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Document 02018R0848-20201114
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
Consolidated text: 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
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
02018R0848 — EN — 14.11.2020 — 001.002
This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document
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REGULATION (EU) 2018/848 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 May 2018 (OJ L 150 14.6.2018, p. 1) |
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REGULATION (EU) 2020/1693 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 November 2020 |
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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
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
This Regulation establishes the principles of organic production and lays down the rules concerning organic production, related certification and the use of indications referring to organic production in labelling and advertising, as well as rules on controls additional to those laid down in Regulation (EU) 2017/625.
Article 2
Scope
This Regulation applies to the following products originating from agriculture, including aquaculture and beekeeping, as listed in Annex I to the TFEU and to products originating from those products, where such products are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union:
live or unprocessed agricultural products, including seeds and other plant reproductive material;
processed agricultural products for use as food;
feed.
This Regulation also applies to certain other products closely linked to agriculture listed in Annex I to this Regulation, where they are, or are intended to be, produced, prepared, labelled, distributed, placed on the market, imported into or exported from the Union.
Member States may apply national rules or, in the absence thereof, private standards, on the production, labelling and control of products originating from mass catering operations. The organic production logo of the European Union shall not be used in the labelling, the presentation or the advertising of such products, and shall not be used to advertise the mass caterer.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
‘organic production’ means the use, including during the conversion period referred to in Article 10, of production methods that comply with this Regulation at all stages of production, preparation and distribution;
‘organic product’ means a product resulting from organic production, other than a product produced during the conversion period referred to in Article 10. The products of hunting or fishing of wild animals are not considered as organic products;
‘agricultural raw material’ means an agricultural product that has not been subjected to any operation of preservation or processing;
‘preventive measures’ means measures that are to be taken by operators at every stage of production, preparation and distribution in order to ensure the preservation of biodiversity and soil quality, measures for the prevention and control of pests and diseases and measures that are to be taken to avoid negative effects on the environment, animal health and plant health;
‘precautionary measures’ means measures that are to be taken by operators at every stage of production, preparation, and distribution to avoid contamination with products or substances that are not authorised for use in organic production in accordance with this Regulation, and to avoid the commingling of organic products with non-organic products;
‘conversion’ means the transition from non-organic to organic production within a given period, during which the provisions of this Regulation concerning organic production apply;
‘in-conversion product’ means a product that is produced during the conversion period referred to in Article 10;
‘holding’ means all the production units operated under single management for the purpose of producing live or unprocessed agricultural products, including products originating from aquaculture and beekeeping, referred to in point (a) of Article 2(1) or products listed in Annex I other than essential oils and yeast;
‘production unit’ means all assets of a holding, such as primary production premises, land parcels, pasturages, open air areas, livestock buildings or parts thereof, hives, fish ponds, containment systems and sites for algae or aquaculture animals, rearing units, shore or seabed concessions, and premises for the storage of crops, of crop products, of algae products, of animal products, of raw materials and of any other relevant inputs managed as described in point (10), point (11) or point (12);
‘organic production unit’ means a production unit, excluding during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production;
‘in-conversion production unit’ means a production unit, during the conversion period referred to in Article 10, which is managed in compliance with the requirements applicable to organic production; it may be constituted of land parcels or other assets for which the conversion period referred to in Article 10 starts at different moments in time;
‘non-organic production unit’ means a production unit which is not managed in compliance with the requirements applicable to organic production;
‘operator’ means the natural or legal person responsible for ensuring that this Regulation is complied with at every stage of production, preparation and distribution that are under that person’s control;
‘farmer’ means a natural or legal person, or a group of natural or legal persons, regardless of the legal status of that group and its members under national law, who exercises an agricultural activity;
‘agricultural area’ means agricultural area as defined in point (e) of Article 4(1) of Regulation (EU) No 1307/2013;
‘plants’ means plants as defined in point (5) of Article 3 of Regulation (EC) No 1107/2009;
‘plant reproductive material’ means plants and all parts of plants, including seeds, at any stage of growth that are capable of, and intended for, producing entire plants;
‘organic heterogeneous material’ means a plant grouping within a single botanical taxon of the lowest known rank which:
presents common phenotypic characteristics;
is characterised by a high level of genetic and phenotypic diversity between individual reproductive units, so that that plant grouping is represented by the material as a whole, and not by a small number of units;
is not a variety within the meaning of Article 5(2) of Council Regulation (EC) No 2100/94 ( 2 );
is not a mixture of varieties; and
has been produced in accordance with this Regulation;
‘organic variety suitable for organic production’ means a variety as defined in Article 5(2) of Regulation (EC) No 2100/94 which:
is characterised by a high level of genetic and phenotypical diversity between individual reproductive units; and
results from organic breeding activities referred to in point 1.8.4 of Part I of Annex II to this Regulation;
‘mother plant’ means an identified plant from which plant reproductive material is taken for the reproduction of new plants;
‘generation’ means a group of plants constituting a single step in the line of descent of plants;
‘plant production’ means production of agricultural crop products including harvesting of wild plant products for commercial purposes;
‘plant products’ means plant products as defined in point (6) of Article 3 of Regulation (EC) No 1107/2009;
‘pest’ means a pest as defined in Article 1(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council ( 3 );
‘biodynamic preparations’ means mixtures traditionally used in biodynamic farming;
‘plant protection products’ means the products referred to in Article 2 of Regulation (EC) No 1107/2009;
‘livestock production’ means the production of domestic or domesticated terrestrial animals, including insects;
‘veranda’ means an additional, roofed, uninsulated, outdoor part of a building intended for poultry, the longest side usually being equipped with wire fencing or netting, with an outdoor climate, natural and, where necessary, artificial illumination, and a littered floor;
‘pullets’ means young animals of the Gallus gallus species that are of an age of less than 18 weeks;
‘laying hens’ means animals of the Gallus gallus species that are intended for the production of eggs for consumption and that are of an age of at least 18 weeks;
‘usable area’ means usable area as defined in point (d) of Article 2(2) of Council Directive 1999/74/EC ( 4 );
‘aquaculture’ means aquaculture as defined in point (25) of Article 4(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council ( 5 );
‘aquaculture products’ means aquaculture products as defined in point (34) of Article 4(1) of Regulation (EU) No 1380/2013;
‘closed recirculation aquaculture facility’ means a facility on land or in a vessel where aquaculture takes place within an enclosed environment involving the recirculation of water and which depends on permanent external energy input to stabilise the environment for the aquaculture animals;
‘energy from renewable sources’ means energy from renewable non-fossil sources such as wind, solar, geothermal, wave, tidal, hydropower, landfill gas, sewage treatment plant gas and biogases;
‘hatchery’ means a place for the breeding, hatching and rearing through the early life stages of aquaculture animals, in particular finfish and shellfish;
‘nursery’ means a place where an intermediate aquaculture production system is applied between the hatchery and grow-out stages. The nursery stage is completed within the first third of the production cycle, with the exception of species undergoing a smoltification process;
‘water pollution’ means pollution as defined in point (33) of Article 2 of Directive 2000/60/EC and in point (8) of Article 3 of Directive 2008/56/EC of the European Parliament and of the Council ( 6 ), in the waters to which each of those Directives applies;
‘polyculture’ means the rearing in aquaculture of two or more species, usually from different trophic levels, in the same culture unit;
‘production cycle’ means the lifespan of an aquaculture animal or alga, from the earliest life stage (fertilised eggs, in the case of aquaculture animals) to harvesting;
‘locally grown species’ means aquaculture species which are neither alien nor locally absent species within the meaning of points (6) and (7), respectively, of Article 3 of Council Regulation (EC) No 708/2007 ( 7 ), as well as the species listed in Annex IV to that Regulation;
‘veterinary treatment’ means all courses of a curative or preventive treatment against an occurrence of a specific disease;
‘veterinary medicinal product’ means a veterinary medicinal product as defined in point (2) of Article 1 of Directive 2001/82/EC of the European Parliament and of the Council ( 8 );
‘preparation’ means the operations of preserving or processing of organic or in-conversion products, or any other operation that is carried out on an unprocessed product without altering the initial product, such as slaughtering, cutting, cleaning or milling, as well as packaging, labelling or alterations made to the labelling relating to organic production;
‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council ( 9 );
‘feed’ means feed as defined in point (4) of Article 3 of Regulation (EC) No 178/2002;
‘feed materials’ mean feed materials as defined in point (g) of Article 3(2) of Regulation (EC) No 767/2009 of the European Parliament and of the Council ( 10 );
‘placing on the market’ means placing on the market as defined in point (8) of Article 3 of Regulation (EC) No 178/2002;
‘traceability’ means the ability to trace and follow food, feed or any product referred to in Article 2(1), and any substance intended or expected to be incorporated into food, feed or any product referred to in Article 2(1), through all stages of production, preparation and distribution;
‘stage of production, preparation and distribution’ means any stage from the primary production of an organic product through its storage, processing, transport, and sale or supply to the final consumer, including, where relevant, labelling, advertising, import, export and subcontracting activities;
‘ingredient’ means an ingredient as defined in point (f) of Article 2(2) of Regulation (EU) No 1169/2011 or, for products other than food, any substance or product used in the manufacture or preparation of products that is still present in the finished product, even in altered form;
‘labelling’ means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a product that are placed on any packaging, document, notice, label, ring or collar that accompanies or refers to that product;
‘advertising’ means any presentation of products to the public, by any means other than a label, that is intended or is likely to influence and shape attitudes, beliefs and behaviours in order to directly or indirectly promote the sale of products;
‘competent authorities’ means competent authorities as defined in point (3) of Article 3 of Regulation (EU) 2017/625;
‘control authority’ means an organic control authority as defined in point (4) of Article 3 of Regulation (EU) 2017/625, or an authority recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union;
‘control body’ means a delegated body as defined in point (5) of Article 3 of Regulation (EU) 2017/625, or a body recognised by the Commission or by a third country recognised by the Commission for the purposes of carrying out controls in third countries for the import of organic and in-conversion products into the Union;
‘non-compliance’ means non-compliance with this Regulation or non-compliance with the delegated or implementing acts adopted in accordance with this Regulation;
‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in point (2) of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council ( 11 ) which is not obtained through the techniques of genetic modification listed in Annex I.B to that Directive;
‘produced from GMOs’ means derived in whole or in part from GMOs but not containing or consisting of GMOs;
‘produced by GMOs’ means derived by using a GMO as the last living organism in the production process, but not containing or consisting of GMOs nor produced from GMOs;
‘food additive’ means a food additive as defined in point (a) of Article 3(2) of Regulation (EC) No 1333/2008 of the European Parliament and of the Council ( 12 );
‘feed additives’ mean feed additives as defined in point (a) of Article 2(2) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council ( 13 );
‘engineered nanomaterial’ means an engineered nanomaterial as defined in point (f) of Article 3(2) of Regulation (EU) 2015/2283 of the European Parliament and of the Council ( 14 );
‘equivalence’ means meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity;
‘processing aid’ means a processing aid as defined in point (b) of Article 3(2) of Regulation (EC) No 1333/2008 for food and in point (h) of Article 2(2) of Regulation (EC) No 1831/2003 for feed;
‘food enzyme’ means a food enzyme as defined in point (a) of Article 3(2) of Regulation (EC) No 1332/2008 of the European Parliament and of the Council ( 15 );
‘ionising radiation’ means ionising radiation as defined in point (46) of Article 4 of Council Directive 2013/59/Euratom ( 16 );
‘prepacked food’ means prepacked food as defined in point (e) of Article 2(2) of Regulation (EU) No 1169/2011;
‘poultry house’ means a fixed or mobile building for accommodating flocks of poultry, which includes all surfaces covered by roofs, including a veranda; the house may be subdivided into separate compartments, each accommodating a single flock;
‘soil-related crop cultivation’ means production in living soil or in soil that is mixed or fertilised with materials and products that are allowed in organic production in connection with the subsoil and bedrock;
‘unprocessed products’ means unprocessed products as defined in point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 17 ), irrespective of packaging or labelling operations;
‘processed products’ means processed products as defined in point (o) of Article 2(1) of Regulation (EC) No 852/2004, irrespective of packaging or labelling operations;
‘processing’ means processing as defined in point (m) of Article 2(1) of Regulation (EC) No 852/2004; this includes the use of substances referred to in Articles 24 and 25 of this Regulation but does not include packaging or labelling operations;
‘integrity of organic or in-conversion products’ means the fact that the product does not exhibit non-compliance which:
in any stage of production, preparation and distribution affects the organic or in-conversion characteristics of the product; or
is repetitive or intentional;
‘pen’ means an enclosure that includes a part in which animals are provided with protection from adverse weather conditions.
CHAPTER II
OBJECTIVES AND PRINCIPLES OF ORGANIC PRODUCTION
Article 4
Objectives
Organic production shall pursue the following general objectives:
contributing to protection of the environment and the climate;
maintaining the long-term fertility of soils;
contributing to a high level of biodiversity;
substantially contributing to a non-toxic environment;
contributing to high animal welfare standards and, in particular, to meeting the species-specific behavioural needs of animals;
encouraging short distribution channels and local production in the various areas of the Union;
encouraging the preservation of rare and native breeds in danger of extinction;
contributing to the development of the supply of plant genetic material adapted to the specific needs and objectives of organic agriculture;
contributing to a high level of biodiversity, in particular by using diverse plant genetic material, such as organic heterogeneous material and organic varieties suitable for organic production;
fostering the development of organic plant breeding activities in order to contribute to favourable economic perspectives of the organic sector.
Article 5
General principles
Organic production is a sustainable management system that is based on the following general principles:
respect for nature’s systems and cycles and the sustainment and enhancement of the state of the soil, the water and the air, of the health of plants and animals, and of the balance between them;
the preservation of natural landscape elements, such as natural heritage sites;
the responsible use of energy and natural resources, such as water, soil, organic matter and air;
the production of a wide variety of high-quality food and other agricultural and aquaculture products that respond to consumers’ demand for goods that are produced by the use of processes that do not harm the environment, human health, plant health or animal health and welfare;
ensuring the integrity of organic production at all stages of the production, preparation and distribution of food and feed;
the appropriate design and management of biological processes, based on ecological systems and using natural resources which are internal to the management system, using methods that:
use living organisms and mechanical production methods;
practice soil-related crop cultivation and land-related livestock production, or practice aquaculture which complies with the principle of the sustainable exploitation of aquatic resources;
exclude the use of GMOs, products produced from GMOs, and products produced by GMOs, other than veterinary medicinal products;
are based on risk assessment and the use of precautionary measures and preventive measures, where appropriate;
the restriction of the use of external inputs; where external inputs are required or the appropriate management practices and methods referred to in point (f) do not exist, the external inputs shall be limited to:
inputs from organic production; in the case of plant reproductive material, priority shall be given to varieties selected for their ability to meet the specific needs and objectives of organic agriculture;
natural or naturally-derived substances;
low solubility mineral fertilisers;
the adaptation of the production process, where necessary and within the framework of this Regulation, to take account of the sanitary status, regional differences in the ecological balance, climatic and local conditions, stages of development and specific husbandry practices;
the exclusion from the whole organic food chain of animal cloning, of rearing artificially induced polyploid animals and of ionising radiation;
the observance of a high level of animal welfare respecting species-specific needs.
Article 6
Specific principles applicable to agricultural activities and aquaculture
As regards agricultural activities and aquaculture, organic production shall, in particular, be based on the following specific principles:
the maintenance and enhancement of soil life and natural soil fertility, soil stability, soil water retention and soil biodiversity, preventing and combating loss of soil organic matter, soil compaction and soil erosion, and the nourishing of plants primarily through the soil ecosystem;
the limitation of the use of non-renewable resources and external inputs to a minimum;
the recycling of waste and by-products of plant and animal origin as input in plant and livestock production;
the maintenance of plant health by preventive measures, in particular the choice of appropriate species, varieties or heterogeneous material resistant to pests and diseases, appropriate crop rotations, mechanical and physical methods and protection of the natural enemies of pests;
the use of seeds and animals with a high degree of genetic diversity, disease resistance and longevity;
in the choosing of plant varieties, having regard to the particularities of the specific organic production systems, focussing on agronomic performance, disease resistance, adaptation to diverse local soil and climate conditions and respect for the natural crossing barriers;
the use of organic plant reproductive material, such as plant reproductive material of organic heterogeneous material and of organic varieties suitable for organic production;
the production of organic varieties through natural reproductive ability and focussing on containment within natural crossing barriers;
without prejudice to Article 14 of Regulation (EC) No 2100/94 and to the national plant variety rights granted under Member States’ national law, the possibility for farmers to use plant reproductive material obtained from their own farms in order to foster genetic resources adapted to the special conditions of organic production;
in the choosing of animal breeds, having regard to a high degree of genetic diversity, the capacity of animals to adapt to local conditions, their breeding value, their longevity, their vitality and their resistance to disease or health problems;
the practice of site-adapted and land-related livestock production;
the application of animal husbandry practices which enhance the immune system and strengthen the natural defence against diseases, including regular exercise and access to open air areas and pastures;
the feeding of livestock with organic feed composed of agricultural ingredients resulting from organic production and of natural non-agricultural substances;
the production of organic livestock products derived from animals that have been raised on organic holdings throughout their lives since birth or hatching;
the continuing health of the aquatic environment and the quality of surrounding aquatic and terrestrial ecosystems;
the feeding of aquatic organisms with feed from sustainably exploited fisheries in accordance with Regulation (EU) No 1380/2013 or with organic feed composed of agricultural ingredients resulting from organic production, including organic aquaculture, and of natural non-agricultural substances;
avoiding any endangerment of species of conservation interest that might arise from organic production.
Article 7
Specific principles applicable to the processing of organic food
The production of processed organic food shall be based, in particular, on the following specific principles:
the production of organic food from organic agricultural ingredients;
the restriction of the use of food additives, of non-organic ingredients with mainly technological and sensory functions, and of micronutrients and processing aids, so that they are used to a minimum extent and only in cases of essential technological need or for particular nutritional purposes;
the exclusion of substances and processing methods that might be misleading as regards the true nature of the product;
the processing of organic food with care, preferably through the use of biological, mechanical and physical methods;
the exclusion of food containing, or consisting of, engineered nanomaterials.
Article 8
Specific principles applicable to the processing of organic feed
The production of processed organic feed shall be based, in particular, on the following specific principles:
the production of organic feed from organic feed materials;
the restriction of the use of feed additives and processing aids, so that they are used to a minimum extent and only in cases of essential technological or zootechnical needs or for particular nutritional purposes;
the exclusion of substances and processing methods that might be misleading as regards the true nature of the product;
the processing of organic feed with care, preferably through the use of biological, mechanical and physical methods.
CHAPTER III
PRODUCTION RULES
Article 9
General production rules
The following products and substances referred to in Article 2(3) of Regulation (EC) No 1107/2009 shall be allowed for use in organic production, provided that they are authorised pursuant to that Regulation:
safeners, synergists and co-formulants as components of plant protection products;
adjuvants that are to be mixed with plant protection products.
The use in organic production of products and substances for purposes other than those covered by this Regulation shall be allowed, provided that their use complies with the principles laid down in Chapter II.
Notwithstanding paragraph 2, a holding may be split into clearly and effectively separated production units for organic, in-conversion and non-organic production, provided that for the non-organic production units:
as regards livestock, different species are involved;
as regards plants, different varieties that can be easily differentiated are involved.
As regards algae and aquaculture animals, the same species may be involved, provided that there is a clear and effective separation between the production sites or units.
In such cases:
the farmer shall notify the competent authority, or, where appropriate, the control authority or the control body, of the start of harvest of each of the products concerned at least 48 hours in advance;
upon completion of the harvest, the farmer shall inform the competent authority, or, where appropriate, the control authority or the control body, of the exact quantities harvested from the units concerned and of the measures taken to separate the products;
the conversion plan and the measures to be taken to ensure the effective and clear separation shall be confirmed each year by the competent authority, or, where appropriate, by the control authority or the control body, after the start of the conversion plan.
Where, in the cases referred to in paragraphs 7, 8 and 9, not all production units of a holding are managed under organic production rules, the operators shall:
keep the products used for the organic and in-conversion production units separate from those used for the non-organic production units;
keep the products produced by the organic, in-conversion and non-organic production units separate from each other;
keep adequate records to show the effective separation of the production units and of the products.
Article 10
Conversion
No previous period may be retroactively recognised as being part of the conversion period, except where:
the operator’s land parcels were subject to measures which were defined in a programme implemented pursuant to Regulation (EU) No 1305/2013 for the purpose of ensuring that no products or substances other than those authorised for use in organic production have been used on those land parcels; or
the operator can provide proof that the land parcels were natural or agricultural areas that, for a period of at least three years, have not been treated with products or substances that are not authorised for use in organic production.
However, the following products produced during the conversion period and in compliance with paragraph 1 may be marketed as in-conversion products:
plant reproductive material, provided that a conversion period of at least 12 months has been complied with;
food products of plant origin and feed products of plant origin, provided that the product contains only one agricultural crop ingredient, and provided that a conversion period of at least 12 months before the harvest has been complied with.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 11
Prohibition of the use of GMOs
Article 12
Plant production rules
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
points 1.3 and 1.4 of Part I of Annex II as regards derogations;
point 1.8.5 of Part I of Annex II as regards the use of in-conversion and non-organic plant reproductive material;
point 1.9.5 of Part I of Annex II by adding further provisions concerning agreements between operators of agricultural holdings, or by amending those added provisions;
point 1.10.1 of Part I of Annex II by adding further pest- and weed-management measures, or by amending those added measures;
Part I of Annex II by adding further detailed rules and cultivation practices for specific plants and plant products, including rules for sprouted seeds, or by amending those added rules.
Article 13
Specific provisions for the marketing of plant reproductive material of organic heterogeneous material
Plant reproductive material of organic heterogeneous material as referred to in paragraph 1 may be marketed following a notification of the organic heterogeneous material by the supplier to the responsible official bodies referred to in Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, made by means of a dossier containing:
the contact details of the applicant;
the species and denomination of the organic heterogeneous material;
the description of the main agronomic and phenotypic characteristics that are common to that plant grouping, including breeding methods, any available results from tests on those characteristics, the country of production and the parental material used;
a declaration by the applicant concerning the truth of the elements in points (a), (b) and (c); and
a representative sample.
That notification shall be sent by registered letter, or by any other means of communication accepted by the official bodies, with confirmation of receipt requested.
Three months after the date shown on the return receipt, provided that no additional information was requested or that no formal refusal for reasons of incompleteness of the dossier or non-compliance as defined in Article 3(57) was communicated to the supplier, the responsible official body shall be deemed to have acknowledged the notification and its content.
After having expressly or implicitly acknowledged the notification, the responsible official body may proceed to the listing of the notified organic heterogeneous material. That listing shall be free of charge to the supplier.
The listing of any organic heterogeneous material shall be communicated to the competent authorities of the other Member States and to the Commission.
Such organic heterogeneous material shall fulfil the requirements laid down in the delegated acts adopted in accordance with paragraph 3.
The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation by setting out rules governing the production and marketing of plant reproductive material of organic heterogeneous material of particular genera or species, as regards:
the description of the organic heterogeneous material, including the relevant breeding and production methods and parental material used;
the minimum quality requirements for seeds lots, including identity, specific purity, germination rates and sanitary quality;
labelling and packaging;
information and samples of production to be kept by the professional operators;
where applicable, maintenance of the organic heterogeneous material.
Article 14
Livestock production rules
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
points 1.3.4.2, 1.3.4.4.2 and 1.3.4.4.3 of Part II of Annex II by reducing the percentages as regards the origin of animals, once sufficient availability on the Union market of organic animals has been established;
point 1.6.6 of Part II of Annex II as regards the limit on organic nitrogen linked to the total stocking density;
point 1.9.6.2(b) of Part II of Annex II as regards the feeding of bee colonies;
points 1.9.6.3(b) and (e) of Part II of Annex II as regards the acceptable treatments for the disinfection of apiaries and the methods and treatments to fight against Varroa destructor;
Part II of Annex II by adding detailed rules on livestock production for species other than species regulated in that Part on 17 June 2018, or by amending those added rules, as regards:
derogations as regards the origin of animals;
nutrition;
housing and husbandry practices;
health care;
animal welfare.
The Commission shall, where appropriate, adopt implementing acts regarding Part II of Annex II providing rules on:
the minimum period to be complied with for feeding of suckling animals with maternal milk, referred to in point 1.4.1(g);
the stocking density and the minimum surface for indoor and outdoor areas that are to be complied with for specific livestock species to ensure that the developmental, physiological and ethological needs of animals are met in accordance with points 1.6.3, 1.6.4 and 1.7.2,
the characteristics of and technical requirements for the minimum surface for indoor and outdoor areas;
the characteristics of and technical requirements for buildings and pens for all livestock species other than bees, to ensure that the developmental, physiological and ethological needs of animals are met in accordance with point 1.7.2;
requirements for vegetation and the characteristics of protected facilities and open air areas.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 15
Production rules for algae and aquaculture animals
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
point 3.1.3.3 of Part III of Annex II as regards feed for carnivorous aquaculture animals;
point 3.1.3.4 of Part III of Annex II by adding further specific rules on feed for certain aquaculture animals, or by amending those added rules;
point 3.1.4.2 of Part III of Annex II as regards veterinary treatments for aquaculture animals;
Part III of Annex II by adding further detailed conditions per species for broodstock management, breeding and juvenile production, or by amending those added detailed conditions.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 16
Production rules for processed food
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
point 1.4 of Part IV of Annex II as regards precautionary measures and preventive measures to be taken by operators;
point 2.2.2 of Part IV of Annex II as regards the types and composition of products and substances that are allowed for use in processed food, as well as conditions under which they may be used;
point 2.2.4 of Part IV of Annex II as regards the calculation of the percentage of agricultural ingredients referred to in points (a)(ii) and (b)(i) of Article 30(5), including the food additives authorised pursuant to Article 24 for use in organic production that are considered as agricultural ingredients for the purpose of such calculations.
Those delegated acts shall not include the possibility of using flavouring substances or flavouring preparations which are neither natural, within the meaning of Article 16(2), (3) and (4) of Regulation (EC) No 1334/2008 of the European Parliament and of the Council ( 20 ), nor organic.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 17
Production rules for processed feed
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 18
Production rules for wine
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
point 3.2 of Part VI of Annex II by adding further oenological practices, processes and treatments that are prohibited, or by amending those added elements;
point 3.3. of Part VI of Annex II.
Article 19
Production rules for yeast used as food or feed
Article 20
Absence of certain production rules for specific livestock species and species of aquaculture animals
Pending the adoption of:
additional general rules for other livestock species than those regulated in point 1.9 of Part II of Annex II in accordance with point (e) of Article 14(2);
the implementing acts referred to in Article 14(3) for livestock species; or
the implementing acts referred to in Article 15(3) for species or group of species of aquaculture animals;
a Member State may apply detailed national production rules for specific species or groups of species of animals in relation to the elements to be covered by the measures referred to in points (a), (b) and (c), provided that those national rules are in accordance with this Regulation, and provided that they do not prohibit, restrict or impede the placing on the market of products which have been produced outside its territory and which comply with this Regulation.
Article 21
Production rules for products not falling within the categories of products referred to in Articles 12 to 19
Those delegated acts shall be based on the objectives and principles of organic production laid down in Chapter II and shall comply with the general production rules laid down in Articles 9, 10 and 11 as well as existing detailed production rules laid down for similar products in Annex II. They shall lay down requirements concerning, in particular, the treatments, practices and inputs that are allowed or prohibited, or conversion periods for the products concerned.
In the absence of the detailed production rules referred to in paragraph 1:
operators shall, as regards products referred to in paragraph 1, comply with the principles laid down in Articles 5 and 6, mutatis mutandis with the principles laid down in Article 7, and with the general production rules laid down in Articles 9 to 11;
a Member State may, as regards products referred to in paragraph 1, apply detailed national production rules, provided that those rules are in accordance with this Regulation, and provided that they do not prohibit, restrict or impede the placing on the market of products which have been produced outside its territory and which comply with this Regulation.
Article 22
Adoption of exceptional production rules
The Commission is empowered to adopt delegated acts in accordance with Article 54 supplementing this Regulation by laying down:
the criteria to determine whether a situation qualifies as catastrophic circumstances deriving from an ‘adverse climatic event’, ‘animal diseases’, an ‘environmental incident’, a ‘natural disaster’ or a ‘catastrophic event’, as defined in points (h), (i), (j), (k) and (l) of Article 2(1) of Regulation (EU) No 1305/2013, respectively, as well as any comparable situation;
specific rules, including possible derogations from this Regulation, on how Member States are to deal with such catastrophic circumstances if they decide to apply this Article; and
specific rules on monitoring and reporting in such cases.
Those criteria and rules shall be subject to the principles of organic production laid down in Chapter II.
Article 23
Collection, packaging, transport and storage
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
Section 2 of Annex III;
Sections 3, 4 and 6 of Annex III by adding further special rules for the transport and reception of the products concerned, or by amending those added rules.
Article 24
Authorisation of products and substances for use in organic production
The Commission may authorise certain products and substances for use in organic production, and shall include any such authorised products and substances in restrictive lists, for the following purposes:
as active substances to be used in plant protection products;
as fertilisers, soil conditioners and nutrients;
as non-organic feed material of plant, algal, animal or yeast origin or as feed material of microbial or mineral origin;
as feed additives and processing aids;
as products for the cleaning and disinfection of ponds, cages, tanks, raceways, buildings or installations used for animal production;
as products for the cleaning and disinfection of buildings and installations used for plant production, including for storage on an agricultural holding;
as products for cleaning and disinfection in processing and storage facilities.
In addition to products and substances authorised in accordance with paragraph 1, the Commission may authorise certain products and substances for use in the production of processed organic food and of yeast used as food or feed, and shall include any such authorised products and substances in restrictive lists, for the following purposes:
as food additives and processing aids;
as non-organic agricultural ingredients to be used for the production of processed organic food;
as processing aids for the production of yeast and yeast products.
The authorisation of the products and substances referred to in paragraph 1 for use in organic production shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole:
they are essential for sustained production and for the use for which they are intended;
all of the products and substances concerned are of plant, algal, animal, microbial or mineral origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available;
in the case of products referred to in point (a) of paragraph 1:
their use is essential for the control of a pest for which other biological, physical or breeding alternatives, cultivation practices or other effective management practices are not available;
if such products are not of plant, algal, animal, microbial or mineral origin and are not identical to their natural form, their conditions for use preclude any direct contact with the edible parts of the crop;
in the case of products referred to in point (b) of paragraph 1, their use is essential for building or maintaining the fertility of the soil or to fulfil specific nutritional requirements of crops, or for specific soil-conditioning purposes;
in the case of products referred to in points (c) and (d) of paragraph 1:
their use is necessary to maintain animal health, animal welfare and vitality and contributes to an appropriate diet fulfilling the physiological and behavioural needs of the species concerned or their use is necessary to produce or preserve feed because the production or preservation of feed is not possible without having recourse to such substances;
feed of mineral origin, trace elements, vitamins or provitamins are of natural origin, except in cases where products or substances from such sources are not available in sufficient quantities or qualities or where alternatives are not available;
the use of non-organic feed material of plant or animal origin is necessary because feed material of plant or animal origin produced in accordance with organic production rules is not available in sufficient quantity;
the use of non-organic spices, herbs and molasses is necessary because such products are not available in organic form; they have to be produced or prepared without chemical solvents and their use is limited to 1 % of the feed ration for a given species, calculated annually as a percentage of the dry matter of feed from agricultural origin.
The authorisation of the products and substances referred to in paragraph 2 for use in the production of processed organic food or for the production of yeast used as food or feed shall be subject to the principles laid down in Chapter II and to the following criteria, which shall be evaluated as a whole:
alternative products or substances authorised in accordance with this Article or techniques compliant with this Regulation are not available;
it would be impossible to produce or preserve the food or to fulfil given dietary requirements provided for on the basis of Union legislation without having recourse to those products and substances;
they are to be found in nature and may only have undergone mechanical, physical, biological, enzymatic or microbial processes, except in cases where products or substances from such sources are not available in sufficient quantities or qualities;
the organic ingredient is not available in sufficient quantity.
The Commission shall publish any requests referred to in this paragraph.
The list of non-organic ingredients referred to in point (b) of paragraph 2 shall be reviewed at least once a year.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 25
Authorisation of non-organic agricultural ingredients for processed organic food by Member States
Article 26
Collection of data concerning the availability on the market of organic and in-conversion plant reproductive material, organic animals and organic aquaculture juveniles
Member States shall have in place systems that allow operators that market organic or in-conversion plant reproductive material, organic animals or organic aquaculture juveniles, and that are able to supply them in sufficient quantities and within a reasonable period, to make public on a voluntary basis, free of charge, together with their names and contact details, information on the following:
the organic and in-conversion plant reproductive material, such as plant reproductive material of organic heterogeneous material or of organic varieties suitable for organic production, excluding seedlings but including seed potatoes, which is available; the quantity in weight of that material; and the period of the year of its availability; such material shall be listed using at least the Latin scientific name;
the organic animals for which derogation may be provided in accordance with point 1.3.4.4 of Part II of Annex II; the number of available animals categorised by sex; information, if relevant, relating to the different species of animals as regards the breeds and strains available; the races of the animals; the age of the animals; and any other relevant information;
the organic aquaculture juveniles available on the holding and their health status in accordance with Council Directive 2006/88/EC ( 21 ) and the production capacity for each aquaculture species.
The Commission may adopt implementing acts providing:
technical details for establishing and maintaining the databases referred to in paragraph 1 and the systems referred to in paragraph 2;
specifications as regards the collection of information referred to in paragraph 1 and 2;
specifications as regards the arrangements for participation in the databases referred to in paragraph 1 and in the systems referred to in paragraphs 2 and 3; and
details as regards the information to be provided by Member States in accordance with Article 53(6).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 27
Obligations and actions in the event of suspicion of non-compliance
Where an operator suspects that a product it has produced, prepared, imported or has received from another operator does not comply with this Regulation, that operator shall, subject to Article 28(2):
identify and separate the product concerned;
check whether the suspicion can be substantiated;
not place the product concerned on the market as an organic or in-conversion product and not use it in organic production, unless the suspicion can be eliminated;
where the suspicion has been substantiated or where it cannot be eliminated, immediately inform the relevant competent authority, or, where appropriate, the relevant control authority or control body, and provide it with available elements, where appropriate;
fully cooperate with the relevant competent authority, or, where appropriate, with the relevant control authority or control body, in verifying and identifying the reasons for the suspected non-compliance.
Article 28
Precautionary measures to avoid the presence of non-authorised products and substances
In order to avoid contamination with products or substances that are not authorised in accordance with the first subparagraph of Article 9(3) for use in organic production, operators shall take the following precautionary measures at every stage of production, preparation and distribution:
put in place and maintain measures that are proportionate and appropriate to identify the risks of contamination of organic production and products with non-authorised products or substances, including systematic identification of critical procedural steps;
put in place and maintain measures that are proportionate and appropriate to avoid risks of contamination of organic production and products with non-authorised products or substances;
regularly review and adjust such measures; and
comply with other relevant requirements of this Regulation that ensure the separation of organic, in-conversion and non-organic products.
Where an operator suspects, due to the presence of a product or substance that is not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production in a product that is intended to be used or marketed as an organic or in-conversion product, that the latter product does not comply with this Regulation, the operator shall:
identify and separate the product concerned;
check whether the suspicion can be substantiated;
not place the product concerned on the market as an organic or in-conversion product and not use it in organic production unless the suspicion can be eliminated;
where the suspicion has been substantiated or where it cannot be eliminated, immediately inform the relevant competent authority, or, where appropriate, the relevant control authority or control body, and provide it with available elements, where appropriate;
fully cooperate with the relevant competent authority, or, where appropriate, with the relevant control authority or control body, in identifying and verifying the reasons for the presence of non-authorised products or substances.
The Commission may adopt implementing acts laying down uniform rules to specify:
the procedural steps to be followed by operators in accordance with points (a) to (e) of paragraph 2 and the relevant documents to be provided by them;
the proportionate and appropriate measures to be adopted and reviewed by operators to identify and avoid risks of contamination in accordance with points (a), (b) and (c) of paragraph 1.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 29
Measures to be taken in the event of the presence of non-authorised products or substances
Where the competent authority, or, where appropriate, the control authority or control body, receives substantiated information about the presence of products or substances that are not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production, or has been informed by an operator in accordance with point (d) of Article 28(2), or detects such products or substances in an organic or an in-conversion product:
it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to determining the source and the cause in order to verify compliance with the first subparagraph of Article 9(3) and with Article 28(1); such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case;
it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a).
The product concerned shall not be marketed as an organic or in-conversion product or used in organic production where the competent authority, or, where appropriate, the control authority or control body, has established that the operator concerned:
has used products or substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production;
has not taken the precautionary measures referred to in Article 28(1); or
has not taken measures in response to relevant previous requests from the competent authorities, control authorities or control bodies.
Where required, the operator concerned shall take such corrective measures as necessary to avoid future contamination.
Member States shall make such information available to the other Member States and to the Commission via a computer system that enables the electronic exchange of documents and information made available by the Commission.
The Commission shall adopt implementing acts laying down uniform rules to specify:
the methodology to be applied by competent authorities, or, where appropriate, by control authorities or control bodies, for the detection and evaluation of the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production;
the details and format of the information to be made available by Member States to the Commission and other Member States in accordance with paragraph 6 of this Article.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
CHAPTER IV
LABELLING
Article 30
Use of terms referring to organic production
Furthermore, no terms, including terms used in trademarks or company names, or practices shall be used in labelling or advertising if they are liable to mislead the consumer or user by suggesting that a product or its ingredients comply with this Regulation.
However, plant reproductive material, food products of plant origin and feed products of plant origin that have been produced during the conversion period, which comply with Article 10(4), may be labelled and advertised as in-conversion products by using the term ‘in-conversion’ or a corresponding term, together with the terms referred to in paragraph 1.
For processed food, the terms referred to in paragraph 1 may be used:
in the sales description, and in the list of ingredients where such a list is mandatory pursuant to Union legislation, provided that:
the processed food complies with the production rules set out in Part IV of Annex II and with the rules laid down in accordance with Article 16(3);
at least 95 % of the agricultural ingredients of the product by weight are organic; and
in the case of flavourings, they are only used for natural flavouring substances and natural flavouring preparations labelled in accordance with Article 16(2), (3) and (4) of Regulation (EC) No 1334/2008 and all of the flavouring components and carriers of flavouring components in the flavouring concerned are organic;
only in the list of ingredients, provided that:
less than 95 % of the agricultural ingredients of the product by weight are organic, and provided that those ingredients comply with the production rules set out in this Regulation; and
the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3);
in the sales description and in the list of ingredients, provided that:
the main ingredient is a product of hunting or fishing;
the term referred to in paragraph 1 is clearly related in the sales description to another ingredient which is organic and different from the main ingredient;
all other agricultural ingredients are organic; and
the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3).
The list of ingredients referred to in points (a), (b) and (c) of the first subparagraph shall indicate which ingredients are organic. The references to organic production may only appear in relation to the organic ingredients.
The list of ingredients referred to in points (b) and (c) of the first subparagraph shall include an indication of the total percentage of organic ingredients in proportion to the total quantity of agricultural ingredients.
The terms referred to in paragraph 1, when used in the list of ingredients referred to in points (a), (b), and (c) of the first subparagraph of this paragraph, and the indication of the percentage referred to in the third subparagraph of this paragraph shall appear in the same colour, identical size and style of lettering as the other indications in the list of ingredients.
For processed feed, the terms referred to in paragraph 1 may be used in the sales description and in the list of ingredients, provided that:
the processed feed complies with the production rules set out in Parts II, III and V of Annex II and with the specific rules laid down in accordance with Article 17(3);
all of the ingredients of agricultural origin that are contained in the processed feed are organic; and
at least 95 % of the dry matter of the product are organic.
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending:
this Article by adding further rules on the labelling of products listed in Annex I, or by amending those added rules; and
the list of terms set out in Annex IV, taking into account linguistic developments within the Member States.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 31
Labelling of products and substances used in crop production
Notwithstanding the scope of this Regulation as set out in Article 2(1), products and substances used in plant protection products or as fertilisers, soil conditioners or nutrients that have been authorised in accordance with Articles 9 and 24 may bear a reference indicating that those products or substances have been authorised for use in organic production in accordance with this Regulation.
Article 32
Compulsory indications
Where products bear terms as referred to in Article 30(1), including products labelled as in-conversion products in accordance with Article 30(3):
the code number of the control authority or control body to which the operator that carried out the last production or preparation operation is subject shall also appear in the labelling; and
in the case of prepacked food, the organic production logo of the European Union referred to in Article 33 shall also appear on the packaging, except in cases referred to in Article 30(3) and points (b) and (c) of Article 30(5).
Where the organic production logo of the European Union is used, an indication of the place where the agricultural raw materials of which the product is composed have been farmed shall appear in the same visual field as the logo and shall take one of the following forms, as appropriate:
‘EU Agriculture’, where the agricultural raw material has been farmed in the Union;
‘non-EU Agriculture’, where the agricultural raw material has been farmed in third countries;
‘EU/non-EU Agriculture’, where a part of the agricultural raw materials has been farmed in the Union and a part of it has been farmed in a third country.
For the purposes of the first subparagraph, the word ‘Agriculture’ may be replaced by ‘Aquaculture’ where appropriate and the words ‘EU’ and ‘non-EU’ may be replaced or supplemented by the name of a country, or by the name of a country and a region, if all of the agricultural raw materials of which the product is composed have been farmed in that country and, if applicable, in that region.
For the indication of the place where the agricultural raw materials of which the product is composed have been farmed, as referred to in the first and third subparagraphs, small quantities by weight of ingredients may be disregarded, provided that the total quantity of the disregarded ingredients does not exceed 5 % of the total quantity by weight of agricultural raw materials.
The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and style of lettering that is more prominent than the name of the product.
The Commission shall adopt implementing acts relating to:
practical arrangements for the use, presentation, composition and size of the indications referred to in point (a) of paragraph 1 and in paragraph 2 of this Article and in Article 33(3);
the assignment of code numbers to control authorities and control bodies;
the indication of the place where the agricultural raw materials were farmed, in accordance with paragraph 2 of this Article and with Article 33(3).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 33
Organic production logo of the European Union
The organic production logo of the European Union may also be used for information and educational purposes related to the existence and advertising of the logo itself, provided that such use is not liable to mislead the consumer as regards the organic production of specific products, and provided that the logo is reproduced in accordance with the rules set out in Annex V. In such case, the requirements of Article 32(2) and point 1.7 of Annex V shall not apply.
The organic production logo of the European Union shall not be used for processed food as referred to in points (b) and (c) of Article 30(5) and for in-conversion products as referred to in Article 30(3).
CHAPTER V
CERTIFICATION
Article 34
Certification system
Where the competent authorities have conferred their responsibilities or delegated certain official control tasks or certain tasks related to other official activities to more than one control authority or control body, the operators or groups of operators shall indicate in the notification referred to in the first subparagraph which control authority or control body verifies whether their activity complies with this Regulation and provides the certificate referred to in Article 35(1).
The Commission may adopt implementing acts to provide details and specifications regarding:
the format and technical means of the notification referred to in paragraph 1;
the arrangements for the publication of the lists referred to in paragraph 6; and
the procedures and the arrangements for publication of the fees referred to in paragraph 7.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 35
Certificate
Competent authorities, or, where appropriate, control authorities or control bodies, shall provide a certificate to any operator or group of operators that has notified its activity in accordance with Article 34(1) and complies with this Regulation. The certificate shall:
be issued in electronic form wherever possible;
allow at least the identification of the operator or group of operators including the list of the members, the category of products covered by the certificate and its period of validity;
certify that the notified activity complies with this Regulation; and
be issued in accordance with the model set out in Annex VI.
For the purposes of paragraphs 1 and 4 of this Article, products shall be classified in accordance with the following categories:
unprocessed plants and plant products, including seeds and other plant reproductive material;
livestock and unprocessed livestock products;
algae and unprocessed aquaculture products;
processed agricultural products, including aquaculture products, for use as food;
feed;
wine;
other products listed in Annex I to this Regulation or not covered by the previous categories.
Member States may exempt from the obligation to be in the possession of a certificate, provided for in paragraph 2, operators that sell unpacked organic products other than feed directly to the final consumer, provided that those operators do not produce, prepare, store other than in connection with the point of sale, or import such products from a third country, or subcontract such activities to a third party, and provided that:
such sales do not exceed 5 000 kg per year;
such sales do not represent an annual turnover in relation to unpacked organic products exceeding EUR 20 000 ; or
the potential certification cost of the operator exceeds 2 % of the total turnover on unpacked organic products sold by that operator.
If a Member State decides to exempt the operators referred to in the first subparagraph, it may set stricter limits than those set in the first subparagraph.
Member States shall inform the Commission and the other Member States of any decision to exempt operators pursuant to the first subparagraph and of the limits up to which such operators are exempted.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 36
Group of operators
Each group of operators shall:
only be composed of members who are farmers or operators that produce algae or aquaculture animals and who in addition may be engaged in processing, preparation or placing on the market of food or feed;
only be composed of members:
of which the individual certification cost represents more than 2 % of each member’s turnover or standard output of organic production and whose annual turnover of organic production is not more than EUR 25 000 or whose standard output of organic production is not more than EUR 15 000 per year; or
who have each holdings of maximum:
be established in a Member State or a third country;
have legal personality;
only be composed of members whose production activities take place in geographical proximity to each other;
set up a joint marketing system for the products produced by the group; and
establish a system for internal controls comprising a documented set of control activities and procedures in accordance with which an identified person or body is responsible for verifying compliance with this Regulation of each member of the group.
The Commission is empowered to adopt delegated acts in accordance with Article 54 amending paragraphs 1 and 2 of this Article by adding provisions, or by amending those added provisions, in particular as regards:
the responsibilities of the individual members of a group of operators;
the criteria to determine the geographical proximity of the members of the group, such as the sharing of facilities or sites;
the set-up and functioning of the system for internal controls, including the scope, content and frequency of the controls to be carried out and the criteria to identify deficiencies in the set-up or functioning of the system for internal controls.
The Commission may adopt implementing acts laying down specific rules concerning:
the composition and dimension of a group of operators;
the documents and record-keeping systems, the system for internal traceability and the list of operators;
the exchange of information between a group of operators and the competent authority or authorities, control authorities or control bodies, and between the Member States and the Commission.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
CHAPTER VI
OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES
Article 37
Relationship with Regulation (EU) 2017/625 and additional rules for official controls and other official activities in relation to organic production and labelling of organic products
The specific rules of this Chapter shall apply, in addition to the rules laid down in Regulation (EU) 2017/625, save as otherwise provided for in Article 40(2) of this Regulation, and in addition to Article 29 of this Regulation, save as otherwise provided for in Article 41(1) of this Regulation, to the official controls and other official activities performed to verify throughout the entire process at all stages of production, preparation and distribution that the products referred to in Article 2(1) of this Regulation have been produced in compliance with this Regulation.
Article 38
Additional rules on official controls and on action to be taken by the competent authorities
Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall include, in particular:
the verification of the application by operators of preventive and precautionary measures, as referred to in Article 9(6) and in Article 28 of this Regulation, at every stage of production, preparation and distribution;
where the holding includes non-organic or in-conversion production units, the verification of the records and of the measures or procedures or arrangements in place to ensure the clear and effective separation between organic, in-conversion and non-organic production units as well as between the respective products produced by those units, and of the substances and products used for organic, in-conversion and non-organic production units; such verification shall include checks on parcels for which a previous period was recognised retroactively as part of the conversion period, and checks on the non-organic production units;
where organic, in-conversion and non-organic products are collected simultaneously by operators, are prepared or stored in the same preparation unit, area or premises, or are transported to other operators or units, the verification of the records and of the measures, procedures or arrangements in place to ensure that operations are carried out separated by place or time, that suitable cleaning measures and, where appropriate, measures to prevent substitution of products are implemented, that organic products and in-conversion products are identified at all times and that organic, in-conversion and non-organic products are stored, before and after the preparation operations, separated by place or time from each other;
the verification of the set-up and functioning of the internal control system of groups of operators;
where operators are exempted from the notification obligation in accordance with Article 34(2) of this Regulation or from the obligation to be in the possession of a certificate in accordance with Article 35(8) of this Regulation, the verification that the requirements for that exemption have been fulfilled and the verification of the products sold by those operators.
Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall be performed throughout the entire process at all stages of production, preparation and distribution on the basis of the likelihood of non-compliance as defined in point (57) of Article 3 of this Regulation, which shall be determined taking into account, in addition to the elements referred to in Article 9 of Regulation (EU) 2017/625, in particular the following elements:
the type, size and structure of the operators and groups of operators;
the length of time during which operators and groups of operators have been involved in organic production, preparation and distribution;
the results of the controls performed in accordance with this Article;
the point in time relevant for the activities carried out;
the product categories;
the type, quantity and value of products and their development over time;
the possibility of commingling of products or contamination with non-authorised products or substances;
the application of derogations or exceptions to the rules by operators and groups of operators;
the critical points for non-compliance and the likelihood of non-compliance at every stage of production, preparation and distribution;
subcontracting activities.
The verification of compliance shall include a physical on-the-spot inspection, except where the following conditions have been satisfied:
the previous controls of the operator or group of operators concerned have not revealed any non-compliance affecting the integrity of organic or in-conversion products during at least three consecutive years; and
the operator or group of operators concerned has been assessed on the basis of the elements referred to in paragraph 2 of this Article and in Article 9 of Regulation (EU) 2017/625 as presenting a low likelihood of non-compliance.
In this case, the period between two physical on-the-spot inspections shall not exceed 24 months.
Official controls performed in accordance with Article 9 of Regulation (EU) 2017/625 for the verification of compliance with this Regulation shall:
be performed in accordance with Article 9(4) of Regulation (EU) 2017/625 while ensuring that a minimum percentage of all official controls of operators or groups of operators are carried out without prior notice;
ensure that a minimum percentage of additional controls to those referred in paragraph 3 of this Article are carried out;
be carried out by taking a minimum number of the samples that have been taken in accordance with point (h) of Article 14 of Regulation (EU) 2017/625;
ensure that a minimum number of operators that are members of a group of operators are controlled in connection with the verification of compliance referred to in paragraph 3 of this Article.
The Commission is empowered to adopt delegated acts in accordance with Article 54:
supplementing this Regulation by laying down specific criteria and conditions for the performance of official controls conducted to ensure the traceability at all stages of production, preparation and distribution, and compliance with this Regulation, concerning:
checks of documentary accounts;
controls performed on specific categories of operators;
where appropriate, the period within which the controls provided for in this Regulation, including the physical on-the-spot inspections referred to in paragraph 3 of this Article, are to be performed and the particular premises in or area on which they are to be performed;
amending paragraph 2 of this Article by adding further elements based on practical experience, or by amending those added elements.
The Commission may adopt implementing acts to specify:
the minimum percentage of all official controls of operators or groups of operators that are to be carried out without prior notice as referred to in point (a) of paragraph 4;
the minimum percentage of additional controls referred to in point (b) of paragraph 4;
the minimum number of samples referred to in point (c) of paragraph 4;
the minimum number of operators that are members of a group of operators referred to in point (d) of paragraph 4.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 39
Additional rules on actions to be taken by the operators and groups of operators
In addition to the obligations laid down in Article 15 of Regulation (EU) 2017/625, operators and groups of operators shall:
keep records to demonstrate their compliance with this Regulation;
make all declarations and other communications that are necessary for official controls;
take relevant practical measures to ensure compliance with this Regulation;
provide, in form of a declaration to be signed and updated as necessary:
the full description of the organic or in-conversion production unit and of the activities to be performed in accordance with this Regulation;
the relevant practical measures to be taken to ensure compliance with this Regulation;
an undertaking:
The Commission may adopt implementing acts to provide details and specifications regarding:
the records for demonstrating compliance with this Regulation;
the declarations and other communications that are necessary for official controls;
the relevant practical measures for ensuring compliance with this Regulation.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 40
Additional rules on the delegation of official control tasks and tasks related to other official activities
Competent authorities may delegate to control bodies certain official control tasks and certain tasks related to other official activities only if the following conditions, in addition to those set out in Chapter III of Regulation (EU) 2017/625, are satisfied:
the delegation contains a detailed description of the delegated official control tasks and tasks related to other official activities, including reporting obligations and other specific obligations, and of the conditions under which the control body may carry them out. In particular, the control body shall have submitted the following to the competent authorities for prior approval:
its risk assessment procedure, which is to determine, in particular, the basis for the intensity and frequency of the verification of compliance of the operators and groups of operators, which is to be established on the basis of the elements referred to in Article 9 of Regulation (EU) 2017/625 and of Article 38 of this Regulation, and which is to be followed for official controls on operators and groups of operators;
the standard control procedure, which is to contain a detailed description of the control measures that the control body undertakes to apply to the operators and groups of operators that are subject to its controls;
a list of measures that are in conformity with the common catalogue referred to in Article 41(4), and that are to be applied to operators and groups of operators in cases of suspected or established non-compliance;
the arrangements for the effective monitoring of the official control tasks and tasks related to other official activities carried out in relation to operators and groups of operators and the arrangements for reporting on those tasks.
The control body shall notify subsequent amendment of the elements referred to in points (i) to (iv) to the competent authority;
those competent authorities have procedures and arrangements in place to ensure the supervision of control bodies, including to verify that the delegated tasks are carried out effectively, independently and objectively, in particular as regards the intensity and frequency of the verification of compliance.
At least once a year, competent authorities shall, pursuant to point (a) of Article 33 of Regulation (EU) 2017/625, organise audits of the control bodies to whom they have delegated official control tasks or tasks related to other official activities.
Competent authorities shall not delegate the following official control tasks and tasks related to other official activities to control bodies:
the supervision and audit of other control authorities or control bodies;
the power to grant derogations other than derogations for the use of plant reproductive material not obtained from organic production;
the authority to receive notifications of activities by operators or groups of operators under Article 34(1) of this Regulation;
the assessment of the likelihood of non-compliance with the provisions of this Regulation that determine the frequency with which physical checks are to be performed on organic consignments prior to their release for free circulation into the Union in accordance with Article 54 of Regulation (EU) 2017/625;
the establishment of the common catalogue of measures referred to in Article 41(4) of this Regulation.
Without prejudice to point (b) of Article 33 of Regulation (EU) 2017/625, before fully or partly withdrawing the delegation of official control tasks or tasks related to other official activities in the cases referred to in that point, competent authorities may fully or partly suspend that delegation:
for a period that shall not exceed 12 months, during which the control body is to remedy the shortcomings identified during audits and inspections or to address the non-compliance about which information was shared with other control authorities and control bodies, with competent authorities as well as with the Commission in accordance with Article 43 of this Regulation; or
for the period during which the accreditation referred to in point (b)(iv) of Article 29 of Regulation (EU) 2017/625, in connection with Article 40(3) of this Regulation, is suspended.
Where the delegation of official control tasks or tasks related to other official activities has been suspended, the control bodies concerned shall not issue certificates referred to in Article 35 for those parts for which the delegation has been suspended. Competent authorities shall decide whether any certificates issued by the control bodies concerned before the date of that partial or full suspension are to remain valid, and shall inform the operators concerned of that decision.
Without prejudice to Article 33 of Regulation (EU) 2017/625, the competent authorities shall lift the suspension of the delegation of official control tasks or tasks related to other official activities as soon as possible once the control body has remedied the shortcomings or non-compliances referred to in point (a) of the first subparagraph or once the accreditation body has lifted the suspension of the accreditation referred to in point (b) of the first subparagraph.
The control bodies shall transmit to the competent authorities:
a list of the operators which were subject to their controls on 31 December of the previous year by 31 January of each year; and
information on the official controls and other official activities carried out in the previous year to support the preparation of the part on organic production and labelling of organic products of the annual report referred to in Article 113 of Regulation (EU) 2017/625 by 31 March of each year.
Article 41
Additional rules on actions in the event of suspected and established non-compliance, and common catalogue of measures
Subject to Article 29, where a competent authority, or, where appropriate, a control authority or control body, suspects or receives substantiated information, including information from other competent authorities, or, where appropriate, from other control authorities or control bodies, that an operator intends to use or to place on the market a product which may not be in compliance with this Regulation but which bears terms referring to the organic production, or where such competent authority, control authority or control body has been informed by an operator of a suspicion of non-compliance in accordance with Article 27:
it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to verifying compliance with this Regulation; such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case;
it shall provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). Before taking such a decision, the competent authority, or, where appropriate, the control authority or control body, shall give the operator an opportunity to comment.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 42
Additional rules on measures in the event of non-compliance affecting integrity
Article 43
Additional rules on the exchange of information
Competent authorities shall share that information with other competent authorities and the Commission via a computer system that enables the electronic exchanges of documents and information made available by the Commission.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
CHAPTER VII
TRADE WITH THIRD COUNTRIES
Article 44
Export of organic products
Article 45
Import of organic and in-conversion products
A product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as an in-conversion product, provided that the following three conditions are met:
the product is a product as referred to in Article 2(1);
one of the following applies:
the product complies with Chapters II, III and IV of this Regulation, and all operators and groups of operators referred to in Article 36, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with this Regulation;
in cases where the product comes from a third country which is recognised in accordance with Article 47, that product complies with the conditions laid down in the relevant trade agreement; or
in cases where the product comes from a third country which is recognised in accordance with Article 48, that product complies with the equivalent production and control rules of that third country and is imported with a certificate of inspection confirming this compliance that was issued by the competent authorities, control authorities or control bodies of that third country; and
the operators in third countries are able at any time to provide the importers and the national authorities in the Union and in those third countries with information allowing the identification of the operators that are their suppliers and the control authorities or control bodies of those suppliers, with a view to ensuring the traceability of the organic or in-conversion product concerned. That information shall also be made available to the control authorities or control bodies of the importers.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 46
Recognition of control authorities and control bodies
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Control authorities or control bodies shall be recognised in accordance with paragraph 1 of this Article for the control of import of the categories of products listed in Article 35(7) if they fulfil the following criteria:
they are legally established in one Member State or third country;
they have the capacity to carry out controls to ensure that the conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in relation to organic products and in-conversion products intended for import into the Union;
they offer adequate guarantees of objectivity and impartiality and are free from any conflict of interest as regards the exercise of their control tasks;
in the case of control bodies, they are accredited under the relevant harmonised standard for ‘Conformity assessment – Requirements for bodies certifying products, processes and services’, the reference of which has been published in the Official Journal of the European Union;
they have the expertise, equipment and infrastructure required to carry out control tasks, and have a sufficient number of suitable qualified and experienced staff; and
they meet any additional criteria that may be laid down in a delegated act adopted pursuant to paragraph 7.
The accreditation referred to in point (d) of paragraph 2 may only be granted by:
a national accreditation body in the Union in accordance with Regulation (EC) No 765/2008; or
an accreditation body outside the Union that is a signatory of a multilateral recognition arrangement under the auspices of the International Accreditation Forum.
The control authorities shall provide the latest assessment report issued by the competent authority, and the control bodies shall provide the accreditation certificate issued by the accreditation body. Where appropriate, control authorities or control bodies shall also provide latest reports on the regular on-the-spot evaluation, surveillance and multiannual re-assessment of their activities.
The recognition of control authorities or of control bodies referred to in paragraph 1 shall in particular be withdrawn without delay, in accordance with the procedure referred to in that paragraph, where serious or repetitive infringements as regards the certification or the controls and actions laid down in accordance with paragraph 8 have been detected and where the control authority or control body concerned has failed to take appropriate and timely remedial action in reaction to a request by the Commission within a period determined by the Commission. Such period shall be determined in accordance with the severity of the problem and in general shall not be less than 30 days.
The Commission is empowered to adopt delegated acts in accordance with Article 54:
amending paragraph 2 of this Article by adding further criteria to those laid down therein for the recognition of the control authorities and control bodies referred to in paragraph 1 of this Article and for the withdrawal of such recognition, or by amending those added criteria;
supplementing this Regulation as regards:
the exercise of the supervision of the control authorities and control bodies recognised by the Commission in accordance with paragraph 1, including on-the-spot examinations; and
the controls and other actions to be performed by those control authorities and control bodies.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 47
Equivalence under a trade agreement
A recognised third country referred to in point (b)(ii) of Article 45(1) is a third country which the Union has recognised under a trade agreement as having a system of production meeting the same objectives and principles by applying rules which ensure the same level of assurance of conformity as those of the Union.
Article 48
Equivalence under Regulation (EC) No 834/2007
That recognition shall expire on ►M1 31 December 2026 ◄ .
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 49
Report from the Commission on the application of Articles 47 and 48
By ►M1 31 December 2022 ◄ , the Commission shall present a report to the European Parliament and the Council on the state of application of Articles 47 and 48, in particular as regards the recognition of third countries for the purpose of equivalence.
CHAPTER VIII
GENERAL PROVISIONS
SECTION 1
Free movement of organic and in-conversion products
Article 50
Non-prohibition and non-restriction of the marketing of organic and in-conversion products
Competent authorities, control authorities and control bodies shall not, on grounds that relate to the production, labelling or presentation of the products, prohibit or restrict the marketing of organic or in-conversion products subject to control by another competent authority, control authority or control body located in another Member State where those products comply with this Regulation. In particular, no official controls and other official activities other than those under Regulation (EU) 2017/625 shall be performed and no fees for official controls and other official activities other than those provided for in Chapter VI of that Regulation shall be collected.
SECTION 2
Information, reporting and related derogations
Article 51
Information relating to the organic sector and trade
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 52
Information relating to the competent authorities, control authorities and control bodies
Members States shall keep a regularly updated list of:
the names and addresses of the competent authorities; and
the names, addresses and code numbers of the control authorities and control bodies.
Member States shall transmit those lists, and any change thereof, to the Commission and make them public, except where such transmission and publication has already taken place in accordance with Article 4(4) of Regulation (EU) 2017/625.
Article 53
Derogations, authorisations and report
From ►M1 1 January 2029 ◄ , based on the conclusions as regards availability of organic plant reproductive material and animals presented in the report provided for in paragraph 7 of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 54 amending this Regulation by:
ending the derogations referred to in point 1.8.5 of Part I of Annex II and in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II, with the exception of point 1.3.4.4.2 of Part II of Annex II, at an earlier date than ►M1 31 December 2036 ◄ or extending them beyond that date; or
ending the derogation referred to in point 1.3.4.4.2 of Part II of Annex II.
By 30 June of each year, Member States shall make available to the Commission and to the other Member States:
information provided in the database referred to in Article 26(1) and in the systems referred to in Article 26(2) and, if relevant, in the systems referred to in Article 26(3);
information on the derogations granted in accordance with point 1.8.5 of Part I of Annex II and points 1.3.4.3 and 1.3.4.4 of Part II of Annex II; and
information on the availability on the Union market of organic protein feed for poultry and porcine animals and on the authorisations granted in accordance with points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II.
By ►M1 31 December 2026 ◄ , the Commission shall present a report to the European Parliament and the Council on the availability on the Union market of and, if relevant, on the causes of limited access to:
organic plant reproductive material;
organic animals covered by the derogations referred to in points 1.3.4.3 and 1.3.4.4 of Part II of Annex II;
organic protein feed intended for the nutrition of poultry and porcine animals subject to the authorisations referred to in points 1.9.3.1(c) and 1.9.4.2(c) of Part II of Annex II.
In drawing up that report, the Commission shall take into account, in particular, the data collected in accordance with Article 26 and the information relating to the derogations and the authorisations referred to in paragraph 6 of this Article.
CHAPTER IX
PROCEDURAL, TRANSITIONAL AND FINAL PROVISIONS
SECTION 1
Procedural provisions
Article 54
Exercise of the delegation
Article 55
Committee procedure
SECTION 2
Repeal and transitional and final provisions
Article 56
Repeal
Regulation (EC) No 834/2007 is repealed.
However, that Regulation shall continue to apply for the purpose of completing the examination of pending applications from third countries, as provided for in Article 58 of this Regulation.
References to the repealed Regulation shall be construed as references to this Regulation.
Article 57
Transitional measures relating to control authorities and control bodies recognised under Article 33(3) of Regulation (EC) No 834/2007
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).
Article 58
Transitional measures relating to applications from third countries submitted under Article 33(2) of Regulation (EC) No 834/2007
Article 59
Transitional measures relating to the first recognition of control authorities and control bodies
By way of derogation from the date of application referred to in the second paragraph of Article 61, Article 46 shall apply from 17 June 2018 insofar as necessary in order to allow a timely recognition of control authorities and control bodies.
Article 60
Transitional measures for stocks of organic products produced in accordance with Regulation (EC) No 834/2007
Products produced in accordance with Regulation (EC) No 834/2007 before ►M1 1 January 2022 ◄ may be placed on the market after that date until stocks are exhausted.
Article 61
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 January 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
OTHER PRODUCTS REFERRED TO IN ARTICLE 2(1)
ANNEX II
DETAILED PRODUCTION RULES REFERRED TO IN CHAPTER III
Part I: Plant production rules
In addition to the production rules laid down in Articles 9 to 12, the rules set out in this Part shall apply to organic plant production.
1. General requirements
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1.1. |
Organic crops, except those which are naturally grown in water, shall be produced in living soil, or in living soil mixed or fertilised with materials and products allowed in organic production, in connection with the subsoil and bedrock. |
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1.2. |
Hydroponic production, which is a method of growing plants which do not naturally grow in water with their roots in a nutrient solution only or in an inert medium to which a nutrient solution is added, is prohibited. |
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1.3. |
By way of derogation from point 1.1, the production of sprouts by moistening of seeds and the obtaining of chicory heads including by dipping in clear water shall be allowed. |
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1.4. |
By way of derogation from point 1.1, the following practices shall be allowed:
(a)
growing plants for the production of ornamentals and herbs in pots to be sold together with the pot to the final consumer;
(b)
growing seedlings or transplants in containers for further transplanting. |
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1.5. |
By way of derogation from point 1.1, growing crops in demarcated beds shall only be allowed for the surfaces that have been certified as organic for that practice before 28 June 2017 in Finland, Sweden and Denmark. No extension of those surfaces shall be permitted. That derogation shall expire on ►M1 31 December 2031 ◄ . By ►M1 31 December 2026 ◄ , the Commission shall present a report to the European Parliament and the Council on the use of demarcated beds in organic agriculture. That report may be accompanied, where appropriate, by a legislative proposal on the use of demarcated beds in organic agriculture. |
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1.6. |
All plant production techniques used shall prevent or minimise any contribution to the contamination of the environment. |
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1.7. |
Conversion 1.7.1. For plants and plant products to be considered as organic products, the production rules laid down in this Regulation shall have been applied with respect to the parcels during a conversion period of at least two years before sowing, or, in the case of grassland or perennial forage, during a period of at least two years before its use as organic feed, or, in the case of perennial crops other than forage, during a period of at least three years before the first harvest of organic products. 1.7.2. Where the land or one or more parcels thereof have been contaminated with products or substances not authorised for use in organic production, the competent authority may decide to extend the conversion period for the land or parcels concerned beyond the period referred to in point 1.7.1. 1.7.3. In the case of treatment with a product or a substance not authorised for use in organic production, the competent authority shall require a new conversion period in accordance with point 1.7.1. That period may be shortened in the following two cases:
(a)
treatment with a product or a substance not authorised for use in organic production as part of a compulsory control measure for pests or weeds, including quarantine organisms or invasive species, imposed by the competent authority of the Member State concerned;
(b)
treatment with a product or a substance not authorised for use in organic production as part of scientific tests approved by the competent authority of the Member State concerned. 1.7.4. In the cases referred to in points 1.7.2 and 1.7.3, the length of the conversion period shall be fixed taking into account the following requirements:
(a)
the process of degradation of the product or substance concerned must 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 placed on the market as organic or in-conversion products. 1.7.4.1. Member States shall inform the Commission and the other Member States of any decision taken by them which lays down compulsory measures related to treatment with a product or a substance not authorised for use in organic production. 1.7.4.2. In the case of treatment with a product or a substance which is not authorised for use in organic production, point 1.7.5(b) shall not apply. 1.7.5. In the case of land associated with organic livestock production:
(a)
the conversion rules shall apply to the whole area of the production unit on which animal feed is produced;
(b)
notwithstanding point (a), the conversion period may be reduced to one year for pasturages and open air areas used by non-herbivore species. |
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1.8. |
Origin of plants including plant reproductive material 1.8.1. For the production of plants and plant products other than plant reproductive material, only organic plant reproductive material shall be used. 1.8.2. To obtain organic plant reproductive material to be used for the production of products other than plant reproductive material, the mother plant and, where relevant, other plants intended for plant reproductive material production shall have been produced in accordance with this Regulation for at least one generation, or, in the case of perennial crops, for at least one generation during two growing seasons. 1.8.3. When choosing organic plant reproductive material, operators shall give preference to organic plant reproductive material suitable for organic agriculture. 1.8.4. For the production of organic varieties suitable for organic production, the organic breeding activities shall be conducted under organic conditions and shall focus on enhancement of genetic diversity, reliance on natural reproductive ability, as well as agronomic performance, disease resistance and adaptation to diverse local soil and climate conditions. All multiplication practices except meristem culture shall be carried out under certified organic management. 1.8.5. Use of in-conversion and non-organic plant reproductive material 1.8.5.1. By way of derogation from point 1.8.1, where the data collected in the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2) shows that the qualitative or quantitative needs of the operator regarding relevant organic plant reproductive material, excluding seedlings, are not met, competent authorities may authorise the use of in-conversion or non-organic plant reproductive material under the conditions laid down in points 1.8.5.3, 1.8.5.4 and 1.8.5.5. Prior to requesting any such derogation, the operator shall consult the database referred to in Article 26(1) or the system referred to in point (a) of Article 26(2) in order to verify whether his or her request is justified. 1.8.5.2. Control authorities or control bodies recognised in accordance with Article 46(1) may authorise operators in third countries to use in-conversion or non-organic plant reproductive material in an organic production unit when organic plant reproductive material is not available in sufficient quality or quantity in the territory of the third country in which the operator is located, under the conditions laid down under points 1.8.5.3, 1.8.5.4 and 1.8.5.5. 1.8.5.3. Non-organic plant reproductive material shall not be treated with plant protection products other than those authorised for the treatment of seed in accordance with Article 24(1) of this Regulation, unless chemical treatment has been prescribed in accordance with Regulation (EU) 2016/2031 for phytosanitary purposes by the competent authority of the Member State concerned for all varieties of a given species in the area in which the plant reproductive material is to be used. 1.8.5.4. The authorisation to use in-conversion or non-organic plant reproductive material shall be obtained before the sowing of the crop. 1.8.5.5. The authorisation to use in-conversion or non-organic plant reproductive material shall be granted only to individual users for one season at a time, and the competent authority responsible for authorisations shall list the quantities of the authorised plant reproductive material. |
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1.9. |
Soil management and fertilisation 1.9.1. In organic plant production, tillage and cultivation practices shall be used that maintain or increase soil organic matter, enhance soil stability and soil biodiversity, and prevent soil compaction and soil erosion. 1.9.2. The fertility and biological activity of the soil shall be maintained and increased:
(a)
except in the case of grassland or perennial forage, by the use of multiannual crop rotation including mandatory leguminous crops as the main or cover crop for rotating crops and other green manure crops;
(b)
in the case of greenhouses or perennial crops other than forage, by the use of short-term green manure crops and legumes as well as the use of plant diversity; and
(c)
in all cases, by the application of livestock manure or organic matter, both preferably composted, from organic production. 1.9.3. Where the nutritional needs of plants cannot be met by the measures provided for in points 1.9.1 and 1.9.2, only fertilisers and soil conditioners that have been authorised pursuant to Article 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records of the use of those products. 1.9.4. The total amount of livestock manure, as defined in Directive 91/676/EEC, used in the in-conversion and organic production units shall not exceed 170 kg of nitrogen per year/hectare of agricultural area used. That limit shall only apply to the use of farmyard manure, dried farmyard manure and dehydrated poultry manure, composted animal excrement, including poultry manure, composted farmyard manure and liquid animal excrement. 1.9.5. Operators of agricultural holdings may establish written cooperation agreements exclusively with operators of other agricultural holdings and undertakings which comply with the organic production rules, for the purpose of spreading surplus manure from organic production units. The maximum limit referred to in point 1.9.4 shall be calculated on the basis of all of the organic production units involved in such cooperation. 1.9.6. Preparations of micro-organisms may be used to improve the overall condition of the soil or to improve the availability of nutrients in the soil or in the crops. 1.9.7. For compost activation, appropriate plant-based preparations and preparations of micro-organisms may be used. 1.9.8. Mineral nitrogen fertilisers shall not be used. 1.9.9. Biodynamic preparations may be used. |
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1.10. |
Pest and weed management 1.10.1. The prevention of damage caused by pests and weeds shall rely primarily on the protection by:
—
natural enemies,
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the choice of species, varieties and heterogeneous material,
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crop rotation,
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cultivation techniques such as biofumigation, mechanical and physical methods, and
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thermal processes such as solarisation and, in the case of protected crops, shallow steam treatment of the soil (to a maximum depth of 10 cm).
1.10.2. Where plants cannot adequately be protected from pests by measures provided for in point 1.10.1 or in the case of an established threat to a crop, only products and substances authorised pursuant to Articles 9 and 24 for use in organic production shall be used, and only to the extent necessary. Operators shall keep records proving the need for the use of such products. 1.10.3. In relation to products and substances used in traps or in dispensers of products and substances other than pheromones, the traps or dispensers shall prevent the products and substances from being released into the environment and shall prevent contact between the products and substances and the crops being cultivated. All traps, including pheromone traps, shall be collected after use and shall be safely disposed of. |
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1.11. |
Products used for cleaning and disinfection Only those products for cleaning and disinfection in plant production authorised pursuant to Article 24 for use in organic production shall be used for that purpose. |
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1.12. |
Record-keeping obligation Operators shall keep records regarding the parcels concerned and the amount of the harvest. |
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1.13. |
Preparation of unprocessed products If preparation operations other than processing are carried out on plants, 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. |
2. Detailed rules for specific plants and plant products
2.1. Rules on mushroom production
For the production of mushrooms, substrates may be used if they are composed only of the following components:
farmyard manure and animal excrement:
either from organic production units or from in-conversion units in their second year of conversion; or
referred to in point 1.9.3, only when the product referred to in point (i) is not available, provided that that farmyard manure and animal excrement do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting;
products of agricultural origin, other than those referred to in point (a), from organic production units;
peat, not treated with chemical products;
wood, not treated with chemical products after felling;
mineral products referred to in point 1.9.3, water and soil.
2.2. Rules concerning the collection of wild plants
The collection of wild plants and parts thereof growing naturally in natural areas, forests and agricultural areas is considered as organic production, provided that:
for a period of at least three years before the collection, those areas were not treated with products or substances other than those authorised pursuant to Articles 9 and 24 for use in organic production;
the collection does not affect the stability of the natural habitat or the maintenance of the species in the collection area.
Part II: Livestock production rules
In addition to the production rules laid down in Articles 9, 10, 11 and 14, the rules laid down in this Part shall apply to organic livestock production.
1. General requirements
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1.1. |
Except in the case of beekeeping, landless livestock production, where the farmer intending to produce organic livestock does not manage agricultural land and has not established a written cooperation agreement with a farmer as regards the use of organic production units or in-conversion production units for that livestock, shall be prohibited. |
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1.2. |
Conversion
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1.3. |
Origin of animals
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1.4. |
Nutrition 1.4.1. General nutrition requirements With regard to nutrition, the following rules shall apply:
(a)
feed for livestock shall be obtained primarily from the agricultural holding where the animals are kept or shall be obtained from organic or in-conversion production units belonging to other holdings in the same region;
(b)
livestock shall be fed with organic or in-conversion feed that meets the animal’s nutritional requirements at the various stages of its development; restricted feeding shall not be permitted in livestock production unless justified for veterinary reasons;
(c)
livestock shall not be kept in conditions or on a diet which may encourage anaemia;
(d)
fattening practices shall always respect the normal nutritional patterns for each species and the animals’ welfare at each stage of the rearing process; force-feeding is forbidden;
(e)
with the exception of porcine animals, poultry and bees, livestock shall have permanent access to pasture whenever conditions allow or shall have permanent access to roughage;
(f)
growth promoters and synthetic amino-acids shall not be used;
(g)
suckling animals shall preferably be fed on maternal milk for a minimum period laid down by the Commission in accordance with point (a) of Article 14(3); milk replacers containing chemically synthesised components or components of plant origin shall not be used during that period;
(h)
feed materials of plant, algal, animal or yeast origin shall be organic;
(i)
non-organic feed materials of plant, algal, animal or yeast origin, feed materials of microbial or of mineral origin, feed additives and processing aids may be used only if they have been authorised pursuant to Article 24 for use in organic production. 1.4.2. Grazing 1.4.2.1. Grazing on organic land Without prejudice to point 1.4.2.2, organic animals shall graze on organic land. However, non-organic animals may use organic pasturage for a limited period each year, provided that they have been raised in an environmental friendly way on land supported under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU) No 1305/2013 and that they are not present on the organic land at the same time as organic animals. 1.4.2.2. Grazing on common land and transhumance 1.4.2.2.1. Organic animals may graze on common land, provided that:
(a)
the common land has not been treated with products or substances not authorised for use in organic production for at least three years;
(b)
any non-organic animals which use the common land have been raised in an environmental friendly way on land supported under Articles 23, 25, 28, 30, 31 and 34 of Regulation (EU) No 1305/2013;
(c)
any livestock products from organic animals that were produced during the period when those animals grazed on common land are not considered as organic products unless adequate segregation from non-organic animals can be proved. 1.4.2.2.2. During the period of transhumance, organic animals may graze on non-organic land when they are being moved on foot from one grazing area to another. During that period, organic animals shall be kept separate from other animals. The uptake of non-organic feed, in the form of grass and other vegetation on which the animals graze, shall be allowed:
(a)
for a maximum of 35 days covering both the outward and return journeys; or
(b)
for a maximum of 10 % of the total feed ration per year, calculated as a percentage of the dry matter of feedstuffs of agricultural origin. 1.4.3. In-conversion feed 1.4.3.1. For agricultural holdings that produce organic livestock:
(a)
up to 25 % on average of the feed formula of rations may comprise in-conversion feed from the second year of conversion. This percentage may be increased to 100 % if this in-conversion feed comes from the holding where the livestock is kept; and
(b)
up to 20 % of the total average amount of feed fed to livestock may originate from the grazing or harvesting of permanent pastures, perennial forage parcels or protein crops sown under organic management on lands in their first year of conversion, provided that those lands are part of the holding itself. When both types of in-conversion feed referred to in points (a) and (b) are being used for feeding, the total combined percentage of such feed shall not exceed the percentage fixed in point (a). 1.4.3.2. The figures in point 1.4.3.1 shall be calculated annually as a percentage of the dry matter of feed of plant origin. |
|
1.5. |
Health care 1.5.1. Disease prevention
1.5.2. Veterinary treatment
|
|
1.6. |
Housing and husbandry practices
|
|
1.7. |
Animal welfare
|
|
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 ►M1 1 January 2024 ◄ ;
(b)
animals shall have access to pasturage for grazing whenever conditions allow;
(c)
notwithstanding point (b), male bovine animals over one year old shall have access to pasturage or an open air area;
(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 ( 27 ), 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 ►M1 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;
(c)
any housing shall have smooth, but not slippery floors;
(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 ►M1 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;
(c)
49 days for Peking ducks;
(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 ►M1 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. 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.
(c)
rabbit farms shall use robust breeds adapted to outdoor conditions;
(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 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. |
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 ( 28 ). 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. |
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 (
29
), 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. |
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.
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:
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.
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;
(c)
species shall be chosen which are robust and can be produced without causing significant damage to wild stocks;
(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 ►M1 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;
(c)
appropriate strains shall be chosen. |
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. |
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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.
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|
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; plant material shall not exceed 60 % of total ingredients. |
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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. |
3.1.4. Health care
3.1.4.1. Disease prevention
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.
3.1.4.2. Veterinary treatments
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.
3.1.5. Housing and husbandry practices
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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. |
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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. |
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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.
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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. |
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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. |
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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. |
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3.1.5.7. |
Containment systems shall be designed, located and operated to minimise the risk of escape incidents. |
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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. |
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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
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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. |
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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. |
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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. |
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3.1.6.4. |
Aeration shall be permitted to ensure animal welfare and health. Mechanical aerators shall be preferably powered by renewable energy sources. |
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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;
(c)
in order to assure the survival of the farm stock. |
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3.1.6.6. |
Appropriate measures shall be taken to keep the duration of the transport of aquaculture animals to a minimum. |
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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. |
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3.1.6.8. |
Eyestalk ablation, including all similar practices such as ligation, incision and pinching, is prohibited. |
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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:
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.
3.2.2. Housing and husbandry practices
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.
3.2.3. Cultivation
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.
3.2.4. Management
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.
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
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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 ( 30 ). |
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1.2. |
Operators producing processed food shall establish and update appropriate procedures based on a systematic identification of critical processing steps. |
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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. |
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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;
(b)
implement suitable cleaning measures, monitor their effectiveness and keep records of those operations;
(c)
guarantee that non-organic products are not placed on the market with an indication referring to organic production. |
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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. |
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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. |
2. Detailed requirements for the production of processed food
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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;
(c)
an in-conversion ingredient shall not be present together with the same ingredient in organic or non-organic form. |
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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 (
31
) 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 (
32
), their use is authorised by that Directive.
2.2.3.
Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose.
2.2.4.
For the purpose of the calculation referred to in Article 30(5), the following rules shall apply:
(a)
certain food additives authorised pursuant to Article 24 for use in organic production shall be calculated as agricultural ingredients;
(b)
preparations and substances referred to in points (a), (c), (d), (e) and (f) of point 2.2.2 shall not be calculated as agricultural ingredients;
(c)
yeast and yeast products shall be calculated as agricultural ingredients. |
Part V: Processed feed production rules
In addition to the general production rules laid down in Articles 9, 11 and 17, the rules laid down in this Part shall apply to the organic production of processed feed.
1. General requirements for the production of processed feed
1.1. Feed additives, processing aids and other substances and ingredients used for processing feed, and any processing practice used, such as smoking, shall comply with the principles of good manufacturing practice.
1.2. Operators that produce processed feed shall establish and update appropriate procedures based on a systematic identification of the 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:
take precautionary measures;
implement suitable cleaning measures, monitor their effectiveness and keep records of those operations;
guarantee that non-organic products are not placed on the market with an indication referring to organic production.
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:
inform the control authority or control body accordingly;
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);
store organic, in-conversion and non-organic products, before and after the operations, separate by place or time from each other;
keep available an updated register of all operations and quantities processed;
take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges between organic, in-conversion and non-organic products;
carry out operations on organic or in-conversion products only after suitable cleaning of the production equipment.
2. Detailed requirements for the production of processed feed
2.1. Organic feed materials, or in-conversion feed materials, shall not enter simultaneously with the same feed materials produced by non-organic means into the composition of the organic feed product.
2.2. Any feed materials used or processed in organic production shall not have been processed with the aid of chemically synthesised solvents.
2.3. Only non-organic feed material of plant, algal, animal or yeast origin, feed material of mineral origin, and feed additives and processing aids authorised pursuant to Article 24 for use in organic production may be used in the processing of feed.
2.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose.
Part VI: Wine
1. Scope
1.1. In addition to the general production rules laid down in Articles 9, 10, 11, 16 and 18, the rules laid down in this Part shall apply to the organic production of the products of the wine sector as referred to in point (l) of Article 1(2) of Regulation (EU) No 1308/2013.
1.2. Commission Regulations (EC) No 606/2009 ( 33 ) and (EC) No 607/2009 ( 34 ) shall apply, save as explicitly provided otherwise in this Part.
2. Use of certain products and substances
2.1. Products of the wine sector shall be produced from organic raw material.
2.2. Only products and substances authorised pursuant to Article 24 for use in organic production may be used for the making of products of the wine sector, including during the oenological practices, processes and treatments, subject to the conditions and restrictions laid down in Regulation (EU) No 1308/2013 and Regulation (EC) No 606/2009, and in particular in Annex I A to the latter Regulation.
3. Oenological practices and restrictions
3.1. Without prejudice to Sections 1 and 2 of this Part and to specific prohibitions and restrictions provided for in points 3.2, 3.3 and 3.4, only oenological practices, processes and treatments, including the restrictions provided for in Article 80 and Article 83(2) of Regulation (EU) No 1308/2013, in Article 3, Articles 5 to 9 and Articles 11 to 14 of Regulation (EC) No 606/2009, and in the Annexes to those Regulations used before 1 August 2010 shall be permitted.
3.2. The use of the following oenological practices, processes and treatments shall be prohibited:
partial concentration through cooling in accordance with point (c) of Section B.1 of Part I of Annex VIII to Regulation (EU) No 1308/2013;
elimination of sulphur dioxide by physical processes in accordance with point 8 of Annex I A to Regulation (EC) No 606/2009;
electrodialysis treatment to ensure the tartaric stabilisation of the wine in accordance with point 36 of Annex I A to Regulation (EC) No 606/2009;
partial dealcoholisation of wine in accordance with point 40 of Annex I A to Regulation (EC) No 606/2009;
treatment with cation exchangers to ensure the tartaric stabilisation of the wine in accordance with point 43 of Annex I A to Regulation (EC) No 606/2009.
3.3. The use of the following oenological practices, processes and treatments is permitted under the following conditions:
heat treatments in accordance with point 2 of Annex I A to Regulation (EC) No 606/2009, provided that the temperature does not exceed 75 °C;
centrifuging and filtration with or without an inert filtering agent in accordance with point 3 of Annex I A to Regulation (EC) No 606/2009, provided that the size of the pores is not smaller than 0,2 micrometres.
3.4. Any amendment introduced after 1 August 2010 concerning the oenological practices, processes and treatments provided for in Regulation (EC) No 1234/2007 or Regulation (EC) No 606/2009 may apply to the organic production of wine only after those measures have been included as permitted in this Section and, if required, after an evaluation in accordance with Article 24 of this Regulation.
Part VII: Yeast used as food or feed
In addition to the general production rules laid down in Articles 9, 11, 16, 17 and 19, the rules laid down in this Part shall apply to the organic production of yeast used as food or feed.
1. General requirements
1.1. For the production of organic yeast, only organically produced substrates shall be used. However, until ►M1 31 December 2024 ◄ , the addition of up to 5 % non-organic yeast extract or autolysate to the substrate (calculated in weight of dry matter) is allowed for the production of organic yeast where operators are unable to obtain yeast extract or autolysate from organic production.
1.2. Organic yeast shall not be present in organic food or feed together with non-organic yeast.
1.3. The following products and substances may be used in the production, confection and formulation of organic yeast:
processing aids authorised pursuant to Article 24 for use in organic production;
products and substances referred to in points (a), (b) and (e) of point 2.2.2 of Part IV.
1.4. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in processing shall be used for that purpose.
ANNEX III
COLLECTION, PACKAGING, TRANSPORT AND STORAGE OF PRODUCTS
1. Collection of products and transport to preparation units
Operators may carry out the simultaneous collection of organic, in-conversion and non-organic products only where appropriate measures have been taken to prevent any possible mixture or exchange between organic, in-conversion and non-organic products and to ensure the identification of the organic and in-conversion products. The operator shall keep the information relating to collection days, hours, the circuit and date and time of the reception of the products available to the control authority or control body.
2. Packaging and transport of products to other operators or units
2.1. Operators shall ensure that organic and in-conversion products are transported to other operators or 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 Union law:
the name and address of the operator and, where different, of the owner or seller of the product;
the name of the product or a description of the compound feedstuff accompanied by a reference to organic production;
the name or the code number of the control authority or control body to which the operator is subject; and
where relevant, the lot identification mark in accordance with a marking system either approved at national level or agreed with the control authority or control body and which permits the linking of the lot with the records referred to in Article 34(5).
The information referred to in points (a) to (d) 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 or the transporter.
2.2. The closing of packaging, containers or vehicles shall not be required where:
the transport takes place directly between two operators, both of which are subject to the organic control system;
the transport includes only organic or only in-conversion products;
the products are accompanied by a document giving the information required under point 2.1; and
both the expediting and the receiving operators keep documentary records of such transport operations available for the control authority or control body.
3. Special rules for transporting feed to other production or preparation units or storage premises
When transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met:
during transport, organically produced feed, in-conversion feed, and non-organic feed are effectively physically separated;
vehicles or containers which have transported non-organic products are only used to transport organic or in-conversion products if:
suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic or in-conversion products and the operators keep records of those operations;
all appropriate measures are implemented, depending on the risks evaluated in accordance with control arrangements, and where necessary, operators guarantee that non-organic products cannot be placed on the market with an indication referring to organic production;
the operator keeps documentary records of such transport operations available for the control authority or control body;
the transport of finished organic or in-conversion feed is separated physically or in time from the transport of other finished products;
during transport, the quantity of products at the start and each individual quantity delivered in the course of a delivery round is recorded.
4. Transport of live fish
4.1. Live fish shall be transported in suitable tanks with clean water which meets their physiological needs in terms of temperature and dissolved oxygen.
4.2. Before transport of organic fish and fish products, tanks shall be thoroughly cleaned, disinfected and rinsed.
4.3. Precautions shall be taken to reduce stress. During transport, the density shall not reach a level which is detrimental to the species.
4.4. Records shall be kept for operations referred to in points 4.1, 4.2 and 4.3.
5. Reception of products from other operators of units
On receipt of an organic or in-conversion product, the operator shall check the closing of the packaging, container or vehicle where it is required and the presence of the indications provided for in Section 2.
The operator shall cross-check the information on the label referred to in Section 2 with the information on the accompanying documents. The result of those verifications shall be explicitly mentioned in the records referred to in Article 34(5).
6. Special rules for the reception of products from a third country
Where organic or in-conversion products are imported from a third country, they shall be transported in appropriate packaging or containers, closed in a manner that prevents the substitution of the content and bearing the identification of the exporter and any other marks and numbers that serve to identify the lot, and shall be accompanied by the certificate of control for import from third countries where appropriate.
On receipt of an organic or in-conversion product imported from a third country, the natural or legal person to whom the imported consignment is delivered and who receives it for further preparation or marketing shall check the closing of the packaging or container and, in the case of products imported in accordance with point (b)(iii) of Article 45(1), shall check that the certificate of inspection referred to in that Article covers the type of product contained in the consignment. The result of this verification shall be explicitly mentioned in the records referred to in Article 34(5).
7. Storage of products
7.1. Areas for the storage of products shall be managed in such a way as to ensure identification of lots and to avoid any mixing or contamination with products or substances not in compliance with the organic production rules. Organic and in-conversion products shall be clearly identifiable at all times.
7.2. No input products or substances other than those authorised pursuant to Articles 9 and 24 for use in organic production shall be stored in organic or in-conversion plant and livestock production units.
7.3. Allopathic veterinary medicinal products, including antibiotics, may be stored in agricultural and aquaculture holdings provided that they have been prescribed by a veterinarian in connection with the treatment referred to in points 1.5.2.2 of Part II and 3.1.4.2(a) of Part III of Annex II, that they are stored in a supervised location and that they are entered in the records referred to in Article 34(5).
7.4. Where operators handle organic, or in-conversion or non-organic products in any combination and the organic or in-conversion products are stored in storage facilities in which also other agricultural products or foodstuffs are stored:
the organic or in-conversion products shall be kept separate from the other agricultural products or foodstuffs;
every measure shall be taken to ensure identification of consignments and to avoid mixtures or exchanges between organic, in-conversion and non-organic products;
suitable cleaning measures, the effectiveness of which has been checked, shall have been carried out before the storage of organic or in-conversion products and the operators shall keep records of those operations.
7.5. Only the products for cleaning and disinfection authorised pursuant to Article 24 for use in organic production shall be used in storage facilities for that purpose.
ANNEX IV
TERMS REFERRED TO IN ARTICLE 30
|
BG |
: |
биологичен. |
|
ES |
: |
ecológico, biológico, orgánico. |
|
CS |
: |
ekologické, biologické. |
|
DA |
: |
økologisk. |
|
DE |
: |
ökologisch, biologisch. |
|
ET |
: |
mahe, ökoloogiline. |
|
EL |
: |
βιολογικό. |
|
EN |
: |
organic. |
|
FR |
: |
biologique. |
|
GA |
: |
orgánach. |
|
HR |
: |
ekološki. |
|
IT |
: |
biologico. |
|
LV |
: |
bioloģisks, ekoloģisks. |
|
LT |
: |
ekologiškas. |
|
LU |
: |
biologesch, ökologesch. |
|
HU |
: |
ökológiai. |
|
MT |
: |
organiku. |
|
NL |
: |
biologisch. |
|
PL |
: |
ekologiczne. |
|
PT |
: |
biológico. |
|
RO |
: |
ecologic. |
|
SK |
: |
ekologické, biologické. |
|
SL |
: |
ekološki. |
|
FI |
: |
luonnonmukainen. |
|
SV |
: |
ekologisk. |
ANNEX V
ORGANIC PRODUCTION LOGO OF THE EUROPEAN UNION AND CODE NUMBERS
1. Logo
1.1. The organic production logo of the European Union shall comply with the model below:
1.2. The reference colour in Pantone is Green Pantone No 376 and Green (50 % Cyan + 100 % Yellow), when a four-colour process is used.
1.3. The organic production logo of the European Union may also be used in black and white as shown, only where it is not practicable to apply it in colour:
1.4. If the background colour of the packaging or label is dark, the symbols may be used in negative format, using the background colour of the packaging or label.
1.5. If a logo is used in colour on a coloured background which makes it difficult to see, a delimiting outer line around the logo can be used to improve contrast with the background colours.
1.6. Where there are indications in a single colour on the packaging, the organic production logo of the European Union may be used in the same colour.
1.7. The organic production logo of the European Union shall have a height of at least 9 mm and a width of at least 13,5 mm; the proportion ratio height/width shall always be 1:1,5. Exceptionally, the minimum size may be reduced to a height of 6 mm for very small packages.
1.8. The organic production logo of the European Union may be associated with graphical or textual elements referring to organic production under the condition that they do not modify or change the nature of the organic production logo of the European Union, nor any of the indications defined in accordance with Article 32. When associated to national or private logos using a green colour different from the reference colour provided for in point 1.2, the organic production logo of the European Union may be used in that non-reference colour.
2. Code numbers
The general format of the code numbers shall be as follows:
AB-CDE-999
where:
‘AB’ is the ISO code for the country where the controls take place;
‘CDE’ is a term, indicated in three letters to be decided by the Commission or each Member State, like ‘bio’ or ‘öko’ or ‘org’ or ‘eko’ establishing a link with organic production; and
‘999’ is the reference number, indicated in maximum three digits, to be assigned by:
each Member State’s competent authority to the control authorities or control bodies to which it has delegated control tasks;
the Commission, to:
ANNEX VI
MODEL OF CERTIFICATE
Certificate pursuant to Article 35(1) of Regulation (EU) 2018/848 on organic production and labelling of organic products
Annex – List of members of group of operators as defined in Article 36 of Regulation (EU) 2018/848
|
Name of member |
Address |
|
|
|
|
|
|
|
|
|
( 1 ) Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).
( 2 ) Council Regulation (EC) No 2100/94 of 27 July 1994 on Community plant variety rights (OJ L 227, 1.9.1994, p. 1).
( 3 ) Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p. 4).
( 4 ) Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).
( 5 ) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).
( 6 ) Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19).
( 7 ) Council Regulation (EC) No 708/2007 of 11 June 2007 concerning use of alien and locally absent species in aquaculture (OJ L 168, 28.6.2007, p. 1).
( 8 ) Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).
( 9 ) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
( 10 ) Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1).
( 11 ) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
( 12 ) Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (OJ L 354, 31.12.2008, p. 16).
( 13 ) Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29).
( 14 ) Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (OJ L 327, 11.12.2015, p. 1).
( 15 ) Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes and amending Council Directive 83/417/EEC, Council Regulation (EC) No 1493/1999, Directive 2000/13/EC, Council Directive 2001/112/EC and Regulation (EC) No 258/97 (OJ L 354, 31.12.2008, p. 7).
( 16 ) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).
( 17 ) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
( 18 ) Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
( 19 ) Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, p. 24).
( 20 ) Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).
( 21 ) Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).
( 22 ) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
( 23 ) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
( 24 ) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).
( 25 ) Council Regulation (EC) No 1/2005 of 22 December 2004 on the protection of animals during transport and related operations and amending Directives 64/432/EEC and 93/119/EC and Regulation (EC) No 1255/97 (OJ L 3, 5.1.2005, p. 1).
( 26 ) Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1).
( 27 ) Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves (OJ L 10, 15.1.2009, p. 7).
( 28 ) 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).
( 29 ) 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).
( 30 ) Good manufacturing practices (GMPs) as defined in Article 3(a) of Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ L 384, 29.12.2006, p. 75).
( 31 ) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).
( 32 ) Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).
( 33 ) Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1).
( 34 ) Commission Regulation (EC) No 607/2009 of 14 July 2009 laying down certain detailed rules for the implementation of Council Regulation (EC) No 479/2008 as regards protected designations of origin and geographical indications, traditional terms, labelling and presentation of certain wine sector products (OJ L 193, 24.7.2009, p. 60).