(1)

On 9 December 2019 the Council authorised the Commission to open negotiations with the Government of Greenland and the Government of Denmark with a view to concluding a new sustainable fisheries partnership agreement and a new implementing protocol thereto.

(2)

The negotiations were successfully concluded with the initialling of the Sustainable Fisheries Partnership Agreement between the European Union, of the one part, and the Government of Greenland and the Government of Denmark, of the other part (‘the Partnership Agreement’) and the Protocol implementing the Sustainable Fisheries Partnership Agreement between the European Union, of the one part, and the Government of Greenland and the Government of Denmark, of the other part (‘the Protocol’) on 11 January 2021.

(3)

The Partnership Agreement repeals the Fisheries Partnership Agreement between the European Community on the one hand, and the Government of Denmark and the Home Rule Government of Greenland, on the other hand (2), which entered into force on 28 June 2007.

(4)

In accordance with Council Decision (EU) 2021/793 (3), the Partnership Agreement and the Protocol were signed on 22 April 2021.

(5)

The Partnership Agreement and the Protocol have been applied on a provisional basis since the date of their signature.

(6)

The Partnership Agreement and the Protocol should be approved.

(7)

Article 12 of the Partnership Agreement establishes the Joint Committee responsible for monitoring its implementation. Furthermore, pursuant to that Article and to Article 4 and Article 7 of the Protocol, the Joint Committee can adopt certain modifications to the Protocol. In order to facilitate the approval of such modifications, the Commission should be authorised, subject to specific substantive and procedural conditions, to approve them on behalf of the Union under a simplified procedure.

(8)

The Union’s position on proposed modifications to the Protocol should be established by the Council. The proposed modifications should be approved unless a blocking minority of Member States in accordance with Article 16(4) of the Treaty on European Union objects to those modifications,

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected designation of origin ‘Nostrano Valtrompia’, registered under Commission Implementing Regulation (EU) No 629/2012 (2).

(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 (3) 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)

The substances bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) are listed in entries 4 to 7 of Annex XIV to Regulation (EC) No 1907/2006 because they meet the criteria set out in point (c) of Article 57 of that Regulation. In accordance with Article 59 of Regulation (EC) No 1907/2006, DEHP has subsequently been additionally identified as meeting the criteria set out in point (f) Article 57 of that Regulation, namely as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment (2). All the four substances have further been identified in accordance with Article 59 of Regulation (EC) No 1907/2006 as meeting the criteria set out in point (f) Article 57 of that Regulation, namely as having endocrine disrupting properties for which there is scientific evidence of probable serious effects to human health (3). In accordance with Article 58(3) of Regulation (EC) No 1907/2006, on 10 July 2019 the European Chemicals Agency (‘the Agency’) recommended (4) the elements referred to in Article 58(1) of that Regulation to be specified for each of those substances.

(2)

The inclusion of intrinsic properties relating to hazards for the environment in the entry for DEHP in Annex XIV to Regulation (EC) No 1907/2006, means that the uses of that substance in medical devices falling within the scope of Council Directive 90/385/EEC (5), Council Directive 93/42/EEC (6) or Directive 98/79/EC of the European Parliament and of the Council (7) are subject to authorisation requirement as the second subparagraph of Article 60(2) of Regulation (EC) No 1907/2006 provides that the Commission shall not consider risks to human health only arising from those uses. As regards the uses of that substance in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (8), the inclusion of intrinsic properties relating to hazards for the environment means that those uses are subject to authorisation requirement as Article 56(5) of Regulation (EC) No 1907/2006 no longer applies to them.

(3)

By including in the entries of DEHP, BBP, DBP and DIBP intrinsic properties referred to in point (f) of Article 57 of Regulation (EC) No 1907/2006, the concentration limit applicable to the presence of those substances in mixtures for the purposes of the exemption set out in Article 56(6) of that Regulation becomes 0,1 % weight by weight.

(4)

Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where specific Union legislation imposes minimum requirements relating to the protection of human health or the environment ensuring proper control of the risks. In accordance with the information currently available, it is not appropriate to set exemptions based on those provisions.

(5)

Commission Regulation (EU) No 143/2011 (9) exempted from the authorisation requirement the use of DEHP, BBP and DBP in the immediate packaging of medicinal products covered by Regulation (EC) No 726/2004 of the European Parliament and of the Council (10), Directive 2001/82/EC of the European Parliament and of the Council (11) and/or Directive 2001/83/EC of the European Parliament and of the Council (12). The judgment of the Court of Justice of 13 July 2017 in Case C-651/15 P, VECCO and Others v. Commission (13), provided clarifications on certain aspects of Article 58(2) of Regulation (EC) No 1907/2006 for granting an exemption from the authorisation requirement. The Commission has re-assessed the exemption set out in Annex XIV to that Regulation and has concluded that it does not meet the conditions in Article 58(2). In particular, in the light of that judgement, Regulation (EC) No 726/2004, and Directives 2001/82/EC and 2001/83/EC do not constitute existing specific Union legislation imposing minimum requirements relating to the protection of human health or the environment for the use of DEHP, BBP and DBP in immediate packaging of medicinal products within the meaning of Article 58(2) of Regulation No 1907/2006 since they do not contain provisions specific to those substances imposing such requirements. Furthermore, Regulation (EC) No 726/2004 and Directives 2001/82/EC and 2001/83/EC lay down requirements related to the protection of human health only, while, as regards DEHP, intrinsic properties relating to hazards for the environment have been included in the entry for that substance in Annex XIV to Regulation (EC) No 1907/2006. Those exemptions are therefore not justified and should be deleted.

(6)

For the uses of DEHP, BBP, DBP and DIBP that will no longer be exempted from the authorisation requirement, it is appropriate to indicate the dates referred to in point (i) of Article 58(1)(c) of Regulation (EC) No 1907/2006, taking into account the Agency’s recommendation of 10 July 2019 and its capacity to handle applications for authorisations. As regards uses of DEHP in medical devices, the dates should also take into account the transitional provisions for the application of Regulations (EU) 2017/745 (14) and (EU) 2017/746 (15) of the European Parliament and of the Council.

(7)

For each of the uses of DEHP, BBP, DBP and DIBP that will no longer be exempted from the authorisation requirement, there are no reasons for which the date referred to in point (ii) of Article 58(1)(c) of Regulation (EC) No 1907/2006 should be set earlier than 18 months than the date referred to in Article point (i) 58(1)(c) of that Regulation.

(8)

During the public consultation conducted by the Agency on its draft recommendation, no specific comments were submitted with regard to possible exemptions for product and process orientated research and development. As there is no information justifying the need for such an exemption, the exemption was not considered.

(9)

As the available information on the uses of the substances concerned by this Regulation is limited, it is not appropriate to set review periods at this stage, pursuant to point (d) of Article 58(1) of Regulation (EC) No 1907/2006.

(10)

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

(11)

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

(1)

In accordance with Article 5(1) and (2) of the Geneva Act, the Competent Authorities of each Contracting Party to the Geneva Act may file applications for international registration of an appellation of origin or geographical indication with the International Bureau of the World Intellectual Property Organization, which registers it in the International Register in accordance with Article 6 of the Geneva Act. In accordance with Article 9 of the Geneva Act, the other Contracting Parties shall protect registered appellations of origin and geographical indications within their own legal system subject to any refusal, renunciation, invalidation or cancellation.

(2)

In accordance with Article 6(4) of the Geneva Act, on 14 December 2020, the International Bureau of the World Intellectual Property Organization notified the Commission that the name 'ម្រេចកំពត'/'Kampot Pepper', applied by Cambodia, had been recorded as Geographical Indication in the International Register of Appellations of Origin and Geographical Indications under the Geneva Act.

(3)

Pursuant to Article 4(1) of Regulation (EU) 2019/1753, the international registration of the Geographical Indication 'ម្រេចកំពត'/'Kampot Pepper' was published in the Official Journal of the European Union (2) to enable possible opposition to be lodged.

(4)

Pursuant to Article 5 of Regulation (EU) 2019/1753, the Commission assessed the international registration of the Geographical Indication 'ម្រេចកំពត'/'Kampot Pepper' against the conditions laid down in that Article and concluded that they are fulfilled.

(5)

As no opposition under Article 6 of Regulation (EU) 2019/1753 has been received by the Commission, the name 'ម្រេចកំពត'/'Kampot Pepper' should be protected in the Union, in accordance with the Geneva Act.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Agricultural Product Quality Policy 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 an authorisation.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of amprolium hydrochloride (COXAM). That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

(3)

The application concerns the authorisation of amprolium hydrochloride (COXAM) as a feed additive for chickens for fattening and chickens reared for laying, to be classified in the additive category ‘coccidiostats and histomonostats’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 13 June 2018 (2) and 27 January 2021 (3) that, under the proposed conditions of use, the amprolium hydrochloride (COXAM) does not have an adverse effect on animal health and the environment. It also concluded that the additive should be considered a potential respiratory and skin sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that it cannot independently evaluate all data relevant to the current application due to the lack of provided data and is therefore unable to conclude on the safety of the additive for the consumer. The Authority further concluded that the additive is efficacious in controlling coccidiosis in chickens for fattening, and that this conclusion is extended to chickens reared for laying. The Authority also concluded that a post-market monitoring plan to monitor the Eimeria spp. resistance should be undertaken. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

Amprolium hydrochloride has already been evaluated by the European Medicines Agency Committee for Medicinal Products for Veterinary Use (EMA CVMP). In its report from January 2001 (4), EMA CVMP concluded that there is no need to establish a maximum residue limit (MRL) for amprolium. Therefore amprolium for poultry is listed in Table 1 of the Annex to Commission Regulation (EC) No 37/2010 (5). On these grounds, the safety of amprolium hydrochloride for the consumer has been sufficiently demonstrated according to Article 8(4)(e) of Regulation (EC) No 1831/2003.

(6)

The assessment of amprolium hydrochloride (COXAM) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that substance should be authorised.

(7)

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