COUNCIL REGULATION (EC) No 1804/1999

of 19 July 1999

supplementing Regulation (EEC) No 2092/91 on organic production of agricultural products and indications referring thereto on agricultural products and foodstuffs to include livestock production

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the European Parliament(2),

Having regard to the opinion of the Economic and Social Committee(3),

Whereas:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EEC) No 2092/91 is hereby amended as follows:

1. Article 1 shall be replaced by the following: "Article 1

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

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

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

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

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

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

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

2. Article 2 shall be replaced by the following: "Article 2

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

- in Spanish: ecológico,

- in Danish: økologisk,

- in German: ökologisch, biologisch,

- in Greek: βιολογικό,

- in English: organic,

- in French: biologique,

- in Italian: biologico,

- in Dutch: biologisch,

- in Portuguese: biológico,

- in Finnish: luonnonmukainen,

- in Swedish: ekologisk.";

3. Article 3 shall be replaced by the following: "Article 3

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

4. The definition "preparation" in Article 4(3) shall be replaced by the following: "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;"

5. The following definitions shall be added to Article 4: "11. 'livestock production' shall mean the production of domestic or domesticated terrestrial animals (including insects) and aquatic species farmed in fresh, salt or brackish water. The products of hunting and fishing of wild animals shall not be considered as organic production;

12. 'genetically modified organism (GMO)' shall mean any organism as defined in Article 2 of Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(5);

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

14. 'use of GMOs and GMO derivatives' shall mean use thereof as foodstuffs, food ingredients (including additives and flavourings), processing aids (including extraction solvents), feedingstuffs, compound feedingstuffs, feed materials, feed additives, processing aids for feedingstuffs, certain products used in animal nutrition (under Directive 82/471/EEC)(6), plant protection products, veterinary medicinal products, fertilisers, soil conditioners, seeds, vegetative reproductive material and livestock;

15. 'veterinary medicinal products' shall mean products as defined in Article 1(2) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(7);

16. 'homeopathic veterinary medicinal products' shall mean products as defined in Article 1(1) of Council Directive 92/74/EEC of 22 September 1992, widening the scope of Directive 81/851/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to veterinary medicinal products and laying down additional provisions on homeopathic veterinary medicinal products(8);

17. 'feedingstuffs' shall mean products as defined in Article 2(a) of Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs(9);

18. 'feed materials' shall mean products as defined in Article 2(a) of Council Directive 96/25/EC of 29 April 1996 on the circulation of feed materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC(10);

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

20. 'feed additives' shall mean products as defined in Article 2(a) of Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs(11);

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

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

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

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

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

6. the following subparagraph shall be added to Article 5(3): "(h) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.";

7. the following paragraph shall be inserted in Article 5: "3a. By way of derogation from paragraphs 1 to 3, trade marks which bear an indication referred to in Article 2, may continue to be used until 1 July 2006 in the labelling and advertising of products which do not comply with this Regulation provided that:

- registration of the trade mark was applied for before 22 July 1991 - and in Finland, Austria, and Sweden before 1 January 1995 - and is in conformity with the First Council Directive 89/104/EEC of 21 December 1988 to approximate the laws of the Member States relating to trade marks(12), and

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

8. the beginning of Article 5(5) shall read as follows: "5. Crop products labelled or advertised in accordance with paragraphs 1 or 3 may bear indications referring to conversion to the organic production method, provided that:";

9. Article 5(5)(d) shall be replaced by the following: "(d) the product contains only one crop ingredient of agricultural origin.";

10. The following subparagraph shall be added to Article 5(5): "(f) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.";

11. The following subparagraph shall be added to Article 5(5a): "(i) the product has been produced without the use of genetically modified organisms and/or any products derived from such organisms.";

12. Article 5(10) shall be replaced by the following: "10. In a product as referred to in Article 1(1), paragraphs (a) and (b), an ingredient obtained according to the rules laid down in Article 6 shall not be present together with the same ingredient not obtained according to those rules.";

13. Article 6(1) shall be replaced by the following: "1. The organic production method implies that for the production of products referred to in Article 1(1)(a) other than seeds and vegetative propagating material:

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

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

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

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

14. Article 6(2) shall be replaced by the following: "2. The organic production method implies that for seeds and vegetative reproductive material, the mother plant in the case of seeds and the parent plant(s) in the case of vegetative propagating material have been produced:

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

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

15. in Article 6(3)(a) and (b) the date "31 December 2000" shall be replaced by "31 December 2003";

16. in Article 6(4) the date 31 December 1999 shall be replaced by 31 December 2002;

17. the introductory sentence of Article 7(1) and subparagraph (a) shall be replaced by the following: "1. Products not authorised at the date of adoption of this Regulation for a purpose indicated in Article 6(1)(b) may be included in Annex II, provided that the following conditions are satisfied:

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

- they are essential for the control of a harmful organism or a particular disease for which other biological, cultural, physical or breeding alternatives are not available, and

- the conditions for their use preclude any direct contact with the seed, the crop, crop products or livestock and livestock products; however, in the case of perennial crops, direct contact may take place, but only outside the growing season of the edible parts (fruits) provided that such application does not indirectly result in the presence of residues of the product in the edible parts, and

- their use does not result in, or contribute to, unacceptable effects on, or contamination of, the environment;"

18. in Article 7, the following paragraph shall be inserted: "1b. With regard to minerals and trace elements used in animal nutrition, additional sources for these products may be included in Annex II provided that they are of natural origin or failing that, synthetic in the same form as natural products."

19. in Article 9(11) the words "of 26 June 1989" shall be deleted.

20. the following paragraph shall be added to Article 9: "12. (a) For livestock meat production Member States shall ensure, without prejudice to the provisions of Annex III, that the inspections relate to all stages of production, slaughter, cutting and any other preparation up to the sale to the consumer to ensure as far as technically possible the traceability of livestock products through the production, processing and any other preparation chain from the unit of production of the livestock until the unit of final packaging and/or labelling. They shall inform the Commission together with the report on supervision referred to in Article 15, on the measures taken and their follow-up.

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

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

21. in Article 11(6)(a) the date "31 December 2002" shall be replaced by "31 December 2005".

22. the following subparagraph shall be added to Article 12: "However, with regard to the rules referred to in Annex I, part B, concerning livestock production, Member States may apply more stringent rules to livestock and livestock products produced within their territory, provided that these rules are in compliance with Community law and do not prohibit or restrict the marketing of other livestock and livestock products that meet the requirements of this Regulation.";

23. Article 13 shall be replaced by the following: "Article 13

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

- detailed rules for applying this Regulation;

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

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

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

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

24. the following Article shall be added after Article 15: "Article 15a

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

25. Annexes I, II, III and VI shall be amended, and Annexes VII and VIII added, in accordance with the Annex hereto.

Article 2

For the purposes of complying with the conversion periods referred to in Annex I, Sections B and C the period which has elapsed before 24 August 2000 shall be taken into account where the operator can demonstrate to the satisfaction of the inspection authority or body that during that period he was producing in accordance with the national rules in force, or failing that, with private standards accepted or recognised by the Member States.

Article 3

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

It shall apply from 24 August 2000. However, the prohibitions on the use of genetically modified organisms and their derivatives set out in this Regulation, and in particular the provisions of Article 5(3)(h), (5)(f) and (5a)(i) and Article 6(1)(d) and (2)(a) and Annex I, Section B, paragraph 4.18 of Regulation (EEC) No 2092/91, shall apply forthwith.

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

Done at Brussels, 19 July 1999.

For the Council

The President

K. HEMILÄ

(1) OJ C 293, 5.10.1996, p. 23.

(2) OJ C 133, 28.4.1997, p. 29.

(3) OJ C 167, 2.6.1997, p. 55.

(4) OJ L 198, 22.7.1991, p. 1. Regulation as last amended by Commission Regulation (EC) No 330/1999 (OJ L 40, 13.2.1999, p. 23).

(5) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 97/35/EC (OJ L 169, 27.6.1997, p. 72).

(6) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).

(7) OJ 22, 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(8) OJ L 297, 13.10.1992, p. 12.

(9) OJ L 86, 6.4.1979, p. 30. Directive as last amended by Directive 98/87/EC (OJ L 318, 27.11.1998, p. 43).

(10) OJ L 125, 23.5.1996, p. 35. Directive as amended by Directive 98/67/EC (OJ L 261, 24.9.1998, p. 10).

(11) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 45/1999 (OJ L 6, 21.1.1999, p. 3).

(12) OJ L 40, 11.2.1989, p. 1. Directive as amended by Decision 92/10/EEC (OJ L 6, 11.1.1992, p. 35).

ANNEX

I. Annex I is amended as follows: 1. in the section headed "Plants and plant products" , the subparagraph on animals and animal products is deleted;

2. the heading "Plants and plant products" is replaced by "A. Plant and plant products";

3. the following heading and sections are added: "B. LIVESTOCK AND LIVESTOCK PRODUCTS FROM THE FOLLOWING SPECIES: BOVINE (INCLUDING BUBALUS AND BISON SPECIES), PORCINE, OVINE, CAPRINE, EQUIDAE , POULTRY.

1. General principles

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

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

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

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

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

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

1.7. By derogation from this principle, livestock not reared in accordance with the provisions of this Regulation can use, for a limited period of time each year, the pasturage of units complying with this Regulation, provided that such animals come from extensive husbandry (as defined in Article 6(5) of Regulation (EC) No 950/97(1) or, for other species not mentioned in that Regulation, the number of animals per ha corresponding to 170 kg of Nitrogen per year/hectare as defined in Annex VII of this Regulation) and provided that other animals which are subject to the requirements of this Regulation are not present on this pasturage at the same time. This derogation must be authorised beforehand by the inspection authority or body.

1.8. By way of a second derogation from this principle, animals reared in accordance with the provisions of this Regulation may be grazed on common land, providing that:

(a) the land has not been treated with products other than those allowed for in Annex II of this Regulation, for at least three years;

(b) any animals which use the land concerned, which are not subject to the requirements of this Regulation, are derived from extensive production, as defined in Article 6(5) of Regulation (EC) No 950/97; or, for other species not mentioned in that Regulation, the number of animals per ha corresponding to 170 kg of Nitrogen per year/hectare as defined in Annex VII of this Regulation;

(c) any livestock products produced by animals reared in accordance with the provisions of this Regulation, whilst using this land, shall not be regarded as being from organic-production, unless adequate segregation from other animals not complying with the requirements of this Regulation, can be proved to the satisfaction of the inspection authority or body.

2. Conversion

2.1. Conversion of land associated with organic livestock production

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

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

2.2. Conversion of livestock and livestock products

2.2.1. If livestock products are to be sold as organic products, the livestock must be reared according to the rules laid down in this Regulation for at least:

- 12 months in the case of equidae and bovines (including bubalus and bison species) for meat production, and in any case at least three quarters of their lifetime,

- six months in the case of small ruminant and pigs; however, during a transitional period of three years expiring on 24 August 2003, the period for pigs shall be four months,

- six months in the case of animals for milk production; however, during a transitional period of three years expiring on 24 August 2003, the period shall be three months,

- 10 weeks for poultry for meat production, brought in before they are three days old,

- six weeks in the case of poultry for egg production.

2.2.2. By derogation from paragraph 2.2.1 and for the constitution of a herd or flock, calves and small ruminants for meat production can be sold as organically reared during a transitional period expiring 31 December 2003, provided that:

- they come from extensive husbrandry,

- they are reared in the organic-production unit until the time of sale or slaughter, for a minimum period of six months for calves and two months for small ruminants,

- the origin of the animals complies with the conditions expressed in the fourth and fifth indents of paragraph 3.4.

2.3. Simultaneous conversion

2.3.1. By derogation from paragraphs 2.2.1, 4.2 and 4.4 if there is simultaneous conversion of the complete production unit, including livestock, pasturage and/or any land used for animal feed, the total combined conversion period for both livestock, pasturage and/or any land used for animal feed, shall be reduced to 24 months subject to the following conditions:

(a) the derogation applies only to the existing animals and their offspring and at the same time also to the land used for animal feed/pasturage before starting the conversion;

(b) the animals are mainly fed with products from the production unit.

3. Origin of the animals

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

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

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

3.4. By way of a second derogation, when a herd or flock is constituted for the first time and organically reared animals are not available in sufficient numbers, non-organically reared livestock may be brought into an organic livestock production unit, subject to the following conditions:

- pullets for the production of eggs must not be more than 18 weeks old,

- chicks for broiler production must be less than three days old at the time when they leave the production unit where they were produced,

- buffalo must be less than six months old,

- calves and horses must be reared according to the rules of this regulation as soon as they are weaned and in any case they must be less than six months old,

- ewes and goats must be reared according to the rules of this regulation as soon as they are weaned and in any case they must be less than 45 days old,

- piglets must be reared according to the rules of this regulation as soon as they are weaned and they must weigh less than 25 kg.

3.5. This derogation, which must be authorised beforehand by the inspection authority or body, applies for a transitional period expiring on 31 December 2003.

3.6. By way of a third derogation, the renewal or reconstitution of the herd or flock shall be authorised by the control authority or body when organically reared animals are not available, and in the following cases:

(a) high mortality of animals caused by health or catastrophic circumstances;

(b) pullets for egg production no more than 18 weeks old;

(c) poultry for meat production less than three days old, and pigs as soon as they are weaned and they must weigh less than 25 kg.

Cases (b) and (c) are authorised for a transitional period expiring on 31 December 2003.

3.7. In the case of pigs, pullets and poultry for meat production, this transitional derogation will be re-examined before the date of expiry to see if there are grounds for an extension to this deadline.

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

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

3.10. These percentages may be increased, up to 40 % following the opinion and agreement of the inspection authority or body, in the following special cases:

- when a major extension to the stockfarm is undertaken;

- when a breed is changed;

- when a new livestock specialisation is developed.

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

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

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

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

4. Feed

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

4.2. Livestock must be fed on organically produced feedingstuffs.

4.3. Furthermore, livestock must be reared in accordance with the rules set out in this Annex, preferably 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.

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 %.

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 a derogation from paragraph 4.2, for a transitional period expiring on 24 August 2005, the use of a limited proportion of conventional feedingstuffs is authorised where the farmer is unable to obtain feed exclusively from organic production. The maximum percentage of conventional feedingstuffs authorised per year is 10 % in the case of herbivores and 20 % for other species. 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 transhumance period, must be 25 %, calculated as a percentage of the dry matter.

4.9. By derogation from paragraph 4.8, when forage production is lost, in particular as a result of exceptional weather conditions, 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 a derogation is warranted. Upon approval by the competent authority, the inspection authority or body shall apply this derogation to individual operators.

4.10. For poultry, the feed formula used in the fattening stage must contain at least 65 % cereals.

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), 1.6 (binders, anti-caking agents and coagulants), 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 above mentioned categories. Antibiotics, coccidiostatics, medicinal substances, growth promoters or any other substance intended to stimulate growth or production shall not be used in animal feeding.

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

5. Disease prevention and veterinary treatment

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

(a) the selection of appropriate breeds or strains of animals as detailed in Section 3;

(b) the application of animal husbandry practices appropriate to the requirements of each species, encouraging strong resistance to disease and the prevention of infections;

(c) the use of high quality feed, together, with regular exercise and access to pasturage, having the effect of encouraging the natural immunological defence of the animal;

(d) ensuring an appropriate density of livestock, thus avoiding overstocking and any resulting animal health problems.

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

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

5.4. The use of veterinary medicinal products in organic farming shall comply with the following principles:

(a) Phytotherapeutic (e.g. plant extracts (excluding antibiotics), essences, etc.), homeopathic products (e.g. plant, animal or mineral substances) and trace elements and products listed in Part C, section 3 of Annex II, shall be used in preference to chemically-synthesised allopathic veterinary medicinal products or antibiotics, provided that their therapeutic effect is effective for the species of animal, and the condition for which the treatment is intended;

(b) If the use of the above products should not prove, or is unlikely to be, effective in combating illness or injury, and treatment is essential to avoid suffering or distress to the animal, chemically-synthesised allopathic veterinary medicinal products or antibiotics may be used under the responsibility of a veterinarian;

(c) The use of chemically synthesised allopathic veterinary medicinal products or antibiotics for preventive treatments is prohibited;

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

(a) the use of substances to promote growth or production, (including antibiotics, coccidiostatics and other artificial aids for growth promotion purposes) and the use of hormones or similar substances to control reproduction (e.g. induction or synchronisation of oestrus), or for other purposes, is prohibited. Nevertheless, hormones may be administered to an individual animal, as a form of therapeutic veterinary treatment;

(b) veterinary treatments to animals, or treatments to buildings, equipment and facilities, which are compulsory under national or Community legislation shall be authorised, including the use of immunological veterinary medicinal products when a disease has been recognised as present in a specific area in which the production unit is located.

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

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

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

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

6.1. Husbandry practices

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

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

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

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

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

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

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

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

6.1.9. For poultry, the minimum age at slaughter shall be:

81 days for chickens,

150 days for capons,

49 days for Peking ducks,

70 days for female Muscovy ducks,

84 days for male Muscovy ducks,

92 days for Mallard ducks,

94 days for guineafowl,

140 days for turkeys and roasting geese.

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

6.2. Transport

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

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

6.3. Identification of livestock products

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

7. Livestock manure

7.1. The total amount of manure, as defined in Directive 91/676/EEC(2), 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 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. Free range areas and livestock housing

8.1. General principles

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. Stocking densities and the avoidance of over grazing

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. Mammals

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(3) 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(4) 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. Poultry

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:

- at least one third shall be solid, that is, not of slatted or of grid construction, and covered with a litter material such as straw, wood shavings, sand or turf;

- in poultry houses for laying hens, a sufficiently large part of the floor area available to the hens must be available for the collection of bird droppings;

- they must have perches of a size and number commensurate with the size of the group and of the birds as laid down in Annex VIII;

- they must have exit/entry pop-holes of a size adequate for the birds, and these pop-holes must have a combined length of at least 4 m per 100 m2 area of the house available to the birds;

- each poultry house must not contain more than:

4800 chickens,

3000 laying hens,

5200 guinea fowl,

4000 female Muscovy or Peking ducks or 3200 male Muscovy or Peking ducks or other ducks,

2500 capons, geese or turkeys;

- the total usable area of poultry houses for meat production on any single production unit, must not exceed 1600 m2.

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. General derogation on the housing of livestock

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.

C. BEEKEEPING AND BEEKEEPING PRODUCTS

1. General principles

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. Conversion period

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. Origin of the bees

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. Siting of the apiaries

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:

(a) ensure enough natural nectar, honeydew and pollen sources for bees and access to water;

(b) be such that, within a radius of 3 km from the apiary site, nectar and pollen sources consist essentially of organically produced crops and/or spontaneous vegetation, according to the requirements of Article 6 and Annex I of this Regulation, and crops not subject to the provisions of this Regulation but treated with low environmental impact methods such as, for example, those described in programs developed under Regulation (EEC) No 2078/92(5) which cannot significantly affect the qualification of beekeeping production as being organic;

(c) maintain enough distance from any non-agricultural production sources possibly leading to contamination, for example: urban centres, motorways, industrial areas, waste dumps, waste incinerators, etc. The inspection authorities or bodies shall establish measures to ensure this requirement.

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

5. Feed

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. Disease prevention and veterinary treatments

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

(a) the selection of appropriate hardy breeds;

(b) the application of certain practices encouraging strong resistance to disease and the prevention of infections, such as: regular renewal of queen bees, systematic inspection of hives to detect any health anomalies, control of male broods in the hives, disinfecting of materials and equipment at regular intervals, destruction of contaminated material or sources, regular renewal of beeswax and sufficient reserves of pollen and honey in hives.

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:

(a) they can be used in so far as the corresponding use is authorised in the Member State in accordance with the relevant Community provisions or national provisions in conformity with Community law;

(b) phytotherapeutic and homeopathic products shall be used in preference to allopathic products chemically synthesised, provided that their therapeutic effect is effective for the condition for which the treatment is intended;

(c) if the use of the abovementioned products should prove or is unlikely to be effective to eradicate a disease or infestation which risks destroying colonies, allopathic chemically synthesised medicinal products may be used under the responsibility of a veterinarian, or other persons authorised by the Member State, without prejudice to the principles laid down in paragraphs (a) and (b) above;

(d) the use of allopathic chemically synthesised medicinal products for preventive treatments is prohibited;

(e) without prejudice to the principle in (a) above formic acid, lactic acid, acetic acid and oxalic acid and the following substances: menthol, thymol, eucalyptol or camphor can be used in cases of infestation with Varroa jacobsoni.

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. Husbandry management practices and identification

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. Characteristics of hives and materials used in beekeeping

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."

II. Annex II is amended as follows: 1. The title of Part B is replaced by the following: "B. PESTICIDES

1. Products for plant protection."

2. The following is inserted after Part B, Section 1 : "2. Products for pest and disease control in livestock buildings and installations:

Products listed in Section 1

Rodenticides"

3. Part C "Other products" is replaced by the following: "C. FEED MATERIALS

1. Feed materials from plant origin

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

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

1.2. Oil seeds, oil fruits, their products and by-products. 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 seed and expeller; palm kernels as expeller; turnip rape seed as expeller and hulls; pumpkin seed as expeller; olive pulp (from physical extraction of olives).

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

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

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

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

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

Carob pods, citrus pulp, apple pomace, tomato pulp, and grape pulp.

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

Molasses as a binding agent in compound feedingstuffs 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.

2. Feed materials from animal origin

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

Raw milks as defined in Article 2 of Directive 92/46/EEC(6), 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 and lactose powder.

2.2. Fish, other marine animals, their products and by-products. 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.

3. Feed materials from mineral origin

The following substances are included in this category:

Sodium:

unrefined sea salt

coarse rock salt

sodium sulphate

sodium carbonate

sodium bicarbonate

sodium chloride

Calcium:

lithotamnion and maerl

Shells of aquatic animals (including cuttlefish bones)

calcium carbonate

calcium lactate

calcium gluconate

Phosphorus:

bone dicalcium phosphate precipitate

defluorinated dicalcium phosphate

defluorinated monocalcium phosphate

Magnesium:

anhydrous magnesia

magnesium sulphate

magnesium chloride

magnesium carbonate

Sulphur:

sodium sulphate"

4. The following Parts are added: "D. FEED ADDITIVES, CERTAIN SUBSTANCES USED IN ANIMAL NUTRITION (DIRECTIVE 82/471/EEC) AND PROCESSING AIDS USED IN FEEDINGSTUFFS

1. Feed additives

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

>TABLE>

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

Vitamins authorised under Directive 70/524/EEC(7):

- preferably derived from raw materials occurring naturally in feedingstuffs, or

- synthetic vitamins identical to natural vitamins only for monogastric animals.

1.3. Enzymes. The following substances are included in this category:

Enzymes authorised under Directive 70/524/EEC.

1.4. Micro-organisms. The following micro-organisms are included in this category:

micro-organisms authorised under Directive 70/524/EEC.

1.5. Preservatives. The following substances are included in this category:

E 236 Formic acid only for silage

E 260 Acetic acid only for silage

E 270 Lactic acid only for silage

E 280 Propionic acid only for silage

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

E 551b Colloidal silica

E 551c Kieselgur

E 553 Sepiolite

E 558 Bentonite

E 559 Kaolinitic clays

E 561 Vermiculite

E 599 Perlite

2. Certain products used in animal nutrition

The following products are included in this category:

-

3. Processing aids used in feedingstuffs

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

Sea salt, coarse rock salt, enzymes, yeasts, whey, sugar, sugar beet pulp, cereal flour, molasses and lactic, acetic, formic, and propionic bacteria.

When weather conditions do not allow for adequate fermentation, the inspection authority or body may authorise the use of lactic, formic, propionic and acetic acids in the production of silage.

E. PRODUCTS AUTHORISED FOR CLEANING AND DISINFECTION OF LIVESTOCK BUILDINGS AND INSTALLATIONS (E.G. EQUIPMENT AND UTENSILS)

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

F. OTHER PRODUCTS"

III. Annex III is amended as follows: 1. The heading of Part A is replaced by "A.1 Plants and plant products from farm production or collection".

2. The following section is inserted: "A.2. Livestock and livestock products produced by animal husbandry

1. When the inspection system applying specifically to livestock production is first implemented, the producer and the inspection body must draw up:

- a full description of the livestock buildings, pasturages 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 such manure agreed with the inspection body or inspection authority, together with a full description of the areas given over to crop production,

- where appropriate, the arrangements laid down by contract with other farms as regards the spreading of manure,

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

- all practical measures to be taken on the livestock farm to ensure compliance with this Regulation.

The description and the measures concerned are to be set out in an inspection report countersigned by the producer concerned.

In addition, the report must specify an undertaking by the producer to carry out operations in accordance with Articles 5 and 6 and to accept, in the event of infringement, enforcement of the measures referred to in Article 9(9) and, where relevant, in Article 10(3).

2. The general requirements on inspection in points 1 and 4 to 8 of Part A.1 covering crops and crop products are applicable to livestock and livestock products.

By way of a derogation from those rules, the storage of allopathic veterinary medicinal products and antibiotics is permitted on holdings provided that they have been prescribed by a veterinarian in connection with treatment as referred to in Annex I, that they are stored in a supervised location and that they are entered in the farm register.

3. The livestock must be identified permanently using techniques adapted to each species, individually in the case of large mammals and individually or by batch in the case of poultry and small mammals.

4. Livestock records must be compiled in the form of a register and kept available to the inspection authorities or bodies at all times at the address of the holding.

Such records, which are to provide a full description of the herd or flock management system, must contain the following information:

- 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 head, 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.

5. Where a producer manages several livestock holdings in the same region, the units which produce livestock or livestock products not covered by Article 1 will also be subject to the inspection system as regards the first, second and third indents of point 1 of this section on livestock and livestock products and as regards the provisions on livestock management, livestock records and the principles governing storage of animal husbandry products used."

3. The title of Part B is replaced by: "B. Units for preparation of plant and livestock products and foodstuffs composed of plant and livestock products."

4. The title of Part C is replaced by: "C. Importers of plant products, livestock products and foodstuffs composed of plant and/or livestock products from third countries."

IV. In Annex VI , the following paragraph is introduced after the first paragraph entitled "General principles" : "Pending the adoption of rules in Sections A and B of this Annex, and in order to cover specifically the preparation of foodstuffs composed of one or more livestock products, national rules shall apply".

V. The following Annexes are added:

"ANNEX VII

>TABLE>

ANNEX VIII

Minimum surface areas indoors and outdoors and other characteristics of housing in the different species and types of production

1. BOVINES, OVINE AND PIGS

>TABLE>

2. POULTRY

>TABLE>"

(1) OJ L 142, 2.6.1997, p. 1. Regulation as amended by Regulation (EC) No 2331/98 (OJ L 291, 30.10.1998, p. 10).

(2) OJ L 375, 31.12.1991, p. 1.

(3) OJ L 340, 11.12.1991, p. 28. Directive as last amended by Directive 97/2/EC (OJ L 25, 28.1.1997, p. 24).

(4) OJ L 340, 11.12.1991, p. 33.

(5) OJ L 215, 30.7.1992, p. 85. Regulation as last amended by Regulation (EC) No 2772/95 (OJ L 288, 1.12.1995, p. 35).

(6) OJ L 268, 14.9.1992, p. 1. Directive as last amended by Directive 94/71/EC (OJ L 368, 31.12.1994, p. 33).

(7) OJ L 270, 14.12.1970, p. 1. Directive as last amended by Directive 98/19/EC (OJ L 96, 28.3.1998, p. 39).