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Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene (Text with EEA relevance)
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Version Superseded: 31/12/2020
Point in time view as at 23/04/2016.
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measures to control hazardous contamination such as that arising from the air, soil, water, fertilisers, plant protection products, biocides, veterinary medicinal products and handling and disposal of waste,
and
measures relating to plant health, animal health and the environment that have implications for feed safety, including programmes for the monitoring and control of zoonoses and zoonotic agents.
to keep clean and, where necessary after cleaning, to disinfect in an appropriate manner, facilities, equipment, containers, crates and vehicles used for producing, preparing, grading, packing, storing and transporting feed;
to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, feed;
to use clean water whenever necessary to prevent hazardous contamination;
to prevent, as far as possible, animals and pests from causing hazardous contamination;
to store and handle wastes and hazardous substances, separately and securely, so as to prevent hazardous contamination;
to ensure that packaging materials are not a source of hazardous contamination of feed;
to take account of the results of any relevant analyses carried out on samples taken from primary products or other samples relevant to feed safety.
any use of plant protection products and biocides;
use of genetically modified seeds;
any occurrence of pests or diseases that may affect the safety of primary products;
the results of any analyses carried out on samples taken from primary products or other samples taken for diagnostic purposes that have importance for feed safety;
the source and quantity of each input of feed and the destination and quantity for each output of feed.
the control of contamination such as mycotoxins, heavy metals, radioactive material;
the use of water, organic waste and fertilisers;
the correct and appropriate use of plant protection products and biocides and their traceability;
the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;
the preparation, storage and traceability of feed materials;
the proper disposal of dead animals, waste and litter;
protective measures to prevent the introduction of contagious diseases transmissible to animals through feed and any obligation to notify the competent authority thereof;
procedures, practices and methods to ensure that feed is produced, prepared, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;
details relating to record-keeping.
For the purposes of this Annex, the following definitions shall apply:
‘ batch ’ means an identifiable quantity of feed determined to have common characteristics, such as origin, variety, type of packaging, packer, consignor or labelling, and, in the case of a production process, a unit of production from a single plant using uniform production parameters or a number of such units, when produced in continuous order and stored together;
[F2‘ products derived from oils and fats ’ means any product derived directly or indirectly from crude or recovered oils and fats by oleochemical or biodiesel processing or distillation, chemical or physical refining, other than:
the refined oil,
products derived from refined oil, and
feed additives;
‘ fat blending ’ means manufacturing of compound feed or, in case of all components belonging to the same entry in PART C of the Annex to Commission Regulation (EU) No 68/2013 (1) which are derived from the same plant or animal species, of feed materials by mixing crude oils, refined oils, animal fats, oils recovered from food business operators falling within the scope of Regulation (EC) No 852/2004 or products derived thereof to produce a blended oil or fat, with the exception of the:
sole storage of consecutive batches, and
exclusive mixing of refined oils;
‘ refined oil or fat ’ means oil or fat that has undergone the process of refining as referred to in No 53 of the glossary of processes listed in Part B of the Annex to Regulation (EU) No 68/2013.] ]
Textual Amendments
Textual Amendments
F1 Inserted by Commission Regulation (EU) No 225/2012 of 15 March 2012 amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing of oils, fats and products derived thereof (Text with EEA relevance).
permit adequate cleaning and/or disinfection;
be such as to minimise the risk of error and to avoid contamination, cross-contamination and any adverse effects generally on the safety and quality of the products. Machinery coming into contact with feed shall be dried following any wet cleaning process.
All scales and metering devices used in the manufacture of feeds shall be appropriate for the range of weights or volumes to be measured and shall be tested for accuracy regularly.
All mixers used in the manufacture of feeds shall be appropriate for the range of weights or volumes being mixed, and shall be capable of manufacturing suitable homogeneous mixtures and homogeneous dilutions. Operators shall demonstrate the effectiveness of mixers with regard to homogeneity.
processing of crude vegetable oil except those under the scope of Regulation (EC) No 852/2004;
oleochemical manufacturing of fatty acids;
manufacturing of biodiesel;
fat blending.]
Feed businesses must have sufficient staff possessing the skills and qualifications necessary for the manufacture of the products concerned. An organisation chart setting out the qualifications (e.g. diplomas, professional experience) and responsibilities of the supervisory staff must be drawn up and made available to the competent authorities responsible for inspection. All the staff must be informed clearly in writing of their duties, responsibilities and powers, especially when any change is made, in such a way as to obtain the desired product quality.
with the requirements of this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
with Annex I to Directive 2002/32/EC of the European Parliament and the Council (2) .]
Feed business operators processing crude vegetable fats and oils:
100 % of the batches of the products derived from oils and fats of vegetable origin, except for the following:
glycerine,
lecithin,
gums,
products referred to in (ii);
acid oils from chemical refining, soap stocks, used filter aids, used bleaching earth and incoming batches of crude coconut oil shall be analysed and documented as part of the HACCP system.
Feed business operators producing animal fat including animal fat processors:
one representative analysis per 5 000 tonnes with a minimum of one representative analysis per year of animal fat and products derived thereof belonging to category 3 material, as referred to in Article 10 of Regulation (EC) No 1069/2009 of the European Parliament and of the Council (5) or from an establishment approved in accordance with Article 4 of Regulation (EC) No 853/2004 of the European Parliament and of the Council (6) .
Feed business operators producing fish oil:
100 % of the batches of fish oil if it is produced from:
products derived from fish oil other than refined fish oil;
fisheries with no monitoring history, of unspecified origin or from the Baltic Sea;
fish by-products from establishments manufacturing fish for human consumption that are not EU approved;
blue whiting or menhaden;
100 % of the outgoing batches of products derived from fish oil other than refined fish oil;
one representative analysis per 2 000 tonnes as regards fish oil not referred to in (i);
fish oil decontaminated by an officially approved treatment as referred to in Annex VIII of Regulation (EC) No 767/2009 and in Commission Regulation (EU) 2015/786 (7) shall be analysed and documented as part of the HACCP system.
Oleochemical industry placing feed on the market:
100 % of incoming batches of animal fats not covered by point (b) or (h), fish oil not covered by point (c) or (h), oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004 and of blended fats and oils;
100 % of the batches of products derived from oils and fats placed as feed on the market, except for the following:
glycerine,
pure distilled fatty acids from splitting,
products referred to in (iii);
crude fatty acids from splitting, fatty acids esterified with glycerol, mono and diglycerides of fatty acids, salts of fatty acids and incoming batches of crude coconut oil shall be analysed and documented as part of the HACCP system.
Biodiesel industry placing feed on the market:
100 % of incoming batches of animal fats not covered by point (b) or (h), fish oil not covered by point (c) or (h), oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004 and of blended fats and oils;
100 % of the batches of products derived from oils and fats placed as feed on the market, except for the following:
glycerine,
lecithin,
gums,
products referred to in (iii);
acid oils from chemical refining, soap stocks and crude coconut oil shall be analysed and documented as part of the HACCP system.
Fat blending establishments:
100 % of incoming batches of crude coconut oil, animal fats not covered by point (b) or (h), fish oil not covered by point (c) or (h), oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004, blended fats and oils and products derived from oils and fats, except for the following:
glycerine,
lecithin,
gums,
products referred to in (ii);
acid oils from chemical refining, crude fatty acids from splitting, pure distilled fatty acids from splitting and soap stocks shall be analysed and documented as part of the HACCP system;
or
100 % of the batches of blended fats and oils intended for feed.
The feed business operator shall declare to the competent authority which alternative he chooses.
Producers of compound feed for food producing animals other than those covered by point (f):
100 % of incoming batches of crude coconut oil, animal fats not covered by point (b) or (h), fish oil not covered by point (c) or (h), oils and fats recovered from food business operators falling within the scope of Regulation (EC) No 852/2004, blended fats and oils and products derived from oils and fats, except for the following:
glycerine,
lecithin,
gums,
products referred to in (ii);
acid oils from chemical refining, crude fatty acids from splitting, pure distilled fatty acids from splitting; filter aids, bleaching earth and soap stocks shall be analysed and documented as part of the HACCP system;
1 % of the batches as regards manufactured compound feed containing products referred to in (i) and (ii).
[F3Importers placing the following feed on the market:
100 % of imported batches of crude coconut oil, animal fats, fish oils, oils and fats recovered from food business operators, blended fats and oils, tocopherols extracted from vegetable oil and tocopheryl acetate made thereof and products derived from oils and fats, except for the following:
glycerine,
lecithin,
gums,
products referred to in (ii);
acid oils from chemical refining, crude fatty acids from splitting, pure distilled fatty acids from splitting and soap stocks shall be analysed and documented as part of the HACCP system.] ]
Textual Amendments
The proof of analysis shall unambiguously link the delivery and the batch or batches tested. This link shall be described in the documented traceability system in place at the premises of the supplier. In particular, when the delivery is obtained from more than one batch or component, the documentary proof to be provided shall be a proof for each of the components of the delivery. In the case where the testing is performed on the outgoing product, the proof that the product has been analysed shall be the analytical report.
Any delivery of products as referred to under point 2(b) (i) or c (iii) shall be accompanied by a proof that these products are in compliance with the requirements of point 2(b)(i) or (c)(iii). If required, the proof of analysis that include the batch or batches delivered must be consigned to the consignee when the operator receives the analysis from the authorised laboratories.
Where a feed business operator mandates a laboratory which is located in a Member State other than the feed business operator ordering the analysis he shall instruct the laboratory to report to its competent authority, which shall inform the competent authority of the Member State where the feed business operator is located.
Feed business operators shall inform the competent authority of the Member State where they are located if they mandate a laboratory located in a third country. Evidence must be provided that the laboratory performs the analysis in accordance with Regulation (EC) No 152/2009.
this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
Annex I to Directive 2002/32/EC.
They shall be kept separate from any other cargo where there is a risk of contamination.
Where this separate use is not possible, the containers shall be efficiently cleaned so as to remove any trace of product if those containers were previously used for products not meeting the requirements of:
this Regulation or of Article 4(2) of Regulation (EC) No 852/2004, and
Annex I to Directive 2002/32/EC.
Animal fats of category 3, as laid down in Article 10 of Regulation (EC) No 1069/2009, intended for use in feed shall be stored and transported in line with that Regulation.]
Documentation relating to the manufacturing process and controls.
Feed businesses must have a system of documentation designed to define and ensure mastery of the critical points in the manufacturing process and to establish and implement a quality control plan. They must keep the results of the relevant controls. This set of documents must be kept so that it is possible to trace the manufacturing history of each batch of products put into circulation and to establish responsibility, if complaints arise.
Documentation relating to traceability, in particular:
for feed additives:
the nature and quantity of the additives produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,
the name and address of the establishment to which the additives were delivered, the nature and quantity of the additives delivered and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture;
for products covered by Directive 82/471/EEC:
the nature of the products and the quantity produced, the respective dates of manufacture and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,
the name and address of the establishments or users (establishments or farmers) to whom these products have been delivered, together with details of the nature and quantity of the products delivered and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture;
for premixtures:
the name and address of the manufacturers or suppliers of additives, the nature and quantity of the additives used and, where appropriate, the number of the batch or of the specific portion of production, in the case of continuous manufacture,
the date of manufacture of the premixture and the batch number where appropriate,
the name and address of the establishment to which the premixture is delivered, the delivery date, the nature and quantity of the premixture delivered, and the batch number where appropriate.
for compound feedingstuffs/feed materials:
the name and address of additive/premixture manufacturers or suppliers, the nature and quantity of the premixture used, with the batch number where appropriate,
the name and address of the suppliers of the feed materials and complementary feeds and the delivery date,
the type, quantity and formulation of the compound feed,
the nature and quantity of feed materials or compound feedingstuffs manufactured, together with the date of manufacture, and the name and address of the buyer (e.g. farmer, other feed business operators).
The grazing of pastures and croplands shall be managed in a way that minimises the contamination of foods of animal origin by physical, biological or chemical hazards.
Where appropriate, an adequate rest period shall be observed before allowing livestock to graze on pasture, crops and crop residues and between grazing rotations to minimise biological cross-contamination from manure, where such a potential problem exists, and to ensure that the withholding periods for agricultural chemical applications are observed.
The animal production unit shall be designed so that it can be adequately cleaned. The animal production unit and feeding equipment shall be cleaned thoroughly and regularly to prevent any build-up of hazards. Chemicals used for cleaning and sanitising shall be used according to instructions and stored away from feed and feeding areas.
A pest control system shall be put in place to control the access of pests to the animal production unit with a view to minimising the possibility of contamination of feed and bedding materials or animal units.
Buildings and feeding equipment shall be kept clean. Systems shall be put in place to regularly remove manure, waste material and other possible sources of contamination of feed.
Feed and bedding material used in the animal production unit shall be frequently changed and not allowed to become mouldy.
Feed shall be stored separately from chemicals and other products prohibited for animal feed. Storage areas and containers shall be kept clean and dry and appropriate pest-control measures implemented where necessary. Storage areas and containers shall be cleaned regularly to avoid unnecessary cross-contamination.
Seed shall be stored properly and in such a way that it is not accessible to animals.
Medicated feed and non-medicated feed intended for different categories or species of animals shall be stored such as to reduce the risk of feeding to non-target animals.
The on-farm feed distribution system shall ensure that the right feed is sent to the right destination. During distribution and feeding, feed shall be handled in such a way as to ensure that contamination does not occur from contaminated storage areas and equipment. Non-medicated feeds shall be handled separately from medicated feeds to prevent contamination.
On-farm feed transport vehicles and feeding equipment shall be cleaned periodically, in particular when used to deliver and distribute medicated feed.
Water for drinking or for acquaculture shall be of appropriate quality for the animals being produced. Where there is cause for concern about contamination of animals or animal products from the water, measures shall be taken to evaluate and minimise the hazards.
Feeding and watering equipment must be designed, constructed and placed in such a way that contamination of feed and water is minimised. Watering systems shall be cleaned and maintained regularly, where possible.
The person responsible for the feeding and handling of animals shall possess the requisite ability, knowledge and competence.
Additives authorised pursuant to Regulation (EC) No 1831/2003:
Nutritional additives: all additives in the group,
Zootechnical additives: all additives in the group,
Technological additives: additives covered by Annex I(1)(b) (‘antioxidants’) of Regulation (EC) No 1831/2003: only those with a fixed maximum content,
Sensory additives: additives covered by Annex I(2)(a) (‘colorants’) of Regulation (EC) No 1831/2003: carotenoids and xantophylls.
Products covered by Directive 82/471/EEC:
Proteins obtained from micro-organisms belonging to the group of bacteria, yeasts, algae, lower fungi: all products in the group (except for subgroup 1.2.1)
Co-products of the manufacture of amino acids by fermentation: all products in the group
Additives authorised under Regulation (EC) No 1831/2003:
Zootechnical additives: additives covered by Annex I(4)(d) (‘other zootechnical additives’) of Regulation (EC) No 1831/2003
Antibiotics: all additives,
Coccidiostats and histomonostats: all additives,
Growth promoters: all additives;
Nutritional additives:
additives covered by Annex I(3)(a) (Vitamins, provitamins and chemically well defined substances having a similar effect) of Regulation (EC) No 1831/2003: A and D,
additives covered by Annex I(3)(b) (‘compounds of trace elements’) of Regulation (EC) No 1831/2003: Cu and Se.
Additives authorised under Regulation (EC) No 1831/2003:
Zootechnical additives: additives covered by Annex I(4)(d) (‘other zootechnical additives’) of Regulation (EC) No 1831/2003
Antibiotics: all additives
Coccidiostats and histomonostats: all additives,
Growth promoters: all additives.
The identifying number must have the following structure:
the character ‘α’ if the feed business is approved;
the ISO code of the Member State or of the third country where the feed business is located;
the national reference number, to a maximum of eight alphanumerical characters.
[F1 [F2Commission Regulation (EU) No 68/2013 of 16 January 2013 on the Catalogue of feed materials ( OJ L 29, 30.1.2013, p. 1 ).] ]
[F2Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed ( OJ L 229, 1.9.2009, p. 1 ).;]
[F1 [F2Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) ( OJ L 300, 14.11.2009, p. 1 ).] ]
[F1 [F2Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin ( OJ L 139, 30.4.2004, p. 55 ).] ]
[F1 [F2Commission Regulation (EU) 2015/786 of 19 May 2015 defining acceptability criteria for detoxification processes applied to products intended for animal feed as provided for in Directive 2002/32/EC of the European Parliament and of the Council ( OJ L 125, 21.5.2015, p. 10 ).] ]
Textual Amendments
F1 Inserted by Commission Regulation (EU) No 225/2012 of 15 March 2012 amending Annex II to Regulation (EC) No 183/2005 of the European Parliament and of the Council as regards the approval of establishments placing on the market, for feed use, products derived from vegetable oils and blended fats and as regards the specific requirements for production, storage, transport and dioxin testing of oils, fats and products derived thereof (Text with EEA relevance).
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