(1)

Pursuant to Article 21 in conjunction with Article 17(5) of Regulation (EC) No 110/2008 of the European Parliament and of the Council (2), the Commission has examined Germany’s application of 28 September 2017 for the approval of amendments to the technical file for the geographical indication ‘Münchener Kümmel’, protected under that Regulation. The amendments include changing the name ‘Münchener Kümmel’ to ‘Münchener Kümmel’/‘Münchner Kümmel’.

(2)

Regulation (EU) 2019/787, which replaces Regulation (EC) No 110/2008, entered into force on 25 May 2019. Under Article 49(1) thereof, Chapter III of Regulation (EC) No 110/2008 on geographical indications is repealed with effect from 8 June 2019. Under Article 22(2) of Regulation (EU) 2019/787, technical files submitted as part of any application before 8 June 2019 under Regulation (EC) No 110/2008 shall be deemed to be product specifications.

(3)

After concluding that the application complied with Regulation (EC) No 110/2008, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 17(6) of that Regulation, in accordance with the first subparagraph of Article 50(4) of Regulation (EU) 2019/787.

(4)

As no notice of opposition under Article 27(1) of Regulation (EU) 2019/787 has been received by the Commission, the amendments to the specification should be approved pursuant to Article 30(2) of that Regulation, which applies mutatis mutandis to product specification amendments,

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

(4)

It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

(1)

Annex XVII to Regulation (EC) No 1907/2006 lays down restrictions on the manufacture, placing on the market and use of certain substances on their own, in mixtures or in articles.

(2)

The number of people in the Union with tattoos or permanent make-up has been increasing steadily, in particular in the young population. The procedures used for tattooing or permanent make-up (referred to collectively as ‘tattooing’), whether involving the use of needles or the application of some other technique such as micro-blading, inevitably cause an injury to the skin barrier. As a result, the inks or other mixtures used for tattooing are absorbed into the body. Mixtures used for tattooing generally consist of colorants and auxiliary ingredients such as solvents, stabilisers, wetting agents, pH regulators, emollients, preservatives and thickeners. The mixtures are introduced into the human skin, inside the eyeball or into mucous membranes. The colorants mostly remain close to where the mixture is administered, so that the tattoo or permanent make-up will remain visible. However, the soluble ingredients in the mixture are distributed within a matter of hours or days across the entire body. In consequence, the skin and other organs are exposed to the effects of those soluble substances over an extended period. Some of those substances have hazardous properties that pose a potential risk to human health. In addition, metabolism of the colorants in the skin, decomposition due to solar radiation exposure and laser irradiation may also lead to the release of hazardous chemicals from the area of the body where the tattoo or permanent make-up is located (2).

(3)

Mixtures placed on the market for use for tattooing purposes are products falling within the scope of Directive 2001/95/EC of the European Parliament and of the Council (3). Directive 2001/95/EC allows producers to place products on the market only if they are safe. Member States enforce this obligation by taking actions in respect of dangerous products on the market and notifying those actions to the Commission through the Community Rapid Information System (RAPEX). RAPEX notifications on chemicals contained in mixtures used for tattooing purposes have been increasing in recent years (4).

(4)

In 2003, the Council of Europe adopted resolution ResAP (2003)2 (5) on the safety of tattoos and permanent make-up. That resolution was superseded in 2008 by resolution ResAP (2008)1 (6) . The 2008 resolution recommended a number of provisions relating to tattooing practices and the chemical composition of mixtures for tattooing purposes to ensure that they do not endanger the health and safety of the public.

(5)

Based on the Council of Europe recommendations, seven Member States put national legislation in place regulating the chemical composition of mixtures for tattooing purposes (7).

(6)

On 12 March 2015, the Commission asked the European Chemicals Agency (‘the Agency’) pursuant to Article 69(1) of Regulation (EC) No 1907/2006 to prepare a dossier in order to assess the risks to human health of certain chemicals contained in mixtures used for tattooing purposes, and the need for Union-wide action beyond the national measures already in place in some Member States and beyond the measures based on the general safety requirements laid down in Directive 2001/95/EC. The dossier prepared by the Agency in response to the Commission’s request is referred to in this Regulation as ‘the Annex XV dossier’.

(7)

The Agency prepared the Annex XV dossier in cooperation with Italy, Denmark and Norway (the Agency and Italy, Denmark and Norway are together referred to as ‘the dossier submitters’) and with the assistance of the German Federal Institute for Risk Assessment and the German Federal Institute for Occupational Health and Safety. On 6 October 2017, the dossier submitters submitted the Annex XV dossier (8). The dossier demonstrated that the risks to human health due to exposure to certain hazardous chemicals in mixtures used for tattooing purposes are not adequately controlled and need to be addressed on a Union-wide basis to achieve a harmonised high level of protection to human health and free movement of goods within the Union.

(8)

The Annex XV dossier proposed a restriction prohibiting both the placing on the market of mixtures for use for tattooing purposes and the use of mixtures for tattooing purposes if they contained any substances classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (9) in the hazard classes carcinogenicity, mutagenicity or toxicity to reproduction category 1A, 1B or 2, skin sensitisation category 1, 1A or 1 B, skin corrosion category 1, 1A, 1B, 1C or skin irritation category 2, or serious eye damage category 1 or eye irritation category 2. The Annex XV dossier also proposed the inclusion of certain substances listed in Annex II or IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council (10) with specific conditions, and substances listed in Table 1 of the Council of Europe resolution ResAP(2008)1 based on the fact that they may either undergo decomposition to or contain residual aromatic amines classified for carcinogenicity or mutagenicity. The Annex XV dossier proposed to exclude from the restriction substances that were classified in the hazard classes carcinogenicity or mutagenicity category 1A, 1B or 2 due to effects following exposure by inhalation only and not through any other route such as dermal or oral.

(9)

In addition, the Annex XV dossier proposed a number of labelling requirements, some of them modified following advice from the Agency’s Forum for Exchange of Information on Enforcement (‘the Forum’) during the opinion development process. The labelling requirements proposed in the Annex XV dossier included a requirement to state the fact that the mixture was for use for tattooing purposes, a requirement to specify a unique reference number for identifying the specific batch, a requirement to list any ingredients classified as hazardous to human health in Part 3 of Annex VI to Regulation (EC) No 1272/2008 but not covered by the proposed restriction, and any ingredients covered by the proposed restriction but used in the mixture below the concentration limit set by the proposed restriction. Furthermore, an additional labelling requirement to indicate the presence of nickel and chromium (VI) was considered necessary, as these particular substances can induce new cases of skin sensitisation and potentially trigger allergic reactions in sensitised persons. The labelling requirements were proposed in order to give consumers and tattooists additional information, to facilitate implementation of the restriction, and to ensure that investigations can be properly carried out in the event of adverse health effects.

(10)

The Annex XV dossier set out two possible restriction options (RO1 and RO2), each with different concentration limits for the substances falling within the scope of the restriction. RO1 contained lower concentration limits than RO2. The two options also contained alternative approaches for handling future updates to Annexes II and IV to Regulation (EC) No 1223/2009. RO1 suggested to apply the restriction not only to substances currently listed in those Annexes (with the requisite conditions), but also to substances listed in those Annexes at any time in the future. In other words, the restriction would apply to those substances automatically without the need to start a further restriction process or to amend Annex XVII to Regulation (EC) No 1907/2006 again. This approach is referred to as ‘dynamic’. RO2 suggested to apply the restriction only to substances currently listed in those Annexes (with the requisite conditions). This approach is referred to as ‘static’. Both options RO1 and RO2 proposed a ‘dynamic’ restriction for substances classified under Regulation (EC) No 1272/2008. This was on the grounds that it was necessary to ensure a sufficient level of protection against the human health risks posed by the presence of substances in mixtures used for tattooing purposes that are classified in the relevant categories under that Regulation.

(11)

On 20 November 2018, the Agency’s Committee for Risk Assessment (RAC) adopted an opinion concluding that the proposed restriction, with certain modifications proposed by RAC, was the most appropriate Union-wide measure to address the identified risk arising from the various substances in question, in terms of both effectiveness in reducing the risk, practicability and monitorability.

(12)

RAC considered that all relevant health hazard classes were covered by the Annex XV dossier and agreed with the hazard assessment for the substances and group of substances. In addition to the restriction options proposed under RO1 and RO2, RAC proposed a modified version of the RO1 concentration limits. RAC considered these modifications necessary because the concentration limits for some substances in RO1 and RO2 did not provide sufficient protection. For other substances, more practicable concentration limits could be proposed, in RAC’s view, while still minimising the risk for human health.

(13)

RAC did not agree with the proposal to exclude two primary aromatic amines listed in Table 1 of the ResAP (2008)1 from the scope of the proposed restriction, namely 6-amino-2-ethoxynaphthaline (CAS No 293733-21-8) and 2,4-xylidine (EC No 202-440-0; CAS No 95-68-1).

(14)

However, RAC agreed with the dossier submitters’ proposal to exclude carcinogenic and mutagenic substances of category 1A, 1B or 2 that present this hazard due to effects following exposure by inhalation only. RAC considered that substances presenting such a hazard due to effects following exposure by inhalation only were not relevant in the case of intradermal exposure to mixtures used for tattooing purposes. In addition, RAC supported the modification put forward by the dossier submitters in response to advice given by the Forum during the opinion-making process. The Forum proposed to exempt substances that are gases at standard temperature and pressure, since they are not expected to be found in mixtures used for tattooing purposes due to their physical state. The only exception would be formaldehyde since the public consultation indicated that formaldehyde can be found in tattoo inks in a dissolved state. RAC also agreed that risks of exposure by tattoo artists to mixtures administered by them for tattooing purposes are out of the scope of the Annex XV dossier.

(15)

RAC did not support the dossier submitters’ proposal for exclusion from the scope of the restriction of 21 colorants (19 non-phthalocyanine and 2 phthalocyanine pigments). Those colorants are banned by Annex II to Regulation (EC) No 1223/2009 for use in hair colours. However, the blue phthalocyanine colorant (Pigment Blue 15:3) is allowed by Annex IV to that Regulation for use in other cosmetic products while the green phthalocyanine colorant (Pigment Green 7) is allowed for other cosmetic products other than eye products. RAC considered that the risk of cancer and possible non-carcinogenic hazards could not be ruled out for the majority of these colorants, primarily due to the lack of adequate information on their hazard properties and on the risk for human health. Moreover, RAC noted that during the public consultation stakeholders pointed out that only two of these colorants, namely the two phthalocyanine-based colorants Pigment Blue 15:3 and Pigment Green 7, were essential for tattooing on account of the fact that there were no safer and technically adequate alternatives available for them.

(16)

RAC supported a dynamic link with both Regulation (EC) No 1223/2009 and Regulation (EC) No 1272/2008 as such links provide greater protection for human health.

(17)

RAC agreed with the dossier submitters that, as regards the date when the new restriction should begin to apply, a transitional period of 12 months would allow sufficient time for actors in the supply chain to meet the new requirements.

(18)

On 15 March 2019, the Agency’s Committee for Socioeconomic Analysis (SEAC) adopted an opinion, indicating that the proposed restriction, with the modifications proposed by RAC and SEAC, was the most appropriate Union-wide measure to address the identified risks in terms of its socioeconomic benefits and socioeconomic costs. SEAC reached that conclusion based on the best available information, taking into account that the significant benefits to society, in terms of the adverse skin effects and other health impacts that would be avoided, were likely to be higher than the compliance costs for industry. Moreover, SEAC concluded that the restriction would not have a significant negative economic impact on the supply chains affected, that it would be affordable in terms of price increases to consumers and that the restriction would minimise risks of regrettable substitution.

(19)

SEAC agreed with the conclusions in the Annex XV dossier and with RAC that a transitional period of 12 months seemed reasonable and sufficient to enable actors involved in the supply chains to comply with the restriction.

(20)

SEAC also supported creating a dynamic link with Regulation (EC) No 1272/2008 that would take into account any future changes to the classification of substances listed in Part 3 of Annex VI of that Regulation on the grounds that it would produce human health benefits more quickly. With regard to future changes to Annex II or Annex IV to Regulation (EC) No 1223/2009, SEAC expressed a slight preference for a static link. In SEAC’s opinion, although a static link may result in a delay in achieving the health benefits provided by the restriction, it would allow for a proper scientific scrutiny of the concentration limits appropriate for the specific use of the substances in tattooing procedures, and also for a proper assessment of the availability of alternatives.

(21)

SEAC agreed with RAC that it was appropriate to restrict the 19 colorants banned in cosmetic products as, according to the information available, some are not currently used for tattooing purposes and there are alternatives available. However, for Pigment Blue 15:3 and Pigment Green 7, comments raised during the public consultation indicated that there were no safer and technically feasible alternatives available to cover this spectrum of colours. As regards Pigment Green 7, comments indicated that it was largely replaced by the brominated Pigment Green 36 although RAC considered that Pigment Green 36 was not a less hazardous alternative. Therefore, SEAC recommended a time-limited derogation of 36 months for both pigments considering the time needed by manufacturers to reformulate the mixtures. In addition, SEAC supported the exemption for gases at standard temperature and pressure in line with RAC’s conclusion that such gases are not expected to be found dissolved in mixtures for tattooing purposes. Based on information from the public consultation SEAC also supported the exclusion of formaldehyde from that exemption.

(22)

SEAC supported the inclusion of labelling requirements and recommended the alignment of the labelling requirements with the requirements of Regulation (EC) No 1272/2008, to prevent duplication of information.

(23)

The Forum was consulted on the proposed restriction in accordance with Article 77(4)(h) of Regulation (EC) No 1907/2006 and its recommendations have been taken into account.

(24)

On 11 June 2019, the Agency submitted the opinions of RAC and SEAC (11) to the Commission.

(25)

Taking into account the Annex XV dossier and the RAC and SEAC opinions, the Commission considers that there is an unacceptable risk to human health arising from certain substances in mixtures for use for tattooing purposes above specific concentration limits. The Commission also considers that the risk needs to be addressed on a Union-wide basis.

(26)

The Commission agrees with RAC and SEAC that, above a certain practical concentration threshold, a wide range of hazardous substances identified for the purposes of Regulation (EC) No 1272/2008, Regulation (EC) No 1223/2009 and Council of Europe resolution ResAP (2008)1 should not be used in tattooing procedures. Moreover, the restriction should also ban the placing on the market of mixtures for use for tattooing purposes if they contain any such substance above the specified practical concentration threshold. By way of an ancillary requirement, suppliers placing mixtures on the market for use for tattooing purposes, within the parameters permitted by the restriction, should be required to provide sufficient information to encourage safe use of their mixtures.

(27)

The Commission agrees with RAC and SEAC that the restriction should not apply to carcinogenic and mutagenic substances with harmonised classification due to effects following exposure by inhalation only. The same analysis applies to reproductive toxicants even though no reproductive toxicant is currently classified due to inhalation exposure only. Therefore, reproductive toxicants with harmonised classification due to effects following exposure by inhalation only should also be excluded from the scope of the restriction.

(28)

The Commission agrees with RAC and SEAC that the restriction should not apply to gaseous substances other than formaldehyde as they are not expected to be present in that state in mixtures used for tattooing purposes.

(29)

The restriction should cover not just substances currently classified in the relevant hazard categories in Part 3 of Annex VI to Regulation (EC) No 1272/2008 but also substances classified in those hazard categories at any point in the future, following an amendment to that Part adding or changing the classification of a substance. Classification under Regulation (EC) No 1272/2008 is based on a careful assessment of the hazard properties of substances. The way that mixtures are administered for tattooing purposes i.e. by introducing them into a part of the body also gives sufficient indications about the potential exposure to these substances. In summary, both the potential hazard(s) of the substances and the way people are exposed to them leads to the conclusion that these substances present a general level of risk to human health that is unacceptable and needs to be addressed by this restriction in accordance with the requirements set out in Title VIII of Regulation (EC) No 1907/2006.

(30)

For any substance that subsequently comes within the terms of the restriction as a result of a subsequent amendment to Part 3 of Annex VI to Regulation (EC) No 1272/2008, the restriction should begin to apply to that substance when the classification in that Part begins to apply. This is usually 18 months after the substance has been included in Annex VI to that Regulation. The 18-month period will provide sufficient time for formulators to find safer alternatives, in particular in those cases that might otherwise lead to regrettable substitution. It is not necessary to address the availability of alternatives for substances classified in the future, as the need to ensure a high level of protection of human health takes precedence over considerations related to technical and economic feasibility of alternatives as regards substances used in tattoo inks.

(31)

Similarly, the restriction should cover not only substances currently listed with the relevant conditions in Annex II or Annex IV to Regulation (EC) No 1223/2009 but also substances listed with any of those conditions at any point in the future, following an amendment to those Annexes listing or changing the listing of a substance. If the substance raises sufficient safety concerns to be restricted in cosmetic products applied on the skin, it must raise at least the same safety concerns when present in mixtures administered for tattooing purposes, which are introduced through the skin into the human body. It is not necessary to address the availability of alternatives for substances falling within the scope of the restriction in the future as the need to protect human health takes precedence over considerations related to technical and economic feasibility of alternatives.

(32)

Nevertheless, as regards those substances that subsequently come within the terms of the restriction as a result of a future amendment to Regulation (EC) No 1223/2009, an additional period of time should be allowed, after the relevant amendment takes effect, in order to give formulators time to adapt to the consequences of the substance coming within the terms of the restriction or to find a safer alternative to it. This is because the assessment required before a substance can be listed in Annex II or Annex IV to Regulation (EC) No 1223/2009 does not allow for specific scrutiny of the substance as regards its effects in mixtures placed on the market for use for tattooing purposes. The additional period of time should be set at 18 months after entry into force of the relevant amendment of Annex II or IV to Regulation (EC) No 1223/2009.

(33)

RAC recommended a reduced concentration limit of 0,01 % for substances classified in the hazard classes skin or eye irritant, skin corrosive or serious eye damage on the basis that the 0,1 % limit proposed by the dossier submitters did not provide sufficient protection in the case of a mixture administered intradermally. During the SEAC consultation it was highlighted that, for some acids and bases used as pH regulators in tattoo mixtures, a concentration of 0,01 % or lower may not be sufficient to achieve their function of adjusting the pH of the mixture. Acids and bases exhibit their irritant or corrosive properties because of their extreme pH values. However, the irritancy or corrosivity of a mixture containing such acids and bases will depend mostly on the overall pH of the mixture itself, rather than on the pH and concentration level of individual substances within in. In the light of these factors, it is appropriate to specify a concentration limit of 0,1 % for irritant or corrosive substances when they are used as pH regulators.

(34)

Currently, labelling requirements for mixtures used for tattooing purposes are not harmonised across the Union. Given the inherent health risks related to substances in tattoo mixtures and the increasing number of people seeking tattoos and permanent make-up, harmonisation of what is written on the packaging is required to ensure proper implementation of the restriction, and thus establish confidence in a Union-wide market of safe products for tattooing purposes, allow essential monitoring and enforcement by authorities, and address and prevent fragmentation of the internal market.

(35)

The Commission considers that, to ensure proper implementation of the restriction and permit direct traceability in case of adverse health effects, a mixture placed on the market in the Union for use for tattooing purposes should be marked with a list of substances added during the process of formulation and present in the mixture for use fortattooing purposes. For the same purpose, the tattooist should provide information marked on the packaging, or included in the instructions for use, to the person undergoing the procedure. The requirement to indicate a full list of ingredients serves to address a possible patchwork of national rules, achieve economies of scale for formulators and harness the full benefits of market harmonisation. Moreover, providing such a full list is also necessary to ensure that the restriction of an extensive list of substances is practically enforceable, monitorable, and effective throughout the Union. The common nomenclature proposed will make it possible to identify the substances by using a unique name in all the Member States. This will enable consumers to easily recognize substances which they have been advised to avoid (for example because of allergies).

(36)

To complement the full list of ingredients and any potential labelling requirements under Regulation (EC) No 1272/2008, the Commission agrees with RAC and SEAC as regards the other pieces of information that should be marked on mixtures for use for tattooing purposes, in particular the unique batch number, the presence of any nickel and chromium (VI), and further safety information on the packaging or in the instructions of use. The Commission also considers that the presence of pH regulating substances should be specifically marked.

(37)

To facilitate compliance of tattooists with this restriction, only mixtures that are marked with the statement ‘Mixture for use in tattoos or permanent make-up’ should be used for tattooing purposes.

(38)

Taking into account the Annex XV dossier, the opinions of RAC and SEAC, the socioeconomic impact and the availability of alternatives, the Commission concludes that the restriction proposed in the Annex XV dossier, with the modifications described, is the most appropriate Union-wide measure to address the risk identified to human health, without imposing a significant burden on suppliers, tattooists or consumers.

(39)

Stakeholders should be allowed sufficient time to take appropriate measures to comply with the new restriction. The Commission considers that a period of 12 months is sufficient for laboratories to establish, and gain the necessary experience with, the analytical methods developed or being developed by the Member States and other stakeholders for checking compliance with the restriction.

(40)

The Commission agrees with SEAC’s recommendation that a longer period should be allowed for Pigment Blue 15:3 and Pigment Green 7 because of the lack of safer and technically adequate alternatives and the time needed by manufacturers to reformulate their mixtures. The Commission considers, that 24 months is sufficient to find safer alternatives and to remove mixtures placed on the market for use for tattooing purposes containing these pigments from the market.

(41)

Mixtures placed on the market for use for tattooing purposes are administered for a variety of reasons, including both aesthetic and medical reasons. Such mixtures may fall within the scope of Regulation (EU) 2017/745 of the European Parliament and of the Council (12). When placed on the market or used exclusively for medical purposes within the meaning of Regulation (EU) 2017/745, the restriction established by this Regulation should not apply to them. In order to ensure a consistent regulatory approach between Regulations (EU) 2017/745 and (EC) No 1907/2006 and to guarantee a high level of protection of human health, when the placing on the market or use of such mixtures may be for both, medical and non-medical purposes, the specific obligations and requirements laid down in both Regulations should apply cumulatively.

(42)

Regulation (EC) No 1907/2006 should therefore be amended accordingly.

(43)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133(1) of Regulation (EC) No 1907/2006,

(1)

Under Regulation (EU) No 531/2012, from 15 June 2017 domestic providers should not levy any surcharge in addition to the domestic retail price on roaming customers in any Member State for any regulated roaming call received, where those calls are within the limits allowed by the fair use policy.

(2)

Regulation (EU) No 531/2012 limits any surcharge applied for receiving regulated roaming calls to the weighted average of maximum mobile termination rates across the Union.

(3)

Commission Implementing Regulation (EU) 2019/2116 (2) sets out the weighted average of maximum mobile termination rates across the Union, to be applied in 2020 on the basis of the data values as of 1 July 2019.

(4)

The Body of European Regulators for Electronic Communications has provided the Commission with updated information from Member States’ national regulatory authorities on the maximum level of mobile termination rates imposed, under Articles 7 and 16 of Directive 2002/21/EC of the European Parliament and of the Council (3) and Article 13 of Directive 2002/19/EC of the European Parliament and of the Council (4) in each national market for wholesale voice call termination on individual mobile networks and on the total number of subscribers in the Member States.

(5)

Under Regulation (EU) No 531/2012, the Commission has calculated the weighted average of the maximum mobile termination rates across the Union by multiplying the maximum mobile termination rate permitted in a given Member State by the total number of subscribers in that Member State, summing that product over all Member States and then dividing the total obtained by the total number of subscribers in all Member States, on the basis of the data values as of 1 July 2020. For Member States whose currency is not the euro, the relevant exchange rate is the average for the second quarter of 2020 obtained from the European Central Bank’s database.

(6)

It is therefore necessary to update the value of the weighted average of maximum mobile termination rates across the Union.

(7)

Implementing Regulation (EU) 2019/2116 should therefore be repealed.

(8)

Under Regulation (EU) No 531/2012, the Commission should annually review the weighted average of maximum mobile termination rates across the Union as set by this Implementing Regulation.

(9)

The measures provided for in this Regulation are in line with the opinion of the Communications Committee, established by Article 22 of Directive 2002/21/EC,

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (the commodities). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)

Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

(3)

Japan is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from the whole of its territory.

(4)

On 5 November 2020, Japan confirmed the presence of HPAI of subtype H5 in a poultry holding on its territory. Due to that confirmed outbreak of HPAI, Japan can no longer be considered as free from that disease and the veterinary authorities of Japan can therefore no longer certify consignments of meat of poultry for human consumption intended for import into or transit through the Union.

(5)

The entry for Japan in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the epidemiological situation in that third country.

(6)

Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

To ensure consistency between verification of annual emissions reports pursuant to Article 15 of Directive 2003/87/EC and verification of activity level data collected pursuant to Commission Implementing Regulation (EU) 2019/1842 (2), as well as to make use of the synergies, it is appropriate to include rules for the verification of annual activity level reports required under Article 3 of Implementing Regulation (EU) 2019/1842 in the legal framework set by Commission Implementing Regulation (EU) 2018/2067 (3).

(2)

Harmonised standards such as the harmonised standard concerning requirements for greenhouse gas validation and verification bodies for use in accreditation or other forms of recognition are regularly revised. A number of amendments should be made to Implementing Regulation (EU) 2018/2067 to align it with revisions in the applicable standards and to strengthen the requirements for procedures of verifiers and for the operation of the verifier’s management system.

(3)

It is important to clarify that the presumption of conformity laid down in Article 4 of Implementing Regulation (EU) 2018/2067 does not exempt the verifier from applying the programme specific requirements in that Implementing Regulation and that that presumption of conformity does not apply to certain provisions in Implementing Regulation (EU) 2018/2067 where it is important to preserve the objectives and principles set out in Annex V to Directive 2003/87/EC.

(4)

Under Commission Delegated Regulation (EU) 2019/331 (4) and Implementing Regulation (EU) 2019/1842, the operator of an installation applying for free allocation in accordance with Article 10a of Directive 2003/87/EC is required to include the relevant monitoring provisions in a monitoring methodology plan. Therefore, it is no longer appropriate to provide for the verification of elements relevant for such free allocation in the scope of verification of the monitoring plan under Implementing Regulation (EU) 2018/2067.

(5)

In order to ensure that the evaluation of verification may be carried out in efficient and timely manner, the rules regarding access of the competent authority to internal verification documentation should be amended.

(6)

To further promote harmonisation within the Union and to improve the effectiveness of the accreditation system, it is important to clarify the eligibility of verifiers requesting accreditation in accordance with Implementing Regulation (EU) 2018/2067.

(7)

Following the publication of Implementing Regulation (EU) 2018/2067, errors of different types have been detected and need to be corrected. In particular, throughout the text, the number of Delegated Regulation 2019/331 was omitted and needs to be inserted.

(8)

Force majeure circumstances beyond the control of the operator or aircraft operator may prevent the verifier from carrying out physical site visits according to Article 21 of Implementing Regulation (EU) 2018/2067. In these cases it is appropriate to allow verifiers to carry out virtual site visits provided specific conditions are met.

(9)

Implementing Regulation (EU) 2018/2067 should therefore be amended and corrected accordingly.

(10)

It is appropriate for the amendments to Implementing Regulation (EU) 2018/2067 to apply to the verification of greenhouse gas emissions, tonne-kilometre data and allocation data related to the fourth trading period. The applicability of the relevant provisions of this Regulation should therefore be deferred to 1 January 2021.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Climate Change Committee,

(1)

Article 2 is replaced by the following:

(2)

Article 3 is amended as follows:

(3)

Article 4 is replaced by the following:

(4)

in Article 6, the first paragraph is replaced by the following:

‘A verified emissions report, tonne-kilometre report, baseline data report, new entrant data report or annual activity level report shall be reliable for users. It shall represent faithfully that, which it either purports to represent or may reasonably be expected to represent.’;

(5)

Article 7 is amended as follows:

(6)

Article 10(1) is amended as follows:

(7)

Article 11(4) is amended as follows:

(8)

in Article 13(1), point (c) is replaced by the following:

(9)

Article 16(2) is amended as follows:

(10)

Article 17 is amended as follows:

(11)

in Article 18, paragraph 3 is replaced by the following:

(12)

in Article 21, paragraphs 4 and 5 are replaced by the following:

(13)

Article 22 is amended as follows:

(14)

in Article 23(4), the introductory sentence is replaced by the following:

‘For the purposes of verifying baseline data report, new entrant data reports or annual activity level reports, the materiality level shall be 5 % of the total reported value of the following:’;

(15)

in Article 26, paragraph 3 is replaced by the following:

(16)

Article 27 is amended as follows:

(17)

in Article 29, the following paragraph 1a is inserted:

(18)

in Article 30(1), point (e) is replaced by the following:

(19)

Article 31 is amended as follows:

(20)

Article 32 is amended as follows:

(21)

the following Article is inserted:

(22)

in Article 37(5), the second subparagraph is replaced by the following:

‘Where the verifier is carrying out verification of baseline data reports, new entrant data reports or annual activity level reports the verification team shall include in addition at least one person with the technical competence and understanding required to assess the specific technical aspects regarding the collection, monitoring and reporting of data relevant for free allocation.’;

(23)

in Article 38(1), point (a) is replaced by the following:

(24)

Article 41 is amended as follows:

(25)

in Article 42, paragraph 1 is replaced by the following:

(26)

Article 43 is amended as follows:

(27)

in Article 44, the second subparagraph is replaced by the following:

‘For the purpose of verifying baseline data reports, new entrant data reports or annual activity level reports, a verifier issuing a verification report to an operator shall in addition be accredited for activity group No 98 referred to in Annex I.’;

(28)

in Article 46(1), the first subparagraph is replaced by the following:

‘Any legal person established under national law of a Member State may request accreditation pursuant to Article 5(1) of Regulation (EC) No 765/2008 and the provisions of this Chapter.’;

(29)

in Article 59(1), point (b) is replaced by the following:

(30)

in Article 60(2), point (a) is replaced by the following:

(31)

in Article 77(1), point (b) is replaced by the following:

(32)

Annex II is amended in accordance with the Annex to this Regulation.

(1)

Article 3 is corrected as follows:

(2)

the second subparagraph of Article 7(4) is amended as follows:

(3)

in the second subparagraph of Article 7(6), ‘…/…’ is replaced by ‘2019/331’;

(4)

Article 10(1) is corrected as follows:

(5)

Article 17(3) is corrected as follows:

(6)

in Article 17(4), the first subparagraph is replaced by the following:

(7)

in Article 19(3), ‘…/…’ is replaced by ‘2019/331’;

(8)

in point (e) of Article 27(1), ‘…/…’ is replaced by ‘2019/331’;

(9)

Article 27(3) is corrected as follows:

(10)

in point (e) of Article 28, ‘…/…’ is replaced by ‘2019/331’;

(11)

in point (c) of Article 30(1), ‘…/…’ is replaced by ‘2019/331’;

(12)

in the third subparagraph of Article 58(2), ‘…/…’ is replaced by ‘2019/331’;

(13)

in Article 69(1), ‘…/…’ is replaced by ‘2019/331’.

(1)

Commission Implementing Regulation (EU) 2018/2066 (2) lays down rules for the monitoring and reporting of greenhouse gas emissions from the activities subject to Directive 2003/87/EC. In particular, Implementing Regulation (EU) 2018/2066 lays down rules on the monitoring of emissions from biomass which are consistent with the rules on the use of biomass laid down in Directive 2009/28/EC of the European Parliament and of the Council (3). Directive (EU) 2018/2001 of the European Parliament and of the Council (4) repeals Directive 2009/28/EC with effect from 1 July 2021. It is therefore appropriate to align the provisions regarding the monitoring and reporting of emissions from biomass laid down in Implementing Regulation (EU) 2018/2066 with the rules laid down in Directive (EU) 2018/2001, in particular as regards the relevant definitions and the sustainability and greenhouse gas emission saving criteria for the use of biomass. Furthermore, since Directive (EU) 2018/2001 lays down the sustainability and greenhouse gas emissions saving criteria for fuels when used for energy purposes, the sustainability criteria for biomass under Implementing Regulation (EU) 2018/2066 should apply only in the case of combustion of biomass in an installation or as a biofuel for aviation. For reasons of legal certainty, it is also necessary to clarify that where the biomass used for combustion does not comply with the sustainability and greenhouse gas emission saving criteria, its carbon content should be considered as fossil carbon.

(2)

Pursuant to Commission Delegated Regulation (EU) 2019/331 (5) and Commission Implementing Regulation (EU) 2019/1842 (6), the operator of an installation applying for free allocation of allowances in accordance with Article 10a of Directive 2003/87/EC is required to include the relevant monitoring provisions in a monitoring methodology plan, subject to approval of the competent authority. No further elements need to be included in the monitoring plans of installations to which free allocation is given. Accordingly, it is no longer necessary to provide the Member States with the possibility to require the inclusion of such elements.

(3)

During the transition phase between the notification of a modification of a monitoring plan and the approval of the new modified monitoring plan by the competent authority, any gap in the monitoring or any application of a less accurate methodology should be avoided. It should therefore be clarified that data collection in this transition period should be based on both the original and the modified monitoring plan and that records should be kept of both monitoring results.

(4)

With a view of ensuring accurate monitoring of source streams involving biogas injected into a gas grid, the rules on determination of the activity data from biogas should be improved and strengthened. In particular, the determination of the biomass fraction should depend on the actual purchase of biogas by the operator, and any potential double counting of the same biogas by different users should be avoided. On the basis of experience gained in application of the methodology for determining the biomass fraction of natural gas from a gas grid, the Commission will assess the need for a review of that methodology.

(5)

Due to typical administrative and practical procedures at aerodromes, it is difficult to ascertain to which aircraft a batch of fuel is physically uplifted. Since aviation fuels are uniform in technical specifications, it is therefore appropriate to allow a monitoring approach for biofuel uplifts based on purchase data, provided that the relevant requirements laid down in Articles 29, 30 and 31 of Directive (EU) 2018/2001 are complied with.

(6)

For consistency reasons, the rounding of data on emissions of greenhouse gases should be aligned with the way verified emissions are rounded in the Union Registry established in accordance with Article 19 of Directive 2003/87/EC.

(7)

In order to reduce administrative burden for operators using certain mixed process materials, the distinction between inorganic carbon, mostly in form of carbonates, and organic carbon should be avoided where possible. In order to align common laboratory practice with the terminology of different source stream types, it is appropriate to include all forms of carbon in the same approach for process emissions. Therefore, the analysis of total carbon of a material instead of separate treatment of total inorganic carbon and total organic carbon should be allowed where possible. As a consequence, the expression ‘non-carbonate carbon’ should be used instead of ‘organic carbon’ to refer to all forms of carbon except carbonates.

(8)

The fifth Assessment Report of the Intergovernmental Panel for Climate Change (7) provides new values for global warming potentials of greenhouse gases. The global warming potentials of greenhouse gases used in the EU Emission Trading System should therefore be adapted to those values and aligned with other Union acts.

(9)

Following the publication of Implementing Regulation (EU) 2018/2066, an error has been detected in a formula used to determine the emissions of C2F6. That error should be corrected.

(10)

Member States are to transpose Directive (EU) 2018/2001 by 30 June 2021. As the monitoring and reporting under Implementing Regulation (EU) 2018/2066 takes place on a calendar year basis, the amendments made in order to align the provisions of that Regulation to Directive (EU) 2018/2001 should start to apply only as of the beginning of the subsequent reporting period, that is from 1 January 2022. The date of application for the other amendments and the correction should be the same as for Implementing Regulation (EU) 2018/2066, that is 1 January 2021. Accordingly, the existing provisions of Implementing Regulation (EU) 2018/2066 on the monitoring and reporting on CO2 emissions from biomass in accordance with Directive 2009/28/EC should continue to apply for the emissions occurring in 2021.

(11)

Implementing Regulation (EU) 2018/2066 should therefore be amended and corrected accordingly.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Climate Change Committee,

(1)

Article 3 is amended as follows:

(2)

in Article 12, paragraph 3 is deleted;

(3)

in Article 16(1), the second subparagraph is replaced by the following:

‘In case of doubt, the operator or aircraft operator shall use in parallel both the modified and the original monitoring plan to carry out all monitoring and reporting in accordance with both plans, and it shall keep records of both monitoring results.’;

(4)

in Article 18(2), the following third subparagraph is added:

‘For the purpose of this paragraph, Article 38(5) shall apply, provided that the relevant information on the sustainability and the greenhouse gas emissions saving criteria of biofuels, bioliquids and biomass fuels used for combustion is available to the operator.’;

(5)

in Article 19, the following paragraph 6 is added:

(6)

Article 38 is amended as follows:

(7)

Article 39 is amended as follows:

(8)

in Article 43(4), the following subparagraph is added:

‘For the purpose of this paragraph, Article 38(5) shall apply.’;

(9)

in Article 47(2), the following subparagraph is added:

‘For the purpose of this paragraph, Article 38(5) shall apply.’;

(10)

Article 54 is replaced by the following:

(11)

in Article 72(1), the first subparagraph is replaced by the following:

‘Total annual emissions of each of the greenhouse gases CO2, N2O and PFCs shall be reported as rounded tonnes of CO2 or CO2(e). The total annual emissions of the installation shall be calculated as the sum of the rounded values for CO2, N2O and PFCs.’;

(12)

Annexes I and X are amended in accordance with Annex I to this Regulation;

(13)

Annexes II, IV and VI are amended in accordance with Annex II to this Regulation.

(1)

the formula ‘C2F6 emissions [t] = CF4 emissions × FCF2F6’ is replaced by ‘C2F6 emissions [t] = CF4 emissions × FC2F6’;

(2)

the definition ‘FCF2F6 = Weight fraction of C2F6 (t C2F6/t CF4)’ is replaced by ‘FC2F6 = Weight fraction of C2F6 (t C2F6/t CF4)’.

(1)

Commission Implementing Regulation (EU) 2020/532 (2) contains certain derogations from, inter alia, Commission Implementing Regulation (EU) No 809/2014 (3) as regards certain administrative and on-the-spot checks applicable within the common agricultural policy.

(2)

Certain elements of checks by monitoring implemented under Article 40a of Implementing Regulation (EU) No 809/2014 require visits in the field. However, due to movement restrictions put in place to address the pandemic of COVID-19, in the year 2020 Member States may not be in a position to carry out those checks as required by that Article. Therefore it is appropriate to provide for a derogation from certain provisions of that Article.

(3)

Implementing Regulation (EU) 2020/532 should therefore be amended accordingly.

(4)

As this Regulation provides for an additional derogation from Implementing Regulation (EU) No 809/2014 in respect of claim year 2020 due to the pandemic of COVID-19, it should enter into force on the day of its publication in the Official Journal of the European Union and apply retroactively from the same date as Implementing Regulation (EU) 2020/532.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Direct Payments and the Rural Development Committee,

(1)

Commission Directive 2005/72/EC (2) included mancozeb as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance mancozeb, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2021.

(4)

Applications for the renewal of the approval of mancozeb were submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicants submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The applications were found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 27 September 2017.

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

(8)

On 20 June 2019, the Authority communicated to the Commission its conclusion (6) on whether mancozeb can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(9)

Following the withdrawal of the United Kingdom from the EU on 31 January 2020, Greece agreed to take over the responsibility as rapporteur Member State.

(10)

According to the provisions of Article 14 of Implementing Regulation (EU) No 844/2012, the Commission referred a draft renewal report to the Standing Committee on Plants, Animals, Food and Feed, for examination in March 2020. During the discussions in the Standing Committee, the new rapporteur Member State Greece informed that it considered as appropriate to evaluate data that in its view had been omitted by the earlier rapporteur Member State. Greece sent its evaluation to the Commission on 2 September 2020 in the form of an updated renewal assessment report. The evaluation was also made available to EFSA, the other Member States and the applicant.

(11)

The draft renewal report was finalised by the Standing Committee on 23 October 2020.

(12)

The Authority indentified certain specific concerns. In particular, it concluded that mancozeb has been classified as toxic for reproduction category 1B and that the new criteria to identify endocrine disrupting properties are met for humans and most likely for non-target organisms. In addition, it concluded that the non-dietary exposure estimates exceed the reference values for the representative uses in tomatoes, potatoes, cereals and grapevines. Therefore for the representative uses considered, non-dietary exposure to mancozeb also cannot be considered as negligible for the purposes of points 3.6.4 and 3.6.5 of Annex II to Regulation (EC) No 1107/2009. Given the concerns identified the derogation provided for in Article 4(7) to Regulation (EC) No 1107/2009 cannot apply.

(13)

The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, on the draft renewal report. The applicants submitted their comments which have been carefully examined.

(14)

However, despite the arguments put forward by the applicants the concerns regarding the active substance could not be eliminated.

(15)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance mancozeb.

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(17)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing mancozeb.

(18)

For plant protection products containing mancozeb, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should at the latest, expire on 4 January 2022.

(19)

Commission Implementing Regulation (EU) 2019/2094 (7) extended until 31 January 2021 the period of approval of mancozeb in order to allow the renewal process to be completed before the expiry of the approval period of that substance. Given that a decision on the non-renewal of the approval has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

(20)

This Regulation does not prevent the submission of a further application for the approval of mancozeb pursuant to Article 7 of Regulation (EC) No 1107/2009.

(21)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

(1)

Directive 2009/48/EC lays down a general obligation to list on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, the names of 11 allergenic fragrances if the concentrations of those fragrances exceed 100 mg/kg in the toy or components thereof. Those allergenic fragrances are listed in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

(2)

The Scientific Committee on Consumer Safety (SCCS), which assists the Commission as an independent risk assessment body in the area of cosmetic products, notes in its opinion of 26 and 27 June 2012 (2) that contact allergy to fragrances is a common, significant and relevant problem in Europe and that exposure to fragrances occurs from the use of other consumer products, such as toys. The SCCS also notes that, in recent years, it has become a trend to add fragrance chemicals to many types of consumer products, such as children’s toys, which may contribute significantly to the fragrance exposure of the consumer by the dermal route. The SCCS adds that the consumer is exposed to fragrance substances from a wide variety of cosmetic products, other consumer products, pharmaceuticals and occupational exposures, and that all those exposures are of importance in the context of contact allergy as it is not the source of exposure that is critical, but the cumulative dose per unit area. In the opinion, a number of established contact allergens in humans are listed in Table 13-1.

(3)

A survey of allergenic substances in products for children carried out by the Environmental Protection Agency in Denmark (3) shows the presence of allergenic fragrances in toys, namely modelling clays, slimes, a doll, a teddy bear, and rubber bands.

(4)

The Expert Group on Toys Safety advises the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety. The mission of its subgroup on Chemicals in Toys (subgroup Chemicals) is to provide advice with regard to chemical substances which may be used in toys.

(5)

The Expert Group on Toys Safety recalled, at its meeting on 13 September 2019 (4), that an allergenic substance, whether present in cosmetic products or in toys, is always allergenic. That so-called intrinsic property of the substance is independent from the use of the substance and is therefore present irrespective of whether the allergenic substance is used in cosmetics or in toys. Consequently, the Expert Group considered that an allergenic substance presenting a risk in cosmetic products could equally present a risk in toys. It therefore underlined the importance to take thorough account of the opinions of the SCCS and of its predecessor committees on allergenic fragrances in cosmetic products when regulating allergenic fragrances in toys.

(6)

At the meeting of the subgroup Chemicals of 3 May 2018 (5), the majority of its members concluded that the established contact allergens in humans listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be added to the list of allergenic fragrances that have to be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, laid down in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC.

(7)

On 13 September 2019, the Expert Group on Toys Safety confirmed the conclusions of the subgroup Chemicals.

(8)

At its meeting on 13 September 2019, the Expert Group on Toys Safety noted that entry 4 in the table in the third paragraph of point 11 of Part III of Annex II to Directive 2009/48/EC on citronellol, CAS number 106-22-9, covers only the mixture of the two enantiomeric forms of citronellol. The labelling requirements should however, according to the Expert Group, also cover the two individual enantiomeric forms listed as CAS numbers 1117-61-9 and 7540-51-4 in Table 13-1 of the SCCS opinion of 26 and 27 June 2012.

(9)

In light of the SCCS opinion of 26 and 27 June 2012 and the recommendation of the Expert Group on Toys Safety of 13 September 2019, the allergenic fragrances listed in Table 13-1 of the SCCS opinion of 26 and 27 June 2012 should be subject to labelling requirements when present in toys. The fragrances that are not yet subject to a prohibition or labelling requirements laid down in Directive 2009/48/EC, should therefore be included in the table in the third paragraph of point 11 of Part III of Annex II to that Directive.

(10)

Directive 2009/48/EC should therefore be amended accordingly.

(11)

The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 47(1) of Directive 2009/48/EC,