Procedure to get the permission on the inspection bodies for organic production according to the Law on the implementation of common market organisations of agricultural products of the EU

PROCEDURE TO GET THE PERMISSION ON THE INSPECTION BODIES FOR ORGANIC PRODUCTION ACCORDING TO THE LAW ON THE IMPLEMENTATION OF COMMON MARKET ORGANISATIONS OF AGRICULTURAL PRODUCTS OF THE EU (PROMULGATED IN THE STATE GAZETTE № 96 FROM 28-TH OF NOVEMBER 2006, ENTERING INTO FORCE SINCE 01.01.2007) The inspection activities over rules for organic production are performed by inspection bodies. The inspection bodies might be local or foreign entities – registered as traders according to Bulgarian or Member State’s Law on Trade, or according to legislation in force in a state representing a side to the European Economic Area Agreement (EEA), after awarding a permission by the Minister of Agriculture and Forestry. LOCAL ENTITIES OR ENTITIES, WHOSE SEAT ARE BASED IN A MEMBER STATE OR IN A STATE REPRESENTING A SIDE TO THE EUROPEAN ECONOMIC AREA AGREEMENT (art. 19) Entities with seat based in a member-state or in a state representing a side to EEA shall submit applications to the MAF, Rural Development Directorate, Agrienvironment and Less favoured Areas Department in order to get a permission to perform control activities over rules for organic production. According to candidate’s needs, they might contact the Agrienvironment and Agrienvironment and Less-favoured Areas Department experts before submission of letter of interest at phone number: +359 (2) 985 11 652 or +359 (2) 985 11 403. The application shall comprise of data for the legal status of the entity: • Court registration or registration in accordance with Law on Trade; • Unique identification code or BULSTAT code; • name (company); • seat, address (address of the management) in Republic of Bulgaria; • subject of activities. Attached to the application have to be submitted: 1. contemporary certificate for entry registration in the Trade register or another register in accordance with the legislation of the member-state or the state being a side to EEA; 2. accreditation certificate issued by the Executive Agency “Bulgarian Accreditation Service” or by the corresponding accreditation authority in the member-state or the state being a side to EEA where the headquarter of the entity is situated. This certificate has to show compliance with the requirements ЕN 45 011 standard, respectively ISO/IEC Guide 65; 3. record. The record consists of: 1. procedure for carrying out inspections, containing detailed description of preventive and inspection measures which the person undertakes to impose in carrying out the inspections and assurance of their objectivity; 2. copy of contracts with the laboratory(ies) that shall carry out the analyses; 3. measures that the inspection body shall take where infringements are found; 4. data for the available technical resources; 5. data for the number of its employees and their qualification and experience in the field of inspection activities. Documents issued in foreign language have to be accompanied by legalized translation in Bulgarian. 2 THIRD COUNTRIES ENTITIES WITH SEAT OUTSIDE THE EU AND EEA (ART. 20) Entities from third countries submit their application to the MAF, Rural Development Directorate, Agrienvironment and Less-favoured Areas Department, Rural Development Directorate in order to be to get a permission to perform control activities over rules for organic production. The application has to be submitted through a branch registered in accordance with art. 17 (a) of Law on Trade. According to candidate’s needs, they might contact the Agrienvironment and Less favoured Areas experts before submission of letter of interest at phone number: +359 (2) 985 11 652 or +359 (2) 985 11 403. The application shall comprise of data for the legal status of the foreign entity: • legal structure; • name (company); • seat, address (address of the management) in Republic of Bulgaria; • subject of activities; • administrative, court/or other registration if applicable under implemented foreign legislation; • data for branch registration or representative address in the country. Attached to the application have to be submitted: 1. copy of the administrative/court/other registration of the foreign entity when the legislation in the respective country makes such provision; 2. copy of the Court Decision for local branch registration of the foreign entity as a trader; 3. copy of the certificate for accreditation which is attested in accordance with the requirements of the standard EN 45 011, respectively ISO/IEC Guide 65 and issued by an accreditation authority in the country which have signed the Multilateral Recognition Arrangement of the International Accreditation Forum. 4. Record. The record consists of: 1. procedure for carrying out inspections, containing detailed description of preventive and inspection measures which the person undertakes to impose in carrying out the inspections and assurance of their objectivity; 2. copy of contracts with the laboratory(ies) that shall carry out the analyses; 3. measures that the inspection body shall take where infringements are found; 4. data for the available technical resources; 5. data for the number of its employees and their qualification and experience in the field of inspection activities. Documents issued in foreign language have to be accompanied by legalized translation in Bulgarian. PROCEDURE FOR APPROVAL The applicant for control body submits the documents in 3 copies. The Secretariat at the Commission on organic farming checks if all the needed documents are provided. In case when a document is missing among the submitted documentation, the applicant shall be informed in written. In such a case, the deadline for license awarding (2 months) stops counting until elimination of lapses. 3 In case if the whole documentation is provided, the Minister of Agriculture and Forestry delegates to experts the verification of the compliance of this documentation with the factual circumstances for performance of control activities. The applicant for control body shall be informed in written for the date when on-the spot verification shall take place at least 3 days earlier and also for the names of the auditors who will participate in it and the agenda. The Minister of Agriculture and Forestry issues an Order for on the spot verification in which are included the names of auditors, the nomination for the head auditor and the date of its implementation. In case if during the verification some incompliance or lapse is found, the experts have to inform the applicant in written in 7 days deadline and provide him/her with instructions for its elimination. In such a case, the deadline for license awarding (2 months) stops counting until elimination of lapses. Following the elimination of the incompliance the experts who performed he verification present their conclusions from the held verification in a report, recognize the elimination of the incompliance found and give evaluation of the compliance of the submitted documentation with the factual circumstances for performance of control activities. The final report is to be completed in no longer than 4 days deadline after the verification took place. The Secretariat informs the Commission on organic farming members for the next sitting and provides each member with a copy of the documentation 5 days before the sitting date. At least 5 working days before the sitting, the applicant has to provide 3 copies of the documentation. The record is of high confidentiality. The documentation could be reached on place only and only in presence of the members of the Secretariat of the Commission on organic farming. The commission’s members accept through signed declaration that shall keep in confidentiality all the information and intelligence related to the applicant for control body and the provided by him documentation. The auditors sign declaration that they do not have any financial relations with the applicant. Then, the sitting of the Commission has to be held. The head auditor presents before the Commission’s members the final report of the auditors where the conclusions from the on the spot verification and from the evaluation of compliance between the submitted documents and the factual circumstances for performance of control activities are provided. It is not allowed any representative of the applicant to participate in the sitting and in the decision-making process. One or more applicant representatives may participate in some point of the agenda of the sitting in case they were invited for rising questions. The Commission provides its position to the Minister of agriculture and forestry. Based on this position the Minister awards through Order a license or provides motivated resignation. The Minister of Agriculture and Forestry shall issue permission or shall state the reason for the refusal within period of two months after the submission the application and the documents referred to in.. The permission is promulgated in The State Gazette. The permission for the same deadline as the accreditation certificate is issued.