(1)

At its meeting on 27 and 28 November 2003, the Council decided to authorise the Presidency assisted by the Secretary-General/High Representative to open negotiations in order to conclude an Agreement on the security of information between the European Union and Canada.

(2)

Following that authorisation, the Presidency negotiated an Agreement with Canada on security procedures for exchanging and protecting classified information.

(3)

That agreement should be approved,

(a)

‘classified information’ means any information that either Party has designated by a security classification and marked as such and which, if disclosed to unauthorised third parties, could cause varying degrees of damage or harm to the interests of that Party. This information may be in oral, visual, electronic, magnetic, or document form, or in the form of material, equipment or technology and includes reproductions, translations, and material in the process of development;

(b)

‘protected information’ means any information that Canada has so designated by means of an appropriate marking and which, if disclosed to unauthorised third parties, could cause injury to a Canadian person, entity or public interest. This information may be in oral, visual, electronic, magnetic, or document form, or in the form of material, equipment or technology and includes reproductions, translations, and material in the process of development;

(c)

‘contractor’ means an individual or legal entity possessing the legal capacity to enter into contracts; this term may also refer to a subcontractor, but does not include an individual engaged by Canada or the EU under a contract of employment;

(d)

‘need-to-know’ means that access to classified information is limited to authorised individuals who need to have access to that classified information in order to perform their official duties;

(e)

‘Federal Government’ means the federal government departments of Canada and all divisions and branches of the federal public administration of Canada;

(f)

‘third party’ means any person or entity other than the Parties.

(a)

for Canada, the entity that is designated by the Government of Canada and whose name is transmitted by diplomatic channel to the EU;

(b)

for the EU, the High Representative of the Union for Foreign Affairs and Security Policy, the Member of the European Commission responsible for security matters, and the Secretary-General of the Council.

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission examined Spain's application for the approval of amendments to the specification for the protected geographical indication ‘Ternasco de Aragón’, registered under Commission Regulation (EC) No 1107/96 (2) as amended by Commission Implementing Regulation (EU) No 583/2013 (3).

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (4) as required by Article 50(2)(a) of that Regulation.

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

(1)

Commission Directive 2001/99/EC (2) included glyphosate 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 glyphosate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2017.

(4)

An application for the renewal of the inclusion of the active substance glyphosate in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. 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 20 December 2013.

(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)

Following the findings of the International Agency for Research on Cancer published on 20 March 2015 as regards the carcinogenic potential of glyphosate, on 29 April 2015 the Commission mandated the Authority to review the underlying information and to include those findings in its conclusion by 13 August 2015.

(9)

To allow for an appropriate evaluation of the information (6) from the International Agency for Research on Cancer and of the extraordinarily high number of comments received from Member States and the public, the Commission extended the deadline for the submission of the Authority's conclusion to 30 October 2015.

(10)

On 30 October 2015 (7), the Authority communicated to the Commission its conclusion on whether glyphosate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for glyphosate to the Standing Committee on Plants, Animals, Food and Feed on 28 January 2016.

(11)

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

(12)

The discussions in the Standing Committee on Plants, Animals, Food and Feed on 18 and 19 May 2016 showed that in the specific situation of glyphosate a number of Member States, in their role as risk managers, considered that it was appropriate to have an opinion of the Committee for Risk Assessment of the European Chemicals Agency (hereinafter ‘the Agency’) on the harmonised classification as regards carcinogenicity of glyphosate, before taking a decision on a renewal of the approval because such an opinion could be relevant for the approval based on the criteria set out in Regulation (EC) No 1107/2009.

(13)

The possible renewal of the approval of glyphosate was also extensively discussed outside of the Standing Committee on Plants, Animals, Food and Feed. On 13 April 2016 (8) and on 24 October 2017 (9), the European Parliament adopted Resolutions on the different draft Commission Implementing Regulations renewing the approval of the active substance glyphosate, and on 6 October 2017 the European Commission officially received a successful European Citizens' Initiative (ECI) (10), referring specifically to glyphosate in one of its three aims, with validated signatures from at least one million European citizens in at least seven Member States.

(14)

As an opinion of the Committee for Risk Assessment of the Agency on the harmonised classification as regards carcinogenicity of glyphosate was deemed necessary, on 17 March 2016, the rapporteur Member State submitted a dossier in accordance with Article 37 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (11), including for the hazard class on carcinogenicity. In view of the time required to assess such a dossier, the approval period of the active substance was extended until 6 months from the date of receipt of the opinion of the Committee for Risk Assessment of the Agency by the Commission but however until 31 December 2017 at the latest by Commission Implementing Regulation (EU) 2016/1056 (12). In the meantime, the conditions of approval of the active substance were amended in the light of new scientific and technical knowledge by Commission Implementing Regulation (EU) 2016/1313 (13).

(15)

The Committee for Risk Assessment of the Agency adopted its opinion (14) on 15 March 2017 and forwarded it to the Commission on 15 June 2017. The Commission published a Notice (15) confirming the date of its receipt in the Official Journal of the European Union on 28 June 2017. In its opinion, the Committee for Risk Assessment of the Agency concluded by consensus that on the basis of the information currently available, no hazard classification for carcinogenicity is justified for glyphosate.

(16)

In its conclusion of October 2015, the Authority identified a data gap to rule out potential endocrine activity observed in one study. Pertinent data became available too late to be included in the peer review. On 27 September 2016 the Commission asked the Authority to assess that additional information. On 7 September 2017 (16) the Authority communicated to the Commission its conclusion on the potential endocrine disrupting properties of glyphosate. In its conclusion, the Authority confirmed that the data gap had been adequately addressed as the weight of evidence indicates that glyphosate does not have endocrine disrupting properties through oestrogen, androgen, thyroid or steroidogenesis mode of action based on a comprehensive database available in the toxicology area. The available ecotoxicology studies did not contradict this conclusion.

(17)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance glyphosate 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.

(18)

It is therefore appropriate to renew the approval of glyphosate.

(19)

While a large amount of information on the active substance glyphosate already exists and has been assessed leading to the conclusion that the approval of the active substance glyphosate should be renewed, additional information on glyphosate is being published at an exceptionally high rate compared to other active substances. Therefore possibilities of rapid future developments in science and technology should be taken into account when deciding on the length of the approval period of glyphosate, also bearing in mind the fact that glyphosate is one of the most widely used herbicides in the Union.

(20)

In light of these specificities and other legitimate factors referred to in the recitals above and bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection that is sought within the Union, from a risk management perspective it is appropriate to provide for a renewal of the approval of glyphosate for a period of five years ensuring a priority re-assessment of glyphosate over other active substances.

(21)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is necessary to include certain conditions and restrictions.

(22)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(23)

Taking into account that the current approval of glyphosate expires on 15 December 2017, this Regulation should enter into force as soon as possible.

(24)

This Regulation should apply from the day after the date of expiry of the approval of the active substance glyphosate as referred to in recital 3.

(25)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The measures provided for in this Regulation are in accordance with the opinion of the appeal committee,

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

Lecithins were authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 an application was submitted for the re-evaluation of preparations of lecithins as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘technological additives’ and in the functional group ‘emulsifiers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 July 2016 (3) that, under the proposed conditions of use, the preparations of lecithins, lecithins hydrolysed and lecithins de-oiled do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations are considered efficacious for use in feed as emulsifiers. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

The assessment of lecithins liquid, lecithins hydrolysed and lecithins de-oiled shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex I to this Regulation.

(6)

It is considered appropriate to harmonise the characteristics of the lecithins, lecithins liquid, lecithins hydrolysed and lecithins de-oiled and the conditions of use to avoid the distortion of the market, Commission Implementing Regulation (EU) 2017/1007 (4) should be amended accordingly.

(7)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

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 Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes imiprothrin.

(2)

Imiprothrin has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

(3)

The United Kingdom was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 20 July 2016.

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 27 June 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5)

According to that opinion, biocidal products of product-type 18 containing imiprothrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(6)

It is therefore appropriate to approve imiprothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(7)

A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(8)

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

(1)

Poland received on 26 November 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance 2-methyl-1,2-benzisothiazol-3(2H)-one in Annex I to that Directive for use in products of product-type 6, in-can preservatives, as described in Annex V to that Directive, which corresponds to product-type 6 as described in Annex V to Regulation (EU) No 528/2012.

(2)

Poland submitted the assessment report together with its recommendations on 24 March 2016 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

(3)

The opinion of the European Chemicals Agency was formulated on 27 June 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(4)

According to that opinion, biocidal products of product-type 6 containing 2-methyl-1,2-benzisothiazol-3(2H)-one may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(5)

It is therefore appropriate to approve 2-methyl-1,2-benzisothiazol-3(2H)-one for use in biocidal products of product-type 6, subject to compliance with certain specifications and conditions.

(6)

Since 2-methyl-1,2-benzisothiazol-3(2H)-one meets the criteria for classification as a skin sensitiser sub-category 1A (strong sensitiser) as specified in point 3.4.2.2.1.2 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating 2-methyl-1,2-benzisothiazol-3(2H)-one should be labelled appropriately when placed on the market.

(7)

A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(8)

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

(1)

In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Skalický rubín’ sent by Slovakia and has published it in the Official Journal of the European Union (2).

(2)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3)

In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Skalický rubín’ should be protected and entered in the register referred to in Article 104 of that Regulation.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

Annex III to Commission Regulation (EC) No 1235/2008 (2) sets out the list of third countries whose systems of production and control measures for organic production of agricultural products are recognised as equivalent to those laid down in Regulation (EC) No 834/2007.

(2)

According to information provided by Costa Rica, the names of the control bodies ‘Kiwa BCS Öko-Garantie GmbH’, ‘Control Union Certifications’ and ‘Primus lab’ have been changed to ‘Kiwa BCS Costa Rica Limitada’, ‘Control Union Perú’ and ‘PrimusLabs.com CR S.A.’ respectively. Costa Rica has also informed the Commission that the ‘Servicio Fitosanitario del Estado, Ministerio de Agricultura y Ganadería’ is no longer a control body and that the other control bodies are the certification issuing bodies, and not the Ministry of Agriculture.

(3)

Japan has informed the Commission that its competent authority has added two control bodies, namely Japan Food Research Laboratories and Leafearth Company, to the list of control bodies recognised by Japan and that the names of ‘Bureau Veritas Japan, Inc.’ and ‘Hyogo prefectural Organic Agriculture Society (HOAS)’ and the internet address of ‘Organic Certification Association’ have changed.

(4)

According to information provided by New Zealand, the internet address of the competent authority has changed.

(5)

The Republic of Korea has informed the Commission that its competent authority has added the control body ‘Industry-Academic Cooperation Foundation, SCNU’ to the list of control bodies recognised by the Republic of Korea.

(6)

The duration of the inclusion of the Republic of Korea in the list in Annex III to Regulation (EC) No 1235/2008 ends on 31 January 2018. Given that the Republic of Korea continues to satisfy the conditions laid down in Article 33(2) of Regulation (EC) No 834/2007, the inclusion should be prolonged for an unspecified period.

(7)

Annex IV to Regulation (EC) No 1235/2008 sets out the list of control authorities and control bodies competent to carry out controls and issue certificates in third countries for the purpose of equivalence.

(8)

The duration of the recognition in accordance with Article 33(3) of Regulation (EC) No 834/2007 of the control bodies listed in Annex IV to Regulation (EC) No 1235/2008 ends on 30 June 2018. Based on the results of the continuous supervision carried out by the Commission, the recognition of those control bodies should be extended until 30 June 2021.

(9)

‘Albinspekt’ has notified the Commission of the change of its address.

(10)

The Commission has received and examined a request from ‘BAȘAK Ekolojik Ürünler Kontrol ve Sertifikasyon Hizmetleri Tic. Ltd’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘BAȘAK Ekolojik Ürünler Kontrol ve Sertifikasyon Hizmetleri Tic. Ltd’ for product categories A and D in respect of Turkey.

(11)

The Commission has received and examined a request from ‘BIOCert Indonesia’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘BIOCert Indonesia’ for Indonesia for product categories A and D.

(12)

The Commission has received and examined a request from ‘bio.inspecta AG’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Afghanistan, China and Nepal.

(13)

The entry of ‘Bolicert Ltd’ in the list set out in Annex IV to Regulation (EC) No 1235/2008 was suspended by Implementing Regulation (EU) 2017/1473 (3). In order to lift the temporary suspension, the Commission invited ‘Bolicert Ltd’ to provide a valid accreditation certificate from IOAS (the accreditation organisation of ‘Bolicert Ltd’) and to take appropriate and timely remedial action in accordance with the requirements of Regulation (EC) No 834/2007. IOAS has informed the Commission that it has decided to lift the suspension because it had received satisfactory information on corrective actions by ‘Bolicert Ltd’. Based on that information, the Commission has concluded that it is justified to include ‘Bolicert Ltd’ in Annex IV again under the same conditions as before the suspension.

(14)

The Commission has received and examined a request from ‘CCPB Srl’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A, B, D, E and F to Albania, Algeria, the United Arab Emirates and South Africa, for product category A to Uganda, for product categories A and D to Afghanistan, Armenia, Ethiopia, Ghana, Nigeria, Senegal and Uzbekistan, for product categories A, D and E to Belarus, Kazakhstan, Moldova, Russia, Serbia, Thailand, Tajikistan and Turkmenistan, for product categories A, B, D and E to Azerbaijan, Kyrgyzstan and Ukraine, for products categories A, B and D to Qatar and for product category D to Tunisia.

(15)

The Commission has received and examined a request from ‘Control Union Certifications’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A, B, C, D, E and F to Brunei, Cook Islands, French Polynesia, Georgia, Grenada, Guyana, Jordan, Kuwait, Lebanon, Papua New Guinea, Sao Tome and Principe, Seychelles, Tajikistan, Turkmenistan and Venezuela, for product categories B, C, D (only wine) and E to Australia, for product categories C and E to New Zealand, for product category B to Tonga and Tunisia and for product category F to Tuvalu.

(16)

The Commission has received and examined a request from ‘Ecocert SA’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories D (wine) and E to Argentina, to extend the recognition for Japan, Kyrgyzstan and Zimbabwe to product category B, the recognition for Georgia and Mozambique to product category E, and the recognition for Paraguay and Uruguay to product category F.

(17)

The Commission has received and examined a request from ‘Florida Certified Organic Growers and Consumers, Inc. (FOG), DBA as Quality Certification Services (QCS)’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Bolivia, Colombia and Laos, for product categories A, C, D and E to Chile, for product category D to Costa Rica and for product categories C and D (processed aquaculture products) to the United States.

(18)

‘IMOswiss AG’ has informed the Commission that it will cease its certification activities in all third countries for which it is recognised as of 1 January 2018 and should no longer be listed in Annex IV to Regulation (EC) No 1235/2008 as from that date.

(19)

‘Kiwa BCS Öko-Garantie GmbH’ has notified the Commission of the change of its internet address.

(20)

The Commission has received and examined a request from ‘Letis S.A’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Afghanistan, Ethiopia, Iran, Kazakhstan, Moldova, Pakistan, Russia, Tajikistan, Turkey and Ukraine.

(21)

‘Organic agriculture certification Thailand’ has notified the Commission of the change of its name to ‘Organic Agriculture Certification Thailand (ACT)’ and of the change of its address.

(22)

The Commission has received and examined a request from ‘Organic Control System’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Bosnia and Herzegovina.

(23)

The Commission has received and examined a request from ‘Organic Standard’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the recognition for Kazakhstan, Kyrgyzstan, Moldova and Russia to product category B and to extend its recognition to wine.

(24)

The Commission has received and examined a request from ‘Organska Kontrola’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A, B and D to Kosovo (4).

(25)

The Commission has received and examined a request from ‘ORSER’ to amend its specifications. Based on the information received, the Commission has concluded that it is justified to extend the geographical scope of its recognition for product categories A and D to Azerbaijan, Bosnia and Herzegovina, Georgia, Iran, Kazakhstan, Kyrgyzstan and Nepal.

(26)

The Commission has received and examined a request from ‘Servicio de Certificación CAAE S.L.U.’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘Servicio de Certificación CAAE S.L.U.’ for product categories A and D in respect of Bolivia, Ecuador, Mexico, Morocco, Peru and Turkey.

(27)

The Commission has received and examined a request from ‘Tse-Xin Organic Certification Corporation’ to be included in the list in Annex IV to Regulation (EC) No 1235/2008. Based on the information received, the Commission has concluded that it is justified to recognise ‘Tse-Xin Organic Certification Corporation’ for product categories A and D in respect of Taiwan.

(28)

The DAkkS, an accreditation organisation in the field of organic agriculture, has informed the Commission that it has decided to suspend its accreditation of ‘Egyptian Center of Organic Agriculture (ECOA)’. Pursuant to Article 12(1)(c) of Regulation (EC) No 1235/2008, the Commission may at any time suspend the entry of a control body from the list in Annex IV to that Regulation, either in the light of the information received or where the control body has not supplied information required. ‘Egyptian Center of Organic Agriculture (ECOA)’ was invited by the Commission to provide a valid accreditation certificate and to take appropriate and timely remedial action in accordance with the requirements of Regulation (EC) No 834/2007, but did not reply satisfactorily within the deadline set. The entry of ‘Egyptian Center of Organic Agriculture (ECOA)’ should therefore be suspended in Annex IV to Regulation (EC) No 1235/2008 until satisfactory information is provided.

(29)

Annex IV to Regulation (EC) No 1235/2008 as amended by Implementing Regulation (EU) 2017/872 (*1) lists ‘IMOcert Latinoamérica Ltda’ as a recognised control body for product categories A and B in respect of Argentina and for product category A in respect of Costa Rica. Since Argentina and Costa Rica are listed in Annex III to Regulation (EC) No 1235/2008 for product categories A and B and for product category A, respectively, ‘IMOcert Latinoamérica Ltda’ could not have been recognised for those countries for those product categories in Annex IV to Regulation (EC) No 1235/2008 in accordance with Article 10(2)(b) of Regulation (EC) No 1235/2008. The recognition for those product categories in respect of those countries should therefore be deleted. ‘IMOcert Latinoamérica Ltda’ had been invited by the Commission not to certify products falling within those product categories on the basis of the erroneous reference to those product categories in respect of Argentina and Costa Rica.

(30)

Annex V to Regulation (EC) No 1235/2008 as amended by Implementing Regulation (EU) 2016/1842 (5) contains the new model of the certificate of inspection for import of organic products under the electronic certification system, to which reference is made in Article 13(2) of Regulation (EC) No 1235/2008. In this Annex, the note corresponding to box 12 of the certificate erroneously refers to box 24 instead of box 21. This error should be corrected.

(31)

Annexes III, IV and V to Regulation (EC) No 1235/2008 should therefore be amended and corrected accordingly.

(32)

The deletion of ‘IMOcert Latinoamérica Ltda’ should apply retroactively from the date of entry into force of Implementing Regulation (EU) 2017/872 and the deletion of ‘IMOswiss AG’ should apply from 1 January 2018.

(33)

The measures provided for in this Regulation are in accordance with the opinion of the Committee on organic production,

(1)

Annex III is amended in accordance with Annex I to this Regulation;

(2)

Annex IV is amended and corrected in accordance with Annex II to this Regulation;

(3)

Annex V is corrected in accordance with Annex III to this Regulation.

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)

The iron compounds Ferric chloride hexahydrate, Ferric oxide, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate were authorised without a time limit by Commission Regulation (EC) No 1334/2003 (3) and Commission Regulation (EC) No 479/2006 (4) in accordance with Directive 70/524/EEC. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the re-evaluation of Ferric chloride hexahydrate, Ferric oxide, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate as feed additives for all animal species. Additionally, in accordance with Article 7 of that Regulation, an application was submitted for Iron dextran as feed additive for piglets. The applicants requested that those additives be classified in the additive category ‘nutritional additives’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

Due to scientific considerations, the European Food Safety Authority (‘the Authority’) recommended in its opinions of 19 June 2013 (5), 30 January 2014 (6), 5 March 2014 (7), 28 April 2014 (8) and 27 January 2016 (9) to rename Ferric as Iron(III) and Ferrous as Iron(II), in order to avoid potential misunderstandings. The Authority also recommended splitting Iron(II) chelate of amino acids into the following two groups, in view of its chemical characteristics: Iron(II) chelate of amino acids hydrate and Iron(II) chelate of protein hydrolysates.

(5)

The Authority concluded that, under the proposed conditions of use, Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate do not have anadverse effect on animal health, consumer safety and the environment. Considering the capacities to be respiratory, eye and skin irritants due to the presence of Nickel in each iron (II) and iron (III) compound, appropriate protective measures should be taken with respect to the handling of the additives concerned and premixtures containing them, in order to avoid that safety concerns for the users would arise.

(6)

In its opinions of 24 January 2017 (10), the Authority concluded that, under the proposed conditions of use, Iron dextran does not have an adverse effect on animal health, consumer safety and the environment, and that no safety concerns for users would arise provided that appropriate protective measures are taken.

(7)

The Authority further concluded that Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates, Iron(II) chelate of glycine hydrate and Iron dextran are effective sources of iron; however, the bioavailability of Iron(II) carbonate varies significantly and is considered to be lower than that for Iron(II) sulphate. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(8)

The assessment of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran for piglets shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied, except for water for drinking. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation and their use via water for drinking should be prohibited.

(9)

As a result of the granting new authorisations for ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferrous sulphate monohydrate’ and ‘Ferrous chelate of glycine, hydrate’ by this Regulation and of the denial of the authorisation for ‘Ferric oxide’, the entries of these substances in Regulations (EC) No 479/2006 and (EC) No 1334/2003 should be deleted.

(10)

As the Authority could not conclude in its opinions of 24 May 2016 (11) on the safety of ferric oxide for the target species, the additive and feed containing it should be withdrawn from the market as soon as possible. For practical reasons, however, a limited transitional period should be allowed for the withdrawal from the market of the products concerned in order to enable operators to comply properly with the withdrawal obligation.

(11)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for Ferric chloride hexahydrate, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate as authorised by Regulation (EC) No 1334/2003 and Regulation (EC) No 479/2006, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(12)

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 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘La Clape’ sent by France and has published it in the Official Journal of the European Union (2).

(2)

No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

(3)

In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘La Clape’ should be protected and entered in the register referred to in Article 104 of that Regulation.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

(2)

In the light of the tenders received for the 15th partial invitation to tender, a minimum selling price should not be fixed.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

(1)

The release for free circulation in the Union of imported controlled substances is subject to quantitative limits.

(2)

The Commission is required to determine those limits and allocate quotas to undertakings.

(3)

Furthermore, the Commission is required to determine the quantities of controlled substances other than hydrochlorofluorocarbons that may be used for essential laboratory and analytical uses, and the companies that may use them.

(4)

The determination of the allocated quotas for essential laboratory and analytical uses has to ensure that the quantitative limits set out in Article 10(6) of Regulation (EC) No 1005/2009 are respected, applying Commission Regulation (EU) No 537/2011 (2). As those quantitative limits include quantities of hydrochlorofluorocarbons licensed for laboratory and analytical uses, the production and import of hydrochlorofluorocarbons for those uses should also be covered by that allocation.

(5)

The Commission has published a notice to undertakings intending to import or export controlled substances that deplete the ozone layer to or from the European Union in 2018 and to undertakings intending to produce or import these substances for laboratory and analytical uses (3) in 2018, and has thereby received declarations on intended imports in 2018.

(6)

The quantitative limits and quotas should be determined for the period 1 January to 31 December 2018, in line with the annual reporting cycle under the Montreal Protocol on Substances that Deplete the Ozone Layer.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 25(1) of Regulation (EC) No 1005/2009,