TITLE IIIPRODUCTION RULES

CHAPTER 2Farm production

Article 11General farm production rules

The entire agricultural holding shall be managed in compliance with the requirements applicable to organic production.

However, in accordance with specific conditions to be laid down in accordance with the procedure referred to in Article 37(2), a holding may be split up into clearly separated units or aquaculture production sites which are not all managed under organic production. As regards animals, different species shall be involved. As regards aquaculture the same species may be involved, provided that there is adequate separation between the production sites. As regards plants, different varieties that can be easily differentiated shall be involved.

Where, in accordance with the second subparagraph, not all units of a holding are used for organic production, the operator shall keep the land, animals, and products used for, or produced by, the organic units separate from those used for, or produced by, the non-organic units and keep adequate records to show the separation.

Article 12Plant production rules

1.

In addition to the general farm production rules laid down in Article 11, the following rules shall apply to organic plant production:

(a)

organic plant production shall use tillage and cultivation practices that maintain or increase soil organic matter, enhance soil stability and soil biodiversity, and prevent soil compaction and soil erosion;

(b)

the fertility and biological activity of the soil shall be maintained and increased by multiannual crop rotation including legumes and other green manure crops, and by the application of livestock manure or organic material, both preferably composted, from organic production;

(c)

the use of biodynamic preparations is allowed;

(d)

in addition, fertilisers and soil conditioners may only be used if they have been authorised for use in organic production under Article 16;

(e)

mineral nitrogen fertilisers shall not be used;

(f)

all plant production techniques used shall prevent or minimise any contribution to the contamination of the environment;

(g)

the prevention of damage caused by pests, diseases and weeds shall rely primarily on the protection by natural enemies, the choice of species and varieties, crop rotation, cultivation techniques and thermal processes;

(h)

in the case of an established threat to a crop, plant protection products may only be used if they have been authorised for use in organic production under Article 16;

(i)

for the production of products other than seed and vegetative propagating material only organically produced seed and propagating material shall be used. To this end, the mother plant in the case of seeds and the parent plant in the case of vegetative propagating material shall have been produced in accordance with the rules laid down in this Regulation for at least one generation, or, in the case of perennial crops, two growing seasons;

(j)

products for cleaning and disinfection in plant production shall be used only if they have been authorised for use in organic production under Article 16.

2.

The collection of wild plants and parts thereof, growing naturally in natural areas, forests and agricultural areas is considered an organic production method provided that:

(a)

those areas have not, for a period of at least three years before the collection, received treatment with products other than those authorised for use in organic production under Article 16;

(b)

the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area.

3.

The measures necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 13Production rules for seaweed

1.

The collection of wild seaweeds and parts thereof, growing naturally in the sea, is considered as an organic production method provided that:

(a)

the growing areas are of high ecological quality as defined by Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy15 and, pending its implementation, of a quality equivalent to designated waters under Directive 2006/113/EC of the European Parliament and of the Council of 12 December 2006 on the quality required of shellfish waters16, and are not unsuitable from a health point of view. Pending more detailed rules to be introduced in implementing legislation, wild edible seaweeds shall not be collected in areas which would not meet the criteria for Class A or Class B areas as defined in Annex II of Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption17;

(b)

the collection does not affect the long term stability of the natural habitat or the maintenance of the species in the collection area.

2.

The farming of seaweeds shall take place in coastal areas with environmental and health characteristics at least equivalent to those outlined in paragraph 1 in order to be considered organic. In addition to this:

(a)

sustainable practices shall be used in all stages of production, from collection of juvenile seaweed to harvesting;

(b)

to ensure that a wide gene-pool is maintained, the collection of juvenile seaweed in the wild should take place on a regular basis to supplement indoor culture stock;

(c)

fertilisers shall not be used except in indoor facilities and only if they have been authorised for use in organic production for this purpose under Article 16.

3.

The measures necessary for the implementation of production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 14Livestock production rules

1.

In addition to the general farm production rules laid down in Article 11, the following rules shall apply to livestock production:

(a)

with regard to the origin of the animals:

  1. (i)

    organic livestock shall be born and raised on organic holdings;

  2. (ii)

    for breeding purposes, non-organically raised animals may be brought onto a holding under specific conditions. Such animals and their products may be deemed organic after compliance with the conversion period referred to in Article 17(1)(c);

  3. (iii)

    animals existing on the holding at the beginning of the conversion period and their products may be deemed organic after compliance with the conversion period referred to in Article 17(1)(c);

(b)

with regard to husbandry practices and housing conditions:

  1. (i)

    personnel keeping animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals;

  2. (ii)

    husbandry practices, including stocking densities, and housing conditions shall ensure that the developmental, physiological and ethological needs of animals are met;

  3. (iii)

    the livestock shall have permanent access to open air areas, preferably pasture, whenever weather conditions and the state of the ground allow this unless restrictions and obligations related to the protection of human and animal health are imposed on the basis of Community legislation;

  4. (iv)

    the number of livestock shall be limited with a view to minimising overgrazing, poaching of soil, erosion, or pollution caused by animals or by the spreading of their manure;

  5. (v)

    organic livestock shall be kept separate from other livestock. However, grazing of common land by organic animals and of organic land by non-organic animals is permitted under certain restrictive conditions;

  6. (vi)

    tethering or isolation of livestock shall be prohibited, unless for individual animals for a limited period of time, and in so far as this is justified for safety, welfare or veterinary reasons;

  7. (vii)

    duration of transport of livestock shall be minimised;

  8. (viii)

    any suffering, including mutilation, shall be kept to a minimum during the entire life of the animal, including at the time of slaughter;

  9. (ix)

    apiaries shall be placed in areas which ensure nectar and pollen sources consisting essentially of organically produced crops or, as appropriate, of spontaneous vegetation or non-organically managed forests or crops that are only treated with low environmental impact methods. Apiaries shall be kept at sufficient distance from sources that may lead to the contamination of beekeeping products or to the poor health of the bees;

  10. (x)

    hives and materials used in beekeeping shall be mainly made of natural materials;

  11. (xi)

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

(c)

with regard to breeding:

  1. (i)

    reproduction shall use natural methods. Artificial insemination is however allowed;

  2. (ii)

    reproduction shall not be induced by treatment with hormones or similar substances, unless as a form of veterinary therapeutic treatment in case of an individual animal;

  3. (iii)

    other forms of artificial reproduction, such as cloning and embryo transfer, shall not be used;

  4. (iv)

    appropriate breeds shall be chosen. The choice of breeds shall also contribute to the prevention of any suffering and to avoiding the need for the mutilation of animals;

(d)

with regard to feed:

  1. (i)

    primarily obtaining feed for livestock from the holding where the animals are kept or from other organic holdings in the same region;

  2. (ii)

    livestock shall be fed with organic feed that meets the animal's nutritional requirements at the various stages of its development. A part of the ration may contain feed from holdings which are in conversion to organic farming;

  3. (iii)

    with the exception of bees, livestock shall have permanent access to pasture or roughage;

  4. (iv)

    non organic feed materials from plant origin, feed materials from animal and mineral origin, feed additives, certain products used in animal nutrition and processing aids shall be used only if they have been authorised for use in organic production under Article 16;

  5. (v)

    growth promoters and synthetic amino-acids shall not be used;

  6. (vi)

    suckling mammals shall be fed with natural, preferably maternal, milk;

(e)

with regard to disease prevention and veterinary treatment:

  1. (i)

    disease prevention shall be based on breed and strain selection, husbandry management practices, high quality feed and exercise, appropriate stocking density and adequate and appropriate housing maintained in hygienic conditions;

  2. (ii)

    disease shall be treated immediately to avoid suffering to the animal; chemically synthesised allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In particular restrictions with respect to courses of treatment and withdrawal periods shall be defined;

  3. (iii)

    the use of immunological veterinary medicines is allowed;

  4. (iv)

    treatments related to the protection of human and animal health imposed on the basis of Community legislation shall be allowed;

(f)

with regard to cleaning and disinfection, products for cleaning and disinfection in livestock buildings and installations, shall be used only if they have been authorised for use in organic production under Article 16.

2.

The measures and conditions necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 15Production rules for aquaculture animals

1.

In addition to the general farm production rules laid down in Article 11, the following rules shall apply to aquaculture animal production:

(a)

with regard to the origin of the aquaculture animals:

  1. (i)

    organic aquaculture shall be based on the rearing of young stock originating from organic broodstock and organic holdings;

  2. (ii)

    when young stock from organic broodstock or holdings are not available, non-organically produced animals may be brought onto a holding under specific conditions;

(b)

with regard to husbandry practices:

  1. (i)

    personnel keeping animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals;

  2. (ii)

    husbandry practices, including feeding, design of installations, stocking densities and water quality shall ensure that the developmental, physiological and behavioural needs of animals are met;

  3. (iii)

    husbandry practices shall minimise negative environmental impact from the holding, including the escape of farmed stock;

  4. (iv)

    organic animals shall be kept separate from other aquaculture animals;

  5. (v)

    transport shall ensure that the welfare of animals is maintained;

  6. (vi)

    any suffering of the animals including the time of slaughtering shall be kept to a minimum;

(c)

with regard to breeding:

  1. (i)

    artificial induction of polyploidy, artificial hybridisation, cloning and production of monosex strains, except by hand sorting, shall not be used;

  2. (ii)

    the appropriate strains shall be chosen;

  3. (iii)

    species-specific conditions for broodstock management, breeding and juvenile production shall be established;

(d)

with regard to feed for fish and crustaceans:

  1. (i)

    animals shall be fed with feed that meets the animal's nutritional requirements at the various stages of its development;

  2. (ii)

    the plant fraction of feed shall originate from organic production and the feed fraction derived from aquatic animals shall originate from sustainable exploitation of fisheries;

  3. (iii)

    in the case of non-organic feed materials from plant origin, feed materials from animal and mineral origin, feed additives, certain products used in animal nutrition and processing aids shall be used only if they have been authorised for use in organic production under Article 16;

  4. (iv)

    growth promoters and synthetic amino-acids shall not be used;

(e)

with regard to bivalve molluscs and other species which are not fed by man but feed on natural plankton:

  1. (i)

    such filter-feeding animals shall receive all their nutritional requirements from nature except in the case of juveniles reared in hatcheries and nurseries;

  2. (ii)

    they shall be grown in waters which meet the criteria for Class A or Class B areas as defined in Annex II of Regulation (EC) No 854/2004;

  3. (iii)

    the growing areas shall be of high ecological quality as defined by Directive 2000/60/EC and, pending its implementation of a quality equivalent to designated waters under Directive 2006/113/EC;

(f)

with regard to disease prevention and veterinary treatment:

  1. (i)

    disease prevention shall be based on keeping the animals in optimal conditions by appropriate siting, optimal design of the holdings, the application of good husbandry and management practices, including regular cleaning and disinfection of premises, high quality feed, appropriate stocking density, and breed and strain selection;

  2. (ii)

    disease shall be treated immediately to avoid suffering to the animal; chemically synthesised allopathic veterinary medicinal products including antibiotics may be used where necessary and under strict conditions, when the use of phytotherapeutic, homeopathic and other products is inappropriate. In particular restrictions with respect to courses of treatment and withdrawal periods shall be defined;

  3. (iii)

    the use of immunological veterinary medicines is allowed;

  4. (iv)

    treatments related to the protection of human and animal health imposed on the basis of Community legislation shall be allowed.

(g)

With regard to cleaning and disinfection, products for cleaning and disinfection in ponds, cages, buildings and installations, shall be used only if they have been authorised for use in organic production under Article 16.

2.

The measures and conditions necessary for the implementation of the production rules contained in this Article shall be adopted in accordance with the procedure referred to in Article 37(2).

Article 16Products and substances used in farming and criteria for their authorisation

1.

The Commission shall, in accordance with the procedure referred to in Article 37(2), authorise for use in organic production and include in a restricted list the products and substances, which may be used in organic farming for the following purposes:

(a)

as plant protection products;

(b)

as fertilisers and soil conditioners;

(c)

as non-organic feed materials from plant origin, feed material from animal and mineral origin and certain substances used in animal nutrition;

(d)

as feed additives and processing aids;

(e)

as products for cleaning and disinfection of ponds, cages, buildings and installations for animal production;

(f)

as products for cleaning and disinfection of buildings and installations used for plant production, including storage on an agricultural holding.

Products and substances contained in the restricted list may only be used 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.

2.

The authorisation of the products and substances referred to in paragraph 1 is subject to the objectives and principles laid down in Title II and the following general and specific criteria which shall be evaluated as a whole:

(a)

their use is necessary for sustained production and essential for its intended use;

(b)

all products and substances shall be of plant, animal, microbial or mineral origin except where products or substances from such sources are not available in sufficient quantities or qualities or if alternatives are not available;

(c)

in the case of products referred to in paragraph 1(a), the following shall apply:

  1. (i)

    their use is essential for the control of a harmful organism or a particular disease for which other biological, physical or breeding alternatives or cultivation practices or other effective management practices are not available;

  2. (ii)

    if products are not of plant, animal, microbial or mineral origin and are not identical to their natural form, they may be authorised only if their conditions for use preclude any direct contact with the edible parts of the crop;

(d)

in the case of products referred to in paragraph 1(b), their use is essential for obtaining or maintaining the fertility of the soil or to fulfil specific nutrition requirements of crops, or specific soil-conditioning purposes;

(e)

in the case of products referred to in paragraph 1(c) and (d), the following shall apply:

  1. (i)

    they are necessary to maintain animal health, animal welfare and vitality and contribute to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or it would be impossible to produce or preserve such feed without having recourse to such substances;

  2. (ii)

    feed of mineral origin, trace elements, vitamins or provitamins shall be of natural origin. In case these substances are unavailable, chemically well-defined analogic substances may be authorised for use in organic production.

3.

(a)

The Commission may, in accordance with the procedure referred to in Article 37(2), lay down conditions and limits as regards the agricultural products to which the products and substances referred to in paragraph 1 can be applied to, the application method, the dosage, the time limits for use and the contact with agricultural products and, if necessary, decide on the withdrawal of these products and substances.

(b)

Where a Member State considers that a product or substance should be added to, or withdrawn from the list referred to in paragraph 1, or that the specifications of use mentioned in subparagraph (a) should be amended, the Member State shall ensure that a dossier giving the reasons for the inclusion, withdrawal or amendments is sent officially to the Commission and to the Member States.

Requests for amendment or withdrawal, as well as decisions thereon, shall be published.

(c)

Products and substances used before adoption of this Regulation for purposes corresponding to those laid down in paragraph 1 of this Article, may continue to be used after said adoption. The Commission may in any case withdraw such products or substances in accordance with Article 37(2).

4.

Member States may regulate, within their territory, the use of products and substances in organic farming for purposes different than those mentioned in paragraph 1 provided their use is subject to objectives and principles laid down in Title II and the general and specific criteria set out in paragraph 2, and in so far as it respects Community law. The Member State concerned shall inform other Member States and the Commission of such national rules.

5.

The use of products and substances not covered under paragraph 1 and 4, and subject to the objectives and principles laid down in Title II and the general criteria in this Article, shall be allowed in organic farming.

Article 17Conversion

1.

The following rules shall apply to a farm on which organic production is started:

(a)

the conversion period shall start at the earliest when the operator has notified his activity to the competent authorities and subjected his holding to the control system in accordance with Article 28(1);

(b)

during the conversion period all rules established by this Regulation shall apply;

(c)

conversion periods specific to the type of crop or animal production shall be defined;

(d)

on a holding or unit partly under organic production and partly in conversion to organic production, the operator shall keep the organically produced and in-conversion products separate and the animals separate or readily separable and keep adequate records to show the separation;

(e)

in order to determine the conversion period referred to above, a period immediately preceding the date of the start of the conversion period, may be taken into account, in so far as certain conditions concur;

(f)

animals and animal products produced during the conversion period referred to in subparagraph (c) shall not be marketed with the indications referred to in Articles 23 and 24 used in the labelling and advertising of products.

2.

The measures and conditions necessary for the implementation of the rules contained in this Article, and in particular the periods referred to in paragraph 1(c) to (f) shall be defined in accordance with the procedure referred to in Article 37(2).