- Guidance Notes on certain provisions of Regulation (EC) No 852/2004 published by the European Commission
- General Provisions
- General Obligations on Food Business Operators
- Food Business Registration and Approval
- Hazard Analysis and Critical Control Points (HACCP)
- Personal 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.
View list of approved food establishments
Hazard Analysis and Critical Control Point (HACCP)
Food business operators carrying out any stage of production, processing and distribution of food after primary production and its associated operations must put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
The HACCP principles referred to above consist of the following:
(a) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;
(b) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;
(c) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;
(d) establishing and implementing effective monitoring procedures at critical control points;
(e) establishing corrective actions when monitoring indicates that a critical control point is not under control;
(f) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in subparagraphs (a) to (e) are working effectively;
(g) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in subparagraphs (a) to (f).
When any modification is made in the product, process, or any step, food business operators shall review the procedure and make the necessary changes to it.
Food business operators must:
(a) provide the competent authority with evidence of their compliance with the requirement to have procedures based on the HACCP principles in the manner that the competent authority requires, taking account of the nature and size of the food business;
(b) ensure that any documents describing the procedures developed in accordance with this are up-to-date at all times;
(c) retain any other documents and records for an appropriate period (as detailed in the relevant S.I.)
The Regulation however, recognises that in businesses undertaking low risk activities the prerequisite hygiene requirements (i.e., the general and specific hygiene requirements outlined in Article 4 and Annex II of Regulation (EC) No. 852/2004) are sufficient to control food safety without the need to develop a HACCP-based system. Additionally, it allows for businesses to follow guides to good practice where typical hazards and controls have been identified.
The FSAI has published Guidance Note No. 11 on Assessment of HACCP Compliance as well as leaflets explaining HACCP and a Safe Catering Pack to help caterers to implement HACCP in their business.
Regulation (EC) No. 852/2004 requires that every person working in a food-handling area must maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing.
No person suffering from, or being a carrier of a disease likely to be transmitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator.
Regulation (EC) No. 852/2004 requires that food business operators (FBOs) must ensure:
- that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity;
- that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of Regulation (EC) No. 852/2004 (i.e., FBOs must put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles) or for the operation of relevant guides have received adequate training in the application of the HACCP principles;
- compliance with any requirements of national law concerning training programmes for persons working in certain food sectors.
The Food Safety Authority of Ireland Act, 1998 contains enforcement provisions which are in addition to the powers to prosecute and other provisions in other specific pieces of food legislation. The provisions in the Food Safety Authority of Ireland Act, 1998 are designed to provide an improved means of reacting to and dealing with situations posing a risk to public health. Enforcement is carried out by authorised officers appointed by the FSAI or its official agents under Section 49 of the Act.
The powers granted to these officers are detailed in Sections 50 and 51 of the Act.
The provisions in the Food Safety Authority of Ireland Act, 1998 are as follows:
- Improvement Order - is issued by the District Court if an Improvement Notice is not complied with.
- An Improvement Notice is issued where in the opinion of the authorised officer:
(a) any activity involving the handling, preparation, etc., of food, or
(b) the condition of a premises (or part thereof) where this activity takes place is such that if it persists, it will or is likely to pose a risk to public health.
- Closure Order - is issued if in the opinion of an authorised officer, there is or there is likely to be a grave and immediate danger to public health at/or in the food premises. Closures Orders can refer to the immediate closure of all or part of the food premises, or all or some of its activities. The Orders may be lifted when the premises has improved to the satisfaction of an authorised officer.
- Prohibition Order - is issued if the activities (handling, processing, disposal, manufacturing, storage, distribution or selling food) involve or are likely to involve a serious risk to public health from a particular product, class, batch or item of food. The effect is to prohibit the sale of the product, either temporarily or permanently.
Note: Orders may pertain to all or part of a food premises, the cessation of all or some of the activities thereat, or the withdrawal/detainment/destruction of described foodstuffs.
View the FSAI enforcement orders database
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