(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.

— 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,

— in Finnish:

luonnonmukainen,

— in Swedish:

ekologisk.

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 ( 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).

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 ( 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.

(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;

(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.

(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;

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

— 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.

(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’;

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

(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.

(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.

(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:

(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.

(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.

(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.

(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:

(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.

(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:

(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.

(a) if they are used for the purpose of plant pest or disease control or for cleaning and disinfecting livestock buildings and installations:

(b) if they are used for fertilization or soil-conditioning purposes:

— 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.

(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.

(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.

(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. ◄

(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. ◄

(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.

(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;

(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.

(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.

(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.

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

(b) have been subject to the inspection system referred to in Article 9 throughout the production and preparation process or, in the case of imported products to equivalent measures; in the case of products imported according to 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;

(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.

(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.

(a) they originate in a third country appearing in a list to be drawn up by a 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:

(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 ►M10  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).

(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 ►M10  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 Article 14.

(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 ►M35  31 December 2006 ◄ , 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 ►M10  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.

Such authorization shall be valid only as long as the abovementioned conditions are shown to be satisfied. ►M10  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.

— 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.

— 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).

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:

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:

In these cases the length of the conversion period shall be fixed taking into account all of the following points:

2.1. The fertility and the biological activity of the soil must be maintained or increased, in the first instance, by:

2.2. Other organic or mineral fertilisers, mentioned in Annex II, may, exceptionally, be applied, as a complement to the extent that:

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.

3. Pests, diseases and weeds shall be controlled by a combination of the following measures:

Only in cases of immediate threat to the crop may recourse be had to products referred to in Annex II.

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:

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):

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.

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:

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.

2.2.1. 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:

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:

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:

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:

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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:

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:

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:

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.

4.1. 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.

4.4. 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 own holding, this percentage can be increased to 60 %. ►M23  These figures shall be expressed as a percentage of the dry matter of feedingstuffs of agricultural origin. ◄

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:

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.

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.

5.1. Disease prevention in organic livestock production shall be based on the following principles:

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:

5.5. In addition to the above principles, the following rules shall apply:

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.

6.1.1. 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:

Where producers do not apply these minimum slaughter ages, they must use slow-growing strains.

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.

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

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 infiltration of the soil.

7.7. To ensure sound fertiliser management, the capacity of such storage facilities for livestock manure must exceed the storage capacity required for the longest period of the year in which any application of fertiliser to the land is either inappropriate (in accordance with the codes of good agricultural practice established by Member States) or when such application is prohibited, in cases where the production unit is located within a designated nitrate vulnerable zone.

8.1.1. Housing conditions for livestock must meet the livestock's biological and ethological needs (e.g. behavioural needs as regards appropriate freedom of movement and comfort). The livestock must have easy access to feeding and watering. Insulation, heating and ventilation of the building must ensure that air circulation, dust level, temperature, relative air humidity and gas concentration, are kept within limits which are not harmful to the animals. The building must permit plentiful natural ventilation and light to enter.

8.1.2. Free-range, open-air exercise areas, or open-air runs must, if necessary, provide sufficient protection against rain, wind, sun and extreme temperatures, depending on the local weather conditions and the breed concerned.

8.2.1. Housing for livestock will not be mandatory in areas with appropriate climatic conditions to enable animals to live outdoors.

8.2.2. The stocking density in buildings shall provide for the comfort and well being of the animals which, in particular, shall depend on the species, the breed and the age of the animals. It shall also take account of the behavioural needs of the animals, which depend in particular on the size of the group and the animals' sex. The optimum density will seek to ensure the animals' welfare by providing them with sufficient space to stand naturally, lie down easily, turn round, groom themselves, assume all natural postures and make all natural movements such as stretching and wing flapping.

8.2.3. The minimum surface areas for indoor housing and outdoor exercise areas, and other characteristics of housing for different species and categories of animals, are laid down in Annex VIII.

8.2.4. The outdoor stocking density of livestock kept on pasturage, other grassland, heathland, wetland, heather, and other natural or semi-natural habitats, must be low enough to prevent poaching of the soil and over grazing of vegetation.

8.2.5. Housing, pens, equipment and utensils must be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Only the products listed in Part E of Annex II can be used for such cleaning and disinfection of livestock buildings and installations. Faeces, urine and uneaten or spilt food must be removed as often as necessary to minimise smell and to avoid attracting insects or rodents. Only the products listed in part B, section 2, of Annex II can be used for the elimination of insects and other pests in buildings and other installations where livestock is kept.

8.3.1. Subject to the provisions in paragraph 5.3, all mammals must have access to pasturage or an open-air exercise area or an open-air run which may be partially covered, and they must be able to use those areas whenever the physiological condition of the animal, the weather conditions and the state of the ground permit, unless there are Community or national requirements relating to specific animal health problems that prevent this. Herbivores, must have access to pasturage whenever conditions allow.

8.3.2. In cases where herbivores have access to pasturage during the grazing period and where the winter-housing system gives freedom of movement to the animals, the obligation to provide open-air exercise areas or open-air runs during the winter months may be waived.

8.3.3. Notwithstanding the last sentence of paragraph 8.3.1, bulls over one year old must have access to pasturage or an open-air exercise area or an open-air run.

8.3.4. By way of derogation from paragraph 8.3.1, the final fattening phase of cattle pigs and sheep for meat production may take place indoors, provided that this indoors period does not exceed one fifth of their lifetime and in any case for a maximum period of three months.

8.3.5. Livestock housing must have smooth, but not slippery floors. At least half of the total floor area must be solid, that is, not of slatted or of grid construction.

8.3.6. The housing must be provided with a comfortable, clean and dry laying/rest area of sufficient size, consisting of a solid construction which is not slatted. Ample dry bedding strewn with litter material must be provided in the rest area. The litter must comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product authorised for use as a fertiliser in organic farming in accordance with Part A of Annex II.

8.3.7. As regards the rearing of calves, from 24 August 2000, all holdings, without derogation, must comply with Directive 91/629/EEC ( 23 ) laying down minimum standards for the protection of calves. The housing of calves in individual boxes is forbidden after the age of one week.

8.3.8. As regards the rearing of pigs, from 24 August 2000, all holdings must comply with Council Directive 91/630/EEC ( 24 ) laying down minimum standards for the protection of pigs. However, sows must be kept in groups, except in the last stages of pregnancy and during the suckling period. Piglets may not be kept on flat decks or in piglet cages. Exercise areas must permit dunging and rooting by the animals. For the purposes of rooting different substrates can be used.

8.4.1. Poultry must be reared in open-range conditions and cannot be kept in cages.

8.4.2. Water fowl must have access to a stream, pond or lake whenever the weather conditions permit in order to respect animal welfare requirements or hygienic conditions.

8.4.3. Buildings for all poultry must meet the following minimum conditions:

8.4.4. In the case of laying hens natural light may be supplemented by artificial means to provide a maximum of 16 hours light per day with a continuous nocturnal rest period without artificial light of at least eight hours.

8.4.5. Poultry, must have access to an open-air run whenever the weather conditions permit and, whenever possible, must have such access for at least one third of their life. These open-air runs must be mainly covered with vegetation be provided with protective facilities, and permit animals to have easy access to adequate numbers of drinking and feeding troughs.

8.4.6. For health reasons, buildings must be emptied of livestock between each batch of poultry reared. The buildings and fittings are to be cleaned and disinfected during this time. In addition, when the rearing of each batch of poultry has been completed, runs must be left empty to allow vegetation to grow back, and for health reasons. Member States will establish the period in which runs must be empty and they will communicate their decision to the Commission and the other Member States. These requirements shall not apply to small numbers of poultry which are not kept in runs and which are free to roam, throughout the day.

8.5.1. By way of derogation from the requirements set out in paragraphs 8.3.1, 8.4.2, 8.4.3 and 8.4.5 and the stocking densities laid down in Annex VIII, the competent authorities of the Member States may authorise derogations from the requirements of these paragraphs and of Annex VIII for a transitional period expiring on 31 December 2010. This derogation can only be applied to livestock producing holdings with existing buildings, constructed before 24 August 1999 and in so far as these livestock buildings comply with national rules concerning organic livestock production, in force prior to that date, or in the absence thereof with private standards accepted or recognised by the Member States.

8.5.2. The operators benefiting from this derogation shall present a plan to the inspection authority or body, containing the arrangements which ensure, at the end of the derogation, compliance with the provisions of this Regulation.

8.5.3. Before 31 December 2006, the Commission shall present a report on the implementation of the provision of paragraph 8.5.1.

1.1. Beekeeping is an important activity that contributes to the protection of the environament and agricultural and forestry production through the pollination action of bees.

1.2. The qualification of beekeeping products as being from organic production is closely bound up both with the characteristic of the hives' treatments and the quality of the environment. This qualification also depends on the conditions for extraction, processing and storage of beekeeping products.

1.3. When an operator runs several beekeeping units in the same area all the units must comply with the requirements of this Regulation. By derogation from this principle, an operator can run units not complying with this Regulation provided that all the requirements of this Regulation are fulfilled with the exception of the provisions laid down in paragraph 4.2 for the siting of the apiaries. In that case, the product cannot be sold with references to organic production methods.

2.1. Beekeeping products can be sold with references to the organic production method only when the provisions laid down in this Regulation have been complied with for at least one year. During the conversion period the wax has to be replaced according to the requirements laid down in paragraph 8.3.

3.1. In the choice of breeds, account must be taken of the capacity of animals to adapt to local conditions, their vitality and their resistance to disease. Preference shall be given to the use of European breeds of Apis mellifera and their local ecotypes.

3.2. Apiaries must be constituted by means of the division of colonies or the acquisition of swarms or hives from units complying with the provisions laid down in this Regulation.

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

3.4. By way of a second derogation, swarms on their own may be acquired from beekeepers not producing in accordance with this Regulation during a transitional period expiring on 24 August 2002 subject to the conversion period.

3.5. By way of a third derogation, the reconstitution of the apiaries shall be authorised by the control authority or body, when apiaries complying with this Regulation are not available, in case of high mortality of animals caused by health or catastrophic circumstances, subject to the conversion period.

3.6. By way of a fourth derogation, for the renovation of the apiaries 10 % per year of the queen bees and swarms not complying with this Regulation can be incorporated into the organic-production unit provided that the queen bees and swarms are placed in hives with combs or comb foundations coming from organic-production units. In the case, the conversion period does not apply.

4.1. The Member States may designate regions or areas where beekeeping complying with this Regulation is not practicable. A map on an appropriate scale listing the location of hives as provided for in Annex III, Part A1, section 2, first indent shall be provided to the inspection authority or body by the beekeeper. Where no such areas are identified, the beekeeper must provide the inspection authority or body with appropriate documentation and evidence, including suitable analyses if necessary, that the areas accessible to his colonies meet the conditions required in this Regulation.

4.2. The siting of the apiaries must:

The above requirements do not apply to areas where flowering is not taking place, or when the hives are dormant.

5.1. At the end of the production season hives must be left with reserves of honey and pollen sufficiently abundant to survive the winter.

5.2. The artificial feeding of colonies is authorised where the survival of the hives is endangered due to extreme climatic conditions. Artificial feeding shall be made with organically produced honey, preferably from the same organic-production unit.

5.3. By way of a first derogation from paragraph 5.2, the competent authorities of the Member States can authorise the use of organically-produced sugar syrup, or organic sugar molasses instead of organically-produced honey in artificial feeding, in particular, when it is required by climatic conditions that provoke crystallisation of honey.

5.4. By way of a second derogation, sugar syrup, sugar molasses and honey not covered by this Regulation may be authorised by the inspection authority or body for artificial feeding during a transitional period expiring on 24 August 2002.

5.5. The following information shall be entered in the register of the apiaries with regard to the use of artificial feeding: type of product, dates, quantities and hives where it is used.

5.6. Other products different from those indicated in paragraphs 5.1 to 5.4 cannot be used in beekeeping which complies with this Regulation.

5.7. Artificial feeding may be carried out only between the last honey harvest and 15 days before the start of the next nectar or honeydew flow period.

6.1. Disease prevention in beekeeping shall be based on the following principles:

6.2. If despite all the above preventive measures, the colonies become sick or infested, they must be treated immediately and, if necessary, the colonies can be placed in isolation apiaries.

6.3. The use of veterinary medicinal products in beekeeping which complies with this Regulation shall respect the following principles:

6.4. In addition to the above principles, veterinary treatments or treatments to hives, combs etc., which are compulsory under national or Community legislation shall be authorised.

6.5. If a treatment is applied with chemically synthesised allopathic products, during such a period, the colonies treated must be placed in isolation apiaries and all the wax must be replaced with wax complying with the conditions laid down in this Regulation. Subsequently, the conversion period of one year will apply to those colonies.

6.6. The requirements laid down in the previous paragraph do not apply to products mentioned in paragraph 6.3(e).

6.7. Whenever veterinary medicinal products are to be used, the type of product (including the indication of the active pharmacological substance) together with details of the diagnosis, the posology, the method of administration, the duration of the treatment and the legal withdrawal period must be recorded clearly and declared to the inspection body or authority before the products are marketed as organically produced.

7.1. The destruction of bees in the combs as a method associated with the harvesting of beekeeping products is prohibited.

7.2. Mutilation such as clipping the wings of queen bees is prohibited.

7.3. The replacement of the queen bees involving the killing of the old queen is permitted.

7.4. The practice of destroying the male brood is permitted only to contain the infestation with Varroa jacobsoni.

7.5. The use of chemical synthetic repellents is prohibited during honey extractions operations.

7.6. The zone where the apiary is situated must be registered together with the identification of the hives. The inspection body or authority must be informed of the moving of apiaries with a deadline agreed on with the inspection authority or body.

7.7. Particular care shall be taken to ensure adequate extraction, processing and storage of beekeeping products. All the measures to comply with these requirements shall be recorded.

7.8. The removals of the supers and the honey extraction operations must be entered in the register of the apiary.

8.1. The hives must be made basically of natural materials presenting no risk of contamination to the environment or the apiculture products.

8.2. With the exception of products mentioned in paragraph 6.3(e) in the hives can be used only natural products such as propolis, wax and plant oils.

8.3. The beeswax for new foundations must come from organic production units. By way of derogation, in particular in the case of new installations or during the conversion period, bees wax not coming from such units may be authorised by the inspection authority or body in exceptional circumstances where organically produced beeswax is not available on the market and provided that it comes from the cap.

8.4. The use of combs, which contain broods, is prohibited for honey extraction.

8.5. For the purposes of protecting materials (frames, hives and combs), in particular from pests, only appropriate products listed in part B, Section 2, of Annex II are permitted.

8.6. Physical treatments such as stream or direct flame are permitted.

8.7. For cleaning and disinfecting materials, buildings, equipment, utensils or products used in beekeeping only the appropriate substances listed in Annex II Part E are permitted.

— use only in accordance with provisions of Annex I,

— use only in accordance with the provisions of the legislation on placing on the market and use of the products concerned applicable in general agriculture in the Member State where the product is used.

— use in accordance with provisions of Annex I,

— only in accordance with the specific provisions of the plant protection product legislation applicable within the Member State where the product is used (where relevant ( 26 )).

— the traps and/or dispensers must prevent the penetration of the substances in the environment and prevent contact of the substances with the crops under cultivation.

— the traps must be collected after use and disposed of safely

2. Products for pest and disease control in livestock buildings and installations:

1.1. Cereals, grains, their products and by-products. Only the following substances are included in this category:

oats as grains, flakes, middlings, hulls and bran; barley as grains, protein and middlings; rice germ expeller; millet as grains; rye as grains and middlings; sorghum as grains; wheat as grains, middlings, bran, gluten feed, gluten and germ; spelt as grains; triticale as grains; maize as grains, bran, middlings, germ expeller and gluten; malt culms; brewers' grains.

1.2. Oil seeds, oil fruits, their products and by-products. Only the following substances are included in this category:

rape seed, expeller and hulls; soya bean as bean, toasted, expeller and hulls; sunflower seed as seed and expeller; cotton as seed and seed expeller; linseed as seed and expeller; sesame seed as expeller; palm kernels as expeller; pumpkin seed as expeller; olives, olive pulp; vegetable oils (from physical extraction).

1.3. Legume seeds, their product and by-products. Only the following substances are included in this category:

chickpeas as seeds, middlings and bran; ervil as seeds, middlings and bran; chickling vetch as seeds submitted to heat treatment, middlings and bran; peas as seeds, middlings, and bran; broad beans as seeds, middlings and bran; horse beans as seeds middlings and bran, vetches as seeds, middlings and bran and lupin as seeds, middlings and bran.

1.4. Tuber, roots, their products and by-products. Only the following substances are included in this category:

sugar beet pulp, potato, sweet potato as tuber, potato pulp (by-product of the extraction of potato starch), potato starch, potato protein and manioc.

1.5. Other seeds and fruits, their products and by-products. Only the following substances are included in this category:

carob, carob pods and meals thereof, pumpkins, citrus pulp; apples, quinces, pears, peaches, figs, grapes and pulps thereof; chestnuts, walnut expeller, hazelnut expeller; cocoa husks and expeller; acorns.

1.6. Forages and roughages. Only the following substances are included in this category:

lucerne, lucerne meal, clover, clover meal, grass (obtained from forage plants), grass meal, hay, silage, straw of cereals and root vegetables for foraging.

1.7. Other plants, their products and by-products. Only the following substances are included in this category:

molasses, seaweed meal (obtained by drying and crushing seaweed and washed to reduce iodine content), powders and extracts of plants, plant protein extracts (solely provided to young animals), spices and herbs.

1.8. The following feed materials may be used until 30 June 2004: rice as grain, rice broken, rice bran, rye feed, rye bran, turnip rape seed expeller, turnip rape seed hulls and tapioca.

2.1. Milk and milk products. Only the following substances are included in the category:

raw milk as defined in Article 2 of Directive 92/46/EEC ( 27 ), milk powder, skimmed milk, skimmed-milk powder, buttermilk, buttermilk powder, whey, whey powder, whey powder low in sugar, whey protein powder (extracted by physical treatment), casein powder, lactose powder, curd and sour milk.

2.2. Fish, other marine animals, their products and by-products. Only the following substances are included in the category:

fish, fish oil and cod-liver oil not refined; fish molluscan or crustacean autolysates, hydrolysate and proteolysates obtained by an enzyme action, whether or not in soluble form, solely provided to young animals. Fish meal.

2.3. Eggs and egg products for use as poultry feed, preferably from the same holding.

Sodium:

Potassium:

potassium chloride;

Calcium:

Phosphorus:

Magnesium:

Sulphur:

sodium sulphate.

Bone dicalcium phosphate precipitate may be used until 30 June 2004.

1.1. Trace elements. Only the following substances are included in this category:

1.2. Vitamins, provitamins and chemically well defined substances having a similar effect. Only the following substances are included in this category:

Producers may benefit from this authorisation only if they have demonstrated to the satisfaction of the inspection body or authority of the Member State that the health and welfare of their animals cannot be guaranteed without the use of these synthetic vitamins.

1.3. Enzymes. Only the following substances are included in this category:

Enzymes authorised under Directive 70/524/EEC.

1.4. Microorganisms. Only the following microorganisms are included in this category:

microorganisms authorised under Directive 70/524/EEC.

1.5. Preservatives. Only the following substances are included in this category:

The use of lactic, formic, propionic and acetic acid in the production of silage shall be only permitted when weather conditions do not allow for adequate fermentation.

1.6. Binders, anti-caking agents and coagulants. Only the following substances are included in this category:

1.7. Antioxidant substances. Only the following substances are included in this category:

1.8. Silage additives. Only the following substances are included in this category:

as from 19 October 2004, enzymes, yeasts and bacteria authorised by Regulation (EC) No 1831/2003 on additives for use in animal nutrition.

3.1. Processing aids for silage. Only the following substances are included in this category:

Potassum and sodium soap

Water and steam

Milk of lime

Lime

Quicklime

Sodium hypochlorite (e.g. as liquid bleach)

Caustic soda

Caustic potash

Hydrogen peroxide

Natural essences of plants

Citric, peracetic acid, formic, lactic, oxalic and acetic acid

Alcohol

Nitric acid (dairy equipment)

Phosporic acid (dairy equipment)

Formaldehyde

Cleaning and disinfection products for teats and milking facilities

Sodium carbonate

— a full description of the unit and/or premises and/or activity,

— all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with this Regulation, and in particular with the requirements in this Annex,

— the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator’s production chain.

— to perform the operations in accordance with Articles 5, 6, 6a and, where relevant, Article 11 of this Regulation, and/or Regulation (EC) No 223/2003,

— to accept, in the event of infringement or irregularities, the enforcement of the measures referred to in Article 9(9) of this Regulation and, where relevant, in Article 10(3) of this Regulation, and

— to accept to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production.

— the supplier and, where different, the seller, or the exporter of the products,

— the nature and the quantities of products as referred to in Article 1 delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs,

— the nature and the quantities of products as referred to in Article 1 held in storage at the premises,

— the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products as referred to in Article 1, which have left the unit or the first consignee's premises or storage facilities,

— in case of operators who do not store or physically handle such products, the nature and the quantities of products as referred to in Article 1 bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.

(a) the name and address of the operator and, where different, of the owner or seller of the product;

(b)  ►M23  the name of the product or a description of the compound feedingstuff accompanied by a reference to the organic production method in accordance with, as applicable, Article 5 of this Regulation or Article 3 of Regulation (EC) No 223/2003. ◄

(c) the name and/or the code number of the inspection body or authority to which the operator is subject; and

(d) where relevant, the lot identification mark according to a marking system either approved at national level or agreed with the inspection body or authority and which permits to link the lot with the accounts referred to in point 6.

— transportation is direct between a producer and another operator who are both subject to the inspection system referred to in Article 9, and

— the products are accompanied by a document giving the information required under the previous subparagraph, and

— the inspection body or authority of both the expediting and the receiving operators have been informed of such transport operations and have agreed thereto. Such agreement might be provided for one or more transport operation(s).

— be drawn up even where the producer limits his activity to the collection of wild plants,

— show the storage and production premises and land parcels and/or collection areas and, where applicable, premises where certain processing and/or packaging operations take place, and

— specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which is not compatible with Article 6(1)(b).

(a) in the case of the production of perennial crop products (edible fruit bearing trees, vines and hops) provided the following conditions are met:

(b) in the case of areas intended for agricultural research agreed by the Member States' competent authorities, provided that conditions 2, 3 and 4 and the relevant part of condition 5 referred to in (a) are met;

(c) in the case of production of seed, vegetative propagating material and transplants, provided that conditions 2, 3 and 4 and the relevant part of condition 5 referred to in (a) are met;

(d) in the case of grassland exclusively used for grazing.

— a full description of the livestock buildings, pasturage, open-air exercise areas, open-air runs, etc., and, where applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials and inputs,

— a full description of the installations for the storage of livestock manure.

— plan for spreading manure agreed with the inspection body or authority, together with a full description of the areas given over to crop production,

— where appropriate, as regards the spreading of manure, the written arrangements with other holdings complying with the provisions of this Regulation,

— management plan for the organic-production livestock unit (e.g. management for feeding, reproduction, health, etc.).

— by species, as regards livestock arriving at the holding: origin and date of arrival, conversion period, identification mark and veterinary record,

— as regards livestock leaving the holding: age, number of heads, weight in case of slaughter, identification mark and destination,

— details of any animals lost and reasons,

— as regards feed: type, including feed supplements, proportions of various ingredients of rations and periods of access to free-range areas, periods of transhumance where restrictions apply,

— as regards disease prevention and treatment and veterinary care: date of treatment, diagnosis, type of treatment product, method of treatment and practitioner's prescription for veterinary care with reasons and withdrawal periods applying before livestock products can be marketed.

— appropriate measures, agreed with the inspection body or authority have been taken in order to guarantee the permanent separation between livestock, livestock products, manure and feedingstuffs of each of the units,

— the producer informs the inspection body or authority in advance of any delivery or selling of the livestock or livestock products,

— the operator informs the inspection body or authority of the exact quantities produced in the units together with all characteristics permitting the identification of the products and confirms that the measures taken to separate the products have been applied.

— units involved in packaging and/or re-packaging of such products,

— units involved in labelling and/or re-labelling of such products.

— the unit must have areas separated by place or time within the premises for the storage of products as referred to in Article 1, before and after the operations,

— operations must be carried out continuously until the complete run has been dealt with, separated by place or time from similar operations performed on products not covered by Article 1,

— if such operations are not carried out at regular times or on a fixed day, they must be announced in advance, with a deadline agreed on with the inspection body or authority,

— every measure must be taken to ensure identification of lots and to avoid mixtures or exchanges with products not obtained in accordance with the rules laid down in this Regulation,

— operations on products in accordance with the rules laid down in this Regulation must be carried out only after cleaning of the production equipment. The effectiveness of the cleaning measures must be checked and recorded.

— the importer shall mean the natural or legal person within the European Community who presents a consignment for release for free circulation into the European Community, either on its own, or through a representative,

— the first consignee shall mean the natural or legal person referred to in Article 11(3)(a) to whom the consignment is delivered and who will receive it for further preparation and/or marketing.

— The full description of the unit referred to under point 3 of the general provisions of this Annex must include the importer's premises and of his import activities, indicating the points of entry of the products into the Community and any other facilities the importer intends to use for the storage of the imported products pending their delivery to the first consignee,

— In addition, the declaration referred to under point 3 of the general provisions must include an undertaking by the importer to ensure that any facilities that the importer will use for storage of products are submitted to inspection, to be carried out either by the inspection body or authority or, when these storage facilities are situated in another Member State or region, by an inspection body or authority approved for inspection in that Member State or region.

— The full description of the unit referred to under point 3 of the general provisions must show the facilities used for the reception and storage. Where other activities, like processing, packaging, labelling and storage of agricultural products before and after the operations concerning them, as well the transport of the products, take place, the relevant provisions under section B shall apply.

— the name and address of the first consignee,

— any details this body or authority may require, such as a copy of the inspection certificate for the importation of products from organic farming. On the request of the inspection body or authority of the importer, the latter must pass the information to the inspection body or authority of the first consignee.

— the products as referred to in Article 1 must be kept separate from the other agricultural products and/or foodstuffs,

— every measure must be taken to ensure identification of consignments and to avoid mixtures or exchanges with products not obtained in accordance with the rules laid down in this Regulation.

— a list of the subcontractors with a description of their activities and the inspection bodies or authorities to which they are subject; these subcontractors must have agreed to have their holding being subject to the inspection regime of Article 9, in accordance with the relevant sections of Annex III,

— all the practical measures, including inter alia an appropriate system of documentary accounts, to be taken at the level of the unit to ensure that the products the operator places on the market can be traced to their suppliers, and, where different, their sellers, as well as to their consignees and, where different, their buyers.

— indicate the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them,

— indicate the facilities used for the storage of other products used to prepare feedingstuffs,

— indicate the facilities used to store products for cleaning and disinfection,

— indicate, where necessary, the description of the compound feedingstuff that the operator intends to produce, in accordance with Article 5(1)(a) of Directive 79/373/EEC, and the livestock species or class for which the compound feedingstuff is intended,

— indicate, where necessary, the name of the feed materials that the operator intends to prepare.

— in particular an indication of the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised substances or products, the cleaning measures implemented and the monitoring of their effectiveness,

— identification of all elements of their activities crucial for guaranteeing at all times that the products referred to in Article 1(1)(c) prepared in such units comply with this Regulation and with Regulation (EC) No 223/2003,

— the establishment and implementation of, compliance with and updating of appropriate procedures, based on the principles of the HACCP (Hazard Analysis and Critical Control Points) system.

(a) organically-produced feedingstuffs or feedingstuffs derived therefrom, in-conversion feedingstuffs or feedingstuffs derived therefrom, and conventional feedingstuffs are effectively physically separated;

(b) all equipment used in units preparing compound feedingstuffs covered by this Regulation is completely separated from equipment used for compound feedingstuffs not covered by this Regulation.

— separation in terms of time is guaranteed and suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing preparation of the products covered by this Regulation; operators must record these operations,

— operators must ensure that all appropriate measures are implemented, depending on the risks evaluated in accordance with point 1, and, where necessary, guarantee that products which do not conform to this Regulation cannot be placed on the market with an indication referring to organic farming.

(a) during transport, organically-produced feedingstuffs or feedingstuffs derived therefrom, in-conversion feedingstuffs or feedingstuffs derived therefrom, and conventional feedingstuffs must be effectively physically separated;

(b) the vehicles and/or containers which have transported products that are not covered by this Regulation may be used to transport products covered by this Regulation if:

(c) the finished products referred to in this Regulation are transported separately from other finished products physically or in time;

(d) during transport, the quantity of products at the start and each individual quantity delivered in the course of a delivery round must be recorded.

(a) Name and address of operator;

(b) Location of premises and, where appropriate, parcels (land register data) where operations are carried out;

(c) Nature of operations and products;

(d) Undertaking by the operator to carry out the operations in accordance with Articles 5, 6, 7 and/or 11;

(e) In the case of an agricultural holding, the date on which the producer ceased to apply products the use of which is not compatible with Articles 6 (1) (6) and 7 on the parcels concerned;

(f) The name of the approved body to which the operator entrusted inspection of his undertaking, where the Member State has implemented the inspection system by approving such bodies.

B.1.1. The Community logo referred to above shall comprise of the models in part B.2 of this Annex.

B.1.2. The indications that must be included in the logo are listed in part B.3 of this Annex. It is possible to combine the logo with the indication mentioned in part A to this Annex.

B.1.3. To use the Community logo and the indications referred to in part B.3 of this Annex, the technical reproduction rules laid down in the graphic manual in part B.4 of this Annex must be complied with.

(a) For a logo with a single indication: minimum size 20 mm diameter.

(b) For a logo with a combination of two indications: minimum size 40 mm diameter.

— Single indication in all the languages

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— 

— The examples of the language combinations referred to in B.3.2

— 

— 

— 

1. ingredients: substances as defined in Article 4 of this Regulation under the restrictions as referred to in Article 6 (4) of Council Directive 79/112/EEC of 18 December 1978 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 ( 30 );

2. ingredients of agricultural origin:

3. ingredients of non-agricultural origin: ingredients other than ingredients of agricultural origin and belonging to at least one of the following categories:

3.1. food additives, including carriers for food additives, as defined under points 5 and 6 hereunder;

3.2. flavourings, as defined under point 7 hereunder;

3.3. water and salt;

3.4. micro-organism preparations;

3.5. minerals (including trace elements) and vitamins;

4. processing aids: substances as defined in Article 1 (3) (a) of Council Directive 89/107/EEC ( 31 ) on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption;

5. food additives: substances as defined in Article 1 (1) and (2) of Directive 89/107/EEC and covered by that Directive or by a comprenhensive Directive as referred to in Article 3 (1) of Directive 89/107/EEC;

6. carriers, including carrier solvents: food additives used to dissolve, dilute, disperse or otherwise physically modify a food additive without altering its technological function in order to facilitate its handling, application or use;

7. flavouring: substances and products as defined in Article 1 (2) of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production ( 32 ), and covered by that Directive.

(i) Any preparations of micro-organisms normally used in food processing, with the exception of micro-organisms genetically modified within the meaning of Article 2 (2) of Directive 90/220/EEC.

C.1. Unprocessed vegetable products as well as products derived therefrom by processes referred to under definition 2(a) of the introduction of this Annex:

C.2. Vegetable products, processed by processes as referred to under definition 2(b) of the introduction of this Annex

C.3. Animal products:

aquatic organisms, not originating from aquaculture, and permitted in conventional foodstuffs preparation