(1)

The Bulgarian language version of Commission Delegated Regulation (EU) 2017/653 (2) contains an error in Annex II, Part 2, point 51 as regards the number of classes by which the CRM are increased.

(2)

The Bulgarian language version of Delegated Regulation (EU) 2017/653 should therefore be corrected accordingly. The other language versions are not affected,

(1)

Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils are widely used fragrance ingredients of many fragrance compounds used in perfumery. The Scientific Committee on Consumer Products (SCCP), subsequently replaced by the Scientific Committee on Consumer Safety (SCCS), concluded in its opinion of 21 June 2005 (2) that Tagetes erecta, Tagetes minuta and Tagetes patula extracts and oils should not be used in cosmetic products as no safe limits had been demonstrated.

(2)

Following the submission in August 2013 of an update dossier on the safety assessment of Tagetes minuta and Tagetes patula extracts and oils, the SCCS adopted a revised opinion on 25 March 2015 (3). In that opinion, as corrected on 13 December 2017 (4), the SCCS concluded that for Tagetes minuta and Tagetes patula extracts and oils in leave-on products (except sunscreen products and products marketed for exposure to natural/artificial UV light), a maximum concentration in ready to use preparation of 0,01 % is safe, provided that the alpha terthienyl (terthiophene) content of those extracts and oils does not exceed 0,35 %. The SCCS thus concluded that Tagetes minuta and Tagetes patula extracts and oils should not be used as ingredients in sunscreen products and in products marketed for exposure to natural/artificial UV light.

(3)

In a comment of 6 October 2016 (5) to its opinion of 25 March 2015, the SCCS indicated that for Tagetes minuta and Tagetes patula extracts and oils in rinse-off products, a maximum concentration in ready to use preparation of 0,1 % should be set.

(4)

In light of the opinion of the SCCP of 21 June 2005 there is a potential risk to human health arising from the use of Tagetes erecta flower extract and Tagetes erecta flower oil in cosmetic products. Those substances should therefore be prohibited in cosmetic products and added in the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009.

(5)

In light of the opinion of the SCCP of 21 June 2005, the revised opinion of the SCCS of 25 March 2015, as corrected on 13 December 2017, and the comment of the SCCS of 6 October 2016, there is a potential risk to human health arising from the use of Tagetes minuta and Tagetes patula flower extracts and flower oils in cosmetic products in a concentration exceeding 0,01 % in leave-on products and 0,1 % in rinse-off products and from the use of those extracts and oils in a leave-on or rinse-off product where the content of alpha terthienyl (terthiophene) in the extracts or oils exceeds 0,35 %. There is also a potential risk to human health arising from the use of Tagetes minuta and Tagetes patula flower extracts and flower oils in any concentration in sunscreen products and products marketed for exposure to natural/artificial UV light. Those substances should therefore be added in the list of restricted substances in Annex III to Regulation (EC) No 1223/2009.

(6)

It is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new prohibitions and restrictions. The complex and lengthy procedure for fragrance reformulation should be reflected in a longer than usual duration of the time periods given to the industry for adjustments of products.

(7)

Annexes II and III to Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(8)

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

(1)

Annex III to Regulation (EC) No 1210/2003 lists public bodies, corporations and agencies and natural and legal persons, bodies and entities of the previous government of Iraq covered by the freezing of funds and economic resources that were located outside Iraq on the date of 22 May 2003 under that Regulation.

(2)

On 5 July 2018, the Sanctions Committee of the United Nations Security Council decided to remove one entry from the list of persons or entities to whom the freezing of funds and economic resources should apply,

(3)

Annex III to Regulation (EC) No 1210/2003 should therefore be amended accordingly,

(1)

Commission Implementing Regulation (EU) No 815/2012 (2) lays down detailed rules for the application of Regulation (EU) No 904/2010, in particular as regards the transmission of registration information of taxable persons using special schemes for telecommunications services, broadcasting services or electronic services provided for in Chapter 6 of Title XII of Council Directive 2006/112/EC (3).

(2)

Following the amendment of Articles 358a and 361 of Directive 2006/112/EC by Council Directive (EU) 2017/2455 (4), taxable persons not established in the Community who are identified for value added tax (VAT) purposes within the Community will be able as of 1 January 2019 to use the special scheme, set out in Section 2 of Chapter 6 of Title XII of Directive 2006/112/EC (the ‘non-Union scheme’), for telecommunications services, broadcasting services or electronic services supplied to non-taxable persons who are established in a Member State or have their permanent address or usually reside in a Member State.

(3)

The common electronic message for the transmission of information to identify taxable persons using the non-Union scheme set out in column B of the table in Annex I to Implementing Regulation (EU) No 815/2012 should therefore be amended accordingly.

(4)

For reasons of consistency, this Regulation should apply from the same date as the provisions of Directive (EU) 2017/2455 introducing the possibility for taxable persons not established in the Community who are identified for VAT purposes within the Community to use the special scheme.

(5)

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

(1)

Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin. In particular, Article 12(1) of that Regulation provides that, with the exception of certain specific cases, products of animal origin are to be imported into the Union only if they originate from third country establishments that appear on lists drawn up and updated in accordance with that Article. Those lists can be consulted on the website of the Directorate-General for Health and Food Safety (2).

(2)

Article 12(2) of Regulation (EC) No 854/2004 requires that third country establishments are placed on those lists only if the competent authorities of the third country guarantee that those establishments, together with any establishments handling raw material of animal origin used in the manufacture of the products of animal origin concerned, comply with relevant Union requirements. In addition, in accordance with Article 12(3) of Regulation (EC) No 854/2004, the competent authorities of the third country concerned should keep those lists of establishments updated and communicate them accordingly to the Commission.

(3)

Article 15(2)(a) of Regulation (EC) No 854/2004 provides that fishery products imported from a factory or freezer vessel flying the flag of a third country are to come from vessels that appear on a list drawn up and updated in accordance with the procedure set out in Article 12(4) of that Regulation.

(4)

In September 2017, a Commission inspection revealed that primary production establishments supplying Brazilian establishments from which imports of fishery products are permitted are neither identified, nor subject to official controls. Consequently, that audit concluded that the competent authority in Brazil is neither in the position to provide the guarantees set out in Article 12(2)(a) and (b) of Regulation (EC) No 854/2004, nor to provide all the guarantees referred to in the health certificate for fishery products laid down in Appendix IV to Annex VI to Commission Regulation (EC) No 2074/2005 (3). Moreover, that inspection revealed serious deficiencies with regard to infrastructure and hygiene requirements in a number of inspected Brazilian establishments from which imports of fishery products are permitted. The aforesaid deficiencies have shown a systemic lack of effective controls by the Brazilian competent authorities with regard to fishery products.

(5)

In reply to the recommendations made in the preliminary inspection report, the Brazilian authorities informed the Commission, in an official letter dated 22 December 2017, that they have suspended the issuance of health certificates for all fishery products intended for export to the Union as of 3 January 2018. However, Member States notified the Commission that consignments of fishery products originating from Brazil were presented at the Union borders with certificates issued after the date of suspension.

(6)

In light of these considerations, and in the absence of new information from the Brazilian authorities, there are no sufficient guarantees that any of the establishments authorised to export fishery products from Brazil to the Union fulfil the conditions of Article 12(2) of Regulation (EC) No 854/2004 and their products therefore constitute a risk for public health. It is therefore appropriate to remove all establishments from the list of Brazilian establishments from which fishery products intended for human consumption can be imported into the Union.

(7)

In light of the risk to public health associated with their products, those establishments should cease to be authorised to export to the Union without delay. It is therefore appropriate that the date of entry into force of this Regulation is the date following that of its publication.

(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)

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.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

That application concerns the authorisation of the preparation of benzoic acid, calcium formate and fumaric acid as a feed additive for chickens for fattening, chickens reared for laying, minor avian species for fattening and reared for laying, to be classified in the additive category ‘zootechnical additives’.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 December 2014 (2) and 28 September 2017 (3) that, under the proposed conditions of use, the preparation of benzoic acid, calcium formate and fumaric acid does not have an adverse effect on animal health, human health or the environment. The Authority also concluded that it has the potential to improve the performance of chickens for fattening and this conclusion can be extended to chickens reared for laying. However, since no conclusions can be drawn on the margin of safety of the additive for major target species, the conclusions on safety cannot be extrapolated to minor avian species for fattening and to minor avian species reared for laying. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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)

The assessment of the preparation of benzoic acid, calcium formate and fumaric acid 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 preparation should be authorised as specified in the Annex to this Regulation.

(6)

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

(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.

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(3)

That application concerns the authorisation of benzoic acid as a feed additive for minor porcine species for fattening and for reproduction, to be classified in the additive category ‘zootechnical additives’.

(4)

That additive was already authorised as a feed additive for use in weaned piglets by Commission Regulation (EC) No 1730/2006 (2), in pigs for fattening by Commission Regulation (EC) No 1138/2007 (3) and in sows by Commission Implementing Regulation (EU) 2016/900 (4).

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 (5) that, under the proposed conditions of use, the benzoic acid does not have an adverse effect on human health or the environment, and that it has a potential to decrease urinary pH in minor porcine species. However, due to the lack of margin of safety in weaned major piglets, the Authority could not extrapolate the conclusion on the safety to weaned minor porcine species. Therefore it was established the additive is safe for minor porcine species for fattening and for reproduction. The Authority does not consider that there is a need for specific requirements of post-market monitoring. 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.

(6)

The assessment of the benzoic acid 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 preparation should be authorised as specified in the Annex to this Regulation.

(7)

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

(1)

The Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (the ‘Agreement’) was signed on 27 June 2014.

(2)

Article 201 of the Agreement provides for the gradual approximation to the Union's customs law and certain international law to be carried out as set out in Annex XXVI to the Agreement.

(3)

Annex XXVI to the Agreement specifies that approximation with the provisions of Council Regulation (EEC) No 2913/92 (2) is to be carried out by the Republic of Moldova within three years following the entry into force of the Agreement.

(4)

Regulation (EEC) No 2913/92 has been repealed and, since 1 May 2016, the substantive provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council (3) are in application in the Union.

(5)

At the meeting of the EU-Republic of Moldova Customs Sub-Committee held on 6 October 2016, it was concluded that Annex XXVI to the Agreement should be amended accordingly,