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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
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Part III: Production rules for algae and aquaculture animals
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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.
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.
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(2), 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;
the collection does not affect significantly the stability of the natural ecosystem or the maintenance of the species in the collection area.
sustainable practices shall be used in all stages of production, from the collection of juvenile algae to harvesting;
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;
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.
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.
The following conversion periods for aquaculture production units shall apply for the following types of aquaculture facilities including the existing aquaculture animals:
for facilities that cannot be drained, cleaned and disinfected, a conversion period of 24 months;
for facilities that have been drained, or fallowed, a conversion period of 12 months;
for facilities that have been drained, cleaned and disinfected, a conversion period of six months;
for open water facilities, including those producing bivalve molluscs, a conversion period of three months.
organic aquaculture shall be based on the rearing of young stock originating from organic broodstock and from organic production units;
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;
species shall be chosen which are robust and can be produced without causing significant damage to wild stocks;
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;
for on-growing purposes, the collection of wild aquaculture juveniles shall be specifically restricted to the following cases:
natural influx of fish or crustacean larvae and juveniles when filling ponds, containment systems and enclosures;
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 2021, 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.
hormones and hormone-derivates shall not be used;
the artificial production of monosex strains, except by hand-sorting, the induction of polyploidy, artificial hybridisation and cloning shall not be used;
appropriate strains shall be chosen.
animals shall be fed with feed that meets the animals’ nutritional requirements at the various stages of its development;
feeding regimes shall be designed with the following priorities:
animal health and welfare;
high product quality, including the nutritional composition of the product, which shall ensure high quality of the final edible product;
low environmental impact;
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;
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;
growth promoters and synthetic amino-acids shall not be used.
such filter-feeding animals shall receive all their nutritional requirements from nature, except in the case of juveniles reared in hatcheries and nurseries;
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.
Feed for carnivorous aquaculture animals shall be sourced with the following priorities:
organic feed of aquaculture origin;
fish meal and fish oil from organic aquaculture trimmings sourced from fish, crustaceans or molluscs;
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;
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;
organic feed materials of plant or animal origin; plant material shall not exceed 60 % of total ingredients.
In the grow-out phase, fish in inland waters, penaeid shrimps and freshwater prawns and tropical freshwater fish shall be fed as follows:
they shall be fed with feed naturally available in ponds and lakes;
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;
where natural feed is supplemented in accordance with point (b):
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;
the feed ration of siamese catfish (Pangasius spp.) may consist of a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries.
With regard to disease prevention, the following rules shall apply:
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;
immunological veterinary medicines may be used;
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;
holding systems, equipment and utensils shall be properly cleaned and disinfected;
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;
only substances for cleaning and disinfection of equipment and facilities authorised pursuant to Article 24 for use in organic production may be used;
with regard to fallowing, the following rules shall apply:
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;
it shall not be mandatory for bivalve mollusc cultivation;
during fallowing the cage or other structure used for aquaculture animal production is emptied, disinfected and left empty before being used again;
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;
ultraviolet light and ozone may only be used in hatcheries and nurseries;
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.
With regard to veterinary treatments, the following rules shall apply:
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;
treatments related to the protection of human and animal health imposed on the basis of Union legislation shall be allowed;
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:
substances from plants, animals or minerals in a homoeopathic dilution;
plants and their extracts not having anaesthetic effects; and
substances such as trace elements, metals, natural immunostimulants or authorised probiotics;
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;
the use of parasite treatments, other than through compulsory control schemes operated by Member States, shall be limited to twice per year, or once per year where the production cycle is less than 18 months;
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;
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.
have sufficient space for their welfare and have the relevant stocking density laid down in the implementing acts referred to in Article 15(3);
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;
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.
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.
flow-through systems shall allow the monitoring and control of the flow rate and water quality of both in-flowing and out-flowing water;
at least 10 % of the perimeter (‘land-water interface’) area shall have natural vegetation.
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;
they shall have suitable cage design, construction and maintenance with regard to their exposure to the operating environment.
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;
abrupt changes in light intensity shall be avoided at the changeover time through the use of dimmable lights or background lighting.
exceptional cases of a change in temperature, a drop in atmospheric pressure or accidental water pollution;
occasional stock management procedures, such as sampling and sorting;
in order to assure the survival of the farm stock.
With regard to the origin of seed, the following rules shall apply:
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:
settlement beds which are unlikely to survive winter weather or are surplus to requirements; or
natural settlement of shellfish seed on collectors;
for the cupped oyster (Crassostrea gigas), preference shall be given to stock which is selectively bred to reduce spawning in the wild;
records shall be kept of how, where and when wild seed was collected to allow traceability back to the collection area;
wild seed may only be collected after the competent authority has granted authorisation to do so.
With regard to housing and husbandry practices, the following rules shall apply:
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;
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;
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.
With regard to cultivation, the following rules shall apply:
cultivation on mussel ropes and other methods listed in the implementing acts referred to in Article 15(3) may be used in organic production;
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.
With regard to management, the following rules shall apply:
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;
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.
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).
Directive 2011/92/EU of the European Parliament and of the Council of 13 December 2011 on the assessment of the effects of certain public and private projects on the environment (OJ L 26, 28.1.2012, p. 1).
Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (OJ L 139, 30.4.2004, p. 206).
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