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 safetyOJ L 31, 1.2.2002, p. 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 stationOJ L 80, 26.3.2011, p. 5. was adopted. That Regulation was later replaced by Commission Implementing Regulation (EU) No 961/2011OJ L 252, 28.9.2011, p. 10..(3)The Japanese authorities have provided information to the Commission that in the many samples taken of sake and other spirit drinks (whiskey and shochu) no radioactivity was detected in all samples. The process of polishing, fermentation and distillation removes the radioactivity nearly completely from the spirit drink itself. The issue will be followed-up based on the continued monitoring of sake, whiskey and shochu by the Japanese authorities. It is therefore appropriate to exclude sake, whiskey and shochu 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.(4)The Japanese authorities have adopted on 24 February 2012 new maximum levels for the sum of caesium-134 and caesium-137, to be applied as from 1 April 2012, with transitional measures foreseen for rice, beef and soybean and processed products thereof, which are lower than the maximum levels established by 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 emergencyOJ L 371, 30.12.1987, p. 11.. The transitional measures for beef have no relevance for the import into the Union as the import of beef from Japan into the Union is not allowed for animal and public health reasons other than radioactivity. The Japanese authorities also informed the Commission that products that are not allowed to be placed on the Japanese market are also not allowed to be exported. It is therefore appropriate, although there is no need for safety reasons, in order to provide consistency between the pre-export controls performed by the Japanese authorities and the controls on the level of radionuclides performed on feed and food originating in or consigned from Japan at the entry into the Union, to apply the same maximum levels in the Union for radionuclides in feed and food from Japan as the maximum levels applicable in Japan as long as these are lower than the values established in Regulation (Euratom) No 3954/87.(5)Shortly after the nuclear accident, controls were required for the presence of iodine-131 and the sum of caesium-134 and caesium-137 in feed and food originating from Japan, as there was evidence that the release of radioactivity into the environment was related to a very large part to iodine-131, caesium-134 and caesium-137, and there was only very limited or no emission of the radionuclides strontium (Sr-90), plutonium (Pu-239) and americium (Am-241). Iodine-131 has a short half-life of 8 days and because there were no releases of radioactivity from the affected nuclear power plant into the environment in recent months and the affected nuclear reactor is now in a stable situation and no further releases to the environment are expected, iodine-131 is no longer present in the environment and consequently also not in feed and food from Japan. Therefore the control for the presence of iodine-131 was no longer required by Commission Implementing Regulation (EU) No 1371/2011 of 21 December 2011 amending Implementing Regulation (EU) No 961/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power stationOJ L 341, 22.12.2011, p. 41.. Therefore there is no need to maintain maximum levels for iodine-131 in this Regulation.(6)Implementing Regulation (EU) No 961/2011 provided also maximum levels for strontium, plutonium and americium in case there would have been new releases to the environment of radioactivity including these radionuclides. Given that the affected nuclear reactor is now in a stable situation, the possibility of new releases of radioactivity to the environment is excluded or very minimal and there have been no significant releases to the environment of strontium, plutonium and americium following the nuclear power plant accident, it is evident that the control for the presence of these radionuclides in food or feed from Japan is not necessary. As a consequence there is no need to maintain maximum levels for these radionuclides in this Regulation.(7)Implementing Regulation (EU) No 961/2011 has been amended at two occasions to take into account the development of the situation. Given that this Regulation provides for further amendments requiring changes to several provisions of that Regulation, it is appropriate to replace Implementing Regulation (EU) No 961/2011 by a new Regulation.(8)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 1ScopeThis Regulation shall apply to feed and food within the meaning of Article 1(2) of Regulation (Euratom) No 3954/87 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)sake falling within CN codes ex22060039 (sparkling), ex22060059 (still, in containers holding 2 litres or less) or ex22060089 (still, in containers holding more than 2 litres);(d)whiskey falling within CN code 220830;(e)shochu falling within CN code ex22089056, ex22089069, ex22089077 or ex22089078.

Article 2DefinitionsFor 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.

Article 3Import into the UnionFeed and food (hereinafter: "the products") referred to in Article 1 may only be imported into the European Union if they comply with this Regulation.

Article 4Maximum levels of caesium-134 and caesium-1371.The products referred to in Article 1, except rice, soybean and processed products thereof, shall comply with the maximum level for the sum of caesium-134 and caesium-137 as set out in Annex II.2.Rice and soybean and processed products thereof shall comply with the maximum level for the sum of caesium-134 and caesium-137 as set out in Annex III.

Article 5Declaration1.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 products have been harvested and/or processed before 11 March 2011; or(b)the products originate in and are consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa, Shizuoka and ~~Shizuoka~~Iwate; or(c)the products are consigned from Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa, Shizuoka and ~~Shizuoka~~Iwate prefectures, but do not originate in one of those prefectures and have not been exposed to radioactivity during transiting; or(d)where the products originate in Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa, Shizuoka and ~~Shizuoka~~Iwate prefectures, the products are accompanied by an analytical report containing the results of sampling and analysis.4.Point (d) 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 6Drawing up and signing of the declaration1.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) or (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 the point (d) 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 7IdentificationEach 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 6(3), on the sanitary certificate and on any commercial documents accompanying the consignment.

Article 8Border inspection posts and designated point of entryConsignments of products referred to in Article 1, except those falling within the scope of Council Directive 97/78/ECOJ L 24, 30.1.1998, p. 9., shall be introduced into the Union through a designated point of entry within the meaning of Article 3(b) of Commission Regulation (EC) No 669/2009OJ L 194, 25.7.2009, p. 11. (hereinafter "designated point of entry").

Article 9Prior notificationFeed 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 10Official controls1.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 at least:(i)5 % of the consignments of products referred to in Article 5(3)(d); and(ii)10 % of the consignments of products referred to in Article 5(3)(b) and (c).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 11CostsAll 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 12Release for free circulationThe consignments may only be released for free circulation if the feed and food business operators or their representative submit to the customs authorities a declaration, as 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)gives 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 13Non-compliant productsProducts 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 14ReportsMember States shall inform the Commission monthly through the Rapid Alert System for Food and Feed (RASFF) of all analytical results obtained.

Article 15RepealImplementing Regulation (EU) No 961/2011 is repealed.References to the repealed Regulation shall be construed as references to this Regulation.

Article 16Transitional measureBy 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 961/2011 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 that Regulation which was issued before 1 April 2012 and the products have left Japan before 15 April 2012.

Article 17Entry into force and period of applicationThis 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 October 2012. The Regulation will be reviewed regularly taking into account the development of the contamination situation.

This Regulation shall be binding in its entirety and directly applicable in all Member States.~~Done at Brussels,~~ ~~29 March 2012~~.~~For the CommissionThe PresidentJosé Manuel~~ ~~Barroso~~ANNEX I 02012R0284-20120701_en_img_1

ANNEX II

Maximum levels for food(Bq/kg) as provided in the Japanese legislationFor 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.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.For rice and rice products, the maximum level applies as from 1 October 2012. Before that date, the maximum level of 500 Bq/kg applies.For soybean and soybean products, the maximum level of 500 Bq/kg applies.

	Foods for infants and young children	Milk and dairy products	Other food, with the exception ofmineral water and similar drinkstea brewed from unfermented leavessoybean and soybean products	Mineral water and similar drinks and tea brewed from unfermented leaves
Sum of caesium-134 and caesium-137	50	50	100	10

Maximum levels for feed(Bq/kg) as provided in the Japanese legislationMaximum level is relative to a feed with a moisture content of 12 %.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).With the exemption of feed for ornamental fish.

	Feed intended for cows and horses	Feed intended for pigs	Feed intended for poultry	Feed for fish
Sum of caesium-134 and caesium-137	100	80	160	40

ANNEX IIITransitional 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)Rice harvested before 30 September 2012 shall not contain radioactive caesium more than 500 Bq/kg.(c)Products made from rice that are manufactured, and/or processed before 30 September 2012 shall not contain radioactive caesium more than 500 Bq/kg.(d)Soybean shall not contain radioactive caesium more than 500 Bq/kg.(e)Products made from soybean shall not contain radioactive caesium more than 500 Bq/kg.