(1)

The Commission has negotiated on behalf of the European Union an agreement with the Republic of Kiribati on the short-stay visa waiver (the ‘Agreement’).

(2)

In accordance with Council Decision (EU) 2016/1197 (2), the Agreement has been signed and is applied on a provisional basis as from 24 June 2016.

(3)

The Agreement sets up a Joint Committee of experts for the management of the Agreement. The Union is to be represented within that Joint Committee by the Commission, which should be assisted by the representatives of the Member States.

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (3); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (4); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(6)

The Agreement should be approved,

(1)

The Commission has negotiated on behalf of the Union an agreement with the Republic of the Marshall Islands on the short-stay visa waiver (the ‘Agreement’).

(2)

In accordance with Council Decision (EU) 2016/1363 (2), the Agreement has been signed and is applied on a provisional basis as from 28 June 2016.

(3)

The Agreement sets up a Joint Committee of experts for the management of the Agreement. The Union is to be represented within that Joint Committee by the Commission, which should be assisted by the representatives of the Member States.

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (3); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (4); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(6)

The Agreement should be approved,

(1)

The Commission has negotiated on behalf of the Union an agreement with the Federated States of Micronesia on the short-stay visa waiver (the ‘Agreement’).

(2)

In accordance with Council Decision (EU) 2016/1879 (2), the Agreement has been signed and is applied on a provisional basis as from 20 September 2016.

(3)

The Agreement sets up a Joint Committee of experts for the management of the Agreement. The Union is to be represented within that Joint Committee by the Commission, which should be assisted by the representatives of the Member States.

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (3); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (4); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(6)

The Agreement should be approved,

(1)

The Commission has negotiated on behalf of the Union an agreement with Solomon Islands on the short-stay visa waiver (the ‘Agreement’).

(2)

In accordance with Council Decision (EU) 2016/1888 (2), the Agreement has been signed and is applied on a provisional basis as from 8 October 2016.

(3)

The Agreement sets up a Joint Committee of experts for the management of the Agreement. The Union is to be represented within that Joint Committee by the Commission, which should be assisted by the representatives of the Member States.

(4)

This Decision constitutes a development of the provisions of the Schengen acquis in which the United Kingdom does not take part, in accordance with Council Decision 2000/365/EC (3); the United Kingdom is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(5)

This Decision constitutes a development of the provisions of the Schengen acquis in which Ireland does not take part, in accordance with Council Decision 2002/192/EC (4); Ireland is therefore not taking part in the adoption of this Decision and is not bound by it or subject to its application.

(6)

The Agreement should be approved,

(1)

Pursuant to Regulation (EC) No 1924/2006 health claims made on foods are prohibited unless they are authorised by the Commission in accordance with that Regulation and included in a list of permitted claims.

(2)

Regulation (EC) No 1924/2006 also provides that applications for authorisations of health claims may be submitted by food business operators to the national competent authority of a Member State. The national competent authority is to forward valid applications to the European Food Safety Authority (EFSA), hereinafter referred to as ‘the Authority’.

(3)

Following receipt of an application the Authority is to inform without delay the other Member States and the Commission thereof, and to deliver an opinion on the health claim concerned.

(4)

The Commission is to decide on the authorisation of health claims taking into account the opinion delivered by the Authority.

(5)

Following an application from Anxiofit Ltd and ExtractumPharma Co Ltd, submitted pursuant to Article 14(1)(a) of Regulation (EC) No 1924/2006, the Authority was required to deliver an opinion on a health claim related to Anxiofit-1 and reduction of subthreshold and mild anxiety (Question No EFSA-Q-2015-00006 (2)). The claim proposed by the applicant was worded as follows: ‘Anxiofit-1 has been shown to ameliorate subthreshold and mild anxiety. Subthreshold and mild anxiety are risk factors in the development of anxiety disorders and depression’.

(6)

On 8 January 2016, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, the scientific evidence is insufficient to establish a cause and effect relationship between the consumption of Anxiofit-1 and reduction of subthreshold and mild anxiety. Accordingly, as the claim does not comply with the requirements of Regulation (EC) No 1924/2006, it should not be authorised.

(7)

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

(1)

Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (SCCP) pursuant to Commission Decision 2004/210/EC (2), concluded that the potential risks of the use of hair dyes were of concern. The SCCP, in its opinions, recommended that the Commission take further steps to control the use of hair dye substances.

(2)

The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity or carcinogenicity.

(3)

Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.

(4)

The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (SCCS) pursuant to Commission Decision 2008/721/EC (3), assessed the safety of individual hair dye substances for which updated files had been submitted by the industry.

(5)

As regards the evaluation of possible consumer health risks by reaction products formed by oxidative hair dye substances during the hair dyeing process, based on the data yet available, the SCCS, in its opinion of 21 September 2010, did not raise any major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the Union.

(6)

In order to ensure the safety of hair dye products for human health, it is appropriate to set up maximum concentrations of ten assessed hair dye substances by taking into account the final opinions given by the SCCS on their safety.

(7)

Since substances N,N'-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine and 2,6-Dihydroxyethylaminotoluene are currently regulated under generic entries 8 and 9 of Annex III to Regulation (EC) No 1223/2009, separate reference numbers should be created for those substances, taking into account conclusions on their safety in the SCCS opinions 1572/16 and 1563/15.

(8)

The definition of a hair product in Regulation (EC) No 1223/2009 excluded the application of hair dye substances on eyelashes. That exclusion was motivated by the fact that the level of risk is different when cosmetic products are applied on the hair on the head and on eyelashes respectively. A specific safety assessment was therefore needed for the application of hair dye substances on eyelashes.

(9)

The SCCS, in its opinion on oxidative hair dye substances and hydrogen peroxide used in products to colour eyelashes of 25 March 2015 (SCCS/1553/15), concluded that oxidative hair dye substances Toluene-2,5-Diamine, p-Aminophenol, 2-Methylresorcinol, Tetraaminopyrimidine Sulfate, Hydroxyethyl-p-Phenylenediamine Sulfate and 2-Amino-3-Hydroxypyridine, listed in Annex III to Regulation (EC) No 1223/2009 and found safe for use in hair dye products, can be safely used by professionals in products intended for colouring eyelashes.

(10)

On the basis of the scientific assessment of those substances, their use should be allowed in products intended for colouring eyelashes. However, in order to avoid any risk connected with the self-application of products intended for colouring eyelashes by consumers, they should be allowed for professional use only. In order to allow professionals to inform consumers about possible adverse effects of the application of products intended for colouring eyelashes and to lower the risk of skin sensitisation to those products, appropriate warnings should be printed on their labels.

(11)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(12)

It is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new requirements and to phase out products concerned which do not comply with those requirements.

(13)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

(1)

The Scientific Committee on Consumer Safety (‘SCCS’), concluded in its opinion of 16 December 2008 (2) that the use of Benzophenone-3 as a UV-filter at a concentration of up to 6 % w/w in cosmetic sunscreen products and up to 0,5 % w/w in all types of cosmetic products to protect the formulation does not pose a risk to human health, apart from its contact allergenic and photoallergenic potential.

(2)

Consequently, the current maximum concentration of 10 % w/w for Benzophenone-3 used as a UV-filter in cosmetic products should be decreased to 6 % w/w.

(3)

Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(4)

The application of the new maximum concentration should be deferred to allow the industry to make the necessary adjustments to product formulations. In particular, undertakings should be granted six months from the entry into force of this Regulation to take the necessary measures to place on the market compliant products and to stop making available products already placed on the market that do not comply with the new maximum concentration.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Ireland received on 14 November 2013 an application from DuPont de Nemours (Deutschland) GmbH for the approval of the active substance oxathiapiprolin. In accordance with Article 9(3) of that Regulation, Ireland, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 16 January 2014 of the admissibility of the application.

(2)

On 1 January 2015, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

(3)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested the applicant to supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 12 February 2016.

(4)

On 26 May 2016, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance oxathiapiprolin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

(5)

On 6 October 2016 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for oxathiapiprolin and a draft Regulation providing that oxathiapiprolin is approved.

(6)

The applicant was given the possibility to submit comments on the review report.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve oxathiapiprolin.

(8)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

(9)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

(10)

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

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 7 July 2015 an application from the Institut technique de l'agriculture biologique (ITAB) for the approval of Satureja montana L. essential oil as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 13 June 2016 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Satureja montana L. essential oil to the Standing Committee on Plants, Animals, Food and Feed on 7 October 2016 and finalised them for the meeting of that Committee on 7 December 2016.

(3)

The documentation provided by the applicant shows that Satureja montana L. essential oil fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

(4)

Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to the essential oil and the components carvacrol and gamma-terpinene specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised.

(5)

The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

(6)

However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

(7)

Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Satureja montana L. essential oil as basic substance.

(8)

This Regulation does not prejudice the submission of a further application for the approval of Satureja montana L. essential oil as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

(9)

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

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 19 October 2015 an application from the Institut technique de l'agriculture biologique (ITAB) for the approval of Origanum vulgare L. essential oil as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 22 June 2016 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Origanum vulgare L. essential oil to the Standing Committee on Plants, Animals, Food and Feed on 7 October 2016 and finalised them for the meeting of that Committee on 7 December 2016.

(3)

The documentation provided by the applicant shows that Origanum vulgare L. essential oil fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

(4)

Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to the essential oil and the components carvacrol, gamma-terpinene and 1,8-cineole specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised.

(5)

The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

(6)

However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

(7)

Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Origanum vulgare L. essential oil as basic substance.

(8)

This Regulation does not prejudice the submission of a further application for the approval of Origanum vulgare L. essential oil as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

(9)

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

(1)

Commission Implementing Regulation (EU) No 686/2012 (2) allocates the evaluation of each active substance to a rapporteur Member State and a co-rapporteur Member State. In agreement with the Member States concerned, it is considered necessary to change the co-rapporteur Member State for the active substance metaldehyde while respecting the balance as regards the distribution of the responsibilities and the work between Member States. The co-evaluation for the purposes of the renewal procedures for metaldehyde should be allocated to Austria.

(2)

Implementing Regulation (EU) No 686/2012 should therefore be amended accordingly.

(3)

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

(1)

Commission Directive 2003/31/EC (2) included linuron as 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 linuron, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2017.

(4)

An application for the renewal of the approval of linuron was 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 applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was 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 (hereinafter ‘the Authority’) and the Commission on 15 April 2015.

(7)

The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 8 June 2016 (6) the Authority communicated to the Commission its conclusion on whether linuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Specific concerns were identified, in particular, child resident exposure is above the toxicological reference value (‘AOEL’) and operator exposure considering handheld sprayer application is also in exceedance of the AOEL even when personal protective equipment is used. Furthermore, a high risk to birds and wild mammals, non-target arthropods and non-target soil macro-organisms was identified. The consumer risk assessment could not be finalised due to a number of serious deficiencies in the data package. In addition, the exposure and risk assessment for several environmental compartments including groundwater could also not be finalised.

(9)

Linuron is classified as toxic for reproduction category 1B in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7). Child resident exposure is above the AOEL for the proposed uses. To demonstrate negligible exposure of humans to the substance under realistic proposed conditions of use, exposure cannot be above the AOEL, therefore use of linuron under realistic proposed conditions of use so that exposure of humans to the substance is negligible, is excluded. In addition, a further requirement to demonstrate negligible exposure is that residues of the active substance shall not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005 of the European Parliament and of the Council (8). A Maximum Residue Level could not be derived from the available data for the proposed use of linuron, however, the available residue trial data for the proposed use indicate that residues of linuron above the default value would be expected and therefore this condition is not fulfilled. Based on these considerations, the requirements set out in Point 3.6.4 of Annex II to Regulation (EC) No 1107/2009 are not fulfilled.

(10)

Furthermore, in addition to the classification of linuron as toxic for reproduction category 1B, linuron is also classified as carcinogenic category 2 in accordance with Regulation (EC) No 1272/2008 and therefore shall be considered to have endocrine disrupting properties in accordance with the third paragraph of Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009. In addition, the available scientific evidence shows that linuron has endocrine disrupting properties that may cause adverse effects on endocrine organs in humans and non-target organisms. Negligible exposure of humans to linuron under realistic conditions of use is excluded for the reasons detailed in recital 9. Based on these considerations, the requirements set out in the first paragraph of Point 3.6.5 of Annex II to Regulation (EC) No 1107/2009 are not fulfilled.

(11)

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

(12)

However, despite the arguments put forward by the applicant, the concerns related to the substance could not be eliminated.

(13)

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 are satisfied. The approval of the active substance linuron should therefore not be renewed.

(14)

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

(15)

Member States should be provided with time to withdraw authorisations for plant protection products containing linuron.

(16)

For plant protection products containing linuron, 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 3 June 2018.

(17)

Commission Implementing Regulation (EU) 2016/950 (9) extended the expiry date of linuron to 31 July 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance. Given that a decision is taken ahead of this extended expiry date, this Regulation should apply as soon as possible.

(18)

This Regulation does not prejudice the submission of a further application for the approval of linuron in accordance with Article 7 of Regulation (EC) No 1107/2009.

(19)

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

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

In accordance with Article 29 of the Schengen Borders Code, the Council adopted on 12 May 2016, on a proposal from the Commission, an Implementing Decision setting out a Recommendation for temporary internal border control in exceptional circumstances putting the overall functioning of the Schengen area at risk (2).

(2)

The Council recommended that five Schengen States (Austria, Germany, Denmark, Sweden and Norway) maintain proportionate temporary border control at a limited number of their internal border sections, for a period of six months, in order to address the serious threat to public policy and internal security in these States by the combination of deficiencies in external border control in Greece and the secondary movements of irregular migrants entering via Greece and who may intend to move to other Schengen States. This period was prolonged by the Council on a proposal from the Commission for another three months on 11 November 2016.

(3)

Under Articles 25 and 29 of the Schengen Borders Code, the initial period recommended by the Council can be further prolonged if the exceptional circumstances persist.

(4)

The Recommendation of 11 November 2016 required that the Schengen States concerned report monthly to the Commission on the outcome of the controls carried out and on the assessment concerning the continued necessity of such controls, when applicable. The Commission received such reports from all the Schengen States concerned. The information contained in these reports demonstrates that the controls have remained within the conditions set by the Recommendation. It also confirms a progressive stabilisation of the situation in these States, with a continuous reduction in the number of persons to whom entry is refused, as well as the number of asylum applications received.

(5)

However, despite this progress, the conditions set out in the Roadmap ‘Back to Schengen’ in order to allow lifting all internal border controls and returning to a normally functioning Schengen area are still not entirely fulfilled. Moreover, in spite of the ongoing progress and the significant improvement related to the external border management that Greece has made in 2016, an important number of irregular migrants still remains in Greece. Based on trends observed in the past, the Member States most affected by the secondary movements of irregular migrants coming from Greece remain exposed to the risk related to their irregular movements.

(6)

In its Communication ‘Back to Schengen — A Roadmap’, the Commission identified the different policies to be put in place to return to a fully functioning Schengen Area. The European Border and Coast Guard Agency is now swiftly becoming operational, allowing it to provide assistance to Greece at the Northern Greek external border as of February 2017.

(7)

Another element identified in the Back to Schengen Roadmap is the implementation of the EU-Turkey Statement. The fourth progress report (3) confirms the trend of a steady delivery of results, albeit in the face of many challenges. This implementation nevertheless needs to be constantly monitored. The same applies to the cooperation agreed upon in the Statement of the Western Balkans Route Leaders meeting.

(8)

The exceptional circumstances constituting a serious threat to public policy and internal security and putting at risk the overall functioning of the Schengen area therefore still persist.

(9)

In light of the facts above, it appears therefore justified, as a last resort measure, to allow a further prolongation of the temporary border controls at the internal borders concerned by the Schengen States currently carrying out such controls, namely Austria, Germany, Denmark, Sweden and the associated country Norway, in accordance with Article 29 of the Schengen Borders Code.

(10)

Based on the factual indicators available at this stage, this prolongation should not exceed three months as from the date of adoption of the present Implementing Decision.

(11)

The Member States that decide to continue carrying out internal border control under the present Implementing Decision should notify the other Member States, the European Parliament and the Commission accordingly.

(12)

Before opting for such controls, the Member States concerned should examine whether other measures alternative to border controls could not be used to effectively remedy the identified threat, such as the exercise of police powers in a manner compatible with Article 23 of the Schengen Borders Code, and decide to reintroduce border controls at the internal borders concerned only as a measure of last resort, when such less restrictive measures for cross-border traffic cannot sufficiently address the threats identified. The Member States concerned should inform of the outcome of this reflection and the reasons for opting for border controls in their notifications.

(13)

The controls under the present Implementing Decision should continue to be carried out only to the necessary extent, limited in their intensity to the absolute minimum necessary and adjusted to the circumstances. Accordingly, it can be envisaged that any further decrease of the flow should lead to suspending the controls at given border sections. Only targeted controls, based on constantly updated risk analysis and intelligence, should be carried out, in order to optimise the benefit of the controls and limit their negative effects on free movement. The Schengen States affected by these controls at the relevant border sections should be admitted to regularly express their views on their necessity; the Schengen State having decided to reintroduce such controls should take these views into account when examining and reviewing the necessity of such checks, with the objective of progressively reducing them.

(14)

At the end of each month of implementation of the present Implementing Decision, a complete report on the results of the checks carried out should be promptly sent to the Commission and the Council, together with an assessment of their continuous necessity when applicable. This report should include the total number of persons checked, the total number of refusals of entry following the checks, the total number of return decisions issued following the checks and the total number of asylum applications received at the internal borders where the checks take place.

(15)

The Council takes note that the Commission has announced that it will continue working with the Schengen States concerned to gradually phase out temporary internal border controls with the objective of returning to a normal functioning of the Schengen area as soon as possible.

(16)

The Council also takes note that the Commission has announced that it will closely monitor the application of this Implementing Decision,

(1)

Avian influenza is an infectious viral disease in birds. Infections with avian influenza viruses in domestic poultry and other captive birds cause two main forms of that disease that are distinguished by their virulence. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most species of birds. That disease may have a severe impact on the profitability of poultry farming.

(2)

In the event of an outbreak of avian influenza in a Member State, there is a risk that the disease agent may spread to other holdings where poultry or other captive birds are kept. As a result, it may spread from one Member State to other Member States or to third countries through trade in live poultry or other captive birds or their products.

(3)

Council Directive 2005/94/EC (3) sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds. That Directive provides for the establishment of protection and surveillance zones in the event of an outbreak of highly pathogenic avian influenza. This regionalisation is applied in particular to preserve the health status of birds in the remainder of the territory of the Member State by preventing the introduction of the pathogenic agent and ensuring the early detection of the disease.

(4)

Since early November 2016, 16 Member States (the ‘concerned Member States’), namely Bulgaria, the Czech Republic, Denmark, Germany, Greece, France, Croatia, Italy, Hungary, the Netherlands, Austria, Poland, Romania, Slovakia, Sweden and the United Kingdom, have notified the Commission of outbreaks of highly pathogenic avian influenza of subtype H5N8 in holdings on their territory where poultry or other captive birds are kept.

(5)

The highly pathogenic avian influenza virus of subtype H5N8 has since the end of October 2016 been detected in large numbers of wild birds, mainly of migratory bird species in the Member States listed above and in addition in Ireland, Spain, Portugal and Slovenia.

(6)

In most Member States, the causative virus was first found in wild birds, before it was detected in holdings that keep poultry or other captive birds.

(7)

Also neighbouring third countries such as the former Yugoslav Republic of Macedonia, Serbia, Switzerland, the Russian Federation and Ukraine have identified the highly pathogenic avian influenza virus of subtype H5N8 on their territories in wild birds or in holdings where poultry or other captive birds are kept.

(8)

In response to the outbreaks of highly pathogenic avian influenza of subtype H5N8 in Denmark, Germany, France, Hungary, the Netherlands, Austria and Sweden the Commission adopted several Commission Implementing Decisions on protection measures addressed to these Member States.

(9)

For reasons of clarity and in order to keep the Member States, third countries and stakeholders up-to-date on the evolution of the epidemiological situation, Commission Implementing Decision (EU) 2016/2122 (4) was adopted to list in one Union act the protection and surveillance zones established by the competent authority of the concerned Member States following outbreaks of highly pathogenic avian influenza of subtype H5N8 in holdings on their territory in accordance with Directive 2005/94/EC. The concerned Member States are listed in the Annex to that Implementing Decision.

(10)

Since the adoption of Implementing Decision (EU) 2016/2122 the epidemic has further evolved and extended its geographical range in particular due to the ongoing seasonal movements of wild migratory birds and the occasional spillover to holdings where poultry and other captive birds are kept. Subsequent virus spread between holdings has also occurred in certain areas with a high density of holdings where poultry cannot be sufficiently protected against contacts with wild birds.

(11)

Implementing Decision (EU) 2016/2122 was subsequently amended by Commission Implementing Decisions (EU) 2016/2219 (5), (EU) 2016/2279 (6), (EU) 2016/2367 (7), (EU) 2017/14 (8), (EU) 2017/116 (9) and (EU) 2017/155 (10) following further outbreaks of highly pathogenic avian influenza of subtype H5N8 in Bulgaria, the Czech Republic, Germany, Greece, France, Croatia, Italy, Hungary, the Netherlands, Austria, Poland, Romania, Slovakia, Sweden and the United Kingdom.

(12)

Since the adoption of Implementing Decision (EU) 2017/155, Bulgaria, the Czech Republic, Germany, Greece, France, Italy, Hungary, Poland, Romania, Slovakia, Sweden and the United Kingdom have reported further outbreaks of highly pathogenic avian influenza of subtype H5N8 in poultry and have taken the necessary measures required in accordance with Directive 2005/94/EC, including the establishment of protection and surveillance zones around outbreaks. In all cases, the Commission examined the measures taken by the concerned Member States in accordance with Directive 2005/94/EC and satisfied itself that the boundaries of the protection and surveillance zones, established by the competent authorities of the concerned Member States, were at a sufficient distance to any holding where an outbreak had been confirmed.

(13)

In addition, surveillance zones are still in place in Croatia and Austria due to previous outbreaks in these Member States. Implementing Decision (EU) 2016/2122 was adopted, and subsequently duly amended, in order to rapidly describe at Union level the protection and surveillance zones established in the concerned Member States in accordance with Directive 2005/94/EC, so as to prevent any unnecessary disturbance to trade within the Union and to avoid unjustified barriers to trade being imposed by third countries.

(14)

The current epidemiological situation is still evolving. Highly pathogenic avian influenza virus of subtype H5N8 virus continues to be identified in wild birds and in poultry or other captive birds in many Member States. In addition, a highly pathogenic avian influenza virus of subtype H5N5 has recently been detected in a number of wild birds of different species, mainly found dead, in Germany, Italy, Croatia, Greece, Poland, the Netherlands and Slovenia. Germany has also notified the Commission of outbreaks of highly pathogenic avian influenza of subtype H5N5 in holdings on its territory where poultry are kept.

(15)

Wild birds, in particular wild migratory water birds, are known to be the natural host for avian influenza viruses. The presence of different subtypes of highly pathogenic avian influenza viruses in wild birds is not unusual, but poses a continuing threat for the direct and indirect introduction of those viruses into holdings where poultry or other captive birds are kept with the risk of the possible subsequent virus spread from an infected holding to other holdings. In addition, the risk for re-assortment and the emergence of new virus subtypes increases.

(16)

On 20 December 2016, EFSA published the statement: ‘Urgent request on avian influenza’ (11) recommending that preventive and control measures should be addressed to highly pathogenic avian influenza subtypes of both H5 and H7 subtypes, as there is no scientific justification to have a differentiated approach.

(17)

Likewise, the Terrestrial Code of the World Organisation for Animal Health (OIE) recommends for highly pathogenic avian influenza subtypes of both H5 and H7 subtypes, the application of the same standards for international trade in live poultry and poultry products.

(18)

Given the evolving epidemiological situation in the Union, and taking into account the seasonality of virus circulation in wild birds, there is a risk that further outbreaks of different subtypes of highly pathogenic avian influenza will occur in the Union in the coming months.

(19)

The Commission is therefore together with Member States continuously assessing the epidemiological situation and keeping the measures under review.

(20)

For reasons of clarity and taking into account the current co-circulation of two and possibly more different highly pathogenic avian influenza viruses during the current epidemic, it is appropriate to extend the scope of the current protection measures in Implementing Decision (EU) 2016/2122 in order to cover all highly pathogenic avian influenza viruses as defined in Annex I to Directive 2005/94/EC, as well as to keep the Member States, third countries and stakeholders up-to-date on the current epidemiological situation. The protection and surveillance zones that have been established by the competent authorities of the Member States in accordance with Directive 2005/94/EC, should be listed again in a single act and the duration of the regionalisation should be fixed taking into account the epidemiology of highly pathogenic avian influenza.

(21)

Implementing Decision (EU) 2016/2122 should therefore be repealed and replaced by this act.

(22)

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

(a)

the protection zones established by their competent authorities, in accordance with Article 16(1)(a) of Directive 2005/94/EC, comprise at least the areas listed as protection zones in Part A of the Annex to this Decision;

(b)

the measures to be applied in the protection zones, as provided for in Article 29(1) of Directive 2005/94/EC, are maintained until at least the dates for the protection zones set out in Part A of the Annex to this Decision.

(a)

the surveillance zones established by their competent authorities in accordance with Article 16(1)(b) of Directive 2005/94/EC, comprise at least the areas listed as surveillance zones in Part B of the Annex to this Decision;

(b)

the measures to be applied in the surveillance zones, as provided for in Article 31 of Directive 2005/94/EC, are maintained until at least the dates for the surveillance zones set out in Part B of the Annex to this Decision.