3.2.2005 EN Official Journal of the European Union L 30/12
COMMISSION DECISION
of 26 January 2005
imposing special conditions on the import of pistachios and certain products derived from pistachios originating in, or consigned from Iran
(notified under document number C(2005) 117)
(Text with EEA relevance)
(2005/85/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
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) thereof,
Whereas:
(1) Commission Decision 97/830/EC of 11 December 1997 repealing Commission Decision 97/613/EC and imposing special conditions on the import of pistachios and certain products derived from pistachios originating in, or consigned from Iran (2) has been substantially amended several times.
(2) The legal basis for Decision 97/830/EC is Article 10 of the Council Directive 93/43/EC of 14 June 1993 on the hygiene of foodstuffs (3). Directive 93/43/EEC will be repealed as from 1 January 2006 by Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (4). This Regulation does no longer contain the legal basis for a safeguard measure.
(3) Regulation (EC) No 178/2002 provides that where it is evident that food or feed originating in the Community or imported from a third country is likely to constitute a serious risk to human health, animal health and the environment, measures are to be adopted.
(4) Pistachios originating in, or consigned from Iran have been found, in many cases, to be contaminated with excessive levels of Aflatoxin B1.
(5) The Scientific Committee for Food has noted that Aflatoxin B1 is a potent genotoxic carcinogen and, even at extremely low doses, contributes to the risk of liver cancer.
(6) The import of pistachios from Iran therefore constitutes a serious threat to public health within the Community and it is imperative to adopt protective measures at Community level.
(7) An examination of conditions of hygiene in Iran was undertaken by the Commission’s Food and Veterinary Office (FVO) for the first time in 1997 and revealed that improvements in hygiene practices and the traceability of pistachios were required. The mission team was unable to check all stages of the handling of pistachios prior to exportation. Commitments were received from the Iranian authorities in particular in relation to improvements in production, handling, sorting, processing, packaging and transport practices. It was therefore appropriate to subject pistachios and certain pistachio products from Iran to special conditions to provide a high level of protection to public health. Follow up missions have been organised in 1998 and 2001. Although during these missions substantial improvements in hygiene practices and the traceability have been observed, there is a continued need imposing special conditions on pistachios and certain pistachio products from Iran to protect public health.
(8) Pistachios and certain pistachio products from Iran may be imported, provided that special conditions are applied.
(9) One of those conditions is that it is necessary to provide that pistachios and products derived from pistachios have been produced, sorted, handled, processed, packaged and transported following good hygienic practices. It is necessary to establish the levels of Aflatoxin B1 and total Aflatoxin in samples taken from the consignment immediately prior to leaving Iran.
(10) It is furthermore necessary for documentary evidence to be provided by the Iranian authorities to accompany each consignment of pistachios originating in, or consigned from Iran, relating to the conditions of production, sorting, handling, processing, packaging and transport and the results of laboratory analysis of the consignment for levels of Aflatoxin B1 and total Aflatoxin.
(11) In the interests of public health, Member States will keep the Commission informed through periodical reports of all analytical results of official controls carried out in respect of consignments of pistachios and certain pistachio products from Iran. Such reports shall be in addition to the notification obligations under the Rapid Alert System for Food and Feed (RASFF) established by Regulation (EC) No 178/2002.
(12) It is important to ensure that the sampling and analysis of consignments of pistachios and pistachio products from Iran are performed in a harmonised manner throughout the Community.
(13) Checks carried out in 2003 and 2004 revealed that a large number of consignments of pistachios from Iran exceeded the maximum level of aflatoxins. It is therefore necessary to restrict the validity of the health certificate in order to limit the duration of transport and storage, when aflatoxins can be formed.
(14) The operation of this Decision should be kept under review in the light of information and guarantees provided by the competent authorities of Iran and of the results of the tests carried out by Member States in order to assess whether the special conditions provide a sufficient level of protection of public health within the Community and whether they are still needed.
(15) The measures provided for in this Decision have a significant impact on the control resources of the Member States. It is therefore appropriate to require that all costs resulting from sampling, analysis, storage and all costs resulting from official measures taken as regards non-compliant consignments are to be borne by the importers or food business operators concerned.
(16) Decision 97/830/EC should accordingly be repealed.
(17) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
1.   Member States may import
— pistachios falling within CN code 0802 50 00, and
— roasted pistachios falling within CN codes 2008 19 13 and 2008 19 93,
originating in, or consigned from Iran, only where the consignment is accompanied by the results of official sampling and analysis, and the health certificate in Annex I, completed, signed and verified by a representative of the Iranian Ministry of Health. The health certificate shall be valid for import carried out no more than four months after the issue date of the health certificate.
2.   Products covered by paragraph 1 may only be imported into the Community through one of the points of entry listed in Annex II.
3.   Each consignment of products covered by paragraph 1 shall be identified with a code which corresponds to the code on the sampling results of the official sampling and analysis and health certificate referred to in paragraph 1.
4.   The competent authorities in each Member State shall ensure that products covered by paragraph 1 are subject to documentary checks to ensure that the requirement for the health certificate and sampling results referred to in paragraph 1, are complied with.
5.   The competent authorities in each Member State shall take a sample for analysis from each consignment of products covered by paragraph 1 for analysis of aflatoxin B1 and total aflatoxin before release onto the market from the point of entry into the Community.
Member States shall submit to the Commission every three months a report of all analytical results of official controls on consignments of products covered by paragraph 1. This report shall be submitted during the month following each quarter (April, July, October, and January).
6.   Any consignment which is to be subjected to sampling and analysis should be held before release onto the market from the point of entry into the Community for a maximum period of 15 working days. The competent authorities of the importing Member State shall issue an accompanying official document establishing that the consignment has been subjected to official sampling and analysis and indicating the result of the analysis.
7.   If a consignment is split, copies of the health certificate and accompanying official documents referred to in paragraphs 1 and 6 and certified by the competent authority of the Member State on whose territory the splitting has taken place, shall accompany each part of the split consignment up to and including the wholesale stage.
This Decision shall be kept under review in the light of information and guarantees provided by the competent authorities of Iran and of the results of the tests carried out by Member States in order to assess whether the special conditions set out in Article 1 provide a sufficient level of protection of public health within the Community and whether they are still necessary.
All costs resulting from sampling, analysis, storage and issuing of accompanying official document and of copies of health certificate and accompanying documents pursuant to Article 1(4) to (7) shall be borne by the food business operator responsible for the consignment or its representative.
Also all costs related to official measures taken by the competent authorities as regards non-compliant consignments of pistachios and certain products derived from pistachios originating in or consigned from Iran shall be borne by the food business operator responsible for the consignment or its representative.
Decision 97/830/EC is repealed.
The Decision shall apply from 1 February 2005.
Member States shall take the measures necessary to comply with this Decision. They shall immediately inform the Commission thereof.
This Decision is addressed to the Member States.