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COUNCIL REGULATION (EEC) N° 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,

(1) Regulation (EEC) No 2092/91(4) provide that the Commission is to put forward proposals before 30 June 1995 concerning the principles for, and specific inspection measures covering, organic production of livestock, unprocessed livestock products and products intended for human consumption containing ingredients of animal origin;

(2) Demand for organically produced agricultural products is rising and consumers are increasingly attracted by such products;

(3) Livestock production allows that range of products to be extended and permits the development on agricultural holdings practising organic farming of complementary activities accounting for a major share of income;

(4) This Regulation harmonizes rules of production, labelling and inspection for the most relevant livestock species; for species, other than aquatic species, for which no rules of production are developed in this Regulation, it is appropriate for consumer protection to harmonize at least the labelling requirements and the inspection system; for aquaculture agriculture products such rules should be developed as soon as possible;

(5) Moreover, livestock production is fundamental to the organization of agricultural production on organic-production holdings in so far as it provides the necessary organic matter and nutrients for cultivated land and accordingly contributes towards soil improvement and the development of sustainable agriculture;

(6) In order to avoid environmental pollution, in particular of natural resources such as the soil and water, organic production of livestock must in principle provide for a close relationship between such production and the land, suitable multiannual rotation systems and the feeding of livestock with organic-farming crop products produced on the holding itself;

(7) In order to prevent pollution of water by nitrogenous compounds, organic-production livestock holdings should have appropriate storage capacity and plans for the spreading of solid and liquid livestock effluents;

(8) Pastoral stockfarming carried out in accordance with the rules of organic farming is an activity particularly suited to the maintenance and exploitation of the potential of abandoned areas;

(9) A wide biological diversity should be encouraged and the choice of breeds should take account of their capacity to adopt to local conditions;

(10) Genetically modified organisms (GMOs) and products derived therefrom are not compatible with the organic production method; in order to maintain consumer confidence in organic production, genetically modified organisms, parts thereof and products derived therefrom should not be used in products labelled as from organic production;

(11) Consumers should be given guarantees that the products have been produced in accordance with this Regulation; as far as technically possible, this should be based on the traceability of livestock products;

(12) Livestock must be fed on grass, fodder and feedingstuffs produced in accordance with the rules of organic farming;

(13) Under the present circumstances, stockfarmers may experience difficulty in securing supplies of feedingstuffs for organically reared livestock and therefore authorization should provisionally be granted for a limited number of non-organically produced feedingstuffs to be used in restricted quantities;

(14) In addition, in order to provide for the basic nutritional requirements of livestock, certain minerals, trace elements and vitamins may need to be used under well defined conditions;

(15) Animal health management should mainly be based on prevention, by measures such as appropriate selection of breeds and strains, a balanced high-quality diet and a favourable environment, in particular as regards rearing density, livestock housing and husbandry practices;

(16) The preventive use of chemically-synthesised allopathic medicinal products is not permitted in organic farming;

(17) However, when animals become sick or injured, they should be treated immediately by giving preference to phytotherapeutic or homeopathic medicinal products and by limiting to a strict minimum the use of chemically-synthesised allopathic medicinal products in order to guarantee the integrity of organic production for consumers it should be possible to take restrictive measures such as doubling the withdrawal period after use of chemically synthesized allopathic medicinal products;

(18) In most cases livestock should have access to free-range exercise areas or grazing, weather conditions permitting, and such free-range areas should in principle be organised under an appropriate system of rotation;

(19) Housing for all species of livestock should satisfy the needs of the animals concerned as regards ventilation, light, space and comfort and sufficient area should accordingly be provided to permit ample freedom of movement for each animal and to develop the animal's natural social behaviour;

(20) Systematic operations which lead to stress, harm, disease or the suffering of animals during the production, handling, transport or slaughtering stages should be reduced to the minimum; however, specific interventions essential to certain types of production may be permitted; the use of certain substances to stimulate growth or modify breeding cycles is not compatible with the principles of organic farming;

(21) The special features of beekeeping call for specific provisions, in particular to ensure that sources of pollen and nectar of adequate quality are available in sufficient quantities;

(22) All operators marketing products of organically reared livestock should be subject to regular and uniform inspections; a register should be kept accessible at the holding and updated with details of livestock arriving at and leaving the holding and any treatment administered;

(23) Regional differences in agricultural and climatological conditions call for certain transitional periods for certain practices, and regarding the characteristics of livestock buildings and installations;

(24) The current diversity of established practices for organic production of livestock between the Member States requires that it should be possible for Member States to apply more restrictive rules for the livestock and livestock products produced in their territory;

(25) The indications in the labelling, advertising material or commercial documents which are considered by the consumer as a reference to the organic production method are reserved by Regulation (EEC) No 2092/91 for products produced in accordance with that regulation;

(26) Certain indications are generally considered by the consumer as a reference to the organic production method;

(27) However, it is necessary to provide a transitional period in order to permit trade-mark holders to adapt their production to the requirements of organic farming, provided that such a transitional period is available only to trade marks bearing the aforementioned indications where application for registration was made before the publication of Regulation (EEC) No 2092/91 and that the consumer is informed appropriately of the fact that the products are not produced according to the organic production method,

Article 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.

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.

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.

Article 2

For the purpose 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 by the indication in use in each Member State, 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 and in particular the following terms or their usual derivatives (such as bio, eco etc.) or diminutives, alone or combined, unless such terms are not applied to agricultural products in foodstuffs or feedingstuffs or clearly have no connection with the method of production:

- in Spanish:                ecológico,
- in Danish:                  økologisk,
- in German:                ökologisch, biologisch,
- in Greek:                   (font not found)
- in English:                 organic,
- in French:                 biologique,
- in Italian:                    biologico,
- in Dutch:                   biologisch,
- in Portuguese:          biológico,
- in Finnish:                 luonnonmukainen,
- in Swedish:               ekologisk.

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.

Definitions

Article 4

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;

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;

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;

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;

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;

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 (1), as last amended by Directive 89/365/EEC (2);

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 (3), as last amended by Directive 86/94/EEC (4), which are intended to be used for cleaning certain products as referred to in Article 1 (1)(a).

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.

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 (5);

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) (6), 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 (7);

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 (8);

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 (9);

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 (10);

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 (11);

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.

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 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.

(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;

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;

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

3a. 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 - and in Finland, Austria, and Sweden before 1 January 1995 - 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 (12), 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.

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.

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:

(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";

(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;

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

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;

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

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);

- 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;

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

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.
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 above mentioned 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

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.

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.

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.

Rules of production

Article 6

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;

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

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.

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 <15 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.

- the introduction, before 31 December 2003 31 December 2000 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 31 December 2000, 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 31 December 2002 31 December 1999 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.

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 of 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 validity amended.

Article 7

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;

- 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.

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.

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.

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

- 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 requirments 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

1. Any operator who produces, prepares or imports from a third country products as specified in Article 1 for the purpose of marketing them shall:
(a) notify this activity to the competent authority of the Member State in which the activity is carried out; such notification shall include the information specified in Annex IV;
(b) submit his undertaking to the inspection system referred to in Article 9.

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

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 producing, preparing or importing from third countries
products as referred to in Article 1 shall be subject.

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 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.

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

(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 <10 laid down in paragraphs 7, 8, 9 and 11

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

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

(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:

(a) ensure that, where an irregularity is found regarding the implementation of Articles 5, 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;

(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;

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

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.

Indication that products are covered by the inspection scheme

Article 10

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 labelling of products as referred to in Article 1 only where such products:

(b) have been subject to the inspection arrangements referred to in Article 9 throughout the production and preparation process;

(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.

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 Article 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.

General enforcement measures

Article 10a

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.

Imports from third countries

Article 11

1. Without prejudice to Article 5, products as specified in Article 1 which are imported from a third country may be marketed only where:

(a) they originate in a third country appearing in a list to be drawn up by Commission decision in accordance with the procedure laid down in Article 14 and were produced in a region or a production unit and under the inspection of an inspection body specified, where appropriate, in the decision concerning the third country in question;

(b) the competent authority or body in the third country has issued a certificate of inspection stating that the lot designated in the certificate:
- was obtained within a system of production applying rules equivalent to those laid down in Article 6 and
- was subject to a system of inspection recognized as equivalent in accordance with paragraph 2 (b).

2. For the purpose of deciding whether, for certain products as specified in Article 1, a third country may at its request be included in the list referred to in paragraph 1 (a), the following shall be taken into account in particular:

(a) the guarantees which the third country can offer, at least in respect of production for export to the Community, as regards the application of rules equivalent to those laid down in Article 6

(b) the effectiveness of the inspection measures applied, which, at least in respect of production for export to the Community, must be equivalent to the inspection measures referred to in Articles 8 and 9 to ensure compliance with the rules referred to in (a). On the basis of this information, the regions or production units of origin, or the bodies whose inspections are deemed to be equivalent, may be specified in the Commission decision.

(a) accompany the goods, in the original copy, to the premises of the first consignee; thereafter the importer must keep the certificate at the disposal of the <10 inspection body and/or inspection authority for not less than two years;

(b) be drawn up in accordance with procedures and a model to be adopted in accordance with the procedure laid down in Art.14.

4. Detailed rules for the implementation of this Article may be determined according to the procedure referred to in Article 14.

5. When examining a request from a third country, the Commission shall require it to supply all the necessary information; it may also entrust experts with the task of carrying out, under its authority, an on-the-spot examination of the rules of production and inspection measures actually applied in the third country in question.

6. (a) By way of derogation from paragraph 1, the importer(s) in a Member State shall be authorized by the competent authority of the Member State to market until 31 December 2005, products imported from a third country not included in the list referred to in paragraph 1 (a) provided the importer(s) furnish(es) the competent authority of the importing Member State with sufficient evidence that the imported products were manufactured according to production rules equivalent to those laid down in Article 6 and were subject to inspection measures of equivalent effectiveness to those referred to in Articles 8 and 9, and that such inspection measures will be permanently and effectively applied.
It shall expire from the time of the decision to include a third country in the list referred to in paragraph 1 (a), unless it concerns a product which was produced in a region not specified in the decision referred to in paragraph 1 (a), and which was not examined in the framework of the request submitted by the third country, and only where that third country has agreed to the continuation of the authorization arrangements provided for in this paragraph.

(b) Where a Member State has received sufficient evidence from an importer, it shall forthwith notify to the Commission and the other Member States the third country from which products are imported and supply detailed information on the production and inspection arrangements and the guarantees that they will be permanently and effectively applied.

(c) At the request of a Member State or at the Commission's initiative, the matter shall be submitted to the Committee referred to in Article 14 for examination. Should it emerge from this examination that the imported products were not manufactured according to equivalent production rules and/or inspection measures of equivalent effectiveness, the Commission shall request the Member State which granted the authorization to withdraw it. It may be decided, in accordance with the procedure laid down in Article 14, that the imports in question shall be prohibited or that their continuation shall be subject to certain of the import conditions being amended within a given period.

(d) The notification referred to in (b) shall not be required where it concerns production and inspection arrangements already notified by another Member State, pursuant to (b), unless significant new evidence is submitted justifying a review of the examination and decision referred to in (c). Before 31 July 1994, the Commission shall re-examine the provisions of paragraph 1 and submit any appropriate proposal for its review.

7. The Commission may, in accordance with the procedure laid down in Article 14 at the request of a Member State, approve a third country's inspection body which has previously been assessed by the Member State concerned and add it to the list referred to in paragraph 1 (a). The Commission shall forward the request to the third country concerned.

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.
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.

Administrative provisions and implementation

Article 13, 14 and 15 on the Administration provisions and implementation at the council level are not relevant for the practitioner of organic production, our Inspectors and customers. For the complete consolidated version visit http://www.prolink.de/%7Ehps/organic/consolid-en.html -

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.

3. Article 5, Article 8 (1) and Article 11 (1) shall apply from 1 January 1993.
In accordance with the procedure laid down in Article 14, the date of application of Article 11 (1) may be deferred for a specified period for imports from a third country where, following a request by the third country, the stage reached in examining the matter does not permit a decision regarding the inclusion of the country concerned in the list provided for in Article 11 (1) (a) before expiry of the period referred to in the first subparagraph.
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.

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