Legalize / European Union / Regulation

Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007

Type Regulation

Publication 2018-06-14

Last updated 2025-03-25

State In force

Department Council of the European Union, European Parliament

Source EUR-Lex

articles 61

Reform history JSON API

1.5.1.7. 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. Rodenticides, to be used only in traps, and products and substances authorised pursuant to Articles 9 and 24 for use in organic production may be used for the elimination of insects and other pests in buildings and other installations where livestock are kept.

1.5.2. Veterinary treatment

1.5.2.1. Where animals become sick or injured despite preventive measures to ensure animal health, they shall be treated immediately.

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

1.5.2.3. Feed materials of mineral origin authorised pursuant to Article 24 for use in organic production, nutritional additives authorised pursuant to Article 24 for use in organic production, and phytotherapeutic and homeopathic products shall be used in preference to treatment with chemically synthesised allopathic veterinary medicinal products, including antibiotics, provided that their therapeutic effect is effective for the species of animal and for the condition for which the treatment is intended.

1.5.2.4. With the exception of vaccinations, treatments for parasites and compulsory eradication schemes, where an animal or a group of animals receives more than three courses of treatments with chemically synthesised allopathic veterinary medicinal products, including antibiotics, within 12 months, or more than one course of treatment if their productive lifecycle is less than one year, neither the livestock concerned nor produce derived from such livestock shall be sold as organic products, and the livestock shall be subject to the conversion periods referred to in point 1.2.

1.5.2.5. The withdrawal period between the last administration to an animal of a chemically synthesised allopathic veterinary medicinal product, including of an antibiotic, under normal conditions of use, and the production of organically produced foodstuffs from that animal shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC, and shall be at least 48 hours.

1.5.2.6. Treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed.

1.5.2.7. Operators shall keep records or documentary evidence of any treatment applied and, in particular, the identification of the animals treated, the date of treatment, diagnosis, the posology, the name of the treatment product and, where applicable, the veterinary prescription for veterinary care, and the withdrawal period applied before livestock products can be marketed and labelled as organic.

1.6. Housing and husbandry practices

1.6.1. 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 ensure the well-being of the animals. The building shall permit plentiful natural ventilation and light to enter.

1.6.2. Housing for livestock shall not be mandatory in areas with appropriate climatic conditions enabling animals to live outdoors. In such cases, animals shall have access to shelters or shady areas to protect them from adverse weather conditions.

1.6.3. The stocking density in buildings shall provide for the comfort, well-being and species-specific needs of the animals, and shall depend in particular 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, to move, to lie down easily, to turn round, to groom themselves, to assume all natural postures and to make all natural movements, such as stretching and wing flapping.

1.6.4. The minimum surface for indoor and outdoor areas, and the technical details relating to housing, laid down in the implementing acts referred to in Article 14(3), shall be complied with.

1.6.5. Open air areas may be partially covered. Verandas shall not be considered as open air areas.

1.6.6. The total stocking density shall not exceed the limit of 170 kg of organic nitrogen per year and hectare of agricultural area.

1.6.7. To determine the appropriate density of livestock referred to in point 1.6.6, the competent authority shall set out the livestock units equivalent to the limit referred to in point 1.6.6, following the figures laid down in each of the specific requirements per type of animal production.

1.6.8. Cages, boxes and flat decks to raise livestock shall not be used for any livestock species.

1.6.9. When livestock is treated individually for veterinary reasons, it shall be kept in spaces that have a solid floor and shall be provided with straw or appropriate bedding. The animal must be able to turn around easily and to lie down comfortably at full length.

1.6.10. Organic livestock may not be reared in a pen on very wet or marshy soil.

1.7. Animal welfare

1.7.1. All persons involved in keeping animals and in handling animals during transport and slaughter shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of the animals and shall have followed adequate training, as required in particular in Council Regulation (EC) No 1/2005 ([^E0026]) and Council Regulation No (EC) 1099/2009 ([^E0027]), to ensure proper application of the rules set out in this Regulation.

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

1.7.3. Livestock shall have permanent access to open air areas that allow the animals to exercise, preferably pasture, whenever weather and seasonal conditions and the state of the ground allow, except where restrictions and obligations related to the protection of human and animal health have been imposed on the basis of Union legislation.

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

1.7.5. Tethering or isolation of livestock shall be prohibited, except in relation to individual animals for a limited period and insofar as this is justified for veterinary reasons. The isolation of livestock may only be authorised, and only for a limited period, where workers’ safety is compromised or for animal welfare reasons. Competent authorities may authorise the tethering of cattle in farms with a maximum of 50 animals (excluding young stock) where 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, and have access to open air areas at least twice a week when grazing is not possible.

1.7.6. Duration of transport of livestock shall be minimised.

1.7.7. Any suffering, pain and distress shall be avoided and shall be kept to a minimum during the entire life of the animal, including at the time of slaughter.

1.7.8. Without prejudice to developments in Union legislation on animal welfare, tail-docking of sheep, beak trimming undertaken in the first three days of life, and dehorning may exceptionally be allowed, but only on a case-by-case basis and only when those practices improve the health, welfare or hygiene of the livestock or where workers’ safety would otherwise be compromised. Disbudding may be allowed only on a case by case basis when it improves the health, welfare or hygiene of the livestock or where workers’ safety would otherwise be compromised. The competent authority shall only authorise such operations where the operator has duly notified and justified the operations to that competent authority and where the operation is to be carried out by qualified personnel.

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

1.7.10. Physical castration shall be allowed in order to maintain the quality of products and traditional production practices, but only under the conditions set out in point 1.7.9.

1.7.11. The loading and unloading of animals shall be carried out without the use of any type of electrical or other painful stimulation to coerce the animals. The use of allopathic tranquillisers, prior to or during transport, shall be prohibited.

1.7.12. Operators shall keep records or documentary evidence of any specific operation applied and justifications for the application of point 1.7.5, 1.7.8, 1.7.9 or 1.7.10. As regards animals leaving the holding, the following data shall be recorded, where relevant: age, number of animals, weight of slaughter animals, appropriate identification (per animal or by batch/flock/hive) date of departure and destination.

1.8. Preparation of unprocessed products

If preparation operations other than processing are carried out on livestock, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations.

1.9. Additional general rules

1.9.1. For bovine animals, ovine animals, caprine animals and equine animals

1.9.1.1. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at least 60 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2024;

(b) animals shall have access to pasturage for grazing whenever conditions allow;

(d) where animals have access to pasturage during the grazing period and where the winter housing system allows the animals to move freely, the obligation to provide open air areas during the winter months may be waived;

(e) rearing systems shall be based on maximum use of grazing pasturage, by reference to the availability of pastures in the different periods of the year;

(f) at least 60 % of the dry matter in daily rations shall consist of roughage, fresh or dried fodder, or silage. This percentage may be reduced to 50 % for animals in dairy production for a maximum period of three months in early lactation.

1.9.1.2. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) housing shall have smooth, but not slippery floors;

(b) housing shall be provided with a comfortable, clean and dry laying or rest area of sufficient size, which shall consist 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 that is authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production;

(c) notwithstanding point (a) of the first subparagraph of Article 3(1) and the second subparagraph of Article 3(1) of Council Directive 2008/119/EC ([^E0028]), the housing of calves in individual boxes shall be forbidden after the age of one week, unless for individual animals for a limited period, and insofar as this is justified for veterinary reasons;

(d) when a calf is treated individually for veterinary reasons, it shall be kept in spaces that have a solid floor and shall be provided with straw bedding. The calf must be able to turn around easily and to lie down comfortably at full length.

1.9.2. For cervine animals

1.9.2.1. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at least 60 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region. This percentage shall be raised to 70 % as from 1 January 2024;

(b) animals shall have access to pasturage for grazing whenever conditions allow;

(c) where animals have access to pasturage during the grazing period and where the winter housing system allows the animals to move freely, the obligation to provide open air areas during the winter months may be waived;

(d) rearing systems shall be based on maximum use of grazing pasturage by reference to the availability of pastures in the different periods of the year;

(e) at least 60 % of the dry matter in daily rations shall consist of roughage, fresh or dried fodder, or silage. This percentage may be reduced to 50 % for female cervine animals in milk production for a maximum period of three months in early lactation;

(f) natural grazing shall be ensured in a pen during the period of vegetation. Pens that cannot provide feed by grazing during the period of vegetation shall not be allowed;

(g) feeding shall only be allowed in the event of a shortage of grazing due to poor weather conditions;

(h) farmed animals in a pen shall be provided with clean and fresh water. If a natural source of water that is easily accessible to animals is not available, watering places shall be provided.

1.9.2.2. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) cervine animals shall be provided with hiding places, shelters and fences that do not harm animals;

(b) in red deer pens, animals must be able to roll in the mud to ensure skin grooming and body temperature regulation;

(d) any housing shall be provided with a comfortable, clean and dry laying or 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 authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production;

(e) feeding places shall be installed in areas protected from the weather and accessible both to animals and to persons attending to them. The soil where feeding places are located shall be consolidated, and the feeding apparatus shall be equipped with a roof;

(f) if permanent access to feed cannot be ensured, the feeding places shall be designed so that all animals can feed at the same time.

1.9.3. For porcine animals

1.9.3.1. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at least 30 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region;

(b) roughage, fresh or dried fodder, or silage shall be added to the daily ration;

(c) where farmers are unable to obtain protein feed exclusively from organic production, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2026 provided that the following conditions are fulfilled:
(i) it is not available in organic form;
(ii) it is produced or prepared without chemical solvents;
(iii) its use is limited to the feeding of piglets of up to 35 kg with specific protein compounds; and
(iv) the maximum percentage authorised per period of 12 months for those animals does not exceed 5 %. The percentage of the dry matter of feed from agricultural origin shall be calculated.

1.9.3.2. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) the housing shall have smooth, but not slippery floors;

(b) the housing shall be provided with a comfortable, clean and dry laying or 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 authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production;

(c) there shall always be a bed made of straw or other suitable material large enough to ensure that all pigs in a pen can lie down at the same time in the most space-consuming way;

(d) sows shall be kept in groups, except in the last stages of pregnancy and during the suckling period, during which time the sow must be able to move freely in her pen and her movement shall only be restricted for short periods;

(e) without prejudice to any additional requirements for straw, a few days before expected farrowing, sows shall be provided with a quantity of straw or other suitable natural material sufficient to enable them to build nests;

(f) exercise areas shall permit dunging and rooting by porcine animals. For the purposes of rooting, different substrates may be used.

1.9.4. For poultry

1.9.4.1. Origin of animals

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 adapted to outdoor rearing.

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

Where slow-growing poultry strains are not used by the farmer, the minimum age at slaughter shall be as follows:

(a) 81 days for chickens;

(b) 150 days for capons;

(d) 70 days for female Muscovy ducks;

(e) 84 days for male Muscovy ducks;

(f) 92 days for Mulard ducks;

(g) 94 days for guinea fowl;

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

(i) 100 days for female turkeys.

1.9.4.2. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at least 30 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region;

(b) roughage, fresh or dried fodder, or silage shall be added to the daily ration;

(c) where farmers are unable to obtain protein feed exclusively from organic production for poultry species, and the competent authority has confirmed that organic protein feed is not available in sufficient quantity, non-organic protein feed may be used until 31 December 2026, provided that the following conditions are fulfilled:
(i) it is not available in organic form;
(ii) it is produced or prepared without chemical solvents;
(iii) its use is limited to the feeding of young poultry with specific protein compounds; and
(iv) the maximum percentage authorised per period of 12 months for those animals does not exceed 5 %. The percentage of the dry matter of feed of agricultural origin shall be calculated.

1.9.4.3. Animal welfare

Live plucking of poultry shall be prohibited.

1.9.4.4. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) at least one third of the floor area shall be solid, that is, not of slatted or of grid construction, and shall be 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) buildings shall be emptied of livestock between each batch of poultry that has been 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 during a period to be established by the Member States in order to allow vegetation to grow back. The operator shall keep records or documentary evidence of the application of such period. Those requirements shall not apply where poultry are not reared in batches, are not kept in runs and are free to roam throughout the day;

(d) poultry shall have access to an open air area for at least one third of their life. However, laying hens and finisher poultry shall have access to an open air area for at least one third of their life, except where temporary restrictions have been imposed on the basis of Union legislation;

(e) continuous daytime open air access shall be provided from as early an age as practically possible and whenever physiological and physical conditions allow, except where temporary restrictions have been imposed on the basis of Union legislation;

(f) by way of derogation from point 1.6.5, in the case of breeding birds and pullets aged under 18 weeks, when the conditions specified in point 1.7.3 as regards restrictions and obligations related to the protection of human and animal health imposed on the basis of Union legislation are met and prevent breeding birds and pullets aged under 18 weeks from having access to open air areas, verandas shall be considered as open air areas and, in such cases, shall have a wire mesh barrier to keep other birds out;

(g) open air areas for poultry shall permit fowl to have easy access to adequate numbers of drinking troughs;

(h) open air areas for poultry shall be covered mainly with vegetation;

(i) under conditions where feed availability from the range area is limited, for example, due to long term snow cover or arid weather conditions, supplementary feeding of roughage shall be included as part of poultry diets;

(j) where poultry are kept indoors due to restrictions or obligations imposed on the basis of Union legislation, they shall have permanent access to sufficient quantities of roughage and suitable material in order to meet their ethological needs;

(k) 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; when weather conditions do not permit such access, they shall have access to water which enables them to dip their head therein so as to clean plumage;

(l) 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;

(m) the total usable surface area for fattening poultry in poultry houses of any production unit shall not exceed 1 600 m²;

(n) not more than 3 000 laying hens shall be allowed in a single compartment of a poultry house.

1.9.5. For rabbits

1.9.5.1. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at least 70 % of the feed shall come from the farm itself or, if this is not feasible or such feed is not available, shall be produced in cooperation with other organic or in-conversion production units and feed operators using feed and feed material from the same region;

(b) rabbits shall have access to pasturage for grazing whenever conditions allow;

(c) rearing systems shall be based on maximum use of grazing pasturage by reference to the availability of pastures in the different periods of the year;

(d) fibrous feed such as straw or hay shall be provided when grass is not sufficient. Forage shall comprise at least 60 % of the diet.

1.9.5.2. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) housing shall be provided with a comfortable, clean and dry laying or 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 authorised pursuant to Article 24 as a fertiliser or soil conditioner for use in organic production;

(b) rabbits shall be kept in groups.

(d) rabbits shall have access to:
(i) covered shelter including dark hiding places;
(ii) an outdoor run with vegetation, preferably pasture;
(iii) a raised platform on which they can sit, either inside or out;
(iv) nesting material for all nursing does.

1.9.6. For bees

1.9.6.1. Origin of animals

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

1.9.6.2. Nutrition

With regard to nutrition, the following rules shall apply:

(a) at the end of the production season hives shall be left with sufficient reserves of honey and pollen for the bees to survive the winter;

(b) bee colonies may only be fed where the survival of the colony is endangered due to climatic conditions. In such case, bee colonies shall be fed with organic honey, organic pollen, organic sugar syrups, or organic sugar.

1.9.6.3. Health care

With regard to health care, the following rules shall apply:

(a) for the purposes of protecting frames, hives and combs, in particular from pests, only rodenticides used in traps, and appropriate products and substances authorised pursuant to Articles 9 and 24 for use in organic production shall be permitted;

(b) physical treatments for disinfection of apiaries such as steam or direct flame shall be permitted;

(c) the practice of destroying the male brood shall only be permitted for the purpose of isolating the infestation of Varroa destructor;

(d) if, despite all preventive measures, the colonies become sick or infested, they shall be treated immediately and, if necessary, may be placed in isolation apiaries;

(e) 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;

(f) if a treatment is applied with chemically synthesised allopathic products, including antibiotics, other than products and substances authorised pursuant to Articles 9 and 24 for use in organic production, for the duration of that treatment, the treated colonies shall be placed in isolation apiaries and all the wax shall be replaced with wax coming from organic beekeeping. Subsequently, the conversion period of 12 months laid down in point 1.2.2 shall apply to those colonies.

1.9.6.4. Animal welfare

With regard to beekeeping, the following additional general rules shall apply:

(a) the destruction of bees in the combs as a method associated with the harvesting of apiculture products shall be prohibited;

(b) mutilation such as clipping the wings of queen bees shall be prohibited.

1.9.6.5. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) apiaries shall be placed in areas which ensure the availability of nectar and pollen sources consisting essentially of organically produced crops or, where appropriate, of spontaneous vegetation or non-organically managed forests or crops that are only treated with low environmental impact methods;

(b) apiaries shall be kept at sufficient distance from sources that may lead to the contamination of apiculture products or to the poor health of the bees;

(c) 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 or spontaneous vegetation or crops treated with low environmental impact methods equivalent to those provided for in Articles 28 and 30 of Regulation (EU) No 1305/2013 which cannot affect the qualification of beekeeping production as being organic. That requirement does not apply where flowering is not taking place, or the bee colonies are dormant;

(d) the hives and materials used in beekeeping shall be made basically of natural materials presenting no risk of contamination to the environment or the apiculture products;

(e) the beeswax for new foundations shall come from organic production units;

(f) only natural products such as propolis, wax and plant oils may be used in the hives;

(g) synthetic chemical repellents shall not be used during honey extraction operations;

(h) brood combs shall not be used for honey extraction;

(i) beekeeping shall not be considered as organic when practiced in regions or areas designated by Member States as regions or areas where organic beekeeping is not practicable.

1.9.6.6. Record-keeping obligations

Operators shall keep a map on an appropriate scale or geographic coordinates of the location of hives to be provided to the control authority or control body demonstrating that the areas accessible to the colonies meet the requirements of this Regulation.

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

The zone where the apiary is situated shall be recorded together with the identification of the hives and the period of moving.

All the measures applied shall be recorded in the register of the apiary, including the removals of the supers and the honey extraction operations. The amount and dates of the collection of honey shall also be recorded.

Part III: Production rules for algae and aquaculture animals

1. General requirements

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

1.2. Organic and non-organic production units shall be adequately separated in accordance with the minimum separation distances set by Member States, where applicable. Such separation measures shall be based on the natural situation, separate water distribution systems, distances, the tidal flow, and the upstream and the downstream location of the organic production unit. Algae and aquaculture production shall not be considered as organic when practiced at locations or in areas designated by Member State authorities as locations or areas which are unsuitable for such activities.

1.3. An environmental assessment that is appropriate to the production unit shall be required for any new operators applying for organic production and producing more than 20 tonnes of aquaculture products per year to ascertain the conditions of the production unit and its immediate environment and likely effects of its operation. The operator shall provide the environmental assessment to the control authority or control body. The content of the environmental assessment shall be based on Annex IV to Directive 2011/92/EU of the European Parliament and of the Council ([^E0029]). If the production unit has already been subject to an equivalent assessment, that assessment may be used for this purpose.

1.4. Mangrove destruction shall not be permitted.

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

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

1.7. Defensive and preventive measures taken against predators in accordance with Directive 92/43/EEC and national rules shall be recorded in the sustainable management plan.

1.8. Where applicable, coordination shall take place with the neighbouring operators in drawing up the management plan.

1.9. Aquaculture and algae business operators shall draw up as part of the sustainable management plan a waste reduction schedule to be put in place at the commencement of operations. Where possible, the use of residual heat shall be limited to energy from renewable sources.

1.10. Preparation of unprocessed products

If preparation operations, other than processing, are carried out on algae or aquaculture animals, the general requirements laid down in points 1.2, 1.3, 1.4, 1.5 and 2.2.3 of Part IV shall apply mutatis mutandis to such operations.

1.11. Operators shall keep available documentary evidence on any derogation from production rules for aquaculture animals obtained in accordance with points 3.1.2.1(d) and (e).

2. Requirements for algae

In addition to the general production rules laid down in Articles 9, 10, 11 and 15, and where relevant in Section 1 of this Part, the rules laid down in this Section shall apply to the organic collection and production of algae. Those rules shall apply mutatis mutandis to the production of phytoplankton.

2.1. Conversion

2.1.1. The conversion period for a production unit for algae collection shall be six months.

2.1.2. The conversion period for a production unit for algae cultivation shall be a period of six months or one full production cycle, whichever is the longer.

2.2. Production rules for algae

2.2.1. The collection of wild algae and parts thereof is considered as organic production provided that:

(a) the growing areas are suitable from a health point of view and are of high ecological status as defined by Directive 2000/60/EC, or are of equivalent quality to:
— the production zones classed as A and B in Regulation (EC) No 854/2004 of the European Parliament and of the Council ([^E0030]), until 13 December 2019, or
— the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019;

(b) the collection does not affect significantly the stability of the natural ecosystem or the maintenance of the species in the collection area.

2.2.2. The cultivation of algae shall take place in areas with environmental and health characteristics at least equivalent to those outlined in point 2.2.1(a) in order to be considered organic. In addition the following production rules shall apply:

(a) sustainable practices shall be used in all stages of production, from the collection of juvenile algae to harvesting;

(b) to ensure that a wide gene-pool is maintained, the collection of juvenile algae in the wild shall take place on a regular basis so as to maintain and increase the diversity of indoor culture stock;

(c) fertilisers shall not be used, except in indoor facilities, and only if they have been authorised pursuant to Article 24 for use in organic production for this purpose. Operators shall keep records of the use of those products, including the date or dates on which each product was used, the name of the product, and the amount applied, with information on the lots/tanks/basins concerned.

2.3. Algae cultivation

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

2.3.2. In facilities on land where external nutrient sources are used, the nutrient levels in the effluent water shall be verifiably the same, or lower, than the inflowing water. Only nutrients of plant or mineral origin authorised pursuant to Article 24 for use in organic production may be used.

Operators shall keep records of the use of those products, including the date or dates on which the product are used, the name of the product, and the amount applied with information on the lots/tanks/basins concerned.

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

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

2.4. Sustainable collection of wild algae

2.4.1. A once-off biomass estimate shall be undertaken at the outset of algae collection.

2.4.2. Documentary accounts shall be maintained in the unit or premises and shall enable the operator to identify and the control authority or control body to verify that the collectors have supplied only wild algae produced in accordance with this Regulation.

2.4.3. Collection shall be carried out in such a way that the amounts collected do not cause a significant impact on the state of the aquatic environment. Measures such as collection technique, minimum sizes, ages, reproductive cycles or size of remaining algae shall be taken to ensure that algae can regenerate and to ensure that by-catches are prevented.

2.4.4. If algae are collected from a shared or common collection area, documentary evidence produced by the relevant authority designated by the Member State concerned shall be available showing that the total collection complies with this Regulation.

3. Requirements for aquaculture animals

In addition to the general production rules laid down in Article 9, 10, 11 and 15, and where relevant in Section 1 of this Part, the rules laid down in this Section shall apply to the organic production of species of fish, crustaceans, echinoderms and molluscs. Those rules also shall apply mutatis mutandis to the production of zooplankton, micro-crustaceans, rotifers, worms and other aquatic feed animals.

3.1. General requirements

3.1.1. Conversion

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

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

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

(d) for open water facilities, including those producing bivalve molluscs, a conversion period of three months.

3.1.2. Origin of aquaculture animals

3.1.2.1. With regard to the origin of the aquaculture animals, the following rules shall apply:

(a) organic aquaculture shall be based on the rearing of young stock originating from organic broodstock and from organic production units;

(b) locally grown species shall be used, and breeding shall aim to produce strains which are better adapted to production conditions, ensuring good animal health and welfare and good utilisation of feed resources. Documentary evidence of their origin and treatment shall be provided for the competent authority, or, where appropriate, the control authority or control body;

(d) for breeding purposes, wild-caught or non-organic aquaculture animals may be brought into a holding only in duly justified cases where no organic breed is available or where new genetic stock for breeding purposes is brought into the production unit after an authorisation has been granted by the competent authority with a view to improving the suitability of genetic stock. Such animals shall be kept under organic management for at least three months before they may be used for breeding. For animals that are on the IUCN Red List of endangered species, the authorisation to use wild-caught specimens may only be granted in the context of conservation programmes recognised by the relevant public authority in charge of the conservation effort;

(e) for on-growing purposes, the collection of wild aquaculture juveniles shall be specifically restricted to the following cases:
(i) natural influx of fish or crustacean larvae and juveniles when filling ponds, containment systems and enclosures;
(ii) restocking of wild fry or crustacean larvae of species that are not on the IUCN Red List of endangered species in extensive aquaculture farming inside wetlands, such as brackish water ponds, tidal areas and costal lagoons, provided that:
— the restocking is in line with management measures approved by the relevant authorities to ensure the sustainable exploitation of the species concerned, and
— the animals are fed exclusively with feed naturally available in the environment. By way of derogation from point (a), Member States may authorise the introduction for on-growing purposes on an organic production unit of a maximum of 50 % of non-organic juveniles of species that were not developed as organic in the Union by 1 January 2022 , provided that at least the latter two thirds of the duration of the production cycle are managed under organic management. Such derogation may be granted for a maximum period of two years and shall not be renewable. For aquaculture holdings situated outside the Union, such derogation may only be granted by control authorities or control bodies that have been recognised in accordance with Article 46(1) for species that were not developed as organic in either the territory of the country in which the holding is located or the Union. Such derogation may be granted for a maximum period of two years and shall not be renewable.

3.1.2.2. With regard to breeding, the following rules shall apply:

(a) hormones and hormone-derivates shall not be used;

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

3.1.2.3. Juvenile production

In the larval rearing of marine fish species, rearing systems (preferably the ‘mesocosm’ or ‘large volume rearing’) may be used. Those rearing systems shall meet the following requirements:

(a) the initial stocking density shall be below 20 eggs or larvae per litre;

(b) the larval rearing tank shall have a volume of minimum 20 m³; and

(c) the larvae shall feed on the natural plankton developing in the tank, supplemented as appropriate by externally produced phytoplankton and zooplankton.

3.1.2.4. Operators shall keep records of the origin of animals, identifying the animals/batches of animals, the date of arrival and type of species, the quantities, the organic or non-organic status, and the conversion period.

3.1.3. Nutrition

3.1.3.1. With regard to feed for fish, crustaceans and echinoderms, the following rules shall apply:

(a) animals shall be fed with feed that meets the animals’ nutritional requirements at the various stages of its development;

(b) feeding regimes shall be designed with the following priorities:
(i) animal health and welfare;
(ii) high product quality, including the nutritional composition of the product, which shall ensure high quality of the final edible product;
(iii) low environmental impact;

(c) the plant fraction of feed shall be organic and the feed fraction derived from aquatic animals shall originate from organic aquaculture or from fisheries that have been certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013;

(d) non-organic feed materials of plant, animal, algal or yeast origin, feed materials of mineral or microbial origin, feed additives, and processing aids shall only be used if they have been authorised under this Regulation for use in organic production;

(e) growth promoters and synthetic amino-acids shall not be used.

3.1.3.2. With regard to bivalve molluscs and other species which are not fed by man, but instead feed on natural plankton, the following rules shall apply:

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

(b) the growing areas shall be suitable from a health point of view and shall either be of high ecological status as defined by Directive 2000/60/EC or of good environmental status as defined by Directive 2008/56/EC or of equivalent quality to:
— the production zones classed as A in Regulation (EC) No 854/2004, until 13 December 2019, or
— the corresponding classification areas set out in the implementing acts adopted by the Commission in accordance with Article 18(8) of Regulation (EU) 2017/625, from 14 December 2019.

3.1.3.3. Specific rules on feed for carnivorous aquaculture animals

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

(a) organic feed of aquaculture origin;

(b) fish meal and fish oil from organic aquaculture trimmings sourced from fish, crustaceans or molluscs;

(c) fish meal and fish oil and feed material of fish origin derived from trimmings of fish, crustaceans or molluscs already caught for human consumption in sustainable fisheries;

(d) fish meal and fish oil and feed material of fish origin derived from whole fish, crustaceans or molluscs caught in sustainable fisheries and not used for human consumption;

(e) organic feed materials of plant or animal origin.

3.1.3.4. Specific rules on feed for certain aquaculture animals

In the grow-out phase, fish in inland waters, penaeid shrimps and freshwater prawns and tropical freshwater fish shall be fed as follows:

(a) they shall be fed with feed naturally available in ponds and lakes;

(b) where natural feed referred to in point (a) is not available in sufficient quantities, organic feed of plant origin, preferably grown on the farm itself, or algae may be used. Operators shall keep documentary evidence of the need to use additional feed;

(c) where natural feed is supplemented in accordance with point (b):
(i) the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) may consist of a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries;
(ii) the feed ration of siamese catfish (Pangasius spp.) may consist of a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries.

In the grow-out phase and in earlier life stages in nurseries and hatcheries, organic cholesterol may be used to supplement the diets of penaeid shrimps and freshwater prawns (Macrobrachium spp.), in order to secure their quantitative dietary need.

3.1.3.5. Operators shall keep records of specific feeding regimes, in particular, on the name and quantity of feed and the use of additional feed, and the respective animals/batches of animals fed.

3.1.4. Health care

3.1.4.1. Disease prevention

With regard to disease prevention, the following rules shall apply:

(a) disease prevention shall be based on keeping the animals in optimal conditions by appropriate siting, taking into account, inter alia, the species’ requirements for good water quality, flow and exchange rate, the optimal design of the holdings, the application of good husbandry and management practices, including regular cleaning and disinfection of premises, high-quality feed, appropriate stocking density, and breed and strain selection;

(b) immunological veterinary medicines may be used;

(c) an animal health management plan shall detail biosecurity and disease prevention practices including a written agreement for health counselling, proportionate to the production unit, with qualified aquaculture animal health services who shall visit the farm at a frequency of not less than once per year or, in the case of bivalve shellfish, not less than once every two years;

(d) holding systems, equipment and utensils shall be properly cleaned and disinfected;

(e) bio-fouling organisms shall be removed only by physical means or by hand and where appropriate returned to the sea at a distance from the farm;

(f) only substances for cleaning and disinfection of equipment and facilities authorised pursuant to Article 24 for use in organic production may be used;

(g) with regard to fallowing, the following rules shall apply:
(i) the competent authority, or, where appropriate, control authority or control body, shall determine whether fallowing is necessary and shall determine the appropriate duration which shall be applied and documented after each production cycle in open water containment systems at sea;
(ii) it shall not be mandatory for bivalve mollusc cultivation;
(iii) during fallowing the cage or other structure used for aquaculture animal production is emptied, disinfected and left empty before being used again;

(h) where appropriate, uneaten fish-feed, faeces and dead animals shall be removed promptly to avoid any risk of significant environmental damage as regards water status quality, to minimise disease risks, and to avoid attracting insects or rodents;

(i) ultraviolet light and ozone may only be used in hatcheries and nurseries;

(j) for biological control of ectoparasites, preference shall be given to the use of cleaner fish and to the use of freshwater, marine water and sodium chloride solutions.

3.1.4.2. Veterinary treatments

With regard to veterinary treatments, the following rules shall apply:

(a) disease shall be treated immediately to avoid suffering to the animal. Chemically synthesised allopathic veterinary medicinal products, including antibiotics, may be used where necessary, under strict conditions and under the responsibility of a veterinarian, where the use of phytotherapeutic, homeopathic and other products is inappropriate. Where appropriate, restrictions with respect to courses of treatment and withdrawal periods shall be defined;

(b) treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed;

(c) when despite preventive measures to ensure animal health referred to in point 3.1.4.1 a health problem arises, veterinary treatments may be used in the following order of preference:
(i) substances from plants, animals or minerals in a homoeopathic dilution;
(ii) plants and their extracts not having anaesthetic effects; and
(iii) substances such as trace elements, metals, natural immunostimulants or authorised probiotics;

(d) the use of allopathic treatments shall be limited to two courses of treatment per year, with the exception of vaccinations and compulsory eradication schemes. However, in the cases of a production cycle of less than a year, a limit of one allopathic treatment shall apply. Where the indicated limits for allopathic treatments are exceeded, the aquaculture animals concerned shall not be marketed as organic products;

(e) the use of parasite treatments, other than through compulsory control schemes operated by Member States, shall be limited as follows:
(i) for salmon, to maximum two courses of treatment per year, or to one course of treatment per year where the production cycle is less than 18 months;
(ii) for all species other than salmon, to two courses of treatment per year, or to one course of treatment per year where the production cycle is less than 12 months;
(iii) for all species, to no more than four courses of treatment in total, regardless of the length of the production cycle of the species;

(f) the withdrawal period for allopathic veterinary treatments and parasite treatments in accordance with point (d), including treatments under compulsory control and eradication schemes, shall be twice the withdrawal period referred to in Article 11 of Directive 2001/82/EC or, where this period is not specified, 48 hours;

(g) any use of veterinary medicinal products shall be declared to the competent authority, or, where appropriate, to the control authority or control body, before the animals are marketed as organic products. Treated stock shall be clearly identifiable.

3.1.4.3. Record-keeping of disease prevention

Operators shall keep records of the disease prevention measures applied giving details of fallowing, cleaning and water treatment, and of any veterinary and other parasite treatment applied and in particular, the date of treatment, diagnosis, the posology, the name of the treatment product, and veterinary prescription for veterinary care, where applicable, and withdrawal periods applied before aquaculture products can be marketed and labelled as organic.

3.1.5. Housing and husbandry practices

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

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

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

(a) have sufficient space for their welfare and have the relevant stocking density laid down in the implementing acts referred to in Article 15(3);

(b) are kept in water of good quality with, inter alia, an adequate flow and exchange rate, sufficient oxygen levels and keeping a low level of metabolites;

(c) are kept in temperature and light conditions in accordance with the requirements of the species and having regard to the geographic location. In considering the effects of stocking density on the welfare of produced fish, the condition of the fish (such as fin damage, other injuries, growth rate, behaviour expressed and overall health) and the water quality shall be monitored and taken into account. In the case of freshwater fish, the bottom type shall be as close as possible to natural conditions. In the case of carp and similar species:
— the bottom shall be natural earth,
— organic and mineral fertilisation of the ponds and lakes shall be carried out only with fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production, with a maximum application of 20 kg nitrogen/ha,
— treatments involving synthetic chemicals for the control of hydrophytes and plant coverage present in production waters shall be prohibited.

Operators shall keep records of monitoring and maintenance measures concerning animal welfare and water quality. In case of fertilisation of ponds and lakes, the operators shall keep records of the application of fertilisers and soil conditioners, including the date of application, the name of the product, the amount applied, and the location of the application concerned.

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

The specific characteristics for production systems and containment systems for species or group of species laid down in the implementing acts referred to in Article 15(3) shall be complied with.

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

(a) flow-through systems shall allow the monitoring and control of the flow rate and water quality of both in-flowing and out-flowing water;

(b) at least 10 % of the perimeter (‘land-water interface’) area shall have natural vegetation.

3.1.5.6. Containment systems at sea shall meet the following conditions:

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

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

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

3.1.5.8. If fish or crustaceans escape, appropriate action shall be taken to reduce the impact on the local ecosystem, including recapture where appropriate. Records shall be kept.

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

3.1.6. Animal welfare

3.1.6.1. All persons involved in keeping aquaculture animals shall possess the necessary basic knowledge and skills as regards the health and the welfare needs of those animals.

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

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

(a) for prolonging natural day length, it shall not exceed a maximum that respects the ethological needs, geographical conditions and general health of the animals; this maximum shall not exceed 14 hours per day, except where necessary for reproductive purposes;

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

3.1.6.4. Aeration shall be permitted to ensure animal welfare and health. Mechanical aerators shall be preferably powered by renewable energy sources.

3.1.6.5. Oxygen may only be used for uses linked to animal health and welfare requirements and for critical periods of production or transport, and only in the following cases:

(a) exceptional cases of a change in temperature, a drop in atmospheric pressure or accidental water pollution;

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

Operators shall keep records of such uses, indicating whether applied under point (a) (b) or (c).

3.1.6.6. Appropriate measures shall be taken to keep the duration of the transport of aquaculture animals to a minimum.

3.1.6.7. Any suffering shall be kept to a minimum during the entire life of the animal, including at the time of slaughter.

3.1.6.8. Eyestalk ablation, including all similar practices such as ligation, incision and pinching, is prohibited.

3.1.6.9. Slaughter techniques shall render fish immediately unconscious and insensible to pain. Handling prior to slaughter shall be performed in a way that avoids injuries while keeping suffering and stress at a minimum. Differences in harvesting sizes, species, and production sites shall be taken into account when considering optimal slaughtering methods.

3.2. Detailed rules for molluscs

3.2.1. Origin of seed

With regard to the origin of seed, the following rules shall apply:

(a) wild seed from outside the boundaries of the production unit may be used in the case of bivalve shellfish, provided that there is no significant damage to the environment, provided that it is permitted by local legislation and provided that the wild seed comes from:
(i) settlement beds which are unlikely to survive winter weather or are surplus to requirements; or
(ii) natural settlement of shellfish seed on collectors;

(b) for the cupped oyster (Crassostrea gigas), preference shall be given to stock which is selectively bred to reduce spawning in the wild;

(c) records shall be kept of how, where and when wild seed was collected to allow traceability back to the collection area;

(d) wild seed may only be collected after the competent authority has granted authorisation to do so.

3.2.2. Housing and husbandry practices

With regard to housing and husbandry practices, the following rules shall apply:

(a) production may be carried out in the same area of water as organic finfish and algae production, in a polyculture system that shall be documented in the sustainable management plan. Bivalve molluscs may also be grown together with gastropod molluscs, such as periwinkles, in polyculture;

(b) organic bivalve mollusc production shall take place within areas delimited by posts, floats or other clear markers and shall, where appropriate, be restrained by net bags, cages or other man made means;

(c) organic shellfish farms shall minimise risks to species of conservation interest. If predator nets are used, their design shall not permit diving birds to be harmed.

3.2.3. Cultivation

With regard to cultivation, the following rules shall apply:

(a) cultivation on mussel ropes and other methods listed in the implementing acts referred to in Article 15(3) may be used in organic production;

(b) the bottom cultivation of molluscs is only permitted where no significant environmental impact is caused at the collection and growing sites. A survey and report supporting the evidence of minimal environmental impact shall be added as a separate chapter to the sustainable management plan, and shall be provided by the operator to the competent authority, or, where appropriate, to the control authority or control body, before starting operations.

3.2.4. Management

With regard to management, the following rules shall apply:

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

(b) biofouling organisms shall be removed by physical means or by hand and where appropriate returned to the sea away from mollusc farms. Molluscs may be treated once during the production cycle with a lime solution to control competing fouling organisms.

3.2.5. Specific cultivation rules for oysters

Cultivation in bags on trestles shall be permitted. Those or other structures in which the oysters are contained shall be set out so as to avoid the formation of a total barrier along the shoreline. Stock shall be positioned carefully on the beds in relation to tidal flow to optimise production. Production shall meet the requirements set out in the implementing acts referred to in Article 15(3).

Part IV: Processed food production rules

In addition to the general production rules laid down in Articles 9, 11 and 16, the rules laid down in this Part shall apply to the organic production of processed food.

1. General requirements for the production of processed food

1.1. Food additives, processing aids and other substances and ingredients used for processing food and any processing practice applied, such as smoking, shall comply with the principles of good manufacturing practice ([^E0031]).

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

1.3. The application of the procedures referred to in point 1.2 shall ensure that the produced processed products comply with this Regulation at all times.

1.4. Operators shall comply with and implement the procedures referred to in point 1.2, and, without prejudice to Article 28, shall in particular,:

(a) take precautionary measures and keep records of those measures;

(b) implement suitable cleaning measures, monitor their effectiveness and keep records of those operations;

1.5. The preparation of processed organic, in-conversion and non-organic products shall be kept separate from each other in time or space. Where organic, in-conversion and non-organic products, in any combination, are prepared or stored in the preparation unit concerned, the operator shall:

(a) inform the competent authority, or, where appropriate, the control authority or control body, accordingly;

(b) carry out the operations continuously until the production run has been completed, separately in place or time from similar operations performed on any other kind of product (organic, in-conversion or non-organic);

(c) store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other;

(d) keep available an updated register of all operations and quantities processed;

(e) take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products;

(f) carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment.

1.6. Products, substances and techniques that reconstitute properties that are lost in the processing and storage of organic food, that correct the results of negligence in the processing of organic food, or that otherwise may be misleading as to the true nature of products intended to be marketed as organic food, shall not be used.

1.7. Operators shall keep available documentary evidence on authorisations for the use of non-organic agricultural ingredients for the production of processed organic food in accordance with Article 25 if they have obtained or used such authorisations.

2. Detailed requirements for the production of processed food

2.1. The following conditions shall apply to the composition of processed organic food:

(a) the product shall be produced mainly from agricultural ingredients or products intended for use as food listed in Annex I; for the purpose of determining whether a product has been produced mainly from those products, added water and salt shall not be taken into account;

(b) an organic ingredient shall not be present together with the same ingredient in non-organic form;

2.2. Use of certain products and substances in processing of food

2.2.1. Only food additives, processing aids and non-organic agricultural ingredients authorised pursuant to Article 24 or Article 25 for use in organic production, and the products and substances referred to in point 2.2.2 may be used in the processing of food, with the exception of products and substances of the wine sector, for which point 2 of Part VI shall apply, and with the exception of yeast, for which point 1.3 of Part VII shall apply.

2.2.2. In the processing of food, the following products and substances may be used:
(a) preparations of micro-organisms and food enzymes normally used in food processing, provided that food enzymes to be used as food additives have been authorised pursuant to Article 24 for use in organic production;
(b) substances and products defined in points (c) and (d)(i) of Article 3(2) of Regulation (EC) No 1334/2008 that have been labelled as natural flavouring substances or natural flavouring preparations in accordance with Article 16(2), (3) and (4) of that Regulation;
(c) colours for stamping meat and eggshells in accordance with Article 17 of Regulation (EC) No 1333/2008;
(d) natural colours and natural coating substances for the traditional decorative colouring of the shell of boiled eggs produced with the intention of placing them on the market at a given period of the year;
(e) drinking water and organic or non-organic salt (with sodium chloride or potassium chloride as basic components) generally used in food processing;
(f) minerals (trace elements included), vitamins, amino acids and micronutrients, provided that:
(i) their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or
(ii) as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers:
— in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council ([^E0032]) their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned, or
— in products regulated by Commission Directive 2006/125/EC ([^E0033]), their use is authorised by that Directive.

Reading this document does not replace reading the official text published in the Official Journal of the European Union. We assume no responsibility for any inaccuracies arising from the conversion of the original to this format.

This text is published under EUR-Lex's own terms of reuse, not a Legalize or public-domain licence. EUR-Lex
Creative Commons Attribution 4.0 International (CC BY 4.0)
© European Union, https://eur-lex.europa.eu — Source: EUR-Lex (Publications Office of the European Union). Reused under the Creative Commons Attribution 4.0 International (CC BY 4.0) licence. Only EU legislation published in the printed Official Journal of the European Union is deemed authentic; consolidated texts are reproduced here for documentation purposes and have been reformatted to Markdown.