This Regulation shall enter into force twenty days after the date of its publication in the Official Journal of the European Union.
It shall apply 18 months after the date on which all of the following acts have entered into force:
(a)
Regulation (EC) No.../2004 (*5);
(b)
Regulation (EC) No.../2004 of the European Parliament and of the Council of laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (11); and
(c)
Directive 2004/41/EC of the European Parliament and of the Council of repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption (12).
However, it shall apply no earlier than 1 January 2006.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 29 April 2004.
For the European Parliament
The President
P. COX
For the Council
The President
M. MCDOWELL
(1)
OJ C 365 E, 19.12.2000, p. 43.
(2)
OJ C 155, 29.5.2001, p. 39.
(3) Opinion of the European Parliament of 15 May 2002 (OJ C 180 E, 31.7.2003, p. 267), Council Common Position of 27 October 2003 (OJ C 48 E, 24.2.2004, p. 1), Position of the European Parliament of 30 March 2004 (not yet published in the Official Journal) and Council Decision of 16 April 2004.
(4) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1). Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
(5)
OJ L 175, 19.7.1993, p. 1. Directive as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).
(6) See page of this Official Journal.
(7)
OJ L 37, 13.2.1993, p. 1. Regulation as amended by Regulation (EC) No 1882/2003.
(8)
OJ L 184, 17.7.1999, p. 23.
(9)
OJ L 330, 5.12.1998, p. 32. Directive as modified by Regulation (EC) No 1882/2003.
(*1) Note to Official Journal: insert No of Regulation laying down specific hygiene rules for food of animal origin.
(*2) Note to Official Journal: insert number of Regulation laying down specific hygiene rules for food of animal origin.
(*3) Note to Official Journal: insert number of Regulation laying down specific hygiene rules for food of animal origin.
(10) Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204, 21.7.1998, p. 37). Directive as amended by Directive 98/48/EC (OJ L 217, 5.8.1998, p. 18).
(*4) Five years after the entry into force of this Regulation.
(*5) Note to Official Journal: insert number of Regulation laying down specific hygiene rules for food of animal origin.
(11) Seep, of this Official Journal.
(12) See p. of this Official Journal.
ANNEX I
PRIMARY PRODUCTION
PART A: GENERAL HYGIENE PROVISIONS FOR PRIMARY PRODUCTION AND ASSOCIATED OPERATIONS
I. SCOPE
1.
This Annex applies to primary production and the following associated operations:
(a)
the transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;
(b)
the transport of live animals, where this is necessary to achieve the objectives of this Regulation; and
(c)
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.
II. HYGIENE PROVISIONS
2.
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.
3.
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:
(a)
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
(b)
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.
4.
Food business operators rearing, harvesting or hunting animals or producing primary products of animal origin are to take adequate measures, as appropriate:
(a)
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;
(b)
to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels;
(c)
as far as possible to ensure the cleanliness of animals going to slaughter and, where necessary, production animals;
(d)
to use potable water, or clean water, whenever necessary to prevent contamination;
(e)
to ensure that staff handling foodstuffs are in good health and undergo training on health risks;
(f)
as far as possible to prevent animals and pests from causing contamination;
(g)
to store and handle waste and hazardous substances so as to prevent contamination;
(h)
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;
(i)
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
(j)
to use feed additives and veterinary medicinal products correctly, as required by the relevant legislation.
5.
Food business operators producing or harvesting plant products are to take adequate measures, as appropriate:
(a)
to keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, facilities, equipment, containers, crates, vehicles and vessels;
(b)
to ensure, where necessary, hygienic production, transport and storage conditions for, and the cleanliness of, plant products;
(c)
to use potable water, or clean water, whenever necessary to prevent contamination;
(d)
to ensure that staff handling foodstuffs are in good health and undergo training on health risks;
(e)
as far as possible to prevent animals and pests from causing contamination;
(f)
to store and handle wastes and hazardous substances so as to prevent contamination;
(g)
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
(h)
to use plant protection products and biocides correctly, as required by the relevant legislation.
6.
Food business operators are to take appropriate remedial action when informed of problems identified during official controls.
III. RECORD-KEEPING
7.
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.
8.
Food business operators rearing animals or producing primary products of animal origin are, in particular, to keep records on:
(a)
the nature and origin of feed fed to the animals;
(b)
veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods;
(c)
the occurrence of diseases that may affect the safety of products of animal origin;
(d)
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
(e)
any relevant reports on checks carried out on animals or products of animal origin.
9.
Food business operators producing or harvesting plant products are, in particular, to keep records on:
(a)
any use of plant protection products and biocides;
(b)
any occurrence of pests or diseases that may affect the safety of products of plant origin; and
(c)
the results of any relevant analyses carried out on samples taken from plants or other samples that have importance to human health.
10.
The food business operators may be assisted by other persons, such as veterinarians, agronomists and farm technicians, with the keeping of records.
PART B: RECOMMENDATIONS FOR GUIDES TO GOOD HYGIENE PRACTICE
1.
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.
2.
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:
(a)
the control of contamination such as mycotoxins, heavy metals and radioactive material;
(b)
the use of water, organic waste and fertilisers;
(c)
the correct and appropriate use of plant protection products and biocides and their traceability;
(d)
the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;
(e)
the preparation, storage, use and traceability of feed;
(f)
the proper disposal of dead animals, waste and litter;
(g)
protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;
(h)
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;
(i)
measures relating to the cleanliness of slaughter and production animals;
(j)
measures relating to record-keeping.
ANNEX II
GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS (EXCEPT WHEN ANNEX I APPLIES)
INTRODUCTION
Chapters V to XII apply to all stages of production, processing and distribution of food and the remaining Chapters apply as follows:
—
Chapter I applies to all food premises, except premises to which Chapter III applies;
—
Chapter II applies to all rooms where food is prepared, treated or processed, except dining areas and premises to which Chapter III applies;
—
Chapter III applies to those premises listed in the heading to the Chapter;
—
Chapter IV applies to all transportation.