2.

Article 11 shall be replaced by the following: ‘Article 11 1. A product imported from a third country may be placed on the Community market labelled as a product with indications referring to the organic production method provided that: (a) the product complies with the provisions set out in Articles 5 and 6 of this Regulation; (b) all operators, including the exporters, have submitted their activities to an inspection body or an inspection authority recognised in accordance with paragraph 2; and, (c) the operators concerned shall be able to provide at any time, to the importers or the national authorities, documentary evidence permitting the identification of the operator who carried out the last operation and the type or range of products under his control, as well as permitting verification of compliance by that operator with points (a) and (b), and the period of validity. 2. The Commission shall, in accordance with the procedure referred to in Article 14(2), recognise the inspection bodies and inspection authorities referred to in paragraph 1(b), including inspection bodies and inspection authorities referred to in Article 9, competent to carry out inspections and to issue documentary evidence referred to in paragraph 1(c) in third countries, and shall establish a list of those inspection bodies and inspection authorities. The inspection bodies shall be accredited to the relevant European Standard EN 45011 or ISO Guide 65 “General requirements for bodies operating product certification systems”, this being the version last published in the Official Journal of the European Union, C series. The inspection bodies shall undergo regular on-the-spot evaluation, monitoring and multi-annual re-assessment of their activities by the accreditation body. When examining requests for recognition, the Commission shall invite the inspection body or authority to supply all the necessary information. The Commission may also entrust experts with the task of examining on-the-spot the rules of production and the inspection activities carried out in the third country by the inspection body or inspection authority concerned. The recognised inspection bodies or inspection authorities shall provide the assessment reports issued by the accreditation body or, as appropriate, the competent authority on the regular on-the-spot evaluation, monitoring and multi-annual re-assessment of their activities. Based on the assessment reports, the Commission, assisted by the Member States, shall ensure appropriate supervision of the recognised inspection bodies and inspection authorities by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions of this Regulation. 3. A product imported from a third country may also be placed on the Community market labelled as a product with indications referring to the organic production method, provided that: (a) the product has been produced in accordance with production standards equivalent to the production rules laid down in Articles 5 and 6 for organic production in the Community; (b) the operators have been subject to inspection measures equivalent to those referred to in Articles 8 and 9, and such inspection measures have been permanently and effectively applied; (c) the operators at all stages of production, preparation and distribution in the third country have submitted their activities to an inspection system recognised in accordance with paragraph 4 or an inspection body or inspection authority recognised in accordance with paragraph 5; and, (d) the product is covered by a certificate of inspection issued by the competent authorities or inspection bodies or inspection authorities of the third country recognised in accordance with paragraph 4, or by an inspection body or inspection authority recognised in accordance with paragraph 5, which confirms that the product satisfies the conditions set out in this paragraph. The original of the certificate must accompany the goods to the premises of the first consignee. Thereafter, the importer must keep the certificate at the disposal of the inspection body and, as appropriate, the inspection authority for not less than two years. 4. The Commission may, in accordance with the procedure referred to in Article 14(2), recognise third countries whose system of production complies with rules equivalent to those laid down in Articles 5 and 6 and whose inspection arrangements are equivalent to those laid down in Article 8 and 9, and may establish a list of these countries. The assessment of equivalency shall take into account Codex Alimentarius guidelines CAC/GL 32. When examining requests for recognition, the Commission shall invite the third country to supply all the necessary information. The Commission may entrust to experts the task of examining on-the-spot the rules of production and the inspection arrangements of the third country concerned. By 31 March of each year, the third countries so recognised shall send a concise annual report to the Commission regarding the implementation and the enforcement of their inspection arrangements. Based on the information in those annual reports, the Commission, assisted by the Member States, shall ensure appropriate supervision of the recognised third countries by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions of this Regulation. 5. For products not imported under paragraph 1 and not imported from a third country which is recognised under paragraph 4, the Commission may, in accordance with the procedure referred to in Article 14(2), recognise the inspection bodies and inspection authorities, including inspection bodies and inspection authorities as referred to in Article 9, competent to carry out inspections and issue certificates in third countries for the purpose of paragraph 3, and establish a list of these inspection bodies and inspection authorities. The assessment of equivalency shall take into account Codex Alimentarius guidelines CAC/GL 32. The Commission shall examine any request for recognition lodged by an inspection body or an inspection authority in a third country. When examining requests for recognition, the Commission shall invite the inspection body or inspection authority to supply all the necessary information. The inspection body or the inspection authority shall undergo regular on-the-spot evaluation, monitoring and multi-annual re-assessment of their activities by an accreditation body or, as appropriate, by a competent authority. The Commission may entrust to experts the task of examining on-the-spot the rules of production and the inspection activities carried out in the third country by the inspection body or inspection authority concerned. The recognised inspection bodies or inspection authorities shall provide the assessment reports issued by the accreditation body or, as appropriate, the competent authority on the regular on-the-spot evaluation, monitoring and multi-annual re-assessment of their activities. Based on those assessment reports, the Commission, assisted by the Member States, shall ensure appropriate supervision of recognised inspection bodies and inspection authorities by regularly reviewing their recognition. The nature of the supervision shall be determined on the basis of an assessment of the risk of the occurrence of irregularities or infringements of the provisions of this Regulation. 6. For a period starting on 1 January 2007 and ending 12 months after the publication of the first list of inspection bodies and inspection authorities recognised pursuant to paragraph 5, the competent authority of a Member State may authorise importers in that Member State, where the importer has notified his activity in accordance with Article 8(1), to place on the market products imported from third countries which are not included in the list referred to in paragraph 4, provided that the importer provides sufficient evidence showing that the conditions referred to in points (a) and (b) of paragraph 3 are satisfied. If those conditions are no longer satisfied, the authorisation shall be immediately withdrawn. Authorisations shall expire at the latest 24 months after the publication of the first list of inspection bodies and inspection authorities recognised pursuant to paragraph 5. The imported product shall be covered by a certificate of inspection issued by the authority or body which has been accepted for issuing the certificate of inspection by the competent authority of the authorising Member State. The original of the certificate must accompany the goods to the premises of the first consignee; thereafter the importer must keep the certificate at the disposal of the inspection body and, as appropriate, the inspection authority for not less than two years. Each Member State shall inform the other Member States and the Commission of each authorisation granted pursuant to this paragraph, including information on the production standards and inspection arrangements concerned. At the request of a Member State or at the Commission's initiative, an authorisation granted pursuant to this paragraph shall be examined by the Committee referred to Article 14. If this examination discloses that the conditions referred to in points (a) and (b) of paragraph 3 of this Article are not satisfied, the Commission shall require the Member State which granted the authorisation to withdraw it. Any authorisation to market products imported from a third country which had, prior to 31 December 2006, been granted to an importer by the competent authority of the respective Member State under this paragraph, shall expire on 31 December 2007 at the latest. 7. The Commission shall, in accordance with the procedure referred to in Article 14(2), adopt detailed rules for the application of this Article, in particular regarding: (a) the criteria and procedures to be followed with regard to the recognition of third countries and inspection bodies and inspection authorities, including the publication of lists of recognised third countries and inspection bodies and inspection authorities; and, (b) the documentary evidence referred to in paragraph 1 and the certificate referred to in paragraphs 3(d) and 6 of this Article, taking into account the advantages of electronic certification including the enhanced protection against fraud.’