EN Official Journal of the European Union L 3/5

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

(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,

Whereas:

(1) Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

(2) 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. Such contamination may constitute a threat to public and animal health in the Union and therefore Commission Implementing Regulation (EU) No 297/2011 (2) was adopted. That Regulation was replaced by Implementing Regulation (EU) No 961/2011 (3) which was later replaced by Implementing Regulation (EU) No 284/2012 (4). The latter was replaced by Implementing Regulation (EU) No 996/2012 (5) which was later replaced by Implementing Regulation (EU) No 322/2014 (6).

(3) Since Implementing Regulation (EU) No 322/2014 provides that the measures provided therein are to be reviewed by 31 March 2015 and in order to take into account the further development of the situation and occurrence data for 2014 on radioactivity in feed and food, it is appropriate to repeal Implementing Regulation (EU) No 322/2014 and adopt a new Regulation.

(4) The existing measures have been reviewed taking into account more than 81 000 occurrence data on radioactivity in feed and food other than beef and more than 237 000 occurrence data on radioactivity in beef, provided by the Japanese authorities concerning the fourth growing season after the accident.

(5) Alcoholic beverages falling within the CN codes 2203 to 2208 are no longer explicitly excluded from the scope as the requirements as regards sampling and analysis and declaration apply to a defined list of feed and food.

(6) The data submitted by the Japanese authorities provide evidence that it is no longer necessary to require the sampling and analysis of feed and food originating in the prefectures of Aomori and Saitama regarding the presence of radioactivity before export to the Union.

(7) For feed and food products originating in the prefecture of Fukushima, the criterion of no non-compliance found by the Japanese authorities for two consecutive years (2013 and 2014), has been used for the current review to lift the requirement of sampling and analysis before export to the Union for those feed and food products. For the other feed and food originating in that prefecture, it is appropriate to maintain the requirement of sampling and analysis before export to the Union.

(8) It is appropriate to present the provisions of this Regulation in a manner that prefectures of which the same feed and food has to be sampled and analysed before export to the Union are grouped together, in order to facilitate the application of this Regulation.

(9) As regards the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Iwate and Chiba, it is currently required to sample and analyse mushrooms, fishery products, rice, soybeans, buckwheat and certain edible wild plants and the processed and derived products thereof, before export to the Union. The same requirements apply to compound foodstuffs containing more than 50 % of those products. The occurrence data for the fourth growing season provide evidence that for several of those feed and food commodities, it is appropriate to no longer require sampling and analysis before export to the Union.

(10) As regards the prefectures of Akita, Yamagata and Nagano, it is currently required to sample and analyse mushrooms and certain edible wild plants and the processed and derived products thereof before export to the Union. The occurrence data for the fourth growing season provide evidence that for one of the edible wild plants, it is appropriate to no longer require sampling and analysis before export to the Union. On the other hand, as a consequence of the finding of non-compliance in an edible wild plant, it is appropriate to require sampling and analysis of this edible wild plant originating from those prefectures.

(11) The occurrence data from the fourth growing season provide evidence that it is appropriate to maintain the requirement for sampling and analysis before export to the Union for mushrooms originating from the prefectures of Shizuoka, Yamanashi and Niigata. As a consequence of the finding of non-compliance in an edible wild plant, it is appropriate to require sampling and analysis of this edible wild plant originating from those prefectures.

(12) The controls performed at import show that the special conditions provided for by Union law are correctly implemented by the Japanese authorities and non-compliance has not been found at import controls for more than three years. Therefore, it is appropriate to keep the low frequency of controls at import and to no longer require that Member States inform the Commission every three months through the rapid alert system for food and feed (RASFF) of all analytical results.

(13) The transitional measures provided for in Japanese legislation, set out in Annex III to Implementing Regulation (EU) No 322/2014, are no longer of relevance for the feed and food currently imported from Japan and should therefore no longer be referred to in this Regulation.

(14) It is appropriate to foresee a review of the provisions of this Regulation when the results of sampling and analysis on the presence of radioactivity of feed and food of the fifth growing season (2015) after the accident are available, i.e. by 30 June 2016. The criteria for the review will be determined at the time of the review.

(15) 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

Scope

This Regulation applies to feed and food within the meaning of Article 1(2) of Council Regulation (Euratom) No 3954/87 (7) (‘the products’) originating in or consigned from Japan, with the exclusion of:

(a) products which have been harvested and/or processed before 11 March 2011;

(b) personal consignments of feed and food of animal origin which are covered by Article 2 of Commission Regulation (EC) No 206/2009 (8);

(c) personal consignments of feed and food other than of animal origin which are non-commercial and destined to a natural person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.

Article 2

Definition

For the purposes of this Regulation, ‘consignment’ means:

— for products for which a sampling and analysis is required by Article 5, a quantity of any of the feed or food falling within the scope of this Regulation of the same class or description, covered by the same document(s), conveyed by the same means of transport and coming from the same prefecture of Japan,

— for the other products falling within the scope of this Regulation, a quantity of any of the feed or food falling within the scope of this Regulation, covered by the same document(s), conveyed by the same means of transport and coming from one or more prefectures of Japan, within the limits set in the declaration referred to in Article 5.

Article 3

Import into the Union

Products may only be imported into the Union if they comply with this Regulation.

Article 4

Maximum levels of caesium-134 and caesium-137

Products shall comply with the maximum level for the sum of caesium-134 and caesium-137 as set out in Annex I.

Article 5

Declaration for certain products

1. Each consignment of mushrooms, fish and fishery products, with the exception of scallops, rice, soybeans, (Japanese) persimmon, Japanese or giant butterbur (fuki), Aralia spp., bamboo shoot, bracken, Japanese royal fern, ostrich fern and koshiabura or a derived product thereof or a compound feed or food containing more than 50 % of those products, originating in or consigned from Japan, shall be accompanied by a valid declaration drawn up and signed in accordance with Article 6.

2. The declaration referred to in paragraph 1 shall attest that the products comply with the legislation in force in Japan.

3. The declaration referred to in paragraph 1 shall furthermore certify that:

(a) the product has been harvested and/or processed before 11 March 2011; or

(b) the product does not originate in and is not consigned from one of the prefectures listed in Annex II (9), for which the sampling and analysis of this product is required; or

(c) the product is consigned 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

(d) 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; or

(e) where the origin of the product or of its ingredients present at more than 50 % is unknown, the product is accompanied by an analytical report containing the results of sampling and analysis.

4. Fish and fishery products caught or harvested in the coastal waters of the prefectures of Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Chiba or Iwate shall be accompanied by a declaration referred to paragraph 1 and by an analytical report containing the results of sampling and analysis, irrespective of where such products are landed.

Article 6

Drawing up and signing of the declaration

1. The declaration referred to in Article 5 shall be drawn up in accordance with the model set out in Annex III.

2. For the products referred to in points (a), (b) and (c) of Article 5(3), the declaration 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 points (d) and (e) of Article 5(3) and in Article 5(4), the declaration 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.

Article 7

Identification

Each consignment of products referred to in Article 5(1) shall be identified by means of a code which shall be indicated on the declaration referred to in Article 5, on the analytical report referred to in Article 6(3), on the common entry document or common veterinary entry document, referred to in Article 9(2) and on the sanitary certificate accompanying the consignment.

Article 8

Border inspection posts and designated point of entry

1. Consignments of products referred to in Article 5(1) shall be introduced into the Union through a designated point of entry within the meaning of point (b) of Article 3 of Commission Regulation (EC) No 669/2009 (10) (‘the designated point of entry’).

2. Paragraph 1 shall not apply to consignments of products referred to in Article 5(1) falling within the scope of Council Directive 97/78/EC (11). Those consignments shall be introduced into the Union via a border inspection post within the meaning of point (g) of Article 2(2) of that Directive.

Article 9

Prior notification

1. Feed and food business operators or their representatives shall give prior notification of the arrival of each consignment of products referred to in Article 5(1).

2. For the purpose of prior notification, feed and food business operators or their representatives shall complete:

(a) for products of non-animal origin: Part I of the common entry document (CED) referred to in point (a) of Article 3 of Regulation (EC) No 669/2009, taking into account the notes for guidance for the CED laid down in Annex II to that Regulation; for the purpose of this Regulation, Box I.13 of the CED can contain more than one commodity code;

(b) for fish and fishery products: the common veterinary entry document (CVED) set out in Annex III to Commission Regulation (EC) No 136/2004 (12).

The respective document shall be transmitted to the competent authority at the designated point of entry or border inspection post, at least two working days prior to the physical arrival of the consignment.

Article 10

Official controls

1. The competent authorities of the border inspection post or designated point of entry shall carry out the following controls on the products referred to in Article 5(1):

(a) documentary checks on all consignments;

(b) 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.

2. In case the result of the laboratory analysis provides evidence that the guarantees provided in the declaration referred to in Article 5 are false, the declaration is considered not to be valid and the consignment of feed and food does not comply with this Regulation.

Article 11

Costs

All costs resulting from the official controls referred to in Article 10 and any measures taken following non-compliance shall be borne by the feed and food business operators.

Article 12

Release for free circulation

1. The release for free circulation of each consignment of products referred to in Article 5(1) shall be subject to the presentation (physically or electronically) by the feed or food business operator or their representative to the custom authorities of a CED duly completed by the competent authority once all official controls have been carried out. The custom authorities shall only release the consignment for free circulation if a favourable decision by the competent authority is indicated in box II.14 of the CED and signed in box II.21 of the CED.

2. Paragraph 1 shall not apply to consignments of products referred to in Article 5(1) falling within the scope of Directive 97/78/EC. The release for free circulation of those consignments shall be subject to Regulation (EC) No 136/2004.

Article 13

Non-compliant products

Products which do not comply with this Regulation shall not be placed on the market. Such products shall be safely disposed of or returned to Japan.

Article 14

Review

This Regulation shall be reviewed before 30 June 2016.

Article 15

Repeal

Implementing Regulation (EU) No 322/2014 is repealed.

Article 16

Transitional provision

By way of derogation from Article 3, products may be imported into the Union under the following conditions:

(a) they comply with Implementing Regulation (EU) No 322/2014; and

(b) either they left Japan before the entry into force of this Regulation or they left Japan after the entry into force of this Regulation but before 1 February 2016 and they are accompanied by a declaration in accordance with Implementing Regulation (EU) No 322/2014 which was issued before the entry into force of this Regulation.

Article 17

Entry into force

This Regulation shall enter into force on the third 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, 5 January 2016. For the Commission The President Jean-Claude JUNCKER

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

(2) 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).

(3) 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).

(4) 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).

(5) 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).

(6) 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).

(7) Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (OJ L 371, 30.12.1987, p. 11).

(8) Commission Regulation (EC) No 206/2009 of 5 March 2009 on the introduction into the Community of personal consignments of products of animal origin and amending Regulation (EC) No 136/2004 (OJ L 77, 24.3.2009, p. 1).

(9) The list of products in Annex II is without prejudice to the requirements of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

(10) Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 11).

(11) Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (OJ L 24, 30.1.1998, p. 9).

(12) Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries (OJ L 21, 28.1.2004, p. 11).

ANNEX I Maximum levels for food (1) (Bq/kg) as provided for in the Japanese legislation Foods for infants and young children Milk and milk-based drinks Mineral water and similar drinks and tea brewed from unfermented leaves Other food Sum of caesium-134 and caesium-137 50 (2) 50 (2) 10 (2) 100 (2)

Maximum levels for feed (3) (Bq/kg) as provided for in the Japanese legislation Feed intended for cattle and horses Feed intended for pigs Feed intended for poultry Feed for fish (5) Sum of caesium-134 and caesium-137 100 (4) 80 (4) 160 (4) 40 (4) (1) For dried products that are intended to be consumed in a reconstituted state, the maximum level applies to the reconstituted product as ready for consumption. For dried mushrooms a reconstitution factor of 5 is of application. For tea, the maximum level applies to the infusion brewed from unfermented tea leaves. The processing factor for dried tea is 50, and therefore a maximum level of 500 Bq/kg on dried tea leaves ensures that the level in the brewed tea does not exceed the maximum level of 10 Bq/kg. (2) In order to ensure consistency with maximum levels currently applied in Japan, these values replace on a provisional basis the values laid down in Regulation (Euratom) No 3954/87. (3) Maximum level is relative to feed with a moisture content of 12 %. (4) In order to ensure consistency with maximum levels currently applied in Japan, these values replace on a provisional basis the values laid down in Commission Regulation (Euratom) No 770/90 of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency (OJ L 83, 30.3.1990, p. 78). (5) With the exemption of feed for ornamental fish.

ANNEX II Feed and food for which sampling and analysis regarding the presence of caesium-134 and caesium-137 are required before export to the Union (a) Products originating in the prefecture of Fukushima: — mushrooms and derived products thereof falling within CN codes 0709 51, 0709 59, 0710 80 61, 0710 80 69, 0711 51 00, 0711 59, 0712 31, 0712 32, 0712 33, 0712 39, 2003 10, 2003 90 and 2005 99 80, — fish and fishery products falling within CN codes 0302, 0303, 0304, 0305, 0306, 0307, 0308, 1504 10, 1504 20, 1604 and 1605 with the exception of scallops falling within CN codes 0307 21, 0307 29 and 1605 52 00, — rice and derived products thereof falling within CN codes 1006, 1102 90 50, 1103 19 50, 1103 20 50, 1104 19 91, 1104 19 99, 1104 29 17, 1104 29 30, 1104 29 59, 1104 29 89, 1104 30 90, 1901, 1904 10 30, 1904 20 95, 1904 90 10 and 1905 90, — soybeans and derived products thereof falling within CN codes 1201 90, 1208 10 and 1507, — giant butterbur or Japanese butterbur (fuki) (Petasites japonicus) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — Aralia spp. and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — bamboo shoot (Phyllostacys pubescens) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90, 0712 90, 2004 90 and 2005 91, — bracken (Pteridium aquilinum) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — koshiabura (shoot of Eleuterococcus sciadophylloides) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — Japanese royal fern (Osmunda japonica) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — ostrich fern (Matteuccia struthioptheris) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — (Japanese) persimmon (Diospyros sp.) and products derived thereof falling within CN codes 0810 70 00, 0810 90, 0811 90, 0812 90 and 0813 50. (b) Products originating in the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Chiba or Iwate: — mushrooms and derived products thereof falling within CN codes 0709 51, 0709 59, 0710 80 61, 0710 80 69, 0711 51 00, 0711 59, 0712 31, 0712 32, 0712 33, 0712 39, 2003 10, 2003 90 and 2005 99 80, — fish and fishery products falling within CN codes 0302, 0303, 0304, 0305, 0306, 0307, 0308, 1504 10, 1504 20, 1604 and 1605 with the exception of scallops falling within CN codes 0307 21, 0307 29 and 1605 52 00, — Aralia spp. and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — bamboo shoot (Phyllostacys pubescens) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90, 0712 90, 2004 90 and 2005 91, — bracken (Pteridium aquilinum) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — Japanese royal fern (Osmunda japonica) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — koshiabura (shoot of Eleuterococcus sciadophylloides) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — ostrich fern (Matteuccia struthioptheris) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90. (c) Products originating in the prefectures of Akita, Yamagata or Nagano: — mushrooms and derived products thereof falling within CN codes 0709 51, 0709 59, 0710 80 61, 0710 80 69, 0711 51 00, 0711 59, 0712 31, 0712 32, 0712 33, 0712 39, 2003 10, 2003 90 and 2005 99 80, — Aralia spp. and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — bamboo shoot (Phyllostacys pubescens) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90, 0712 90, 2004 90 and 2005 91, — Japanese royal fern (Osmunda japonica) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90, — koshiabura (shoot of Eleuterococcus sciadophylloides) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90. (d) Products originating in the prefectures of Yamanashi, Shizuoka or Niigata: — mushrooms and derived products thereof falling within CN codes 0709 51, 0709 59, 0710 80 61, 0710 80 69, 0711 51 00, 0711 59, 0712 31, 0712 32, 0712 33, 0712 39, 2003 10, 2003 90 and 2005 99 80, — koshiabura (shoot of Eleuterococcus sciadophylloides) and derived products thereof falling within CN codes 0709 99, 0710 80, 0711 90 and 0712 90. (e) Compound products containing more than 50 % of the products listed under points (a) to (d) of this Annex.