Commission Regulation (EC) No 889/2008Show full title

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.

2. This Regulation shall not apply to the following products:

(a) products originating from aquaculture;

(b) seaweed;

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

(d) yeasts used as food or feed.

However, Title II, Title III and Title IV shall apply mutatis mutandis to products referred to in points (a), (b) and (c) of the first subparagraph until detailed production rules for those products are laid down on the basis of Regulation (EC) No 834/2007.

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;

(f)

‘production unit’ meaning all assets to be used for a production sector such as production premises, land parcels, pasturages, open air areas, livestock buildings, the premises for the storage of crops, crop products, livestock products, raw materials and any other input relevant for this specific production sector;

(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.

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

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(2) 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.

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(3) 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(4) 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(5) 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(6) or in Article 22 of Council Regulation 1257/1999(7) 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

Article 19 Feed from own holding or from other organic holdings

1. In the case of herbivores, except during the period each year when the animals are under transhumance subject to Article 17(4), at least 50 % of the feed shall come from the farm unit itself or in case this is not feasible, be produced in cooperation with other organic farms primarily in the same region.

2. 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.

3. The feeding of bee colonies shall only be permitted where the survival of the hives is endangered due to climatic conditions and only between the last honey harvest and 15 days before the start of the next nectar or honeydew flow period. Feeding shall be with organic honey, organic sugar syrup, or organic sugar.

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

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 60 %.

2. Up to 20 % of the total average amount of feedingstuffs fed to the livestock may originate from the grazing or harvesting of permanent pastures or perennial forage parcels 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.

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

Article 22 Products and substances referred to in Article 14(1)(d)(iv) of Regulation (EC) No 834/2007

1. Non-organic feed materials of plant and animal origin may be used in organic production subject to the restrictions laid down in Article 43 and only if they are listed in Annex V and the restrictions laid down therein are complied with.

2. Organic feed materials of animal origin, and feed materials of mineral origin may be used in organic production and only if they are listed in Annex V and the restrictions laid down therein are complied with.

3. Products and by-products from fisheries may be used in organic production only if they are listed in Annex V and the restrictions laid down therein are complied with.

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

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.

2. Phytotherapeutic, homoepathic products, trace elements and products listed in Annex V, part 3 and in Annex VI, part 1.1. shall be used in preference to chemically-synthesized 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.

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

1. For the purposes 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.

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.

CHAPTER 3 Processed products

Article 26 Rules for the production of processed feed and food

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

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

3. The application of the procedures referred to in paragraph 2 shall guarantee at all times that the produced processed products comply with the organic production rules.

4. Operators shall comply with and implement the procedures referred to in paragraph 2. 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 these operations;

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

5. Further to the provisions laid down in paragraphs 2 and 4, when 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 performed 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 thereof 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.

Article 27 Use of certain products and substances in processing of food

1. For the purpose 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 wine:

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

(b) preparations of micro-organisms and enzymes normally used in food processing;

(c) substances, and products as defined in Articles 1(2)(b)(i) and 1(2)(c) of Council Directive 88/388/EEC(8) 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(9);

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

(f) minerals (trace elements included), vitamins, aminoacids, and micronutrients, only authorised as far their use is legally required in the foodstuffs in which they are incorporated.

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.

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.

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.

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.

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.

2. In case of organic plant and livestock 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 Article 14(1)(e)(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.

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.

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.

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 31 December 2011, 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.

Article 43 Use of non-organic feed of agricultural origin

Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply, the use of a limited proportion of non-organic feed of plant and animal origin is allowed where farmers are unable to obtain feed exclusively from organic production. The maximum percentage of non-organic feed authorised per period of 12 months for species other than herbivores shall be:

(a)

10 % during the period from 1 January 2009 to 31 December 2009;

(b)

5 % during the period from 1 January 2010 to 31 December 2011.

The figures shall be calculated annually as a percentage of the dry matter of feed from agricultural origin. The maximum percentage authorised of non-organic feed in the daily ration shall be 25 % calculated as a percentage of the dry matter.

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

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(10) 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. Authorisation may only be granted during periods for which the database is updated in accordance with Article 49(3).

Section 3 Exceptional production rules related to specific management problems in organic livestock in accordance with Article 22(2)(d) of Regulation (EC) No 834/2007

Article 46 Specific management problems in organic livestock

The final fattening phase of adult bovines for meat production may take place indoors, provided that this indoors period does not exceed one fifth of their lifetime and in any case for a maximum period of three months.

Section 4 Exceptional production rules related to catastrophic circumstances in accordance with Article 22(2)(f) of Regulation (EC) No 834/2007

Article 47 Catastrophic circumstances

The competent authority may authorise on a temporary basis:

(a)

in the case of high mortality of animals caused by health or catastrophic circumstances, the renewal or reconstitution of the herd or flock with non-organic animals, when organically reared animals are not available;

(b)

in case of high mortality of bees caused by health or catastrophic circumstances, the reconstitution of the apiaries with non-organic bees, when organic apiaries are not available;

(c)

the use of non-organic feedingstuffs for a limited period and in relation to a specific area by individual operators, when forage production is lost or when restrictions are imposed, in particular as a result of exceptional meteorological conditions, the outbreak of infectious diseases, the contamination with toxic substances, or as a consequence of fires;

(d)

the feeding of bees with organic honey, organic sugar or organic sugar syrup in case of long lasting exceptional weather conditions or catastrophic circumstances, which hamper the nectar or honeydew production.

Upon approval by the competent authority, the individual operators shall keep documentary evidence of the use of the above exceptions. Member States shall inform each other and the Commission on the exceptions they have granted under point (c) of the first subparagraph within 1 month from its approval.

CHAPTER 7 Seed data base

Article 48 Database

1. Each Member State shall ensure that a computerised database is established for the listing of the varieties for which seed or seed potatoes obtained by the organic production method are available on its territory.

2. The database shall be managed either by the competent authority of the Member State or by an authority or body designated for this purpose by the Member State, hereinafter referred to as ‘manager of the database’. Member States may also designate an authority or a private body in another country.

3. Each Member State shall inform the Commission and the other Member States of the authority or private body designated to manage the database.

Article 49 Registration

1. Varieties for which seed or seed potatoes produced by the organic production method are available shall be registered in the database referred to in Article 48 at the request of the supplier.

2. Any variety which has not been registered in the database shall be considered as unavailable with regard to Article 45(5).

3. Each Member State shall decide in which period of the year the database has to be regularly updated for each species or group of species cultivated on its territory. The database shall hold information with regard to that decision.

Article 50 Conditions for registration

1. For registration, the supplier shall:

(a) demonstrate that he or the last operator, in cases where the supplier is only dealing with pre-packaged seed or seed potatoes, has been subject to the control system referred to in Article 27 of Regulation (EC) No 834/2007;

(b) demonstrate that the seed or seed potatoes to be placed on the market comply with the general requirements applicable to seed and seed potatoes;

(c) make available all the information required under Article 51 of this Regulation, and undertake to update this information at the request of the manager of the database or whenever such updating is necessary to ensure that the information remains reliable.

2. The manager of the database may, with the approval by the competent authority of the Member State, refuse a supplier's application for registration or delete a previously accepted registration if the supplier does not comply with the requirements set out in paragraph 1.

Article 51 Registered information

1. For each registered variety and for each supplier, the database referred to in Article 48 shall contain at least the following information:

(a) the scientific name of the species and the variety denomination;

(b) the name and contact details of the supplier or his representative;

(c) the area where the supplier can deliver the seed or seed potatoes to the user in the usual time needed for the delivery;

(d) the country or region in which the variety is tested and approved for the purpose of the common catalogues of varieties of agricultural plant species and vegetable species as defined in Council Directives 2002/53/EC on the common catalogue of varieties of agricultural plant species(11) and 2002/55/EC on the marketing of vegetable seed(12);

(e) the date from which the seed or seed potatoes will be available;

(f) the name and/or code number of the control authority or control body in charge of the control of the operator as referred to in Article 27 of Regulation (EC) No 834/2007.

2. The supplier shall immediately inform the manager of the database if any of the registered varieties are no longer available. The amendments shall be recorded in the database.

3. Besides the information specified in paragraph 1, the database shall contain a list of the species listed in Annex X.

Article 52 Access to information

1. The information in the database referred to in Article 48 shall be available through the Internet, free of cost, to the users of seed or seed potatoes and to the public. Member States may decide that any user who has notified its activity in accordance with Article 28(1)(a) of Regulation (EC) No 834/2007 may obtain, on request, an extract of data concerning one or several groups of species from the database manager.

2. The Member States shall ensure that all users referred to in paragraph 1 are informed, at least once a year, about the system and how to obtain the information in the database.

Article 53 Registration fee

Each registration may be subject to the levying of a fee, which shall represent the cost of inserting and maintaining the information in the database referred to in Article 48. The competent authority of the Member State shall approve the amount of the fee charged by the manager of the database.

Article 54 Annual report

1. The authorities or bodies designated to grant authorisations in accordance with Article 45 shall register all authorisations, and shall make this information available in a report to the competent authority of the Member State and to the manager of the database.

The report shall contain, for each species concerned by an authorisation according to Article 45(5), the following information:

(a) the scientific name of the species and the variety denomination;

(b) the justification for the authorisation indicated by a reference to Article 45(5)(a), (b), (c) or (d);

(c) the total number of authorisations;

(d) the total quantity of seed or seed potatoes involved;

(e) the chemical treatment for phytosanitary purposes, as referred to in Article 45(2).

2. For authorisations according to Article 45(8) the report shall contain the information referred to in point (a) of the second subparagraph of paragraph 1 of this Article and the period for which the authorisations were in force.

Article 55 Summary report

The competent authority of the Member State shall, before 31 March each year, collect the reports and send a summary report covering all authorisations of the Member State from the previous calendar year to the Commission and to the other Member States. The report shall cover the information specified in Article 54. The information shall be published in the database referred to in Article 48. The competent authority may delegate the task of collecting the reports to the manager of the database.

Article 56 Information upon request

Upon request from a Member State or the Commission, detailed information on authorisations granted in individual cases shall be made available to other Member States or to the Commission.

TITLE III LABELLING

CHAPTER 1 Community Logo

Article 57 Community logo

In accordance with Article 25(3) of Regulation (EC) No 834/2007, the Community logo shall follow the model in Annex XI to this Regulation.

The Community logo shall be used in accordance with the technical reproduction rules laid down in Annex XI to this Regulation.

Article 58 Conditions for the use of the code number and place of origin

1. The indication of the code number of the control authority or control body referred to in Article 24(1)(a) of Regulation (EC) 834/2007 shall,

(a) start with the acronym identifying the Member State or the third country, as referred to in the international standard for the two letter country codes under ISO 3166 (Codes for the representation of names of countries and their subdivisions);

(b) include a term which establishes a link with the organic production method, as referred to in Article 23(1) of Regulation (EC) No 834/2007;

(c) include a reference number to be decided by the competent authority; and

(d) be placed immediately below the Community logo, where the Community logo is used in the labelling.

2. The indication of the place where the agricultural raw materials of which the products is composed have been farmed, as referred to in Article 24(1)(c) of Regulation (EC) 834/2007, shall be placed immediately below the code number referred to in paragraph 1.

CHAPTER 2 Specific labelling requirements for feed

Article 59 Scope, use of trade marks and sales descriptions

This Chapter shall not apply to pet food and feed for fur animals or feed for aquaculture animals.

The trade marks and sales descriptions bearing an indication referred to in Article 23(1) of Regulation (EC) No 834/2007 may be used only if at least 95 % of the product's dry matter is comprised of feed material from the organic production method.

Article 60 Indications on processed feed

1. Without prejudice to Articles 61 and 59, second paragraph of this Regulation, the terms referred to in Article 23(1) of Regulation (EC) 834/2007 may be used on processed feed provided that:

(a) the processed feed complies with the provisions of Regulation (EC) 834/2007 and in particular with Article 14(1) (d) (iv) and (v) and Article 18 thereof;

(b) the processed feed complies with the provisions of this Regulation and in particular with Articles 22 and 26 thereof;

(c) at least 95 % of the product's dry matter is organic.

2. Subject to the requirements laid down in points (a) and (b) of paragraph 1, the following statement is permitted in the case of products comprising variable quantities of feed materials from the organic production method and/or feed materials from products in conversion to organic farming and/or non-organic materials:

‘may be used in organic production in accordance with Regulations (EC) 834/2007 and (EC) 889/2008’

Article 61 Conditions for the use of indications on processed feed

1. The indication provided for in Article 60 shall be:

(a) separate from the wording referred to in Article 5 of Council Directive 79/373/EEC(13) or in Article 5(1) of Council Directive 96/25/EC(14);

(b) presented in a colour, format or character font that does not draw more attention to it than to the description or name of the animal feedingstuff referred to in Article 5(1)(a) of Directive 79/373/EEC or in Article 5(1)(b) of Directive 96/25/EC respectively;

(c) accompanied, in the same field of vision, by an indication by weight of dry matter referring:

(i)

to the percentage of feed material(s) from the organic production method;

(ii)

to the percentage of feed material(s) from products in conversion to organic farming;

(iii)

to the percentage of feed material(s) not covered by points (i) and (ii);

(iv)

to the total percentage of animal feed of agricultural origin;

(d) accompanied by a list of names of feed materials from the organic production method;

(e) accompanied by a list of names of feed materials from products in conversion to organic production.

2. The indication provided for in Article 60 may be also accompanied by a reference to the requirement to use the feedingstuffs in accordance with Articles 21 and 22.

CHAPTER 3 Other specific labelling requirements

Article 62 In-conversion products of plant origin

In-conversion products of plant origin may bear the indication ‘product under conversion to organic farming’ provided that:

(a)

a conversion period of at least 12 months before the harvest has been complied with;

(b)

the indication shall appear in a colour, size and style of lettering which is not more prominent than the sales description of the product, the entire indication shall have the same size of letters;

(c)

the product contains only one crop ingredient of agricultural origin;

(d)

the indication is linked to the code number of the control body or control authority as referred to in Article 27(10) of Regulation 834/2007.

TITLE IV CONTROLS

CHAPTER 1 Minimum control requirements

Article 63 Control arrangements and undertaking by the operator

1. When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:

(a) a full description of the unit and/or premises and/or activity;

(b) all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules;

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

Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator.

2. The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:

(a) to perform the operations in accordance with the organic production rules;

(b) to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;

(c) to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production.

The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures.

3. For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:

(a) Name and address of operator;

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

(c) Nature of operations and products;

(d) Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;

(e) In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned;

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

Article 64 Modification of control arrangements

The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.

Article 65 Control visits

1. The control authority or control body shall carry out at least once a year a physical inspection of all operators.

2. The control authority or control body may take samples for testing of products not authorised for organic production or for checking production techniques not in conformity with the organic production rules. Samples may also be taken and analysed for detecting possible contamination by products not authorised for organic production. However, such analysis shall be carried out where the use of products not authorised for organic production is suspected.

3. A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative.

4. Moreover, the control authority or control body shall carry out random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with the organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products.

Article 66 Documentary accounts

1. Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify:

(a) the supplier and, where different, the seller, or the exporter of the products;

(b) the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs;

(c) the nature and the quantities of organic products held in storage at the premises;

(d) the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities;

(e) in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.

2. The documentary accounts shall also comprise the results of the verification at reception of organic products and any other information required by the control authority or control body for the purpose of proper control. The data in the accounts shall be documented with appropriate justification documents. The accounts shall demonstrate the balance between the input and the output.

3. Where an operator runs several production units in the same area, the units for non organic products, together with storage premises for input products must also be subject to the minimum control requirements.

Article 67 Access to facilities

1. The operator shall:

(a) give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents;

(b) provide the control authority or control body with any information reasonably necessary for the purposes of the control;

(c) submit, when requested by the control authority or control body, the results of its own quality assurance programmes.

2. In addition to the requirements set out in paragraph 1, importers and first consignees shall submit the information on imported consignments referred to in Article 84.

Article 68 Documentary evidence

For the purpose of the application of Article 29(1) of Regulation (EC) No 834/2007 the control authorities and the control bodies shall use the model of the documentary evidence set out in Annex XII to this Regulation.

Article 69 Vendor declaration

For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.

CHAPTER 2 Specific control requirements for plants and plant products from farm production or collection

Article 70 Control arrangements

1. The full description of the unit referred to in Article 63(1)(a) shall:

(a) be drawn up even where the operator limits his activity to the collection of wild plants;

(b) indicate the storage and production premises and land parcels and/or collection areas and, where applicable, premises where certain processing and/or packaging operations take place; and

(c) specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which is not compatible with the organic production rules.

2. In case of collection of wild plants, the practical measures referred to in Article 63(1)(b) shall include any guarantees given by third parties which the operator can provide to ensure that the provisions of Article 12(2) of Regulation (EC) No 834/2007 are complied with.

Article 71 Communications

Each year, before the date indicated by the control authority or control body, the operator shall notify the control authority or control body of its schedule of production of crop products, giving a breakdown by parcel.

Article 72 Plant production records

Plant production records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. In addition to Article 71 such records shall provide at least the following information:

(a)

as regards the use of fertiliser: date of application, type and amount of fertiliser, parcels concerned;

(b)

as regards the use of plant protection products: reason and date of treatment, type of product, method of treatment;

(c)

as regards purchase of farm inputs: date, type and amount of purchased product;

(d)

as regards harvest: date, type and amount of organic or in conversion crop production.

Article 73 Several production units run by the same operator

Where an operator runs several production units in the same area, the units producing non-organic crops, together with storage premises for farm input products shall also be subject to the general and the specific control requirements laid down in Chapter 1 and this Chapter of this Title.

CHAPTER 3 Control requirements for livestock and livestock products produced by animal husbandry

Article 74 Control arrangements

1. When the control system applying specifically to livestock production is first implemented, the full description of the unit referred to in Article 63(1)(a) shall include:

(a) a full description of the livestock buildings, pasturage, open air areas, etc., and, where applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials and inputs;

(b) a full description of the installations for the storage of livestock manure.

2. The practical measures referred to in Article 63(1)(b) shall include:

(a) a plan for spreading manure agreed with the control body or authority, together with a full description of the areas given over to crop production;

(b) where appropriate, as regards the spreading of manure, the written arrangements with other holdings as referred to in Article 3(3) complying with the provisions of the organic production rules;

(c) a management plan for the organic-production livestock unit.

Article 75 Identification of livestock

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

Article 76 Livestock records

Livestock records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. Such records shall provide a full description of the herd or flock management system comprising at least the following information:

(a)

as regards animals arriving at the holding: origin and date of arrival, conversion period, identification mark and veterinary record;

(b)

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

(c)

details of any animals lost and reasons thereof;

(d)

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

(e)

as regards disease prevention and treatment and veterinary care: date of treatment, details of the diagnosis, the posology; type of treatment product, the indication of the active pharmacological substances involved method of treatment and veterinary prescription for veterinary care with reasons and withdrawal periods applying before livestock products can be marketed labelled as organic.

Article 77 Control measures on veterinary medicinal products for livestock

Whenever veterinary medicinal products are used the information according to Article 76(e) is to be declared to the control authority or body before the livestock or livestock products are marketed as organically produced. Livestock treated shall be clearly identified, individually in the case of large animals; individually, or by batch, or by hive, in the case of poultry, small animals and bees.

Article 78 Specific control measures on beekeeping

1. A map on an appropriate scale listing the location of hives shall be provided to the control authority or control body by the beekeeper. Where no areas are identified in accordance with Article 13(2), the beekeeper shall provide the control authority or control body with appropriate documentation and evidence, including suitable analyses if necessary, that the areas accessible to his colonies meet the conditions required in this Regulation.

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

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

4. The zone where the apiary is situated shall be registered together with the identification of the hives. The control body or authority shall be informed of the moving of apiaries by a deadline agreed on with the control authority or body.

5. Particular care shall be taken to ensure adequate extraction, processing and storage of beekeeping products. All the measures to comply with this requirement shall be recorded.

6. The removals of the supers and the honey extraction operations shall be entered in the register of the apiary.

Article 79 Several production units run by the same operator

Where an operator manages several production units, as provided for in Articles 17(1), 40 and 41, the units which produce non-organic livestock or non-organic livestock products shall also be subject to the control system as laid down in Chapter 1 and this Chapter of this Title.

CHAPTER 4 Control requirements for units for preparation of plant and livestock products and foodstuffs composed of plant and livestock products

Article 80 Control arrangements

In the case of a unit involved in the preparation for its own account or for account of a third party, and including in particular units involved in packaging and/or re-packaging of such products or units involved in labelling and/or re-labelling of such products, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception, the processing, packaging, labelling and storage of agricultural products before and after the operations concerning them, as well as the procedures for the transport of the products.

CHAPTER 5 Control requirements for imports of plants, plant products, livestock, livestock products and foodstuffs comprising plant and/or livestock products, animal feedingstuffs, compound feedingstuffs and feed materials from third countries

Article 81 Scope

This Chapter applies to any operator involved, as importer and/or as first consignee, in the import and/or reception, for its own account or for account of another operator, of organic products.

Article 82 Control arrangements

1. In the case of the importer, the full description of the unit referred to in Article 63(1)(a) shall include the importer's premises and of his import activities, indicating the points of entry of the products into the Community and any other facilities the importer intends to use for the storage of the imported products pending their delivery to the first consignee.

In addition, the declaration referred to in Article 63(2) shall include an undertaking by the importer to ensure that any facilities that the importer will use for storage of products are submitted to control, to be carried out either by the control body or control authority or, when these storage facilities are situated in another Member State or region, by a control body or authority approved for control in that Member State or region.

2. In the case of the first consignee, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception and storage.

3. Where the importer and the first consignee are the same legal person and operate in one single unit, the reports referred to in the second subparagraph of Article 63(2) may be formalised within one single report.

Article 83 Documentary accounts

The importer and the first consignee shall keep separate stock and financial records, unless where they are operating in one single unit.

On request of the control authority or control body, any details on the transport arrangements from the exporter in the third country to the first consignee and, from the first consignee's premises or storage facilities to the consignees within the Community shall be provided.

Article 84 Information on imported consignments

The importer shall, in due time, inform the control body or control authority of each consignment to be imported into the Community, providing:

(a)

the name and address of the first consignee;

(b)

any details the control body or authority may reasonably require,

(i)

in case of products imported in accordance with Article 32 of Regulation (EC) No 834/2007, the documentary evidence referred to in that Article;

(ii)

in case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, a copy of the certificate of inspection referred to in that Article.

On the request of the control body or control authority of the importer, the latter shall forward the information referred to in the first paragraph to the control body or control authority of the first consignee.

Article 85 Control visits

The control authority or control body shall check the documentary accounts referred to in Article 83 of this Regulation and the certificate referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 or the documentary evidence referred to in Article 32(1)(c) of the latter Regulation.

Where the importer performs the import operations by different units or premises, he shall make available on request the reports referred to in the second subparagraph of Article 63(2) of this Regulation for each of these facilities.

CHAPTER 6 Control requirements for units involved in the production, preparation or import of organic products and which have contracted out to third parties in part or in total the actual operations concerned

Article 86 Control arrangements

With regard to the operations, which are contracted out to third parties, the full description of the unit referred to in Article 63(1)(a) shall include:

(a)

a list of the subcontractors with a description of their activities and an indication of the control bodies or authorities to which they are subject;

(b)

written agreement by the subcontractors that their holding will be subject to the control regime of Title V of Regulation (EC) No 834/2007;

(c)

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

CHAPTER 7 Control requirements for units preparing feed

Article 87 Scope

This Chapter applies to any unit involved in the preparation of products referred to in Article 1(2)(c) of Regulation (EC) No 834/2007 on its own account or on behalf of a third party.

Article 88 Control arrangements

1. The full description of the unit referred to in Article 63(1)(a) shall indicate:

(a) the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them;

(b) the facilities used for the storage of other products used to prepare feedingstuffs;

(c) the facilities used to store products for cleaning and disinfection;

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

(e) where necessary, the name of the feed materials that the operator intends to prepare.

2. The measures to be taken by operators, as referred to in Article 63(1)(b), to guarantee compliance with the organic production rules shall include the indications of measures referred to in Article 26.

3. The control authority or control body shall use these measures to carry out a general evaluation of the risks attendant on each preparation unit and to draw up a control plan. This control plan shall provide for a minimum number of random samples depending on the potential risks.

Article 89 Documentary accounts

For the purposes of proper control of the operations, the documentary accounts referred to in Article 66 shall include information on the origin, nature and quantities of feed materials, additives, sales and finished products.

Article 90 Control visits

The control visit referred to in Article 65 shall comprise a full physical inspection of all premises. Moreover, the control authority or control body shall make targeted visits based on a general evaluation of the potential risks of non-compliance with the organic production rules.

The control body or authority shall pay particular attention to the critical control points pointed out for the operator, with a view to establishing whether the surveillance and checking operations are carried out correctly.

All the premises used by the operator for the conduct of his activities may be checked as frequently as the attendant risks warrant.

CHAPTER 8 Infringements and exchange of information

Article 91 Measures in case of suspicion of infringements and irregularities

1. Where an operator considers or suspects that a product which he has produced, prepared, imported or that he has received from another operator, is not in compliance with organic production rules, he shall initiate procedures either to withdraw from this product any reference to the organic production method or to separate and identify the product. He may only put it into processing or packaging or on the market after elimination of that doubt, unless it is placed on the market without indication referring to the organic production method. In case of such doubt, the operator shall immediately inform the control body or authority. The control authority or control body may require that the product cannot be placed on the market with indications referring to the organic production method until it is satisfied, by the information received from the operator or from other sources, that the doubt has been eliminated.

2. Where a control authority or control body has a substantiated suspicion that an operator intends to place on the market a product not in compliance with the organic production rules but bearing a reference to the organic production method, this control authority or control body can require that the operator may provisionally not market the product with this reference for a time period to be set by that control authority or control body. Before taking such a decision, the control authority or control body shall allow the operator to comment. This decision shall be supplemented by the obligation to withdraw from this product any reference to the organic production method if the control authority or control body is sure that the product does not fulfil the requirements of organic production.

However, if the suspicion is not confirmed within the said time period, the decision referred to in the first subparagraph shall be cancelled not later than the expiry of that time period. The operator shall cooperate fully with the control body or authority in resolving the suspicion.

3. Member States shall take whatever measures and sanctions are required to prevent fraudulent use of the indications referred to in Title IV of Regulation (EC) No 834/2007 and Title III and/or Annex XI of this Regulation.

Article 92 Exchange of information

1. Where the operator and his subcontractors are checked by different control authorities or control bodies, the declaration referred to in Article 63(2) shall include an agreement by the operator on his behalf and that of his subcontractors, that the different control bodies or control authorities can exchange information on the operations under their control and on the way this exchange of information can be implemented.

2. Where a Member State finds irregularities or infringements relating to the application of this Regulation in a product coming from another Member State and bearing indications as referred to in Title IV of Regulation (EC) No 834/2007 and Title III and/or Annex XI of this Regulation, it shall inform the Member State which designated the control body or control authority and the Commission thereby.

TITLE V TRANSMISSION OF INFORMATION TO THE COMMISSION, TRANSITIONAL AND FINAL PROVISIONS

CHAPTER 1 Transmission of information to the Commission

Article 93 Statistical information

1. Member States shall provide the Commission with the annual statistical information on organic production referred to in Article 36 of Regulation (EC) No 834/2007 by using the computer system enabling electronic exchanges of documents and information made available by the Commission (Eurostat) before 1 July each year.

2. The statistical information referred to in paragraph 1 shall comprise, in particular the following data:

(a) the number of organic producers, processors, importers and exporters;

(b) the organic crop production and crop area under conversion and under organic production;

(c) the organic livestock numbers and the organic animal products;

(d) the data on organic industrial production by type of activities.

3. For the transmission of the statistical information referred to in paragraphs 1 and 2, Member States shall use the Single Entry point provided by the Commission (Eurostat).

4. The provisions relating to the characteristics of statistical data and metadata shall be defined within the context of the Community Statistical Programme on the basis of models or questionnaires made available via the system referred to in paragraph 1.

Article 94 Other information

1. Member States shall provide the Commission with the following information by using the computer system enabling electronic exchanges of documents and information made available by the Commission (DG Agriculture and rural development) for information other than statistical information:

(a) before 1 January 2009, the information referred to in Article 35(a) of Regulation (EC) No 834/2007 and afterwards each modification when that appears;

(b) by 31 March each year, the information referred to in Article 35(b) of Regulation (EC) No 834/2007, as regards control authorities and bodies approved on 31 December of the previous year,

(c) before 1 July each year, all other information required or needed in accordance with this Regulation.

2. The data shall be communicated, entered and updated in the system referred to in paragraph 1 under the responsibility of the competent authority as referred to in Article 35 of Regulation (EC) No 834/2007, by the authority itself or by the body to which that function has been delegated.

3. The provisions relating to the characteristics of data and metadata shall be defined on the basis of models or questionnaires made available via the system referred to in paragraph 1.

CHAPTER 2 Transitional and final provisions

Article 95 Transitional measures

1. For a transitional period expiring on 31 December 2010, cattle may be tethered in buildings already existing before 24 August 2000, provided that regular exercise is provided and rearing takes place in line with animal welfare requirements with comfortably littered areas as well as individual management and provided that the competent authority has authorised this measure. The competent authority may continue authorising this measure upon request of individual operators for its application in a limited period ending before the 31 December 2013, under the additional condition that the controls visits referred to in Article 65(1) are carried out at least twice a year.

2. The competent authority may authorise, for a transitional period expiring on 31 December 2010, the exceptions concerning housing conditions and stocking density granted to livestock producing holdings on the basis of the derogation provided for in part B, paragraph 8.5.1 of Annex I to Regulation (EEC) No 2092/91. The operators benefiting from this extension shall present a plan to the control authority or control body, containing the description of arrangements which are intended to ensure compliance with the provisions of the organic production rules by the end of the transitional period. The competent authority may continue authorising this measure upon request of individual operators for its application in a limited period ending before the 31 December 2013, under the additional condition that the controls visits referred to in Article 65(1) are carried out at least twice a year.

3. For a transition period expiring 31 December 2010 the final fattening phase of sheep and pigs for meat production as laid down under point 8.3.4 of Annex I.B of Regulation (EEC) No 2092/91 may take place indoors under the condition that the controls visits referred to in Article 65(1) are carried out at least twice a year.

4. The castration of piglets may be carried out without the application of anaesthesia and/or analgesia during a transition period expiring on 31 December 2011.

5. Pending the inclusion of detailed processing rules for pet food, national rules or in the absence thereof, private standards accepted or recognised by the Member States shall apply.

6. For the purpose of Article 12(1)(j) of Regulation (EC) No 834/2007 and pending the inclusion of specific substances according to Article 16(f) of that Regulation, only products authorised by the competent authorities may be used.

7. Authorisations of non-organic ingredients of agricultural origin granted by Member States under Regulation (EEC) No 207/93 may be deemed granted as under this Regulation. However, authorisations granted in accordance with Article 3(6) of the former Regulation shall expire on 31 December 2009.

8. For a transitional period expiring on the 1 July 2010, the operators may continue to use in the labelling the provisions as laid down in Regulation (EEC) No 2092/91 for:

(i)

the system for calculation the percentage of organic ingredients of food;

(ii)

the code number and/or the name of the control body or control authority.

9. Stocks of products produced, packaged and labelled before 1 January 2009 in accordance with Regulation (EEC) No 2092/91 may continue to be brought on the market bearing terms referring to organic production until stocks are exhausted.

10. Packaging material in accordance with Regulation (EEC) No 2092/91 may continue to be used for products brought to the market bearing terms referring to organic production until 1 January 2012, where the product otherwise complies with the requirements of Regulation (EC) 834/2007.

Article 96 Repeal

Regulations (EEC) No 207/93, (EC) No 223/2003 and (EC) No 1452/2003 are repealed.

References to the repealed Regulations and to Regulation (EEC) No 2092/91 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIV.

Article 97 Entry into force and application

This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.

It shall apply as from 1 January 2009.

However, paragraph 2(a) of Article 27 and Article 58 shall apply as of 1 July 2010.

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

Done at Brussels, 5 September 2008.

For the Commission

Mariann Fischer Boel

Member of the Commission