167.

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) ( 172 ) In order to achieve the objectives of Regulation (EC) No 1069/2009, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to supplement amend that Regulation as regards an end point in the manufacturing chain and to supplement it as regards : [Am. 462] — an end point in the manufacturing chain; [Am. 463] — the determination of serious transmissible diseases; — the conditions designed to prevent the spread of diseases transmissible to humans or animals; — the risk categories in order to take into account scientific progress as regards the assessment of the level of risk; — checks and controls of uses of animal by-products and derived products and conditions for feeding; — derogations for research and other specific purposes; — certain measures relating to collection, transport and disposal; — authorisation of alternative methods of use or disposal of animal by-products or derived products; — certain measures relating to collection and identification; — certain measures relating to category and transport; — certain measures relating to collection, transport and traceability; — certain measures relating to registration and approval; — the placing on the market of animal by-products and derived products destined for feeding to farmed animals; — the placing on the market and use of organic fertilisers and soil improvers; — certain measure relating to other derived products; — certain measures relating to the import and transit products; — purposes for exports of category 1 material, Category 2 material and products derived therefrom; — controls for dispatch to other Member States. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. In order to ensure uniform conditions for the implementation of Regulation (EC) No 1069/2009, implementing powers should be conferred on the Commission concerning certain documentation, parameters for the manufacturing process and testing requirements applicable to the end product. models for health certificates, commercial documents and declarations which are to accompany consignments, specifying the conditions under which it can be stated that the animal by- products or derived products concerned have been collected or manufactured in accordance with the requirements of this Regulation Those powers should be exercised in accordance with Regulation (EU) No 182/2011. Accordingly, Regulation (EC) No 1069/2009 is amended as follows: (1) Article 5 is amended as follows: (a) in paragraph 1, the fourth subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to amend the endpoint in the manufacturing chain for the products referred to in points (a) and (b) of the third subparagraph of this paragraph, taking into account scientific and technical developments. Where imperative grounds of urgency so require, the Commission is empowered to adopt delegated acts in accordance with Article 51b to amend the endpoint in the manufacturing chain for the products referred to in points (a) and (b) of the third subparagraph of this paragraph, taking into account scientific and technical developments.’; (b) in paragraph 2, the third subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a concerning to amend this Regulation as regards an end point in the manufacturing chain, beyond which derived products referred to in this paragraph are no longer subject to the requirements of this Regulation.’; [Am. 464] (2) Article 6 is amended as follows: (a) in paragraph 1, the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by establishing rules concerning the measures referred to in point (b)(ii) of the first subparagraph.’; [Am. 465] (b) in paragraph 2, the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by establishing rules concerning the measures referred to in the first subparagraph.’; [Am. 466] (3) in Article 7, paragraph 4 is replaced by the following: ‘4 The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by establishing rules concerning the measures referred to in paragraphs 2 and 3.’; [Am. 467] (4) in Article 11, paragraph 2 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 468] (b) the second subparagraph is deleted; (5) Article 15 is amended as follows: (a) the title is replaced by the following: ‘Delegated powers’ (b) paragraph 1 is amended as follows: (i) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 469] (ii) the second subparagraph is deleted; (6) in Article 17(2), the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down the conditions referred to in the first subparagraph.’; [Am. 470] (7) in Article 18, paragraph 3 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 471] (b) the second subparagraph is deleted; (8) in Article 19, paragraph 4 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 472] (b) the second subparagraph is deleted. (9) in Article 20, paragraph 11 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘Following receipt of the opinion of the EFSA, the Commission is empowered to adopt delegated acts in accordance with Article 51a as regards to supplement this Regulation by adopting the following:’; [Am. 473] (b) the second subparagraph is deleted; (10) in Article 21, paragraph 6 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 474] (b) the second subparagraph is deleted; (11) Article 27 is amended as follows: (a) the title of Article 27 is replaced by the following: ‘Delegated powers’; (b) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement the Regulation by establishing rules concerning the following measures related to this Section and to Section 1 of this Chapter:’; [Am. 475] (c) the second subparagraph is deleted; (12) in Article 31, paragraph 2 is replaced by the following: ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by establishing rules concerning measures relating to the public and animal health conditions for the collection, processing and treatment of animal by-products and derived products referred to in paragraph 1.’; [Am. 476] (13) in Article 32, paragraph 3 is amended as follows: (a) in the first subparagraph, the introductory phrase is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down measures relating to the following:’; [Am. 477] (b) the second subparagraph is deleted; (14) Article 40 is replaced with the following: ‘Article 40 Delegated and implementing powers 1. The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation, concerning the conditions for: [Am. 478] (a) the placing on the market of imported pet food or of pet food produced from imported materials, from Category 1 material referred to in Article 8(c); (b) the safe sourcing and movement of material to be used under conditions which exclude risks to public and animal health; (c) the safe use of derived products which pose a risk to public or animal health. 2. The Commission shall is empowered to adopt implementing delegated acts in accordance with Article 51a, to amend this Regulation, concerning the following: [Am. 479] (a) documentation as referred to in the first subparagraph of Article 37(2); (b) parameters for the manufacturing process as referred to in the first paragraph of Article 38, in particular as regards the application of physical or chemical treatments to the material used; (c) testing requirements applicable to the end product. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 52(3).’; [Am. 480] (15) Article 41 is amended as follows: (a) in paragraph 1, the second subparagraph is replaced by the following: ‘The Commission shall adopt implementing acts laying down the conditions referred to in point (b) of the first subparagraph. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 52(3) is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down the conditions referred to in point (b) of the first subparagraph .’; [Am. 481] (b) in paragraph 3, the third subparagraph is replaced by the following: ‘The Commission shall is empowered to adopt implementing acts laying down the requirements provided for in the first subparagraph. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 52(3) delegated acts in accordance with Article 51a to supplement this Regulation by laying down the requirements provided for in the first subparagraph. .’; [Am. 482] (16) Article 42 is amended as follows: (a) the title is replaced by the following: ‘Delegated and implementing powers’; (b) paragraph 2 is replaced by the following: ‘2. The Commission is empowered to adopt delegated acts in accordance with Article 51a laying to supplement this Regulation , by laying down the following: [Am. 483] (a) conditions for the import and transit of Category 1 and Category 2 materials and for products derived therefrom; (b) restrictions regarding public or animal health applicable to imported Category 3 material or products derived therefrom which may be laid down by reference to the lists of third countries or parts of third countries drawn up in accordance with Article 41(4) or for other public or animal health purposes; (c) conditions for the manufacture of animal by-products or derived products in establishments or plants in third countries; such conditions may include the arrangements for controls of such establishments or plants by the competent authority concerned and may exempt certain types of establishments or plants handling animal by-products or derived products from approval or registration as referred to in point (b) of the second subparagraph of Article 41(3). The Commission shall adopt implementing acts establishing models for health certificates, commercial documents and declarations which are to accompany consignments, specifying the conditions under which it can be stated that the animal by- products or derived products concerned have been collected or manufactured in accordance with the requirements of this Regulation. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 52(3).’; (17) in Article 43(3), the second subparagraph is replaced by the following: ‘The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by establishing rules concerning the rules referred to in the first subparagraph.’; [Am. 484] (18) in Article 45, paragraph 4 is replaced by the following: ‘4. The Commission may adopt implementing delegated acts laying down detailed arrangements for implementing to supplement this Article, including rules concerning the reference methods for microbiological analyses. Those implementing delegated acts shall be adopted in accordance with the procedure referred to in Article 52(3) 51a .’; [Am. 485] (19) in Article 48, paragraphs 7 and 8 are replaced by the following: ‘7. The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by laying down the following: [Am. 486] (a) a specified time period for the decision of the competent authority as referred to in paragraph 1; (b) supplementary conditions for the dispatch of animal by-products or derived products referred to in paragraph 4; (c) models for the health certificates which have to accompany consignments sent in accordance with paragraph 5. The Commission shall adopt implementing acts laying down the conditions under which animal by-products or derived products intended to be used for exhibitions, artistic activities, for diagnostic, educational or research purposes may be sent to other Member States, by way of derogation from paragraph 1 to 5 of this Article. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 52(3). 8. The Commission is empowered to adopt delegated acts in accordance with Article 51a to supplement this Regulation by specifying the conditions subject to which the competent authorities may allow derogations from paragraphs 1 to 4 as regards the following: [Am. 487] (a) the dispatch of manure transported between two points located on the same farm or between farms located in the border regions of Member States sharing a common border; (b) the dispatch of other animal by-products transported between establishments or plants located in the border regions of Member States sharing a common border; and (c) the transport of a dead pet animal for incineration to an establishment or plant located in the border region of another Member State sharing a common border.’; (20) the following Articles 51a and 51b are inserted: ‘Article 51a Exercise of the delegation 1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article. 2. The delegation of power to adopt delegated acts referred to in Article 5(1) and (2), Article 6(1), and (2), Article 7(4), Article 11(2), Article 15(1), Article 17(2), Article 18(3), Article 19(4), Article 20(11), Article 21(6), Article 27, Article 31(2), Article 32(3), Article 40(1) and (2) , the second subparagraph of Article 41(1) , the third subparagraph of Article 41(3 ), the first subparagraph of Article 42(2), Article 43(3), Article 45(4), the first subparagraph of paragraph 7 and paragraph 8 of Article 48, Article 48(7) and Article 48(8) shall be conferred on the Commission for an indeterminate a period of five years from … [date of entry into force of this Omnibus amending Regulation ]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period. 3. The delegation of power referred to in Article 5(1) and (2), Article 6(1), and (2), Article 7(4), Article 11(2), Article 15(1), Article 17(2), Article 18(3), Article 19(4), Article 20(11), Article 21(6), Article 27, Article 31(2), Article 32(3), Article 40(1) and (2) , the second subparagraph of Article 41(1) , the third subparagraph of Article 41(3 ), the first subparagraph of Article 42(2), Article 43(3), Article 45(4), the first subparagraph of paragraph 7 and paragraph 8 of Article 48 Article 48(7) and Article 48(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making of 13 April 2016 (*239). 5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council. 6. A delegated act adopted pursuant to Article 5(1) and (2), Article 6(1), and (2), Article 7(4), Article 11(2), Article 15(1), Article 17(2), Article 18(3), Article 19(4), Article 20(11), Article 21(6), Article 27, Article 31(2), Article 32(3), Article 40(1) and (2) , the second subparagraph of Article 41(1) , the third subparagraph of Article 41(3 ), the first subparagraph of Article 42(2), Article 43(3), Article 45(4), the first subparagraph of paragraph 7 and paragraph 8 of Article 48 Article 48(7) and Article 48(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. [Am. 488] Article 51b Urgency procedure 1. Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure. 2. Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 51a(6). In such a case, the Commission shall repeal the act without delay following the notification of the decision to object by the European Parliament or the Council. (*239) OJ L 123, 12.5.2016, p. 1.’;" (21) in Article 52, paragraphs 4, 5 and 6 are deleted.