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This Annex applies to primary production and the following associated operations:
the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;
the transport of live animals, where this is necessary to achieve the objectives of this Regulation;
and
in the case of products of plant origin, fishery products and wild game, transport operations to deliver primary products, the nature of which has not been substantially altered, from the place of production to an establishment.
As far as possible, food business operators are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo.
Notwithstanding the general duty laid down in paragraph 2, food business operators are to comply with appropriate Community and national legislative provisions relating to the control of hazards in primary production and associated operations, including:
measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste;
and
measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents.
Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:
to keep any facilities used in connection with primary production and associated operations, including facilities used to store and handle feed, clean and, where necessary after cleaning, to disinfect them in an appropriate manner;
to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels;
as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals;
to use potable water, or clean water, whenever necessary to prevent contamination;
to ensure that staff handling foodstuffs are in good health and undergo training on health risks;
as far as possible to prevent animals and pests from causing contamination;
to store and handle waste and hazardous substances so as to prevent contamination;
to prevent the introduction and spread of contagious diseases transmissible to humans through food, including by taking precautionary measures when introducing new animals and reporting suspected outbreaks of such diseases to the competent authority;
to take account of the results of any relevant analyses carried out on samples taken from animals or other samples that have importance to human health;
and
to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation.
Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:
to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels;
to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, plant products;
to use potable water, or clean water, whenever necessary to prevent contamination;
to ensure that staff handling foodstuffs are in good health and undergo training on health risks;
as far as possible to prevent animals and pests from causing contamination;
to store and handle wastes and hazardous substances so as to prevent contamination;
to take account of the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health;
and
to use plant protection products and biocides correctly, as required by the relevant legislation.
Food business operators are to take appropriate remedial action when informed of problems identified during official controls.
Food business operators are to keep and retain records relating to measures put in place to control hazards in an appropriate manner and for an appropriate period, commensurate with the nature and size of the food business. Food business operators are to make relevant information contained in these records available to the competent authority and receiving food business operators on request.
Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:
the nature and origin of feed fed to the animals;
veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods;
the occurrence of diseases that may affect the safety of products of animal origin;
the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health;
and
any relevant reports on checks carried out on animals or products of animal origin.
Food business operators producing or harvesting plant products are, in particular, to keep records on:
any use of plant protection products and biocides;
any occurrence of pests or diseases that may affect the safety of products of plant origin;
and
the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.
The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm technicians, with the keeping of records.
National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations.
Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:
the control of contamination such as mycotoxins, heavy metals and 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, use and traceability of feed;
the proper disposal of dead animals, waste and litter;
protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;
procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;
measures relating to the cleanliness of slaughter and production animals;
measures relating to record-keeping.