Introduction

The history of much modern food safety legislation can be traced back to Victorian England, when widespread adulteration of food was a serious problem. This was not only fraudulent, but was often dangerous. For example, toxic salts of lead and mercury were sometimes used to provide additional colour in sugar confectionery intended for children. The urgent need to curb these practices lead to the introduction of the first Food Adulteration Act in 1860. Since then, food law has evolved steadily into the sophisticated framework of legislation that now exists to protect consumers in most parts of the world.

Food safety legislation is a very complex subject, and a detailed examination of the law as it relates to food safety hazards is beyond the scope of this book. Furthermore, the body of food safety legislation is constantly being added to and amended, so that any written work on the subject is almost certain to be out of date by the time it is published.

Note: Readers are strongly advised to consult a reputable specialist or legal adviser if they require more detailed information, or have specific questions on food safety legislation.

What follows, therefore, is a concise overview of food safety legislation in the EU and in the USA, with a brief mention of some of the international aspects of food law. It is intended to be neither detailed, nor exhaustive. The intention is to give an overall impression of the approach to food safety regulation and enforcement taken by the authorities in two of the worlds' most highly developed and complex food markets.

European legislation

Much of the food safety legislation now in force in the countries of the European Union (EU) originates from the European Commission (EC), rather than from national authorities. There are two main legal instruments by which the Commission can introduce new food legislation. The first of these is the Directive, which sets out an objective, but allows national authorities to determine how that objective is to be achieved, and cannot be enforced in individual Member States until implemented into national legislation. The second instrument is the Regulation, which is 'directly applicable' and becomes law in all Member States as soon as it comes into force, without the need to change national legislation. Both Directives and Regulations may be described as 'horizontal', dealing with one aspect of food, such as hygiene, across all commodities, or 'vertical, applying to particular foods.

Although the EC initiates new Directives and Regulations, an established path of consultation, amendment and review must be followed before proposed legislation can be formally adopted by the European Parliament and by the Council of Ministers. Finally, the new legislation is published in the Official Journal of the EU and then comes into force. This process can take years, especially if there are contentious issues involved. The development of new food safety and hygiene measures is now informed by the scientific analysis and evaluation of food safety hazards. It is usual for the EC to submit a request for a risk analysis to be undertaken by the European Food Safety Authority (EFSA), before legislative proposals are drawn up.

Until comparatively recently, food safety in the EU was largely regulated by a complicated system of horizontal and vertical food hygiene Directives that had evolved over many years. This system inevitably included some anomalies and duplication, and was not implemented uniformly in all Member States. The situation became increasingly unsatisfactory, particularly in view of the planned accession of a number of new member countries. Consequently, the Commission carried out a comprehensive review of the EU food hygiene legislation in the late 1990s. The result was the introduction of the 'Food Hygiene Package' of EU legislation, which came into force on 1 January 2006.

The Food Hygiene Package

The Package consists of three main Regulations, which applied immediately throughout the EU. These are:

• Regulation (EC) 852/2004 on the hygiene of foodstuffs

• Regulation (EC) 853/2004 setting out specific hygiene requirements for foods of animal origin

• Regulation (EC) 854/2004 setting out specific requirements for organising official controls on products of animal origin intended for human consumption

Regulation 852/2004 contains general hygiene requirements for all food businesses and covers a wide range of topics, including the general obligations of businesses in regard to food hygiene, the requirements for hazard analysis critical control point- (HACCP) based food safety management procedures, hygiene requirements for premises and equipment, staff training and personal hygiene, heat processes and packaging. Regulation 853/2004 supplements 852/2004 by adding specific hygiene requirements for meat, milk, fish and egg production, as well as for by-products, such as gelatine. Regulation 854/2004 deals only with the organisation of the official controls needed for animal products in the human food chain.

The approach of the new Regulations is described as 'farm to fork', in that it applies to all stages in the food supply chain, including farmers and growers involved in primary production -- a sector not covered by previous food hygiene legislation. All food businesses must also register with the 'competent authority', so that they can be clearly identified. The inclusion of HACCP in the Regulations is another key development, clearly signifying that this is now the preferred method of ensuring food safety.

The development of guidance documents on the new legislation in individual Member States has been encouraged, and a number of these have been produced by the EC and at national level, by authorities such as the UK Food Standards Agency, and by industry bodies and trade associations.

Other EU legislation

While the 2006 Food Hygiene Regulations provide the current backbone of food safety legislation in the EU, they do not by any means include all of the food safety requirements that food businesses need to be aware of. For example, a large number of new 'implementing regulations' have also been introduced to deal with specific topics and amendments to the Hygiene Regulations.

The Microbiological Criteria Regulation

One of the most important implementing regulations for all food businesses is Regulation (EC) 2073/2005 on microbiological criteria for foodstuffs, often referred to as the MCR, which came into force on 1 January 2006. This Regulation brought together microbiological criteria for specific foods that had previously been scattered across a number of vertical directives and presented them in a common format.

The MCR includes some of the criteria from previous legislation in unchanged form, but others have been removed and some new criteria have been introduced. The primary purpose of the criteria set out in the Regulation is the validation and verification of HACCP procedures, rather than as stand-alone food safety controls. It is important for all food businesses to be aware of the requirements of this Regulation.

Food contaminants regulations

On 1 March 2007, three new EU regulations came into force, dealing with a range of chemical contaminants in foods. The most important of these from a food industry point of view is Regulation (EC) 1881/2006, which replaces (EC) 466/2001 and sets maximum permitted levels for certain contaminants in foodstuffs. This Regulation covers a number of contaminants, including mycotoxins, heavy metals, chloropropanols, PAH, dioxins and PCBs.

US Legislation

The system of food safety legislation in the USA is quite different in structure from that of the EU. Despite this, the main objective of protecting the consumer from exposure to unsafe and unwholesome food products is much the same. The system is based on flexible and science-based federal and state laws and the basic responsibility of industry to produce safe foods. A risk-based, precautionary approach is built in to the legislative system.

Federal legislation

The basic foundation of US food safety legislation is determined by Congress in the form of authorising statutes, which are designed to achieve specific food safety objectives and to establish the level of public protection. These are generally broad in scope, but also define the limits of regulation. Important statutes include the following:

• Federal Food, Drug and Cosmetic Act
• Federal Meat Inspection Act
• Poultry Products Inspection Act
• Egg Products Inspection Act
• Food Quality Protection Act
• Public Health Service Act

Implementation of these statutes is the responsibility of a number of executive agencies, and is accomplished by the development and enforcement of regulations. The main federal regulatory organisations concerned with food safety are the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS). However, other agencies, including the Department of Health and Human Services (DHHS) and the Environmental Protection Agency (EPA), also play important regulatory roles.

Responsibility for food safety is divided largely between the FSIS and the FDA according to food sector. The FSIS is responsible for the safety of all meat, poultry and egg products, while the FDA assumes responsibility for all other foods. In addition, the EPA has a key role in protecting consumers from risks posed by pesticides in food.

Food safety regulations are developed using a risk analysis approach in a transparent process that encourages the participation of industry and consumers. All significant comments must be addressed in the final regulation. Once this has been published in the Federal Register, it can be enforced. Examples of regulations developed in this way include the HACCP regulations and the introduction of performance standards for pathogen reduction and control. All current regulations are listed in the Code of Federal Regulations.

State legislation

In addition to the federal system of food safety legislation, there is an additional layer of regulation at the state level. States have their own legislative assemblies that are able to pass state laws and these may then be implemented as regulations by the local authorities for health and/or agriculture. Generally, state regulations should follow national food safety policy, but there may be differences in the detail, and some states, such as California, have passed state food safety laws. For example, the California state legislature recently passed a law requiring that meat from cloned animals be labelled as such, although this conflicts with current federal policy. Many states also have their own microbiological standards or guidelines for foods.

International aspects of food safety legislation

Although most countries have developed food legislation structures on a national, or regional basis, there has also been a degree of international cooperation. This has been achieved mainly through the activities of the Codex Alimentarius Commission, a body set up in 1963 by the World Health Organization and the Food and Agriculture Organization with the aim of promoting the coordination of food standards work carried out by national authorities and other bodies

Since its inception, Codex has developed and agreed a series of food standards, codes of practice, guidelines and other recommendations intended to protect consumer health and ensure fair trade practices. Codex standards cover a range of topics, including maximum residue limits for pesticides, food contaminants and toxins. Codes of practice include food hygiene principles, HACCP and control of veterinary drug use. Codex has also published 'principles' covering microbiological criteria and risk assessment.

Sources of further information

Published

Europe

MacMaolain C.
EU food law: protecting consumers and health in a common market
Oxford, Hart Publishing, 2007.

USA

Curtis P.A.
A guide to food laws and regulations
Oxford, Blackwell Publishing, 2005.

On the web

Europe

European Commission -- basic food hygiene legislation page
http://ec.europa.eu/food/food/biosafety/hygienelegislation/comm_rules_en.htm

European Commission -- basic food hygiene guidance documents
http://ec.europa.eu/food/food/biosafety/hygienelegislation/guide_en.htm

EUR-Lex -- Direct free access to European Union Law with full search facility
http://eur-lex.europa.eu/en/index.htm

UK Food Standards Agency European legislation pages
http://www.food.gov.uk/foodindustry/regulation/europeleg/

UK Food Standards Agency guidance on the 2006 food hygiene legislation
http://www.food.gov.uk/foodindustry/guidancenotes/hygguid/fhlguidance/

USA

Code of Federal Regulations
http://www.gpoaccess.gov/cfr/index.html

Information for FDA-regulated industry
http://www.fda.gov/oc/industry/default.htm

USDA Food Safety and Inspection Service -- Regulations & Policies page
http://www.fsis.usda.gov/Regulations_&_Policies/index.asp

California Department of Health Services Food and Drug Branch -- Sherman food, drug and cosmetic law
http://www.dhs.ca.gov/fdb/HTML/General/Sheindex.htm

Other useful sites for legislation

Codex Alimentarius Commission
http://www.codexalimentarius.org/

Foodlaw Reading -- Reading University site on EU and international food law maintained by Dr D.J. Jukes
http://www.rdg.ac.uk/foodlaw/

Food Standards Australia New Zealand (FSANZ) -- Food Standards Code pages (includes food safety standards for Australia)
http://www.foodstandards.gov.au/thecode/

Japanese Food Safety Commission -- pages in English
http://www.fsc.go.jp/english/