Initial Application to market in the EU organic products from third Countries according to Article 19 Regulation (EC) No.
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1 Initial Application to market in the EU organic products from third Countries according to Article 19 Regulation (EC). 1235/2008 Cert. no.: Ref. no.: IMPORTANT Before you start to complete this form, please read the tes for Guidance carefully. Please complete this form by a computer or use block letters and black ink. Send the completed form, together with all the required supporting documentation to the: Ministry of Environment and Food of Denmark The Danish Agricultural Agency Administrative Area Control, Organic Farming Augustenborg Slot Augustenborg Denmark Tel. (+45) jordbrugskontrol@lbst.dk Section 1 Details of the importer 1. Company name Certification no. Page 1 out of 11
2 Section 2 Details of the first consignee in the EU If it is not yet know which company/unit is going to receive the products in Denmark, this has to be revealed together with the arrival of the goods before their release. Same as importer. The first consignee is not yet known. 2. Company name 3. Name of the inspection body of the first consignee Name: The same inspection body as importer. Page 2 out of 11
3 Section 3 Details of product(s) to be imported 4. Third country from which the products are to be imported: 5. Product list: Details of the agricultural products and/or feedstuffs which are to be imported and estimated annual quantities. English name (Scientific) Name CN-Code In conversion (C)* Organic (O) Estimated annual quantity (please specify SI-unit: t, kg, l) *Please indicate start of the conversion period. If necessary continue or attach the product list according to item 4 on a separate sheet and tick this box. If the product is composed of more than one ingredient, give details of the ingredients and processing aids of each product on the product specification sheet (Annex A). Use a separate sheet for each product, attach the product label to it and tick this box. Product list (continued) in annex no. Multi-ingredient product, see Annex A. Page 3 out of 11
4 Section 4 Details of the exporter in the third country 6. Company name 7. Name of the inspection body of the exporter Name: Date of last inspection: Proof of compliance with ISO 65 / EN 45011: Please provide evidence how equivalence of the certification held by the suppliers of the exporter to Reg. (EC). 834/2007 and Reg. (EC). 889/2008 as amended is assessed by the inspection body of the exporter. If the exporter is inspected by more than one inspection body, please provide name and of all the other inspection bodies. Confirmation/Accreditation certificate. Information as annex no. Information as annex no. Page 4 out of 11
5 Only if different to question 6, give the name and of the third country body responsible for issuing the certificates of inspection (Reg. (EC). 1235/2008 as amended) for the products to be imported to the EU. t applicable. 8. Company name Section 5 Details of the operator carrying out the most recent production/processing operation in the third country Please tick this box if the exporter and the operator carrying out the most recent preparation operation in the third country are identical. Then you do not need to complete section 4. Same as exporter. 9. Company name 10. Name of the inspection body of this operator Same as for the exporter. In other cases: Name: Date of last inspection: Proof of compliance with ISO 65 / EN 45011: Confirmation/Accreditation certificate. Page 5 out of 11
6 Section 6 Details of the production/processing unit(s) and agricultural holding(s) in the third country Please tick the box below if more than three production/processing units and/or eight agricultural holdings are involved. In this case, please attach a flowchart indicating the product flow and all preparation units as well as agricultural holdings involved including the following information: 1. Production/processing units: Name and, third country, inspection body in the third country, date of last inspection. Please attach copies of certificates. 2. Agricultural holdings: Name and, third country, inspection body in the third country, organic area, area under conversion and conventional area, start of conversion period, date of first and last inspection Please attach copies of certificates If you enclose a flowchart including the necessary information to this application, you do not need to complete item 11 and 13. However do not forget to complete item 12 and Production/Processing units Flowchart as annex no. A Name and Third country Date of last inspection Type of production/processing certificate for unit Inspection Body Same as for the exporter. Full Name Address Proof of ISO 65 compliance* B Name and Third country Date of last inspection Type of production/processing certificate for unit Inspection Body Same as for the exporter. Full Name Address Proof of ISO 65 compliance* C Name and Third country Date of last inspection Page 6 out of 11
7 Type of production/processing certificate for unit Inspection Body Same as for the exporter. Full Name Address Proof of ISO 65 compliance* *Proof of ISO 65 compliance for the inspection body: Please quote numbers: 1: Option 1 (Accreditation EA/IAF-member) 2: Option 2 (Competent authority in the third country) 3: Option 3 (Competent EU-authority) 12. Production rules and inspection measures for production/processing units in the third country Please indicate whether there are differences between the production rules and inspection measures in the third country and the provisions of Reg. (EC). 834/2007 and Reg. (EC). 889/2008. differences. Differences see annex 13. Details of the agricultural holding(s) D Name(s) and (es) Organic, in conversion and conventional area (ha) Start of conversion period Date of first inspection Date of last inspection E F G H Page 7 out of 11
8 I J K Inspection Body Same as for the exporter. Full Name Address Proof of ISO 65 compliance* *Proof of ISO 65 compliance for the inspection body: Please quote numbers: 1: Option 1 (Accreditation EA/IAF-member) 2: Option 2 (Competent authority in the third country) 3: Option 3 (Competent EU-authority) 14. Production rules and inspection measures for agricultural production units in the third country Do cooperatives, grower groups or contract growers produce the product(s)?. Yes, Annex B. Please indicate whether there are differences between the production rules and inspection measures in the third country and the provisions of Reg. (EC). 834/2007 and Reg. (EC) 889/2008. differences. Differences see annex Section 7 Supporting documentation 15. Documentation Please enclose the latest inspection reports of the inspection body in the third country/third countries of the companies and holdings involved. Documentation of: The exporter The production/processing unit(s) The agricultural holding(s) Page 8 out of 11
9 Section 8 Declarations 16. Declaration of the inspection body of the exporter in the third country The units and holdings mentioned in section 4 and 5 of this application are subject to production rules as well as to control procedures regarding the production of organic products: For every product mentioned in section 3 supplied by the exporter and received from the suppliers mentioned in section 4 and 5, differences of the applied production rules and control procedures from the requirements in Regulation (EC). 834/2007 and Regulation (EC). 889/2008 as amended have been identified and examined. Taking into account these differences, we consider the applied production rules to be at least equivalent to those of Regulation (EC). 834/2007 and Regulation (EC). 889/2008 as amended and the inspection measures to be as effective as the inspection measures according to Regulation (EC). 834/2007 and Regulation (EC). 889/2008 as amended. The inspection measures are permanently applied. Feeding stuff, compound feedstuffs and feed materials are produced and labelled according to Regulation (EC). 834/2007 and Regulation (EC). 889/2008. A permanent system to ensure the non-utilization of GMO and GMO-derivatives is in place on all stages of the production chain submitted to the inspection measures. Date Position in the company Signature Stamp Name in block letters: 17. Declaration of the Danish importer: I declare that: I am familiar with the legal basis for imports of organic products from third countries and the contents of the tes for Guidance. I am aware that every shipment has to be announced to the Danish AgriFish Agency, Department of Organics, 24 hours or at least one complete working day before its release for free circulation by the customs authorities. The importer is at all times responsible for the observation of current organic rules either provided by the EU or by the Danish legal system. The importer has the responsibility to inform the Danish AgriFish Agency of any changes in the production or inspection rules of the inspection bodies during the validity period of the import authorization. The importer accepts that import information is going to be published and stored in a national database and in the EU-database OFIS with access limited to competent authorities and control bodies. The information provided in this application is correct to the best of my knowledge. Date Signature Position in the company Name in block letters: Page 9 out of 11
10 Annex A ONLY FOR USE IN THE CASE OF PRODUCTS WITH MORE THAN ONE INGREDIENT AND/OR UTILIZATION OF PROCESSING AIDS Name of the product: Recipe of the product at the time of processing: Name of ingredients % weight Organic agricultural ingredients: Sum n-organic agricultural ingredients: Sum Ingredients of nonagricultural origin (Reg. (EC). 889/2008 as amended) INS-. Sum Total 100% List of processing aids and other products used: Processing aids and other products (Reg. (EC). 889/2008 as amended) Page 10 out of 11
11 Annex B ONLY FOR USE IN THE CASE OF GROWER GROUPS 18. Details of the grower group Type of group: Co-operative Contract growers Other (please specify), see annex Number of small-scale farmers at the date of last inspection: 19. Internal control system (ICS) te: Tick the corresponding box. If Yes: please include a page reference to the last Inspection report of the external inspection body responsible for the grower group. Grower contracts covering compliance with organic standards and ICS available? Defined responsibilities in the management of the grower group for the ICS? Description of each small-scale farm including maps of land parcels, preparation and storage facilities available? Technical Assistance and internal inspection separated? Internal inspection conducted at least one a year, covering 100% of small-scale farmers per year? Sanctions imposed by the grower group itself on members due to irregularities? 20. External inspection te: Tick the corresponding box. If Yes: please include a page reference to the last report of the external inspection body responsible for the grower group. Number of small-scale farmers externally inspected at the date of last inspection: Percentage of small-scale farmers externally inspected at the date of last inspection: % ICS evaluated by the inspection body? Functionality and effectiveness of the ICS confirmed by the inspection body? Page 11 out of 11
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