1991R2092 — EN — 15.02.2008 — 030.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

Amended by:





Amended by:





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COUNCIL REGULATION (EEC) No 2092/91

of 24 June 1991

on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs







THE COUNCIL OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof, Having regard to the proposal from the Commission ( 1 ), Having regard to the opinion of the European Parliament ( 2 ), Having regard to the opinion of the Economic and Social Committee ( 3 ), Whereas demand from consumers for organically produced agricultural products and foodstuffs is increasing; whereas a new market for agricultural products is thus being created by this phenomenon; Whereas the market price for such products is higher, while the way in which they are produced involves less intensive use of land; whereas, therefore, in the context of the reorientation of the common agricultural policy, this type of production may contribute towards the attainment of a better balance between supply of, and demand for, agricultural products, the protection of the environment and the conservation of the countryside; Whereas, in response to the rising demand, agricultural products and foodstuffs are being placed on the market with indications stating or implying to purchasers that they have been produced organically or without the use of synthetic chemicals; Whereas some Member States have already adopted rules and inspection arrangements for the use of such indications; Whereas a framework of Community rules on production, labelling and inspection will enable organic farming to be protected in so far as it will ensure conditions of fair competition between the producers of products bearing such indications and give the market for organic products a more distinctive profile by ensuring transparency at all stages of production and processing, thereby improving the credibility of such products in the eyes of consumers; Whereas organic production methods constitute a specific form of production at farm level; whereas, consequently, it should be provided that, on the labelling of processed products, indications referring to organic production methods should relate to the ingredients obtained by such methods; Whereas, for the implementation of the arrangements concerned, provision should be made for flexible procedures whereby certain technical details or measures may be amended, amplified or further defined in order to take account of experience gained; whereas, within a suitable period, this Regulation will be supplemented by equivalent rules covering livestock production; Whereas, in the interests of the producers and purchasers of products bearing indications referring to organic production methods, the minimum principles which must be complied with in order for products to be presented with such indications should be laid down; Whereas organic production methods entail significant restrictions on the use of fertilizers and pesticides which may have detrimental effects on the environment or result in the presence of residues in agricultural produce; whereas, in this context, practices accepted in the Community when this Regulation is adopted must be complied with in accordance with codes of practice followed in the Community when this Regulation is adopted; whereas, moreover, in the future, the principles governing the authorization of products which may be used in this type of farming must be established; Whereas, moreover, organic farming involves varied cultivation practices and limited use of non-synthetic fertilizers and conditioners of low solubility; whereas these practices should be specified and conditions for the use of certain non-synthetic products laid down; Whereas the procedures laid down make possible, if this appears necessary, the addition to Annex I of more specific provisions aimed at avoiding the presence of certain residues of synthetic chemicals from sources other than agriculture (environmental contamination) in the products obtained by such production methods; Whereas, to ensure compliance with the rules on production, all stages of production and marketing should normally be subject to inspection; Whereas all operators producing, preparing, importing or marketing products bearing indications referring to organic production methods must be subject to a regular inspection system, meeting minimum Community requirements and carried out by designated inspection authorities and/or by approved and supervised bodies; whereas provision should be made for a Community indication of inspection to appear on the labelling of the products concerned, HAS ADOPTED THIS REGULATION:







Scope

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Article 1

1. This Regulation shall apply to the following products, where such products bear, or are intended to bear, indications referring to the organic production method:

(a) unprocessed agricultural crop products; also livestock and unprocessed livestock products, to the extent that principles of production and specific inspection rules for them are introduced in Annexes I and III;

(b) processed agricultural crop and livestock products intended for human consumption prepared essentially from one or more ingredients of plant and/or animal origin;

(c) feedingstuffs, compound feedingstuffs and feed materials not covered under subparagraph (a) as from the entry into force of this Regulation referred to in paragraph 3.

2. By way of derogation from paragraph 1, where the detailed production rules are not laid down in Annex I for certain animal species, the rules provided for labelling in Article 5 and for the inspections in Articles 8 and 9 shall apply for these species and the products therefrom, with the exception of aquaculture and aquaculture products. Pending the inclusion of detailed production rules, national rules or in the absence thereof private standards accepted or recognised by the Member States shall apply.

3. The Commission shall, not later than 24 August 2001, propose a regulation in accordance with the procedure in Article 14 providing for labelling requirements as well as inspection requirements and precautionary measures for products mentioned in paragraph (1)(c), as far as these requirements are related to the organic production method.

Pending the adoption of the Regulation referred to in the first subparagraph for the products mentioned in paragraph (1)(c), national rules in conformity with Community law or, in the absence thereof, private standards accepted or recognised by the Member States shall apply.

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Article 2

For the purposes of this Regulation a product shall be regarded as bearing indications referring to the organic production method where, in the labelling, advertising material or commercial documents, such a product, its ingredients or feed materials are described in terms suggesting to the purchaser that the product, its ingredients or feed materials have been obtained in accordance with the rules of production laid down in Article 6. In particular, the following terms or their usual derivatives (such as bio, eco etc.) or diminutives, alone or combined, shall be regarded as indications referring to the organic production method throughout the Community and in any Community language, unless they are not applied to agricultural products in foodstuffs or feedingstuffs or clearly have no connection with this method of production:

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— in Bulgarian: биологичен,

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— in Spanish: ecológico,

— in Danish: økologisk,

— in German: ökologisch, biologisch,

— in Greek: βιολογικό,

— in English: organic,

— in French: biologique,

— in Italian: biologico,

— in Dutch: biologisch,

— in Portuguese: biológico,

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— in Romanian: ecologic,

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— in Finnish: luonnonmukainen,

— in Swedish: ekologisk.

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Article 3

This Regulation shall apply without prejudice to other Community provisions or national provisions, in conformity with Community law, concerning products specified in Article 1, such as provisions governing the production, preparation, marketing, labelling and inspection, including legislation in foodstuffs and animal nutrition.

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Definitions

Article 4

For the purpose of this Regulation:

1. ‘labelling’ shall mean any words, particulars, trade marks, brand names, pictorial matter or symbols on any packaging, document, notice, label, board or collar accompanying or referring to a product specified in Article 1;

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2. ‘production’ shall mean the operations on the agricultural holding involved in producing, packaging and initially labelling as products of organic production agricultural products produced on that holding;

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3. ‘preparation’ shall mean the operations of preserving and/or processing of agricultural products (including slaughter and cutting for livestock products), and also packaging and/or alterations made to the labelling concerning the presentation of the organic production method of the fresh, preserved and/or processed products;

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4. ‘marketing’ shall mean holding or displaying for sale, offering for sale, selling, delivering or placing on the market in any other form;

5. ‘operator’ shall mean any natural or legal person who produces, prepares or imports from a third country, with a view to the subsequent marketing thereof, products as referred to in Article 1, or who markets such products;

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6. ‘ingredients’ shall mean the substances, including additives, used in the preparation of the products specified in Article 1 (1) (b), as defined in Article 6 (4) of Directive 79/112/EEC on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer;

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7. ‘plant protection products’ shall mean products as defined in Article 2 (1) of Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on the market and use of plant protection products containing certain active substances ( 4 ), as last amended by Directive 89/365/EEC ( 5 );

8. ‘detergents’ shall mean substances and preparations, within the meaning of Council Directive 73/404/EEC of 22 November 1973 on the approximation of the laws of the Member States relating to detergents ( 6 ), as last amended by Directive 86/94/EEC ( 7 ), which are intended to be used for cleaning certain products as referred to in Article 1 (1) (a).

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9. ‘prepackaged foodstuff’ shall mean any single item as defined in Article 1 (3) (b) of Directive 79/112/EEC;

10. ‘list of ingredients’ shall mean the list of ingredients referred to in Article 6 of Directive 79/112/EEC;

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11. ‘livestock production’ shall mean the production of domestic or domesticated terrestrial animals (including insects) and aquatic species farmed in fresh, salt or brackish water. The products of hunting and fishing of wild animals shall not be considered as organic production;

12. ‘genetically modified organism (GMO)’ shall mean any organism as defined in Article 2 of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms ( 8 );

13. ‘GMO derivative’ shall mean any substance which is either produced from or produced by GMOs, but does not contain them;

14. ‘use of GMOs and GMO derivatives’ shall mean use thereof as foodstuffs, food ingredients (including additives and flavourings), processing aids (including extraction solvents), feedingstuffs, compound feedingstuffs, feed materials, feed additives, processing aids for feedingstuffs, certain products used in animal nutrition (under Directive 82/471/EEC) ( 9 ), plant protection products, veterinary medicinal products, fertilisers, soil conditioners, seeds, vegetative reproductive material and livestock;

15. ‘veterinary medicinal products’ shall mean products as defined in Article 1(2) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products ( 10 );

16. ‘homeopathic veterinary medicinal products’ shall mean products as defined in Article 1(1) of Council Directive 92/74/EEC of 22 September 1992, widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products ( 11 );

17. ‘feedingstuffs’ shall mean products as defined in Article 2(a) of Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs ( 12 );

18. ‘feed materials’ shall mean products as defined in Article 2(a) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC ( 13 );

19. ‘compound feedingstuffs’ shall mean products as defined in Article 2(b) of Directive 79/373/EEC;

20. ‘feed additives’ shall mean products as defined in Article 2(a) of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs ( 14 );

21. ‘certain products used in animal nutrition’ shall mean nutritional products within the scope of Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition;

22. ‘organic-production unit/holding/stockfarm’ shall mean a unit, holding or stockfarm complying with the rules of this Regulation;

23. ‘organically-produced feedingstuffs/feed materials’ shall mean feedingstuffs/feed materials produced in accordance with the rules of production laid down in Article 6;

24. ‘in-conversion feedingstuffs/feed materials’ shall mean feedingstuffs/feed materials complying with the rules of production laid down in Article 6, except for the conversion period where those rules apply for at least one year before the harvest;

25. ‘conventional feedingstuffs/feed materials’ shall mean feedingstuffs/feed materials not covered by the categories mentioned in paragraphs 23 and 24.

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Labelling

Article 5

1. The labelling and advertising of a product specified in Article 1 (1) (a) may refer to organic production methods only where:

(a) such indications show clearly that they relate to a method of agricultural production;

(b) the product was produced in accordance with the rules laid down in ►M10 Article 6 ◄ or imported from a third country under the arrangements laid down in Article 11;

(c) the product was produced or imported by an operator who is subject to the inspection measures laid down in Articles 8 and 9;

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(d) in the case of products prepared after 1 January 1997, the labelling refers to the name and/or the code number of the inspection authority or body to which the operator is subject. Member States shall decide whether to require a reference to the name and/or to the code number and shall notify the Commission accordingly.

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3. The labelling and advertising of a product specified in Article 1 (1) (b) may bear indications referring to organic production methods in the sales description of the product only where:

(a) at least 95 % of the ingredients of agricultural origin of the product are, or are derived from, products obtained in accordance with the rules laid down in Article 6 or imported from third countries under the arrangements laid down in Article 11;

(b) all the other ingredients of agricultural origin of the product are included in Annex VI, Section C or have been provisionally authorized by a Member State in accordance with any implementing measures adopted where appropriate pursuant to paragraph 7;

(c) the product contains only substances listed in Annex VI, Section A, as ingredients of non-agriculural origin;

(d) the products or its ingredients of agricultural origin, referred to in subparagraph (a), have not been subjected to treatments involving the use of substances not listed in Annex VI, Section B;

(e) the product or its ingredients have not been subjected to treatments involving the use of ionizing radiation;

(f) the product has been prepared or imported by an operator who is subject to the inspection measures laid down in Articles 8 and 9;

(g) in the case of products prepared after 1 January 1997, the labelling refers to the name and/or the code number of the inspection authority or body to which the operator who has carried out the most recent preparation operation is subject. Member States shall decide whether to require a reference to the name and/or to the code number and shall notify the Commission accordingly. The indications referring to organic production methods must make it clear that they relate to a method of agricultural production and must be accompanied by a reference to the ingredients of agricultural origin concerned, unless such reference is clearly given in the list of ingredients;

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(h) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.

By way of derogation from paragraphs 1 to 3, trade marks which bear an indication referred to in Article 2 may continue to be used until 1 July 2006 in the labelling and advertising of products which do not comply with this Regulation provided that:

— registration of the trade mark was applied for before 22 July 1991 - unless the second subparagraph below applies - and is in conformity with the First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks ( 15 ), and

— the trade mark is already reproduced with a clear, prominent, and easily readable indication that the products are not produced according to the organic production method as prescribed in this Regulation.

The date of application referred to in the first indent of the first subparagraph is, for Finland, Austria, and Sweden, 1 January 1995 and, for the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia, 1 May 2004. ◄

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4. Ingredients of agricultural origin may be included in Annex VI, Section C only where it has been shown that such ingredients are of agricultural origin and are not produced in sufficient quantity in the Community in accordance with the rules laid down in Article 6, or cannot be imported from third countries in accordance with the rules laid down in Article 11.

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5. Crop products labelled or advertised in accordance with paragraphs 1 or 3 may bear indications referring to conversion to the organic production method, provided that:

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(a) the requirements referred to in paragraph 1 or paragraph 3 respectively are fully satisfied, with the exception of that concerning the length of the conversion period referred to in paragraph 1 of Annex I;

(b) a conversion period of at least 12 months before the harvest has been complied with;

(c) such indications do not mislead the purchaser of the product regarding its difference from products which satisfy all the requirements of paragraphs 1 or 3. After 1 January 1996, such indications must take the form of the words ‘product under conversion to organic farming’, and must appear in a colour, size and style of lettering which is not more prominent than the sales description of the product; in this indication the words ‘organic farming’ shall not be more prominent than the words ‘product under conversion to’;

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(d) the product contains only one crop ingredient of agricultural origin;

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(e) for products prepared after 1 January 1997, the labelling refers to the name and/or the code number of the inspection authority or body to which the operator who has carried out the most recent production or preparation operation is subject. Member States shall decide whether to require a reference to the name and/or to the code number and shall notify the Commission accordingly;

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(f) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.

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5a. Without prejudice to the provisions of paragraph 3, the labelling and advertising of a product as referred to in Article 1 (1) (b) may only bear indications referring to organic production methods where:

(a) at least 70 % of the ingredients of agricultural origin are, or are derived from, products obtained in accordance with the rules laid down in Article 6 or imported from third countries under the arrangements laid down in Article 11;

(b) all the other ingredients of agricultural origin of the product are included in Annex VI, Section C or have been provisionally authorized by a Member State in accordance with any implementation measures adopted where appropriate pursuant to paragraph 7;

(c) the indications referring to organic production methods appear in the list of ingredients and only in clear relation to those ingredients obtained according to the rules laid down in Article 6 or imported from third countries under the arrangements laid down in Article 11; they appear in the same colour and with an identical size and style of lettering as the other indications in the list of ingredients. Such indications must also appear in a separate statement set in the same visual field as the sales description and indicating the percentage of the ingredients of agricultural origin or derived therefrom which were obtained in accordance with the rules laid down in Article 6 or were imported from third countries under the arrangements laid down in Article 11. The statement may not appear in a colour, size and style of lettering which is more prominent than the sales description of the product. The statement shall be in the following form: ‘X % of the agricultural ingredients were produced in accordance with the rules of organic production’;

(d) the product contains only substances listed in Annex VI, Section A as ingredients of non-agricultural origin;

(e) the product or its ingredients of agricultural origin referred to in subparagraph (a) have not been subjected to treatments involving the use of substances not listed in Annex VI, Section B;

(f) the product or its ingredients have not been subjected to treatments involving the use of ionizing radiation;

(g) the product has been prepared or imported by an operator who is subject to the inspection measures laid down in Articles 8 and 9;

(h) for products prepared after 1 January 1997, the labelling refers to the name and/or the code number of the inspection authority or inspecting body to which the operator who has carried out the most recent production or preparation operation is subject. Member States shall decide whether to require a reference to the name and/or to the code number and/or shall notify the Commission accordingly;

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(i) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.

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6. During a transitional period expiring on 31 December 1997, the labelling and advertising of a product as referred to in Article 1 (1) (b) prepared partly from ingredients not satisfying the requirements in paragraph 3 (a) may refer to organic production methods provided that:

(a) at least 50 % of the ingredients of agricultural origin satisfy the requirements referred to in paragraph 3 (a);

(b) the product satisfies the requirements referred to in paragraph 3 (c), (d), (e) and (f);

(c) the indications referring to organic production methods: — appear only in the list of ingredients as provided for in Directive 79/112/EEC, as last amended by Directive 89/395/EEC, — clearly refer to only those ingredients obtained according to the rules referred to in Article 6 or imported under the arrangements laid down in Article 11;

(d) the ingredients and their relative levels appear in descending order by weight in the list of ingredients;

(e) indications in the list of ingredients appear in the same colour and with an identical size and style of lettering.

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7. Detailed rules concerning the implementation of this Article may be established according to the procedure laid down in Article 14.

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8. Limitative lists of the substances and products referred to in paragraph 3 (b), (c) and (d) and paragraph 5a (b), (d) and (e) shall be established in Annex VI, Sections A, B and C, according to the procedure laid down in Article 14.

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Conditions of use and compositional requirements of these ingredients and substances may be specified.

Where a Member State considers that a product should be added to the abovementioned lists or that amendments should be made thereto, it shall ensure that a dossier giving the reasons for the inclusion or the amendments is sent officially to the other Member States and the Commission, which shall present it to the Committee referred to in Article 14.

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9. For the calculation of the percentages referred to in paragraphs 3 and 6, the rules provided for in Articles 6 and 7 of Directive 79/112/EEC shall be applied.

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10. In a product as referred to in Article 1(1), paragraphs (a) and (b), an ingredient obtained according to the rules laid down in Article 6 shall not be present together with the same ingredient not obtained according to those rules.

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11. Before 1 January 1999, the Commission shall review the provisions of this Article and of Article 10 and submit any appropriate proposals for their revision.

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Rules of production

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Article 6

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1. The organic production method implies that for the production of products referred to in Article 1(1)(a) other than seeds and vegetative propagating material:

(a) at least the requirements of Annex I and, where appropriate, the detailed rules relating thereto, must be satisfied;

(b) only products composed of substances mentioned in Annex I or listed in Annex II may be used as plant protection products, fertilisers, soil conditioners, feedingstuffs, feed materials, compound feedingstuffs, feed additives, substances used in animal nutrition under Directive 82/471/EEC, cleaning and disinfecting products for livestock buildings and installations, products for pest and disease control of livestock buildings and installations or for another purpose where such purpose is specified in Annex II in regard to certain products. They may be used only under the specific conditions laid down in Annexes I and II in so far as the corresponding use is authorised in general agriculture in the Member States concerned in accordance with the relevant Community provisions or national provisions in conformity with Community law;

(c) only seed or vegetative propagating material produced by the organic production method referred to in paragraph 2 is used;

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(d) genetically modified organisms and/or any product derived from such organisms must not be used, with the exception of veterinary medicinal products.

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2. The organic production method implies that for seeds and vegetative reproductive material, the mother plant in the case of seeds and the parent plant(s) in the case of vegetative propagating material have been produced:

(a) without the use of genetically modified organisms and/or any products derived from such organisms, and

(b) in accordance with subparagraphs (a) and (b) of paragraph 1 for at least one generation or, in the case of perennial crops, two growing seasons.

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3.

(a) By way of derogation from paragraph 1 (c), seeds and vegetative propagating material not obtained by the organic production method may, during a transitional period expiring on ►M15 31 December 2003 ◄ and with the approval of the competent authority of the Member State, be used in so far as users of such propagating material can show to the satisfaction of the inspection body or authority of the Member State that they were unable to obtain on the market propagating material for an appropriate variety of the species in question and satisfying the requirements of paragraph 2. In that case, propagating material which is not treated with products not listed in Annex II, Section B must be used, if available on the Community market. Member States shall inform the other Member States and the Commission of any authorization granted under this paragraph.

(b) The procedure laid down in Article 14 may be applied to decide on: — the introduction, before ►M15 31 December 2003 ◄ , of restrictions concerning the transitional measure referred to in subparagraph (a) with regard to certain species and/or types of propagating material and/or the absence of chemical treatment, — the maintenance, after ►M15 31 December 2003 ◄ , of the derogation provided for in subparagraph (a) with regard to certain species and/or types of propagating material and with regard to the whole Community or certain parts thereof, — the introduction of procedural rules and criteria concerning the derogation referred to in subparagraph (a) and the information thereon communicated to the professional organizations concerned, to other Member States and the Commission.

4. Before ►M15 31 December 2002 ◄ , the Commission shall review the provisions of this Article, in particular paragraph 1 (c) and paragraph 2 and submit any appropriate proposals with a view to their revision.

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Article 6a

1. For the purposes of this Article, ‘seedlings’ shall mean whole seedlings intended for planting for plant production.

2. The organic production method implies that when producers use seedlings, they have been produced in accordance with Article 6.

3. By way of derogation from paragraph 2, seedlings not obtained by organic production methods may be used during a transitional period expiring on 31 December 1997 in so far as the following conditions are met:

(a) the competent authority of the Member State has authorized the use after the user or users of such material have demonstrated to the satisfaction of the inspection body or authority of the Member State that they were not able to obtain an appropriate variety of the species in question on the Community market;

(b) the seedlings have not been treated, since sowing, with any products other than those listed in Annex II, Sections A and B;

(c) the seedlings come from a producer who has accepted an inspection system equivalent to the arrangements laid down in Article 9 and has agreed to apply the restriction in subparagraph (b); this provision shall enter into force on 1 January 1996;

(d) after planting, the seedlings must have been cultivated in accordance with the provisions of Article 6 (1) (a) and (b) for a period of at least six weeks before harvesting;

(e) the labelling of any product containing ingredients derived from such seedlings may not include the indication referred to in Article 10;

(f) without prejudice to any restriction resulting from the procedure referred to in paragraph 4, any authorization granted under this paragraph shall be withdrawn as soon as the shortage comes to an end, and shall expire on 31 December 1997 at the latest.

4.

(a) Where an authorization as referred to in paragraph 3 has been granted, the Member State shall immediately notify to the other Member State and to the Commission the following information: — the date of the authorization, — the name of the variety and species concerned, — the quantities that are required and the justification for those quantities, — the expected period of the storage, — any other information requested by the Commission or the Member States.

(b) If the information submitted by any Member State of the Commission and to the Member State which granted the authorization shows that an appropriate variety is available during the period of the storage, the Member State shall consider withdrawing the authorization or reducing its period of validity, and shall inform the Commission and the other Member States of the measures it has taken, within 10 days of the date of receipt of the information.

(c) At the request of a Member State or at the Commission's initiative, the matter shall be submitted for examination to the Committee referred to in Article 14. It may be decided, in accordance with the procedure laid down in Article 14, that the authorization shall be withdrawn or its period of valdity amended.

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Article 7

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1. Products not authorised at the date of adoption of this Regulation for a purpose indicated in Article 6(1)(b) may be included in Annex II, provided that the following conditions are satisfied:

(a) if they are used for the purpose of plant pest or disease control or for cleaning and disinfecting livestock buildings and installations: — they are essential for the control of a harmful organism or a particular disease for which other biological, cultural, physical or breeding alternatives are not available, and — the conditions for their use preclude any direct contact with the seed, the crop, crop products or livestock and livestock products; however, in the case of perennial crops, direct contact may take place, but only outside the growing season of the edible parts (fruits) provided that such application does not indirectly result in the presence of residues of the product in the edible parts, and — their use does not result in, or contribute to, unacceptable effects on, or contamination of, the environment;

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(b) if they are used for fertilization or soil-conditioning purposes: — they are essential for specific nutrition requirements of crops or specific soil-conditioning purposes which cannot be satisfied by the practices mentioned in Annex I, and — their use does not result in unacceptable effects on the environment or contribute to the contamination thereof.

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1a. The conditions provided for in paragraph 1 shall not apply to products which were in common use before the adoption of this Regulation according to the codes of practice on organic farming followed in the Community.

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1b. With regard to minerals and trace elements used in animal nutrition, additional sources for these products may be included in Annex II provided that they are of natural origin or failing that, synthetic in the same form as natural products.

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2. If need be, the following may be specified for any product included in Annex II:

— the detailed description of the product,

— the conditions of its use and compositional and/or solubility requirements, with regard in particular to the need to insure for these products a minimal presence of residues on edible parts of the crop and on edible crop products as well as a minimum effect on the environment,

— particular labelling requirements for products referred to in Article 1 where such products are obtained with the aid of certain products referred to in Annex II.

3. Amendments to Annex II, concerning either inclusion or cancelling of products as referred to in paragraph 1 or inclusion or amendments of specifications as referred to in paragraph 2, shall be adopted by the Commission in accordance with the procedure laid down in Article 14.

4. Where a Member State considers that a product should be added to Annex II or that amendments should be made thereto, it shall ensure that a dossier giving the reasons for the inclusion or the amendments is sent officially to the other Member States and the Commission, which shall introduce it to the committee referred to in Article 14.







Inspection system

Article 8

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1. Any operator who produces, prepares, stores or imports from a third country products as specified in Article 1 with a view to the subsequent marketing thereof, or who markets such products, shall:

(a) notify this activity to the competent authority of the Member State where the activity is carried out; such notification shall include the information referred to in Annex IV;

(b) submit his undertaking to the inspection system referred to in Article 9.

Member States may exempt from the application of this paragraph operators who sell such products directly to the final consumer or user provided they do not produce, prepare, store other than in connection with the point of sale, or import such products from a third country.

Where an operator contracts out any of the activities referred to in the first subparagraph to a third party, that operator shall nonetheless be subject to the requirements referred to in points (a) and (b), and the subcontracted activities shall be subject to the inspection system referred to in Article 9.

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2. Member States shall designate an authority or body for the reception of notifications.

Member States may provide for the communication of any additional information which they consider to be necessary for effective supervision of the operators concerned.

3. The competent authority shall ensure that an updated list containing the names and addresses of operators subject to the inspection system is made available to interested parties.

Article 9

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1. Member States shall set up an inspection system operated by one or more designated inspection authorities and/or by approved private bodies to which the operators referred to in Article 8(1) shall be subject.

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2. Member States shall adopt the measures necessary to ensure that an operator who complies with the provisions of this Regulation and pays his contribution to inspection expenses has access to the inspection system.

3. The inspection system shall comprise at least the application of the precautionary and inspection measures specified in Annex III.

4. For the application of the inspection system operated by private bodies, Member States shall designate an authority responsible for the approval and supervision of such bodies.

5. For the approval of a private inspection body, the following shall be taken into account:

(a) the standard inspection procedure to be followed, containing a detailed description of the inspection measures and precautions which the body undertakes to impose on operators subject to its inspection;

(b) the penalties which the body intends to apply where ►M10 irregularities and/or infringements ◄ are found;

(c) the availability of appropriate resources in the form of qualified staff, administrative and technical facilities, inspection experience and reliability;

(d) the objectivity of the inspection body vis-à-vis the operators subject to its inspection.

6. After an inspection body has been approved, the competent authority shall:

(a) ensure that the inspections carried out by the inspection body are objective;

(b) verify the effectiveness of its inspections;

(c) take cognizance of any ►M10 irregularities and/or infringements ◄ found and penalties applied;

(d) withdraw approval of the inspection body where it fails to satisfy the requirements referred to in (a) and (b) or no longer fulfils the criteria indicated in paragraph 5 or fails to satisfy the requirements ►M10 laid down in paragraphs 7, 8, 9 and 11. ◄

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6a. Before 1 January 1996, Member States shall issue a code number to each inspection body or authority approved or designated in accordance with the provisions of this Article. They shall inform the other Member States and the Commission thereof; the Commission shall publish the code numbers in the list referred to in the last subparagraph of Article 15.

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7. The inspection authority and the approved inspection bodies referred to in paragraph 1 shall:

(a) ensure that at least the inspection measures and precautions specified in Annex III are applied to undertakings subject to their inspection;

(b) not disclose information and data they obtain in their inspection activity to persons other than the person responsible for the undertaking concerned and the competent public authorities. ►M28 However, upon request duly justified by the necessity to guarantee that the products have been produced in accordance with this Regulation, they shall exchange with other inspection authorities or approved inspection bodies relevant information on the results of their inspection. They may also exchange the abovementioned information on their own initiative. ◄

8. Approved inspection bodies shall:

(a) give the competent authority, for inspection purposes, access to their offices and facilities, together with any information and assistance deemed necessary by the competent authority for the fulfilment of its obligations pursuant to this Regulation;

(b) send to the competent authority of the Member State by 31 January each year a list of operators subject to their inspection on 31 December of the previous year and present to the said authority a concise annual report.

9. The inspection authority and inspection bodies referred to in paragraph 1 shall:

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(a) ensure that, where an irregularity is found regarding the implementation of Articles 5 and 6 or of the provisions referred to in Articles 3 and 4 of Commission Regulation (EC) No 223/2003 of 5 February 2003 on labelling requirements related to the organic production method for feedingstuffs, compound feedingstuffs and feed materials ( 16 ), or of the measures referred to in Annex III, the indications provided for in Article 2 referring to the organic production method are removed from the entire lot or production run affected by the irregularity concerned;

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(b) where a manifest infringement, or an infringement with prolonged effects is found, prohibit the operator concerned from marketing products with indications referring to the organic production method for a period to be agreed with the competent authority of the Member State.

10. The following may be adopted in accordance with the procedure laid down in Article 14:

(a) detailed rules concerning the requirements indicated in paragraph 5 and the measures listed in paragraph 6;

(b) implementation measures concerning the provisions of paragraph 9.

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11. As from 1 January 1998 and without prejudice to the provisions of paragraphs 5 and 6, approved inspection bodies must satisfy the requirements laid down in the conditions of standard EN 45011 ►M15 ————— ◄ .

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12.

(a) For livestock meat production Member States shall ensure, without prejudice to the provisions of Annex III, that the inspections relate to all stages of production, slaughter, cutting and any other preparation up to the sale to the consumer to ensure as far as technically possible the traceability of livestock products through the production, processing and any other preparation chain from the unit of production of the livestock until the unit of final packaging and/or labelling. They shall inform the Commission together with the report on supervision referred to in Article 15, on the measures taken and their follow-up.

(b) For other livestock products different from meat, further provisions to ensure, as far as technically possible, traceability will be set out in Annex III.

(c) In any event the measures taken under Article 9 shall ensure that consumers are given guarantees that the products have been produced in accordance with this Regulation.

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Indication that products are covered by the inspection scheme

Article 10

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1. The indication and/or the logo shown in Annex V indicating that products are covered by the specific inspection scheme, may appear on the labeling of products as referred to in Article 1 only where such products:

(a) satisfy the requirements of Article 5 (1) or (3);

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(b) have been subject to the inspection system referred to in Article 9, or have been imported in conformity with Article 11; however, in the case of products imported in conformity with Article 11(6), the implementation of the inspection system shall comply with requirements equivalent to those provided for in Article 9, and in particular paragraph 4 thereof;

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(c) are sold directly by the producer or preparer to the ultimate consumer in sealed packaging, or placed on the market as prepackaged foodstuffs; in the case of direct sales by the producer or preparer to the ultimate consumer, the sealed packaging is not required when the labelling enabled the product requiring this indication to be identified clearly and unambiguously;

(d) show on the labelling the name and/or business name of the producer, preparer or vendor together with the name or code number of the inspection authority or body, and any indication required in accordance with the provisions of the regulations on the labelling of foodstuffs, in accordance with Community legislation.

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2. No claim may be made on the label or advertising material that suggests to the purchaser that the indication shown in Annex V constitutes a guarantee of superior organoleptic, nutritional or salubrious quality.

3. The inspection authority and inspection bodies referred to in Article 9 (1) must:

(a) ensure that, where an irregularity is found under ►M10 Articles 5 and 6 ◄ or the measures referred to in Annex III, the indication shown in Annex V is removed from the entire lot or production run affected by the irregularity concerned;

(b) where a manifest infringement, or an infringement with prolonged effects, is found, withdraw from the operator concerned the right to use the indication shown in Annex V for a period to be agreed with the competent authority of the Member State.

4. Rules on withdrawal of the indication shown in Annex V where certain infringements of Articles 5, 6 and 7 or of the requirements and measures in Annex III are detected may be adopted in accordance with the procedure laid down in Article 14.

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General enforcement measures

Article 10 a

1. Where a Member State finds irregularities or infringements relating to the application of this Regulation in a product coming from another Member State and bearing indications as referred to in Article 2 and/or Annex V, it shall inform the Member State which designated the inspection authority or approved the inspection body and the Commission thereby.

2. Member States shall take whatever measures and action are required to prevent fraudulent use of the indications referred to in Article 2 and/or Annex V.

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Imports from third countries

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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 set out in or pursuant to 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 of equivalent effectiveness 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 of equivalent effectiveness 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 set out in or pursuant to 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 set out in or pursuant to 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.

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Free movement within the Community

Article 12

Member States may not, on grounds relating to the method of production, to labelling or to the presentation of that method, prohibit or restrict the marketing of products as specified in Article 1 that meet the requirements of this Regulation.

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However, with regard to the rules referred to in Annex I, part B, concerning livestock production, Member States may apply more stringent rules to livestock and livestock products produced within their territory, provided that these rules are in compliance with Community law and do not prohibit or restrict the marketing of other livestock and livestock products that meet the requirements of this Regulation.

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Administrative provisions and implementation

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Article 13

The following may be adopted in accordance with the procedure laid down in Article 14:

— detailed rules for applying this Regulation;

— amendments to Annexes I to IV, VI, VII and VIII;

— amendments to Annex V in order to define a Community logo to accompany or replace the indication that products are covered by the inspection scheme;

— restrictions and implementation measures for applying the derogation as referred to in Article 6, (1) (d) for veterinary medicinal products;

— implementation measures according to scientific evidence or technical progress to apply the prohibition on the use of GMOs and GMOs derivatives with regard, in particular, to a de minimis threshold for unavoidable contamination which shall not be exceeded.

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Article 14

1. The Commission shall be assisted by a committee.

2. Where reference is made to this Article, Articles 5 and 7 of Decision 1999/468/EC ( 17 ) shall apply.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

3. The Committee shall adopt its Rules of Procedure.

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Article 15

Before 1 July each year, Member States shall inform the Commission of measures taken in the preceding year for the implementation of this Regulation and shall communicate in particular:

— a list of the operators who, on 31 December of the previous year, had given notification under Article 8 (1) (a) and are subject to the inspection system referred to in Article 9,

— a report on supervision pursuant to Article 9 (6).

In addition, by 31 March each year, Member States shall inform the Commission of the list of inspection bodies approved on 31 December of the previous year, their legal and operational structure, their standard inspection procedure, their penalty arrangements and, where appropriate, their mark.

The Commission shall each year publish, in the ‘C’ series of the Official Journal of the European Communities, the lists of approved bodies notified to it within the deadlines laid down in the foregoing subparagraph.

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Article 15a

In respect of the measures set out in this Regulation, particularly those to be implemented by the Commission, with a view to meeting the objectives laid down in Articles 9 and 11 and the technical annexes, the necessary appropriations shall be set aside each year during the budgetary procedure.

▼B

Article 16

1. This Regulation shall enter into force on the day of its publication in the Official Journal of the European Communities.

2. Within nine months of the entry into force of this Regulation, Member States shall implement Articles 8 and 9.

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3. Article 5, Article 8 (1) and Article 11 (1) shall apply from 1 January 1993.

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For the purposes of complying with the conversion period referred to in paragraph 1 of Annex I, the period which has elapsed before the entry into force of this Regulation shall be taken into account where the operator can demonstrate to the satisfaction of the inspection body that during that period he was producing in accordance with the national provisions in force or, failing that, with the recognized international standards for organic production.

4. For 12 months following the entry into force of this Regulation, Member States may, by way of derogation from Article 6 (1), authorize the use in their territory of products containing substances not listed in Annex II, where they consider that the requirements of Article 7 (1) are satisfied.

5. For a period expiring 12 months after the establishment of Annex VI in accordance with Article 5 (7), Member States may continue to authorize, in accordance with their national provisions, the use of substances not listed in the said Annex VI.

6. Each Member State shall inform the other Member States and the Commission of substances authorized pursuant to paragraphs 4 and 5.

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX I

PRINCIPLES OF ORGANIC PRODUCTION AT FARM LEVEL

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A. PLANT AND PLANT PRODUCTS

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1.1. The principles laid down in Article 6(1)(a), (b) and (d) and set out in particular in this Annex must normally have been applied on the parcels during a conversion period of at least two years before sowing, or, in the case of grassland, at least two years before its exploitation as feedingstuff from organic farming, or, in the case of perennial crops other than grassland, at least three years before the first harvest of products as referred to in Article 1(1)(a). The conversion period shall commence at the earliest on the date on which the producer notified his activity in accordance with Article 8 and submitted his holding to the inspection system provided for in Article 9.

1.2. However, the inspection authority or body may decide, in agreement with the competent authority, to recognise retroactively as being part of the conversion period any previous period in which: (a) the land parcels were part of a programme implemented pursuant to Council Regulation (EEC) No 2078/92 of 30 June 1992 on agricultural production methods compatible with the requirements of the protection of the environment and the maintenance of the countryside ( 18 ) or Chapter VI of Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) and amending and repealing certain Regulations ( 19 ), or as part of another official programme, provided that the programmes concerned guarantee that products not listed in parts A and B of Annex II have not been used on those parcels; or (b) the parcels were natural or agricultural areas which were not treated with products not listed in parts A and B of Annex II. This period can be taken into consideration retroactively only under the condition that satisfactory proof has been furnished to the inspection authority or body allowing it to satisfy itself that the conditions were met for a period of at least three years.

1.3. The inspection authority or body may, with the approval of the competent authority, decide, in certain cases, to extend the conversion period beyond the period laid down in paragraph 1.1 having regard to previous parcel use.

1.4. In the case of parcels which have already been converted to or were in the process of conversion to organic farming, and which are treated with a product not listed in Annex II, the Member State may reduce the length of the conversion period to less than the period laid down in paragraph 1.1 in the following two cases: (a) parcels treated with a product not listed in part B of Annex II as part of a compulsory disease or pest control measure imposed by the competent authority of the Member State within its own territory or in certain parts thereof for a specific crop production; (b) parcels treated with a product not listed in parts A or B of Annex II as part of scientific tests approved by the competent authority of the Member State. In these cases the length of the conversion period shall be fixed taking into account all of the following points: — the process of degradation of the plant protection product concerned must guarantee, at the end of the conversion period, an insignificant level of residues in the soil and, in the case of a perennial crop, in the plant, — the harvest following the treatment may not be sold with reference to organic production methods, — the Member State concerned must inform the other Member States and the Commission of its decision to require compulsory treatment.

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2.1. The fertility and the biological activity of the soil must be maintained or increased, in the first instance, by: (a) cultivation of legumes, green manures or deep-rooting plants in an appropriate multi-annual rotation programme; (b) incorporation of livestock manure from organic livestock production in accordance with the provisions and within the restrictions of part B, point 7.1, of this Annex; (c) incorporation of other organic material, composted or not, from holdings producing according to the rules of this Regulation.

2.2. Other organic or mineral fertilisers, mentioned in Annex II, may, exceptionally, be applied, as a complement to the extent that: — adequate nutrition of the crop being rotated or soil conditioning are not possible by the methods set out under (a), (b) and (c) of the preceding subparagraph, — with regard to the products in Annex II referring to manure and/or animal excrements: these products may only be used to the extent that, in combination with the livestock manure referred to in point 2(1)(b) above, the restrictions as referred to in part B, section 7.1, of this Annex are satisfied.

2.3. For compost activation appropriate plant-based preparations or preparations of micro-organisms, not genetically modified in the meaning of point 12 of Article 4 may be used. So-called ‘biodynamic preparations’ from stone meal, farmyard manure or plants may also be used for the purposes covered by this paragraph and by paragraph 2.1.

2.4. Appropriate preparations of micro-organisms, not genetically modified in the meaning of point 12 of Article 4 and permitted in general agriculture in the Member State concerned, may be used to improve the overall condition of the soil or the availability of nutrients in the soil or in the crops, where the need for such use has been recognised by the inspection body or inspection authority.

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3. Pests, diseases and weeds shall be controlled by a combination of the following measures: — choice of appropriate species and varieties, — appropriate rotation programme, — mechanical cultivation procedures, — protection of natural enemies of pests through provisions favourable to them (e.g. hedges, nesting sites, release of predators), — flame weeding. Only in cases of immediate threat to the crop may recourse be had to products referred to in Annex II.

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4. The collection of edible plants and parts thereof, growing naturally in natural areas, forests and agricultural areas, is considered an organic production method provided that: — those areas have received no treatments with products other than those referred to in Annex II for a period of three years before the collection; — the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area.

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5. For production of mushrooms, substrates may be used, if they are composed only of the following components:

5.1. farmyard manure and animal excrements (including the products referred to in indents 1 to 4 of Annex II, Part A to Regulation (EEC) No 2092/91): (a) either from holdings producing according to the organic production method; (b) or satisfying the requirements referred to in Annex II, Part A, indents 1 to 4, of Regulation (EEC) No 2092/91, only up to 25 % ( 20 ), and only when the product under 5.1(a) is not available;

5.2. products of agricultural origin, other than those covered under point 5.1 (e.g. straw), from holdings producing according to organic production method;

5.3. peat not chemically treated;

5.4. wood, not treated with chemical products after felling;

5.5. mineral products of Annex II, Part A to Regulation (EEC) No 2092/91, water and soil.

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B. LIVESTOCK AND LIVESTOCK PRODUCTS FROM THE FOLLOWING SPECIES: BOVINE (INCLUDING BUBALUS AND BISON SPECIES), PORCINE, OVINE, CAPRINE, EQUIDAE, POULTRY.

1. General principles

1.1. Livestock production forms an integral part of many agricultural holdings practising organic farming.

1.2. Livestock production must contribute to the equilibrium of agricultural production systems by providing for the nutrient requirements of crops and by improving the soil's organic matter. It can thus help establish and maintain soil-plant, plant-animal and animal-soil interdependence. As part of this concept, landless production (‘production hors sol’) is not in conformity with the rules of this Regulation.

1.3. By utilising renewable natural resources (livestock manure, legumes and fodder crops), the cropping/stockfarming system and the pasturage systems allow soil fertility to be maintained and improved in the long term and contributes to the development of sustainable agriculture.

1.4. Organic stockfarming is a land-related activity. Except where authorised by way of exception in this Annex, livestock must have access to a free-range area and the number of animals per unit of area must be limited to ensure integrated management of livestock and crop production on the production unit, so minimising any form of pollution, in particular of the soil and of surface and ground water. The number of livestock must be closely related to the area available in order to avoid problems of over-grazing and erosion and to allow for the preading of livestock manure so that any adverse effect on the environment can be avoided. Detailed rules on the use of livestock manure are set out in Section 7.

1.5. In organic stockfarming, all livestock on one and the same production unit must be reared in accordance with the rules laid down in this Regulation.

1.6. However, livestock not reared in accordance with the provisions of this Regulation may be present on the holding provided they are reared on units where the buildings and parcels are separated clearly from the units producing in accordance with the rules of this Regulation, and a different species is involved.

1.7. By derogation from this principle, livestock not reared in accordance with the provisions of this Regulation can use, for a limited period of time each year, the pasturage of units complying with this Regulation, provided that such animals come from extensive husbandry (as defined in Article 6(5) of Regulation (EC) No 950/97 ( 21 ) or, for other species not mentioned in that Regulation, the number of animals per ha corresponding to 170 kg of Nitrogen per year/hectare as defined in Annex VII of this Regulation) and provided that other animals which are subject to the requirements of this Regulation are not present on this pasturage at the same time. This derogation must be authorised beforehand by the inspection authority or body.

1.8. By way of a second derogation from this principle, animals reared in accordance with the provisions of this Regulation may be grazed on common land, providing that: (a) the land has not been treated with products other than those allowed for in Annex II of this Regulation, for at least three years; (b) any animals which use the land concerned, which are not subject to the requirements of this Regulation, are derived from extensive production, as defined in Article 6(5) of Regulation (EC) No 950/97; or, for other species not mentioned in that Regulation, the number of animals per ha corresponding to 170 kg of Nitrogen per year/hectare as defined in Annex VII of this Regulation; (c) any livestock products produced by animals reared in accordance with the provisions of this Regulation, whilst using this land, shall not be regarded as being from organic-production, unless adequate segregation from other animals not complying with the requirements of this Regulation, can be proved to the satisfaction of the inspection authority or body.

2. Conversion

2.1. Conversion of land associated with organic livestock production

2.1.1. Where a production unit is converted, the whole area of the unit used for animal feed must comply with the rules on organic farming, using the conversion periods established in part A of this Annex relating to plants and plant products.

2.1.2. By derogation from this principle, the conversion period may be reduced to one year for pasturages, open air runs and exercise areas used by non-herbivore species. This period may be reduced to six months where the land concerned has not, in the recent past, received treatments with products other than those referred to in Annex II of this Regulation. This derogation must be authorised by the inspection authority or body.

2.2. Conversion of livestock and livestock products

2.2.1. If livestock products are to be sold as organic products, the livestock must be reared according to the rules laid down in this Regulation for at least: — 12 months in the case of equidae and bovines (including bubalus and bison species) for meat production, and in any case at least three quarters of their lifetime, — six months in the case of small ruminant and pigs; however, during a transitional period of three years expiring on 24 August 2003, the period for pigs shall be four months, — six months in the case of animals for milk production; however, during a transitional period of three years expiring on 24 August 2003, the period shall be three months, — 10 weeks for poultry for meat production, brought in before they are three days old, — six weeks in the case of poultry for egg production.

2.2.2. By derogation from paragraph 2.2.1 and for the constitution of a herd or flock, calves and small ruminants for meat production can be sold as organically reared during a transitional period expiring 31 December 2003, provided that: — they come from extensive husbrandry, — they are reared in the organic-production unit until the time of sale or slaughter, for a minimum period of six months for calves and two months for small ruminants, — the origin of the animals complies with the conditions expressed in the fourth and fifth indents of paragraph 3.4.

2.3. Simultaneous conversion

2.3.1. By derogation from paragraphs 2.2.1, 4.2 and 4.4 if there is simultaneous conversion of the complete production unit, including livestock, pasturage and/or any land used for animal feed, the total combined conversion period for both livestock, pasturage and/or any land used for animal feed, shall be reduced to 24 months subject to the following conditions: (a) the derogation applies only to the existing animals and their offspring and at the same time also to the land used for animal feed/pasturage before starting the conversion; (b) the animals are mainly fed with products from the production unit.

3. Origin of the animals

3.1. In the choice of breeds or strains, account must be taken of the capacity of animals to adapt to local conditions; their vitality, and their resistance to disease. In addition, breeds or strains of animals shall be selected to avoid specific diseases or health problems associated with some breeds or strains used in intensive production (e.g. porcine stress syndrome, PSE Syndrome, sudden death, spontaneous abortion, difficult births requiring caesarean operations, etc.). Preference is to be given to indigenous breeds and strains.

3.2. Livestock must come from production units which comply with the rules on the various types of livestock production laid down in Article 6 and in this Annex. Throughout their life, this system of production must be applied.

3.3. By way of a first derogation, subject to the prior approval by the inspection authority or body, livestock existing on the livestock production unit, not complying with the rules of this Regulation can be converted.

3.4. By way of a second derogation, when a herd or flock is constituted for the first time and organically reared animals are not available in sufficient numbers, non-organically reared livestock may be brought into an organic livestock production unit, subject to the following conditions: ▼M31 — pullets for the production of eggs and poultry for meat production must be less than three days old, ▼M15 — young buffalo for breeding purposes must be less than six months old, — calves and foals for breeding purposes must be reared according to the rules of this Regulation as soon as they are weaned and in any case they must be less than six months old, — lambs and kids for breeding purposes must be reared according to the rules of this Regulation as soon as they are weaned and in any case must be less than 60 days old, — piglets for breeding purposes must be reared according to the rules of this Regulation as soon as they are weaned and they must weigh less than 35 kg.

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3.5. This derogation must be authorised beforehand by the inspection authority or body.

3.6. By way of a third derogation, the renewal or reconstitution of the herd or flock shall be authorised by the control authority or body when organically reared animals are not available, and in the following cases: (a) high mortality of animals caused by health or catastrophic circumstances; (b) pullets for egg production and poultry for meat production less than three days old. (c) piglets for breeding purposes, which must be reared according to the rules of this regulation as soon as they are weaned and must weigh less than 35 kg. Case (c) is authorised for a transitional period expiring on 31 July 2006.

3.7. Notwithstanding the provisions laid down in points 3.4. and 3.6., non-organically reared pullets for egg production of not more than 18 weeks may be brought into an organic livestock unit when organically reared pullets are not available, subject to following conditions: — prior authorisation of the competent authority, and — from 31 December 2005, the provisions laid down in paragraphs 4 (Feed) and 5 (Disease prevention and veterinary treatment) of this Annex I shall apply to non-organically reared pullets intended to be brought into organic livestock units.

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3.8. By way of a fourth derogation, subject to a maximum of 10 % of adult equine or bovine (including bubalus and bison species) livestock and 20 % of the adult porcine, ovine and caprine livestock, livestock may be brought in, as female (nulliparous) animals, from non organic-production stockfarms per year, for supplementing natural growth and for the renewal of the herd or flock, when organically reared animals are not available, and only when authorised by the control authority or body.

3.9. The percentages laid down in the above derogation shall not apply to production units with less than 10 equine or bovine animals, or with less than five porcine, ovine or caprine animals. For these units, any renewal as mentioned above shall be limited to a maximum of one animal per year.

3.10. These percentages may be increased, up to 40 % following the opinion and agreement of the inspection authority or body, in the following special cases: — when a major extension to the stockfarm is undertaken, — when a breed is changed, — when a new livestock specialisation is developed, — when breeds are in danger of being lost to farming. Animals of those breeds must not necessarily be nulliparous.

3.11. By way of a fifth derogation, males for breeding may be brought in from non organic-production stockfarms provided that the animals are subsequently reared and always fed in accordance with the rules laid down in this Regulation.

3.12. Where livestock comes from units not complying with the present Regulation, in accordance with the conditions and restrictions set out in paragraphs 3.3 to 3.11 above, the periods laid down in paragraph 2.2.1 must be observed if the products are to be sold as being from organic production and during these periods all the rules set out in this Regulation must be complied with.

3.13. Where livestock is obtained from units not complying with this Regulation, special attention must be paid to animal health measures. The inspection authority or body may apply, depending on local circumstances, special measures, such as screening tests, and quarantine periods.

3.14. The Commission will present a report by 31 December 2003 concerning the availability of originally reared livestock with a view to presenting a proposal, if appropriate, to the Standing Committee aimed at ensuring that all organic meat production should come from animals that were born and raised on organic-production holdings.

4. Feed

4.1. Feed is intended to ensure quality production rather than maximising production, while meeting the nutritional requirements of the livestock at various stages of their development. Fattening practices are authorised in so far as they are reversible at any stage of the rearing process. Force-feeding is forbidden.

4.2. Livestock must be fed on organically produced feedingstuffs.

4.3. Furthermore, livestock must be reared in accordance with the rules set out in this Annex, using feed from the unit or, when this is not possible, using feed from other units or enterprises subject to the provisions of this Regulation. Moreover, in the case of herbivores, except during the period each year when the animals are under transhumance, at least 50 % of the feed shall come from the farm unit itself or in case this is not feasible, be produced in cooperation with other organic farms.

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4.4. Until 31 December 2008, up to 50 % of the feed formula of rations on average may comprise in-conversion feedingstuffs. When the in-conversion feedingstuffs come from a unit of the holding itself, this percentage may be increased to 80 %. As from 1 January 2009, up to 30 % of the feed formula of rations on average may comprise in-conversion feedingstuffs. When the in-conversion feedingstuffs come from a unit of the holding itself, this percentage may be increased to 60 %. Up to 20 % of the total average amount of feedingstuffs fed to the livestock may originate from the grazing or harvesting of permanent pastures or perennial forage parcels in their first year of conversion, provided that they are part of the holding itself and have not been part of an organic production unit of that holding in the last five years. When both in-conversion feedingstuffs and feedingstuffs from parcels in their first year of conversion are being used, the total combined percentage of such feedingstuffs shall not exceed the maximum percentages fixed in the first and second paragraphs. These figures shall be calculated annually as a percentage of the dry matter of feedingstuffs of agricultural origin.

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4.5. The feeding of young mammals must be based on natural milk, preferably maternal milk. All mammals must be fed on natural milk for a minimum period, depending on the species concerned, which shall be three months for bovines (including bubalus and bison species) and equidae, 45 days for sheep and goats and 40 days for pigs.

4.6. Where relevant, Member States shall designate areas or regions where transhumance (including movements of animals to grazing areas in mountains) is practicable, without prejudice to the provisions on the feeding of livestock laid down in this Annex.

4.7. Rearing systems for herbivores are to be based on maximum use of pasturage according to the availablity of pastures in the different periods of the year. At least 60 % of the dry matter in daily rations is to consist of roughage, fresh or dried fodder, or silage. Nevertheless, the inspection authority or body can permit a reduction to 50 % for animals in dairy production for a maximum period of three months in early lactation.

4.8. By way of derogation from paragraph 4.2, the use of a limited proportion of conventional feedingstuffs of agricultural origin is authorised where farmers can show to the satisfaction of the inspection body or authority of the Member State that they are unable to obtain feed exclusively from organic production. The maximum percentage of conventional feedingstuffs authorised per period of 12 months is: (a) for herbivores: 5 % during the period from 25 August 2005 to 31 December 2007; (b) for other species: — 15 % during the period from 25 August 2005 to 31 December 2007, — 10 % during the period from 1 January 2008 to 31 December 2009, — 5 % during the period from 1 January 2010 to 31 December 2011. These figures shall be calculated annually as a percentage of the dry matter of feedingstuffs from agricultural origin. The maximum percentage authorised of conventional feedingstuffs in the daily ration, except during the period each year when the animals are under transhumance, must be 25 % calculated as a percentage of the dry matter.

4.9. By derogation from paragraph 4.8. when forage production is lost or when restrictions are imposed, in particular as a result of exceptional meteorological conditions, the outbreak of infectious diseases, the contamination with toxic substances, or as a consequence of fires, the competent authorities of the Member States can authorise for a limited period and in relation to a specific area, a higher percentage of conventional feedingstuffs where such authorisation is warranted. Upon approval by the competent authority, the inspection authority or body shall apply this derogation to individual operators. Member States will inform each other and the Commission on the derogations they have granted.

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4.10. Notwithstanding point 4.13, during the period of transhumance animals may graze on conventional land when they are being moved on foot from one grazing area to another. The uptake of conventional feed, in the form of grass and other vegetation on which the animals graze, during this period shall not exceed 10 % of the total feed ration per year. This figure shall be calculated as a percentage of the dry matter of feedingstuffs from agricultural origin.

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4.11. Roughage, fresh or dried fodder, or silage must be added to the daily ration for pigs and poultry.

4.12. Only products listed in Annex II, Part D, sections 1.5 and 3.1 can be used as additives and processing aids, respectively, in silage.

4.13. Conventional feed materials of agricultural origin can be used for animal feeding only if listed in Annex II, Part C, section 1 (feed materials from plant origin), subject to the quantitative restrictions imposed in this Annex, and only if they are produced or prepared without the use of chemical solvents.

4.14. Feed materials from animal origin (whether conventional or organically produced) can only be used if listed in Annex II, Part C, section 2, and subject to the quantitative restrictions imposed in this Annex.

4.15. No later than 24 August 2003, Part C, sections 1, 2, 3 and Part D of Annex II will be reviewed with the aim of removing, in particular, conventional feed materials of agricultural origin produced organically in sufficient quantity in the Community.

4.16. In order to satisfy nutritional requirements of livestock, only products listed in Annex II, Part C, section 3 (feed materials from mineral origin), and part D, sections 1.1 (trace elements) and 1.2 (vitamins, pro-vitamins and chemically well-defined substances having a similar effect), can be used for animal feeding.

4.17. Only products listed in Annex II, part D, sections 1.3 (enzymes), 1.4 (microorganisms), 1.5 (preservatives), 1.6 (binders, anti-caking agents and coagulants), 1.7 (antioxidant substances), 1.8 (silage additives), 2 (certain products used in animal nutrition) and 3 (processing aids in feedingstuffs) can be used in animal feeding for the purposes indicated in respect to the abovementioned categories. Antibiotics, coccidiostatics, medicinal substances, growth promoters or any other substance intended to stimulate growth or production shall not be used in animal feeding.

4.18. Feedingstuffs, feed materials, compound feedingstuffs feed additives, processing aids for feedingstuffs and certain products used in animal nutrition must not have been produced with the use of genetically modified organisms or products derived therefrom.

5. Disease prevention and veterinary treatment

5.1. Disease prevention in organic livestock production shall be based on the following principles: (a) the selection of appropriate breeds or strains of animals as detailed in Section 3; (b) the application of animal husbandry practices appropriate to the requirements of each species, encouraging strong resistance to disease and the prevention of infections; (c) the use of high quality feed, together, with regular exercise and access to pasturage, having the effect of encouraging the natural immunological defence of the animal; (d) ensuring an appropriate density of livestock, thus avoiding overstocking and any resulting animal health problems.

5.2. The principles set out above, should limit animal-health problems so that they can be controlled mainly by prevention.

5.3. If, despite all of the above preventive measures, an animal becomes sick or injured, it must be treated immediately, if necessary in isolation, and in suitable housing.

5.4. The use of veterinary medicinal products in organic farming shall comply with the following principles: (a) Phytotherapeutic (e.g. plant extracts (excluding antibiotics), essences, etc.), homeopathic products (e.g. plant, animal or mineral substances) and trace elements and products listed in Part C, section 3 of Annex II, shall be used in preference to chemically-synthesised allopathic veterinary medicinal products or antibiotics, provided that their therapeutic effect is effective for the species of animal, and the condition for which the treatment is intended; (b) If the use of the above products should not prove, or is unlikely to be, effective in combating illness or injury, and treatment is essential to avoid suffering or distress to the animal, chemically-synthesised allopathic veterinary medicinal products or antibiotics may be used under the responsibility of a veterinarian; (c) The use of chemically synthesised allopathic veterinary medicinal products or antibiotics for preventive treatments is prohibited;

5.5. In addition to the above principles, the following rules shall apply: (a) the use of substances to promote growth or production, (including antibiotics, coccidiostatics and other artificial aids for growth promotion purposes) and the use of hormones or similar substances to control reproduction (e.g. induction or synchronisation of oestrus), or for other purposes, is prohibited. Nevertheless, hormones may be administered to an individual animal, as a form of therapeutic veterinary treatment; (b) veterinary treatments to animals, or treatments to buildings, equipment and facilities, which are compulsory under national or Community legislation shall be authorised, including the use of immunological veterinary medicinal products when a disease has been recognised as present in a specific area in which the production unit is located.

5.6. Whenever veterinary medicinal products are to be used the type of product must be recorded clearly, (including an indication of the active pharmacological substances involved) together with details of the diagnosis; the posology; the method of administration; the duration of the treatment, and the legal withdrawal period. This information is to be declared to the inspection authority or body before the livestock or livestock products are marketed as organically produced. Livestock treated must be clearly identified, individually in the case of large animals; individually or by batch, in the case of poultry and small animals.

5.7. The withdrawal period between the last administration of an allopathic veterinary medicinal product to an animal under normal conditions of use, and the production of organically produced foodstuffs from such animals, is to be twice the legal withdrawal period or, in a case in which this period is not specified, 48 hours.

5.8. With the exception of vaccinations, treatments for parasites and any compulsory eradication schemes established by Member States, where an animal or group of animals receive more than two or a maximum of three courses of treatments with chemically-synthesised allopathic veterinary medicinal products or antibiotics within one year (or more than one course of treatment if their productive lifecycle is less than one year) the lifestock concerned, or produce derived from them, may not be sold as being products produced in accordance with this Regulation, and the livestock must undergo the conversion periods laid down in Section 2 of this Annex, subject to the agreement of the inspection authority or body.

6. Husbandry management practices, transport and identification of livestock products

6.1. Husbandry practices

6.1.1. In principle, the reproduction of organically reared livestock should be based on natural methods. Nevertheless artificial insemination is permitted. Other forms of artificial or assisted reproduction (for example embryo transfers) are prohibited.

6.1.2. Operations such as attaching elastic bands to the tails of sheep, tail-docking, cutting of teeth, trimming of beaks and dehorning must not be carried out systematically in organic farming. Some of these operations may, however, be authorised by the inspection authority or body, for reasons of safety (for example dehorning in young animals) or if they are intended to improve the health, welfare or hygiene of the livestock. Such operations must be carried out at the most appropriate age by qualified personnel and any suffering to the animals must be reduced to a minimum.

6.1.3. Physical castration is allowed in order to maintain the quality of products and traditional production practices (meat-type pigs, bullocks, capons, etc.) but only under the conditions set out in the last sentence of the paragraph 6.1.2.

6.1.4. Keeping livestock tethered is forbidden. Nevertheless, by derogation from this principle, the inspection authority or body, can authorise this practice for individual animals upon justification by the operator, that this is necessary for safety or welfare reasons, and that such tethering is only for a limited period of time.

6.1.5. By derogation from the provisions laid down in paragraph 6.1.4, cattle can be tethered in buildings already existing before 24 August 2000, provided that regular exercise is provided and rearing takes place in line with animal welfare requirements with comfortably littered areas as well as individual management. This derogation which must be authorised by the inspection authority or body shall apply for a transitional period expiring on 31 December 2010.

6.1.6. By a further derogation, cattle in small holdings can be tethered if it is not possible to keep the cattle in groups appropriate to their behaviour requirements, provided they have at least twice a week access to pastures, open air runs or exercise areas. This derogation, which must be authorised by the inspection authority or body, shall apply to holdings which meet the requirements of natural rules concerning organic production of livestock effective until 24 August 2000, or in the absence thereof of private standards accepted or recognised by the Member States.

6.1.7. Before 31 December 2006, the Commission will present a report on the implementation of the provisions of paragraph 6.1.5.

6.1.8. Where livestock are reared in groups, the size of the group must depend upon their stage of development and the behavioural needs of the species concerned. The keeping of livestock in conditions, or on a diet, which may encourage anaemia, is prohibited.

6.1.9. For poultry, the minimum age at slaughter shall be: 81 days for chickens, 150 days for capons, 49 days for Peking ducks, 70 days for female Muscovy ducks, 84 days for male Muscovy ducks, 92 days for Mallard ducks, 94 days for guineafowl, 140 days for turkeys and roasting geese. Where producers do not apply these minimum slaughter ages, they must use slow-growing strains.

6.2. Transport

6.2.1. Transport of livestock must be carried out so as to limit the stress suffered by the animals in accordance with the relevant national or Community legislation in force. Loading and unloading must be carried out with caution and without the use of any type of electrical stimulation to coerce the animals. The use of any allopathic tranquilliser, prior to and during transport, is prohibited.

6.2.2. During the period leading up to and at the time of slaughter, livestock must be handled in such a way that stress to the animals is reduced to a minimum.

6.3. Identification of livestock products

6.3.1. Livestock and livestock products are to be identified at all stages of their production, preparation, transport and marketing.

7. Livestock manure

7.1. The total amount of manure, as defined in Directive 91/676/EEC ( 22 ), applied on the holding may not exceed 170 kg of Nitrogen per year/hectare of agricultural area used, the amount specified in Annex III of the abovementioned Directive. Where necessary, the total stocking density shall be reduced to avoid exceeding the limit expressed above.

7.2. To determine the appropriate density of livestock referred to above, the livestock units equivalent to 170 kg of Nitrogen per year/hectare of agricultural area used for the various categories of animals shall be set out by the competent authorities of the Member States, taking, as a guideline, the figures laid down in Annex VII.

7.3. Member States shall communicate to the Commission and to the other Member States, any deviation from these figures and provide the reasons justifying such changes. This requirement relates only to the calculation of the maximum number of livestock for the purposes of ensuring that the limit of 170 kg of Nitrogen from manure per year/hectare is not exceeded. It is without prejudice to the stocking densities for animal health and welfare purposes laid down in Section 8 and in Annex VIII.

7.4. Organic-production holdings may establish cooperation ►M22 exclusively ◄ with other holdings and enterprises, which comply with the provisions of this Regulation, with the intention of spreading surplus manure from organic production. The maximum limit of 170 kg of Nitrogen from manure per year/hectare of agricultural area used, will be calculated on the basis of all of the organic-production units involved in such a cooperation.

7.5. Member States may establish lower limits than those specified in paragraphs 7.1 to 7.4, taking into account the characteristics of the area concerned, the application of other nitrogen fertilisers to the land and the nitrogen supply to the crops from the soil.

7.6. Storage facilities for livestock manure must be of a capacity to preclude the pollution of water by direct discharge, or by run-off and infiltr