.7.3. By dermal route Testing by the dermal route is necessary only if: — inhalation of the substance is unlikely, or — skin contact in production and/or use is likely, and either — the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin, or — the results of an in vitro dermal penetration study (OECD 428) demonstrate high dermal absorption and bioavailability |
|
|
|
8.8. Toxicokinetics and metabolism studies in mammals |
||
|
The toxicokinetics and metabolism studies should provide basic data about the rate and extent of absorption, the tissue distribution and the relevant metabolic pathway including the degree of metabolism, the routes and rate of excretion and the relevant metabolites |
|
|
|
8.8.1. Further toxicokinetic and metabolism studies in mammals Additional studies might be required based on the outcome of the toxicokinetic and metabolism study conducted in rat. These further studies shall be required if: — there is evidence that metabolism in the rat is not relevant for human exposure — route-to-route extrapolation from oral to dermal/inhalation exposure is not feasible Where it is considered appropriate to obtain information on dermal absorption, the assessment of this endpoint shall proceed using a tiered approach for assessment of dermal absorption |
ADS |
|
|
8.9. Repeated dose toxicity In general, only one route of administration is necessary and the oral route is the preferred route. However, in some cases it may be necessary to evaluate more than one route of exposure. For the evaluation of the safety of consumers in relation to active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route Testing by the dermal route shall be considered if: — skin contact in production and/or use is likely, and — inhalation of the substance is unlikely, and — one of the following conditions is met: —(i) toxicity is observed in an acute dermal toxicity test at lower doses than in the oral toxicity test, or (ii) information or test data indicate dermal absorption is comparable or higher than oral absorption, or (iii) dermal toxicity is recognised for structurally related substances and for example is observed at lower doses than in the oral toxicity test or dermal absorption is comparable or higher than oral absorption Testing by the inhalation route shall be considered if: — exposure of humans via inhalation is likely taking into account the vapour pressure of the substance (volatile substances and gases have vapour pressure > 1 × 10–2 Pa at 20 °C), and/or — there is the possibility of exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers) |
|
The repeated dose toxicity study (28 or 90 days) does not need to be conducted if: — a substance undergoes immediate disintegration and there are sufficient data on the cleavage products for systemic and local effects and no synergistic effects are expected, or — relevant human exposure can be excluded in accordance with Section 3 of Annex IV In order to reduce testing carried out on vertebrates and in particular the need for free-standing single-endpoint studies, the design of the repeated dose toxicity studies shall take account of the possibility to explore several endpoints within the framework of one study |
|
8.9.1. Short-term repeated dose toxicity study (28 days), preferred species is rat |
|
The short-term toxicity study (28 days) does not need to be conducted if: (i) a reliable sub-chronic (90 day) study is available, provided that the most appropriate species, dosage, solvent and route of administration were used, (ii) the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met: — other available data indicate that the substance may have a dangerous property that cannot be detected in a short-term toxicity study, or — appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites in certain tissues or organs which would possibly remain undetected in a short term toxicity study but which are liable to result in adverse effects after prolonged exposure |
|
8.9.2. Sub-chronic repeated dose toxicity study (90 days), preferred species is rat |
|
The sub-chronic toxicity study (90 days) does not need to be conducted if: — a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the criteria for classifying the substance as H372 and H373 (Regulation (EC) No 1272/2008), for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor allows the extrapolation towards the NOAEL-90 days for the same route of exposure, and — a reliable chronic toxicity study is available, provided that an appropriate species and route of administration were used, or — the substance is unreactive, insoluble, not bioaccumulative and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited human exposure |
|
8.9.3. Long-term repeated dose toxicity (≥ 12 months) |
|
The long-term toxicity study (≥ 12 months) does not need to be conducted if: — Long-term exposure can be excluded and no effects have been seen at the limit dose in the 90-day study or — a combined long-term repeated dose/carcinogenicity study (8.11.1) is undertaken |
|
8.9.4. Further repeat dose studies Further repeat dose studies including testing on a second species (non-rodent), studies of longer duration or through a different route of administration shall be undertaken in case of: — no other information on toxicity for a second non-rodent species is provided for, or — failure to identify a no observed adverse effect level (NOAEL) in the 28- or the 90-day study, unless the reason is that no effects have been observed at the limit dose, or — substances bearing positive structural alerts for effects for which the rat or mouse is an inappropriate or insensitive model, or — toxicity of particular concern (e.g. serious/severe effects), or — indications of an effect for which the available data is inadequate for toxicological and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity, hormonal activity), or — concern regarding local effects for which a risk characterisation cannot be performed by route-to route extrapolation, or — particular concern regarding exposure (e.g. use in biocidal products leading to exposure levels which are close to the toxicologically relevant dose levels), or — effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28- or the 90-day study, or — the route of administration used in the initial repeated dose study was inappropriate in relation to the expected route of human exposure and route-to-route extrapolation cannot be made. |
ADS |
|
|
8.10. Reproductive toxicity For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
|
The studies need not be conducted if: — the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or — the substance is known to be a germ cell mutagen and appropriate risk management measures are implemented including measures related to reproductive toxicity, or — the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available provided that the dataset is sufficiently comprehensive and informative), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and the pattern of use indicates there is no or no significant human exposure — If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as Reproductive toxicity Cat 1A or 1B: May damage fertility (H360F), and the available data are adequate to support a robust risk assessment, then no further testing for fertility will be necessary. However, testing for developmental toxicity must be considered — If a substance is known to cause developmental toxicity, meeting the criteria for classification as Reproductive toxicity Cat 1A or 1B: May damage the unborn child (H360D), and the available data are adequate to support a robust risk assessment, then no further testing for developmental toxicity will be necessary. However, testing for effects on fertility must be considered |
|
8.10.1. Pre-natal developmental toxicity study, preferred species is rabbit; oral route of administration is the preferred route. The study shall be initially performed on one species |
|
|
|
8.10.2. Two-generation reproductive toxicity study, rat, oral route of administration is the preferred route. If another reproductive toxicity test is used justification shall be provided. The extended one-generation reproductive toxicity study adopted at OECD level shall be considered as an alternative approach to the multi-generation study |
|
|
|
8.10.3. Further pre-natal developmental toxicity study. A decision on the need to perform additional studies on a second species or mechanistic studies should be based on the outcome of the first test (8.10.1) and all other relevant available data (in particular rodent reprotox studies). Preferred species is rat, oral route of administration |
ADS |
|
|
8.11. Carcinogenicity See 8.11.1 for new study requirements |
|
A carcinogenicity study does not need to be conducted if: — the substance is classified as mutagen category 1A or 1B. The default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required |
|
8.11.1. Combined carcinogenicity study and long-term repeated dose toxicity Rat, oral route of administration is the preferred route. If an alternative route is proposed a justification must be provided. For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
|
|
|
8.11.2. Carcinogenicity testing in a second species — A second carcinogenicity study should normally be conducted using the mouse as test species — For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
|
|
|
8.12. Relevant health data, observations and treatments |
||
|
Justification should be provided if data is not available |
|
|
|
8.12.1. Medical surveillance data on manufacturing plant personnel |
|
|
|
8.12.2. Direct observation, e.g. clinical cases, poisoning incidents |
|
|
|
8.12.3. Health records, both from industry and any other available sources |
|
|
|
8.12.4. Epidemiological studies on the general population |
|
|
|
8.12.5. Diagnosis of poisoning including specific signs of poisoning and clinical tests |
|
|
|
8.12.6. Sensitisation/allergenicity observations |
|
|
|
8.12.7. Specific treatment in case of an accident or poisoning: first aid measures, antidotes and medical treatment, if known |
|
|
|
8.12.8. Prognosis following poisoning |
|
|
|
8.13. Additional studies Additional data which may be required depending on the characteristics and intended use of the active substance Other available data: Available data from emerging methods and models, including toxicity pathway-based risk assessment, in vitro and ‘omic’ (genomic, proteomic, metabolomic, etc.) studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening shall be submitted in parallel |
ADS |
|
|
8.13.1. Phototoxicity |
ADS |
|
|
8.13.2. Neurotoxicity including developmental neurotoxicity — The preferred test species is the rat unless another test species is justified to be more appropriate — For delayed neurotoxicity tests the preferred species will be the adult hen — If anticholinesterase activity is detected a test for response to reactivating agents should be considered If the active substance is an organophosphorus compound or if there is any evidence e.g. knowledge of the mechanism of action or from repeat dose studies that the active substance may have neurotoxic or developmental neurotoxic properties then additional information or specific studies will be required. For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
ADS |
|
|
8.13.3. Endocrine disruption If there is any evidence from in vitro, repeat dose or reproduction toxicity studies, that the active substance may have endocrine disrupting properties then additional information or specific studies shall be required to: — elucidate the mode/mechanism of action — provide sufficient evidence for relevant adverse effects For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
ADS |
|
|
8.13.4. Immunotoxicity including developmental immunotoxicity If there is any evidence, from skin sensitisation, repeat dose or reproduction toxicity studies, that the active substance may have immunotoxic properties then additional information or specific studies shall be required to: — elucidate the mode/mechanism of action — provide sufficient evidence for relevant adverse effects in humans For evaluation of consumer safety of active substances that may end up in food or feed, it is necessary to conduct toxicity studies by the oral route |
ADS |
|
|
8.13.5. Mechanistic data — any studies necessary to clarify effects reported in toxicity studies |
ADS |
|
|
8.14. Studies related to the exposure of humans to the active substance |
ADS |
|
|
8.15. Toxic effects on livestock and pets |
ADS |
|
|
8.16. Food and feeding stuffs studies including for food-producing animals and their products (milk, eggs and honey) Additional information related to the exposure of humans to the active substance contained in biocidal products |
ADS |
|
|
8.16.1. Proposed acceptable residue levels i.e. maximum residue limits (MRL) and the justification of their acceptability |
ADS |
|
|
8.16.2. Behaviour of the residue of the active substance on the treated or contaminated food or feeding stuffs including the kinetics of disappearance Residue definitions should be provided where relevant. It is also important to compare residues found in toxicity studies with residues formed in food-producing animals and their products, as well as food and feed |
ADS |
|
|
8.16.3. Overall material balance for the active substance Sufficient residue data from supervised trials on food- producing animals and their products, as well as food and feed, to demonstrate that residues likely to arise from the proposed use would not be of concern for human or animal health |
ADS |
|
|
8.16.4. Estimation of potential or actual exposure of humans to the active substance and residues through diet and other means |
ADS |
|
|
8.16.5. If residues of the active substance occur in or on feeding stuffs for a significant period of time or are found in food of animal origin after treatment on or around food-producing animals (e.g. direct treatment on animals or indirect treatment of animal houses or surroundings) then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin |
ADS |
|
|
8.16.6. Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the active substance |
ADS |
|
|
8.16.7. Any other available information that is relevant It may be appropriate to include information on migration into food, especially in the case of treatment of food contact materials |
ADS |
|
|
8.16.8. Summary and evaluation of data submitted under 8.16.1 to 8.16.8 It is important to establish whether the metabolites found in food (from animals or plants) are the same as those tested in toxicity studies. Otherwise values for risk assessment (e.g. ADI) are not valid for the residues found |
ADS |
|
|
8.17. If the active substance is to be used in products for action against plants including algae then tests shall be required to assess toxic effects of metabolites from treated plants, if any, where different from those identified in animals |
ADS |
|
|
8.18. Summary of mammalian toxicology Provide overall evaluation and conclusion with regard to all toxicological data and any other information concerning the active substances including NOAEL |
|
|
|
9. ECOTOXICOLOGICAL STUDIES |
||
|
9.1. Toxicity to Aquatic Organisms |
||
|
9.1.1. Short-term toxicity testing on fish When short-term fish toxicity data is required the threshold approach (tiered strategy) should be applied |
|
The study does not need to be conducted if: — a valid long-term aquatic toxicity study on fish is available |
|
9.1.2. Short-term toxicity testing on aquatic invertebrates |
||
|
9.1.2.1. Daphnia magna |
|
|
|
9.1.2.2. Other species |
ADS |
|
|
9.1.3. Growth inhibition study on algae |
||
|
9.1.3.1. Effects on growth rate of green algae |
|
|
|
9.1.3.2. Effects on growth rate of cyanobacteria or diatoms |
|
|
|
9.1.4. Bioconcentration |
|
The experimental determination may not need to be carried out if: — it can be demonstrated on the basis of physico-chemical properties (e.g. log Kow < 3) or other evidence that the substance has a low potential for bioconcentration |
|
9.1.4.1. Estimation methods |
||
|
9.1.4.2. Experimental determination |
||
|
9.1.5. Inhibition of microbial activity The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria |
|
|
|
9.1.6. Further Toxicity Studies on Aquatic Organisms If the results of the ecotoxicological studies, studies on fate and behaviour and/or the intended use(s) of the active substance indicate a risk for the aquatic environment, or if long-term exposure is expected, then one or more of the tests described in this Section shall be conducted |
ADS |
|
|
9.1.6.1. Long term toxicity testing on Fish (a) Fish Early Life Stage (FELS) Test (b) Fish short term toxicity test on embryo and sack fry stages (c) Fish juvenile growth test (d) Fish full life cycle test |
ADS |
|
|
9.1.6.2. Long term toxicity testing on invertebrates (a) Daphnia growth and reproduction study (b) Other species reproduction and growth (e.g. Mysid) (c) Other species development and emergence (e.g. Chironomus) |
ADS |
|
|
9.1.7. Bioaccumulation in an appropriate aquatic species |
ADS |
|
|
9.1.8. Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk |
ADS |
|
|
9.1.9. Studies on sediment- dwelling organisms |
ADS |
|
|
9.1.10. Effects on aquatic macrophytes |
ADS |
|
|
9.2. Terrestrial toxicity, initial tests |
ADS |
|
|
9.2.1. Effects on soil micro-organisms |
||
|
9.2.2. Effects on earthworms or other soil- dwelling non-target invertebrates |
||
|
9.2.3. Acute toxicity to plants |
||
|
9.3. Terrestrial tests, long term |
ADS |
|
|
9.3.1. Reproduction study with earthworms or other soil-dwelling non-target invertebrates |
||
|
9.4. Effects on birds |
ADS |
For endpoint 9.4.3 the study does not need to be conducted if: — the dietary toxicity study shows that the LC50 is above 2 000 mg/kg |
|
9.4.1. Acute oral toxicity |
||
|
9.4.2. Short-term toxicity — eight-day dietary study in at least one species (other than chickens, ducks and geese) |
||
|
9.4.3. Effects on reproduction |
||
|
9.5. Effects on arthropods |
ADS |
|
|
9.5.1. Effects on honeybees |
||
|
9.5.2. Other non-target terrestrial arthropods, e.g. predators |
||
|
9.6. Bioconcentration, terrestrial |
ADS |
|
|
9.7. Bioaccumulation, terrestrial |
ADS |
|
|
9.8. Effects on other non-target, non-aquatic organisms |
ADS |
|
|
9.9. Effects on mammals |
ADS |
Data are derived from the mammalian toxicological assessment. The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported |
|
9.9.1. Acute oral toxicity |
||
|
9.9.2. Short term toxicity |
||
|
9.9.3. Long term toxicity |
||
|
9.9.4. Effects on reproduction |
||
|
9.10. Identification of endocrine activity |
ADS |
|
|
10. ENVIRONMENTAL FATE AND BEHAVIOUR |
||
|
10.1. Fate and behaviour in water and sediment |
||
|
10.1.1. Degradation, initial studies |
||
|
If the assessment performed indicates the need to investigate further the degradation of the substance and its degradation products or the active substance has an overall low or absent abiotic degradation, then the tests described in 10.1.3 and 10.3.2 and where appropriate — in 10.4 shall be required. The choice of the appropriate test(s) depends on the results of the initial assessment performed |
|
|
|
10.1.1.1. Abiotic |
|
|
|
(a) Hydrolysis as a function of pH and identification of breakdown products — The identification of breakdown products is required when the breakdown products at any sampling time are present at ≥ 10 % |
|
|
|
(b) Phototransformation in water, including identification of transformation products |
|
|
|
10.1.1.2. Biotic |
|
|
|
(a) Ready biodegradability |
|
|
|
(b) Inherent biodegradability (where appropriate) |
|
|
|
10.1.2. Adsorption/desorption |
|
|
|
10.1.3. Rate and route of degradation including identification of metabolites and degradation products |
||
|
10.1.3.1. Biological sewage treatment |
|
|
|
(a) Aerobic biodegradation |
ADS |
|
|
(b) Anaerobic biodegradation |
ADS |
|
|
(c) STP simulation test |
ADS |
|
|
10.1.3.2. Biodegradation in freshwater |
|
|
|
(a) Aerobic aquatic degradation study |
ADS |
|
|
(b) Water/sediment degradation test |
ADS |
|
|
10.1.3.3. Biodegradation in sea water |
ADS |
|
|
10.1.3.4. Biodegradation during manure storage |
ADS |
|
|
10.1.4. Adsorption and desorption in water/aquatic sediment systems and, where relevant, adsorption and desorption of metabolites and degradation products |
ADS |
|
|
10.1.5. Field study on accumulation in sediment |
ADS |
|
|
10.1.6. Inorganic substances: information on fate and behaviour in water |
ADS |
|
|
10.2. Fate and behaviour in soil |
ADS |
|
|
10.2.1. Laboratory study on rate and route of degradation including identification of the processes involved and identification of any metabolites and degradation products in one soil type (unless pH dependent route) under appropriate conditions Laboratory studies on rate of degradation in three additional soil types |
ADS |
|
|
10.2.2. Field studies, two soil types |
ADS |
|
|
10.2.3. Soil accumulation studies |
ADS |
|
|
10.2.4. Adsorption and desorption in at least three soil types and, where relevant, adsorption and desorption of metabolites and degradation products |
ADS |
|
|
10.2.5. Further studies on sorption |
|
|
|
10.2.6. Mobility in at least three soil types and where relevant mobility of metabolites and degradation products |
ADS |
|
|
10.2.6.1. Column leaching studies |
|
|
|
10.2.6.2. Lysimeter studies |
|
|
|
10.2.6.3. Field leaching studies |
|
|
|
10.2.7. Extent and nature of bound residues The determination and characteristics of bound residues is recommended to be combined with a soil simulation study |
ADS |
|
|
10.2.8. Other soil degradation studies |
ADS |
|
|
10.2.9. Inorganic substances: information on fate and behaviour in soil |
|
|
|
10.3. Fate and behaviour in air |
||
|
10.3.1. Phototransformation in air (estimation method) Identification of transformation products |
|
|
|
10.3.2. Fate and behaviour in air, further studies |
ADS |
|
|
10.4. Additional studies on fate and behaviour in the environment |
ADS |
|
|
10.5. Definition of the residue |
ADS |
|
|
10.5.1. Definition of the residue for risk assessment |
||
|
10.5.2. Definition of the residue for monitoring |
|
|
|
10.6. Monitoring data |
ADS |
|
|
10.6.1. Identification of all degradation products (> 10 %) must be included in the studies on degradation in soil, water and sediments |
|
|
|
11. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||
|
11.1. Recommended methods and precautions concerning handling, use, storage, transport or fire |
|
|
|
11.2. In case of fire, nature of reaction products, combustion gases etc. |
|
|
|
11.3. Emergency measures in case of accident |
|
|
|
11.4. Possibility of destruction or decontamination following release in or on the following: (a) air (b) water, including drinking water (c) soil |
|
|
|
11.5. Procedures for waste management of the active substance for industry or professional users |
|
|
|
11.6. Possibility of reuse or recycling |
|
|
|
11.7. Possibility of neutralisation of effects |
|
|
|
11.8. Conditions for controlled discharge including leachate qualities on disposal |
|
|
|
11.9. Conditions for controlled incineration |
|
|
|
11.10. Identification of any substances falling within the scope of List I or List II of the Annex to Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances (3), of Annexes I and II to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration (4), of Annex I to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy (5), of Part B of Annex I to Directive 98/83/EC or Annexes VIII and X to Directive 2000/60/EC |
|
|
|
12. CLASSIFICATION, LABELLING AND PACKAGING |
||
|
12.1. State any existing classification and labelling |
|
|
|
12.2. The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008 |
||
|
In addition, for each entry, the reasons why no classification is given for an endpoint should be provided |
|
|
|
12.2.1. Hazard classification |
|
|
|
12.2.2. Hazard pictogram |
|
|
|
12.2.3. Signal word |
|
|
|
12.2.4. Hazard statements |
|
|
|
12.2.5. Precautionary statements including prevention, response, storage and disposal |
|
|
|
12.3. Specific concentration limits, where applicable, resulting from the application of Regulation (EC) No 1272/2008 |
|
|
|
13. SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
|
|
|
(1)
The information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different.
(2)
The information provided should be for the purified active substance of stated specification.
(3)
OJ L 20, 26.1.1980, p. 43.
(4)
OJ L 372, 27.12.2006, p. 19.
(5)
OJ L 348, 24.12.2008, p. 84. |
||
TITLE 2
MICRO-ORGANISMS
Core data set and additional data set for active substances
Information required to support the approval of an active substance is listed in the table below.
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.
|
Column 1 Information required |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
|
1. APPLICANT |
||
|
1.1. Name and address |
|
|
|
1.2. Contact person |
|
|
|
1.3. Manufacturer (name, address and location of manufacturing plant) |
|
|
|
2. IDENTITY OF THE MICRO-ORGANISM |
||
|
2.1. Common name of the micro-organism (including alternative and superseded names) |
|
|
|
2.2. Taxonomic name and strain |
|
|
|
2.3. Collection and culture reference number where the culture is deposited |
|
|
|
2.4. Methods, procedures and criteria used to establish the presence and identity of the micro-organism |
|
|
|
2.5. Specification of the technical grade active ingredient |
|
|
|
2.6. Method of production and quality control |
|
|
|
2.7. Content of the micro-organism |
|
|
|
2.8. Identity and content of impurities, additives, contaminating micro-organisms |
|
|
|
2.9. Analytical profile of batches |
|
|
|
3. BIOLOGICAL PROPERTIES OF THE MICRO-ORGANISM |
||
|
3.1. General information on the micro-organism |
||
|
3.1.1. Historical background |
|
|
|
3.1.2. Historical uses |
|
|
|
3.1.3. Origin, natural occurrence and geographical distribution |
|
|
|
3.2. Development stages/life cycle of the micro-organism |
|
|
|
3.3. Relationships to known plant or animal or human pathogens |
|
|
|
3.4. Genetic stability and factors affecting it |
|
|
|
3.5. Information on the production of metabolites (especially toxins) |
|
|
|
3.6. Production and resistance to antibiotics and other anti-microbial agents |
|
|
|
3.7. Robustness to environmental factors |
|
|
|
3.8. Further information on the micro-organism |
|
|
|
4. METHODS OF DETECTION AND IDENTIFICATION |
||
|
4.1. Analytical methods for the analysis of the micro-organism as manufactured |
|
|
|
4.2. Methods used for monitoring purposes to determine and quantify residues (viable or non-viable) |
|
|
|
5. EFFECTIVENESS AGAINST TARGET ORGANISM |
||
|
5.1. Function and mode of control e.g. attracting, killing, inhibiting |
|
|
|
5.2. Infectiveness, dispersal and colonisation ability |
|
|
|
5.3. Representative organism(s) controlled and products, organisms or objects to be protected |
|
|
|
5.4. Effects on representative target organism(s) Effects on materials, substances and products |
|
|
|
5.5. Likely concentration at which the micro-organism will be used |
|
|
|
5.6. Mode of action (including time delay) |
|
|
|
5.7. Efficacy data |
|
|
|
5.8. Any known limitations on efficacy |
||
|
5.8.1. Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies |
|
|
|
5.8.2. Observations on undesirable or unintended side effects |
|
|
|
5.8.3. Host specificity, range and effects on species other than the target organism |
|
|
|
5.9. Methods to prevent loss of virulence of seed stock of the micro-organism |
|
|
|
6. INTENDED USES AND EXPOSURE |
||
|
6.1. Field of use(s) envisaged |
|
|
|
6.2. Product-type(s) |
|
|
|
6.3. Detailed description of the use pattern(s) |
|
|
|
6.4. Category of users for which the micro-organism should be approved |
|
|
|
6.5. Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006 |
||
|
6.5.1. Information on human exposure associated with the intended uses and disposal of the active substance |
|
|
|
6.5.2. Information on environmental exposure associated with the intended uses and disposal of the active substance |
|
|
|
6.5.3. Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance |
|
|
|
7. EFFECT ON HUMAN AND ANIMAL HEALTH |
|
Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
|
7.1. Basic information |
||
|
7.1.1. Medical data |
|
|
|
7.1.2. Medical surveillance on manufacturing plant personnel |
|
|
|
7.1.3. Sensitisation/allergenicity observations |
|
|
|
7.1.4. Direct observation, e.g. clinical cases Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression |
|
|
|
7.2. Basic studies |
||
|
7.2.1. Sensitisation |
|
|
|
7.2.2. Acute toxicity, pathogenicity, and infectiveness |
||
|
7.2.2.1. Acute oral toxicity, pathogenicity and infectiveness |
|
|
|
7.2.2.2. Acute inhalatory toxicity, pathogenicity and infectiveness |
ADS |
|
|
7.2.2.3. Intraperitoneal/subcutaneous single dose |
ADS |
|
|
7.2.3. In vitro genotoxicity testing |
|
|
|
7.2.4. Cell culture study |
|
|
|
7.2.5. Information on short-term toxicity and pathogenicity |
ADS |
|
|
7.2.5.1. Health effects after repeated inhalatory exposure |
ADS |
|
|
7.2.6. Proposed treatment: first aid measures, medical treatment |
|
|
|
7.3. Specific toxicity, pathogenicity and infectiveness studies |
ADS |
|
|
7.4. Genotoxicity — in vivo studies in somatic cells |
ADS |
|
|
7.5. Genotoxicity — in vivo studies in germ cells |
ADS |
|
|
7.6. Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation |
|
|
|
7.7. Residues in or on treated articles, food and feedingstuffs |
ADS |
|
|
7.7.1. Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs |
ADS |
|
|
7.7.2. Further information required |
ADS |
|
|
7.7.2.1. Non-viable residues |
ADS |
|
|
7.7.2.2. Viable residues |
ADS |
|
|
7.8. Summary and evaluation of residues in or on treated articles, food and feedingstuffs |
ADS |
|
|
8. EFFECTS ON NON-TARGET ORGANISMS |
|
Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex. |
|
8.1. Effects on aquatic organisms |
||
|
8.1.1. Effects on fish |
|
|
|
8.1.2. Effects on freshwater invertebrates |
|
|
|
8.1.3. Effects on algae growth |
|
|
|
8.1.4. Effects on plants other than algae |
ADS |
|
|
8.2. Effects on earthworms |
|
|
|
8.3. Effects on soil micro-organisms |
|
|
|
8.4. Effects on birds |
|
|
|
8.5. Effects on bees |
|
|
|
8.6. Effects on arthropods other than bees |
|
|
|
8.7. Further studies |
ADS |
|
|
8.7.1. Terrestrial plants |
ADS |
|
|
8.7.2. Mammals |
ADS |
|
|
8.7.3. Other relevant species and processes |
ADS |
|
|
8.8. Summary and evaluation of effects on non-target organisms |
|
|
|
9. ENVIRONMENTAL FATE AND BEHAVIOUR |
||
|
9.1. Persistence and multiplication |
||
|
9.1.1. Soil |
|
|
|
9.1.2. Water |
|
|
|
9.1.3. Air |
|
|
|
9.1.4. Mobility |
|
|
|
9.1.5. Summary and evaluation of fate and behaviour in the environment |
|
|
|
10. MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||
|
10.1. Recommended methods and precautions concerning handling, storage, transport or fire |
|
|
|
10.2. Emergency measures in case of an accident |
|
|
|
10.3. Procedures for destruction or decontamination |
|
|
|
10.4. Procedures for waste management |
|
|
|
10.5. Monitoring plan to be used for the active micro-organism including handling, storage, transport and use |
|
|
|
11. CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM |
||
|
11.1. Relevant risk group specified in Article 2 of Directive 2000/54/EC |
|
|
|
12. SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
|
|
ANNEX III
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
1. This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(1).
2. The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS). The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products.
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the product, existing data, information which is part of the CDS and the types of products and the exposure patterns related to these uses.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table. The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply. In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product. For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation.
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product. Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on the website of the Agency.
The applicant has the obligation to initiate a pre-submission consultation. In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrates that the applicant proposes to carry out.
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) or Article 44(2).
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria in Article 19(1)(b) are met.
3. A detailed and full description of studies conducted and of the methods used shall be included. It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements.
4. The formats made available by the Agency shall be used for submission of the dossiers. In addition, IUCLID shall be used for those parts of the dossiers to which IUCLID applies. Formats and further guidance on data requirements and dossier preparation are available on the Agency homepage.
5. Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation (EC) No 440/2008. However, if a method is inappropriate or not described, other methods shall be used which are scientifically appropriate, whenever possible internationally recognised, and their appropriateness must be justified in the application. When test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and, where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
6. Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency. Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.
7. Where testing is done, a detailed quantitative and qualitative description (specification) of the product used for each test and its impurities must be provided.
8. Where test data exist that have been generated before 17 July 2012 by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State, on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing.
9. New tests involving vertebrates shall be conducted as the last available option to comply with the data requirements set out in this Annex when all the other data sources have been exhausted. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
TITLE 1
CHEMICAL PRODUCTS
Core data set and additional data set for chemical products
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
|
Column 1 Information required: |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
|
1. APPLICANT |
||
|
1.1. Name and address, etc. |
|
|
|
1.2. Contact person |
|
|
|
1.3. Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s)) |
|
|
|
2. IDENTITY OF THE BIOCIDAL PRODUCT |
||
|
2.1. Trade name or proposed trade name |
|
|
|
2.2. Manufacturer’s development code and number of the product, if appropriate |
|
|
|
2.3. Complete quantitative (g/kg, g/l or % w/w (v/v)) composition of the biocidal product, i.e. declaration of all active substances and non-active substances (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative information on the composition of the active substance(s) contained in the biocidal product. For non-active substances, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided. In addition, all relevant information on individual ingredients, their function and, in the case of a reaction mixture, the final composition of the biocidal product shall be given |
|
|
|
2.4. Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution |
|
|
|
2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC |
|
|
|
3. PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES |
||
|
3.1. Appearance (at 20 °C and 101,3 kPa) |
||
|
3.1.1. Physical state (at 20 °C and 101,3 kPa) |
|
|
|
3.1.2. Colour (at 20 °C and 101,3 kPa) |
|
|
|
3.1.3. Odour (at 20 °C and 101,3 kPa) |
|
|
|
3.2. Acidity/alkalinity The test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10 |
|
|
|
3.3. Relative density (liquids) and bulk, tap density (solids) |
|
|
|
3.4. Storage stability, stability and shelf-life |
||
|
3.4.1. Storage stability tests |
||
|
3.4.1.1. Accelerated storage test |
|
|
|
3.4.1.2. Long term storage test at ambient temperature |
|
|
|
3.4.1.3. Low temperature stability test (liquids) |
|
|
|
3.4.2. Effects on content of the active substance and technical characteristics of the biocidal product |
||
|
3.4.2.1. Light |
|
|
|
3.4.2.2. Temperature and humidity |
|
|
|
3.4.2.3. Reactivity towards container material |
|
|
|
3.5. Technical characteristics of the biocidal product |
||
|
3.5.1. Wettability |
|
|
|
3.5.2. Suspensibility, spontaneity and dispersion stability |
|
|
|
3.5.3. Wet sieve analysis and dry sieve test |
|
|
|
3.5.4. Emulsifiability, re-emulsifiability and emulsion stability |
|
|
|
3.5.5. Disintegration time |
|
|
|
3.5.6. Particle size distribution, content of dust/fines, attrition, friability |
|
|
|
3.5.7. Persistent foaming |
|
|
|
3.5.8. Flowability/Pourability/Dustability |
|
|
|
3.5.9. Burning rate — smoke generators |
|
|
|
3.5.10. Burning completeness — smoke generators |
|
|
|
3.5.11. Composition of smoke — smoke generators |
|
|
|
3.5.12. Spraying pattern — aerosols |
|
|
|
3.5.13. Other technical characteristics |
|
|
|
3.6. Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised |
||
|
3.6.1. Physical compatibility |
|
|
|
3.6.2. Chemical compatibility |
|
|
|
3.7. Degree of dissolution and dilution stability |
|
|
|
3.8. Surface tension |
|
|
|
3.9. Viscosity |
|
|
|
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISTICS |
||
|
4.1. Explosives |
|
|
|
4.2. Flammable gases |
|
|
|
4.3. Flammable aerosols |
|
|
|
4.4. Oxidising gases |
|
|
|
4.5. Gases under pressure |
|
|
|
4.6. Flammable liquids |
|
|
|
4.7. Flammable solids |
|
|
|
4.8. Self-reactive substances and mixtures |
|
|
|
4.9. Pyrophoric liquids |
|
|
|
4.10. Pyrophoric solids |
|
|
|
4.11. Self-heating substances and mixtures |
|
|
|
4.12. Substances and mixtures which in contact with water emit flammable gases |
|
|
|
4.13. Oxidising liquids |
|
|
|
4.14. Oxidising solids |
|
|
|
4.15. Organic peroxides |
|
|
|
4.16. Corrosive to metals |
|
|
|
4.17. Additional physical indications of hazard |
||
|
4.17.1. Auto-ignition temperatures of products (liquids and gases) |
|
|
|
4.17.2. Relative self-ignition temperature for solids |
|
|
|
4.17.3. Dust explosion hazard |
|
|
|
5. METHODS OF DETECTION AND IDENTIFICATION |
||
|
5.1. Analytical method including validation parameters for determining the concentration of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product |
|
|
|
5.2. In so far as not covered by Annex II 5.2 and 5.3, analytical methods for monitoring purposes including recovery rates and the limits of determination of relevant components of the biocidal product and/or residues thereof, where relevant in or on the following: |
ADS |
|
|
5.2.1. Soil |
ADS |
|
|
5.2.2. Air |
ADS |
|
|
5.2.3. Water (including drinking water) and sediment |
ADS |
|
|
5.2.4. Animal and human body fluids and tissues |
ADS |
|
|
5.3. Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the material treated with it come into contact with food- producing animals, food of plant and animal origin or feeding stuffs) |
ADS |
|
|
6. EFFECTIVENESS AGAINST TARGET ORGANISMS |
||
|
6.1. Function, e.g. fungicide, rodenticide, insecticide, bactericide Mode of control e.g. attracting, killing, inhibiting |
|
|
|
6.2. Representative organism(s) to be controlled and products, organisms or objects to be protected |
|
|
|
6.3. Effects on representative target organisms |
|
|
|
6.4. Likely concentration at which the active substance will be used |
|
|
|
6.5. Mode of action (including time delay) |
|
|
|
6.6. The proposed label claims for the product and, where label claims are made, for treated articles |
|
|
|
6.7. Efficacy data to support these claims, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate and relevant |
|
|
|
6.8. Any known limitations on efficacy |
||
|
6.8.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
|
|
|
6.8.2. Observations on undesirable or unintended side effects e.g. on beneficial and other non-target organisms |
|
|
|
6.9. Summary and evaluation |
|
|
|
7. INTENDED USES AND EXPOSURE |
||
|
7.1. Field(s) of use envisaged for biocidal products and, where appropriate, treated articles |
|
|
|
7.2. Product-type |
|
|
|
7.3. Detailed description of intended use pattern(s) for biocidal products and, where appropriate, treated articles |
|
|
|
7.4. User e.g. industrial, trained professional, professional or general public (non-professional) |
|
|
|
7.5. Likely tonnage to be placed on the market per year and, where relevant, for different use categories |
|
|
|
7.6. Method of application and a description of this method |
|
|
|
7.7. Application rate and, if appropriate, the final concentration of the biocidal product and active substance in a treated article or in the system in which the product is to be used, e.g. cooling water, surface water, water used for heating purposes |
|
|
|
7.8. Number and timing of applications, and where relevant, any particular information relating to geographical location or climatic variations including necessary waiting periods, clearance times, withdrawal periods or other precautions to protect human health, animal health and the environment |
|
|
|
7.9. Proposed instructions for use |
|
|
|
7.10. Exposure data in conformity with Annex VI to this Regulation |
||
|
7.10.1. Information on human exposure associated with production and formulation, proposed/expected uses and disposal |
|
|
|
7.10.2. Information on environmental exposure associated with production and formulation, proposed/expected uses and disposal |
|
|
|
7.10.3. Information on exposure from treated articles including leaching data (either laboratory studies or model data) |
|
|
|
7.10.4. Information regarding other products that the product is likely to be used together with, in particular the identity of the active substances in these products, if relevant, and the likelihood of any interactions |
|
|
|
8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS |
||
|
8.1. Skin corrosion or skin irritation The assessment of this endpoint shall be carried out according to the sequential testing strategy for dermal irritation and corrosion set out in the Appendix to Test Guideline B.4. Acute Toxicity-Dermal Irritation/Corrosion (Annex B.4. to Regulation (EC) No 440/2008) |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture sufficient to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.2. Eye irritation (1) The assessment of this endpoint shall be carried out according to the sequential testing strategy for eye irritation and corrosion as set down in the Appendix to Test Guideline B.5.Acute Toxicity: Eye Irritation/Corrosion (Annex B.5. to Regulation (EC) No 440/2008) |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/ECand Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.3. Skin sensitisation The assessment of this endpoint shall comprise the following consecutive steps: 1. an assessment of the available human, animal and alternative data 2. in vivo testing The Murine Local Lymph Node Assay (LLNA) including, where appropriate, the reduced variant of the assay, is the first-choice method for in vivo testing. If another skin sensitisation test is used justification shall be provided |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected — the available information indicates that the product should be classified for skin sensitisation or corrosivity; or — the substance is a strong acid (pH < 2,0) or base (pH > 11,5) |
|
8.4. Respiratory sensitisation |
ADS |
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.5. Acute toxicity — Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.5.1. By oral route |
|
|
|
8.5.2. By inhalation |
|
|
|
8.5.3. By dermal route |
|
|
|
8.5.4. For biocidal products that are intended to be authorised for use with other biocidal products, the risks to human health, animal health and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried out using combinations of the products |
|
Testing on the mixture of products does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.6. Information on dermal absorption Information on dermal absorption when exposure occurs to the biocidal product. The assessment of this endpoint shall proceed using a tiered approach |
|
|
|
8.7. Available toxicological data relating to: — non-active substance(s) (i.e. substance(s) of concern), or — a mixture that a substance(s) of concern is a component of If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP) |
|
8.8. Food and feedingstuffs studies |
ADS |
|
|
8.8.1. If residues of the biocidal product remain in or on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin |
ADS |
|
|
8.9. Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product |
ADS |
|
|
8.10. Other test(s) related to the exposure to humans Suitable test(s) and a reasoned case will be required for the biocidal product In addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed |
ADS |
|
|
9. ECOTOXICOLOGICAL STUDIES |
||
|
9.1. Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required — Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) — Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary |
|
|
|
9.2. Further Ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 9 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product |
|
|
|
9.3. Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk |
ADS |
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
|
9.4. If the biocidal product is in the form of bait or granules the following studies may be required: |
||
|
9.4.1. Supervised trials to assess risks to non-target organisms under field conditions |
|
|
|
9.4.2. Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk |
|
|
|
9.5. Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated |
ADS |
|
|
10. ENVIRONMENTAL FATE AND BEHAVIOUR |
||
|
The test requirements below are applicable only to the relevant components of the biocidal product |
|
|
|
10.1. Foreseeable routes of entry into the environment on the basis of the use envisaged |
|
|
|
10.2. Further studies on fate and behaviour in the environment Further studies chosen from among the endpoints referred to in Section 10 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required. For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern |
ADS |
|
|
10.3. Leaching behaviour |
ADS |
|
|
10.4. Testing for distribution and dissipation in the following: |
ADS |
|
|
10.4.1. Soil |
ADS |
|
|
10.4.2. Water and sediment |
ADS |
|
|
10.4.3. Air |
ADS |
|
|
10.5. If the biocidal product is to be sprayed near to surface waters then an overspray study may be required to assess risks to aquatic organisms or plants under field conditions |
ADS |
|
|
10.6. If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees and non-target arthropods under field conditions |
ADS |
|
|
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||
|
11.1. Recommended methods and precautions concerning handling, use, storage, disposal, transport or fire |
|
|
|
11.2. Identity of relevant combustion products in cases of fire |
|
|
|
11.3. Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical treatment if available; emergency measures to protect the environment |
|
|
|
11.4. Possibility of destruction or decontamination following release in or on the following: |
||
|
11.4.1. Air |
|
|
|
11.4.2. Water, including drinking water |
|
|
|
11.4.3. Soil |
|
|
|
11.5. Procedures for waste management of the biocidal product and its packaging for industrial use, use by trained professionals, professional users and non-professional users (e.g. possibility of reuse or recycling, neutralisation, conditions for controlled discharge, and incineration) |
|
|
|
11.6. Procedures for cleaning application equipment where relevant |
|
|
|
11.7. Specify any repellents or poison control measures included in the product that are present to prevent action against non-target organisms |
|
|
|
12. CLASSIFICATION, LABELLING, AND PACKAGING |
||
|
As established in point (b) of Article 20(1), proposals including justification for the hazard and precautionary statements in accordance with the provisions set in Directive 1999/45/EC and Regulation (EC) No 1272/2008 must be submitted. Example labels, instructions for use and safety data sheets shall be provided |
|
|
|
12.1. Hazard classification |
|
|
|
12.2. Hazard pictogram |
|
|
|
12.3. Signal word |
|
|
|
12.4. Hazard statements |
|
|
|
12.5. Precautionary statements including prevention, response, storage and disposal |
|
|
|
12.6. Proposals for safety-data sheets should be provided, where appropriate |
|
|
|
12.7. Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included |
|
|
|
13. EVALUATION AND SUMMARY The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
|
|
|
(1)
Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties. |
||
TITLE 2
MICRO-ORGANISMS
Core data set and additional data set
Information required to support the authorisation of a biocidal product is listed in the table below.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
|
Column 1 Information required: |
Column 2 All data is CDS unless indicated as ADS |
Column 3 Specific rules for adaptation from standard information concerning some of the information requirements that may require recourse to testing of vertebrates |
|
1. APPLICANT |
||
|
1.1. Name and address |
|
|
|
1.2. Contact person |
|
|
|
1.3. Manufacturer and formulator of the biocidal product and the micro-organism(s) (names, addresses, including location of plant(s)) |
|
|
|
2. IDENTITY OF THE BIOCIDAL PRODUCTS |
||
|
2.1. Trade name or proposed trade name |
|
|
|
2.2. Manufacturer’s development code and number of the biocidal product, if appropriate |
|
|
|
2.3. Detailed quantitative (g/kg, g/l or % w/w (v/v)) and qualitative information on the constitution, composition and function of the biocidal product, e.g. micro-organism, active substance(s) and product non-active substances and any other relevant components. All relevant information on individual ingredients and the final composition of the biocidal product shall be given |
|
|
|
2.4. Formulation type and nature of the biocidal product |
|
|
|
2.5. Where the biocidal product contains an active substance that has been manufactured in locations or according to processes or from starting materials other than those of the active substance evaluated for the purpose of approval pursuant to Article 9 of this Regulation, evidence has to be provided that technical equivalence has been established in accordance with Article 54 of this Regulation or has been established, following an evaluation having started before 1 September 2013, by a competent authority designated in accordance with Article 26 of Directive 98/8/EC |
|
|
|
3. BIOLOGICAL, PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES OF THE BIOCIDAL PRODUCT |
||
|
3.1. Biological properties of the micro-organism in the biocidal product |
|
|
|
3.2. Appearance (at 20 °C and 101,3 kPa) |
||
|
3.2.1. Colour (at 20 °C and 101,3 kPa) |
|
|
|
3.2.2. Odour (at 20 °C and 101,3 kPa) |
|
|
|
3.3. Acidity, alkalinity and pH value |
|
|
|
3.4. Relative density |
|
|
|
3.5. Storage stability, stability and shelf-life |
||
|
3.5.1. Effects of light |
|
|
|
3.5.2. Effects of temperature and humidity |
|
|
|
3.5.3. Reactivity towards the container |
|
|
|
3.5.4. Other factors affecting stability |
|
|
|
3.6. Technical characteristics of the biocidal product |
||
|
3.6.1. Wettability |
|
|
|
3.6.2. Suspensibility and suspension stability |
|
|
|
3.6.3. Wet sieve analysis and dry sieve test |
|
|
|
3.6.4. Emulsifiability, re-emulsifiability, emulsion stability |
|
|
|
3.6.5. Particle size distribution content of dust/fines, attrition and friability |
|
|
|
3.6.6. Persistent foaming |
|
|
|
3.6.7. Flowability/Pourability/Dustability |
|
|
|
3.6.8. Burning rate — smoke generators |
|
|
|
3.6.9. Burning completeness — smoke generators |
|
|
|
3.6.10. Composition of smoke — smoke generators |
|
|
|
3.6.11. Spraying patterns — aerosols |
|
|
|
3.6.12. Other technical characteristics |
|
|
|
3.7. Physical, chemical and biological compatibility with other products including biocidal products with which its use is to be authorised or registered |
||
|
3.7.1. Physical compatibility |
|
|
|
3.7.2. Chemical compatibility |
|
|
|
3.7.3. Biological compatibility |
|
|
|
3.8. Surface tension |
|
|
|
3.9. Viscosity |
|
|
|
4. PHYSICAL HAZARDS AND RESPECTIVE CHARACTERISITICS |
||
|
4.1. Explosives |
|
|
|
4.2. Flammable gases |
|
|
|
4.3. Flammable aerosols |
|
|
|
4.4. Oxidising gases |
|
|
|
4.5. Gases under pressure |
|
|
|
4.6. Flammable liquids |
|
|
|
4.7. Flammable solids |
|
|
|
4.8. Oxidising liquids |
|
|
|
4.9. Oxidising solids |
|
|
|
4.10. Organic peroxides |
|
|
|
4.11. Corrosive to metals |
|
|
|
4.12. Other physical indications of hazard |
||
|
4.12.1. Auto-ignition temperatures of products (liquids and gases) |
|
|
|
4.12.2. Relative self-ignition temperature for solids |
|
|
|
4.12.3. Dust explosion hazard |
|
|
|
5. METHODS OF DETECTION AND IDENTIFICATION |
||
|
5.1. Analytical method for determining the concentration of the micro-organism(s) and substances of concern in the biocidal product |
|
|
|
5.2. Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance nor the article treated with it does not come into contact with food-producing animals, food of plant and animal origin or feeding stuffs) |
ADS |
|
|
6. EFFECTIVENESS AGAINST TARGET ORGANISM |
||
|
6.1. Function and mode of control |
|
|
|
6.2. Representative pest organism(s) to be controlled and products, organisms or objects to be protected |
|
|
|
6.3. Effects on representative target organisms |
|
|
|
6.4. Likely concentration at which micro-organism will be used |
|
|
|
6.5. Mode of action |
|
|
|
6.6. The proposed label claims for the product |
|
|
|
6.7. Efficacy data to support these claims, including any available standard protocols, laboratory tests, or field trials used including performance standards, where appropriate and relevant |
|
|
|
6.8. Any other known limitations on efficacy including resistance |
||
|
6.8.1. Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies |
|
|
|
6.8.2. Observations on undesirable or unintended side effects |
|
|
|
7. INTENDED USES AND EXPOSURE |
||
|
7.1. Field of use envisaged |
|
|
|
7.2. Product-type |
|
|
|
7.3. Detailed description of intended use |
|
|
|
7.4. User e.g. industrial, trained professional, professional or general public (non-professional) |
|
|
|
7.5. Method of application and a description of this method |
|
|
|
7.6. Application rate and if appropriate the final concentration of the biocidal product or the micro-organism active substance in a treated article or the system in which the product is to be used (e.g. in the application device or bait) |
|
|
|
7.7. Number and timing of applications and duration of protection Any particular information relating to the geographical location or climatic variations including necessary waiting periods for re-entry or necessary withdrawal period or other precautions to protect human health, animal health and the environment |
|
|
|
7.8. Proposed instructions for use |
|
|
|
7.9. Exposure data |
||
|
7.9.1. Information on human exposure associated with the proposed/expected uses and disposal |
|
|
|
7.9.2. Information on environmental exposure associated with the proposed/expected uses and disposal |
|
|
|
8. TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) and synergistic effects between any of the components are not expected |
|
8.1. Skin corrosion or irritation |
|
|
|
8.2. Eye irritation |
|
|
|
8.3. Skin sensitisation |
|
|
|
8.4. Respiratory sensitisation |
ADS |
|
|
8.5. Acute toxicity — Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach |
|
|
|
8.5.1. Oral |
|
|
|
8.5.2. Inhalation |
|
|
|
8.5.3. Dermal |
|
|
|
8.5.4. Additional acute toxicity studies |
|
|
|
8.6. Information on dermal absorption if required |
|
|
|
8.7. Available toxicological data relating to: — non-active substance(s) (i.e. substance(s) of concern), or — a mixture that a substance(s) of concern is a component of — If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II, shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of |
|
Testing on the product/mixture does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.8. Supplementary studies for combinations of biocidal products For biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans, animals and the environment arising from the use of these product combinations shall be assessed. As an alternative to acute toxicity studies, calculations can be used. In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried using combinations of the products |
|
Testing on the mixture of products does not need to be conducted if: — there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected |
|
8.9. Residues in or on treated articles, food and feedingstuffs |
ADS |
|
|
9. ECOTOXICOLOGICAL STUDIES |
||
|
9.1. Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required — Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP) — Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary |
|
|
|
9.2. Further ecotoxicological studies Further studies chosen from among the endpoints referred to in Section 8 of Annex II ‘Micro-organisms’ for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product |
|
|
|
9.3. Effects on any other specific non-target organisms (flora and fauna) believed to be at risk |
ADS |
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment |
|
9.4. If the biocidal product is in the form of bait or granules |
ADS |
|
|
9.4.1. Supervised trials to assess risks to non-target organisms under field conditions |
||
|
9.4.2. Studies on acceptance by ingestion of the biocidal product by any non-target organisms thought to be at risk |
||
|
9.5. Secondary ecological effect e.g. when a large proportion of a specific habitat type is treated |
ADS |
|
|
10. ENVIRONMENTAL FATE AND BEHAVIOUR |
||
|
10.1. Foreseeable routes of entry into the environment on the basis of the use envisaged |
|
|
|
10.2. Further studies on fate and behaviour in the environment Where relevant, all the information required in Section 9 of Annex II ‘Micro-organisms’ may be required for the product For products that are used outside, with direct emission to soil, water or surfaces, the components in the product may influence the fate and behaviour (and ecotoxicity) of the active substance. Data are required unless it is scientifically justified that the fate of the components in the product is covered by the data provided for the active substance and other identified substances of concern |
ADS |
|
|
10.3. Leaching behaviour |
ADS |
|
|
10.4. If the biocidal product is to be sprayed outside or if potential for large scale formation of dust is given then data on overspray behaviour may be required to assess risks to bees under field conditions |
ADS |
|
|
11. MEASURES TO BE ADOPTED TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT |
||
|
11.1. Recommended methods and precautions concerning: handling, storage, transport or fire |
|
|
|
11.2. Measures in the case of an accident |
|
|
|
11.3. Procedures for destruction or decontamination of the biocidal product and its packaging |
||
|
11.3.1. Controlled incineration |
|
|
|
11.3.2. Others |
|
|
|
11.4. Packaging and compatibility of the biocidal product with proposed packaging materials |
|
|
|
11.5. Procedures for cleaning application equipment where relevant |
|
|
|
11.6. Monitoring plan to be used for the active micro-organism and other micro-organism(s) contained in the biocidal product including handling, storage, transport and use |
|
|
|
12. CLASSIFICATION, LABELLING AND PACKAGING |
||
|
Example labels, instructions for use and safety data sheets shall be provided |
|
|
|
12.1. Indication on the need for the biocidal product to carry the biohazard sign specified in Annex II to Directive 2000/54/EC |
|
|
|
12.2. Precautionary statements including prevention, response, storage and disposal |
|
|
|
12.3. Proposals for safety-data sheets should be provided, where appropriate |
|
|
|
12.4. Packaging (type, materials, size, etc.), compatibility of the product with proposed packaging materials to be included |
|
|
|
13. SUMMARY AND EVALUATION The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed |
|
|
ANNEX IV
GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS
This Annex sets out rules to be followed when the applicant proposes to adapt the data requirements set out in Annexes II and III in accordance with Article 6(2) and (3) or Article 21(1) and (2), without prejudice to the specific rules set out in Annex III on the use of the calculation methods for classification of mixtures to avoid testing on vertebrates.
The reasons for such adaptations to the data requirements must be clearly stated under the appropriate heading of the dossier referring to the specific rule(s) of this Annex.
1. TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY
1.1. Use of existing data
|
1.1.1. |
Data on physical-chemical properties from experiments not carried out according to GLP or the relevant test methods. Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
(1)
adequacy of the data for the purpose of classification and labelling and risk assessment;
(2)
sufficient adequate and reliable documentation is provided to assess the equivalency of the study; and
(3)
the data are valid for the endpoint being investigated and the study is performed using an acceptable level of quality assurance. |
|
1.1.2. |
Data on human health and environmental properties from experiments not carried out according to GLP or the relevant test methods. Data shall be considered to be equivalent to data generated by the corresponding test methods if the following conditions are met:
(1)
adequacy of the data for the purpose of classification and labelling and risk assessment;
(2)
adequate and reliable coverage of the key parameters/endpoints foreseen to be investigated in the corresponding test methods;
(3)
exposure duration comparable to or longer than the corresponding test methods if exposure duration is a relevant parameter;
(4)
adequate and reliable documentation of the study is provided; and
(5)
the study is performed using a system of quality assurance. |
|
1.1.3. |
Historical human data As a general rule, in accordance with Article 7(3) of Regulation (EC) No 1272/2008, tests on humans shall not be performed for the purposes of this Regulation. However, existing historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data, biomonitoring studies, clinical studies and human volunteer studies performed in accordance with internationally accepted ethical standards shall be considered. Data collected on humans shall not be used to lower the safety margins resulting from tests or studies on animals. The strength of the data for a specific human health effect depends, among other things, on the type of analysis and the parameters covered, and on the magnitude and specificity of the response and consequently the predictability of the effect. Criteria for assessing the adequacy of the data include:
(1)
the proper selection and characterisation of the exposed and control groups;
(2)
adequate characterisation of exposure;
(3)
sufficient length of follow-up for disease occurrence;
(4)
valid method for observing an effect;
(5)
proper consideration of bias and confounding factors; and
(6)
a reasonable statistical reliability to justify the conclusion. In all cases adequate and reliable documentation shall be provided. |
1.2. Weight of evidence
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or does not have a particular dangerous property, while the information from each single source alone is considered insufficient to support this notion. There may be sufficient weight of evidence from the use of positive results of newly developed test methods, not yet included in the relevant test methods or from an international test method recognised by the Commission as being equivalent, leading to the conclusion that a substance has a particular dangerous property. However, if the newly developed test method has been approved by the Commission, but has not yet been published, its results may be taken into account even where this leads to the conclusion that a substance does not have a particular dangerous property.
Where consideration of all the available data provides sufficient weight of evidence for the presence or absence of a particular dangerous property:
In all cases adequate and reliable documentation shall be provided.
1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence, but not the absence of a given dangerous property. Results of (Q)SARs may be used instead of testing when the following conditions are met:
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on the use of (Q)SARs.
1.4. In vitro methods
Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria.
Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests. However, such confirmation may be waived if the following conditions are met:
results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;
results are adequate for the purpose of classification and labelling and risk assessment; and
adequate and reliable documentation of the applied method is provided.
In the case of negative results, these exemptions do not apply. A confirmation test may be requested on a case-by-case basis.
1.5. Grouping of substances and read-across approach
Substances whose physico-chemical, toxicological and ecotoxicological properties are similar or follow a regular pattern as a result of structural similarity may be considered as a group or ‘category’ of substances. Application of the group concept requires that physico-chemical properties, human and animal health effects, and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach). This avoids the need to test every substance for every endpoint.
The similarities may be based on:
a common functional group indicating the presence of dangerous properties;
common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals and indicates the presence of dangerous properties; or
a constant pattern in the changing of the potency of the properties across the category.
If the group concept is applied, substances shall be classified and labelled on this basis.
In all cases results shall:
In all cases, adequate and reliable documentation of the applied method shall be provided.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on technically and scientifically justified methodology for the grouping of substances.
2. TESTING IS TECHNICALLY NOT POSSIBLE
Testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion, or the radio-labelling of the substance required in certain studies may not be possible. The guidance given in the relevant test methods, more specifically on the technical limitations of a specific method, shall always be respected.
3. PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING
|
3.1. |
Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available. In that case, the following conditions shall be met:
—
An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought.
—
If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies.
—
The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.
However, testing cannot be omitted for non-threshold effects. As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing. If relevant, the Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the criteria established in accordance with Article 6(4) and Article 21(3). |
|
3.2. |
In all cases, adequate justification and documentation shall be provided. The justification shall be based on an exposure assessment, in accordance with the relevant Technical Notes for Guidance where available. |
ANNEX V
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
MAIN GROUP 1: Disinfectants
These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Product-type 1: Human hygiene
Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals
Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.
Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.
Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.
Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
Product-type 3: Veterinary hygiene
Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.
Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Product-type 4: Food and feed area
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.
Products used to be incorporated into materials which may enter into contact with food.
Product-type 5: Drinking water
Products used for the disinfection of drinking water for both humans and animals.
MAIN GROUP 2: Preservatives
Unless otherwise stated these product-types include only products to prevent microbial and algal development.
Product-type 6: Preservatives for products during storage
Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.
Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.
Product-type 7: Film preservatives
Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
Product-type 8: Wood preservatives
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects.
This product-type includes both preventive and curative products.
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration.
This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.
Product-type 10: Construction material preservatives
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.
Product-type 11: Preservatives for liquid-cooling and processing systems
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.
Product-type 12: Slimicides
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
Product-type 13: Working or cutting fluid preservatives
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.
MAIN GROUP 3: Pest control
Product-type 14: Rodenticides
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Product-type 15: Avicides
Products used for the control of birds, by means other than repulsion or attraction.
Product-type 16: Molluscicides, vermicides and products to control other invertebrates
Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.
Product-type 17: Piscicides
Products used for the control of fish, by means other than repulsion or attraction.
Product-type 18: Insecticides, acaricides and products to control other arthropods
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.
Product-type 19: Repellents and attractants
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.
Product-type 20: Control of other vertebrates
Products used for the control of vertebrates other than those already covered by the other product-types of this main group, by means other than repulsion or attraction.
MAIN GROUP 4: Other biocidal products
Product-type 21: Antifouling products
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Product-type 22: Embalming and taxidermist fluids
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
ANNEX VI
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
|
CONTENTS |
|
|
Terms and definitions |
|
|
Introduction |
|
|
Assessment |
|
|
— |
General principles |
|
— |
Effects on human and animal health |
|
— |
Effects on the environment |
|
— |
Effects on target organisms |
|
— |
Efficacy |
|
— |
Summary |
|
Conclusions |
|
|
— |
General principles |
|
— |
Effects on human and animal health |
|
— |
Effects on the environment |
|
— |
Effects on target organisms |
|
— |
Efficacy |
|
— |
Summary |
|
Overall integration of conclusions |
|
TERMS AND DEFINITIONS
Correspondence with the criteria set out in Article 19(1)(b)
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:
Technical definitions
(a) Hazard identification
The identification of the adverse effects which a biocidal product has an inherent capacity to cause.
(b) Dose (concentration) — response (effect) assessment
The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
(c) Exposure assessment
The determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.
(d) Risk characterisation
The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.
(e) Environment
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.
INTRODUCTION
1. This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b). A decision by a Member State or the Commission to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this Annex. Detailed technical guidance regarding the application of this Annex is available on the website of the Agency.
2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials, the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information.
3. In order to ensure a high and harmonised level of protection of human health, animal health and the environment, any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product, taking into account any cumulative and synergistic effects.
4. A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
5. Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern present in the biocidal product. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
6. In order to carry out a risk assessment, data are required. These data are detailed in Annexes II and III and take account of the fact that there are a wide variety of applications as well as different product-types and that this has an impact on the associated risks. The data required shall be the minimum necessary to carry out an appropriate risk assessment. The evaluating body shall take due consideration of the requirements of Articles 6, 21 and 62 in order to avoid duplication of data submissions. Data may also be required on a substance of concern present in a biocidal product. For in-situ generated active substances, the risk assessment includes also the possible risks from the precursor(s).
7. The results of the risk assessments carried out on the active substance and on the substances of concern present in the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself.
8. When making evaluations of a biocidal product the evaluating body shall:
take into consideration other relevant technical or scientific information which is reasonably available to them with regard to the properties of the biocidal product, its components, metabolites, or residues;
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.
9. The application of these common principles shall, when taken together with the other conditions set out in Article 19, lead to the competent authorities or the Commission deciding whether or not a biocidal product can be authorised. Such authorisation may include restrictions on use or other conditions. In certain cases the competent authorities may conclude that more data are required before an authorisation decision can be made.
10. In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the competent authorities or the Commission shall also evaluate whether the conditions of Article 5(2) can be satisfied.
11. During the process of evaluation, applicants and the evaluating bodies shall cooperate in order to resolve quickly any questions on the data requirements, to identify at an early stage any additional studies required, to amend any proposed conditions for the use of the biocidal product, or to modify its nature or its composition in order to ensure full compliance with the requirements of Article 19 and of this Annex. The administrative burden, especially for SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment.
12. The judgments made by the evaluating body during the evaluation must be based on scientific principles, preferably recognised at international level, and must be made with the benefit of expert advice.
ASSESSMENT
General principles
13. The data submitted in support of an application for authorisation of a biocidal product shall be validated by the evaluating or receiving competent authority in accordance with the relevant articles of the Regulation. After validation of these data the competent authorities shall utilise them by carrying out a risk assessment based on the proposed use. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
14. A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these. The risk assessment shall cover the proposed normal use of the biocidal product, together with a realistic worst-case scenario including any relevant production and disposal issue. The assessment shall also take account of how any ‘treated articles’ treated with or containing the product may be used and disposed of. Active substances that are generated in-situ and the associated precursors shall also be considered.
15. In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account. The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the scientific definitions and methodologies for the assessment of cumulative and synergistic effects.
16. For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible. It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation.
17. The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active substances and for any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product. Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner.
18. The risk assessment shall determine:
the hazards due to the physico-chemical properties,
the risk to humans and animals,
the risk to the environment,
the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.
19. In certain cases it may be concluded that further data are required before a risk assessment can be finalised. Any such additional data requested shall be the minimum necessary to complete such a risk assessment.
20. The information provided on the biocidal product family shall permit the evaluating body to reach a decision on whether all the products within the biocidal product family comply with the criteria under Article 19(1)(b).
21. Where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances.
Effects on human and animal health
Effects on human health
22. The risk assessment shall take account of the following potential effects arising from the use of the biocidal product and the populations liable to exposure.
23. The effects previously mentioned result from the properties of the active substance and any substance of concern present. They are:
24. The populations previously mentioned are:
In considering these populations, particular attention should be given to the need to protect vulnerable groups within these populations.
25. The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product.
26. The evaluating body shall apply points 27 to 30 when carrying out a dose (concentration) - response (effect) assessment on an active substance or a substance of concern present in a biocidal product.
27. For repeated dose toxicity and reproductive toxicity the dose-response relationship shall be assessed for each active substance or substance of concern and, where possible, a NOAEL identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors may be used as reference values.
28. For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL on the basis of tests conducted in accordance with the requirements of this Regulation. For acute toxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or another appropriate dose-effect descriptor shall be derived. For the other effects it shall be sufficient to determine whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the biocidal product.
29. For mutagenicity and carcinogenicity, a non-threshold assessment should be carried out if the active substance or substance of concern is genotoxic and carcinogenic. If the active substance or a substance of concern is not genotoxic a threshold assessment shall be carried out.
30. With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the possibility of identifying a dose/concentration below which adverse effects are unlikely to occur, particularly in a subject already sensitised to a given substance, it shall be sufficient to evaluate whether the active substance or substance of concern has an inherent capacity to cause such effects as a result of the use of the biocidal product.
31. When carrying out the risk assessment special consideration shall be given to toxicity data derived from observations of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or epidemiology surveys.
32. An exposure assessment shall be carried out for each of the human populations (professional users, non-professional users and humans exposed directly or indirectly via the environment), for which exposure to a biocidal product occurs or can reasonably be foreseen, with particular attention paid to the pathways of exposure relevant for vulnerable groups. The objective of the assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of concern, including relevant metabolites and degradation products to which a population is, or may be exposed during use of the biocidal product and articles treated with that product.
33. The exposure assessment shall be based on the information in the technical dossier provided in conformity with Articles 6 and 21 and on any other available and relevant information. Particular account shall be taken, as appropriate, of:
34. When conducting the exposure assessment, special consideration shall be given to adequately measured, representative exposure data where such data are available. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied.
These models shall:
Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties shall also be considered.
35. Where, for any of the effects set out in point 23 a reference value has been identified, the risk characterisation shall entail comparison of the reference value with the evaluation of the dose/concentration to which the population will be exposed. Where a reference value cannot be established a qualitative approach shall be used.
Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.
Effects on animal health
36. Using the same relevant principles as described in the section dealing with effects on humans, the evaluating body shall consider the risks posed to animals from the biocidal product.
Effects on the environment
37. The risk assessment shall take account of any adverse effects arising in any of the three environmental compartments — air, soil and water (including sediment) — and of the biota, following the use of the biocidal product.
38. The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product.
39. A dose (concentration) — response (effect) assessment shall be carried out in order to predict the concentration below which adverse effects in the environmental compartment of concern are not expected to occur. This shall be carried out for the active substance and for any substance of concern present in the biocidal product. This concentration is known as PNEC. However, in some cases, it may not be possible to establish a PNEC and a qualitative estimation of the dose (concentration) — response (effect) then has to be made.
40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted in accordance with requirements of Articles 6 and 20. It shall be calculated by applying an assessment factor to the reference values resulting from tests on organisms, e.g. LD50 (median lethal dose), LC50 (median lethal concentration), EC50 (median effective concentration), IC50 (concentration causing 50 % inhibition of a given parameter, e.g. growth), NOEL(C) (no-observed-effect level (concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). Where appropriate, other dose-effect descriptors may be used as reference values.
41. An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a limited number of species to the real environment. Therefore, in general, the more extensive the data and the longer the duration of the tests, the smaller the degree of uncertainty and the size of the assessment factor.
42. For each environmental compartment, an exposure assessment shall be carried out in order to predict the likely concentration of each active substance or substance of concern present in the biocidal product. This concentration is known as the predicted environmental concentration (PEC). However, in some cases it may not be possible to establish a PEC and a qualitative estimate of exposure then has to be made.
43. A PEC, or where necessary a qualitative estimate of exposure, need only be determined for the environmental compartments to which emissions, discharges, disposal or distributions (including any relevant contribution from articles treated with biocidal products) are known or are reasonably foreseeable.
44. The PEC, or the qualitative estimation of exposure, shall be determined taking account of, in particular and where appropriate:
45. When conducting the exposure assessment, special consideration shall be given to adequately measured, representative exposure data where such data are available. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied. The characteristics of these models shall be as listed in point 34. Where appropriate, on a case-by-case basis, relevant monitoring data from substances with analogous use and exposure patterns or analogous properties should also be considered.
46. For any given environmental compartment, the risk characterisation shall, as far as possible, entail comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived.
47. If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of exposure.
48. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) if it contains any substance of concern or relevant metabolites or breakdown or reaction products fulfilling the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006, or if it has endocrine-disrupting properties unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Effects on target organisms
49. An assessment shall be made to demonstrate that the biocidal product does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate, the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated.
50. The evaluating body shall, where relevant, evaluate the possibility of the development by the target organism of resistance or cross-resistance to an active substance in the biocidal product.
Efficacy
51. Data submitted by the applicant shall be sufficient to substantiate the efficacy claims for the product. Data submitted by the applicant or held by the evaluating body must be able to demonstrate the efficacy of the biocidal product against the target organism when used normally in accordance with the conditions of authorisation.
52. Testing should be carried out according to Union guidelines where these are available and applicable. Where appropriate, other methods from the list below can be used. If relevant acceptable field data exist, these can be used.
Summary
53. In each of the areas where risk assessments have been carried out, the evaluating body shall combine the results for the active substance together with the results for any substance of concern to produce an overall assessment for the biocidal product itself. This shall also take account of any cumulative or synergistic effects.
54. For biocidal product containing more than one active substance, any adverse effects shall also be considered together to produce an overall assessment for the biocidal product itself.
CONCLUSIONS
General principles
55. The purpose of the evaluation is to establish whether or not the product complies with the criteria set down in point (b) of Article 19(1). The evaluating body shall reach its conclusion as a result of the integration of the risks arising from each active substance together with the risks from each substance of concern present in the biocidal product, based on the assessment carried out in accordance with points 13 to 54 of this Annex.
56. In establishing compliance with the criteria set out in point (b) of Article 19(1), the evaluating body shall arrive at one of the following conclusions for each product-type and each area of use of the biocidal product for which application has been made:
that the biocidal product complies with the criteria;
that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria;
that it is not possible, without additional data, to establish if the biocidal product complies with the criteria;
that the biocidal product does not comply with the criteria.
57. The evaluating body shall, when seeking to establish whether a biocidal product complies with the criteria in point (b) of Article 19(1), take into account uncertainty arising from the variability in the data used in the evaluation process.
58. If the conclusion arrived at by the evaluating body is that additional information or data are required, then the evaluating body shall justify the need for any such information or data. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.
Effects on human and animal health
Effects on human health
59. The evaluating body shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment. In reaching these conclusions, particular attention shall be paid to vulnerable groups among the different populations.
60. The evaluating body shall examine the relationship between exposure and effect. A number of factors need to be considered when examining this relationship. One of the most important factors is the nature of the adverse effect of the substance under consideration. These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, immunotoxicity, reproductive toxicity, disruption of the endocrine system together with physico-chemical properties, and any other adverse properties of the active substance or substance of concern, or of their relevant metabolites or degradation products.
61. Typically, the margin of exposure (MOEref) — the ratio between the dose descriptor and the exposure concentration — is in the region of 100, but a MOEref that is higher or lower than this may also be appropriate depending on, among other things, the nature of the critical effects and the sensitivity of the population.
62. The evaluating body shall, where appropriate, conclude that criterion (iii) under point (b) of Article 19(1) can only be complied with by application of prevention and protection measures including the design of work processes, engineering controls, use of adequate equipment and materials, application of collective protection measures and, where exposure cannot be prevented by other means, application of individual protection measures including the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order to reduce exposure for professional operators.
63. If, for non-professional users, the wearing of personal protective equipment would be the only possible method for reducing exposure to an acceptable level for this population, the product shall not normally be considered as complying with criterion (iii) under point (b) of Article 19(1) for this population.
Effects on animal health
64. Using the same relevant criteria as described in the section dealing with effects on human health, the evaluating body shall consider whether criterion (iii) under point (b) of Article 19(1) is complied with for animal health.
Effects on the environment
65. The basic tool used in the decision-making is the PEC/PNEC ratio or, if this is not available, a qualitative estimation. Due consideration shall be given to the accuracy of this ratio due to variability in the data used both in measurements of concentration and of estimation.
In the determination of the PEC, the most appropriate model should be used taking into account the environmental fate and behaviour of the biocidal product.
66. For any given environmental compartment, if the PEC/PNEC ratio is equal to or less than 1, the risk characterisation shall be that no further information and/or testing is necessary. If the PEC/PNEC ratio is greater than 1, the evaluating body shall judge, on the basis of the size of that ratio and on other relevant factors, whether further information and/or testing is required to clarify the concern or appropriate risk reduction measures are necessary, or whether the biocidal product cannot comply with criterion (iv) under point (b) of Article 19(1).
Water
67. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impact on non-target organisms in the aquatic, marine or estuarine environment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. In particular, the evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1), where under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments), would undermine the achievement of compliance with the standards laid down in:
68. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, exceeds the lower of the following concentrations:
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
69. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where the foreseeable concentration of the active substance or a substance of concern, or of relevant metabolites, breakdown or reaction products to be expected in surface water or its sediments after use of the biocidal product under the proposed conditions of use:
unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
70. The proposed instructions for use of the biocidal product, including procedures for cleaning application equipment, must be such that, if followed, they minimise the likelihood of accidental contamination of water or its sediments.
Soil
71. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in soil, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Air
72. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) of point (b) of Article 19(1) where there is a reasonably foreseeable possibility of unacceptable effect on the air compartment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Non-target organisms
73. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal product, if for any active substance or substance of concern:
74. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants being exposed to the biocidal product, if for any active substance, substance of concern, relevant metabolite, breakdown or reaction product the PEC/PNEC ratio is above 1, unless it is clearly established in the risk assessment that under field conditions no unacceptable impact, either directly or indirectly, occurs on the viability of such micro-organisms.
Effects on target organisms
75. Where the development of resistance or cross-resistance to the active substance in the biocidal product is likely, the evaluating body shall consider actions to minimise the consequences of this resistance. This may involve modification of the conditions under which an authorisation is given. However, where the development of resistance or cross-resistance cannot be reduced sufficiently, the evaluating authority shall conclude that the biocidal product does not satisfy criterion (ii) under point (b) of Article 19(1).
76. A biocidal product intended to control vertebrates shall not normally be regarded as satisfying criterion (ii) under point (b) of Article 19(1) unless:
For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target vertebrate.
Efficacy
77. The level, consistency and duration of protection, control or other intended effects must, as a minimum, be similar to those resulting from suitable reference products, where such products exist, or to other means of control. Where no reference products exist, the biocidal product must give a defined level of protection or control in the areas of proposed use. Conclusions as to the performance of the biocidal product must be valid for all areas of proposed use and for all areas in the Member State or, where appropriate, in the Union, except where the biocidal product is intended for use in specific circumstances. The evaluating body shall evaluate dose-response data generated in appropriate trials (which must include an untreated control) involving dose rates lower than the recommended rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.
Summary
78. In relation to the criteria set out in points (iii) and (iv) of Article 19(1)(b), the evaluating body shall combine the conclusions arrived at for the active substance(s) and the substances of concern to produce overall summary conclusions for the biocidal product itself. A summary of the conclusions in relation to the criteria set out in points (i) and (ii) of Article 19(1)(b) shall also be made.
OVERALL INTEGRATION OF CONCLUSIONS
The evaluating body shall, on the basis of the evaluation carried out in accordance with the principles set down in this Annex, come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria laid down under point (b) of Article 19(1).
ANNEX VII
CORRELATION TABLE
|
Directive 98/8/EC |
This Regulation |
|
— |
Article 1 |
|
Article 1 |
Article 2 |
|
Article 2 |
Article 3 |
|
Article 10 |
Article 4 |
|
Article 10 |
Article 5 |
|
— |
Article 6 |
|
Article 11(1)(a) |
6(1) |
|
Article 11(1)(a)(i) and (ii) |
6(2) |
|
— |
6(3) |
|
— |
6(4) |
|
— |
Article 7 |
|
Article 11(1)(a) |
7(1) |
|
— |
7(2) |
|
— |
7(3) |
|
— |
7(4) |
|
— |
7(5) |
|
— |
7(6) |
|
— |
Article 8 |
|
Article 11(2), first subparagraph |
8(1) |
|
Article 11(2), second subparagraph |
8(2) |
|
Article 10(1), first subparagraph |
8(3) |
|
— |
8(4) |
|
— |
Article 9 |
|
11(4) |
9(1) |
|
— |
9(2) |
|
— |
Article 10 |
|
Article 33 |
Article 11 |
|
Article 10(4) |
Article 12 |
|
— |
12(1) |
|
— |
12(2) |
|
— |
12(3) |
|
— |
Article 13 |
|
— |
Article 14 |
|
— |
Article 15 |
|
— |
Article 16 |
|
— |
Article 17 |
|
Article 3(1) |
17(1) |
|
Article 8(1) |
17(2) |
|
— |
17(3) |
|
Article 3(6) |
17(4) |
|
Article 3(7) |
17(5) |
|
— |
17(6) |
|
— |
Article 18 |
|
— |
Article 19 |
|
Article 5(1) |
19(1) |
|
Article 5(1)(b) |
19(2) |
|
— |
19(3) |
|
Article 5(2) |
19(4) |
|
— |
19(5) |
|
Article 2(1)(j) |
19(6) |
|
— |
19(7) |
|
— |
19(8) |
|
— |
19(9) |
|
— |
Article 20 |
|
Article 8(2) |
20(1) |
|
Article 8(12) |
20(2) |
|
— |
20(3) |
|
— |
Article 21 |
|
— |
Article 22 |
|
Article 5(3) |
22(1) |
|
— |
22(2) |
|
— |
Article 23 |
|
— |
23(1) |
|
Article 10(5)(i) |
23(2) |
|
— |
23(3) |
|
— |
23(4) |
|
— |
23(5) |
|
— |
23(6) |
|
Article 33 |
Article 24 |
|
— |
Article 25 |
|
— |
Article 26 |
|
— |
Article 27 |
|
— |
Article 28 |
|
— |
Article 29 |
|
— |
Article 30 |
|
— |
Article 31 |
|
Article 4 |
Article 32 |
|
— |
Article 33 |
|
— |
Article 34 |
|
— |
Article 35 |
|
Article 4(4) |
Article 36 |
|
— |
Article 37 |
|
— |
Article 38 |
|
— |
Article 39 |
|
— |
Article 40 |
|
— |
Article 41 |
|
— |
Article 42 |
|
— |
Article 43 |
|
— |
Article 44 |
|
— |
Article 45 |
|
— |
Article 46 |
|
— |
Article 47 |
|
Article 7 |
Article 48 |
|
Article 7 |
Article 49 |
|
Article 7 |
Article 50 |
|
— |
Article 51 |
|
— |
Article 52 |
|
— |
Article 53 |
|
— |
Article 54 |
|
Article 15 |
Article 55 |
|
Article 17 |
Article 56 |
|
— |
Article 57 |
|
— |
Article 58 |
|
Article 12 |
Article 59 |
|
— |
Article 60 |
|
— |
60(1) |
|
Article 12(1)(c)(ii) and (1)(b) and (1)(d)(ii) |
60(2) |
|
Article 12(2)(c)(i) and (ii) |
60(3) |
|
— |
Article 61 |
|
— |
Article 62 |
|
— |
Article 63 |
|
Article 13(2) |
63(1) |
|
— |
63(2) |
|
— |
63(3) |
|
Article 13(1) |
Article 64 |
|
— |
Article 65 |
|
Article 24 |
65(1) |
|
— |
65(2) |
|
Article 24 |
65(3) |
|
— |
65(4) |
|
— |
Article 66 |
|
— |
66(1) |
|
— |
66(2) |
|
— |
66(3) |
|
Article 19(1) |
66(4) |
|
— |
Article 67 |
|
— |
Article 68 |
|
— |
Article 69 |
|
Article 20(1) and 20(2) |
Article 69(1) |
|
Article 20(3) |
Article 69(2) |
|
Article 20(6) |
Article 69(2) |
|
Article 21, second subparagraph |
Article 70 |
|
— |
Article 71 |
|
— |
Article 72 |
|
Article 22(1), first and second subparagraphs |
72(1) |
|
Article 22(1), third subparagraph |
72(2) |
|
Article 22(2) |
72(3) |
|
— |
Article 73 |
|
— |
Article 74 |
|
— |
Article 75 |
|
— |
Article 76 |
|
— |
Article 77 |
|
— |
Article 78 |
|
— |
Article 79 |
|
— |
Article 80 |
|
— |
80(1) |
|
Article 25 |
80(2) |
|
— |
80(3) |
|
Article 26 |
Article 81 |
|
Article 28 |
Article 82 |
|
— |
Article 83 |
|
— |
Article 84 |
|
Article 29 |
Article 85 |
|
— |
Article 86 |
|
— |
Article 87 |
|
Article 32 |
Article 88 |
|
— |
Article 89 |
|
— |
Article 90 |
|
— |
Article 91 |
|
— |
Article 92 |
|
— |
Article 93 |
|
— |
Article 94 |
|
— |
Article 95 |
|
— |
Article 96 |
|
— |
Article 97 |
|
Annex IA |
Annex I |
|
Annex II A, III A and IV A |
Annex II |
|
Annex II B, III B and IV B |
Annex III |
|
— |
Annex IV |
|
Annex V |
Annex V |
|
Annex VI |
Annex VI |
( 1 ) OJ L 92, 7.4.1990, p. 42.
( 2 ) OJ L 311, 28.11.2001, p. 1.
( 3 ) OJ L 311, 28.11.2001, p. 67.
( 4 ) OJ L 136, 30.4.2004, p. 1.
( 5 ) OJ L 139, 30.4.2004, p. 1.
( 6 ) OJ L 139, 30.4.2004, p. 55.
( 7 ) OJ L 354, 31.12.2008, p. 34.
( 8 ) OJ L 229, 1.9.2009, p. 1.
( 9 ) OJ L 309, 24.11.2009, p. 1.
( 10 ) OJ L 170, 30.6.2009, p. 1.
( 11 ) OJ 196, 16.8.1967, p. 1.
( 12 ) OJ L 183, 29.6.1989, p. 1.
( 13 ) OJ L 131, 5.5.1998, p. 11.
( 14 ) OJ L 330, 5.12.1998, p. 32.
( 15 ) OJ L 200, 30.7.1999, p. 1.
( 16 ) OJ L 262, 17.10.2000, p. 21.
( 17 ) OJ L 327, 22.12.2000, p. 1.
( 18 ) OJ L 158, 30.4.2004, p. 50.
( 19 ) OJ L 158, 30.4.2004, p. 7.
( 20 ) OJ L 376, 27.12.2006, p. 21.
( 21 ) OJ L 204, 31.7.2008, p. 1.
( 22 ) OJ L 353, 31.12.2008, p. 1.
( 23 ) OJ L 309, 24.11.2009, p. 71.
( 24 ) OJ L 286, 31.10.2009, p. 1.
( 25 ) OJ L 276, 20.10.2010, p. 33.
( 26 ) OJ L 334, 17.12.2010, p. 17.
( 27 ) OJ L 124, 20.5.2003, p. 36.
( 28 ) OJ L 275, 20.10.2011, p. 38.
( 29 ) Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1).
( 30 ) Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
( 31 ) Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
( 32 ) Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).
( 33 ) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
( 34 ) OJ L 66, 4.3.2004, p. 45.
( 35 ) Guidance on data sharing established in accordance with Regulation (EC) No 1907/2006.
( 36 ) OJ L 218, 13.8.2008, p. 30.
( 37 ) OJ L 145, 31.5.2001, p. 43.
( 38 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
( 39 ) OJ L 142, 31.5.2008, p. 1.
( 40 ) OJ L 276, 20.10.2010, p. 33.
( 41 ) OJ L 50, 20.2.2004, p. 44.
( 42 ) See definition of vulnerable groups in Article 3.
( 43 ) OJ L 164, 25.6.2008, p. 19.