Here you can find the general hygiene rules that are applicable to all food businesses. More specific hygiene rules that only apply to certain types of food businesses (generally food businesses handling or processing foods of animal origin such as meat, fish, and milk processors), can be found in this section by choosing a link below.
The legislation setting out the general principles of food law (Regulation (EC) No. 178/2002) should also be consulted for the rules setting out food safety requirements and responsibilities of food business, including requirements for traceability.
- Hygiene of foodstuffs - applies to all food businesses irrespective of size or type. Includes food stalls, mobile food businesses and home businesses.
- Specific hygiene rules for foods of animal origin - these may apply if you process or handle food of animal origin, e.g., meat, fish, milk processors
- Microbiological criteria for foodstuffs - sets food safety and process hygiene criteria which may need to be tested against
- Implementing rules
- Transitional measures
- National rules
- Guides to Good Hygiene Practice
EU and national legislation about food hygiene
Regulation (EC) No. 852/2004 (OJ L 226, p3, 25.06.2004) of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.04.2004)
- Commission Regulation (EC) No 1019/2008 (OJ L 277, 7, 18.10.2008) of 17 October 2008 amending Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs
- Regulation (EC) No 219/2009 (OJ L 87, p109-154, 31.03.2009) of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny — Adaptation to the regulatory procedure with scrutiny — Part Two
- Commission Regulation (EU) No 579/2014 (OJ L 160, p14-20, 29.5.2014) of 28 May 2014 granting derogation from certain provisions of Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council as regards the transport of liquid oils and fats by sea
- Consolidated version of Regulation (EC) No 852/2004 (as at 24th March 2021)
As Regulation (EC) No. 852/2004 applies to all food businesses, it has been transposed by a number of Government Departments in so far as it relates to their area of responsibility.
For food businesses registered and supervised by the Health Services Executive (HSE)
European Communities (Hygiene of Foodstuffs) (S.I. No. 369 of 2006)
- European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2009 (S.I. No. 380 of 2009)
- European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2010 (S.I. No. 497 of 2010)
- European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2018 (S.I. No. 82 of 2018)
- European Communities (Hygiene of Foodstuffs) (Amendment) Regulations 2020 (S.I. No. 47 2020)
In addition to the above, a number of Statutory Instruments (SIs) have been made by the Minster for Health in relation to food safety using the power granted in the health acts, these include the Food Hygiene Regulations which remain on the Irish Statute Book.
Food Hygiene Regulations, 1950 (S.I. No. 205 of 1950)
- Food Hygiene (Amendment) Regulations, 1952 (S.I. No. 289 of 1952)
- Food Hygiene (Amendment) Regulations, 1961 (S.I. No. 24 of 1961)
- Food Hygiene (Amendment) Regulations, 1971 (S.I. No. 322 of 1971)
- Food Hygiene (Amendment) Regulations, 1989 (S.I. No. 62 of 1989)
S.I. No. 369 of 2006 gives effect to Regulation (EC) No. 852/2004 on the hygiene of foodstuffs. It revokes Regulations 26B, 26C, 26D and Part IV of the Regulations of 1950.
Regulations 9, 10 and 11 of the Food Hygiene Regulations 1950 (S.I. No. 205 of 1950) are revoked by the European Communities (General Food Law) Regulations 2007 (S.I. No. 747 of 2007) which transposes Regulation (EC) No. 178/2002 (see section titled General principles of food law).
For food businesses registered and supervised by the Department of Agriculture, Food and the Marine, the Sea-Fisheries Protection Authority or local authorities
European Communities (Food and Feed Hygiene) Regulations 2020, S.I. No. 22 of 2020
Guidance Notes on certain provisions of Regulation (EC) No 852/2004 published by the European Commission
- Commission staff working document on the Understanding of certain provisions on flexibility provided in the hygiene package - Guidelines for the competent authorities
- Commission Staff working document on the Understanding of certain provisions on flexibility provided in the Hygiene Package (Frequently Asked Questions - Guidelines for food business operators)
- Commission Notice (2022/C 355/01) on the implementation of food safety management systems covering Good Hygiene Practices and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses
- Guidance Document on the Implementation of certain provisions of Regulation (EC) No 852/2004 on the hygiene of foodstuffs
- Guidelines for the development of Community guides to good practice for hygiene or for the application of the HACCP principles in accordance with Article 9 of Regulations (EC) No 852/2004 on the Hygiene of Foodstuffs and Article 22 of Regulation (EC) No 183/2005 laying down requirements for feed hygiene
Regulation (EC) No 852/2004 defines food hygiene as meaning ‘the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use'.
Regulation (EC) No. 852/2004 does not apply to:
- primary production for private domestic use;
- the domestic preparation, handling or storage of food for private domestic consumption;
- the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;
- collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.
General Obligations on Food Business Operators
A general obligation is placed on food business operators to ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in Regulation (EC) No. 852/2004.
Food business operators carrying out primary production and those associated operations listed below must comply with the general hygiene provisions laid down in Part A of Annex I to Regulation (EC) No 852/2004 and any specific requirements provided for in Regulation (EC) No 853/2004 (for products of animal origin)
Associated operations currently listed in Part A of Annex 1 of Regulation (EC) 852/2004 are as follows:
(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 Regulation (EC) 852/2004
(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.
Production, processing and distribution of food
Food business operators carrying out any stage of production, processing and distribution of food after primary production and its associated operations must comply with the general hygiene requirements laid down in Annex II to Regulation (EC) No 852/2004 and any specific requirements provided for in Regulation (EC) No 853/2004 which lays down specific hygiene rules for food of animal origin.
Annex II sets out the general hygiene requirements for all food business operators (other than those involved in primary production and associated operations). The following areas are covered:
- Chapter I: General requirements for food premises
- Chapter II: Specific requirements in rooms where foodstuffs are prepared, treated or processed
- Chapter III: Requirements for movable and/or temporary premises (such as marquees, market stalls, mobile sales vehicles), premises used primarily as a private dwelling-house but where foods are regularly prepared for placing on the market and vending machines
- Chapter IV: Transport - Conveyances and/or containers used for transporting foodstuffs
- Chapter V: Equipment with which food comes into contact
- Chapter VI: Food waste
- Chapter VII: Water supply
- Chapter VIII: Personal Hygiene
- Chapter IX: Provisions applicable to foodstuffs
- Chapter X: Provisions applicable to the wrapping and packaging of foodstuffs
- Chapter XI: Heat treatment
- Chapter XII: Staff Training
Food business operators must, as appropriate, adopt the following specific hygiene measures:
(a) compliance with microbiological criteria for foodstuffs
(b) implement procedures necessary to meet targets set to achieve the objectives of Regulation (EC) No 852/2004
(c) compliance with temperature control requirements for foodstuffs
(d) maintenance of the cold chain
(e) sampling and analysis of foodstuffs
When Regulation (EC) No 852/2004 or Regulation (EC) No 853/2004 and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other European Community or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.
Food Business Registration and Approval
Regulation (EC) No. 852/2004 requires that all food businesses must be registered with the supervising competent authority, e.g., for those business supervised by the HSE (e.g., restaurants, caterers, supermarkets, wholesale operators), a food business operator is obliged to notify the HSE of each establishment under its control. Changes to a food business (e.g., change of proprietor, the type of food being handled, the amount of food being produced) must also be notified to the HSE.
In addition to the registration required by Regulation (EC) No. 852/2004, if a food business makes or handles products of animal origin (meat, fish, live bivalve molluscs, milk and associated products) it must also comply with Regulation (EC) No. 853/2004 which sets out specific hygiene rules for foods of animal origin.
S.I. No. 22 of 2020 sets out the requirements for the approval of a food business supervised by the Department of Agriculture, Food and the Marine, the Sea-Fisheries Authority, a local authority or the Health Service Executive.
Once a registering authority grants a food business approval, it will issue a "certificate of approval" to the holder of the food business. This certificate of approval contains:
(a) the name of the holder of the food business approval,
(b) the address of the premises to which the food business approval relates,
(c) the nature of the activity to which the approval relates,
(d) the conditions to which the approval is subject,
(e) the period of validity (if any) of the approval, and
(f) a unique reference number that identifies the food business.
The holder of a food business approval is obliged to display the certificate of approval prominently on the premises to which the approval relates during business hours.