Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries
Modified by
- Commission Regulation (EC) No 537/2009of 19 June 2009amending Regulation (EC) No 1235/2008, as regards the list of third countries from which certain agricultural products obtained by organic production must originate to be marketed within the Community(Text with EEA relevance), 32009R0537, June 20, 2009
- Commission Regulation (EU) No 471/2010of 31 May 2010amending Regulation (EC) No 1235/2008, as regards the list of third countries from which certain agricultural products obtained by organic production must originate to be marketed within the Union(Text with EEA relevance), 32010R0471, June 1, 2010
- Commission Implementing Regulation (EU) No 590/2011of 20 June 2011amending Regulation (EC) No 1235/2008, laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries(Text with EEA relevance), 32011R0590, June 21, 2011
- Commission Implementing Regulation (EU) No 1084/2011of 27 October 2011amending and correcting Regulation (EC) No 1235/2008, laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries, 32011R1084, October 28, 2011
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1. "certificate of inspection": means the certificate of inspection referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 covering one consignment; 2. "documentary evidence": means the document referred to in Article 68 of Commission Regulation (EC) No 889/2008 and in Article 6 of this Regulation, for which the model is set out in Annex II to this Regulation;OJ L 250, 18.9.2008, p. 1 .3. "consignment": means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country; 4. "first consignee": means the natural or legal person as defined in Article 2(d) of Regulation (EC) No 889/2008; 5. "verification of the consignment": means the verification by the relevant Member States’ authorities of the certificate of inspection to satisfy Article 13 of this Regulation, and, where these authorities consider appropriate, of the products, in relation to the requirements of Regulation (EC) No 834/2007, of Regulation (EC) No 889/2008 and of this Regulation; 6. "relevant Member States authorities": means the customs authorities or other authorities, designated by the Member States; 7. "assessment report": means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries.
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(a) the name and address of the control body or control authority, including e-mail and Internet address and their code number; (b) the third countries concerned and in which the products have their origin; (c) the product categories concerned for each third country; (d) the duration of the inclusion in the list; (e) the Internet address where the list of operators subject to the control system can be found, including their certification status and the product categories concerned, as well as suspended and decertified operators and products.
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(a) an overview of the activities of the control body or control authority in the third country or third countries concerned, including an estimate of the number of operators involved and an indication of the expected nature and quantities of agricultural products and foodstuffs originated from the third country or third countries concerned and intended for export to the Community under the rules set out in Article 32(1) and (2) of Regulation (EC) No 834/2007; (b) a detailed description of how Titles II, III and IV of Regulation (EC) No 834/2007 as well as the provisions of Regulation (EC) No 889/2008 have been implemented in the third country or in each of the third countries concerned; (c) a copy of the assessment report as set out in the fourth subparagraph of Article 32(2) of Regulation (EC) No 834/2007: -
(i) proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 32(1) and (2) of Regulation (EC) No 834/2007; (ii) giving guarantees on the elements referred to in Article 27(2), (3), (5), (6) and (12) of Regulation (EC) No 834/2007; (iii) ensuring that the control body or control authority meets the control requirements and precautionary measures set out in Title IV of Regulation (EC) No 889/2008; and (iv) confirming that it has effectively implemented its control activities according to these conditions and requirements;
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(d) proof that the control body or authority has notified its activities to the authorities of the third country concerned and its undertaking to respect the legal requirements imposed on it by the authorities of the third country concerned; (e) the website address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products; (f) an undertaking to comply with the provisions of Article 5 of this Regulation; (g) any other information deemed relevant by the control body or control authority or by the Commission.
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(a) if, after the control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or control authority referred to in Article 3(2) shall also be notified to the Commission; (b) a control body or control authority included in the list shall keep available and communicate at first request all information related to its control activities in the third country; it shall give access to its offices and facilities to experts designated by the Commission; (c) by 31 March every year, the control body or control authority shall send a concise annual report to the Commission; the annual report shall update the information of the technical dossier referred to in Article 4(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries during the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; it shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 32(2) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary; (d) in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority in the list referred to in Article 3; a similar decision may also be made where a control body or authority has not supplied information required or where it has not agreed to an on-the-spot examination; (e) the control body or control authority shall make available to interested parties, on an Internet website, a continuously updated list of operators and products certified as organic.
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(a) the product categories concerned; (b) the origin of the products; (c) a reference to the production standards applied in the third country; (d) the competent authority in the third country responsible for the control system, its address, including e-mail and Internet addresses; (e) the control authority or authorities in the third country and/or the control body or bodies recognised by the said competent authority to carry out controls, their addresses, including, when appropriate, e-mail and Internet addresses; (f) the authority or authorities or the control body or bodies responsible in the third country for issuing certificates with a view to importing into the Community, their addresses and their code numbers and, when appropriate, their e-mail and Internet addresses; (g) the duration of the inclusion in the list.
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(a) general information on the development of organic production in the third country, the products produced, the area in cultivation, the production regions, the number of producers, the food processing taking place; (b) an indication of the expected nature and quantities of organic agricultural products and foodstuffs intended for export to the Community; (c) the production standards applied in the third country as well as an assessment of their equivalence to the standards applied in the Community; (d) the control system applied in the third country, including the monitoring and supervisory activities carried out by the competent authorities in the third country, as well as an assessment of its equivalent effectiveness when compared to the control system applied in the Community; (e) the Internet or other address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status and the product categories concerned; (f) the information the third country proposes to include in the list as referred to in Article 7; (g) an undertaking to comply with the provisions of Article 9; (h) any other information deemed relevant by the third country or by the Commission.
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(a) if, after a third country has been included in the list, any changes are made to the measures in force in the third country or their implementation and in particular to its control system, that third country shall notify the Commission thereof; requests to amend the information in respect of a third country referred to in Article 7(2) shall also be notified to the Commission; (b) the annual report referred to in Article 33(2) of Regulation (EC) No 834/2007 shall update the information of the technical dossier referred to in Article 8(2) of this Regulation; it shall describe in particular the monitoring and supervisory activities carried out by the competent authority of the third country, the results obtained and the corrective measures taken; (c) in the light of any information received, the Commission may at any time amend the specifications relating to the third country and may suspend the entry of that country from the list referred to in Article 7; a similar decision may also be made where a third country has not supplied information required or where it has not agreed to an on-the-spot examination.
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(a) the name, address and code number of the control body or authority, and, when appropriate, its e-mail and Internet address; (b) the third countries not listed in the list provided for in Article 7 where the products have their origin; (c) the product categories concerned for each third country; (d) the duration of the inclusion in the list; and (e) the Internet website where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products.
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(a) an overview of the activities of the control body or control authority in the third country or third countries, including an estimate of the number of operators involved and the expected nature and quantities of agricultural products and foodstuffs intended for export to the Community under the rules set out in Article 33(1) and (3) of Regulation (EC) No 834/2007; (b) a description of the production standards and control measures applied in the third countries, including an assessment of the equivalence of these standards and measures with Titles III, IV and V of Regulation (EC) No 834/2007 as well as with the associated implementing rules laid down in Regulation (EC) No 889/2008; (c) a copy of the assessment report as set out in the fourth subparagraph of Article 33(3) of Regulation (EC) No 834/2007: -
(i) proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 33(1) and (3) of Regulation (EC) No 834/2007; (ii) confirming that it has effectively implemented its activities according to those conditions; and (iii) demonstrating and confirming the equivalence of the production standards and control measures referred to in subparagraph (b) of this paragraph;
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(d) proof that the control body or control authority has notified its activities to the authorities of each of the third countries concerned and its undertaking to respect the legal requirements imposed on it by the authorities of each of the third countries concerned; (e) the Internet website where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products; (f) an undertaking to comply with the provisions of Article 12; (g) any other information deemed relevant by the control body or control authority or by the Commission.
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(a) if, after a control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or authority referred to in Article 10(2), shall also be notified to the Commission; (b) by 31 March every year, the control body or control authority shall send a concise annual report to the Commission. The annual report shall update the information of the technical dossier referred to in Article 11(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries in the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; It shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 33(3) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary; (c) in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority from the list referred to in Article 10; a similar decision may also be made where a control body or control authority has not supplied information required or where it has not agreed to an on-the-spot examination; (d) the control body or control authority shall make available to interested parties, by electronic means, a continuously updated list of operators, and of products certified as organic.
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(a) the submission of an original certificate of inspection to the relevant Member State’s authority; and (b) on the verification of the consignment by the relevant Member State’s authority and the endorsement of the certificate of inspection in accordance with paragraph 8 of this Article.
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(a) the control authority or control body which has been accepted for issuing the certificate of inspection, as referred to in Article 7(2), from a third country recognised under Article 8(4); or (b) the control authority or control body in the third country listed for the third country concerned recognised under Article 11(5).
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(a) it has carried out a documentary check on the basis of all relevant inspection documents, including in particular the production plan for the products concerned, transport documents and commercial documents; and (b) it has either made a physical check of the consignment, or it has received an explicit declaration of the exporter declaring that the consignment concerned has been produced and/or prepared in accordance with Article 33 of Regulation (EC) No 834/2007; it shall carry out a risk-oriented verification of the credibility of this declaration.
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(a) the certificate of inspection referred to in paragraph 3(b) shall, at the time it is submitted in accordance with paragraph 1, include in box 16 the declaration of the competent authority in the Member State which granted the authorisation according to the procedure provided for in Article 19; (b) the competent authority in the Member State which granted the authorisation may delegate the competence for the declaration in box 16 to the control authority or control body inspecting the importer in accordance with the control measures set out in Title V of Regulation (EC) No 834/2007, or to the authorities defined as the Member State’s relevant authorities; (c) the declaration in box 16 is not required: -
(i) when the importer presents an original document, issued by the competent authority of the Member State which granted the authorisation in accordance with Article 19 of this Regulation, demonstrating that the consignment is covered by that authorisation; or (ii) when the Member State’s authority, which granted the authorisation referred to in Article 19, has given satisfactory evidence that the consignment is covered by that authorisation, directly to the authority in charge of the verification of the consignment; this procedure of direct information is optional for the Member State which granted the authorisation;
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(d) the document giving the evidence required in points c(i) and (ii), shall include: -
(i) the reference number of the import authorisation and the date of expiration of the authorisation; (ii) the name and address of the importer; (iii) the third country of origin; (iv) the details of the issuing body or authority, and, where different, the details of the inspection body or authority in the third country; (v) the names of the products concerned.
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(a) packaging or repackaging; or (b) labelling concerning the presentation of the organic production method.
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(a) live or unprocessed agricultural products and vegetative propagating material and seeds for cultivation with the exception of: -
livestock and livestock products, bearing or intended to bear indications referring to conversion;
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(b) processed agricultural products for use as food with the exception of: -
livestock products bearing or intended to bear indications referring to conversion.
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Food Safety SA, www.foodsafety.com.ar Instituto Argentino para la Certificación y Promoción de Productos Agropecuarios Orgánicos SRL (Argencert), www.argencert.com Letis SA, www.letis.com.ar Organización Internacional Agropecuaria (OIA), www.oia.com.ar
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(a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin.
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Australian Certified Organic Pty. Ltd., www.australianorganic.com.au Australian Quarantine and Inspection Service (AQIS), www.aqis.gov.au Bio-dynamic Research Institute (BDRI), www.demeter.org.au NASAA Certified Organic (NCO), www.nasaa.com.au Organic Food Chain Pty Ltd (OFC), www.organicfoodchain.com.au AUS-QUAL Pty Ltd, www.ausqual.com.au
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(a) live or unprocessed agricultural products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food and feed.
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Atlantic Certified Organic Cooperative Limited (ACO), www.atlanticcertifiedorganic.ca British Columbia Association for Regenerative Agriculture (BCARA), www.centifiedorganic.bc.ca Certification Services Limited Liability Company (CCOF), www.ccof.org Centre for Systems Integration (CSI), www.csi-ics.com Consorzio per il Controllo dei Prodotti Biologici Società a responsabilità limitata (CCPB SRL), www.ccpb.it Control Union Certifications (CUC), www.controlunion.com Ecocert Canada, www.ecocertcanada.com Fraser Valley Organic Producers Association (FVOPA), www.fvopa.ca Global Organic Alliance, www.goa-online.org International Certification Services Incorporated (ICS), www.ics-intl.com LETIS SA, www.letis.com.ar Oregon Tilth Incorporated (OTCO), http://tilth.org Organic Certifiers, www.organiccertifiers.com Organic Crop Improvement Association (OCIA), www.ocia.org/ Organic Producers Association of Manitoba Cooperative Incorporated (OPAM), www.opam-mb.com Pacific Agricultural Certification Society (PACS), www.pacscertifiedorganic.ca Pro-Cert Organic Systems Ltd (Pro-Cert), www.ocpro.ca/ Quality Assurance International Incorporated (QAI), www.qai-inc.com Quality Certification Services (QCS), www.qcsinfo.org Organisme de Certification Québec Vrai (OCQV), www.quebecvrai.org SAI Global Certification Services Limited, www.saiglobal.com
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(a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed crop products for use as food.
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BCS Oko-Garantie, www.bcs-oeko.com Eco-LOGICA, www.eco-logica.com Control Union Certifications, www.cuperu.com Mayacert, www.mayacert.com
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(a) unprocessed crop and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin.
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Aditi Organic Certifications Pvt. Ltd, www.aditicert.net APOF Organic Certification Agency (AOCA), www.aoca.in Bureau Veritas Certification India Pvt. Ltd, www.bureauveritas.co.in Chhattisgarh Certification Society (CGCERT), www.cgcert.com Control Union Certifications, www.controlunion.com ECOCERT India Private Limited, www.ecocert.in Food Cert India Pvt. Ltd, www.foodcert.in IMO Control Private Limited, www.imo.ch Indian Organic Certification Agency (Indocert), www.indocert.org Intertek India Pvt. Ltd, www.intertek.com ISCOP (Indian Society for Certification of Organic products), www.iscoporganiccertification.com Lacon Quality Certification Pvt. Ltd, www.laconindia.com Natural Organic Certification Association, www.nocaindia.com OneCert Asia Agri Certification private Limited, www.onecertasia.in SGS India Pvt. Ltd, www.in.sgs.com Tamil Nadu Organic Certification Department (TNOCD), www.tnocd.net TUV India Pvt. Ltd, www.tuvindia.co.in/0_mngmt_sys_cert/orgcert.htm Uttaranchal State Organic Certification Agency (USOCA), www.organicuttarakhand.org/products_certification.htm Vedic Organic certification Agency, www.vediccertification.com Rajasthan Organic Certification Agency (ROCA), http://www.rajasthankrishi.gov.in/Departments/SeedCert/index_eng.asp
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(a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin.
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either from the Community, or from a third country in the framework of a regime which is recognised as equivalent in accordance with the provisions of Article 33(2) of Regulation (EC) No 834/2007.
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Agrior Ltd.-Organic Inspection & Certification, www.agrior.co.il IQC Institute of Quality & Control, www.iqc.co.il LAB-PATH Ltd, www.lab-path.co.il Plant Protection and Inspection Services (PPIS), www.ppis.moag.gov.il Skal Israel Inspection & Certification, www.skal.co.il Secal Israel Inspection and certification, www.skal.co.il
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(a) unprocessed crop products and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one or more ingredients of plant origin.
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Hyogo prefectural Organic Agriculture Society (HOAS), www.hyoyuken.org AFAS Certification Center Co., Ltd, www.afasseq.com NPO Kagoshima Organic Agriculture Association, www.koaa.or.jp Center of Japan Organic Farmers Group, www.yu-ki.or.jp Japan Organic & Natural Foods Association, http://jona-japan.org/organic Ecocert-QAI Japan Ltd, http://ecocert.qai.jp Japan Certification Services, Inc., www.pure-foods.co.jp OCIA Japan, www.ocia-jp.com Overseas Merchandise Inspection Co., Ltd, www.omicnet.com/index.html.en Organic Farming Promotion Association, www3.ocn.ne.jp/~yusuikyo ASAC Stands for Axis’ System for Auditing and Certification and Association for Sustainable Agricultural Certification, www.axis-asac.net Environmentally Friendly Rice Network, www.epfnetwork.org/okome Ooita Prefecture Organic Agricultural Research Center, www.d-b.ne.jp/oitayuki AINOU, www.ainou.or.jp/ainohtm/disclosure/nintei-kouhyou.htm SGS Japan Incorporation, www.jp.sgs.com/ja/home_jp_v2.htm Ehime Organic Agricultural Association, www12.ocn.ne.jp/~aiyuken/ninntei20110201.html Center for Eco-design Certification Co. Ltd, http://www.eco-de.co.jp/list.html Organic Certification Association, www.yuukinin.jimdo.com Japan Eco-system Farming Association, www.npo-jefa.com Hiroshima Environment and Health Association, www.kanhokyo.or.jp/jigyo/jigyo_05A.html Assistant Center of Certification and Inspection for Sustainability, www.accis.jp Organic Certification Organization Co. Ltd, www.oco45.net
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products produced during the conversion period and products containing an ingredient of agricultural origin produced during the conversion period.
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either from the Community, or from a third country for which Switzerland has recognised that the products have been produced and controlled in that third country to rules equivalent to those laid down in the Swiss legislation.
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Bio Test Agro (BTA), www.bio-test-agro.ch bio.inspecta AG, www.bio-inspecta.ch Institut für Marktökologie (IMO); www.imo.ch ProCert Safety AG, www.procert.ch
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(a) unprocessed crop and vegetative propagating material and seeds for cultivation; (b) processed agricultural products for use as food composed essentially of one of more ingredients of plant origin.
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Ecocert SA en Tunisie, www.ecocert.com Istituto Mediterraneo di Certificazione IMC, www.imcert.it Instituto per la certificazione etica e ambientale (ICEA), www.icea.info BCS, www.bcs-oeko.com Lacon, www.lacon-institute.com
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(a) live or unprocessed agricultural products and vegetative propagating material and seeds for cultivation, with the exception of: -
livestock and livestock products bearing or intended to bear indications referring to conversion, products from aquaculture;
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(b) processed agricultural products for use as food with the exception of: -
livestock products bearing or intended to bear indications referring to conversion, products containing products from aquaculture.
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either from the Community, or from a third country within the framework of a regime which is recognised as equivalent in accordance with the provisions of Article 33(2) of Regulation (EC) No 834/2007, or from a third country whose rules of production and inspection system have been recognised as equivalent to the MAF Official Organic Assurance Programme Technical Rules for Organic Production on the basis of assurances and information provided by this country’s competent authority in accordance with the provisions established by MAF and provided that only organically produced ingredients intended to be incorporated, up to a maximum of 5 % of products of agricultural origin, in products of category 1(b) prepared in New Zealand are imported.
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AsureQuality Limited, www.organiccertification.co.nz BioGro New Zealand, www.biogro.co.nz
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the text, the format, on one single sheet, the layout and the dimensions of the boxes.
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the text, the format, the layout and the dimensions of the boxes.
Regulation (EC) No 345/2008 | Regulation (EC) No 605/2008 | This Regulation |
---|---|---|
— | Article 1(1) | Article 1 |
— | Article 1(2) | — |
— | Article 2, introductory words and point 1 | Article 2, introductory words and point 1 |
— | Article 2, point 2 | |
Article 2, point 2 | Article 2, point 3 | |
Article 2, point 3 | Article 2, point 4 | |
Article 2, point 4 | — | |
Article 2, point 5 | Article 2, point 5 | |
— | — | Article 3 |
— | — | Article 4 |
— | — | Article 5 |
— | — | Article 6 |
Article 1 | — | Article 7 |
Article 2(1) | — | Article 8(1) |
Article 2(2) | — | Article 8(2) |
Article 2(3) | — | Article 8(3) |
Article 2(4) | — | Article 8(3) and 9(2) |
— | — | Article 8(4) |
Article 2(5) | Article 9(1) | |
Article 2(6) | Article 9(3) and 9(4) | |
— | — | Article 10 |
— | — | Article 11 |
— | — | Article 12 |
— | Articles 3 and 4 | Article 13 |
— | Article 5 | Article 14 |
— | Article 6 | Article 15 |
— | — | Article 16 |
— | — | Article 17 |
— | Article 7(1) | — |
— | Article 7(2) | — |
— | — | Article 18 |
— | — | Article 19 |
Article 3 | Article 8 | Article 20 |
Article 4 | Article 9 | Article 21 |
Annex II | — | — |
— | — | Annex I |
— | — | Annex II |
Annex I | — | Annex III |
— | — | Annex IV |
— | Annex I | Annex V |
— | Annex II | Annex VI |
Annex III | Annex IV | Annex VII |