Commission Delegated Regulation (EU) 2023/2652 of 15 September 2023 amending and correcting Delegated Regulation (EU) 2022/2292 with regard to requirements for the entry into the Union of honey, meat, highly refined products, gelatine capsules, fishery products and requirements for private attestation and amending Delegated Regulation (EU) 2021/630 as regards private attestation requirements for composite products exempted from official controls at border control posts

Official Journal EN of the European Union L series 2023/2652 28.11.2023 COMMISSION DELEGATED REGULATION (EU) 2023/2652 of 15 September 2023 amending and correcting Delegated Regulation (EU) 2022/2292 with regard to requirements for the entry into the Union of honey, meat, highly refined products, gelatine capsules, fishery products and requirements for private attestation and amending Delegated Regulation (EU) 2021/630 as regards private attestation requirements for composite products exempted from official controls at border control posts (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)(1), and in particular Article 77(1), point (k), and Article 126(1) thereof,

Whereas:

(1) Regulation (EU) 2017/625 lays down rules for the performance of official controls and other official activities by the competent authorities of the Member States, in particular to ensure that consignments of animals and goods from third countries or regions thereof intended for human consumption entering the Union comply with the relevant requirements established by the rules referred to in Article 1(2) thereof, with the exception of points (d), (e), (g) and

(h) of that Article, or with requirements recognised to be at least equivalent.

(2) Commission Delegated Regulation (EU) 2022/2292(2) supplements Regulation (EU) 2017/625 as regards the requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption.

(3) Article 2 of Delegated Regulation (EU) 2022/2292, should be clear about which honey and apiculture products fall within the scope of the requirements on honey and apiculture products laid down in that Delegated Regulation. It is therefore necessary to refer to the definition of these products in Council Directive 2001/110/EC(3).

(4) For fishery products from wild catch, evidence of compliance with the additional requirements laid down in Article 4 of Delegated Regulation (EU) 2022/2292 provide sufficient guarantees of compliance with Union legislation on food and feed safety. For fishery products from wild catch, the contamination from the environment is the main food safety hazard. Compliance with the requirements laid down in Article 4 of Delegated Regulation

(EU) 2022/2292 provide guarantees as regards compliance with EU requirements related to contamination from the environment, in particular with the requirements laid down in Commission Regulation (EU) 2023/915(4).

(1) OJ L 95, 7.4.2017, p. 1.

(2) Commission Delegated Regulation (EU) 2022/2292 of 6 September 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with regard to requirements for the entry into the Union of consignments of food-producing animals and certain goods intended for human consumption (OJ L 304, 24.11.2022, p. 1).

(3) Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47).

(4) Commission Regulation (EU) 2023/915 of 25 April 2023 on maximum levels for certain contaminants in food and Repealing Regulation (EC) No 1881/2006 (OJ L 119, 5.5.2023, p. 103).

ELI: http://data.europa.eu/eli/reg_del/2023/2652/oj 1/7EN OJ L, 28.11.2023 Furthermore, official controls of fishery products from wild catch have to be performed by third countries as regards residues and contaminants in accordance with Article 70 of Commission Implementing Regulation

(EU) 2019/627(5). It is therefore appropriate to exempt fishery products from wild catch from the additional requirements laid down in Articles 6 to 12 of Delegated Regulation (EU) 2022/2292.

(5) The results of a recent Union coordinated action have shown that a significant percentage of adulterated honey or other adulterated apiculture products imported into the Union is present on the Union market(6).

(6) In order to ensure that honey and other apicultural products intended for human consumption from third countries intended to be placed on the Union market comply with the rules on food, food safety, integrity and wholesomeness at all stages of production, processing and distribution of food, including rules aimed at ensuring fair practices in trade and protecting consumer interests and information referred to in Article 1(2), point (a), of Regulation

(EU) 2017/625, it is necessary to intensify official controls on such products.

(7) Article 65(4) of Regulation (EU) 2017/625 requires the competent authorities of the Member States to intensify official controls on consignments where they have reason to suspect fraudulent or deceptive practices. Article 65(5) of that Regulation requires these competent authorities to notify the Commission and the other Member States of their decision to intensify these official controls. Commission Implementing Regulation (EU) 2019/1873(7) lays down rules on procedures at border control posts for a coordinated performance by competent authorities of intensified official controls on certain products entering the Union for placing on the market, in order to ensure a harmonised approach to the coordinated performance of such intensified official controls. Article 3(1) of that Implementing Regulation requires that, when notifying the Commission and the other Members States of their decision to intensify official controls, the competent authorities are to indicate the establishment of origin, which is to appear on a list drawn up in accordance with Article 127(3), points (e)(ii) and (iii), of Regulation (EU) 2017/625.

There is no such list of third countries’ establishments producing honey or other apicultural products intended for human consumption. It is therefore necessary to establish such list.

(8) In accordance with Article 15 of Delegated Regulation (EU) 2022/2292, consignments of fresh meat, minced meat, meat preparations, mechanically separated meat, certain meat products, gelatine and collagen are only to enter the Union if they have been manufactured from raw materials obtained in slaughterhouses, game-handling establishments, cutting plants and establishments handling fishery products in third countries approved and listed in accordance with Article 13 of Delegated Regulation (EU) 2022/2292. Such products of animal origin should also be allowed for entry into the Union if derived from raw materials obtained in Member States since such raw materials also comply with the requirements laid down in Union legislation. Therefore, Article 15 of Delegated Regulation (EU) 2022/2292 should be amended accordingly.

(5) Commission Implementing Regulation (EU) 2019/627 of 15 March 2019 laying down uniform practical arrangements for the performance of official controls on products of animal origin intended for human consumption in accordance with Regulation

(EU) 2017/625 of the European Parliament and of the Council and amending Commission Regulation (EC) No 2074/2005 as regards official controls (OJ L 131, 17.5.2019, p. 51).

(6) European Commission, Joint Research Centre, Ždiniaková, T., Lörchner, C., De Rudder, O.et al., EU coordinated action to deter certain fraudulent practices in the honey sector – Analytical testing results of imported honey, Publications Office of the European Union, 2023:

https://data.europa.eu/doi/10.2760/184511 and European Commission, Directorate-General for Health and Food Safety, EU Coordinated Action From the hives, sampling, investigations and results: https://food.ec.europa.eu/system/files/2023-03/official- controls_food-fraud_2021-2_honey_report_euca.pdf

(7) Commission Implementing Regulation (EU) 2019/1873 of 7 November 2019 on the procedures at border control posts for a coordinated performance by competent authorities of intensified official controls on products of animal origin, germinal products, animal by-products and composite products (OJ L 289, 8.11.2019, p. 50).

2/7 ELI: http://data.europa.eu/eli/reg_del/2023/2652/ojEN OJ L, 28.11.2023

(9) In accordance with Article 21 of Delegated Regulation (EU) 2022/2292, consignments of certain products intended for human consumption are only allowed to enter the Union if accompanied by an official certificate. It should be clarified that this requirement also applies to food producing animals. In addition, Article 21(1) of that Delegated Regulation provides that consignments of certain products are authorised to enter the Union only where they are accompanied by an official certificate except in the case of consignments for which the Union is not the final destination. However, animals and goods intended for human consumption only for transit through the Union are excluded from the scope of Delegated Regulation (EU) 2022/2292. Article 21(1) of Delegated Regulation

(EU) 2022/2292 should be amended by deleting the reference to the Union not being the final destination, to be consistent with the scope of that Delegated Regulation.

(10) The requirements on composite products laid down in Articles 21 and 22 of Delegated Regulation (EU) 2022/2292 refer to processed meat. Since ‘processed meat’ is not defined in Union legislation and in order to be consistent with other requirements related to composite products laid down in that Delegated Regulation, it is appropriate to replace the words ‘processed meat’ by ‘meat products’ in Articles 21 and 22 of Delegated Regulation (EU) 2022/2292.

(11) Article 21(1), point (f), of Delegated Regulation (EU) 2022/2292 establishes a derogation from the official certification requirements for shelf-stable composite products containing gelatine and collagen. Article 21(1), point

(f), of that Delegated Regulation should be amended to clarify that that derogation does not apply when the gelatine and collagen is derived from ruminant bones since official certification of such gelatine and collagen is required in accordance with Article 16 of, and Chapter C of Annex IX to Regulation (EC) No 999/2001 of the European Parliament and of the Council(8).

(12) Article 21(3) of Delegated Regulation (EU) 2022/2292 also establishes a derogation for gelatine capsules from the official certification requirements in the case where gelatine capsules are not derived from ruminant bones. It should be clarified that that derogation applies not only to the entry into the Union of empty capsules but also to gelatine capsules filled with products of animal origin, without prejudice to the certification requirements that apply to the products of animal origin contained in such filled gelatine capsules, or when entering the Union as composite products. Therefore, Article 21 of Delegated Regulation (EU) 2022/2292 should be amended accordingly.

(13) Shelf-stable composite products where the only animal products present in the final composite product are vitamin D3, food additives, food enzymes or food flavourings represent a negligible risk for human and animal health. For that reason, these composite products, are exempted from official controls at border control posts under Article 3(1) of Commission Delegated Regulation (EU) 2021/630(9) and from the requirements laid down in Article 20(2) and (3) of Delegated Regulation (EU) 2022/2292. Shelf-stable composite products exempted from official controls at border control posts are considered of low risk to human and animal health and are subject to private attestation requirement. Since shelf-stable composite products where the only animal products present in the final composite product are vitamin D3, food additives, food enzymes or food flavourings are considered of negligible risk for human and animal health, these composite products should be exempted from the requirement to be accompanied by a private attestation at the time of their placing on the market. Therefore, Article 3(2) of Delegated Regulation (EU) 2021/630 and Article 22(2) of Delegated Regulation (EU) 2022/2292 should be amended accordingly.

(14) The rules on shelf-stable composite products exempted from official controls at border control posts and on official controls to be performed on such composite products are substantively linked and are intended to be applied in tandem. Since the amendments to Article 3(2) of Delegated Regulation (EU) 2021/630 and Article 22(2) to Delegated Regulation (EU) 2022/2292 are linked to each other insofar as they concern the exemption from the requirement for shelf-stable composite products where the only animal product present in the final composite

(8) Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (OJ L 147, 31.5.2001, p. 1).

(9) Commission Delegated Regulation (EU) 2021/630 of 16 February 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards certain categories of goods exempted from official controls at border control posts and amending Commission Decision 2007/275/EC (OJ L 132, 19.4.2021, p. 17).

ELI: http://data.europa.eu/eli/reg_del/2023/2652/oj 3/7EN OJ L, 28.11.2023 product are food improvement agents, namely vitamin D3, food additives, food enzymes or food flavourings to be accompanied by a private attestation at the time of their placing on the market, in the interests of simplicity and transparency, to facilitate the application of the rules and avoid their multiplication in different acts, and because both amendments should take effect on the same date to avoid legal uncertainty, they should be laid down in a single act.

(15) In accordance with Article 14, points (d) and (e), of Delegated Regulation (EU) 2022/2292, establishments producing highly refined products of animal origin or gelatine capsules are not required to appear on the lists referred to in Article 13 of that Delegated Regulation. Since Article 14 creates ambiguity as regards the requirements for the entry into the Union of these products and for reasons of consistency with Article 13 of that Delegated Regulation, gelatine capsules and highly refined products identified by CN codes and HS headings not referred to in Article 13 of Delegated Regulation (EU) 2022/2292, should not be referred to in Article 14 of that Delegated Regulation. Article 14, points (d) and (e), of that Delegated Regulation should therefore be corrected.

(16) In Article 21, errors occurred in the list of the Harmonised System subheadings for sprouts and seeds intended for the production of sprouts, laid down in Part Two of Annex I to Council Regulation (EEC) No 2658/87(10). These errors are substantial as they identify the sprouts and the seeds intended for sprouts to which the conditions for entry into the Union apply. These subheadings in Article 21, point 1(c), of Delegated Regulation (EU) 2022/2292, should therefore be corrected.

(17) An error was made in the number of Commission Delegated Regulation (EU) 2022/1644(11)referred to in Annex I, Part II, Section C, point (2)(a). For the sake of legal certainty, it is appropriate to correct it.

(18) Sufficient time should be given to third countries to comply with the new requirement on the listing of establishments authorised to export honey and other apiculture products intended for human consumption to the Union concerned by the amendments being made to Article 13 of Delegated Regulation (EU) 2022/2292 by this Regulation. A transitional period should therefore be provided for this requirement.

(19) Delegated Regulations (EU) 2022/2292 and (EU) 2021/630 should be amended and corrected accordingly,

HAS ADOPTED THIS REGULATION:

Article 1 Amendments to Delegated Regulation (EU) 2022/2292 Delegated Regulation (EU) 2022/2292 is amended as follows:

(1) in Article 2, the following points (34a) and (34b) are inserted after point (34): ‘(34a) “honey” shall be understood as honey within the meaning of Council Directive 2001/110/EC (*) including as regards the main types of honey;

(34b) “apiculture products” means honey, beeswax, royal jelly, propolis or pollen, intended for human consumption; _____________ (*) Council Directive 2001/110/EC of 20 December 2001 relating to honey (OJ L 10, 12.1.2002, p. 47).’;

(10) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

(11) Commission Delegated Regulation (EU) 2022/1644 of 7 July 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with specific requirements for the performance of official controls on the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof (OJ L 248, 26.9.2022, p. 3).

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(2) in Article 5(2), the fourth indent is replaced by the following: ‘— fishery products from wild catch, insects, frogs, frogs’ legs, snails, reptiles and reptile meat.’;

(3) in Article 13(1), the following point (c) is added: ‘(c) honey and other apiculture products for which the following HS headings have been laid down in Part Two of Annex I to Regulation (EEC) No 2658/87: 0409, 0410, 1212, 1521or 1702.’;

(4) in Article 15, the introductory paragraph is replaced by the following: ‘Consignments of the following products of animal origin shall only enter the Union if they have been manufactured from raw materials obtained in slaughterhouses, game-handling establishments, cutting plants and establishments handling fishery products, appearing on lists of establishments drawn up and kept up to date in accordance with Article 127(3), point (e), of Regulation (EU) 2017/625 or obtained in Member States:’;

(5) Article 21 is amended as follows:

(a) paragraph 1 is amended as follows:

(i) the introductory paragraph is replaced by the following: ‘Each consignment of the following animals and goods shall enter the Union for placing on the market only

where the consignment is accompanied by an official certificate:’;

(ii) point (f) is replaced by the following: ‘(f) composite products referred to in Article 20(2), points (a) and (b) with the exclusion of shelf-stable composite products that do not contain meat products other than

(i) gelatine or collagen not derived from ruminant bones

(ii) highly refined products as described in Annex III, Section XVI of Regulation (EC) No 853/2004, intended for human consumption.’;

(b) paragraph 3 is replaced by the following: ‘3. No official certificate shall be required for the entry into the Union of gelatine capsules covered by HS headings 3913, 3926or 9602of Part Two of Annex I to Regulation (EEC) No 2658/87, nor for gelatine capsules as part of the products of animal origin referred to in point 1(b) of this Article or as part of the composite products referred to in Article 20(1) of this Regulation, where those capsules are not derived from ruminant bones.’;

(6) in Article 22(1), point (a) is replaced by the following: ‘(a) the consignments of the composite products referred to in Article 20(2), point (b), where the composite products do not contain colostrum-based products or meat products other than:

(i) gelatine or collagen not derived from ruminant bones;

(ii) highly refined products as described in Annex III, Section XVI of Regulation (EC) No 853/2004, intended for human consumption;’;

(7) Article 22(2) is replaced by the following: ‘2. By way of derogation from paragraph 1 of this Article, for the composite products exempted from official controls at border control posts in accordance with Article 48, point (h), of Regulation (EU) 2017/625, the private attestation shall accompany the composite products at the time of their placing on the market, except for the products referred to in Article 20(4) of this Regulation, for which a private attestation is not required.’.

ELI: http://data.europa.eu/eli/reg_del/2023/2652/oj 5/7EN OJ L, 28.11.2023 Article 2 Corrections to Delegated Regulation (EU) 2022/2292 Delegated Regulation (EU) 2022/2292 is corrected as follows:

(1) Article 14 is corrected as follows:

(a) point (d) is replaced by the following: ‘(d) production of highly refined products of animal origin referred to by HS headings 2932or 3503of Part Two of Annex I to Regulation (EEC) No 2658/87.’;

(b) point (e) is deleted;

(2) in Article 21(1), point (c) is replaced by the following: ‘(c) sprouts and seeds intended for the production of sprouts and referred to by the following HS subheadings:

0704 90, 0706 90, 0708 10, 0708 20, 0708 90, 0713 10, 0713 33, 0713 34, 0713 35, 0713 39, 0713 40, 0713 50, 0713 60, 0713 90, 0910 99, 1201 10, 1201 90, 1207 50, 1207 99, 1209 10, 1209 21, 1209 91 or 1214 90of Part Two of Annex I to Regulation (EEC) No 2658/87;’;

(3) in Annex I, Part II, Section C, point (2)(a) is replaced by the following: ‘(a) point A.1 of Annex II to Delegated Regulation (EU) 2022/1644 for group A substances referred to in Annex I to Delegated Regulation (EU) 2022/1644;’.

Article 3 Amendment to Delegated Regulation (EU) 2021/630 In Article 3 of Delegated Regulation (EU) 2021/630, paragraph 2 is replaced by the following: ‘2. At the time of placing on the market, shelf-stable composite products referred to in paragraph 1, point (a), shall be accompanied by a private attestation in accordance with the model laid down in Annex V to Commission Implementing Regulation (EU) 2020/2235 (*).

_____________ (*) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) 2017/625 of the European Parliament and of the Council as regards model animal health certificates, model official certificates and model animal health/official certificates, for the entry into the Union and movements within the Union of consignments of certain categories of animals and goods, official certification regarding such certificates and repealing Regulation (EC) No 599/2004, Implementing Regulations (EU) No 636/2014 and (EU) 2019/628, Directive 98/68/EC and Decisions 2000/572/EC, 2003/779/EC and 2007/240/EC (OJ L 442,

30.12.2020, p. 1).’.

Article 4 Transitional provision Consignments of honey and of other apiculture products intended for human consumption may enter the Union from establishments that are not listed in accordance with Article 13 of Delegated Regulation (EU) 2022/2292 for a period of 12 months from the date of publication of this Regulation in the Official Journal of the European Union.

Article 5 Entry into force This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

6/7 ELI: http://data.europa.eu/eli/reg_del/2023/2652/ojEN OJ L, 28.11.2023 This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 15 September 2023.

For the Commission The President Ursula VON DER LEYEN

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