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Document 02008R0889-20210101
Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
Consolidated text: Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
02008R0889 — EN — 01.01.2021 — 018.001
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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COMMISSION REGULATION (EC) No 889/2008 of 5 September 2008 (OJ L 250 18.9.2008, p. 1) |
Amended by:
COMMISSION REGULATION (EC) No 889/2008
of 5 September 2008
laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control
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Content |
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Title I |
Introductory provisions |
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Title II |
Rules on production, preservation, processing, packaging, transport and storage of organic products |
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Chapter 1 |
Plant production |
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Chapter 1a |
Seaweed production |
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Chapter 2 |
Livestock production |
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Section 1 |
Origin of animals |
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Section 2 |
Livestock housing and husbandry practices |
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Section 3 |
Feed |
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Section 4 |
Disease prevention and veterinary treatment |
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Chapter 2a |
Aquaculture animal production |
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Section 1 |
General rules |
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Section 2 |
Origin of aquaculture animals |
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Section 3 |
Aquaculture Husbandry practices |
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Section 4 |
Breeding |
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Section 5 |
Feed for fish, crustaceans and echinodermes |
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Section 6 |
Specific rules for molluscs |
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Section 7 |
Disease prevention and veterinary treatment |
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Chapter 3 |
Preserved and processed products |
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Chapter 3a |
Specific rules for the making of wine |
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Chapter 4 |
Collection, packaging, transport, storage of products |
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Chapter 5 |
Conversion rules |
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Chapter 6 |
Exceptional production rules |
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Section 1 |
Climatic, geographical or structural constraints |
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Section 2 |
Non-availability of organic farm input |
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Section 3 |
Specific management problems in organic livestock |
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Section 3a |
Exceptional production rules with regard to the use of specific products and substances in the processing in accordance with Article 22(2)(e) of Regulation (EC) No 834/2007 |
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Section 4 |
Catastrophic circumstances |
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Chapter 7 |
Seed data base |
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Title III |
Labelling |
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Chapter 1 |
Organic production logo of the European Union |
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Chapter 2 |
Specific labelling requirements for feed |
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Chapter 3 |
Other specific labelling requirements |
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Title IV |
Controls |
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Chapter 1 |
Minimum control requirements |
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Chapter 2 |
Control requirements for plants and plant products |
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Chapter 2a |
Specific control requirements for seaweed |
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Chapter 3 |
Control requirements for livestock and livestock products |
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Chapter 3a |
Specific control requirements for aquaculture animal production |
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Chapter 4 |
Control requirements for units for preparation of plant, seaweed, livestock and aquaculture animal products and foodstuffs composed thereof |
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Chapter 5 |
Control requirements for imports of organic products from third countries |
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Chapter 6 |
Control requirements for units using contracts to third parties |
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Chapter 7 |
Control requirements for units preparing feed |
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Chapter 8 |
Infringements and exchange of information |
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Chapter 9 |
Supervision by competent authorities |
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Title V |
Transmission of information to the Commission, transitional and final provisions |
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Chapter 1 |
Transmission of information to the Commission |
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Chapter 2 |
Transitional and final provisions |
TITLE I
INTRODUCTORY PROVISIONS
Article 1
Subject matter and scope
This Regulation shall not apply to:
livestock species other than those referred to in Article 7; and
to aquaculture animals other than those referred to in Article 25a.
However, Title II, Title III and Title IV shall apply mutatis mutandis to such products until detailed production rules for those products are laid down on the basis of Regulation (EC) No 834/2007.
Article 2
Definitions
In addition to the definitions laid down in Article 2 of Regulation (EC) No 834/2007, the following definitions shall apply for the purposes of this Regulation:
‘non-organic’: means not coming from or not related to a production in accordance to Regulation (EC) No 834/2007 and this Regulation;
‘veterinary medicinal products’: means products as defined in Article 1(2) of Directive 2001/82/EC of the European Parliament and of the Council ( 1 ) concerning the Community code relating to veterinary medicinal products;
‘importer’: means the natural or legal person within the community who presents a consignment for release for free circulation into the Community, either in person, or through a representative;
‘first consignee’ means the natural or legal person to whom the imported consignment is delivered and who will receive it for further preparation and/or marketing;
‘holding’ means all the production units operated under a single management for the purpose of producing agricultural products;
‘production unit’ means all assets to be used for a production sector such as production premises, land parcels, pasturages, open air areas, livestock buildings, fish ponds, containment systems for seaweed or aquaculture animals, shore or seabed concessions, the premises for the storage of crops, crop products, seaweed products, animal products, raw materials and any other input relevant for this specific production sector;
‘hydroponic production’ means the method of growing plants with their roots in a mineral nutrient solution only or in an inert medium, such as perlite, gravel or mineral wool to which a nutrient solution is added;
‘veterinary treatment’ means all courses of a curative or preventive treatment against one occurrence of a specific disease;
‘in-conversion feedingstuffs’ means feedingstuffs produced during the conversion period to organic production, with the exclusion of those harvested in the 12 months following the beginning of the conversion as referred to in Article 17(1)(a) of Regulation (EC) No 834/2007;
‘closed recirculation aquaculture facility’ means a facility where aquaculture takes place within an enclosed environment on land or on a vessel involving the recirculation of water, and depending on permanent external energy input to stabilize the environment for the aquaculture animals;
‘energy from renewable sources’ means renewable non-fossil energy sources: wind, solar, geothermal, wave, tidal, hydropower, landfill gas, sewage treatment plant gas and biogases;
‘hatchery’ means a place of breeding, hatching and rearing through the early life stages of aquaculture animals, finfish and shellfish in particular;
‘nursery’ means a place where an intermediate farming system, between the hatchery and grow-out stages is applied. The nursery stage is completed within the first third of the production cycle with the exception of species undergoing a smoltification process;
‘pollution’ in the framework of aquaculture and seaweed production means the direct or indirect introduction into the aquatic environment of substances or energy as defined in Directive 2008/56/EC of the European Parliament and of the Council ( 2 ) and in Directive 2000/60/EC of the European Parliament and of the Council ( 3 ), in the waters where they respectively apply;
‘polyculture’ in the framework of aquaculture and seaweed production, means the rearing of two or more species usually from different trophic levels in the same culture unit;
‘production cycle’ in the framework of aquaculture and seaweed production, means the lifespan of an aquaculture animal or seaweed from the earliest life stage to harvesting;
‘locally grown species’ in the framework of aquaculture and seaweed production, means those which are neither alien nor locally absent species under Council Regulation (EC) No 708/2007 ( 4 ). Those species listed in Annex IV of Regulation (EC) No 708/2007 may be considered as locally grown species;
‘stocking density’ in the framework of aquaculture, means the live weight of animals per cubic metre of water at any time during the grow-out phase and in the case of flatfish and shrimp the weight per square metre of surface;
‘control file’ means all the information and documents transmitted, for the purposes of the control system, to the competent authorities of the Member State or to control authorities and control bodies by an operator subject to the control system as referred to in Article 28 of Regulation (EC) No 834/2007, including all the relevant information and documents relating to that operator or the activities of that operator held by competent authorities, control authorities and control bodies, with the exception of information or documents that have no bearing on the operation of the control system;
‘preserving’ means any action, different from farming and harvesting, that is carried out on products, but which does not qualify as processing as defined in point (u), including all actions referred to in point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council ( 5 ) and excluding packaging or labelling of the product;
‘processing’ means any action referred to in point (m) of Article 2(1) of Regulation (EC) No 852/2004, including the use of substances referred to in Article 19(2)(b) of Regulation (EC) No 834/2007. Packaging or labelling operations shall not be considered as processing.
TITLE II
RULES ON PRODUCTION, PRESERVATION, PROCESSING, PACKAGING, TRANSPORT AND STORAGE OF ORGANIC PRODUCTS
CHAPTER 1
Plant Production
Article 3
Soil management and fertilisation
Article 4
Prohibition of hydroponic production
Hydroponic production is prohibited.
Article 5
Pest, disease and weed management
Article 6
Specific rules on mushroom production
For production of mushrooms, substrates may be used, if they are composed only of the following components:
farmyard manure and animal excrements:
either from holdings producing according to the organic production method;
or referred to in Annex I, only when the product referred to in point (i) is not available; and when they do not exceed 25 % of the weight of total components of the substrate, excluding the covering material and any added water, before composting;
products of agricultural origin, other than those referred to in point (a), from holdings producing according to organic production method;
peat not chemically treated;
wood, not treated with chemical products after felling;
mineral products referred to in Annex I, water and soil.
CHAPTER 1a
Seaweed production
Article 6a
Scope
This Chapter lays down detailed production rules for seaweed.
For the purposes of this Chapter ‘seaweed’ includes multi-cellular marine algae, phytoplankton and micro-algae.
Article 6b
Suitability of aquatic medium and sustainable management plan
Where minimum separation distances are set Member States shall provide this information to operators, other Member States and the Commission.
The plan shall be updated annually and shall detail the environmental effects of the operation, the environmental monitoring to be undertaken, and list measures to be taken to minimise negative impacts on the surrounding aquatic and terrestrial environments, including, where applicable, nutrient discharge into the environment per production cycle or per annum. The plan shall record the surveillance and repair of technical equipment.
Article 6c
Sustainable harvesting of wild seaweed
Article 6d
Seaweed Cultivation
Article 6e
Antifouling measures and cleaning of production equipment and facilities
CHAPTER 2
Livestock production
Article 7
Scope
This Chapter lays down detailed production rules for the following species: bovine including bubalus and bison, equidae, porcine, ovine, caprine, poultry (species as mentioned in Annex III) and bees.
Article 8
Origin of organic animals
Article 9
Origin of non-organic animals
Non-organic young mammals, when a herd or flock is constituted for the first time, shall be reared in accordance with the organic production rules immediately after they are weaned. Moreover, the following restrictions shall apply at the date on which the animals enter the herd:
buffalo, calves and foals shall be less than six months old;
lambs and kids shall be less than 60 days old;
piglets shall weigh less than 35 kg.
Non-organic adult male and nulliparous female mammals, for the renewal of a herd or flock, shall be reared subsequently in accordance with the organic production rules. Moreover, the number of female mammals is subject to the following restrictions per year:
up to a maximum of 10 % of adult equine or bovine, including bubalus and bison species, livestock and 20 % of the adult porcine, ovine and caprine livestock, as female animals;
for units with less than 10 equine or bovine animals, or with less than five porcine, ovine or caprine animals any renewal as mentioned above shall be limited to a maximum of one animal per year.
This provision of this paragraph will be reviewed in 2012 with a view to phase it out.
The percentages referred to in paragraph 3 may be increased up to 40 %, subject to prior authorisation by the competent authority, in the following special cases:
when a major extension to the farm is undertaken;
when a breed is changed;
when a new livestock specialisation is initiated;
when breeds are in danger of being lost to farming as laid down in Annex IV to Commission Regulation (EC) No 1974/2006 ( 8 ) and in that case animals of those breeds must not necessarily be nulliparous.
Article 10
Rules pertaining to housing conditions
Article 11
Specific housing conditions and husbandry practices for mammals
Article 12
Specific housing conditions and husbandry practices for poultry
Buildings for all poultry shall meet the following conditions:
at least one third of the floor area shall be solid, that is, not of slatted or of grid construction, and covered with a litter material such as straw, wood shavings, sand or turf;
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;
they shall have perches of a size and number commensurate with the size of the group and of the birds as laid down in Annex III;
they shall have exit/entry pop-holes of a size adequate for the birds, and these pop-holes shall have a combined length of at least 4 m per 100 m2 area of the house available to the birds;
each poultry house shall not contain more than:
4 800 chickens,
3 000 laying hens,
5 200 guinea fowl,
4 000 female Muscovy or Peking ducks or 3 200 male Muscovy or Peking ducks or other ducks,
2 500 capons, geese or turkeys;
the total usable area of poultry houses for meat production on any single unit, shall not exceed 1 600 m2;
poultry houses shall be constructed in a manner allowing all birds easy access to open air area.
To prevent the use of intensive rearing methods, poultry shall either be reared until they reach a minimum age or else shall come from slow-growing poultry strains. Where slow-growing poultry strains are not used by the operator the following minimum age at slaughter shall be:
81 days for chickens,
150 days for capons,
49 days for Peking ducks,
70 days for female Muscovy ducks,
84 days for male Muscovy ducks,
92 days for Mallard ducks,
94 days for guinea fowl,
140 days for male turkeys and roasting geese and
100 days for female turkeys.
The competent authority shall define the criteria of slow-growing strains or draw up a list thereof and provide this information to operators, other Member States and the Commission.
Article 13
Specific requirements and housing conditions in beekeeping
Article 14
Access to open air areas
Article 15
Stocking density
Article 16
Prohibition of landless livestock production
Landless livestock production, by which the operator of the livestock does not manage agricultural land and/or has not established a written cooperation agreement with another operator according to Article 3(3), is prohibited.
Article 17
Simultaneous production of organic and non-organic livestock
Organic animals may be grazed on common land, providing that:
the land has not been treated with products not authorised for organic production for at least three years;
any non-organic animals which use the land concerned are derived from a farming system equivalent to those as described in Article 36 of Regulation (EC) No 1698/2005 or in Article 22 of Regulation 1257/1999;
any livestock products from organic animals, whilst using this land, shall not be regarded as being from organic-production, unless adequate segregation from non-organic animals can be proved.
Article 18
Management of animals
Operations such as attaching elastic bands to the tails of sheep, tail-docking, cutting of teeth, trimming of beaks and dehorning shall not be carried out routinely in organic farming. However, some of these operations may be authorised by the competent authority for reasons of safety or if they are intended to improve the health, welfare or hygiene of the livestock on a case-by-case basis.
Any suffering to the animals shall be reduced to a minimum by applying adequate anaesthesia and/or analgesia and by carrying out the operation only at the most appropriate age by qualified personnel.
Article 19
Feed from own holding and other sources
The feeding of bee colonies shall only be permitted where the survival of the hives is endangered due to climatic conditions. Feeding shall be with organic honey, organic sugar syrups, or organic sugar.
Article 20
Feed meeting animals' nutritional requirements
Article 21
In-conversion feed
Article 22
Use of certain products and substances in feed
For the purposes of Article 14(1)(d)(iv) of Regulation (EC) No 834/2007 only the following substances may be used in the processing of organic feed and feeding organic animals:
non-organic feed materials of plant or animal origin, or other feed materials that are listed in Section 2 of Annex V, provided that:
they are produced or prepared without chemical solvents; and
the restrictions laid down in Article 43 or Article 47(c) are complied with;
non-organic spices, herbs, and molasses, provided that:
their organic form is not available;
they are produced or prepared without chemical solvents; and
their use is limited to 1 % of the feed ration of a given species, calculated annually as a percentage of the dry matter of feed from agricultural origin;
organic feed materials of animal origin;
feed materials of mineral origin that are listed in Section 1 of Annex V;
products from sustainable fisheries, provided that:
they are produced or prepared without chemical solvents;
their use is restricted to non-herbivores; and
the use of fish protein hydrolysate is restricted solely to young animals;
salt as sea salt, coarse rock salt;
feed additives listed in Annex VI.
Article 23
Disease prevention
Housing, pens, equipment and utensils shall be properly cleaned and disinfected to prevent cross-infection and the build-up of disease carrying organisms. Faeces, urine and uneaten or spilt feed shall be removed as often as necessary to minimise smell and to avoid attracting insects or rodents.
For the purpose of Article 14(1)(f) of Regulation (EC) No 834/2007, only products listed in Annex VII may be used for cleaning and disinfection of livestock buildings installations and utensils. Rodenticides (to be used only in traps), and the products listed in Annex II, can be used for the elimination of insects and other pests in buildings and other installations where livestock is kept.
Article 24
Veterinary treatment
With the exception of vaccinations, treatments for parasites and compulsory eradication schemes where an animal or group of animals receive more than three courses of treatments with chemically-synthesised allopathic veterinary medicinal products or antibiotics within 12 months, or more than one course of treatment if their productive lifecycle is less than one year, the livestock concerned, or produce derived from them, may not be sold as organic products, and the livestock shall undergo the conversion periods laid down in Article 38(1).
Records of documented evidence of the occurrence of such circumstances shall be kept for the control body or control authority.
Article 25
Specific rules on disease prevention and veterinary treatment in beekeeping
For the purpose of protecting frames, hives and combs, in particular from pests, only rodenticides (to be used only in traps), and appropriate products listed in Annex II, are permitted.
CHAPTER 2a
Aquaculture animal production
Article 25a
Scope
This Chapter lays down detailed production rules for species of fish, crustaceans, echinoderms and molluscs as covered by Annex XIIIa.
It applies mutatis mutandis to zooplankton, micro-crustaceans, rotifers, worms and other aquatic feed animals.
Article 25b
Suitability of aquatic medium and sustainable management plan
Article 25c
Simultaneous production of organic and non-organic aquaculture animals
Article 25d
Origin of organic aquaculture animals
Article 25e
Origin and management of non-organic aquaculture animals
For on-growing purposes the collection of wild aquaculture juveniles is specifically restricted to the following cases:
natural influx of fish or crustacean larvae and juveniles when filling ponds, containment systems and enclosures;
European glass eel, provided that an approved eel management plan is in place for the location and artificial reproduction of eel remains unsolved;
the collection of wild fry of species other than European eel for on-growing in traditional extensive aquaculture farming inside wetlands, such as brackish water ponds, tidal areas and costal lagoons, closed by levees and banks, provided that:
the restocking is in line with management measures approved by the relevant authorities in charge of the management of the fish stocks in question to ensure the sustainable exploitation of the species concerned, and
the fish are fed exclusively with feed naturally available in the environment.
Article 25f
General aquaculture husbandry rules
The husbandry environment of the aquaculture animals shall be designed in such a way that, in accordance with their species specific needs, the aquaculture animals shall:
have sufficient space for their wellbeing;
be kept in water of good quality with sufficient oxygen levels, and
be kept in temperature and light conditions in accordance with the requirements of the species and having regard to the geographic location;
in the case of freshwater fish the bottom type shall be as close as possible to natural conditions;
in the case of carp the bottom shall be natural earth.
Article 25g
Specific rules for aquatic containment systems
Rearing units on land shall meet the following conditions:
for flow-through systems it shall be possible to monitor and control the flow rate and water quality of both in-flowing and out-flowing water;
at least five percent of the perimeter (‘land-water interface’) area shall have natural vegetation.
Containment systems at sea shall:
be located where water flow, depth and water-body exchange rates are adequate to minimize the impact on the seabed and the surrounding water body;
shall have suitable cage design, construction and maintenance with regard to their exposure to the operating environment.
Article 25h
Management of aquaculture animals
The following restrictions shall apply to the use of artificial light:
for prolonging natural day-length it shall not exceed a maximum that respects the ethological needs, geographical conditions and general health of farmed animals, this maximum shall not exceed 16 hours per day, except for reproductive purposes;
Abrupt changes in light intensity shall be avoided at the changeover time by the use of dimmable lights or background lighting.
All such use is to be recorded in the aquaculture production record.
The use of oxygen is only permitted for uses linked to animal health requirements and critical periods of production or transport, in the following cases:
exceptional cases of temperature rise or drop in atmospheric pressure or accidental pollution,
occasional stock management procedures such as sampling and sorting,
in order to assure the survival of the farm stock.
Documentary evidence shall be maintained.
Article 25i
Prohibition of hormones
The use of hormones and hormone derivates is prohibited.
Article 25j
General rules on feeds
Feeding regimes shall be designed with the following priorities:
animal health;
high product quality, including the nutritional composition which shall ensure high quality of the final edible product;
low environmental impact.
Article 25k
Specific rules on feeds for carnivorous aquaculture animals
Feed for carnivorous aquaculture animals shall be sourced with the following priorities:
organic feed products of aquaculture origin;
fish meal and fish oil from organic aquaculture trimmings;
fish meal and fish oil and ingredients of fish origin derived from trimmings of fish already caught for human consumption in sustainable fisheries;
organic feed materials of plant or animal origin;
feed products derived from whole fish caught in fisheries certified as sustainable under a scheme recognised by the competent authority in line with the principles laid down in Regulation (EU) No 1380/2013 of the European Parliament and of the Council ( 14 ).
▼M15 —————
Article 25l
Specific rules on feeds for certain aquaculture animals
Where natural feed is supplemented according to paragraph 2:
the feed ration of siamese catfish (Pangasius spp.) as referred to in Section 9 of Annex XIIIa may comprise a maximum of 10 % fishmeal or fish oil derived from sustainable fisheries;
the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) referred to in Section 7 of Annex XIIIa may comprise a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries. In order to secure the quantitative dietary needs of those shrimps and prawns, organic cholesterol may be used to supplement their diets. Where organic cholesterol is not available, non-organic cholesterol derived from wool, shellfish or other sources may be used. The option to supplement their diet with cholesterol applies both in the grow-out stage and in earlier life stages in nurseries and hatcheries.
Article 25la
Specific rules on feeds for organic juveniles
In the larval rearing of organic juveniles, conventional phytoplankton and zooplankton may be used as feed.
Article 25m
Products and substances as referred to in Article 15(1)(d)(iii) of Regulation (EC) No 834/2007
Article 25n
Growing area
Article 25o
Sourcing of seed
Provided that there is no significant damage to the environment and if permitted by local legislation, wild seed from outside the boundaries of the production unit can be used in the case of bivalve shellfish provided it comes from:
settlement beds which are unlikely to survive winter weather or are surplus to requirements, or
natural settlement of shellfish seed on collectors.
Records shall be kept of how, where and when wild seed was collected to allow traceability back to the collection area.
However, the maximum percentage of seed from non- organic bivalve shellfish hatcheries that may be introduced to the organic production units shall be 80 % by 31 December 2011, 50 % by 31 December 2014 and 0 % by 31 December 2016.
Article 25p
Management
Article 25q
Cultivation rules
Article 25r
Specific cultivation rules for oysters
Cultivation in bags on trestles is permitted. These or other structures in which the oysters are contained shall be set out so as to avoid the formation of a total barrier along the shoreline. Stock shall be positioned carefully on the beds in relation to tidal flow to optimise production. Production shall meet the criteria listed in the Annex XIIIa, Section 8.
Article 25s
General rules on disease prevention
With regard to fallowing:
The competent authority shall determine whether fallowing is necessary and the appropriate duration which shall be applied and documented after each production cycle in open water containment systems at sea. Fallowing is also recommended for other production methods using tanks, fishponds, and cages;
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.
Article 25t
Veterinary treatments
When despite preventive measures to ensure animal health, according to Article 15(1)(f)(i) of Regulation (EC) No 834/2007, a health problem arises, veterinary treatments may be used in the following order of preference:
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.
CHAPTER 3
Preserved and processed products
Article 26
Rules for preserving products and for the production of processed feed and food
The application of those procedures shall guarantee at all times that preserved or processed products comply with the organic production rules.
Operators shall comply with and implement the procedures referred to in paragraph 1. In particular, operators shall:
take precautionary measures to avoid the risk of contamination by unauthorised substances or products;
implement suitable cleaning measures, monitor their effectiveness and record those measures;
guarantee that non-organic products are not placed on the market with an indication referring to the organic production method.
Where non-organic products are also prepared or stored in the preparation unit concerned, the operator shall:
carry out the operations continuously until the complete run has been dealt with, separated by place or time from similar operations carried out on non-organic products;
store organic products, before and after the operations, separate by place or time from non-organic products;
inform the control authority or control body of the operations referred to in points (a) and (b) and keep available an updated register of all operations and quantities processed;
take the necessary measures to ensure identification of lots and to avoid mixtures or exchanges with non-organic products;
carry out operations on organic products only after suitable cleaning of the production equipment.
Article 27
Use of certain products and substances in processing of food
For the purposes of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be used in the processing of organic food, with the exception of products of the wine sector, for which the provisions of Chapter 3a shall apply:
◄substances listed in Annex VIII to this Regulation;
preparations of micro-organisms and enzymes normally used in food processing; ►M1 however, enzymes to be used as food additives have to be listed in Annex VIII, Section A; ◄
substances, and products as defined in Articles 1(2)(b)(i) and 1(2)(c) of Council Directive 88/388/EEC ( 15 ) labelled as natural flavouring substances or natural flavouring preparations, according to Articles 9(1)(d) and (2) of that Directive;
colours for stamping meat and eggshells in accordance with, respectively, Article 2(8) and Article 2(9) of European Parliament and Council Directive 94/36/EC ( 16 );
drinking water and salt (with sodium chloride or potassium chloride as basic components) generally used in food processing;
minerals (trace elements included), vitamins, amino acids and micronutrients, provided that:
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
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:
For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007,
food additives listed in Annex VIII and marked with an asterisk in the column of the additive code number, shall be calculated as ingredients of agricultural origin;
preparations and substances referred to in paragraph (1)(b),(c),(d),(e) and (f) of this Article and substances not marked with an asterisk in the column of the additive code number shall not be calculated as ingredients of agricultural origin;
yeast and yeast products shall be calculated as ingredients of agricultural origin as of 31 December 2013.
The use of the following substances listed in Annex VIII shall be re-examined before 31 December 2010:
Sodium nitrite and potassium nitrate in Section A with a view to withdrawing these additives;
Sulphur dioxide and potassium metabisulphite in Section A;
Hydrochloric acid in Section B for the processing of Gouda, Edam and Maasdammer cheeses, Boerenkaas, Friese, and Leidse Nagelkaas.
The re-examination referred to in point (a) shall take account of the efforts made by Member States to find safe alternatives to nitrites/nitrates and in establishing educational programmes in alternative processing methods and hygiene for organic meat processors/manufacturers.
Article 27a
For the purpose of the application of Article 20(1) of Regulation (EC) No 834/2007, the following substances may be used in the production, confection and formulation of yeast:
substances listed in Annex VIII, Section C to this Regulation;
products and substances referred to in Article 27(1)(b) and (e) of this Regulation.
Article 28
Use of certain non-organic ingredients of agricultural origin in processing food
For the purpose of Article 19(2)(c) of Regulation (EC) No 834/2007, non-organic agricultural ingredients listed in Annex IX to this Regulation can be used in the processing of organic food.
Article 29
Authorisation of non-organic food ingredients of agricultural origin by Member State
Where an ingredient of agricultural origin is not included in Annex IX to this Regulation, that ingredient may only be used under the following conditions:
the operator has notified to the competent authority of the Member State all the requisite evidence showing that the ingredient concerned is not produced in sufficient quantity in the Community in accordance with the organic production rules or cannot be imported from third countries;
the competent authority of the Member State has provisionally authorised, the use for a maximum period of 12 months after having verified that the operator has undertaken the necessary contacts with suppliers in the Community to ensure himself of the unavailability of the ingredients concerned with the required quality requirements;
no decision has been taken, in accordance with the provisions of paragraphs 3 or 4 that a granted authorisation with regard to the ingredient concerned shall be withdrawn.
The Member State may prolong the authorisation provided for in point (b) a maximum of three times for 12 months each.
Where an authorisation as referred to in paragraph 1 has been granted, the Member State shall immediately notify to the other Member States and to the Commission, the following information:
the date of the authorisation and in case of a prolonged authorisation, the date of the first authorisation;
the name, address, telephone, and where relevant, fax and e-mail of the holder of the authorisation; the name and address of the contact point of the authority which granted the authorisation;
the name and, where necessary, the precise description and quality requirements of the ingredient of agricultural origin concerned;
the type of products for the preparation of which the requested ingredient is necessary;
the quantities that are required and the justification for those quantities;
the reasons for, and expected period of, the shortage;
the date on which the Member State sends this notification to the other Member States and the Commission. The Commission and/or Member States may make this information available to the public.
Article 29a
Specific provisions for seaweed
If the final product is dehydrated seaweed, potable water may also be used for flushing. Salt may be used for removal of moisture.
CHAPTER 3a
Specific rules for the making of wine
Article 29b
Scope
Article 29c
Use of certain products and substances
Article 29d
Oenological practices and restrictions
The use of the following oenological practices, processes and treatments is prohibited:
partial concentration through cooling according to point (c) of Section B.1 of Annex XVa to Regulation (EC) No 1234/2007;
elimination of sulphur dioxide by physical processes according to point 8 of Annex I A to Regulation (EC) No 606/2009;
electrodialysis treatment to ensure the tartaric stabilisation of the wine according to point 36 of Annex I A to Regulation (EC) No 606/2009;
partial dealcoholisation of wine according to point 40 of Annex I A to Regulation (EC) No 606/2009;
treatment with cation exchangers to ensure the tartaric stabilisation of the wine according to point 43 of Annex I A to Regulation (EC) No 606/2009.
The use of the following oenological practices, processes and treatments is permitted under the following conditions:
for heat treatments according to point 2 of Annex I A to Regulation (EC) No 606/2009, the temperature shall not exceed 70 °C;
for centrifuging and filtration with or without an inert filtering agent according to point 3 of Annex I A to Regulation (EC) No 606/2009, the size of the pores shall be not smaller than 0,2 micrometer.
The use of the following oenological practices, processes and treatments shall be re-examined by the Commission before ►M16 1 August 2018 ◄ with a view to phase out or to further restrict those practices:
heat treatments as referred to in point 2 of Annex I A to Regulation (EC) No 606/2009;
use of ion exchange resins as referred to in point 20 of Annex I A to Regulation (EC) No 606/2009;
reverse osmosis according to point (b) of Section B.1 of Annex XVa to Regulation (EC) No 1234/2007.
CHAPTER 4
Collection, packaging, transport and storage of products
Article 30
Collection of products and transport to preparation units
Operators may carry out simultaneous collection of organic and non-organic products, only where appropriate measures are taken to prevent any possible mixture or exchange with non-organic products and to ensure the identification of the organic products. The operator shall keep the information relating to collection days, hours, circuit and date and time of reception of the products available to the control body or control authority.
Article 31
Packaging and transport of products to other operators or units
Operators shall ensure that organic products are transported to other units, including wholesalers and retailers, only in appropriate packaging, containers or vehicles closed in such a manner that substitution of the content cannot be achieved without manipulation or damage of the seal and provided with a label stating, without prejudice to any other indications required by law:
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 feedingstuff accompanied by a reference to the organic production method;
the name and/or the code number of the control body or authority to which the operator is subject; and
where relevant, the lot identification mark according to a marking system either approved at national level or agreed with the control body or authority and which permits to link the lot with the accounts referred to in Article 66.
The information referred to in points (a) to (d) of the first subparagraph may also be presented on an accompanying document, if such a document can be undeniably linked with the packaging, container or vehicular transport of the product. This accompanying document shall include information on the supplier and/or the transporter.
The closing of packaging, containers or vehicles shall not be required where:
transportation is direct between an operator and another operator who are both subject to the organic control system, and
the products are accompanied by a document giving the information required under paragraph 1, and
both the expediting and the receiving operators shall keep documentary records of such transport operations available for the control body or control authority of such transport operations.
Article 32
Special rules for transporting feed to other production/preparation units or storage premises
In addition to the provisions of Article 31, when transporting feed to other production or preparation units or storage premises, operators shall ensure that the following conditions are met:
during transport, organically-produced feed, in-conversion feed, and non-organic feed shall be effectively physically separated;
the vehicles and/or containers which have transported non-organic products are used to transport organic products provided that:
suitable cleaning measures, the effectiveness of which has been checked, have been carried out before commencing the transport of organic products; operators shall record these operations,
all appropriate measures are implemented, depending on the risks evaluated in accordance with Article 88(3) and, where necessary, operators shall guarantee that non-organic products cannot be placed on the market with an indication referring to organic production,
the operator shall keep documentary records of such transport operations available for the control body or control authority;
the transport of finished organic feed shall be 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 shall be recorded.
Article 32a
Transport of live fish
Article 33
Reception of products from other units and other operators
On receipt of an organic product, the operator shall check the closing of the packaging or container where it is required and the presence of the indications provided to in Article 31.
The operator shall crosscheck the information on the label referred to in Article 31 with the information on the accompanying documents. The result of these verifications shall be explicitly mentioned in the documentary accounts referred to in Article 66.
Article 34
Special rules for the reception of products from a third country
Organic products shall be imported from a third country in appropriate packaging or containers, closed in a manner preventing substitution of the content and provided with identification of the exporter and with any other marks and numbers serving to identify the lot and with the certificate of control for import from third countries as appropriate.
On receipt of an organic product, imported from a third country, the first consignee shall check the closing of the packaging or container and, in the case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, shall check that the certificate mentioned in that Article covers the type of product contained in the consignment. The result of this verification shall be explicitly mentioned in the documentary accounts referred to in Article 66 of this Regulation.
Article 35
Storage of products
In case where operators handle both non-organic products and organic products and the latter are stored in storage facilities in which also other agricultural products or foodstuffs are stored:
the organic products shall be kept separate from the other agricultural products and/or foodstuffs;
every measure shall be taken to ensure identification of consignments and to avoid mixtures or exchanges with non-organic products;
suitable cleaning measures, the effectiveness of which has been checked, have been carried out before the storage of organic products; operators shall record these operations.
CHAPTER 5
Conversion rules
Article 36
Plant and plant products
The competent authority may decide to recognise retroactively as being part of the conversion period any previous period in which:
the land parcels were subject of measures defined in a programme implemented pursuant to Regulations (EC) No 1257/99, (EC) No 1698/2005, or in another official programme, provided that the measures concerned ensure that products not authorised for organic production have not been used on those parcels, or
the parcels were natural or agricultural areas which were not treated with products not authorised for organic production.
The period referred to in point (b) of the first subparagraph can be taken into consideration retroactively only where satisfactory proof has been furnished to the competent authority allowing it to satisfy itself that the conditions were met for a period of at least three years.
In the case of parcels which have already been converted to or were in the process of conversion to organic farming, and which are treated with a product not authorised for organic production, the Member State may shorten the conversion period referred to in paragraph 1 in the following two cases:
parcels treated with a product not authorised for organic production as part of a compulsory disease or pest control measure imposed by the competent authority of the Member State;
parcels treated with a product not authorised for organic production as part of scientific tests approved by the competent authority of the Member State.
In the cases provided for in points (a) and (b) of the first subparagraph, the length of the conversion period shall be fixed taking into account of the following factors:
the process of degradation of the product concerned shall guarantee, at the end of the conversion period, an insignificant level of residues in the soil and, in the case of a perennial crop, in the plant;
the harvest following the treatment may not be sold with reference to organic production methods.
The Member State concerned shall inform the other Member States and the Commission of its decision to require compulsory measures.
Article 36a
Seaweed
Article 37
Specific conversion rules for land associated with organic livestock production
Article 38
Livestock and livestock products
Where non-organic livestock has been brought onto a holding in accordance with Article 14(1)(a)(ii) of Regulation (EC) No 834/2007 and Article 9 and/or Article 42 of this Regulation and if livestock products are to be sold as organic products, the production rules as referred to in Articles 9, 10, 11 and 14 of Regulation (EC) No 834/2007 and in Chapter 2 of Title II and where applicable in Article 42 of this Regulation must have been applied for at least:
12 months in the case of equidae and bovines, including bubalus and bison species, for meat production, and in any case at least three quarters of their lifetime;
six months in the case of small ruminants and pigs and animals for milk production;
10 weeks for poultry for meat production, brought in before they are three days old;
six weeks in the case of poultry for egg production.
Article 38a
Aquaculture animal production
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 farming bivalve molluscs, a three month conversion period.
CHAPTER 6
Exceptional production rules
Article 39
Tethering of animals
Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, competent authorities may authorise cattle in small holdings to be tethered if it is not possible to keep the cattle in groups appropriate to their behaviour requirements, provided they have access to pastures during the grazing period according to Article 14(2), and at least twice a week access to open air areas when grazing is not possible.
Article 40
Parallel production
Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, a producer may run organic and non-organic production units in the same area:
in the case of the production of perennial crops, which require a cultivation period of at least three years, where varieties cannot be easily differentiated, provided the following conditions are met:
the production in question forms part of a conversion plan in respect of which the producer gives a firm undertaking and which provides for the beginning of the conversion of the last part of the area concerned to organic production in the shortest possible period which may not in any event exceed a maximum of five years;
appropriate measures have been taken to ensure the permanent separation of the products obtained from each unit concerned;
the control authority or control body is notified of the harvest of each of the products concerned at least 48 hours in advance;
upon completion of the harvest, the producer informs the control authority or control body of the exact quantities harvested on the units concerned and of the measures applied to separate the products;
the conversion plan and the control measures referred to in Chapter 1 and 2 of Title IV have been approved by the competent authority; this approval shall be confirmed each year after the start of the conversion plan;
in the case of areas intended for agricultural research or formal education agreed by the Member States' competent authorities and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;
in the case of production of seed, vegetative propagating material and transplants and provided the conditions set out in point (a)(ii)(iii)(iv) and the relevant part of point (v) are met;
in the case of grassland exclusively used for grazing.
The competent authority may authorise holdings carrying out agricultural research or formal education to rear organic and non-organic livestock of the same species, where the following conditions are met:
appropriate measures, notified in advance to the control authority or control body, have been taken in order to guarantee the permanent separation between livestock, livestock products, manure and feedingstuffs of each of the units;
the producer informs the control authority or control body in advance of any delivery or selling of the livestock or livestock products;
the operator informs the control authority or control body of the exact quantities produced in the units together with all characteristics permitting the identification of the products and confirms that the measures taken to separate the products have been applied.
Article 41
Management of beekeeping units for the purpose of pollination
Where the conditions laid down in Article 22(2)(a) of Regulation (EC) No 834/2007 apply, for the purpose of pollination actions an operator may run organic and non-organic beekeeping units on the same holding, provided that all the requirements of the organic production rules are fulfilled, with the exception of the provisions for the siting of the apiaries. In that case the product cannot be sold as organic.
The operator shall keep documentary evidence of the use of this provision.
Article 42
Use of non-organic animals
Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply, and with prior authorisation of the competent authority,
when a flock is constituted for the first time, renewed or reconstituted and organically reared poultry are not available in sufficient numbers, non-organically reared poultry may be brought into an organic poultry production unit, provided that the pullets for the production of eggs and poultry for meat production are less than three days old;
non-organically reared pullets for egg production of not more than 18 weeks may be brought into an organic livestock unit until ►M22 31 December 2021 ◄ , when organically reared pullets are not available and provided that the relevant provisions laid down in Section 3 and 4 of Chapter 2 are complied with.
Article 43
Use of non-organic protein feed of plant and animal origin for livestock
Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply and where farmers are unable to obtain protein feed exclusively from organic production, the use of a limited proportion of non-organic protein feed is allowed for porcine and poultry species.
The maximum percentage of non-organic protein feed authorised per period of 12 months for those species shall be 5 % for calendar years 2018, 2019, 2020 and 2021.
The figures shall be calculated annually as a percentage of the dry matter of feed from agricultural origin.
The operator shall keep documentary evidence of the need for the use of this provision.
Article 44
Use of non-organic beeswax
In the case of new installations or during the conversion period, non-organic beeswax may be used only
where beeswax from organic beekeeping is not available on the market;
where it is proven free of contamination by substances not authorised for organic production; and
provided that it comes from the cap.
Article 45
Use of seed or vegetative propagating material not obtained by the organic production method
Where the conditions laid down in Article 22(2)(b) of Regulation (EC) No 834/2007 apply,
seed and vegetative propagating material from a production unit in conversion to organic farming may be used,
where point (a) is not applicable, Member States may authorise the use of non-organic seed or vegetative propagating material if not available from organic production. However, for the use of non-organic seed and seed potatoes the following paragraphs (2) to (9) apply.
Species for which it is established that organically produced seed or seed potatoes are available in sufficient quantities and for a significant number of varieties in all parts of the Community are set out in Annex X.
The species listed in Annex X may not be subject of authorisations pursuant to paragraph 1(b), unless these are justified by one of the purposes referred to in paragraph 5(d).
Authorisation to use seed or seed potatoes not obtained by the organic production method may only be granted in the following cases:
where no variety of the species which the user wants to obtain is registered in the database referred to in Article 48;
where no supplier, meaning an operator who markets seed or seed potatoes to other operators, is able to deliver the seed or seed potatoes before sowing or planting in situations where the user has ordered the seed or seed potatoes in reasonable time;
where the variety which the user wants to obtain is not registered in the database referred to in Article 48, and the user is able to demonstrate that none of the registered alternatives of the same species are appropriate and that the authorisation therefore is significant for his production;
where it is justified for use in research, test in small-scale field trials or for variety conservation purposes agreed by the competent authority of the Member State.
By way of derogation from paragraph 7, the competent authority of the Member State may grant to all users a general authorisation:
for a given species when and in so far as the condition laid down in paragraph 5(a) is fulfilled;
for a given variety when and in so far as the conditions laid down in paragraph 5(c) are fulfilled.
The authorisations referred to in the first subparagraph shall be clearly indicated in the database referred to in Article 48.
Article 46
Specific management problems in organic livestock
The final fattening phase of adult bovines for meat production may take place indoors, provided that this indoors period does not exceed one fifth of their lifetime and in any case for a maximum period of three months.
Article 46a
Addition of non-organic yeast extract
Where the conditions laid down in Article 22(2)(e) of Regulation (EC) No 834/2007 apply, the addition of up to 5 % non-organic yeast extract or autolysate to the substrate (calculated in dry matter) is allowed for the production of organic yeast, where operators are unable to obtain yeast extract or autolysate from organic production.
The availability of organic yeast extract or autolysate shall be re-examined by 31 December 2013 with a view to withdrawing this provision.
Article 47
Catastrophic circumstances
The competent authority may authorise on a temporary basis:
in the case of high mortality of animals caused by health or catastrophic circumstances, the renewal or reconstitution of the herd or flock with non-organic animals, when organically reared animals are not available and provided that the respective conversion period are applied to the non-organic animals;
in case of high mortality of bees caused by health or catastrophic circumstances, the reconstitution of the apiaries with non-organic bees, when organic apiaries are not available;
the use of non-organic feedingstuffs for a limited period and in relation to a specific area by individual operators, when forage production is lost or when restrictions are imposed, in particular as a result of exceptional meteorological conditions, the outbreak of infectious diseases, the contamination with toxic substances, or as a consequence of fires;
the feeding of bees with organic honey, organic sugar or organic sugar syrup in case of long lasting exceptional weather conditions or catastrophic circumstances, which hamper the nectar or honeydew production;
the use of sulphur dioxide up to the maximum content to be fixed in accordance with the Annex I B to Regulation (EC) No 606/2009 if the exceptional climatic conditions of a given harvest year deteriorate the sanitary status of organic grapes in a specific geographical area because of severe bacterial attacks or fungal attacks, which oblige the winemaker to use more sulphur dioxide than in previous years to obtain a comparable final product;
in the case of high mortality of aquaculture animals caused by circumstances listed in Article 57(1)(a) to (d) of Regulation (EU) No 508/2014 of the European Parliament and of the Council ( 24 ), the renewal or reconstitution of the aquaculture stock with non-organic aquaculture animals, when organically reared animals are not available and provided that at least the latter two thirds of the duration of the production cycle are managed under organic management.
Upon approval by the competent authority, the individual operators shall keep documentary evidence of the use of the above exceptions. Member States shall inform each other and the Commission on the exceptions they have granted under points (c) and (e) of the first paragraph.
CHAPTER 7
Seed data base
Article 48
Database
Article 49
Registration
Article 50
Conditions for registration
For registration, the supplier shall:
demonstrate that he or the last operator, in cases where the supplier is only dealing with pre-packaged seed or seed potatoes, has been subject to the control system referred to in Article 27 of Regulation (EC) No 834/2007;
demonstrate that the seed or seed potatoes to be placed on the market comply with the general requirements applicable to seed and seed potatoes;
make available all the information required under Article 51 of this Regulation, and undertake to update this information at the request of the manager of the database or whenever such updating is necessary to ensure that the information remains reliable.
Article 51
Registered information
For each registered variety and for each supplier, the database referred to in Article 48 shall contain at least the following information:
the scientific name of the species and the variety denomination;
the name and contact details of the supplier or his representative;
the area where the supplier can deliver the seed or seed potatoes to the user in the usual time needed for the delivery;
the country or region in which the variety is tested and approved for the purpose of the common catalogues of varieties of agricultural plant species and vegetable species as defined in Council Directives 2002/53/EC on the common catalogue of varieties of agricultural plant species ( 25 ) and 2002/55/EC on the marketing of vegetable seed ( 26 );
the date from which the seed or seed potatoes will be available;
the name and/or code number of the control authority or control body in charge of the control of the operator as referred to in Article 27 of Regulation (EC) No 834/2007.
Article 52
Access to information
Article 53
Registration fee
Each registration may be subject to the levying of a fee, which shall represent the cost of inserting and maintaining the information in the database referred to in Article 48. The competent authority of the Member State shall approve the amount of the fee charged by the manager of the database.
Article 54
Annual report
The authorities or bodies designated to grant authorisations in accordance with Article 45 shall register all authorisations, and shall make this information available in a report to the competent authority of the Member State and to the manager of the database.
The report shall contain, for each species concerned by an authorisation according to Article 45(5), the following information:
the scientific name of the species and the variety denomination;
the justification for the authorisation indicated by a reference to Article 45(5)(a), (b), (c) or (d);
the total number of authorisations;
the total quantity of seed or seed potatoes involved;
the chemical treatment for phytosanitary purposes, as referred to in Article 45(2).
Article 55
Summary report
The competent authority of the Member State shall, before 31 March each year, collect the reports and send a summary report covering all authorisations of the Member State from the previous calendar year to the Commission and to the other Member States. The report shall cover the information specified in Article 54. The information shall be published in the database referred to in Article 48. The competent authority may delegate the task of collecting the reports to the manager of the database.
Article 56
Information upon request
Upon request from a Member State or the Commission, detailed information on authorisations granted in individual cases shall be made available to other Member States or to the Commission.
TITLE III
LABELLING
CHAPTER 1
Organic production logo of the European Union
Article 57
Organic logo of the EU
In accordance with Article 25(3) of Regulation (EC) No 834/2007, the organic production logo of the European Union (hereinafter ‘Organic logo of the EU’) shall follow the model set out in Part A of Annex XI to this Regulation.
For the purpose of labelling, the organic logo of the EU shall only be used if the product concerned is produced in accordance with the requirements of Regulation (EC) No 834/2007, of Commission Regulation (EC) No 1235/2008 ( 27 ) and of this Regulation, by operators who comply with the requirements of the control system referred to in Articles 27, 28, 29, 32 and 33 of Regulation (EC) No 834/2007.
Article 58
Conditions for the use of the code number and place of origin
The indication of the code number of the control authority or control body referred to in Article 24(1)(a) of Regulation (EC) 834/2007 shall,
start with the acronym identifying the Member State or the third country, as referred to in the international standard for the two letter country codes under ISO 3166 (Codes for the representation of names of countries and their subdivisions);
include a term which establishes a link with the organic production method, as referred to in Article 23(1) of Regulation (EC) No 834/2007 in accordance with Part B(2) of Annex XI to this Regulation;
include a reference number to be decided by the Commission or by the competent authority of the Member States in accordance with Part B(3) of Annex XI to this Regulation; and
be placed in the same visual field as the Organic logo of the EU, where the Organic logo of the EU is used in the labelling.
CHAPTER 2
Specific labelling requirements for feed
Article 59
Scope, use of trade marks and sales descriptions
This Chapter shall not apply to pet food and feed for fur animals.
The trade marks and sales descriptions bearing an indication referred to in Article 23(1) of Regulation (EC) No 834/2007 may be used only if all ingredients of plant or animal origin are from the organic production method and at least 95 % of the product’s dry matter is comprised of such ingredients.
Article 60
Indications on processed feed
The terms referred to in Article 23(1) of Regulation (EC) No 834/2007 and the Organic logo of the EU may be used on processed feed provided that all the following requirements are complied with:
the processed feed complies with the provisions of Regulation (EC) No 834/2007 and in particular with Article 14(1)(d)(iv) and (v) for livestock or with Article 15(1)(d) for aquaculture animals and Article 18 thereof;
the processed feed complies with the provisions of this Regulation and in particular with Articles 22 and 26 thereof;
all ingredients of plant or animal origin contained in the processed feed are from the organic production method;
at least 95 % of the product’s dry matter is comprised of organic agricultural products.
Subject to the requirements laid down in points (a) and (b) of paragraph 1, the following statement is permitted in the case of products comprising variable quantities of feed materials from the organic production method and/or feed materials from products in conversion to organic farming and/or products as referred to in Article 22 of this Regulation:
‘may be used in organic production in accordance with Regulations (EC) No 834/2007 and (EC) No 889/2008’.
Article 61
Conditions for the use of indications on processed feed
The indication provided for in Article 60 shall be:
presented in a colour, format or character font that does not draw more attention to it than to the description or name of the animal feedingstuff referred to in Article 5(1)(a) of Directive 79/373/EEC or in Article 5(1)(b) of Directive 96/25/EC respectively;
accompanied, in the same field of vision, by an indication by weight of dry matter referring:
to the percentage of feed material(s) from the organic production method;
to the percentage of feed material(s) from products in conversion to organic farming;
to the percentage of feed material(s) not covered by points (i) and (ii);
to the total percentage of animal feed of agricultural origin;
accompanied by a list of names of feed materials from the organic production method;
accompanied by a list of names of feed materials from products in conversion to organic production.
CHAPTER 3
Other specific labelling requirements
Article 62
In-conversion products of plant origin
In-conversion products of plant origin may bear the indication ‘product under conversion to organic farming’ provided that:
a conversion period of at least 12 months before the harvest has been complied with;
the indication shall appear in a colour, size and style of lettering which is not more prominent than the sales description of the product, the entire indication shall have the same size of letters;
the product contains only one crop ingredient of agricultural origin;
the indication is linked to the code number of the control body or control authority as referred to in Article 27(10) of Regulation 834/2007.
TITLE IV
CONTROLS
CHAPTER 1
Minimum control requirements
Article 63
Control arrangements and undertaking by the operator
When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:
a full description of the unit and/or premises and/or activity;
all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules;
the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator's production chain;
the specific characteristics of the production method used, where the operator intends to request documentary evidence in accordance with Article 68(2).
Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator.
The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:
to perform the operations in accordance with the organic production rules;
to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;
to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production;
to accept, in cases where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies in accordance with the control system set up by Member State concerned, the exchange of information between those authorities or bodies;
to accept, in cases where the operator and/or the subcontractors of that operator change their control authority or control body, the transmission of their control files to the subsequent control authority or control body;
to accept, in cases where the operator withdraws from the control system, to inform without delay the relevant competent authority and control authority or control body;
to accept, in cases where the operator withdraws from the control system, that the control file is kept for a period of at least five years;
to accept to inform the relevant control authority or authorities or control body or bodies without delay of any irregularity or infringement affecting the organic status of their product or organic products received from other operators or subcontractors.
The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures.
For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:
Name and address of operator;
Location of premises and, where appropriate, parcels (land register data) where operations are carried out;
Nature of operations and products;
Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;
In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned;
The name of the approved body to which the operator entrusted control of his undertaking, where the Member State has implemented the control system by approving such bodies.
Article 64
Modification of control arrangements
The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.
Article 65
Control visits
The control authority or control body shall take and analyse samples in each case where the use of products or techniques not authorised for organic production is suspected. In such cases no minimum number of samples to be taken and analysed shall apply.
Samples may also be taken and analysed by the control authority or control body in any other case for detecting of products not authorised for organic production, for checking production techniques not in conformity with the organic production rules or for detecting possible contamination by products not authorised for organic production.
Article 66
Documentary accounts
Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify:
the supplier and, where different, the seller, or the exporter of the products;
the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs;
the nature and the quantities of organic products held in storage at the premises;
the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities;
in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.
Article 67
Access to facilities
The operator shall:
give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents;
provide the control authority or control body with any information reasonably necessary for the purposes of the control;
submit, when requested by the control authority or control body, the results of its own quality assurance programmes.
Article 68
Documentary evidence
In case of electronic certification as referred to in Article 29(3) of Regulation (EC) No 834/2007, the signature in box 8 of the documentary evidence shall not be required if the authenticity of the documentary evidence is otherwise shown by a tamper-proof electronic method.
Applications for complementary documentary evidence shall contain in box 2 of the model set out in Annex XIIa the relevant entry listed in Annex XIIb.
Article 69
Vendor declaration
For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.
CHAPTER 2
Specific control requirements for plants and plant products from farm production or collection
Article 70
Control arrangements
The full description of the unit referred to in Article 63(1)(a) shall:
be drawn up even where the operator limits his activity to the collection of wild plants;
indicate the storage and production premises and land parcels and/or collection areas and, where applicable, premises where certain processing and/or packaging operations take place; and
specify the date of the last application on the parcels and/or collection areas concerned of products, the use of which is not compatible with the organic production rules.
Article 71
Communications
Each year, before the date indicated by the control authority or control body, the operator shall notify the control authority or control body of its schedule of production of crop products, giving a breakdown by parcel.
Article 72
Plant production records
Plant production records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. In addition to Article 71 such records shall provide at least the following information:
as regards the use of fertiliser: date of application, type and amount of fertiliser, parcels concerned;
as regards the use of plant protection products: reason and date of treatment, type of product, method of treatment;
as regards purchase of farm inputs: date, type and amount of purchased product;
as regards harvest: date, type and amount of organic or in conversion crop production.
Article 73
Several production units run by the same operator
Where an operator runs several production units in the same area, the units producing non-organic crops, together with storage premises for farm input products shall also be subject to the general and the specific control requirements laid down in Chapter 1 and this Chapter of this Title.
CHAPTER 2a
Specific control requirements for seaweed
Article 73a
Control arrangements for seaweed
When the control system applying specifically to seaweed is first implemented, the full description of the site referred to in Article 63(1)(a) shall include:
a full description of the installations on land and at sea;
the environmental assessment as outlined in Article 6b(3) where applicable;
the sustainable management plan as outlined in Article 6b(4) where applicable;
for wild seaweed a full description and a map of shore and sea collection areas and land areas where post collection activities take place shall be drawn up.
Article 73b
Seaweed Production Records
Seaweed production records shall be compiled in the form of a register by the operator and kept available for the control authorities or control bodies at all times at the premises of the holding. It shall provide at least the following information:
list of species, date and quantity harvested;
date of application, type and amount of fertiliser used.
For collection of wild seaweeds the register shall also contain:
history of harvesting activity for each species in named beds;
harvest estimate (volumes) per season;
sources of possible pollution for harvest beds;
sustainable annual yield for each bed.
CHAPTER 3
Control requirements for livestock and livestock products produced by animal husbandry
Article 74
Control arrangements
When the control system applying specifically to livestock production is first implemented, the full description of the unit referred to in Article 63(1)(a) shall include:
a full description of the livestock buildings, pasturage, open air areas, etc., and, where applicable, the premises for the storage, packaging and processing of livestock, livestock products, raw materials and inputs;
a full description of the installations for the storage of livestock manure.
The practical measures referred to in Article 63(1)(b) shall include:
a plan for spreading manure agreed with the control body or authority, together with a full description of the areas given over to crop production;
where appropriate, as regards the spreading of manure, the written arrangements with other holdings as referred to in Article 3(3) complying with the provisions of the organic production rules;
a management plan for the organic-production livestock unit.
Article 75
Identification of livestock
The livestock shall be identified permanently using techniques adapted to each species, individually in the case of large mammals and individually or by batch in the case of poultry and small mammals.
Article 76
Livestock records
Livestock records shall be compiled in the form of a register and kept available to the control authorities or bodies at all times at the premises of the holding. Such records shall provide a full description of the herd or flock management system comprising at least the following information:
as regards animals arriving at the holding: origin and date of arrival, conversion period, identification mark and veterinary record;
as regards livestock leaving the holding: age, number of heads, weight in case of slaughter, identification mark and destination;
details of any animals lost and reasons thereof;
as regards feed: type, including feed supplements, proportions of various ingredients of rations and periods of access to free-range areas, periods of transhumance where restrictions apply;
as regards disease prevention and treatment and veterinary care: date of treatment, details of the diagnosis, the posology; type of treatment product, the indication of the active pharmacological substances involved method of treatment and veterinary prescription for veterinary care with reasons and withdrawal periods applying before livestock products can be marketed labelled as organic.
Article 77
Control measures on veterinary medicinal products for livestock
Whenever veterinary medicinal products are used the information according to Article 76(e) is to be declared to the control authority or body before the livestock or livestock products are marketed as organically produced. Livestock treated shall be clearly identified, individually in the case of large animals; individually, or by batch, or by hive, in the case of poultry, small animals and bees.
Article 78
Specific control measures on beekeeping
Article 79
Several production units run by the same operator
Where an operator manages several production units, as provided for in Articles 17(1), 40 and 41, the units which produce non-organic livestock or non-organic livestock products shall also be subject to the control system as laid down in Chapter 1 and this Chapter of this Title.
CHAPTER 3a
Specific control requirements for aquaculture animal production
Article 79a
Control arrangements for aquaculture animal production
When the control system applying specifically to aquaculture animal production is first implemented, the full description of the unit referred to in Article 63(1)(a) shall include:
a full description of the installations on land and at sea;
the environmental assessment as outlined in Article 6b(3) where applicable;
the sustainable management plan as outlined in Article 6b(4) where applicable;
in the case of molluscs a summary of the special chapter of the sustainable management plan as required by Article 25q(2).
Article 79b
Aquaculture animal production records
The following information shall be provided by the operator in the form of a register which shall be kept up to date and made available for the control authorities or control bodies at all times at the premises of the holding
the origin, date of arrival and conversion period of animals arriving at the holding:
the number of lots, the age, weight and destination of animals leaving the holding;
records of escapes of fish;
for fish the type and quantity of feed and in the case of carp and related species a documentary record of the use additional feed;
veterinary treatments giving details of the purpose, date of application, method of application, type of product and withdrawal period;
disease prevention measures giving details of fallowing, cleaning and water treatment.
Article 79c
Specific control visits for bivalve molluscs
For bivalve mollusc production inspection visits shall take place before and during maximum biomass production.
Article 79d
Several production units run by the same operator
When an operator manages several production units as provided for in Articles 25c, the units which produce non-organic aquaculture animals shall also be subject to the control system as laid down in Chapter 1and this Chapter.
CHAPTER 4
►M2 Control requirements for units for preparation of plant, seaweed, livestock and aquaculture animal products and foodstuffs composed thereof ◄
Article 80
Control arrangements
In the case of a unit involved in the preparation for its own account or for account of a third party, and including in particular units involved in packaging and/or re-packaging of such products or units involved in labelling and/or re-labelling of such products, the full description of the unit referred to in Article 63(1)(a) shall show the facilities used for the reception, the processing, packaging, labelling and storage of agricultural products before and after the operations concerning them, as well as the procedures for the transport of the products.
CHAPTER 5
►M2 Control requirements for imports of organic products from third countries ◄
Article 81
Scope
This Chapter applies to any operator involved, as importer and/or as first consignee, in the import and/or reception, for its own account or for account of another operator, of organic products.
Article 82
Control arrangements
In the case of the importer, the full description of the unit referred to in Article 63(1)(a) shall include the importer's premises and of his import activities, indicating the points of entry of the products into the Community and any other facilities the importer intends to use for the storage of the imported products pending their delivery to the first consignee.
In addition, the declaration referred to in Article 63(2) shall include an undertaking by the importer to ensure that any facilities that the importer will use for storage of products are submitted to control, to be carried out either by the control body or control authority or, when these storage facilities are situated in another Member State or region, by a control body or authority approved for control in that Member State or region.
Article 83
Documentary accounts
The importer and the first consignee shall keep separate stock and financial records, unless where they are operating in one single unit.
On request of the control authority or control body, any details on the transport arrangements from the exporter in the third country to the first consignee and, from the first consignee's premises or storage facilities to the consignees within the Community shall be provided.
Article 84
Information on imported consignments
The importer shall, in due time, inform the control body or control authority of each consignment to be imported into the Community, providing:
the name and address of the first consignee;
any details the control body or authority may reasonably require,
in case of products imported in accordance with Article 32 of Regulation (EC) No 834/2007, the documentary evidence referred to in that Article;
in case of products imported in accordance with Article 33 of Regulation (EC) No 834/2007, a copy of the certificate of inspection referred to in that Article.
On the request of the control body or control authority of the importer, the latter shall forward the information referred to in the first paragraph to the control body or control authority of the first consignee.
The importer shall transmit the information referred to in the first and second paragraphs by using the electronic Trade Control and Expert System (TRACES) established by Commission Decision 2003/24/EC ( 30 ).
Article 85
Control visits
The control authority or control body shall check the documentary accounts referred to in Article 83 of this Regulation and the certificate referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 or the documentary evidence referred to in Article 32(1)(c) of the latter Regulation.
Where the importer performs the import operations by different units or premises, he shall make available on request the reports referred to in the second subparagraph of Article 63(2) of this Regulation for each of these facilities.
CHAPTER 6
Control requirements for units involved in the production, preparation or import of organic products and which have contracted out to third parties in part or in total the actual operations concerned
Article 86
Control arrangements
With regard to the operations, which are contracted out to third parties, the full description of the unit referred to in Article 63(1)(a) shall include:
a list of the subcontractors with a description of their activities and an indication of the control bodies or authorities to which they are subject;
written agreement by the subcontractors that their holding will be subject to the control regime of Title V of Regulation (EC) No 834/2007;
all the practical measures, including inter alia an appropriate system of documentary accounts, to be taken at the level of the unit to ensure that the products the operator places on the market can be traced to, as appropriate, their suppliers, sellers, consignees and buyers.
CHAPTER 7
Control requirements for units preparing feed
Article 87
Scope
This Chapter applies to any unit involved in the preparation of products referred to in Article 1(2)(c) of Regulation (EC) No 834/2007 on its own account or on behalf of a third party.
Article 88
Control arrangements
The full description of the unit referred to in Article 63(1)(a) shall indicate:
the facilities used for the reception, preparation and storage of the products intended for animal feed before and after the operations concerning them;
the facilities used for the storage of other products used to prepare feedingstuffs;
the facilities used to store products for cleaning and disinfection;
where necessary, the description of the compound feedingstuff that the operator intends to produce, in accordance with Article 5(1)(a) of Directive 79/373/EEC, and the livestock species or class for which the compound feedingstuff is intended;
where necessary, the name of the feed materials that the operator intends to prepare.
Article 89
Documentary accounts
For the purposes of proper control of the operations, the documentary accounts referred to in Article 66 shall include information on the origin, nature and quantities of feed materials, additives, sales and finished products.
Article 90
Control visits
The control visit referred to in Article 65 shall comprise a full physical inspection of all premises. Moreover, the control authority or control body shall make targeted visits based on a general evaluation of the potential risks of non-compliance with the organic production rules.
The control body or authority shall pay particular attention to the critical control points pointed out for the operator, with a view to establishing whether the surveillance and checking operations are carried out correctly.
All the premises used by the operator for the conduct of his activities may be checked as frequently as the attendant risks warrant.
CHAPTER 8
Infringements and exchange of information
Article 91
Measures in case of suspicion of infringements and irregularities
Where a control authority or control body has a substantiated suspicion that an operator intends to place on the market a product not in compliance with the organic production rules but bearing a reference to the organic production method, this control authority or control body can require that the operator may provisionally not market the product with this reference for a time period to be set by that control authority or control body. Before taking such a decision, the control authority or control body shall allow the operator to comment. This decision shall be supplemented by the obligation to withdraw from this product any reference to the organic production method if the control authority or control body is sure that the product does not fulfil the requirements of organic production.
However, if the suspicion is not confirmed within the said time period, the decision referred to in the first subparagraph shall be cancelled not later than the expiry of that time period. The operator shall cooperate fully with the control body or authority in resolving the suspicion.
Article 92
Exchange of information between control authorities, control bodies and competent authorities
The previous control authority or control body shall hand over the relevant elements of the control file of the operator concerned and the reports referred to in the second subparagraph of Article 63(2) to the subsequent control authority or control body.
The new control authority or control body shall ensure that non-conformities noted in the report of the previous control authority or control body have been or are being addressed by the operator.
That competent authority may require, on its own initiative, also any other information on irregularities or infringements.
In case of irregularities or infringements found with regard to products under the control of other control authorities or control bodies, it shall also inform those authorities or bodies without delay.
Article 92a
Exchange of information between different Member States and the Commission
It shall inform the Member State which sent the notification, the other Member States and the Commission of the result of the investigation and of the action taken by replying to the original notification via the system referred to in Article 94(1). The reply shall be sent within 30 calendar days from the date of the original notification.
Article 92b
Publication of information
Member States shall make available to the public, in an appropriate manner including publication on the internet, the updated lists referred to in Article 28(5) of Regulation (EC) No 834/2007 containing updated documentary evidence related to each operator, as provided for in Article 29(1) of that Regulation and using the model set out in Annex XII to this Regulation. The Member States shall duly observe the requirements of the protection of personal data as laid down in Directive 95/46/EC of the European Parliament and of the Council ( 32 ).
CHAPTER 9
Supervision by competent authorities
Article 92c
Supervisory activities relating to control bodies
Those supervisory activities shall include an assessment of the internal procedures of the control bodies for the controls, the management and examination of control files in the light of the obligations established by Regulation (EC) No 834/2007 and the verification of handling of non-conformities and the handling of appeals and complaints.
The risk analysis procedure shall be designed in such a way that:
the result of the risk analysis provides the basis for determining the intensity of the unannounced or announced annual inspections and visits;
additional random control visits carried out in accordance with Article 65(4) of at least 10 % of operators under contract in accordance with the risk category are performed;
at least 10 % of all inspections and visits carried out in accordance with Article 65(1) and (4) are unannounced;
the selection of operators to be submitted to unannounced inspections and visits is determined on the basis of the risk analysis and that these are planned according to the level of risk.
Article 92d
Catalogue of measures in case of irregularities and infringements
Competent authorities shall adopt and communicate to control bodies that have been delegated control tasks, a catalogue at least listing infringements and irregularities affecting the organic status of products and corresponding measures to be applied by control bodies in case of infringements or irregularities by operators under their control who are involved in organic production.
Competent authorities may include other relevant information in the catalogue on their own initiative.
Article 92e
Annual inspection of control bodies
Competent authorities shall organise an annual inspection of the control bodies that have been delegated control tasks in accordance with Article 27(4)(b) of Regulation (EC) No 834/2007. For the purposes of the annual inspection, the competent authority shall take into account the results of the work of the national accreditation body as referred to in Article 2(11) of Regulation (EC) No 765/2008. During the annual inspection, the competent authority shall, in particular, verify:
the compliance with the control body’s standard control procedure as submitted by the control body to the competent authority in accordance with Article 27(6)(a) of Regulation (EC) No 834/2007;
that the control body has a sufficient number of suitable qualified and experienced staff in accordance with Article 27(5)(b) of Regulation (EC) No 834/2007 and that training concerning risks affecting the organic status of products has been implemented;
that the control body has and follows documented procedures and templates for:
the annual risk analysis in accordance with Article 27(3) of Regulation (EC) No 834/2007;
preparing a risk-based sampling strategy, conducting sampling and laboratory analysis;
information exchange with other control bodies and with the competent authority;
initial and follow-up controls of operators under their control;
the application and follow-up to the catalogue of measures to be applied in case of infringements or irregularities;
observing the requirements of the protection of personal data for the operators under its control as laid down by the Member States where that competent authority operates and in accordance with Directive 95/46/EC.
Article 92f
Organic data in the multi-annual national control plan and annual report
Member States shall ensure that their multi-annual national control plans referred to in Article 41 of Regulation (EC) No 882/2004 cover the supervision of controls performed on the organic production in accordance with this Regulation and to include the specific data on that supervision, hereinafter referred to as ‘the organic data’, in the annual report referred to in Article 44 of Regulation (EC) No 882/2004. The organic data shall cover the topics listed in Annex XIIIb to this Regulation.
The organic data shall be based on information on the controls performed by the control bodies and/or control authorities and on audits performed by the competent authority.
The data shall be presented according to the templates provided for in Annex XIIIc to this Regulation as from 2015 for the year 2014.
Member States may insert the organic data as an organic chapter of their national control plan and their annual report.
TITLE V
TRANSMISSION OF INFORMATION TO THE COMMISSION, TRANSITIONAL AND FINAL PROVISIONS
CHAPTER 1
Transmission of information to the Commission
Article 93
Statistical information
The statistical information referred to in paragraph 1 shall comprise, in particular the following data:
the number of organic producers, processors, importers and exporters;
the organic crop production and crop area under conversion and under organic production;
the organic livestock numbers and the organic animal products;
the data on organic industrial production by type of activities;
the number of organic aquaculture animal production units;
the volume of organic aquaculture animal production;
optionally, the number of organic seaweed units and the volume of organic seaweed production.
Article 94
Other information
Member States shall provide the Commission with the following information by using the computer system enabling electronic exchanges of documents and information made available by the Commission (DG Agriculture and rural development) for information other than statistical information:
by 30 June 2017, the information referred to in Article 35(a) of Regulation (EC) No 834/2007, including email address and internet address, and afterwards any changes thereto;
by 30 June 2017, the information referred to in Article 35(b) of Regulation (EC) No 834/2007, including address, email address and internet address, and afterwards any changes thereto;
before 1 July each year, all other information required or needed in accordance with this Regulation;
within one month from their approval, the exceptions granted by the Member States under points (c) and (e) of the first paragraph of Article 47;
by 30 June 2017, the name, address, email address and internet address of the relevant Member State's competent authorities as defined in point (6) of Article 2 of Regulation (EC) No 1235/2008, and afterwards any changes thereto.
CHAPTER 2
Transitional and final provisions
Article 95
Transitional measures
For a transitional period expiring on the 1 July 2010, the operators may continue to use in the labelling the provisions as laid down in Regulation (EEC) No 2092/91 for:
the system for calculation the percentage of organic ingredients of food;
the code number and/or the name of the control body or control authority.
Stocks of wines produced until 31 July 2012 in accordance with either Regulation (EEC) No 2092/91 or Regulation (EC) No 834/2007 may continue to be brought on the market until stocks are exhausted, and subject to the following labelling requirements:
the Community organic production logo as referred to in Article 25(1) of Regulation (EC) No 834/2007, called from 1 July 2010 the ‘Organic logo of the EU’ may be used provided that the wine-making process complies with Chapter 3a of Title II of this Regulation;
operators using ‘Organic logo of the EU’ shall keep recorded evidence, for a period of at least five years after they placed on the market that wine obtained from organic grapes, including of the corresponding quantities of wine in litres, per wine category and per year;
where the evidence referred to in point (b) of this paragraph is not available, such wine may be labelled as ‘wine made from organic grapes’, provided that it complies with the requirements of this Regulation except those provided for in Chapter 3a of Title II thereof;
wine labelled as ‘wine made from organic grapes’ cannot bear the ‘Organic logo of the EU’.
Article 96
Repeal
Regulations (EEC) No 207/93, (EC) No 223/2003 and (EC) No 1452/2003 are repealed.
References to the repealed Regulations and to Regulation (EEC) No 2092/91 shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIV.
Article 97
Entry into force and application
This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
It shall apply as from 1 January 2009.
However, paragraph 2(a) of Article 27 and Article 58 shall apply as of 1 July 2010.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
Fertilisers, soil conditioners and nutrients referred to in Article 3(1) and Article 6d(2)
Note:
A: authorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007
B: authorised under Regulation (EC) No 834/2007
|
Authorisation |
Name Compound products or products containing only materials listed hereunder: |
Description, compositional requirements, conditions for use |
|
A |
Farmyard manure |
Product comprising a mixture of animal excrements and vegetable matter (animal bedding). Factory farming origin forbidden |
|
A |
Dried farmyard manure and dehydrated poultry manure |
Factory farming origin forbidden |
|
A |
Composted animal excrements, including poultry manure and composted farmyard manure included |
Factory farming origin forbidden |
|
A |
Liquid animal excrements |
Use after controlled fermentation and/or appropriate dilution Factory farming origin forbidden |
|
B |
Composted or fermented mixture of household waste |
Product obtained from source separated household waste, which has been submitted to composting or to anaerobic fermentation for biogas production Only vegetable and animal household waste Only when produced in a closed and monitored collection system, accepted by the Member State Maximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable |
|
A |
Peat |
Use limited to horticulture (market gardening, floriculture, arboriculture, nursery) |
|
A |
Mushroom culture wastes |
The initial composition of the substrate shall be limited to products of this Annex |
|
A |
Dejecta of worms (vermicompost) and insects |
|
|
A |
Guano |
|
|
A |
Composted or fermented mixture of vegetable matter |
Product obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production |
|
B |
Biogas digestate containing animal by-products co-digested with material of plant or animal origin as listed in this Annex |
Animal by-products (including by-products of wild animals) of category 3 and digestive tract content of category 2 (categories 2 and 3 as defined in Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1)) must not be from factory farming origin. The Processes have to be in accordance with Commission Regulation (EU) No 142/2011. Not to be applied to edible parts of the crop |
|
B |
Products or by-products of animal origin as below: Blood meal Hoof meal Horn meal Bone meal or degelatinised bone meal Fish meal Meat meal Feather, hair and ‘chiquette’ meal Wool Fur (1) Hair Dairy products Hydrolysed proteins (2) |
(1) Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable (2) Not to be applied to edible parts of the crop |
|
A |
Products and by-products of plant origin for fertilisers |
Examples: oilseed cake meal, cocoa husks, malt culms |
|
B |
Hydrolysed proteins of plant origin |
|
|
A |
Seaweeds and seaweed products |
As far as directly obtained by: (i) physical processes including dehydration, freezing and grinding (ii) extraction with water or aqueous acid and/or alkaline solution (iii) fermentation |
|
A |
Sawdust and wood chips |
Wood not chemically treated after felling |
|
A |
Composted bark |
Wood not chemically treated after felling |
|
A |
Wood ash |
From wood not chemically treated after felling |
|
A |
Soft ground rock phosphate |
Product as specified in point 7 of Annex IA.2. to Regulation (EC) No 2003/2003 of the European Parliament and of the Council (2). Cadmium content less than or equal to 90 mg/kg of P205 |
|
A |
Aluminium-calcium phosphate |
Product as specified in point 6 of Annex IA.2. to Regulation (EC) No 2003/2003, Cadmium content less than or equal to 90 mg/kg of P205 Use limited to basic soils (pH > 7,5) |
|
A |
Basic slag |
Products as specified in point 1 of Annex IA.2. to Regulation (EC) No 2003/2003 |
|
A |
Crude potassium salt or kainit |
Products as specified in point 1 of Annex IA.3. to Regulation (EC) No 2003/2003 |
|
A |
Potassium sulphate, possibly containing magnesium salt |
Product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts |
|
A |
Stillage and stillage extract |
Ammonium stillage excluded |
|
A |
Calcium carbonate, for instance: chalk, marl, ground limestone, Breton ameliorant, (maerl), phosphate chalk |
Only of natural origin |
|
B |
Mollusc waste |
Only from sustainable fisheries, as defined in Article 4 (1) (7) of Regulation (EU) No 1380/2013 or organic aquaculture |
|
B |
Egg shells |
Factory farming origin forbidden. |
|
A |
Magnesium and calcium carbonate |
Only of natural origin e.g. magnesian chalk, ground magnesium, limestone |
|
A |
Magnesium sulphate (kieserite) |
Only of natural origin |
|
A |
Calcium chloride solution |
Foliar treatment of apple trees, after identification of deficit of calcium |
|
A |
Calcium sulphate (gypsum) |
Products as specified in point 1 of Annex ID. to Regulation (EC) No 2003/2003 Only of natural origin |
|
A, B |
Industrial lime from sugar production |
By-product of sugar production from sugar beet and sugar cane |
|
A |
Industrial lime from vacuum salt production |
By-product of the vacuum salt production from brine found in mountains |
|
A |
Elemental sulphur |
Products as specified in Annex ID.3 to Regulation (EC) No 2003/2003 |
|
A |
Trace elements |
Inorganic micronutrients listed in part E of Annex I to Regulation (EC) No 2003/2003 |
|
A |
Sodium chloride |
|
|
A |
Stone meal and clays |
|
|
B |
Leonardite (Raw organic sediment rich in humic acids) |
Only if obtained as a by-product of mining activities |
|
B |
Humic and fulvic acids |
Only if obtained by inorganic salts/solutions excluding ammonium salts; or obtained from drinking water purification |
|
B |
Xylite |
Only if obtained as a by-product of mining activities (e.g. by-product of brown coal mining) |
|
B |
Chitin (Polysaccharide obtained from the shell of crustaceans) |
Only if obtained from sustainable fisheries, as defined in Article 4(1)(7) of Regulation (EU) No 1380/2013 or organic aquaculture |
|
B |
Organic rich sediment from fresh water bodies formed under exclusion of oxygen (e.g. sapropel) |
Only organic sediments that are by-products of fresh water body management or extracted from former freshwater areas When applicable, extraction should be done in a way to cause minimal impact on the aquatic system Only sediments derived from sources free from contaminations of pesticides, persistent organic pollutants and petrol like substances Maximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable |
|
B |
Biochar — pyrolysis product made from a wide variety of organic materials of plant origin and applied as a soil conditioner |
Only from plant materials, untreated or treated with products included in Annex II. Maximum value of 4 mg polycyclic aromatic hydro-carbons (PAHs) per kg dry matter (DM). This value shall be reviewed every second year, taking into account the risk of accumulation due to multiple applications |
|
(1)
Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/ 2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
(2)
Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1). |
||
ANNEX II
Pesticides — Plant protection products referred to in Article 5(1)
All the substances listed in this Annex have to comply at least with the conditions for use as specified in the Annex to Commission Implementing Regulation (EU) No 540/2011 ( 34 ). More restrictive conditions for use for organic production are specified in the second column of each table.
1. Substances of plant or animal origin
|
Name |
Description, compositional requirement, conditions for use |
|
Allium sativum (Garlic extract) |
|
|
Azadirachtin extracted from Azadirachta indica (Neem tree) |
|
|
Beeswax |
Only as pruning agent/wound protectant |
|
COS-OGA |
|
|
Hydrolysed proteins excluding gelatine |
|
|
Laminarin |
Kelp shall be either grown organically in accordance with Article 6d or harvested in a sustainable way in accordance with Article 6c |
|
Maltodextrin |
|
|
Pheromones |
Only in traps and dispensers. |
|
Plant oils |
All uses authorised, except herbicide . |
|
Pyrethrins |
Only from plant origin |
|
Quassia extracted from Quassia amara |
Only as insecticide, repellent |
|
Repellents by smell of animal or plant origin/sheep fat |
Only on non-edible parts of the crop and where crop material is not ingested by sheep or goats |
|
Salix spp. Cortex (a.k.a. willow bark) |
|
|
Terpenes (eugenol, geraniol and thymol) |
|
2. Basic substances
|
Basic substances based on food (including: Lecithins, sucrose, fructose, vinegar, whey, chitosan hydrochloride (1), and Equisetum arvense etc.) |
Only those basic substances as defined by Article 23 of Regulation (EC) No 1107/2009 (2) which are food as defined in Article 2 of Regulation (EC) No 178/2002 and have plant or animal origin Substances not to be used as herbicides |
|
(1)
Obtained from sustainable fisheries or organic aquaculture.
(2)
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (OJ L 309, 24.11.2009, p. 1). |
|
3. Micro-organisms or substances produced by or derived from micro-organisms
|
Name |
Description, compositional requirement, conditions for use |
|
Micro-organisms |
Not from GMO origin |
|
Spinosad |
|
|
Cerevisane |
|
4. Substances other than those mentioned in Sections 1, 2 and 3
|
Name |
Description, compositional requirement, conditions or restrictions to use |
|
Aluminium silicate (Kaolin) |
|
|
Calcium hydroxide |
When used as fungicide, only in fruit trees, including nurseries, to control Nectria galligena |
|
Carbon dioxide |
|
|
Copper compounds in the form of: copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture, and tribasic copper sulphate |
|
|
Diammonium phosphate |
Only as attractant in traps |
|
Ethylene |
|
|
Fatty acids |
All uses authorised, except herbicide |
|
Ferric phosphate (iron (III) orthophosphate) |
Preparations to be surface-spread between cultivated plants |
|
Hydrogen peroxide |
|
|
Kieselgur (diatomaceous earth) |
|
|
Lime sulphur (calcium polysulphide) |
|
|
Paraffin oil |
|
|
Potassium and sodium hydrogen carbonate (a.k.a. potassium /sodium bicarbonate) |
|
|
Pyrethroids (only deltamethrin or lambda-cyhalothrin) |
Only in traps with specific attractants; only against Bactrocera oleae and Ceratitis capitata Wied |
|
Quartz sand |
|
|
Sodium chloride |
All uses authorised, except herbicide |
|
Sulphur |
|
ANNEX III
Minimum surface areas indoors and outdoors and other characteristics of housing in the different species and types of production referred to in Article 10(4)
1. Bovines, equidae, ovine, caprine and porcine
|
|
Indoors area (net area available to animals) |
Outdoors area (exercise area, excluding pasturage) |
|
|
|
Live weight minimum (kg) |
M2/head |
M2/head |
|
Breeding and fattening bovine and equidae |
up to 100 |
1,5 |
1,1 |
|
up to 200 |
2,5 |
1,9 |
|
|
up to 350 |
4,0 |
3 |
|
|
over 350 |
5 with a minimum of 1 m2/100 kg |
3,7 with a minimum of 0,75 m2/100 kg |
|
|
Dairy cows |
|
6 |
4,5 |
|
Bulls for breeding |
|
10 |
30 |
|
Sheep and goats |
|
1,5 sheep/goat |
2,5 |
|
|
0,35 lamb/kid |
0,5 |
|
|
Farrowing sows with piglets up to 40 days |
|
7,5 sow |
2,5 |
|
Fattening pigs |
up to 50 |
0,8 |
0,6 |
|
up to 85 |
1,1 |
0,8 |
|
|
up to 110 |
1,3 |
1 |
|
|
Over 110 kg |
1,5 |
1,2 |
|
|
Piglets |
over 40 days and up to 30 kg |
0,6 |
0,4 |
|
Brood pigs |
|
2,5 female |
1,9 |
|
|
6 male If pens are used for natural service: 10 m2/boar |
8,0 |
|
2. Poultry
|
|
Indoors area (net area available to animals) |
Outdoors area (m2 of area available in rotation/head) |
||
|
|
No animals/m2 |
cm perch/animal |
nest |
|
|
Laying hens |
6 |
18 |
7 laying hens per nest or in case of common nest 120 cm2/bird |
4, provided that the limit of 170 kg of N/ha/year is not exceeded |
|
Fattening poultry (in fixed housing) |
10 with a maximum of 21 kg liveweight/m2 |
20 (for guinea fowl only) |
|
4 broilers and guinea fowl 4,5 ducks 10 turkey 15 geese In all the species mentioned above the limit of 170 kg of N/ha/year is not exceeded |
|
Fattening poultry in mobile housing |
16 (1) in mobile poultry houses with a maximum of 30 kg liveweight/m2 |
|
|
2,5 , provided that the limit of 170 kg of N/ha/year is not exceeded |
|
(1)
Only in the case of mobile houses not exceeding 150 m2 floor space. |
||||
ANNEX IV
Maximum number of animals per hectare referred to in Article 15 (2)
|
Class or species |
Maximum number of animals per ha equivalent to 170 kg N/ha/year |
|
Equines over six months old |
2 |
|
Calves for fattening |
5 |
|
Other bovine animals less than one year old |
5 |
|
Male bovine animals from one to less than two years old |
3,3 |
|
Female bovine animals from one to less than two years old |
3,3 |
|
Male bovine animals two years old or over |
2 |
|
Breeding heifers |
2,5 |
|
Heifers for fattening |
2,5 |
|
Dairy cows |
2 |
|
Cull dairy cows |
2 |
|
Other cows |
2,5 |
|
Female breeding rabbits |
100 |
|
Ewes |
13,3 |
|
Goats |
13,3 |
|
Piglets |
74 |
|
Breeding sows |
6,5 |
|
Pigs for fattening |
14 |
|
Other pigs |
14 |
|
Table chickens |
580 |
|
Laying hens |
230 |
ANNEX V
Feed materials as referred to in Article 22(d), Article 24(2) and Article 25m(1)
1. FEED MATERIALS OF MINERAL ORIGIN
|
Authorisation |
Substance |
Conditions for use |
|
A |
Calcareous marine shells |
|
|
A |
Maerl |
|
|
A |
Lithotamn |
|
|
A |
Calcium gluconate |
|
|
A |
Calcium carbonate |
|
|
A |
Defluorinated monocalciumphosphate |
|
|
A |
Defluorinated dicalciumphosphate |
|
|
A |
Magnesium oxide (anhydrous magnesia) |
|
|
A |
Magnesium sulphate |
|
|
A |
Magnesium chloride |
|
|
A |
Magnesium carbonate |
|
|
A |
Calcium magnesium phosphate |
|
|
A |
Magnesium phosphate |
|
|
A |
Monosodium phosphate |
|
|
A |
Calcium sodium phosphate |
|
|
A |
Monoammonium phosphate (ammonium dihydrogen orthophosphate) |
Only for aquaculture |
|
A |
Sodium chloride |
|
|
A |
Sodium bicarbonate |
|
|
A |
Sodium carbonate |
|
|
A |
Sodium sulphate |
|
|
A |
Potassium chloride |
|
2. OTHER FEED MATERIALS
Fermentation (by-)products from microorganisms the cells of which have been inactivated or killed:
|
A |
Saccharomyces cerevisiae |
|
|
A |
Saccharomyces carlsbergiensis |
|
ANNEX VI
Feed additives used in animal nutrition referred to in Article 22(g), Article 24(2) and Article 25m(2)
Feed additives listed in this Annex must be authorised under Regulation (EC) No 1831/2003 of the European Parliament and of the Council.
1. TECHNOLOGICAL ADDITIVES
(a) Preservatives
|
ID numbers or Functional groups |
Substance |
Description, conditions for use |
|
|
|
E 200 |
Sorbic acid |
|
|
|
E 236 |
Formic acid |
|
|
|
E 237 |
Sodium formate |
|
|
|
E 260 |
Acetic acid |
|
|
|
E 270 |
Lactic acid |
|
|
|
E 280 |
Propionic acid |
|
|
|
E 330 |
Citric acid |
|
(b) Antioxidants
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
|
|
1b306(i) |
Tocopherol extracts from vegetable oils |
|
|
|
1b306(ii) |
Tocopherol-rich extracts from vegetable oils (delta rich) |
|
(c) Emulsifiers, stabilisers, thickeners and gelling agents
|
ID numbers or Functional groups |
Substance |
Description, conditions for use |
|
|
|
1c322 |
Lecithins |
Only when derived from organic raw material. |
|
|
|
|
Use restricted to aquaculture animal feed. |
(d) Binders and anti-caking agents
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
|
|
E 412 |
Guar gum |
|
|
|
E 535 |
Sodium ferrocyanide |
Maximum dose rate of 20 mg/kg NaCl calculated as ferrocyanide anion. |
|
|
E 551b |
Colloidal silica |
|
|
|
E 551c |
Kieselgur (diatomaceous earth, purified) |
|
|
|
1m558i |
Bentonite |
|
|
|
E 559 |
Kaolinitic clays, free of asbestos |
|
|
|
E 560 |
Natural mixtures of steatites and chlorite |
|
|
|
E 561 |
Vermiculite |
|
|
|
E 562 |
Sepiolite |
|
|
|
E 566 |
Natrolite-Phonolite |
|
|
|
1g568 |
Clinoptilolite of sedimentary origin |
|
|
|
E 599 |
Perlite |
|
(e) Silage additives
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
1k 1k236 |
Enzymes, micro-organisms Formic acid, |
Use restricted to production of silage when weather conditions do not allow for adequate fermentation. The use of formic, propionic acid and their sodium salts in the production of silage shall only be permitted when weather conditions do not allow for adequate fermentation |
|
1k237 |
Sodium formate |
|
|
1k280 |
Propionic acid |
|
|
1k281 |
Sodium propionate |
2. SENSORY ADDITIVES
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
2b |
Flavouring compounds |
Only extracts from agricultural products. |
|
|
Castanea sativa Mill.: Chestnut extract |
|
3. NUTRITIONAL ADDITIVES
(a) Vitamins, pro-vitamins and chemically well-defined substances having similar effect
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
3a |
Vitamins and provitamins |
Derived from agricultural products. If derived synthetically, only those identical to vitamins derived from agricultural products may be used for monogastric animals and aquaculture animals. If derived synthetically, only vitamins A, D and E identical to vitamins derived from agricultural products may be used for ruminants; the use is subject to prior authorisation of the Member States based on the assessment of the possibility for organic ruminants to obtain the necessary quantities of the said vitamins through their feed rations. |
|
3a920 |
Betaine anhydrous |
Only for monogastric animals Only from natural origin and when available from organic origin |
(b) Compounds of trace elements
|
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
|
E1 Iron |
|
|
|
|
3b101 |
Iron(II) carbonate (siderite) |
|
|
|
3b103 |
Iron(II) sulphate monohydrate |
|
|
|
3b104 |
Iron(II) sulphate heptahydrate |
|
|
|
3b201 |
Potassium iodide |
|
|
|
3b202 |
Calcium iodate, anhydrous |
|
|
|
3b203 |
Coated granulated calcium iodate anhydrous |
|
|
|
3b301 |
Cobalt(II) acetate tetrahydrate |
|
|
|
3b302 |
Cobalt(II) carbonate |
|
|
|
3b303 |
Cobalt(II) carbonate hydroxide (2:3) monohydrate |
|
|
|
3b304 |
Coated granulated cobalt(II) carbonate hydroxide (2:3) monohydrate |
|
|
|
3b305 |
Cobalt(II) sulphate heptahydrate |
|
|
|
3b402 |
Copper(II) carbonate dihydroxy monohydrate |
|
|
|
3b404 |
Copper (II) oxide |
|
|
|
3b405 |
Copper(II) sulphate pentahydrate |
|
|
|
3b409 |
Dicopper chloride trihydroxide (TBCC) |
|
|
|
3b502 |
Manganese (II) oxide |
|
|
|
3b503 |
Manganous sulfate, monohydrate |
|
|
|
3b603 |
Zinc oxide |
|
|
|
3b604 |
Zinc sulphate heptahydrate |
|
|
|
3b605 |
Zinc sulphate monohydrate |
|
|
|
3b609 |
Zinc chloride hydroxide monohydrate (TBZC) |
|
|
|
3b701 |
Sodium molybdate dihydrate |
|
|
|
3b801 |
Sodium selenite |
|
|
|
3b810, 3b811, 3b812, 3b813 and 3b817 |
Selenised yeast inactivated |
|
4. ZOOTECHNICAL ADDITIVES
|
ID number or Functional groups |
Substance |
Description, conditions for use |
|
4a, 4b, 4c and 4d |
Enzymes and microorganism in the category of ‘Zootechnical additives’ |
|
ANNEX VII
Products for cleaning and disinfection
|
1. |
Products for cleaning and disinfection of buildings and installations for livestock production referred to in Article 23(4):
—
Potassium and sodium soap
—
Water and steam
—
Milk of lime
—
Lime
—
Quicklime
—
Sodium hypochlorite (e.g. as liquid bleach)
—
Caustic soda
—
Caustic potash
—
Hydrogen peroxide
—
Natural essences of plants
—
Citric, peracetic acid, formic, lactic, oxalic and acetic acid
—
Alcohol
—
Nitric acid (dairy equipment)
—
Phosporic acid (dairy equipment)
—
Formaldehyde
—
Cleaning and disinfection products for teats and milking facilities
—
Sodium carbonate
|
|
2. |
Products for cleaning and disinfection for aquaculture animals and seaweed production referred to in Articles 6e(2), 25s(2) and 29a.
|
ANNEX VIII
Certain products and substances for use in production of processed organic food, yeast and yeast products referred to in Article 27(1)(a) and Article 27a(a)
SECTION A — FOOD ADDITIVES, INCLUDING CARRIERS
For the purpose of the calculation referred to in Article 23(4)(a)(ii) of Regulation (EC) No 834/2007, food additives marked with an asterisk in the column of the code number, shall be calculated as ingredients of agricultural origin
|
Code |
Name |
Preparation of foodstuffs of |
Specific conditions and restrictions in addition to Regulation (EC) No 1333/2008 |
|
|
plant origin |
Animal origin |
|||
|
E 153 |
Vegetable carbon |
|
X |
Ashy goat cheese Morbier cheese |
|
E 160b* |
Annatto, Bixin, Norbixin |
|
X |
Red Leicester cheese Double Gloucester cheese Cheddar Mimolette cheese |
|
E 170 |
Calcium carbonate |
X |
X |
Shall not be used for colouring or calcium enrichment of products |
|
E 220 |
Sulphur dioxide |
X |
X(Only for mead) |
In fruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar: 100 mg/l (Maximum levels available from all sources, expressed as SO2 in mg/l) |
|
E 223 |
Sodium metabisulphite |
|
X |
Crustaceans |
|
E 224 |
Potassium metabisulphite |
X |
X (Only for mead) |
In fruit wines (wine made from fruits other than grapes, including cider and perry) and mead with and without added sugar: 100 mg/l (Maximum levels available from all sources, expressed as SO2 in mg/l) |
|
E250 |
Sodium nitrite |
|
X |
For meat products. May only be used, if it has been demonstrated to the satisfaction of the competent authority that no technological alternative, giving the same guarantees and/or allowing to maintain the specific features of the product, is available. Not in combination with E252. Indicative ingoing amount expressed as NaNO2: 80 mg/kg, maximum residual amount expressed as NaNO2: 50 mg/kg |
|
E252 |
Potassium nitrate |
|
X |
For meat products. May only be used, if it has been demonstrated to the satisfaction of the competent authority that no technological alternative, giving the same guarantees and/or allowing to maintain the specific features of the product, is available. Not in combination with E250. Indicative ingoing amount expressed as NaNO3: 80 mg/kg, maximum residual amount expressed as NaNO3: 50 mg/kg |
|
E 270 |
Lactic acid |
X |
X |
|
|
E 290 |
Carbon dioxide |
X |
X |
|
|
E 296 |
Malic acid |
X |
|
|
|
E 300 |
Ascorbic acid |
X |
X |
With regard to foodstuffs of animal origin: Meat products |
|
E 301 |
Sodium ascorbate |
|
X |
With regard to foodstuffs of animal origin: Meat products in connection with nitrates and nitrites |
|
E 306(*) |
Tocopherol-rich extract |
X |
X |
Anti-oxidant |
|
E 322(*) |
Lecithins |
X |
X |
With regard to foodstuffs of animal origin: Milk products. Only when derived from organic production. Applicable as of 1 January 2022. Until that date, only when derived from organic raw material. |
|
E 325 |
Sodium lactate |
|
X |
Milk-based and meat products |
|
E 330 |
Citric acid |
X |
X |
|
|
E 331 |
Sodium citrates |
X |
X |
|
|
E 333 |
Calcium citrates |
X |
|
|
|
E 334 |
Tartaric acid (L(+)-) |
X |
X(Only for mead) |
With regard to foodstuffs of animal origin: Mead. |
|
E 335 |
Sodium tartrates |
X |
|
|
|
E 336 |
Potassium tartrates |
X |
|
|
|
E 341 (i) |
Monocalcium phosphate |
X |
|
Raising agent for self-raising flour |
|
E 392* |
Extracts of Rosemary |
X |
X |
Only when derived from organic production |
|
E 400 |
Alginic acid |
X |
X |
With regard to foodstuffs of animal origin: milk-based products |
|
E 401 |
Sodium alginate |
X |
X |
With regard to foodstuffs of animal origin: milk-based products ►M22 and sausages based on meat ◄ |
|
E 402 |
Potassium alginate |
X |
X |
With regard to foodstuffs of animal origin: milk-based products |
|
E 406 |
Agar |
X |
X |
With regard to foodstuffs of animal origin: milk-based products and meat products |
|
E 407 |
Carrageenan |
X |
X |
With regard to foodstuffs of animal origin: milk-based products |
|
E 410* |
Locust bean gum |
X |
X |
Only when derived from organic production. Applicable as of 1 January 2022. |
|
E 412* |
Guar gum |
X |
X |
Only when derived from organic production. Applicable as of 1 January 2022. |
|
E 414* |
Arabic gum |
X |
X |
Only when derived from organic production. Applicable as of 1 January 2022. |
|
E 415 |
Xanthan gum |
X |
X |
|
|
E 417 |
Tara gum powder |
X |
X |
Thickener Only when derived from organic production. Applicable as of 1 January 2022. |
|
E 418 |
Gellan gum |
X |
X |
High-acyl form only Only when derived from organic production. Applicable as of 1 January 2022. |
|
E 422 |
Glycerol |
X |
X |
Only from plant origin Only when derived from organic production. Applicable as of 1 January 2022. For plant extracts, flavourings, humectant in gel capsules and as a surface coating of tablets |
|
E 440 (i)* |
Pectin |
X |
X |
With regard to foodstuffs of animal origin: milk-based products |
|
E 464 |
Hydroxypropyl methyl cellulose |
X |
X |
Encapsulation material for capsules |
|
E 500 |
Sodium carbonates |
X |
X |
|
|
E 501 |
Potassium carbonates |
X |
|
|
|
E 503 |
Ammonium carbonates |
X |
|
|
|
E 504 |
Magnesium carbonates |
X |
|
|
|
E 509 |
Calcium chloride |
|
X |
Milk coagulation |
|
E 516 |
Calcium sulphate |
X |
|
Carrier |
|
E 524 |
Sodium hydroxide |
X |
|
Surface treatment of ‘Laugengebäck’ and regulation of acidity in organic flavourings |
|
E 551 |
Silicon dioxide |
X |
X |
For herbs and spices in dried powdered form, flavourings and propolis |
|
E 553b |
Talc |
X |
X |
With regard to foodstuffs of animal origin: surface treatment of sausages |
|
E 901 |
Beeswax |
X |
|
As a glazing agent for confectionary only. Beeswax from organic production |
|
E 903 |
Carnauba wax |
X |
|
As a glazing agent for confectionary As a mitigating method for mandatory extreme cold treatment of fruit as a quarantine measure against harmful organisms (Commission Implementing Directive (EU) 2017/1279) (1) Only when derived from organic production. Applicable as of 1 January 2022. Until that date, only when derived from organic raw material. |
|
E 938 |
Argon |
X |
X |
|
|
E 939 |
Helium |
X |
X |
|
|
E 941 |
Nitrogen |
X |
X |
|
|
E 948 |
Oxygen |
X |
X |
|
|
E 968 |
Erythritol |
X |
X |
Only when derived from organic production without using ion exchange technology |
|
(1)
Commission Implementing Directive (EU) 2017/1279 of 14 July 2017 amending Annexes I to V to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 184, 15.7.2017, p. 33). |
||||
SECTION B — PROCESSING AIDS AND OTHER PRODUCTS, WHICH MAY BE USED FOR PROCESSING OF INGREDIENTS OF AGRICULTURAL ORIGIN FROM ORGANIC PRODUCTION
|
Name |
Preparation of all foodstuffs of plant origin |
Preparation of all foodstuffs of animal origin |
Specific conditions and restrictions in addition to Regulation (EU) No 1333/2008 |
|
Water |
X |
X |
Drinking water within the meaning of Council Directive 98/83/EC |
|
Calcium chloride |
X |
►M22 X ◄ |
Coagulation agent ►M22 With regard to foodstuffs of animal origin: sausages based on meat ◄ |
|
Calcium carbonate |
X |
|
|
|
Calcium hydroxide |
X |
|
|
|
Calcium sulphate |
X |
|
Coagulation agent |
|
Magnesium chloride (or nigari) |
X |
|
Coagulation agent |
|
Potassium carbonate |
X |
|
With regard to foodstuffs of plant origin: drying of grapes |
|
Sodium carbonate |
X |
X |
|
|
Lactic acid |
|
X |
With regard to foodstuffs of animal origin: for the regulation of the pH of the brine bath in cheese production |
|
L(+)lactic acid from fermentation |
X |
|
With regard to foodstuffs of plant origin: for the preparation of plant protein extracts |
|
Citric acid |
X |
X |
|
|
Sodium hydroxide |
X |
|
With regard to foodstuffs of plant origin: for sugar(s) production; for oil production excluding olive oil production; for the preparation of plant protein extracts |
|
Sulphuric acid |
X |
X |
Gelatine production Sugar(s) production |
|
Hop extract |
X |
|
With regard to foodstuffs of plant origin: only for antimicrobial purposes in production of sugar. When available from organic production |
|
Pine rosin extract |
X |
|
With regard to foodstuffs of plant origin: only for antimicrobial purposes in production of sugar. When available from organic production |
|
Hydrochloric acid |
|
X |
With regard to foodstuffs of animal origin: Gelatine production; for the regulation of the pH of the brine bath in the processing of Gouda-, Edam and Maasdammer cheeses, Boerenkaas, Friese and Leidse Nagelkaas |
|
Ammonium hydroxide |
|
X |
With regard to foodstuffs of animal origin: gelatine production |
|
Hydrogen peroxide |
|
X |
With regard to foodstuffs of animal origin: gelatine production |
|
Carbon dioxide |
X |
X |
|
|
Nitrogen |
X |
X |
|
|
Ethanol |
X |
X |
Solvent |
|
Tannic acid |
X |
|
Filtration aid |
|
Egg white albumin |
X |
|
|
|
Casein |
X |
|
|
|
Gelatin |
X |
|
|
|
Isinglass |
X |
|
|
|
Vegetable oils |
X |
X |
Greasing, releasing or anti-foaming agent. Only when derived from organic production |
|
Silicon dioxide gel or colloidal solution |
X |
|
|
|
Activated carbon |
X |
►M22 X ◄ |
|
|
Talc |
X |
|
In compliance with the specific purity criteria for food additive E 553b |
|
Bentonite |
X |
X |
With regard to foodstuffs of animal origin: as a sticking agent for mead |
|
Cellulose |
X |
X |
With regard to foodstuffs of animal origin: Gelatine production |
|
Diatomaceous earth |
X |
X |
With regard to foodstuffs of animal origin: Gelatine production |
|
Perlite |
X |
X |
With regard to foodstuffs of animal origin: Gelatine production |
|
Hazelnut shells |
X |
|
|
|
Rice meal |
X |
|
|
|
Beeswax |
X |
|
Releasing agent. Beeswax from organic production |
|
Carnauba wax |
X |
|
Releasing agent. Only when derived from organic production. Applicable as of 1 January 2022. Until that date, only when derived from organic raw material |
|
Acetic acid/vinegar |
|
X |
Only when derived from organic production. For fish processing only. From natural fermentation, Not to be produced by or from GMO |
|
Thiamin hydrochloride |
X |
X |
Only for use in processing of fruit wines, including cider and perry and mead |
|
Diammonium phosphate |
X |
X |
Only for use in processing of fruit wines, including cider and perry and mead |
|
Wood fibre |
X |
X |
The source of timber should be restricted to certified, sustainably harvested wood. Wood used must not contain toxic components (post-harvest treatment, naturally occurring toxins or toxins from micro-organisms) |
SECTION C — PROCESSING AIDS FOR THE PRODUCTION OF YEAST AND YEAST PRODUCTS
|
Name |
Primary yeast |
Yeast confections/ formulations |
Specific conditions |
|
Calcium chloride |
X |
|
|
|
Carbon dioxide |
X |
X |
|
|
Citric acid |
X |
|
For the regulation of the pH in yeast production |
|
Lactic acid |
X |
|
For the regulation of the pH in yeast production |
|
Nitrogen |
X |
X |
|
|
Oxygen |
X |
X |
|
|
Potato starch |
X |
X |
For filtering Only when derived from organic production |
|
Sodium carbonate |
X |
X |
For the regulation of the pH |
|
Vegetable oils |
X |
X |
Greasing, releasing or anti-foaming agent Only when derived from organic production |
ANNEX VIIIa
Products and substances authorised for use or addition in organic products of the wine sector referred to in Article 29c
|
Type of treatment in accordance with Annex I A to Regulation (EC) No 606/2009 |
Name of products or substances |
Specific conditions, restrictions within the limits and conditions set out in Regulation (EC) No 1234/2007 and Regulation (EC) No 606/2009 |
|
Point 1: Use for aeration or oxygenation |
— Air — Gaseous oxygen |
|
|
Point 3: Centrifuging and filtration |
— Perlite — Cellulose — Diatomeceous earth |
Use only as an inert filtering agent |
|
Point 4: Use in order to create an inert atmosphere and to handle the product shielded from the air |
— Nitrogen — Carbon dioxide — Argon |
|
|
Points 5, 15 and 21: Use |
— Yeasts (1), yeast cell walls |
|
|
Point 6: Use |
— Di-ammonium phosphate — Thiamine hydrochloride — Yeast autolysates |
|
|
Point 7: Use |
— Sulphur dioxide — Potassium bisulphite or potassium metabi-sulphite |
(a) The maximum sulphur dioxide content shall not exceed 100 milligrams per litre for red wines as referred to in point 1(a) of Part A of Annex I B to Regulation (EC) No 606/ 2009 and with a residual sugar level lower than 2 grams per litre; (b) The maximum sulphur dioxide content shall not exceed 150 milligrams per litre for white and rosé wines as referred to in point 1(b) of Part A of Annex I B to Regulation (EC) No 606/2009 and with a residual sugar level lower than 2 grams per litre; (c) For all other wines, the maximum sulphur dioxide content applied in accordance with Annex I B to Regulation (EC) No 606/2009 on 1 August 2010, shall be reduced by 30 milligrams per litre. |
|
Point 9: Use |
— Charcoal for oenological use |
|
|
Point 10: Clarification |
— Edible gelatine (2) — Plant proteins from wheat or peas (2) — Isinglass (2) — Egg white albumin (2) — Tannins (2) — Potato proteins (2) — Yeast protein extracts (2) — Casein — Chitosan derived from Aspergillus niger — Potassium caseinate — Silicon dioxide — Bentonite — Pectolytic enzymes |
|
|
Point 12: Use for acidification purposes |
— Lactic acid — L(+)Tartaric acid |
|
|
Point 13: Use for deacidification purposes |
— L(+)Tartaric acid — Calcium carbonate — Neutral potassium tartrate — Potassium bicarbonate |
|
|
Point 14: Addition |
— Aleppo pine resin |
|
|
Point 17: Use |
— Lactic bacteria |
|
|
Point 19: Addition |
— L-Ascorbic acid |
|
|
Point 22: Use for bubbling |
— Nitrogen |
|
|
Point 23: Addition |
— Carbon dioxide |
|
|
Point 24: Addition for wine stabilisation purposes |
— Citric acid |
|
|
Point 25: Addition |
— Tannins (2) |
|
|
Point 27: Addition |
— Meta-tartaric acid |
|
|
Point 28: Use |
— Acacia gum (2) (= gum arabic) |
|
|
Point 30: Use |
— Potassium bitartrate |
|
|
Point 31: Use |
— Cupric citrate |
|
|
Point 35: Use |
— Yeast mannoproteins |
|
|
Point 38: Use |
— Oak chips |
|
|
Point 39: Use |
— Potassium alginate |
|
|
Point 44: Use |
— Chitosan derived from Aspergillus niger |
|
|
Point 51: Use |
— Inactivated yeast |
|
|
Type of treatment in accordance with Annex III, point A(2)(b) to Regulation (EC) No 606/2009 |
— Calcium sulphate |
Only for ‘vino generoso’ or ‘vino generoso de licor’ |
|
(1)
For the individual yeast strains: if available, derived from organic raw material.
(2)
Derived from organic raw material if available. |
||
ANNEX IX
Ingredients of agricultural origin which have not been produced organically referred to in Article 28
1. UNPROCESSED VEGETABLE PRODUCTS AS WELL AS PRODUCTS DERIVED THEREFROM BY PROCESSES
1.1. Edible fruits, nuts and seeds:
|
— acorns |
Quercus spp. |
|
— cola nuts |
Cola acuminata |
|
— gooseberries |
Ribes uva-crispa |
|
— maracujas (passion fruit) |
Passiflora edulis |
|
— raspberries (dried) |
Rubus idaeus |
|
— red currants (dried) |
Ribes rubrum |
1.2. Edible spices and herbs:
|
— pepper (Peruvian) |
Schinus molle L. |
|
— horseradish seeds |
Armoracia rusticana |
|
— lesser galanga |
Alpinia officinarum |
|
— safflower flowers |
Carthamus tinctorius |
|
— watercress herb |
Nasturtium officinale |
1.3. Miscellaneous:
Algae, including seaweed, permitted in non-organic foodstuffs preparation
2. VEGETABLE PRODUCTS
2.1. Fats and oils whether or not refined, but not chemically modified, derived from plants other than:
|
— cocoa |
Theobroma cacao |
|
— coconut |
Cocos nucifera |
|
— olive |
Olea europaea |
|
— sunflower |
Helianthus annuus |
|
— palm |
Elaeis guineensis |
|
— rape |
Brassica napus, rapa |
|
— safflower |
Carthamus tinctorius |
|
— sesame |
Sesamum indicum |
|
— soya |
Glycine max |
2.2. The following sugars, starches and other products from cereals and tubers:
2.3. Miscellaneous:
3. ANIMAL PRODUCTS
aquatic organisms, not originating from aquaculture, and permitted in no-organic foodstuffs preparation
ANNEX X
Species for which organically produced seed or seed potatoes are available in sufficient quantities and for a significant number of varieties in all parts of the Community referred to in Article 45(3)
ANNEX XI
A. Organic logo of the EU, referred to in Article 57
1. The Organic logo of the EU shall comply with the model below:
2. The reference colour in Pantone is Green Pantone No 376 and Green (50 % Cyan + 100 % Yellow), when a four-colour process is used.
3. The Organic logo of the EU can also be used in black and white as shown, only where it is not practicable to apply it in colour:
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.
5. If a symbol is used in colour on a coloured background, which makes it difficult to see, a delimiting outer line around the symbol can be used to improve contrast with the background colours.
6. In certain specific situations where there are indications in a single colour on the packaging, the Organic logo of the EU may be used in the same colour.
7. The Organic logo of the EU must 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.
8. The Organic logo of the EU may be associated with graphical or textual elements referring to organic farming, under the condition that they do not modify or change the nature of the Organic logo of the EU, nor any of the indications mentioned at Article 58. When associated to national or private logos using a green colour different from the reference colour mentioned in point 2, the Organic logo of the EU may be used in that non-reference colour.
▼M4 —————
B. Code numbers referred to in Article 58
The general format of the code numbers is as follows:
AB-CDE-999
Where:
‘AB’ is the ISO code as specified in Article 58(1)(a) for the country where the controls take place; and
‘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 the organic production method as specified in Article 58(1)(b); and
‘999’ is the reference number, indicated in maximum three digits, to be attributed, as specified in Article 58(1)(c) by:
each Member State’s competent authority to the Control Authorities or Control Bodies to which they have delegated control tasks in accordance with Article 27 of Regulation (EC) No 834/2007;
the Commission, to:
the Control Authorities and Control Bodies referred to in Article 3(2)(a) of Commission Regulation (EC) No 1235/2008 ( 37 ) and listed in Annex I to that Regulation;
the third countries’ competent authorities or Control Bodies referred to in Article 7(2)(f) of Regulation (EC) No 1235/2008 and listed in Annex III to that Regulation;
the Control Authorities and Control Bodies referred to in Article 10(2)(a) of Regulation (EC) No 1235/2008, and listed in Annex IV to that Regulation;
each Member State’s competent authority to the Control Authority or Control Body which has been authorised until 31 December 2012 for issuing the certificate of inspection in accordance with Article 19(1) fourth subparagraph of Regulation (EC) No 1235/2008 (import authorisations), upon proposal of the Commission.
The Commission shall make the code numbers available to the public by any appropriate technical means, including publication on the Internet.
ANNEX XII
Model of documentary evidence to the operator according to Article 29(1) of Regulation (EC) No 834/2007 referred to in ►M6 Article 68(1) ◄ of this Regulation