02008R0889 — EN — 12.11.2018 — 016.001

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Amended by:









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COMMISSION REGULATION (EC) No 889/2008

of 5 September 2008

laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control







Content Title I Introductory provisions Title II Rules on production, preservation, processing, packaging, transport and storage of organic products Chapter 1 Plant production Chapter 1a Seaweed production Chapter 2 Livestock production Section 1 Origin of animals Section 2 Livestock housing and husbandry practices Section 3 Feed Section 4 Disease prevention and veterinary treatment Chapter 2a Aquaculture animal production Section 1 General rules Section 2 Origin of aquaculture animals Section 3 Aquaculture Husbandry practices Section 4 Breeding Section 5 Feed for fish, crustaceans and echinodermes Section 6 Specific rules for molluscs Section 7 Disease prevention and veterinary treatment Chapter 3 Preserved and processed products Chapter 3a Specific rules for the making of wine Chapter 4 Collection, packaging, transport, storage of products Chapter 5 Conversion rules Chapter 6 Exceptional production rules Section 1 Climatic, geographical or structural constraints Section 2 Non-availability of organic farm input Section 3 Specific management problems in organic livestock Section 3a Exceptional production rules with regard to the use of specific products and substances in the processing in accordance with Article 22(2)(e) of Regulation (EC) No 834/2007 Section 4 Catastrophic circumstances Chapter 7 Seed data base Title III Labelling Chapter 1 Organic production logo of the European Union Chapter 2 Specific labelling requirements for feed Chapter 3 Other specific labelling requirements Title IV Controls Chapter 1 Minimum control requirements Chapter 2 Control requirements for plants and plant products Chapter 2a Specific control requirements for seaweed Chapter 3 Control requirements for livestock and livestock products Chapter 3a Specific control requirements for aquaculture animal production Chapter 4 Control requirements for units for preparation of plant, seaweed, livestock and aquaculture animal products and foodstuffs composed thereof Chapter 5 Control requirements for imports of organic products from third countries Chapter 6 Control requirements for units using contracts to third parties Chapter 7 Control requirements for units preparing feed Chapter 8 Infringements and exchange of information Chapter 9 Supervision by competent authorities Title V Transmission of information to the Commission, transitional and final provisions Chapter 1 Transmission of information to the Commission Chapter 2 Transitional and final provisions







TITLE I

INTRODUCTORY PROVISIONS

Article 1

Subject matter and scope

1. This Regulation lays down specific rules on organic production, labelling and control in respect of products referred to in Article 1(2) of Regulation (EC) No 834/2007.

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2. This Regulation shall not apply to:

(a) livestock species other than those referred to in Article 7; and

(b) to aquaculture animals other than those referred to in Article 25a.

However, Title II, Title III and Title IV shall apply mutatis mutandis to such products until detailed production rules for those products are laid down on the basis of Regulation (EC) No 834/2007.

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Article 2

Definitions

In addition to the definitions laid down in Article 2 of Regulation (EC) No 834/2007, the following definitions shall apply for the purposes of this Regulation:

(a) ‘non-organic’: means not coming from or not related to a production in accordance to Regulation (EC) No 834/2007 and this Regulation;

(b) ‘veterinary medicinal products’: means products as defined in Article 1(2) of Directive 2001/82/EC of the European Parliament and of the Council ( 1 ) concerning the Community code relating to veterinary medicinal products;

(c) ‘importer’: means the natural or legal person within the community who presents a consignment for release for free circulation into the Community, either in person, or through a representative;

(d) ‘first consignee’ means the natural or legal person to whom the imported consignment is delivered and who will receive it for further preparation and/or marketing;

(e) ‘holding’ means all the production units operated under a single management for the purpose of producing agricultural products;

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(f) ‘production unit’ means all assets to be used for a production sector such as production premises, land parcels, pasturages, open air areas, livestock buildings, fish ponds, containment systems for seaweed or aquaculture animals, shore or seabed concessions, the premises for the storage of crops, crop products, seaweed products, animal products, raw materials and any other input relevant for this specific production sector;

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(g) ‘hydroponic production’ means the method of growing plants with their roots in a mineral nutrient solution only or in an inert medium, such as perlite, gravel or mineral wool to which a nutrient solution is added;

(h) ‘veterinary treatment’ means all courses of a curative or preventive treatment against one occurrence of a specific disease;

(i) ‘in-conversion feedingstuffs’ means feedingstuffs produced during the conversion period to organic production, with the exclusion of those harvested in the 12 months following the beginning of the conversion as referred to in Article 17(1)(a) of Regulation (EC) No 834/2007;

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(j) ‘closed recirculation aquaculture facility’ means a facility where aquaculture takes place within an enclosed environment on land or on a vessel involving the recirculation of water, and depending on permanent external energy input to stabilize the environment for the aquaculture animals;

(k) ‘energy from renewable sources’ means renewable non-fossil energy sources: wind, solar, geothermal, wave, tidal, hydropower, landfill gas, sewage treatment plant gas and biogases;

(l) ‘hatchery’ means a place of breeding, hatching and rearing through the early life stages of aquaculture animals, finfish and shellfish in particular;

(m) ‘nursery’ means a place where an intermediate farming system, between the hatchery and grow-out stages is applied. The nursery stage is completed within the first third of the production cycle with the exception of species undergoing a smoltification process;

(n) ‘pollution’ in the framework of aquaculture and seaweed production means the direct or indirect introduction into the aquatic environment of substances or energy as defined in Directive 2008/56/EC of the European Parliament and of the Council ( 2 ) and in Directive 2000/60/EC of the European Parliament and of the Council ( 3 ), in the waters where they respectively apply;

(o) ‘polyculture’ in the framework of aquaculture and seaweed production, means the rearing of two or more species usually from different trophic levels in the same culture unit;

(p) ‘production cycle’ in the framework of aquaculture and seaweed production, means the lifespan of an aquaculture animal or seaweed from the earliest life stage to harvesting;

(q) ‘locally grown species’ in the framework of aquaculture and seaweed production, means those which are neither alien nor locally absent species under Council Regulation (EC) No 708/2007 ( 4 ). Those species listed in Annex IV of Regulation (EC) No 708/2007 may be considered as locally grown species;

(r) ‘stocking density’ in the framework of aquaculture, means the live weight of animals per cubic metre of water at any time during the grow-out phase and in the case of flatfish and shrimp the weight per square metre of surface;

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(s) ‘control file’ means all the information and documents transmitted, for the purposes of the control system, to the competent authorities of the Member State or to control authorities and control bodies by an operator subject to the control system as referred to in Article 28 of Regulation (EC) No 834/2007, including all the relevant information and documents relating to that operator or the activities of that operator held by competent authorities, control authorities and control bodies, with the exception of information or documents that have no bearing on the operation of the control system;

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(t) ‘preserving’ means any action, different from farming and harvesting, that is carried out on products, but which does not qualify as processing as defined in point (u), including all actions referred to in point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 5 ) and excluding packaging or labelling of the product;

(u) ‘processing’ means any action referred to in point (m) of Article 2(1) of Regulation (EC) No 852/2004, including the use of substances referred to in Article 19(2)(b) of Regulation (EC) No 834/2007. Packaging or labelling operations shall not be considered as processing.







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TITLE II

RULES ON PRODUCTION, PRESERVATION, PROCESSING, PACKAGING, TRANSPORT AND STORAGE OF ORGANIC PRODUCTS

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CHAPTER 1

Plant Production

Article 3

Soil management and fertilisation

1. Where the nutritional needs of plants cannot be met by measures provided for in Article 12(1)(a), (b) and (c) of Regulation (EC) No 834/2007, only fertilisers and soil conditioners referred to in Annex I to this Regulation may be used in organic production and only to the extent necessary. Operators shall keep documentary evidence of the need to use the product.

2. The total amount of livestock manure, as defined in Council Directive 91/676/EEC ( 6 ) concerning the protection of waters against pollution caused by nitrates from agricultural sources, applied on the holding may not exceed 170 kg of nitrogen per year/hectare of agricultural area used. This limit shall only apply to the use of farmyard manure, dried farmyard manure and dehydrated poultry manure, composted animal excrements, including poultry manure, composted farmyard manure and liquid animal excrements.

3. Organic-production holdings may establish written cooperation agreements exclusively with other holdings and enterprises which comply with the organic production rules, with the intention of spreading surplus manure from organic production. The maximum limit as referred to in paragraph 2, shall be calculated on the basis of all of the organic-production units involved in such cooperation.

4. Appropriate preparations of micro-organisms may be used to improve the overall condition of the soil or the availability of nutrients in the soil or in the crops.

5. For compost activation appropriate plant-based preparations or preparations of micro-organisms may be used.

Article 4

Prohibition of hydroponic production

Hydroponic production is prohibited.

Article 5

Pest, disease and weed management

1. Where plants cannot be adequately protected from pests and diseases by measures provided for in Article 12 (1)(a), (b), (c) and (g) of Regulation (EC) No 834/2007, only products referred to in Annex II to this Regulation may be used in organic production. Operators shall keep documentary evidence of the need to use the product.

2. For products used in traps and dispensers, except pheromone dispensers, the traps and/or dispensers, shall prevent the substances from being released into the environment and prevent contact between the substances and the crops being cultivated. The traps shall be collected after use and disposed off safely.

Article 6

Specific rules on mushroom production

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

(a) farmyard manure and animal excrements:

(i) either from holdings producing according to the organic production method;

(ii) or referred to in Annex I, only when the product referred to in point (i) is not available; and when they do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting;

(b) products of agricultural origin, other than those referred to in point (a), from holdings producing according to organic production method;

(c) peat not chemically treated;

(d) wood, not treated with chemical products after felling;

(e) mineral products referred to in Annex I, water and soil.

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CHAPTER 1a

Seaweed production

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Article 6a

Scope

This Chapter lays down detailed production rules for seaweed.

For the purposes of this Chapter ‘seaweed’ includes multi-cellular marine algae, phytoplankton and micro-algae.

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Article 6b

Suitability of aquatic medium and sustainable management plan

1. Operations shall be situated in locations that are not subject to contamination by products or substances not authorised for organic production, or pollutants that would compromise the organic nature of the products.

2. Organic and non-organic production units shall be separated adequately. Such separation measures shall be based on the natural situation, separate water distribution systems, distances, the tidal flow, the upstream and the downstream location of the organic production unit. Member State authorities may designate locations or areas which they consider to be unsuitable for organic aquaculture or seaweed harvesting and may also set up minimum separation distances between organic and non-organic production units.

Where minimum separation distances are set Member States shall provide this information to operators, other Member States and the Commission.

3. An environmental assessment proportionate to the production unit shall be required for all new operations applying for organic production and producing more than 20 tonnes of aquaculture products per year to ascertain the conditions of the production unit and its immediate environment and likely effects of its operation. The operator shall provide the environmental assessment to the control body or control authority. The content of the environmental assessment shall be based on Annex IV to Council Directive 85/337/EEC ( 7 ). If the unit has already been subject to an equivalent assessment, then its use shall be permitted for this purpose.

4. The operator shall provide a sustainable management plan proportionate to the production unit for aquaculture and seaweed harvesting.

The plan shall be updated annually and shall detail the environmental effects of the operation, the environmental monitoring to be undertaken, and list measures to be taken to minimise negative impacts on the surrounding aquatic and terrestrial environments, including, where applicable, nutrient discharge into the environment per production cycle or per annum. The plan shall record the surveillance and repair of technical equipment.

5. Aquaculture and seaweed business operators shall by preference use renewable energy sources and re-cycle materials and shall draw up as part of the sustainable management plan a waste reduction schedule to be put in place at the commencement of operations. Where possible, the use of residual heat shall be limited to energy from renewable sources.

6. For seaweed harvesting a once-off biomass estimate shall be undertaken at the outset.

Article 6c

Sustainable harvesting of wild seaweed

1. Documentary accounts shall be maintained in the unit or premises and shall enable the operator to identify and the control authority or control body to verify that the harvesters have supplied only wild seaweed produced in accordance with Regulation (EC) No 834/2007.

2. Harvesting shall be carried out in such a way that the amounts harvested do not cause a significant impact on the state of the aquatic environment. Measures shall be taken to ensure that seaweed can regenerate, such as harvest technique, minimum sizes, ages, reproductive cycles or size of remaining seaweed.

3. If seaweed is harvested from a shared or common harvest area, documentary evidence shall be available that the total harvest complies with this Regulation.

4. With respect to Article 73b(2)(b) and (c), these records must provide evidence of sustainable management and of no long-term impact on the harvesting areas.

Article 6d

Seaweed Cultivation

1. Seaweed culture at sea shall only utilise nutrients naturally occurring in the environment, or from organic aquaculture animal production, preferably located nearby as part of a polyculture system.

2. In facilities on land where external nutrient sources are used the nutrient levels in the effluent water shall be verifiably the same, or lower, than the inflowing water. Only nutrients of plant or mineral origin and as listed in Annex I may be used.

3. Culture density or operational intensity shall be recorded and shall maintain the integrity of the aquatic environment by ensuring that the maximum quantity of seaweed which can be supported without negative effects on the environment is not exceeded.

4. Ropes and other equipment used for growing seaweed shall be re-used or recycled where possible.

Article 6e

Antifouling measures and cleaning of production equipment and facilities

1. Bio-fouling organisms shall be removed only by physical means or by hand and where appropriate returned to the sea at a distance from the farm.

2. Cleaning of equipment and facilities shall be carried out by physical or mechanical measures. Where this is not satisfactory only substances as listed in Annex VII, Section 2 may be used.

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CHAPTER 2

Livestock production

Article 7

Scope

This Chapter lays down detailed production rules for the following species: bovine including bubalus and bison, equidae, porcine, ovine, caprine, poultry (species as mentioned in Annex III) and bees.







Section 1

Origin of animals

Article 8

Origin of organic animals

1. In the choice of breeds or strains, account shall 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, such as porcine stress syndrome, PSE Syndrome (pale-soft-exudative), sudden death, spontaneous abortion and difficult births requiring caesarean operations. Preference is to be given to indigenous breeds and strains.

2. For bees, preference shall be given to the use of Apis mellifera and their local ecotypes.

Article 9

Origin of non-organic animals

1. In accordance with Article 14(1)(a)(ii) of Regulation (EC) No 834/2007, non-organic animals may be brought onto a holding for breeding purposes, only when organic animals are not available in sufficient number and subject to the conditions provided for in paragraphs 2 to 5 of this Article.

2. Non-organic young mammals, when a herd or flock is constituted for the first time, shall be reared in accordance with the organic production rules immediately after they are weaned. Moreover, the following restrictions shall apply at the date on which the animals enter the herd:

(a) buffalo, calves and foals shall be less than six months old;

(b) lambs and kids shall be less than 60 days old;

(c) piglets shall weigh less than 35 kg.

3. Non-organic adult male and nulliparous female mammals, for the renewal of a herd or flock, shall be reared subsequently in accordance with the organic production rules. Moreover, the number of female mammals is subject to the following restrictions per year:

(a) up 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, as female animals;

(b) for units with less than 10 equine or bovine animals, or with less than five porcine, ovine or caprine animals any renewal as mentioned above shall be limited to a maximum of one animal per year.

This provision of this paragraph will be reviewed in 2012 with a view to phase it out.

4. The percentages referred to in paragraph 3 may be increased up to 40 %, subject to prior authorisation by the competent authority, in the following special cases:

(a) when a major extension to the farm is undertaken;

(b) when a breed is changed;

(c) when a new livestock specialisation is initiated;

(d) when breeds are in danger of being lost to farming as laid down in Annex IV to Commission Regulation (EC) No 1974/2006 ( 8 ) and in that case animals of those breeds must not necessarily be nulliparous.

5. For the renovation of apiaries, 10 % per year of the queen bees and swarms may be replaced by non-organic queen bees and swarms in 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.







Section 2

Livestock housing and husbandry practices

Article 10

Rules pertaining to housing conditions

1. Insulation, heating and ventilation of the building shall 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 shall permit plentiful natural ventilation and light to enter.

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

3. The stocking density in buildings shall provide for the comfort, the well being and the species-specific needs 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 density shall 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.

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

Article 11

Specific housing conditions and husbandry practices for mammals

1. Livestock housing shall have smooth, but not slippery floors. At least half of the indoor surface area as specified in Annex III shall be solid, that is, not of slatted or of grid construction.

2. The housing shall 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 shall be provided in the rest area. The litter shall comprise straw or other suitable natural material. The litter may be improved and enriched with any mineral product listed in Annex I.

3. Notwithstanding Article 3(3) of Council Directive 91/629/EEC ( 9 ) the housing of calves in individual boxes shall be forbidden after the age of one week.

4. Notwithstanding Article 3(8) of Council Directive 91/630/EEC ( 10 ) sows shall be kept in groups, except in the last stages of pregnancy and during the suckling period.

5. Piglets shall not be kept on flat decks or in piglet cages.

6. Exercise areas shall permit dunging and rooting by porcine animals. For the purposes of rooting different substrates can be used.

Article 12

Specific housing conditions and husbandry practices for poultry

1. Poultry shall not be kept in cages.

2. Water fowl shall have access to a stream, pond, lake or a pool whenever the weather and hygienic conditions permit in order to respect their species-specific needs and animal welfare requirements.

3. Buildings for all poultry shall meet the following conditions:

(a) at least one third of the floor area 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;

(b) in poultry houses for laying hens, a sufficiently large part of the floor area available to the hens shall be available for the collection of bird droppings;

(c) they shall have perches of a size and number commensurate with the size of the group and of the birds as laid down in Annex III;

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

(e) each poultry house shall not contain more than:

(i) 4 800 chickens,

(ii) 3 000 laying hens,

(iii) 5 200 guinea fowl,

(iv) 4 000 female Muscovy or Peking ducks or 3 200 male Muscovy or Peking ducks or other ducks,

(v) 2 500 capons, geese or turkeys;

(f) the total usable area of poultry houses for meat production on any single unit, shall not exceed 1 600 m2;

(g) poultry houses shall be constructed in a manner allowing all birds easy access to open air area.

4. 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.

5. To prevent the use of intensive rearing methods, poultry shall either be reared until they reach a minimum age or else shall come from slow-growing poultry strains. Where slow-growing poultry strains are not used by the operator the following minimum age at slaughter shall be:

(a) 81 days for chickens,

(b) 150 days for capons,

(c) 49 days for Peking ducks,

(d) 70 days for female Muscovy ducks,

(e) 84 days for male Muscovy ducks,

(f) 92 days for Mallard ducks,

(g) 94 days for guinea fowl,

(h) 140 days for male turkeys and roasting geese and

(i) 100 days for female turkeys.

The competent authority shall define the criteria of slow-growing strains or draw up a list thereof and provide this information to operators, other Member States and the Commission.

Article 13

Specific requirements and housing conditions in beekeeping

1. The siting of the apiaries shall 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 and/or crops treated with low environmental impact methods equivalent to those as described in Article 36 of Council Regulation (EC) No 1698/2005 ( 11 ) or in Article 22 of Council Regulation 1257/1999 ( 12 ) which cannot affect the qualification of beekeeping production as being organic. The above mentioned requirements do not apply where flowering is not taking place, or the hives are dormant.

2. The Member States may designate regions or areas where beekeeping complying with organic production rules is not practicable.

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

4. The bees wax for new foundations shall come from organic production units.

5. Without prejudice to Article 25, only natural products such as propolis, wax and plant oils can be used in the hives.

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

7. The use of brood combs is prohibited for honey extraction.

Article 14

Access to open air areas

1. Open air areas may be partially covered.

2. In accordance with Article 14(1)(b)(iii) of Regulation (EC) No 834/2007 herbivores shall have access to pasturage for grazing whenever conditions allow.

3. 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 areas during the winter months may be waived.

4. Notwithstanding paragraph 2, bulls over one year old shall have access to pasturage or an open air area.

5. Poultry shall have access to an open air area for at least one third of their life.

6. Open air areas for poultry shall be mainly covered with vegetation and be provided with protective facilities and permit fowl to have easy access to adequate numbers of drinking and feeding troughs.

7. Where poultry are kept indoors due to restrictions or obligations imposed on the basis of Community legislation, they shall permanently have access to sufficient quantities of roughage and suitable material in order to meet their ethological needs.

Article 15

Stocking density

1. The total stocking density shall be such as not to exceed the limit of 170 kg of nitrogen per year and hectare of agricultural area as referred to in Article 3(2).

2. To determine the appropriate density of livestock referred to above, the competent authority shall set out the livestock units equivalent to the above limit, taking as a guideline, the figures laid down in Annex IV or the relevant national provisions adopted pursuant to Directive 91/676/EEC.

Article 16

Prohibition of landless livestock production

Landless livestock production, by which the operator of the livestock does not manage agricultural land and/or has not established a written cooperation agreement with another operator according to Article 3(3), is prohibited.

Article 17

Simultaneous production of organic and non-organic livestock

1. Non organic livestock 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 organic production rules and a different species is involved.

2. Non-organic livestock may use organic pasturage for a limited period of time each year, provided that such animals come from a farming system as defined in paragraph 3(b) and that organic animals are not present at the same time on that pasture.

3. Organic animals may be grazed on common land, providing that:

(a) the land has not been treated with products not authorised for organic production for at least three years;

(b) any non-organic animals which use the land concerned are derived from a farming system equivalent to those as described in Article 36 of Regulation (EC) No 1698/2005 or in Article 22 of Regulation 1257/1999;

(c) any livestock products from organic animals, whilst using this land, shall not be regarded as being from organic-production, unless adequate segregation from non-organic animals can be proved.

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

5. Operators shall keep documentary evidence of the use of provisions referred to in this Article.

Article 18

Management of animals

1. Operations such as attaching elastic bands to the tails of sheep, tail-docking, cutting of teeth, trimming of beaks and dehorning shall not be carried out routinely in organic farming. However, some of these operations may be authorised by the competent authority for reasons of safety or if they are intended to improve the health, welfare or hygiene of the livestock on a case-by-case basis.

Any suffering to the animals shall be reduced to a minimum by applying adequate anaesthesia and/or analgesia and by carrying out the operation only at the most appropriate age by qualified personnel.

2. Physical castration is allowed in order to maintain the quality of products and traditional production practices but only under the conditions set out in the second subparagraph of paragraph 1.

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

4. Loading and unloading of animals shall be carried out without the use of any type of electrical stimulation to coerce the animals. The use of allopathic tranquillisers, prior to or during transport, is prohibited.







Section 3

Feed

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Article 19

Feed from own holding and other sources

1. In case of herbivores, except during the period each year when the animals are under transhumance subject to Article 17(4), at least 60 % of the feed shall come from the farm unit itself or in case this is not feasible, be produced in cooperation with other organic farms in the same region.

2. In case of pigs and poultry, at least 20 % of the feed shall come from the farm unit itself or in case this is not feasible, be produced in the same region in cooperation with other organic farms or feed business operators.

3. In the case of bees, at the end of the production season hives shall be left with sufficient reserves of honey and pollen to survive the winter.

The feeding of bee colonies shall only be permitted where the survival of the hives is endangered due to climatic conditions. Feeding shall be with organic honey, organic sugar syrups, or organic sugar.

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Article 20

Feed meeting animals' nutritional requirements

1. All young mammals shall be fed on maternal milk in preference to natural milk, for a minimum period of three months for bovines including bubalus and bison species and equidae, 45 days for sheep and goats and 40 days for pigs.

2. Rearing systems for herbivores are to be based on maximum use of grazing pasturage according to the availability of pastures in the different periods of the year. At least 60 % of the dry matter in daily rations of herbivores shall consist of roughage, fresh or dried fodder, or silage. A reduction to 50 % for animals in dairy production for a maximum period of three months in early lactation is allowed.

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

4. The keeping of livestock in conditions, or on a diet, which may encourage anaemia, is prohibited.

5. Fattening practices shall be reversible at any stage of the rearing process. Force-feeding is forbidden.

Article 21

In-conversion feed

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1. Up to 30 % of the feed formula of rations on average may comprise in-conversion feedingstuffs. When the in-conversion feedingstuffs come from a unit of the holding itself, this percentage may be increased to 100 %.

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2. Up to 20 % of the total average amount of feedingstuffs fed to livestock may originate from the grazing or harvesting of permanent pastures, perennial forage parcels or protein crops, sown under organic management on lands in their first year of conversion, provided that they are part of the holding itself and have not been part of an organic production unit of that holding in the last five years. When both in-conversion feedingstuffs and feedingstuffs from parcels in their first year of conversion are being used, the total combined percentage of such feedingstuffs shall not exceed the maximum percentages fixed in paragraph 1.

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3. The figures in paragraph 1 and 2 shall be calculated annually as a percentage of the dry matter of feedingstuffs of plant origin.

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Article 22

Use of certain products and substances in feed

For the purposes of Article 14(1)(d)(iv) of Regulation (EC) No 834/2007 only the following substances may be used in the processing of organic feed and feeding organic animals:

(a) non-organic feed materials of plant or animal origin, or other feed materials that are listed in Section 2 of Annex V, provided that:

(i) they are produced or prepared without chemical solvents; and

(ii) the restrictions laid down in Article 43 or Article 47(c) are complied with;

(b) non-organic spices, herbs, and molasses, provided that:

(i) their organic form is not available;

(ii) they are produced or prepared without chemical solvents; and

(iii) their use is limited to 1 % of the feed ration of a given species, calculated annually as a percentage of the dry matter of feed from agricultural origin;

(c) organic feed materials of animal origin;

(d) feed materials of mineral origin that are listed in Section 1 of Annex V;

(e) products from sustainable fisheries, provided that:

(i) they are produced or prepared without chemical solvents;

(ii) their use is restricted to non-herbivores; and

(iii) the use of fish protein hydrolysate is restricted solely to young animals;

(f) salt as sea salt, coarse rock salt;

(g) feed additives listed in Annex VI.

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Section 4

Disease prevention and veterinary treatment

Article 23

Disease prevention

1. The use of chemically synthesised allopathic veterinary medicinal products or antibiotics for preventive treatment is prohibited, without prejudice to Article 24(3).

2. 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 or for other purposes (e.g. induction or synchronisation of oestrus), is prohibited.

3. Where livestock is obtained from non-organic units, special measures such as screening tests or quarantine periods may apply, depending on local circumstances.

4. Housing, pens, equipment and utensils shall be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Faeces, urine and uneaten or spilt feed shall be removed as often as necessary to minimise smell and to avoid attracting insects or rodents.

For the purpose of Article 14(1)(f) of Regulation (EC) No 834/2007, only products listed in Annex VII may be used for cleaning and disinfection of livestock buildings installations and utensils. Rodenticides (to be used only in traps), and the products listed in Annex II, can be used for the elimination of insects and other pests in buildings and other installations where livestock is kept.

5. Buildings shall be emptied of livestock between each batch of poultry reared. The buildings and fittings shall be cleaned and disinfected during this time. In addition, when the rearing of each batch of poultry has been completed, runs shall be left empty to allow vegetation to grow back. Member States shall establish the period for which runs must be empty. The operator shall keep documentary evidence of the application of this period. These requirements shall not apply where poultry is not reared in batches, is not kept in runs and is free to roam, throughout the day.

Article 24

Veterinary treatment

1. Where despite preventive measures to ensure animal health as laid down in Article 14(1)(e)(i) of Regulation (EC) No 834/2007 animals become sick or injured they shall be treated immediately, if necessary in isolation and in suitable housing.

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2. Phytotherapeutic and homeopathic products, trace elements and products listed in Section 1 of Annex V and in Section 3 of Annex VI shall be used in preference to chemically-synthesised allopathic veterinary treatment or antibiotics, provided that their therapeutic effect is effective for the species of animal, and the condition for which the treatment is intended.

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3. If the use of measures referred to in paragraph 1 and 2 is not effective in combating illness or injury, and if treatment is essential to avoid suffering or distress of the animal, chemically-synthesised allopathic veterinary medicinal products or antibiotics may be used under the responsibility of a veterinarian.

4. With the exception of vaccinations, treatments for parasites and compulsory eradication schemes where an animal or group of animals receive more than three courses of treatments with chemically-synthesised allopathic veterinary medicinal products or antibiotics within 12 months, or more than one course of treatment if their productive lifecycle is less than one year, the livestock concerned, or produce derived from them, may not be sold as organic products, and the livestock shall undergo the conversion periods laid down in Article 38(1).

Records of documented evidence of the occurrence of such circumstances shall be kept for the control body or control authority.

5. 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 as referred to in Article 11 of Directive 2001/82/EC or, in a case in which this period is not specified, 48 hours.

Article 25

Specific rules on disease prevention and veterinary treatment in beekeeping

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1. For the purpose of cleaning and disinfection of frames, hives and combs, sodium hydroxide may be used.

For the purpose of protecting frames, hives and combs, in particular from pests, only rodenticides (to be used only in traps), and appropriate products listed in Annex II, are permitted.

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2. Physical treatments for disinfection of apiaries such as steam or direct flame are permitted.

3. The practice of destroying the male brood is permitted only to isolate the infestation of Varroa destructor.

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

5. Veterinary medicinal products may be used in organic beekeeping 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.

6. Formic acid, lactic acid, acetic acid and oxalic acid as well as menthol, thymol, eucalyptol or camphor may be used in cases of infestation with Varroa destructor.

7. If a treatment is applied with chemically synthesised allopathic products, during such a period, the colonies treated shall be placed in isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping. Subsequently, the conversion period of one year laid down in Article 38(3) will apply to those colonies.

8. The requirements laid down in paragraph 7 shall not apply to products listed in paragraph 6.

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CHAPTER 2a

Aquaculture animal production







Section 1

General rules

Article 25a

Scope

This Chapter lays down detailed production rules for species of fish, crustaceans, echinoderms and molluscs as covered by Annex XIIIa.

It applies mutatis mutandis to zooplankton, micro-crustaceans, rotifers, worms and other aquatic feed animals.

Article 25b

Suitability of aquatic medium and sustainable management plan

1. The provisions of Article 6b(1) to (5) shall apply to this Chapter.

2. Defensive and preventive measures taken against predators under Council Directive 92/43/EEC ( 13 ) and national rules shall be recorded in the sustainable management plan.

3. Verifiable coordination shall take place with the neighbouring operators in drawing up their management plans where applicable.

4. For aquaculture animal production in fishponds, tanks or raceways, farms shall be equipped with either natural-filter beds, settlement ponds, biological filters or mechanical filters to collect waste nutrients or use seaweeds and/or animals (bivalves and algae) which contribute to improving the quality of the effluent. Effluent monitoring shall be carried out at regular intervals where appropriate.

Article 25c

Simultaneous production of organic and non-organic aquaculture animals

1. The competent authority may permit hatcheries and nurseries to rear both organic and non-organic juveniles in the same holding provided there is clear physical separation between the units and a separate water distribution system exists.

2. In case of grow-out production, the competent authority may permit organic and non-organic aquaculture animal production units on the same holding provided Article 6b(2) of this Regulation is complied with and where different production phases and different handling periods of the aquaculture animals are involved.

3. Operators shall keep documentary evidence of the use of provisions referred to in this Article.







Section 2

Origin of aquaculture animals

Article 25d

Origin of organic aquaculture animals

1. Locally grown species shall be used and breeding shall aim to give strains which are more adapted to farming conditions, good health and good utilisation of feed resources. Documentary evidence of their origin and treatment shall be provided for the control body or control authority.

2. Species shall be chosen which can be farmed without causing significant damage to wild stocks.

Article 25e

Origin and management of non-organic aquaculture animals

1. For breeding purposes or for improving genetic stock and when organic aquaculture animals are not available, wild caught or non-organic aquaculture animals may be brought into a holding. Such animals shall be kept under organic management for at least three months before they may be used for breeding.

2. For on-growing purposes and when organic aquaculture juvenile animals are not available non-organic aquaculture juveniles may be brought into a holding. At least the latter two thirds of the duration of the production cycle shall be managed under organic management.

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3. The maximum percentage of non-organic aquaculture juveniles introduced to the farm shall be 80 % by 31 December 2011, 50 % by 31 December 2014 and 0 % by 31 December 2016.

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4. For on-growing purposes the collection of wild aquaculture juveniles is specifically restricted to the following cases:

(a) natural influx of fish or crustacean larvae and juveniles when filling ponds, containment systems and enclosures;

(b) European glass eel, provided that an approved eel management plan is in place for the location and artificial reproduction of eel remains unsolved;

(c) the collection of wild fry of species other than European eel for on-growing in traditional extensive aquaculture farming inside wetlands, such as brackish water ponds, tidal areas and costal lagoons, closed by levees and banks, provided that:

(i) the restocking is in line with management measures approved by the relevant authorities in charge of the management of the fish stocks in question to ensure the sustainable exploitation of the species concerned, and

(ii) the fish are fed exclusively with feed naturally available in the environment.

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Section 3

Aquaculture Husbandry practices

Article 25f

General aquaculture husbandry rules

1. The husbandry environment of the aquaculture animals shall be designed in such a way that, in accordance with their species specific needs, the aquaculture animals shall:

(a) have sufficient space for their wellbeing;

(b) be kept in water of good quality with sufficient oxygen levels, and

(c) be kept in temperature and light conditions in accordance with the requirements of the species and having regard to the geographic location;

(d) in the case of freshwater fish the bottom type shall be as close as possible to natural conditions;

(e) in the case of carp the bottom shall be natural earth.

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2. Stocking density and husbandry practices are set out in Annex XIIIa by species or group of species. In considering the effects of stocking density and husbandry practices on the welfare of farmed fish, the condition of the fish (such as fin damage, other injuries, growth rate, behaviour expressed and overall health) and the water quality shall be monitored.

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3. The design and construction of aquatic containment systems shall provide flow rates and physiochemical parameters that safeguard the animals’ health and welfare and provide for their behavioural needs.

4. Containment systems shall be designed, located and operated to minimize the risk of escape incidents.

5. If fish or crustaceans escape, appropriate action must be taken to reduce the impact on the local ecosystem, including recapture, where appropriate. Documentary evidence shall be maintained.

Article 25g

Specific rules for aquatic containment systems

1. Closed recirculation aquaculture animal production facilities are prohibited, with the exception of hatcheries and nurseries or for the production of species used for organic feed organisms.

2. Rearing units on land shall meet the following conditions:

(a) for flow-through systems it shall be possible to monitor and control the flow rate and water quality of both in-flowing and out-flowing water;

(b) at least five percent of the perimeter (‘land-water interface’) area shall have natural vegetation.

3. Containment systems at sea shall:

(a) be located where water flow, depth and water-body exchange rates are adequate to minimize the impact on the seabed and the surrounding water body;

(b) shall have suitable cage design, construction and maintenance with regard to their exposure to the operating environment.

4. Artificial heating or cooling of water shall only be permitted in hatcheries and nurseries. Natural borehole water may be used to heat or cool water at all stages of production.

Article 25h

Management of aquaculture animals

1. Handling of aquaculture animals shall be minimised, undertaken with the greatest care and proper equipment and protocols used to avoid stress and physical damage associated with handling procedures. Broodstock shall be handled in a manner to minimize physical damage and stress and under anaesthesia where appropriate. Grading operations shall be kept to a minimum and as required to ensure fish welfare.

2. The following restrictions shall apply to the use of artificial light:

(a) for prolonging natural day-length it shall not exceed a maximum that respects the ethological needs, geographical conditions and general health of farmed animals, this maximum shall not exceed 16 hours per day, except for reproductive purposes;

(b) Abrupt changes in light intensity shall be avoided at the changeover time by the use of dimmable lights or background lighting.

3. Aeration is permitted to ensure animal welfare and health, under the condition that mechanical aerators are preferably powered by renewable energy sources.

All such use is to be recorded in the aquaculture production record.

4. The use of oxygen is only permitted for uses linked to animal health requirements and critical periods of production or transport, in the following cases:

(a) exceptional cases of temperature rise or drop in atmospheric pressure or accidental pollution,

(b) occasional stock management procedures such as sampling and sorting,

(c) in order to assure the survival of the farm stock.

Documentary evidence shall be maintained.

5. Slaughter techniques shall render fish immediately unconscious and insensible to pain. Differences in harvesting sizes, species, and production sites must be taken into account when considering optimal slaughtering methods.







Section 4

Breeding

Article 25i

Prohibition of hormones

The use of hormones and hormone derivates is prohibited.







Section 5

Feed for fish, crustaceans and echinodermes

Article 25j

General rules on feeds

Feeding regimes shall be designed with the following priorities:

(a) animal health;

(b) high product quality, including the nutritional composition which shall ensure high quality of the final edible product;

(c) low environmental impact.

Article 25k

Specific rules on feeds for carnivorous aquaculture animals

1. Feed for carnivorous aquaculture animals shall be sourced with the following priorities:

(a) organic feed products of aquaculture origin;

(b) fish meal and fish oil from organic aquaculture trimmings;

(c) fish meal and fish oil and ingredients of fish origin derived from trimmings of fish already caught for human consumption in sustainable fisheries;

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(d) organic feed materials of plant or animal origin;

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(e) feed products derived from whole fish caught in fisheries certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013 of the European Parliament and of the Council ( 14 ).

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3. The feed ration may comprise a maximum of 60 % organic plant products.

4. Astaxanthin derived primarily from organic sources, such as organic crustacean shells may be used in the feed ration for salmon and trout within the limit of their physiological needs. If organic sources are not available natural sources of astaxanthin (such as Phaffia yeast) may be used.

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5. Histidine produced through fermentation may be used in the feed ration for salmonid fish when the feed sources listed in paragraph 1 do not provide a sufficient amount of histidine to meet the dietary needs of the fish and prevent the formation of cataracts.

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Article 25l

Specific rules on feeds for certain aquaculture animals

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1. In the grow-out stages, aquaculture animals as referred to in Annex XIIIa, Section 6, Section 7 and Section 9 shall be fed with feed naturally available in ponds and lakes.

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2. Where natural feed resources are not available in sufficient quantities as referred to in paragraph 1, organic feed of plant origin, preferably grown on the farm itself or seaweed may be used. Operators shall keep documentary evidence of the need to use additional feed.

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3. Where natural feed is supplemented according to paragraph 2:

(a) the feed ration of siamese catfish (Pangasius spp.) as referred to in Section 9 of Annex XIIIa may comprise a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries;

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(b) the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) referred to in Section 7 of Annex XIIIa may comprise a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries. In order to secure the quantitative dietary needs of those shrimps and prawns, organic cholesterol may be used to supplement their diets. Where organic cholesterol is not available, non-organic cholesterol derived from wool, shellfish or other sources may be used. The option to supplement their diet with cholesterol applies both in the grow-out stage and in earlier life stages in nurseries and hatcheries.

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Article 25la

Specific rules on feeds for organic juveniles

In the larval rearing of organic juveniles, conventional phytoplankton and zooplankton may be used as feed.

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Article 25m

Products and substances as referred to in Article 15(1)(d)(iii) of Regulation (EC) No 834/2007

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1. Feed materials of mineral origin may be used in organic aquaculture only if listed in Section 1 of Annex V.

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2. Feed additives, certain products used in animal nutrition and processing aids may be used if listed in Annex VI and the restrictions laid down therein are complied with.







Section 6

Specific rules for molluscs

Article 25n

Growing area

1. Bivalve mollusc farming may be carried out in the same area of water as organic finfish and seaweed farming in a polyculture system to be documented in the sustainable management plan. Bivalve molluscs may also be grown together with gastropod molluscs, such as periwinkles, in polyculture.

2. Organic bivalve mollusc production shall take place within areas delimited by posts, floats or other clear markers and shall, as appropriate, be restrained by net bags, cages or other man made means.

3. Organic shellfish farms shall minimise risks to species of conservation interest. If predator nets are used their design shall not permit diving birds to be harmed.

Article 25o

Sourcing of seed

1. Provided that there is no significant damage to the environment and if permitted by local legislation, wild seed from outside the boundaries of the production unit can be used in the case of bivalve shellfish provided it comes from:

(a) settlement beds which are unlikely to survive winter weather or are surplus to requirements, or

(b) natural settlement of shellfish seed on collectors.

Records shall be kept of how, where and when wild seed was collected to allow traceability back to the collection area.

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However, the maximum percentage of seed from non- organic bivalve shellfish hatcheries that may be introduced to the organic production units shall be 80 % by 31 December 2011, 50 % by 31 December 2014 and 0 % by 31 December 2016.

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2. For the cupped oyster, Crassostrea gigas, preference shall be given to stock which is selectively bred to reduce spawning in the wild.

Article 25p

Management

1. Production shall use a stocking density not in excess of that used for non-organic shellfish in the locality. Sorting, thinning and stocking density adjustments shall be made according to the biomass and to ensure animal welfare and high product quality.

2. Biofouling organisms shall be removed by physical means or by hand and where appropriate returned to the sea away from shellfish farms. Shellfish may be treated once during the production cycle with a lime solution to control competing fouling organisms.

Article 25q

Cultivation rules

1. Cultivation on mussel ropes and other methods listed in Annex XIIIa, Section 8 may be eligible for organic production.

2. Bottom cultivation of molluscs is only permitted where no significant environmental impact is caused at the collection and growing sites. The evidence of minimal environmental impact shall be supported by a survey and report on the exploited area to be provided by the operator to the control body or control authority. The report shall be added as a separate chapter to the sustainable management plan.

Article 25r

Specific cultivation rules for oysters

Cultivation in bags on trestles is permitted. These or other structures in which the oysters are contained shall be set out so as to avoid the formation of a total barrier along the shoreline. Stock shall be positioned carefully on the beds in relation to tidal flow to optimise production. Production shall meet the criteria listed in the Annex XIIIa, Section 8.







Section 7

Disease prevention and veterinary treatment

Article 25s

General rules on disease prevention

1. The animal health management plan in conformity with Article 9 of Directive 2006/88/EC shall detail biosecurity and disease prevention practices including a written agreement for health counselling, proportionate to the production unit, with qualified aquaculture animal health services who shall visit the farm at a frequency of not less than once per year and not less than once every two years in the case of bivalve shellfish.

2. Holding systems, equipment and utensils shall be properly cleaned and disinfected. Only products listed in Annex VII, Sections 2.1 to 2.2 may be used.

3. With regard to fallowing:

(a) The competent authority shall determine whether fallowing is necessary and the appropriate duration which shall be applied and documented after each production cycle in open water containment systems at sea. Fallowing is also recommended for other production methods using tanks, fishponds, and cages;

(b) it shall not be mandatory for bivalve mollusc cultivation;

(c) during fallowing the cage or other structure used for aquaculture animal production is emptied, disinfected and left empty before being used again.

4. Where appropriate, uneaten fish-feed, faeces and dead animals shall be removed promptly to avoid any risk of significant environmental damage as regards water status quality, minimize disease risks, and to avoid attracting insects or rodents.

5. Ultraviolet light and ozone may be used only in hatcheries and nurseries.

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6. For biological control of ectoparasites, preference shall be given to the use of cleaner fish and to the use of freshwater, marine water and sodium chloride solutions.

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Article 25t

Veterinary treatments

1. When despite preventive measures to ensure animal health, according to Article 15(1)(f)(i) of Regulation (EC) No 834/2007, a health problem arises, veterinary treatments may be used in the following order of preference:

(a) substances from plants, animals or minerals in a homoeopathic dilution;

(b) plants and their extracts not having anaesthetic effects, and

(c) substances such as: trace elements, metals, natural immunostimulants or authorised probiotics.

2. The use of allopathic treatments is limited to two courses of treatment per year, with the exception of vaccinations and compulsory eradication schemes. However, in the cases of a production cycle of less than a year a limit of one allopathic treatment applies. If the mentioned limits for allopathic treatments are exceeded the concerned aquaculture animals can not be sold as organic products.

3. The use of parasite treatments, not including compulsory control schemes operated by Member States, shall be limited to twice per year or once per year where the production cycle is less than 18 months.

4. The withdrawal period for allopathic veterinary treatments and parasite treatments according to paragraph 3 including treatments under compulsory control and eradication schemes shall be twice the legal withdrawal period as referred to in Article 11 of Directive 2001/82/EC or in a case in which this period in not specified 48 hours.

5. Whenever veterinary medicinal products are used, such use is to be declared to the control body or the control authority before the animals are marketed as organic. Treated stock shall be clearly identifiable.







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CHAPTER 3

Preserved and processed products

Article 26

Rules for preserving products and for the production of processed feed and food

1. Operators preserving products or producing processed feed or food shall establish and update appropriate procedures based on a systematic identification of critical processing steps.

The application of those procedures shall guarantee at all times that preserved or processed products comply with the organic production rules.

2. Operators shall comply with and implement the procedures referred to in paragraph 1. In particular, operators shall:

(a) take precautionary measures to avoid the risk of contamination by unauthorised substances or products;

(b) implement suitable cleaning measures, monitor their effectiveness and record those measures;

(c) guarantee that non-organic products are not placed on the market with an indication referring to the organic production method.

3. Where non-organic products are also prepared or stored in the preparation unit concerned, the operator shall:

(a) carry out the operations continuously until the complete run has been dealt with, separated by place or time from similar operations carried out on non-organic products;

(b) store organic products, before and after the operations, separate by place or time from non-organic products;

(c) inform the control authority or control body of the operations referred to in points (a) and (b) and keep available an updated register of all operations and quantities processed;

(d) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges with non-organic products;

(e) carry out operations on organic products only after suitable cleaning of the production equipment.

4. Additives, processing aids and other substances and ingredients used for processing feed or food and any processing practice applied, such as smoking, shall respect the principles of good manufacturing practice.

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Article 27

Use of certain products and substances in processing of food

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For the purposes of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be used in the processing of organic food, with the exception of products of the wine sector, for which the provisions of Chapter 3a shall apply:

◄

(a) substances listed in Annex VIII to this Regulation;

(b) preparations of micro-organisms and enzymes normally used in food processing; ►M1 however, enzymes to be used as food additives have to be listed in Annex VIII, Section A; ◄

(c) substances, and products as defined in Articles 1(2)(b)(i) and 1(2)(c) of Council Directive 88/388/EEC ( 15 ) labelled as natural flavouring substances or natural flavouring preparations, according to Articles 9(1)(d) and (2) of that Directive;

(d) colours for stamping meat and eggshells in accordance with, respectively, Article 2(8) and Article 2(9) of European Parliament and Council Directive 94/36/EC ( 16 );

(e) drinking water and salt (with sodium chloride or potassium chloride as basic components) generally used in food processing;

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(f) minerals (trace elements included), vitamins, amino acids and micronutrients, provided that:

(i) their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or

(ii) as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers:

— in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council ( 17 ), their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned,

— in products regulated by Commission Directive 2006/125/EC ( 18 ), their use is authorised by that Directive, or

— in products regulated by Commission Directive 2006/141/EC ( 19 ), their use is authorised by that Directive.

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2. For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007,

(a) food additives listed in Annex VIII and marked with an asterisk in the column of the additive code number, shall be calculated as ingredients of agricultural origin;

(b) preparations and substances referred to in paragraph (1)(b),(c),(d),(e) and (f) of this Article and substances not marked with an asterisk in the column of the additive code number shall not be calculated as ingredients of agricultural origin;

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(c) yeast and yeast products shall be calculated as ingredients of agricultural origin as of 31 December 2013.

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3. The use of the following substances listed in Annex VIII shall be re-examined before 31 December 2010:

(a) Sodium nitrite and potassium nitrate in Section A with a view to withdrawing these additives;

(b) Sulphur dioxide and potassium metabisulphite in Section A;

(c) Hydrochloric acid in Section B for the processing of Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese, and Leidse Nagelkaas.

The re-examination referred to in point (a) shall take account of the efforts made by Member States to find safe alternatives to nitrites/nitrates and in establishing educational programmes in alternative processing methods and hygiene for organic meat processors/manufacturers.

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4. For the traditional decorative colouring of the shell of boiled eggs produced with the intention to place them on the market at a given period of the year, the competent authority may authorise for the period referred to above, the use of natural colours and natural coating substances. The authorisation may comprise synthetic forms of iron oxides and iron hydroxides until 31 December 2013. Authorisations shall be notified to the Commission and the Member States.

Article 27a

For the purpose of the application of Article 20(1) of Regulation (EC) No 834/2007, the following substances may be used in the production, confection and formulation of yeast:

(a) substances listed in Annex VIII, Section C to this Regulation;

(b) products and substances referred to in Article 27(1)(b) and (e) of this Regulation.

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Article 28

Use of certain non-organic ingredients of agricultural origin in processing food

For the purpose of Article 19(2)(c) of Regulation (EC) No 834/2007, non-organic agricultural ingredients listed in Annex IX to this Regulation can be used in the processing of organic food.

Article 29

Authorisation of non-organic food ingredients of agricultural origin by Member State

1. Where an ingredient of agricultural origin is not included in Annex IX to this Regulation, that ingredient may only be used under the following conditions:

(a) the operator has notified to the competent authority of the Member State all the requisite evidence showing that the ingredient concerned is not produced in sufficient quantity in the Community in accordance with the organic production rules or cannot be imported from third countries;

(b) the competent authority of the Member State has provisionally authorised, the use for a maximum period of 12 months after having verified that the operator has undertaken the necessary contacts with suppliers in the Community to ensure himself of the unavailability of the ingredients concerned with the required quality requirements;

(c) no decision has been taken, in accordance with the provisions of paragraphs 3 or 4 that a granted authorisation with regard to the ingredient concerned shall be withdrawn.

The Member State may prolong the authorisation provided for in point (b) a maximum of three times for 12 months each.

2. Where an authorisation as referred to in paragraph 1 has been granted, the Member State shall immediately notify to the other Member States and to the Commission, the following information:

(a) the date of the authorisation and in case of a prolonged authorisation, the date of the first authorisation;

(b) the name, address, telephone, and where relevant, fax and e-mail of the holder of the authorisation; the name and address of the contact point of the authority which granted the authorisation;

(c) the name and, where necessary, the precise description and quality requirements of the ingredient of agricultural origin concerned;

(d) the type of products for the preparation of which the requested ingredient is necessary;

(e) the quantities that are required and the justification for those quantities;

(f) the reasons for, and expected period of, the shortage;

(g) the date on which the Member State sends this notification to the other Member States and the Commission. The Commission and/or Member States may make this information available to the public.

3. Where a Member State submits comments to the Commission and to the Member State which granted the authorisation, which show that supplies are available during the period of the shortage, the Member State shall consider withdrawal of the authorisation or reducing the envisaged period of validity, and shall inform the Commission and the other Member States of the measures it has taken or will take, within 15 working days from the date of receipt of the information.

4. At the request of a Member State or at the Commission's initiative, the matter shall be submitted for examination to the Committee set up in accordance with Article 37 of Regulation (EC) No 834/2007. It may be decided, in accordance with the procedure laid down in paragraph 2 of that Article, that a previously granted authorisation shall be withdrawn or its period of validity amended, or where appropriate, that the ingredient concerned shall be included in Annex IX to this Regulation.

5. In case of an extension as referred to in the second subparagraph of paragraph 1, the procedures of paragraphs 2 and 3 shall apply.

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Article 29a

Specific provisions for seaweed

1. If the final product is fresh seaweed, flushing of freshly harvested seaweed shall use seawater.

If the final product is dehydrated seaweed, potable water may also be used for flushing. Salt may be used for removal of moisture.

2. The use of direct flames which come in direct contact with the seaweed shall be prohibited for drying. If ropes or other equipment are used in the drying process they shall be free of anti-fouling treatments and cleaning or disinfection substances except where a product is listed in Annex VII for this use.

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CHAPTER 3a

Specific rules for the making of wine

Article 29b

Scope

1. This Chapter lays down specific rules for the organic production of the products of the wine sector as referred to in Article 1(1)(l) of Council Regulation (EC) No 1234/2007 ( 20 ).

2. Commission Regulations (EC) No 606/2009 ( 21 ) and (EC) No 607/2009 ( 22 ) shall apply, save as explicitly provided otherwise in this Chapter.

Article 29c

Use of certain products and substances

1. For the purposes of Article 19(2)(a) of Regulation (EC) No 834/2007, products of the wine sector shall be produced from organic raw material.

2. For the purposes of Article 19(2)(b) of Regulation (EC) No 834/2007, only products and substances listed in Annex VIIIa to this Regulation can be used for the making of products of the wine sector, including during the processes and oenological practices, subject to the conditions and restrictions laid down in Regulation (EC) No 1234/2007 and Regulation (EC) No 606/2009 and in particular in Annex I A to that Regulation.

3. Products and substances listed in Annex VIIIa to this Regulation and marked with an asterisk, derived from organic raw material, shall be used if available.

Article 29d

Oenological practices and restrictions

1. Without prejudice to Article 29c and to specific prohibitions and restrictions provided for in paragraphs 2 to 5 of this Article, only oenological practices, processes and treatments, including the restrictions provided for in Article 120c and 120d of Regulation (EC) No 1234/2007 and in Articles 3, 5 to 9 and 11 to 14 of Regulation (EC) No 606/2009 and in their Annexes, used before 1 August 2010 are permitted.

2. The use of the following oenological practices, processes and treatments is prohibited:

(a) partial concentration through cooling according to point (c) of Section B.1 of Annex XVa to Regulation (EC) No 1234/2007;

(b) elimination of sulphur dioxide by physical processes according to point 8 of Annex I A to Regulation (EC) No 606/2009;

(c) electrodialysis treatment to ensure the tartaric stabilisation of the wine according to point 36 of Annex I A to Regulation (EC) No 606/2009;

(d) partial dealcoholisation of wine according to point 40 of Annex I A to Regulation (EC) No 606/2009;

(e) treatment with cation exchangers to ensure the tartaric stabilisation of the wine according to point 43 of Annex I A to Regulation (EC) No 606/2009.

3. The use of the following oenological practices, processes and treatments is permitted under the following conditions:

(a) for heat treatments according to point 2 of Annex I A to Regulation (EC) No 606/2009, the temperature shall not exceed 70 °C;

(b) for centrifuging and filtration with or without an inert filtering agent according to point 3 of Annex I A to Regulation (EC) No 606/2009, the size of the pores shall be not smaller than 0,2 micrometer.

4. The use of the following oenological practices, processes and treatments shall be re-examined by the Commission before ►M16 1 August 2018 ◄ with a view to phase out or to further restrict those practices:

(a) heat treatments as referred to in point 2 of Annex I A to Regulation (EC) No 606/2009;

(b) use of ion exchange resins as referred to in point 20 of Annex I A to Regulation (EC) No 606/2009;

(c) reverse osmosis according to point (b) of Section B.1 of Annex XVa to Regulation (EC) No 1234/2007.

5. Any amendment introduced after 1 August 2010, as regards the oenological practice, processes and treatments provided for in Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009, may be applicable in the organic production of wine only after the adoption of the measures necessary for the implementation of the production rules provided for in Article 19(3) of Regulation (EC) No 834/2007 and, if required, an evaluation process according to Article 21 of that Regulation.

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CHAPTER 4

Collection, packaging, transport and storage of products

Article 30

Collection of products and transport to preparation units

Operators may carry out simultaneous collection of organic and non-organic products, only where appropriate measures are taken to prevent any possible mixture or exchange with non-organic products and to ensure the identification of the organic products. The operator shall keep the information relating to collection days, hours, circuit and date and time of reception of the products available to the control body or control authority.

Article 31

Packaging and transport of products to other operators or units

1. Operators shall ensure that organic products are transported to other units, including wholesalers and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution of the content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without prejudice to any other indications required by law:

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

(b) the name of the product or a description of the compound feedingstuff accompanied by a reference to the organic production method;

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

(d) where relevant, the lot identification mark according to a marking system either approved at national level or agreed with the control body or authority and which permits to link the lot with the accounts referred to in Article 66.

The information referred to in points (a) to (d) of the first subparagraph may also be presented on an accompanying document, if such a document can be undeniably linked with the packaging, container or vehicular transport of the product. This accompanying document shall include information on the supplier and/or the transporter.

2. The closing of packaging, containers or vehicles shall not be required where:

(a) transportation is direct between an operator and another operator who are both subject to the organic control system, and

(b) the products are accompanied by a document giving the information required under paragraph 1, and

(c) both the expediting and the receiving operators shall keep documentary records of such transport operations available for the control body or control authority of such transport operations.

Article 32

Special rules for transporting feed to other production/preparation units or storage premises

In addition to the provisions of Article 31, when transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met:

(a) during transport, organically-produced feed, in-conversion feed, and non-organic feed shall be effectively physically separated;

(b) the vehicles and/or containers which have transported non-organic products are used to transport organic products provided that:

(i) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic products; operators shall record these operations,

(ii) all appropriate measures are implemented, depending on the risks evaluated in accordance with Article 88(3) and, where necessary, operators shall guarantee that non-organic products cannot be placed on the market with an indication referring to organic production,

(iii) the operator shall keep documentary records of such transport operations available for the control body or control authority;

(c) the transport of finished organic feed shall be separated physically or in time from the transport of other finished products;

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

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Article 32a

Transport of live fish

1. Live fish shall be transported in suitable tanks with clean water which meets their physiological needs in terms of temperature and dissolved oxygen.

2. Before transport of organic fish and fish products, tanks shall be thoroughly cleaned, disinfected and rinsed.

3. Precautions shall be taken to reduce stress. During transport, the density shall not reach a level which is detrimental to the species.

4. Documentary evidence shall be maintained for paragraphs 1 to 3.

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Article 33

Reception of products from other units and other operators

On receipt of an organic product, the operator shall check the closing of the packaging or container where it is required and the presence of the indications provided to in Article 31.

The operator shall crosscheck the information on the label referred to in Article 31 with the information on the accompanying documents. The result of these verifications shall be explicitly mentioned in the documentary accounts referred to in Article 66.

Article 34

Special rules for the reception of products from a third country

Organic products shall be imported from a third country in appropriate packaging or containers, closed in a manner preventing substitution of the content and provided with identification of the exporter and with any other marks and numbers serving to identify the lot and with the certificate of control for import from third countries as appropriate.

On receipt of an organic product, imported from a third country, the first consignee shall check the closing of the packaging or container and, in the case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, shall check that the certificate mentioned in that Article covers the type of product contained in the consignment. The result of this verification shall be explicitly mentioned in the documentary accounts referred to in Article 66 of this Regulation.

Article 35

Storage of products

1. For the storage of products, areas shall be managed in such a way as to ensure identification of lots and to avoid any mixing with or contamination by products and/or substances not in compliance with the organic production rules. Organic products shall be clearly identifiable at all times.

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2. In case of organic plant, seaweed, livestock and aquaculture animal production units, storage of input products other than those authorised under this Regulation is prohibited in the production unit.

3. 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 Articles 14(1)(e)(ii) or 15(1)(f)(ii) of Regulation (EC) No 834/2007, that they are stored in a supervised location and that they are entered in the livestock record as referred to in Article 76 of this Regulation, or as appropriate, in the aquaculture production records as referred to in Article 79b of this Regulation.

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4. In case where operators handle both non-organic products and organic products and the latter are stored in storage facilities in which also other agricultural products or foodstuffs are stored:

(a) the organic products shall be kept separate from the other agricultural products and/or foodstuffs;

(b) every measure shall be taken to ensure identification of consignments and to avoid mixtures or exchanges with non-organic products;

(c) suitable cleaning measures, the effectiveness of which has been checked, have been carried out before the storage of organic products; operators shall record these operations.







CHAPTER 5

Conversion rules

Article 36

Plant and plant products

1. For plants and plant products to be considered organic, the production rules as referred to in Articles 9, 10, 11 and 12 of Regulation (EC) No 834/2007 and Chapter 1 of this Regulation and where applicable the exceptional production rules in Chapter 6 of this Regulation must have been applied on the parcels during a conversion period of at least two years before sowing, or, in the case of grassland or perennial forage, at least two years before its use as feed from organic farming, or, in the case of perennial crops other than forage, at least three years before the first harvest of organic products.

2. The competent authority may decide to recognise retroactively as being part of the conversion period any previous period in which:

(a) the land parcels were subject of measures defined in a programme implemented pursuant to Regulations (EC) No 1257/99, (EC) No 1698/2005, or in another official programme, provided that the measures concerned ensure that products not authorised for organic production have not been used on those parcels, or

(b) the parcels were natural or agricultural areas which were not treated with products not authorised for organic production.

The period referred to in point (b) of the first subparagraph can be taken into consideration retroactively only where satisfactory proof has been furnished to the competent authority allowing it to satisfy itself that the conditions were met for a period of at least three years.

3. The competent authority may decide, in certain cases, where the land had been contaminated with products not authorised for organic production, to extend the conversion period beyond the period referred to in paragraph 1.

4. In the case of parcels which have already been converted to or were in the process of conversion to organic farming, and which are treated with a product not authorised for organic production, the Member State may shorten the conversion period referred to in paragraph 1 in the following two cases:

(a) parcels treated with a product not authorised for organic production as part of a compulsory disease or pest control measure imposed by the competent authority of the Member State;

(b) parcels treated with a product not authorised for organic production as part of scientific tests approved by the competent authority of the Member State.

In the cases provided for in points (a) and (b) of the first subparagraph, the length of the conversion period shall be fixed taking into account of the following factors:

(a) the process of degradation of the product concerned shall guarantee, at the end of the conversion period, an insignificant level of residues in the soil and, in the case of a perennial crop, in the plant;

(b) the harvest following the treatment may not be sold with reference to organic production methods.

The Member State concerned shall inform the other Member States and the Commission of its decision to require compulsory measures.

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Article 36a

Seaweed

1. The conversion period for a seaweed harvesting site shall be six months.

2. The conversion period for a seaweed cultivation unit shall be the longer of six months or one full production cycle.

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Article 37

Specific conversion rules for land associated with organic livestock production

1. The conversion rules as referred to in Article 36 of this Regulation shall apply to the whole area of the production unit on which animal feed is produced.

2. Notwithstanding the provisions in paragraph 1, the conversion period may be reduced to one year for pasturages and open air areas used by non-herbivore species. This period may be reduced to six months where the land concerned has not during the last year, received treatments with products not authorised for organic production.

Article 38

Livestock and livestock products

1. Where non-organic livestock has been brought onto a holding in accordance with Article 14(1)(a)(ii) of Regulation (EC) No 834/2007 and Article 9 and/or Article 42 of this Regulation and if livestock products are to be sold as organic products, the production rules as referred to in Articles 9, 10, 11 and 14 of Regulation (EC) No 834/2007 and in Chapter 2 of Title II and where applicable in Article 42 of this Regulation must have been applied for at least:

(a) 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;

(b) six months in the case of small ruminants and pigs and animals for milk production;

(c) 10 weeks for poultry for meat production, brought in before they are three days old;

(d) six weeks in the case of poultry for egg production.

2. Where non-organic animals exist on a holding at the beginning of the conversion period in accordance with Article 14(1)(a)(iii) of Regulation (EC) No 834/2007 their products may be deemed organic 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 existing animals and their offspring, pasturage and/or any land used for animal feed, may be reduced to 24 months, if the animals are mainly fed with products from the production unit.

3. Beekeeping products can be sold with references to the organic production method only when the organic production rules have been complied with for at least one year.

4. The conversion period for apiaries does not apply in the case of application of Article 9(5) of this Regulation.

5. During the conversion period the wax shall be replaced with wax coming from organic beekeeping.

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Article 38a

Aquaculture animal production

1. The following conversion periods for aquaculture production units shall apply for the following types of aquaculture facilities including the existing aquaculture animals:

(a) for facilities that cannot be drained, cleaned and disinfected, a conversion period of 24 months;

(b) for facilities that have been drained, or fallowed, a conversion period of 12 months;

(c) for facilities that have been drained, cleaned and disinfected a conversion period of six months;

(d) for open water facilities including those farming bivalve molluscs, a three month conversion period.

2. The competent authority may decide to recognize retroactively as being part of the conversion period any previously documented period in which the facilities were not treated or exposed to products not authorized for organic production.

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CHAPTER 6

Exceptional production rules







Section 1

Exceptional production rules related to climatic, geographical or structural constraints in accordance with Article 22(2)(a) of Regulation (EC) No 834/2007

Article 39

Tethering of animals

Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, competent authorities may authorise cattle in small holdings to be tethered if it is not possible to keep the cattle in groups appropriate to their behaviour requirements, provided they have access to pastures during the grazing period according to Article 14(2), and at least twice a week access to open air areas when grazing is not possible.

Article 40

Parallel production

1. Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, a producer may run organic and non-organic production units in the same area:

(a) in the case of the production of perennial crops, which require a cultivation period of at least three years, where varieties cannot be easily differentiated, provided the following conditions are met:

(i) the production in question forms part of a conversion plan in respect of which the producer gives a firm undertaking and which provides for the beginning of the conversion of the last part of the area concerned to organic production in the shortest possible period which may not in any event exceed a maximum of five years;

(ii) appropriate measures have been taken to ensure the permanent separation of the products obtained from each unit concerned;

(iii) the control authority or control body is notified of the harvest of each of the products concerned at least 48 hours in advance;

(iv) upon completion of the harvest, the producer informs the control authority or control body of the exact quantities harvested on the units concerned and of the measures applied to separate the products;

(v) the conversion plan and the control measures referred to in Chapter 1 and 2 of Title IV have been approved by the competent authority; this approval shall be confirmed each year after the start of the conversion plan;

(b) in the case of areas intended for agricultural research or formal education agreed by the Member States' competent authorities and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;

(c) in the case of production of seed, vegetative propagating material and transplants and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;

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

2. The competent authority may authorise holdings carrying out agricultural research or formal education to rear organic and non-organic livestock of the same species, where the following conditions are met:

(a) appropriate measures, notified in advance to the control authority or control body, have been taken in order to guarantee the permanent separation between livestock, livestock products, manure and feedingstuffs of each of the units;

(b) the producer informs the control authority or control body in advance of any delivery or selling of the livestock or livestock products;

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

Article 41

Management of beekeeping units for the purpose of pollination

Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, for the purpose of pollination actions an operator may run organic and non-organic beekeeping units on the same holding, provided that all the requirements of the organic production rules are fulfilled, with the exception of the provisions for the siting of the apiaries. In that case the product cannot be sold as organic.

The operator shall keep documentary evidence of the use of this provision.







Section 2

Exceptional production rules related to non-availability of organic farm inputs in accordance with Article 22(2)(b) of Regulation (EC) No 834/2007

Article 42

Use of non-organic animals

Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply, and with prior authorisation of the competent authority,

(a) when a flock is constituted for the first time, renewed or reconstituted and organically reared poultry are not available in sufficient numbers, non-organically reared poultry may be brought into an organic poultry production unit, provided that the pullets for the production of eggs and poultry for meat production are less than three days old;

(b) non-organically reared pullets for egg production of not more than 18 weeks may be brought into an organic livestock unit until ►M20 31 December 2020 ◄ , when organically reared pullets are not available and provided that the relevant provisions laid down in Section 3 and 4 of Chapter 2 are complied with.

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Article 43

Use of non-organic protein feed of plant and animal origin for livestock

Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply and where farmers are unable to obtain protein feed exclusively from organic production, the use of a limited proportion of non-organic protein feed is allowed for porcine and poultry species.

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The maximum percentage of non-organic protein feed authorised per period of 12 months for those species shall be 5 % for calendar years 2018, 2019 and 2020.

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The figures shall be calculated annually as a percentage of the dry matter of feed from agricultural origin.

The operator shall keep documentary evidence of the need for the use of this provision.

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Article 44

Use of non-organic beeswax

In the case of new installations or during the conversion period, non-organic beeswax may be used only

(a) where beeswax from organic beekeeping is not available on the market;

(b) where it is proven free of contamination by substances not authorised for organic production; and

(c) provided that it comes from the cap.

Article 45

Use of seed or vegetative propagating material not obtained by the organic production method

1. Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply,

(a) seed and vegetative propagating material from a production unit in conversion to organic farming may be used,

(b) where point (a) is not applicable, Member States may authorise the use of non-organic seed or vegetative propagating material if not available from organic production. However, for the use of non-organic seed and seed potatoes the following paragraphs (2) to (9) apply.

2. Non-organic seed and seed potatoes may be used, provided that the seed or seed potatoes are not treated with plant protection products, other than those authorised for treatment of seed in accordance with Article 5(1), unless chemical treatment is prescribed in accordance with Council Directive 2000/29/EC ( 23 ) for phytosanitary purposes by the competent authority of the Member State for all varieties of a given species in the area where the seed or seed potatoes are to be used.

3. Species for which it is established that organically produced seed or seed potatoes are available in sufficient quantities and for a significant number of varieties in all parts of the Community are set out in Annex X.

The species listed in Annex X may not be subject of authorisations pursuant to paragraph 1(b), unless these are justified by one of the purposes referred to in paragraph 5(d).

4. Member States may delegate the responsibility for granting the authorisation referred to in paragraph 1(b) to another public administration under their supervision or to the control authorities or control bodies referred to in Article 27 of Regulation (EC) No 834/2007.

5. Authorisation to use seed or seed potatoes not obtained by the organic production method may only be granted in the following cases:

(a) where no variety of the species which the user wants to obtain is registered in the database referred to in Article 48;

(b) where no supplier, meaning an operator who markets seed or seed potatoes to other operators, is able to deliver the seed or seed potatoes before sowing or planting in situations where the user has ordered the seed or seed potatoes in reasonable time;

(c) where the variety which the user wants to obtain is not registered in the database referred to in Article 48, and the user is able to demonstrate that none of the registered alternatives of the same species are appropriate and that the authorisation therefore is significant for his production;

(d) where it is justified for use in research, test in small-scale field trials or for variety conservation purposes agreed by the competent authority of the Member State.

6. The authorisation shall be granted before the sowing of the crop.

7. The authorisation shall be granted only to individual users for one season at a time and the authority or body responsible for the authorisations shall register the quantities of seed or seed potatoes authorised.

8. By way of derogation from paragraph 7, the competent authority of the Member State may grant to all users a general authorisation:

(a) for a given species when and in so far as the condition laid down in paragraph 5(a) is fulfilled;

(b) for a given variety when and in so far as the conditions laid down in paragraph 5(c) are fulfilled.

The authorisations referred to in the first subparagraph shall be clearly indicated in the database referred to in Article 48.

9. Authorisati