Background to the 2006 food hygiene legislation

The package of legislation:

• modernises, consolidates and simplifies the previous EU food hygiene legislation
• applies effective and proportionate controls throughout the food chain, from primary production to sale or supply to the final consumer
• focuses controls on what is necessary for public health protection
• clarifies that it is the primary responsibility of food business operators to produce food safely

As EU regulations, the legislation is directly applicable law. The regulations are:

• Regulation (EC) 852/2004 on the hygiene of foodstuffs
• Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal origin
• Regulation (EC) 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

The general hygiene requirements for all food business operators are laid down in Regulation 852/2004. Regulation 853/2004 supplements Regulation 852/2004 in that it lays down specific requirements for food businesses dealing with foods of animal origin. Regulation 854/2004 relates to the organisation of official controls on products of animal origin intended for human consumption.

The legislation introduces a 'farm to fork' approach to food safety, by including primary production (that is, farmers and growers) in food hygiene legislation, for the first time in the majority of cases.

All food businesses need to be registered with the competent authority, such as the Meat Hygiene Service or the local authority environmental health department, depending on the type of business. A key part of the legislation is the requirement for food business operators (except farmers and growers) to put in place, implement and maintain a permanent procedure, or procedures, based on HACCP principles. The legislation is structured so that it can be applied flexibly and proportionately commensurate with the nature of the food business.

Under the application of subsidiarity, certain requirements in the legislation are given effect by national legislation. A wide range of straightforward information on the legislation is given in the 'Hygiene legislation' link below.

There were two other parts to the package: Directive 2004/41 repeals the previous EU legislation or, in some cases, amends still existing legislation and Directive 2002/99 (which falls under Defra policy responsibility) lays down the animal health rules on products of animal origin for human consumption.

Amended copies of the food hygiene regulations were published on 2 June (2004/41) and 25 June 2004 (852, 853 and 854/2004). The regulations have been amended since by the EU implementing measures (see below) and in the case of 854/2004 by Regulation (EC) 882/2004, the Official Feed and Food Controls Regulation.

Regular consultations on the legislation have been carried out by the Agency since it was first issued. These can be seen in the Consultations section of this website.

Since publication of the EU Food Hygiene Regulations in 2004, a number of implementing regulations and transitional measures that support the application of the EU regulations have also been published. A list of these is set out below, most recent first. Copies of these regulations in pdf format can be found on this page except those dealing with microbiological criteria for foodstuffs (a link to the relevant page is provided).

The most recent implementing measure was published in the EU Official Journal (OJ) on the 7 December 2007 and amended the regulation on Microbiological Criteria for Foodstuffs (Regulation (EC) No 2073/2005). Before this, on 25 October 2007. a raft of other implementing regulations were published. As EU regulations, these will apply directly and, as such, need no further transcription into national legislation. It will, however, be necessary to provide for them being enforced as part of the other EU food hygiene regulations. Consequentially, a draft version of the Food Hygiene (England) (Amendment) Regulations 2008 was issued as part of a consultation on 2 October 2007.

The Regulations are:

• Commission Regulation (EC) 1441/2007 – amends Regulation (EC) 2073/2005 (published 7 December 2007)

Those published 25 October 2007 are:

• Commission Regulation (EC) 1243/2007 – amends Annex III of Regulation (EC) 853/2004
• Commission Regulation (EC) 1244/2007 – amends Regulation (EC) 2074/2005
• Commission Regulation (EC) 1245/2007 – amends Annex I of Regulation (EC) 2075/2005
• Commission Regulation (EC) 1246/2007 – amends Regulation (EC) 2076/2005

These join the following implementing legislation:

• Commission Regulation (EC) No 1662/2006 amending Regulation 853/2004
• Commission Regulation (EC) No 1663/2006 amending Regulation (EC) 853/2004
• Commission Regulation (EC) No 1664/2006 amending Commission Regulation (EC) No 2074/2005
• Commission Regulation (EC) No 1665/2006 amending Comission Regulation (EC) No 2075/2005
• Commission Regulation (EC) No 1666/2006 amending Regulation (EC) No 2076/2005 laying down transitional arrangements for the implementation of Regulations (EC) No 853/2004, (EC) No 854/2004 and (EC) No 882/2004

On 22 December 2005 the Commission published the first suite of remaining implementing and transitional regulations in the EU Official Journal. The regulations are:

• Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs
• Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under 853/2004 and for the organisation of official controls under 854/2004 and 882/2004, derogating from 852/2004 and amending 853/2004 and 854/2004
• Commission Regulation (EC) No 2075/2005 of 5 December 2005 laying down specific rules on official controls for trichinella in meat
• Commission Regulation (EC) No 2076/2005 of 5 December 2005 laying down transitional arrangements for the implementation of 853/2004, 854/2004 and 882/2004 and amending 853/2004 and 854/2004

This followed on 14 October 2005:

• Commission Regulation (EC) No 1688/2005 of 14 October 2005 implementing 853/2004 as regards special guarantees concerning salmonella for consignments to Finland and Sweden of certain meat and eggs

Information regarding the development of the legislation can be found via the link below to 'History of 2006 food hygiene legislation'. Access to copies of the published regulations is from this page.

The FSA has produced a number of guidance documents to the new regulations to help food businesses understand what they need to do to comply with the regulations. This includes a general guidance to the law and three summary guides for certain food sectors and should be read together with the EU and national legislation.

The FSA has also produced a guide for the meat industry. Other guidance is also available including some from the European Commission on various aspects of the legislation.

National legislation in the form of a Statutory Instrument (SI) in England, and equivalent legislation in Scotland, Wales and Northern Ireland, is required to give effect to the EU regulations. This broadly covers:

• offences, penalties and powers of entry
• revocation of existing implementing legislation
• enacting the national measures required or provided for in the EU regulations
• any consequential amendments (where the revocation of existing legislation requires changed references in other pieces of legislation)

The Food Hygiene (England) Regulations 2006 (SI 2006/14) came into force on 11 January 2006 (separate but similar national legislation also came into force that day in Scotland, Wales and Northern Ireland.) The national legislation in all four UK countries also applied the provisions of the EU Microbiological Criteria Regulation. The legislation can be found on the Office of Public Sector Information (OPSI) website, via the link below.

The Official Feed and Food Controls (England) Regulations 2006 (SI 2006/15) also applied from 11 January 2006. These regulations apply the EU Official Feed and Food Controls Regulation (OFFC) in England. The EU OFFC Regulation sets out general requirements for competent authorities that are responsible for checking that businesses comply with feed and food legislation and also animal health and welfare rules. It also sets out the role of the Commission's Food and Veterinary Office.

The Food Hygiene (England) Regulations 2005 were in force from only 1 January 2006 until 10 January 2006. A full explanation as to why was provided in a letter issued 23 December 2005 to stakeholders – the letter (see below) highlighted the effects resulting from a delay in publication of the EU implementing measures and transitional arrangements late in 2005.

The Agency has produced Regulatory Impact Assessments (RIAs) at various stages in the development of the legislation.

These are assessments of the legislation's requirements, the impact on industry, enforcement authorities and other sectors, and of the costs and benefits.

During 2007 RIAs have been replaced across Government, for legislation or policy affecting England only, by Impact Assessments, which will provide similar information in a more formal structure.