COMMISSION IMPLEMENTING REGULATION (EU) 2021/1533

of 17 September 2021

imposing special conditions governing the import of feed and food originating in or dispatched from Japan following the accident at the Fukushima nuclear power station and repealing Implementing Regulation (EU) 2016/6

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b)(ii) thereof,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on 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) (2), and in particular Article 54(4), first subparagraph, point (b), and Article 90, first paragraph, points (a), (c) and (f), thereof,

Whereas:

(1) Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan exceeded the action levels in food applicable in Japan. As such contamination may constitute a threat to public and animal health in the Union, the Commission Implementing Regulation (EU) No 297/2011 (3) imposed special conditions governing the importation of food and feed originating in or consigned from Japan. That Implementing Regulation was repealed and replaced successively by Commission Implementing Regulations (EU) No 961/2011 (4), (EU) No 284/2012 (5), (EU) No 996/2012 (6), (EU) No 322/2014 (7) and (EU) 2016/6 (8). In order to ensure consistency and facilitate implementation, those Regulations set out the maximum radionuclide levels by aligning with the values set out in relevant Japanese law and that practice should be maintained.

(2) Regulation (EU) 2017/625 requires that goods subject to an emergency measure provided for in acts adopted in accordance with Article 53 of Regulation (EC) No 178/2002 are subject to official controls at their entry into the Union.

(3) To facilitate the performance of official controls of food and feed subject to this Regulation at their entry into the Union, it is appropriate to establish a single model official certificate. It is also appropriate to lay down requirements for issuing official certificates in addition to the requirements laid down in Chapter VII of Title II of Regulation (EU) 2017/625 and, for certificates issued on paper, to those laid down in Article 39(1) of Commission Implementing Regulation (EU) 2019/1715 (9), and in Article 5 of Commission Implementing Regulation (EU) 2020/2235 (10). Furthermore, to ensure a coherent approach, it is appropriate to provide that official certificates issued in accordance with this Regulation should be replaced in accordance with the procedures for the issuance of replacement certificates laid down in Implementing Regulation (EU) 2020/2235.

(4) The existing measures have been reviewed, taking into account more than 87 000 occurrence data on radioactivity in feed and food other than beef and more than 429 000 occurrence data on radioactivity in beef provided by the Japanese authorities for the ninth and tenth growing seasons following the accident (data reported from January 2019 until December 2020).

(5) In light of those data, it appears that the obligation to sample and analyse products before export to the Union must be maintained or established for certain products, but it may be lifted for others. In particular, in addition to the products already subject to that obligation, it is appropriate to require the sampling and analysis of wild mushrooms and derived products originating from the prefectures of Iwate, Nagano, Niigata and Ibaraki, of fish and fishery products from Gunma, of wild bracken and derived products from Fukushima and of Japanese royal fern and derived products from the prefecture of Miyagi. However, the requirement to perform sampling and analysis before export to the Union may be lifted as regards Aralia sprout and derived products originating from the prefectures of Fukushima, Miyagi and Gunma, bamboo and derived products from the prefecture of Fukushima, mushrooms and derived products from the prefecture of Gunma, and koshiabura and derived products from the prefectures of Shizuoka, Yamanashi and Yamagata. Furthermore, the non-compliances in mushrooms were only found in wild mushrooms, in bracken only in wild bracken and in (Japanese) persimmon only in dried (Japanese) persimmon. It is therefore appropriate to limit the requirement to sample and analyse only wild or dried forms of these products, respectively.

(6) The official controls performed at entry into the Union show that the special conditions provided for by Union law are correctly implemented by the Japanese authorities, and no cases of non-compliance with Union law have been found during official import controls for more than nine years. Therefore, it is appropriate to keep the low frequency of official controls at entry into the Union of food and feed subject to this Regulation.

(7) It is appropriate to provide for a review of this Regulation when the results of the sampling and analysis for the presence of radioactivity in feed and food of the eleventh and twelfth growing seasons (2021 and 2022) after the accident are available.

(8) Since the amendments to Implementing Regulation (EU) 2016/6 are substantial, it is appropriate, for reasons of clarity, to replace it.

(9) To allow a smooth transition to the new measures, it is appropriate to provide for a transitional measure for consignments accompanied by official declarations issued in accordance with Implementing Regulation (EU) 2016/6, provided that such official declarations were issued before the entry into force of this Regulation.

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

HAS ADOPTED THIS REGULATION:

Article 1 Subject matter and scope 1. This Regulation lays down conditions for entry into the Union as regards food, including minor food, and feed within the meaning of Article 1 of Council Regulation (Euratom) 2016/52 (11) (‘the products’), originating in or dispatched from Japan and intended for placing on the Union market. 2. This Regulation shall not apply to the following categories of consignments of the products not exceeding the gross weight of 10 kg of fresh product or 2 kg of dry product: (a) consignments sent as trade samples, laboratory samples or as display items for exhibitions, which are not intended to be placed on the market; (b) consignments which form part of passengers’ personal luggage and are intended for personal consumption or use; (c) non-commercial consignments sent to natural persons, which are not intended to be placed on the market; (d) consignments intended for scientific purposes. In case of doubt over the intended use of the products the burden of proof lies respectively with the owner of the personal luggage and with the recipient.

Article 2 Definitions For the purposes of this Regulation, the ‘coming from the same territory or third country’, as referred to in Article 3, point (37), of Regulation (EU) 2017/625, means: — coming from the same prefecture of Japan, for products for which sampling and analysis is required by Article 4; — coming from one or more prefectures of Japan, all falling within the same situation as referred to in Article 4(3), for the other products falling within the scope of this Regulation.

Article 3 Conditions for entry into the Union 1. The products may only enter the Union if they comply with this Regulation. 2. The products shall comply with the maximum level for the sum of caesium-134 and caesium-137 as set out in Annex I. 3. Each consignment of products listed in Annex II, with reference to the relevant code from the Combined Nomenclature, originating in or dispatched from Japan, shall be accompanied by the official certificate referred to in Article 4. Each consignment shall be identified by means of an identification code, which shall be indicated on the official certificate and on the Common Health Entry Document (CHED) referred to in Article 56 of Regulation (EU) 2017/625. 4. The list of products in Annex II is without prejudice to the requirements of Regulation (EU) 2015/2283 of the European Parliament and of the Council (12)

Article 4 Official certificate 1. Each consignment of products referred to and falling under the CN codes mentioned in Annex II and the compound products containing in quantity more than 50 % of the products listed in Annex II, originating in or dispatched from Japan, shall be accompanied by a valid original official certificate drawn up and signed in accordance with Article 5. 2. The official certificate referred to in paragraph 1 shall attest that the products comply with Japanese applicable law and with the maximum level for the sum of caesium-134 and caesium-137 as set out in Annex I. 3. The official certificate referred to in paragraph 1 shall furthermore state that one of the following applies: (a) the product does not originate in and is not dispatched from one of the prefectures listed in Annex II, for which the sampling and analysis of this product is required; (b) the product is dispatched from but does not originate in one of the prefectures listed in Annex II, for which the sampling and analysis of this product is required, and has not been exposed to radioactivity during transiting or processing; (c) the product originates in one of the prefectures listed in Annex II, for which the sampling and analysis of this product is required and is accompanied by an analytical report containing the results of sampling and analysis; (d) the origin of the product or of its ingredients present in quantity at more than 50 % is unknown and the product is accompanied by an analytical report containing the results of sampling and analysis. 4. Fish and fishery products referred to in Annex II, which are caught or harvested in the coastal waters of the prefecture of Fukushima and Gunma, shall be accompanied by the official certificate referred to in paragraph 1 and by an analytical report containing the results of sampling and analysis, irrespective of where in Japan such products are landed.

Article 5 Drawing up and signing of the official certificate 1. The official certificate referred to in Article 4 shall be drawn up in accordance with the model set out in Annex III. 2. For the products referred to in Article 4(3), points (a) and (b), the official certificate shall be signed by an authorised representative of the competent Japanese authority or by an authorised representative of an instance authorised by the competent Japanese authority under the authority and supervision of the competent Japanese authority. 3. For the products referred to in Article 4(3), points (c) and (d), and in Article 4(4), the official certificate shall be signed by an authorised representative of the competent Japanese authority and shall be accompanied by an analytical report containing the results of sampling and analysis. 4. The official certificate shall meet the requirements for official certificates laid down in Article 5 of Implementing Regulation (EU) 2020/2235. 5. The competent authorities may issue a replacement official certificate only in accordance with the rules laid down in Article 6 of Implementing Regulation (EU) 2020/2235. 6. The official certificate shall be completed on the basis of the instructions set out in Annex IV to this Regulation.

Article 6 Official controls at entry into the Union 1. The consignments of products referred to in Article 4(1) shall be subject to official controls at their entry into the Union, at border control posts. 2. Products other than those referred to in Article 4(4) may be subject to identity and physical checks at the control points referred to in Article 53(1)(a) of Regulation (EU) 2017/625, performed in accordance with Commission Delegated Regulation (EU) 2019/2123 (13). 3. In addition to documentary checks on all consignments, the competent authorities of the border control post or control points shall carry out random identity checks and random physical checks, including laboratory analysis on the presence of caesium-134 and caesium-137. The analytical results shall be available within a maximum of five working days.

Article 7 Release for free circulation Customs authorities shall only allow the release for free circulation of consignments of the products referred to in Article 4(1) upon presentation of a duly finalised common health entry document, as provided for in Article 57(2)(b) of Regulation (EU) 2017/625, which confirms that the consignment is in compliance with the applicable rules referred to in Article 1(2) of that Regulation.

Article 8 Review This Regulation shall be reviewed before 30 June 2023.

Article 9 Repeal Implementing Regulation (EU) 2016/6 is repealed.

Article 10 Transitional provision Consignments of feed and food falling under the scope of Implementing Regulation (EU) 2016/6 which are accompanied by an official declaration issued in accordance with Implementing Regulation (EU) 2016/6 before 10 October 2021 may be imported into the Union under the conditions laid down by Implementing Regulation (EU) 2016/6.

Article 11 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 17 September 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 31, 1.2.2002, p. 1.

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

(3) Commission Implementing Regulation (EU) No 297/2011 of 25 March 2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station (OJ L 80, 26.3.2011, p. 5).

(4) Commission Implementing Regulation (EU) No 961/2011 of 27 September 2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and repealing Regulation (EU) No 297/2011 (OJ L 252, 28.9.2011, p. 10).

(5) Commission Implementing Regulation (EU) No 284/2012 of 29 March 2012 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and repealing Implementing Regulation (EU) No 961/2011 (OJ L 92, 30.3.2012, p. 16).

(6) Commission Implementing Regulation (EU) No 996/2012 of 26 October 2012 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and repealing Implementing Regulation (EU) No 284/2012 (OJ L 299, 27.10.2012, p. 31).

(7) Commission Implementing Regulation (EU) No 322/2014 of 28 March 2014 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station (OJ L 95, 29.3.2014, p. 1).

(8) Commission Implementing Regulation (EU) 2016/6 of 5 January 2016 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and repealing Implementing Regulation (EU) No 322/2014 (OJ L 3, 6.1.2016, p. 5).

(9) Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) (OJ L 261, 14.10.2019, p. 37).

(10) Commission Implementing Regulation (EU) 2020/2235 of 16 December 2020 laying down rules for the application of Regulations (EU) 2016/429 and (EU) No 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) No 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).

(11) Council Regulation (Euratom) 2016/52 of 15 January 2016 laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/990 (OJ L 13, 20.1.2016, p. 2).

(12) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).

(13) Commission Delegated Regulation (EU) 2019/2123 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for the cases where and the conditions under which identity checks and physical checks on certain goods may be performed at control points and documentary checks may be performed at distance from border control posts (OJ L 321, 12.12.2019, p. 64).