EN Official Journal of the European Union L 299/31

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

(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 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 (2) was adopted. That Regulation was replaced by Commission Implementing Regulation (EU) No 961/2011 (3) which was later replaced by Commission Implementing Regulation (EU) No 284/2012 (4).

(3) Implementing Regulation (EU) No 284/2012 has been amended several times to take into account the development of the situation. Since now further amendments are required, it is appropriate to replace Implementing Regulation (EU) No 284/2012 by a new Regulation.

(4) The existing measures have been reviewed taking into account more than 26 000 occurrence data on radioactivity in feed and food provided by the Japanese authorities concerning the second growing season after the accident.

(5) It is appropriate to exclude personal consignments from the application of the provisions of this Regulation. For food and feed of animal orgin reference should be made to the provisions provided for in Commission Regulation (EC) No 206/2009 of 5 March 2009 on the introduction into the Community of personal consingments of products of animal origin and amending Regulation (EC) 136/2004 (5). For other feed and food, it should be provided that consignments can only be considered as personal consignments if they are non-commercial and are destined to a private person for personal consumption or use.

(6) The Japanese authorities have provided extensive information to the Commission that in addition to the already exempted alcoholic beverages (sake, whiskey and shochu) also other alcoholic beverages do not contain measurable levels of radioactivity. The process of polishing and fermentation reduces the radioactivity in the alcoholic beverage to a significant extent. It is therefore appropriate to exclude certain other alcoholic beverages from the scope of this Regulation in order to reduce the administrative burden for the Japanese authorities and the competent authorities of the importing Member States.

(7) 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 Yamanashi and Shizuoka on the presence of radioactivity before export to the Union. The requirement for sampling and analyses should only be maintained for tea from Shizuoka and mushrooms from Shizuoka and Yamanashi.

(8) Since non-compliant or significant levels of radioactivity continue to be found in feed and food originating in the prefecture of Fukushima, it is appropriate to maintain the existing requirement of sampling and analysis before export to the Union for all feed and food originating in that prefecture. However, the general exemptions, such as for alcoholic beverages and personal consignments, should continue to apply in relation to such feed and food.

(9) As regards the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Iwate, Chiba and Kanagawa for which it is currently required to sample and analyse all feed and food before export to the Union, it is appropriate to limit that requirement to mushrooms, tea, fishery products, certain edible wild plants, certain vegetables, certain fruits, rice and soybeans and the processed and derived products thereof. The same requirements should apply to compound foodstuffs containing more than 50 % of (an) ingredient(s) for which pretesting before export to the Union is required.

(10) 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 occurred for more than a year. Therefore it is appropriate to reduce the frequency of controls at import and the reporting of the results to the Commission.

(11) It is appropriate to foresee a next review of the provisions when the results of sampling and analysis on the presence of radioactivity of feed and food of the third growing season after the accident will be available, i.e. by 31 March 2014. However, for the products for which the harvest is mainly in the second part of the second growing season and therefore all the data of the second growing season are not yet available, it is appropriate to foresee a review of the provisions for these products by 31 March 2013.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation shall apply to feed and food within the meaning of Article 1(2) of Council Regulation (Euratom) No 3954/87 (6) originating in or consigned from Japan, with the exclusion of:

(a) products which left Japan before 28 March 2011;

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

(c) alcoholic beverages falling within CN codes 2203 to 2208;

(d) personal consignments of feed and food of animal origin which are covered by Article 2 of Regulation (EC) 206/2009;

(e) personal consignments of feed and food other than of animal origin which are not-commercial and destined to a private person for personal consumption and use only. In case of doubt, the burden of proof lies with the recipient of the consignment.

Article 2

Definitions

For the purposes of this Regulation, ‧transitional measures provided in the Japanese legislation‧ means the transitional measures adopted by the Japanese authorities on 24 February 2012 as regards the maximum levels for the sum of caesium-134 and caesium-137 as set out in Annex III.

‘Consignment’ means 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(s) of Japan, within the limits permitted by the declaration referred to in Article 5.

Article 3

Import into the Union

Feed and food (hereinafter -‧the products‧) referred to in Article 1 may only be imported into the Union if they comply with this Regulation.

Article 4

Maximum levels of caesium-134 and caesium-137

1. The products referred to in Article 1, except those appearing in Annex III, shall comply with the maximum level for the sum of caesium-134 and caesium-137 as as set out in Annex II.

2. Products appearing in Annex III shall comply with the maximum level for radioactive caesium set out in that Annex.

Article 5

Declaration

1. Each consignment of products referred to in Article 1 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:

(a) attest that the products comply with the legislation in force in Japan and

(b) specify whether the products are falling or not under the transitional measures provided for in the Japanese legislation.

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, other than tea and mushrooms originating in the prefecture Shizuoka and other than mushrooms originating in the prefecture Yamanashi, originates in and is consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate; or

(c) the product originates in and is consigned from Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate but is not listed in Annex IV to this Regulation (and consequently no analysis before export is required); or

(d) the product is consigned from Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, but does not originate in one of those prefectures and has not been exposed to radioactivity during transiting; or

(e) where the product is tea or mushrooms originating in Shizuoka prefecture or mushrooms originating in Yamanashi prefecture, or a derived product thereof or a compound feed or food containing more than 50 % of these products, the product is accompanied by an analytical report containing the results of sampling and analysis; or

(f) where the product, listed in Annex IV to this Regulation, originates in Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, or is a compound feed or food containing more than 50 % of these products, the product is accompanied by an analytical report containing the results of sampling and analysis. The list of products in Annex IV 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 (7); or

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

4. Point (f) of paragraph 3 shall apply also to products caught or harvested in the coastal waters of the prefectures referred to therein, 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 I.

2. For the products referred to in the points (a), (b), (c) or (d) 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 the point (e), (f) and (g) of Article 5(3), 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 1 shall be identified by means of a code which shall be indicated on the declaration referred to in Article 5(1), on the analytical report referred to in Article 5(3), on the sanitary certificate and on any commercial documents accompanying the consignment.

Article 8

Border inspection posts and designated point of entry

Consignments of products referred to in Article 1, except those falling within the scope of Council Directive 97/78/EC (8), 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 (9) (hereinafter – ‧the designated point of entry‧).

Article 9

Prior notification

Feed and food business operators or their representatives shall give prior notification of the arrival of each consignment of the products referred to in Article 1, at least two working days prior to the physical arrival of the consignment to the competent authorities at the border inspection post or at the designated point of entry.

Article 10

Official controls

1. The competent authorities of the border inspection post or designated point of entry shall carry out:

(a) documentary checks on all consignments of products referred to in Article 1;

(b) physical checks and identity checks, including laboratory analysis on the presence of caesium-134 and caesium-137, on 5 % of the consignments.

2. Consignments shall be kept under official control, for a maximum of five working days, pending the availability of the results of the laboratory analysis.

3. In case the result of the laboratory analysis provides evidence that the guarantees provided in the declaration are false, the declaration is considered not to be valid and the consignment of feed and food does not comply with the provisions of 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

The consignments may only be released into free circulation if the feed and food business operator or its representative submits to the customs authorities the declaration referred to in Article 5(1), which:

(a) has been duly endorsed by the competent authority at the border inspection post or designated point of entry; and

(b) provides evidence that the official controls referred to in Article 10 have been carried out and that the results of those controls have been favourable.

Article 13

Non-compliant products

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

Article 14

Reports

Member States shall inform the Commission every three months through the Rapid Alert System for Food and Feed (RASFF) of all analytical results obtained. That report shall be submitted during the month following each quarter.

Article 15

Repeal

Implementing Regulation (EU) No 284/2012 is repealed.

References to the repealed Regulation shall be construed as references to this Regulation.

Article 16

Transitional measure

By way of derogation from Article 3, products referred to in Article 1 may be imported into the Union if they comply with Implementing Regulation (EU) No 284/2012 where:

(a) the products left Japan before the entry into force of this Regulation; or

(b) the products are accompanied by a declaration in accordance with Implementing Regulation (EU) No 284/2012 which was issued before 1 November 2012 and the products have left Japan before 1 December 2012.

Article17

Entry into force and period of application

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

It shall apply from the date of entry into force until 31 March 2014.

This Regulation shall be reviewed before 31 March 2013 as regards the products of which the harvest is mainly between August and November and as regards fish and fishery products.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 26 October 2012. For the Commission The President José Manuel BARROSO

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

(2) OJ L 80, 26.3.2011, p. 5.

(3) OJ L 252, 28.9.2011, p. 10.

(4) OJ L 92, 30.3.2012, p. 16.

(5) OJ L 77, 24.3.2009, p. 1.

(6) OJ L 371, 30.12.1987, p. 11.

(7) OJ L 43, 14.2.1997, p. 1.

(8) OJ L 24, 30.1.1998, p. 9.

(9) OJ L 194, 25.7.2009, p. 11.

ANNEX I Declaration for the import into the Union of … (Product and country of origin) Batch identification Code … Declaration Number … According to the provisions of the Commission Implementing Regulation (EU) No 996/2012 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 the … (authorised representative referred to in Article 6 (2) or 6(3) of Implementing Regulation (EU) No 996/2012) DECLARES that the … … (products referred to in Article 1) of this consignment composed of: … … (description of consignment, product, number and type of packages, gross or net weight) embarked at … (embarkation place) on … (date of embarkation) by … (identification of transporter) going to … (place and country of destination) which comes from the establishment … … (name and address of establishment) is compliant with the legislation in force in Japan as regards the maximum levels for the sum of caesium-134 and caesium-137. DECLARES that the consignment concerns feed or food  not falling under the transitional measures provided in the Japanese legislation (see Annex III to Implementing Regulation (EU) No 996/2012) as regards the maximum level for the sum of caesium-134 and caesium-137  falling under the transitional measures provided in the Japanese legislation (see Annex III to Implementing Regulation (EU) No 996/2012) as regards the maximum level for the sum of caesium-134 and caesium-137 DECLARES that the consignment concerns:  feed or food that has been harvested and/or processed before 11 March 2011;  feed or food that originates in and is consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate, other than tea and mushrooms originating in Shizuoka prefecture and other than mushrooms originating in Yamanashi prefecture;  feed and food that is consigned from Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, but does not originate in one of those prefectures and has not been exposed to radioactivity during transiting;  feed and food not listed in Annex IV to Implementing Regulation (EU) No 996/2012, that originates in and is consigned from Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate;  tea or mushrooms or a compound feed or food containing more than 50 % of these products, originating in Shizuoka prefecture, and has been sampled on … (date), subjected to laboratory analysis on … (date) in the … (name of laboratory), to determine the level of the radionuclides, caesium-134 and caesium-137. The analytical report is attached;  mushrooms or a compound feed or food containing more than 50 % of these products, originating in Yamanashi prefecture, and has been sampled on … (date), subjected to laboratory analysis on … (date) in the … (name of laboratory), to determine the level of the radionuclides, caesium-134 and caesium-137. The analytical report is attached;  feed and food listed in Annex IV to Implementing Regulation (EU) No 996/2012 or a compound feed or food containing more than 50 % of these products, that originates in Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Chiba, Kanagawa and Iwate prefectures, and has been sampled on … (date), subjected to laboratory analysis on … (date) in the … (name of laboratory), to determine the level of the radionuclides, caesium-134 and caesium-137. The analytical report is attached;  feed and food of unknown origin or containing more than 50 % of (an) ingredient(s) of unknown origin and has been sampled on … (date), subjected to laboratory analysis on … (date) in the … (name of laboratory), to determine the level of the radionuclides, caesium-134 and caesium-137. The analytical report is attached. Done at … on… Stamp and signature of the authorised representative referred to in Article 6(2) or (3) of Implementing Regulation (EU) No 996/2012, Part to be completed by the competent authority at the border inspection post (BIP) or designated point of entry (DPE)  The consignment has been accepted to be presented to the custom authorities for release into free circulation in the Union  The consignment has NOT been accepted to be presented to the custom authorities into release for free circulation in the Union … (Competent authority, Member State) … Date Stamp Signature

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

Maximum levels for feed (3) (Bq/kg) as provided 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 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 Council Regulation (Euratom) No 3954/87. (3) Maximum level is relative to a feed with a moisture content of 12 %. (4) In order to ensure consistency with maximum levels currently applied in Japan, this value replaces on a provisional basis the value laid down in Commission Regulation (Euratom) No 770/90 (OJ L 83, 30.3.1990, p. 78). (5) With the exemption of feed for ornamental fish.

ANNEX III Transitional measures provided in Japanese legislation and of application for this Regulation (a) Milk and dairy products, mineral water and similar drinks that are manufactured and/or processed before 31 March 2012 shall not contain radioactive caesium more than 200 Bq/kg. Other foods, except for rice, soybean and processed products thereof that are manufactured, and/or processed before 31 March 2012 shall not contain radioactive caesium more than 500 Bq/kg. (b) Products made from rice that are manufactured, and/or processed before 30 September 2012 shall not contain radioactive caesium more than 500 Bq/kg. (c) Soybean harvested and placed on the market before 31 December 2012 shall not contain radioactive caesium more than 500 Bq/kg. (d) Products made from soybean that are manufactured and/or processed before 31 December 2012 shall not contain radioactive caesium more than 500 Bq/kg.