CHAPTER ONE
GENERAL PRINCIPLES
OF FOOD LAW
Introduction
This chapter will consider some of the general principles of food law including how food is regulated at European Union level and at national level along with some of the main concepts set out in Regulation (EC) No 178/2002 (the General Food Law Regulation or GFLR).
Background
Adulteration, often with hazardous substances, and misdescription of food and drink have been the scourge of consumers and legitimate food businesses for a very long time.
Legislation alone cannot provide the answer but it can set rules for what is prohibited and what punishment can be expected by those who fail to comply.
An early example of this can be seen in the Adulteration of Coffee Act 1718 (5 Geo. 1 c. 11) which provided a penalty of 20 pounds
“against divers evil-disposed persons who at the time or soon after roasting of coffee, make use of water, grease, butter, or such like material whereby the same is made unwholesome and greatly increased in weight, to the prejudice of His Majesty’s Revenue, the health of his subjects, and to the loss of all fair and honest dealers.”
In the following century, scientists and others identified many examples of adulterous and misleading practices and were not afraid to “name and shame” those responsible. One of the early pioneers of this work was German chemist Frederick Accum whose lengthy and informative work, A Treatise on Adulterations of Food and Culinary Poisons, was published in 1820. Accum identified, uncovered and publicised the widespread problem of food and drink adulteration and his efforts were followed by Thomas Wakley and Arthur Hill Hassall. Their innovation, along with the development of scientific techniques and the creation of the public analyst service, greatly helped in the detection of these illegal practices and sowed the seeds for a modern framework of food law and regulation.
While history often helps to inform modern thinking, for the purposes of this book, a useful starting point for a general understanding of current food law and regulation is the European Commission’s White Paper on Food Safety dated 12th January 2000 (COM (1999) 719 final).
The White Paper followed a number of high profile food crises including BSE in cattle and the Belgian dioxin contamination of animal feed in 1999 and was published when the time was ripe for the creation of a co-ordinated and integrated approach to food safety and best practice in responding to food crises. All stakeholders have an important role to play in adopting a system that regulates food along the entire food supply chain; from “farm to fork” or from “conception to consumption”. The White Paper, on page 3, announced a “radical new approach” to “guarantee a high level of food safety”.
The White Paper led to the creation of the European Food Safety Authority (EFSA) and the enactment of the General Food Law Regulation, arguably the lynchpin of modern food regulation.
Current food regulation in the European Union and in Member States
Current food law is based on a mix of European Union law (Regulations, Directives etc.) and national law (Acts of Parliament, Statutory Instruments etc.) supplemented, where necessary, with rules from Codex Alimentarius, Codes of Practice, guidance and case law.
At EU level, the two main pieces of legislation come in the form of Regulations and Directives.
An EU Regulation is “binding in its entirety and directly applicable in all Member States”; the same law applies throughout the EU. Member States are left to enact laws giving effect to the Regulation and dealing with ancillary matters such as enforcement and punishment for non-compliance.
A Regulation may empower Member States to adopt their own rules on certain aspects of the legislation (see for example the provision of food information in respect of non-prepacked foods contained in Article 44 of Regulation (EC) No 1169/2011).
A Directive on the other hand is “addressed to the Member States” which then enact national laws giving effect to the object and purpose of the Directive. Where this creates divergence and uncertainty between the food laws of Member States there may be an impact on intra-EU trade.
EU laws can be found in many places, one of which being the “Eur-lex” website. This can be used to research legislation, identify amendments thereto and see a list of relevant case law.
EU food law is enacted following a process that involves the Parliament (the peoples’ representatives), the Commission (the EU “civil service”), the Council (ministers from the Member States), the Court of Justice of the European Union (interpreting EU law) and the European Food Safety Authority (providing advice on scientific issues).
EU law has to be relevant to and have regard to the 500+ million EU citizens with their differing needs, requirements, language, culture and history. This can result in a law based on compromise which the national institutions must then interpret, apply and enforce.
Interpreting EU law requires a careful assessment of the wording of the legal provision but also, and of particular relevance for food law, by having regard to the context in which the law occurs and the objectives pursued by the rules of which it is part (see for example Merck Case 292/82, and Verband Sozialer Wettwerb eV v Innova GmbH Case C-19/15). This often means going beyond the mere “letter of the law”.
For further reading in relation to interpretation of hygiene laws in an EU context see the decisions of the Court of Justice of the European Union in, Albrecht and others Case C-382/10, 6 October 2011 (containers for self-service retail of bread and bakery products) and Astrid Preissl Case C-381/10 (the installation of a washbasin in food premises). They are discussed further in chapter 3.
In a national context within the UK, the High Court has confirmed the above position concerning interpreting EU law; “when interpreting these [food hygiene] Regulations, it is necessary to have regard to the purpose for which they were created, namely, to protect consumers with regard to food hygiene.” (Kothari, Naik and Raw Lasan Ltd v London Borough of Harrow [2009] EWHC 1354 (Admin))
Where the national court is concerned with the interpretation of a particular EU law, or particular wording within it, the matter might be referred to the Court of Justice of the European Union for a preliminary ruling under Article 267 of the Treaty on the Functioning of the European Union (TFEU). The Court of Justice will then provide a decision on the correct interpretation and the case returns to the national court which will resolve the issue in dispute having regard to the decision of the Court of Justice. This does not mean that the national court must slavishly follow the CJEU’s ruling.
A recent example of the interaction between EU and national law can be seen in the case of R. (on the application of Newby Foods Limited) v Food Standards Agency concerning the interpretation of relatively short, but commercially and practically very important, provisions of Regulation (EC) 853/2004 on the hygiene rules for products of animal origin.
That case has been the subject of numerous hearings in the High Court and Court of Appeal (see [2017] EWCA Civ 400) in addition to the ruling by the CJEU. At the time of writing, early 2018, an appeal to the Supreme Court is pending.
Other general EU principles which are relevant to the food lawyer include the Precautionary Principle under which action may be taken where a food is potentially dangerous but where the risk has not been fully determined. The principle of Subsidiarity means that the EU may only take action when the objectives of the proposal cannot be sufficiently achieved by the Member States; i.e. an EU-wide response is required. The principle of Proportionality means that EU actions may not exceed what is necessary to achieve the objects of EU rules; this is also very important in the context of the interpretation and application of EU and national rules, particularly in the area of enforcement.
The extent to which food law, regulation and enforcement will be affected once the UK exits the European Union is the subject of much speculation and indeed some degree of concern.
A final point should be made about current food law and regulation within the UK. Care must be taken to identify the appropriate competent authority having jurisdiction over the particular product or activity. This includes matters of policy and responsibility for enforcement.
Mutual Recognition
Food is an international commodity and as such the food business and its advisers need access to competent local market advice. While the law may be the same or similar, it is important to ascertain what the trading conditions are like “on the ground” and how the laws are regulated and enforced by the competent authorities.
In an EU context, the principle of mutual recognition provides that a product lawfully produced or marketed in one EU country may be sold in other Member States without being subject to financial or other barriers.
This arises from the creation of the internal market and the general prohibition on imposing restrictions on imports and exports within the European Union (see for example, Articles 26, 28 and 30 of the TFEU).
Member States may not create rules which amount to “quantitative restrictions” on the movement of products (see Articles 34 and 35 of the TFEU).
However, prohibitions may be imposed on grounds of “the protection of health and life of humans, animals or plants”, but this must not amount to a “means of arbitrary discrimination or a disguised restriction on trade between Member States” (see Article 36 of the TFEU).
Any attempt to go behind the free movement of goods must be justified, proportionate and for the benefit of consumers.
When assessing the impact of a particular restriction, regard must be had to the product itself and whether or not there are any EU-wide harmonised rules regarding the composition or labelling of the product which apply in the Member States.
For further reading about the principles of mutual recognition, reference may be made to, Procureur du Roi v Dassonville v S. A. ETS Fourcroy and S. A. Breuval et Cie, Civil Parties (Case 8/74) [1974] 2 C.M.L.R. 436 (Scotch Whisky); and Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein (Case 120/78) [1979] 3 C.M.L.R. 494 (French liqueur, ‘Cassis de Dijon’) and EC Commission v Spain (Case C-12/00) and EC Commission v Italy (Case C-14/00) (chocolate).
The General Food Law Regulation – Regulation
(EC) 178/2002
The General Food Law Regulation (GFLR) contains some of the key building blocks of knowledge for a wider understanding of current EU food law and how it should be interpreted and applied. Specific matters covered in the GFLR include, unsafe food (Article 14), traceability (Article 18) and the withdrawal or recall of food hazardous to consumers (Article 19). These issues are covered in later chapters.
The General Food Law Regulation – some basic concepts
Scope (Article 1) and general application (Article 4)
The twin principles of the GFLR are; “a high level of protection of human health and consumers’ interests in relation to food”, and “ensuring the effective functioning of the internal market”.
The Regulation applies generally to all stages of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals.
Food (Article 2)
The definition of food (also described as “foodstuff”) is:
“any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”.
This includes; drink, chewing gum and any substance incorporated into the food during its manufacture, preparation or treatment, but excludes; feed, live animals (unless prepared for placing on the market for human consumption), plants prior to harvesting, medicinal products, cosmetics, tobacco, narcotic or psychotropic substances, and residues and contaminants.
Objectives (Article 5 and Article 8)
The main objectives of food law include; a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade. Food law should allow consumers to make informed choices in relation to the foods they consume.
Food business operator (Article 3 and Article 17)
The food business operator (FBO) is “the natural or legal persons responsible for ensuring that the requirements of food law are met within the business under their control”.
Establishing the identity of the correct FBO is a matter of law and fact. Questions of control and/or the extent of control over particular aspects of the food business may be important as the FBO is usually the person against whom enforcement action is taken.
The FBO may be a company and/or an individual, and as was said at paragraph 21 of the judgment in The Queen on the Application of Rasool v Tower Bridge Magistrates’ Court [2013] EWHC 4736 (Admin) “it is clearly right that it is possible in law for there to be more than one FBO”.
Food law (Article 3)
This means the laws, regulations and administrative provisions governing food in general, and food safety in particular, whether at Community or national level; it covers any stage of production, processing and distribution of food, and also of feed produced for, or fed to, food-producing animals
Food business (Article 3)
This is any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food. The concept of “undertakings” in food law is based on an assessment of the degree and level of organisation of the activities.
Each situation is different and detailed instructions should be obtained but it is likely that somebody who handles, prepares, stores or serves food occasionally, on an ad hoc basis and on a small scale may not be deemed to be an “undertaking” (see for example, paragraph 3.2.1 of the Food Standards Agency’s Food Law Practice Guidance (England) 2017). This may include a one-off event in a village hall.
This issue is particularly important to determine whether registration is required, see below, but even if it is not, those in charge must still take steps to protect the safety of the food they are making and/or selling.
Stages of production, processing and distribution (Article 3)
The definitions of food law and food business refer to obligations at any stages of production, processing and distribution. This means;
“any stage, including import, from and including the primary production of a food, up to and including its storage, transport, sale or supply to the final consumer and, where relevant, the importation, production, manufacture, storage, transport, distribution, sale and supply of feed”.
Hazard and risk (Articles 3 and 6)
The GFLR states that food law is based on risk analysis. This combines risk assessment, risk analysis and risk communication.
A hazard is “a biological, chemical or physical agent in or condition of food or feed with the potential to cause an adverse health effect” and risk is “a function of the probability of an adverse health effect and the severity of that risk, consequential to a hazard” (my emphasis).
There must therefore be a hazard before there can be a risk; an important concept when advising in respect of food safety and food hygiene.
Placing on the market (Article 3)
This is much wider than a mere sale or supply and is defined as;
“the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution, and other forms of transfer themselves”.
The phrase can be seen in the prohibition in Article 14; “food shall not be placed on the market if it is unsafe”.
Rapid alert system (Article 50)
This is a system “for the notification of a direct or indirect risk to human health derived from food or feed”. This is part of the Commission’s emergency planning and crisis management to protect consumers from harm. It is particularly beneficial to warn consumers in several Member States that a food has been identified as hazardous to their health.
Pre-market notification or permission
Businesses
In general terms, a food business will either register with the competent authority (e.g. a restaurant registers with the local authority in whose area the business operates) or it requires approval from the competent authority (e.g. a slaughterhouse requiring approval from the Food Standards Agency).
Registration is done by completing a food business registration form which is often available on-line. This tells the competent authority, the local council for example, that the business is operating and provides information about the activities taking place (what type of food is being sold, is it mainly prepacked or is on-site production taking place). The FBO does not have to wait for permission before it can start trading. The business must thereafter notify the authority if there is “any significant change in activities” or if the business closes down (Article 6 of Regulation 852/2004 on the Hygiene of Foodstuffs).
The authority will add the business to its list of food premises which it will inspect in accordance with its own policy. The frequency of inspection being related to the level of risk created by the type of activity taking place (a small retailer selling mainly prepackaged food is likely to have fewer hazards and therefore a lower risk profile than a large restaurant business or large retailer making food on site).
Food businesses that handle products of animal origin are usually required to obtain prior approval from the relevant competent authority (e.g. the FSA). This is a formal process in which the FBO, its premises and its activities are inspected and only if everything is in order will approval be given. The FBO cannot begin trading unless and until approval is given which may be conditional or final.
Businesses that only need to register may have very infrequent contact with officials from their competent authority. However, business requiring approval may be supervised by Official Veterinarians (OVs) who are present whenever the activities are taking place (e.g. slaughtering of animals) and the OV may report issues of non-compliance as and when they occur; sometimes on a daily basis.
Products
Unlike some consumer products, medicines for example, food does not generally require a licence, authorisation or permit before it may be placed on the market.
However, the legislation should be carefully checked and by way of example, EU legislation provides for the pre-market notification of certain products and this will depend on the law in a particular Member State.
The EU law on food supplements provides that a Member State may require the FBO to notify the competent authority before a supplement is placed on the market. A food supplement may not be placed on the market in Ireland unless the FBO has sent a notification, including copies of the product labels, to the Food Safety Authority of Ireland. The FSAI will review the form and the label and may, but is not required to, notify the FBO if it identifies a problem and/or it may liaise with other competent authorities (for example with the Health Products Regulatory Authority if the product is making medicinal claims). Similar pre-market notification provisions do not apply to food supplements in the UK.
Irrespective of any requirement for notification or pre-market contact with the competent authority, responsibility for ensuring compliance with food law rests with the FBO.
Conclusion
A solid understanding of the basic principles of food law is essential for those who are new to the area and also for established practitioners to avoid falling into the trap of “familiarity breeds contempt”.
Going back to basics and checking the actual legal definitions contained in the GFLR can be useful when asked to advise on a food law issue. This may be particularly useful when identifying the correct food business operator, reviewing the concepts of hazard and risk, and defining unsafe food.
Establishing a network of trusted food law advisers within the EU and in other local markets will help the food business expand and diversify its trading opportunities. With the onset of Brexit, this is more important than ever.