Background to the 2006 food hygiene legislation

The legislation:

• modernised, consolidated and simplified 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 (from 'farm to fork')
• 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

The three basic EU food hygiene 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.

All food businesses are required to be registered with the competent authority; which competent authority will depend on the type of business. Food business operators (except farmers and growers) are also required to put in place, implement and maintain a permanent procedure, or procedures, based on HACCP principles. The legislation is structured to ensure that the appropriate level of public health protection is in place without placing unnecessary burdens on businesses. Food businesses can apply the legislation flexibly and proportionately according to the nature of the business.

A wide range of information on the legislation is given in the 'Hygiene legislation' link below.
Amended copies of the food hygiene regulations were published on 2 June (2004/41) and 25 June 2004 (852/2004, 853/2004 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.

As part of the development of the legislation, the Agency has consulted stakeholders on various issues. These can be seen in the Consultations section of this website.

In January 2006, when the new hygiene legislation first applied, the European Commission committed itself to providing a report by May 2009 on the experience gained by Member States and stakeholders as regards the progress of the legislation. This report was finally published by the commission in July 2009.

The Agency has issued a letter to interested parties seeking views on the report. The letter, the Commission’s report and the Commission’s document accompanying the report (SANCO/4150/2009) can be found at the bottom of the page.

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

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

The EU Official Feed and Food Controls Regulation (OFFC) also applied from 11 January 2006 and set out general requirements for the competent authorities responsible for checking that businesses comply with feed and food legislation (and animal health and welfare rules). It also sets out the role of the Commission's Food and Veterinary Office. The OFFC Regulation is also given effect by a Statutory Instrument in England (and equivalents in Scotland, Wales and Northern Ireland).

Links to the national legislation on the Office of Public Sector Information web site for England, Scotland, Wales and Northern Ireland for both the food hygiene regulations and the OFFC regulations can be found through the relevant country information under the 'Find out more' section below.

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.

The most recent implementing measures were published in the EU Official Journal (OJ) on the 20 October 2008. As with the other EU regulations, it will be necessary to amend national legislation in England, Scotland, Wales and Northern Ireland to provide for their enforcement. A link to a page listing all of the implementing measures and transitional arrangements can be found below. The Regulations applying microbiological criteria for foodstuffs are linked through another page.

Information regarding the negotiations and development of the legislation can be found via the link below to 'History of 2006 food hygiene legislation negotiations.

The FSA has produced a number of guidance documents to the 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.

As central competent authority for the food hygiene legislation, the FSA is required to ensure that application of the legislation is proportionate, risk-based and outcome-focussed. How it does this is set out in the attached 'Principles underpinning application by the FSA of the EU food hygiene regulations' paper.

During 2007, the Regulatory Impact Assessment (RIA) was replaced (for legislation or policy affecting England only) by the Impact Assessment (IA). An IA is a policy tool which assesses the impact in terms of costs, benefits and risks of (usually) a proposed regulation which could affect businesses, charities or the voluntary sector.

IAs have been published with each consultation on the legislation providing stakeholders with the opportunity to make comment on their contents.