foodlaw | 17:21, 29 July 2010

By Daniele Pisanello, Food Lawyer, Lex Alimentaria Food Law Office

In general terms EU Food Law is a distinguished case of product-law as regulations on pharmaceuticals, cosmetics, toys, machineries et cetera are. However EU Food Law has a number of peculiarities the other product regulatory frameworks rarely have: the groundbreaking tool lies on the existence of a definition of Food Law both at EU and Member State level: Nomen omen! [1]

Definition of Food Law within EU Single Market is as follows: “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”.[2] Two elements are clearly highlighted by the mentioned provision: i) “food in general” and ii) “food safety” in particular. Such a two-fold objective is confirmed by Article 5 of GFL according to which: “food law shall pursue one or more of the general objectives of a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment” (Article 5, par. 1, of GFL). It is important to bear in mind that such a definition applies to all legal acts or measures governing foodstuffs adopted at both the Community and national levels. Consequently, public authorities and private operators should pay attention to both elements: safety management and the other legal issues enclosed in the definition of Food Law, namely: protection of consumers interests, fair practices and, where appropriate, the protection of animal health and welfare, plant health and the environment.[3]

Secondly, EU Food Law is based upon general principles specifically governing the food market: risk analysis and precautionary principle, consumer protection and transparency.

Thirdly, the complex regulatory organization and the establishment of an Independent Authority play for an increased distinction of food (and feed) regulations from the other sister – regulations.

Fourthly, EU regulation on food calls for a more stringent integration within national systems for control of conformity.[4]

Since its very beginning, European legal acts in the domain of food trade called for more integration, mutual cooperation and assistance between public authorities. EU Food Law dates back to 1960s as veterinary activities in the EEC Commission were first formalised in 1963, when Directorate-General VI – Agriculture – established a new Directorate F – Agricultural Legislation – with Division F.3 in charge of harmonisation of the legislative, regulatory and administrative matters in the Member States. The year before (1962) the plan for a Common Agricultural Policy was adopted. As the demand for fresh meat increased dramatically in Europe in the 1950s and 1960s it was decided to harmonise the veterinary requirements for trade in live cattle and swine and in fresh meat, between the Member States: in 1964 the Council adopted the Directive 64/432/EEC on animal health problems affecting intra-Community trade in bovine animals and swine and the Directive 64/433/EEC on health conditions for granting temporary and limited derogations from Community health rules on the production and marketing of fresh meat. This piece of legislation harmonised veterinary legislation in the Member States based upon the following principles: the responsibility of the exporting Member State, the control procedure, the importance of certification, the safety clause. Its scope was “partial harmonisation”, i.e. the rules were limited to products traded between the Member States.[5]

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (hereinafter, also General Food Law, GFL) gave rise to a number of innovations: i) general principles of Food Law (Risk Analysis, Precautionary Principle, Protection of consumers’ interests and principles of transparency); ii) general framework on risk assessment and risk management and the establishment of an Independent Authority dealing with risk assessment (the European Food Safety Authority, EFSA); iii) new and general obligations for food business operators (general safety requirements,[6] duty of compliance,[7] traceability[8], withdrawn of unsafe foods[9], and product presentation[10]); iv) general outline on food control within the Single Market[11], including importing and exporting foodstuffs[12].

Such a general set of rules has to be integrated with a number of sectoral legislations laying down rules for specific products (baby foods, supplements, products of animal origin et cetera) or aspects (Food Hygiene, for example), specific product safety and quality requirements, presentation rules (labelling and promotion), and other aspects. As of today, European Union has a well planned food policy involving Community and National Level and an intensive training programme, managed by the Commission Services.

Objectives of EU food Law as addressed by General Food Law are to ensure a high level of protection of human life and health and the protection of consumers’ interests, including fair practices in food trade, taking account of, where appropriate, the protection of animal health and welfare, plant health and the environment; and to achieve the free movement in the Community of food and feed manufactured or marketed according to the general principles and requirements of EU law. Other ground principle is proportionality as set out in Article 5 of the Treaty, according to which EU Regulation should not go beyond what is necessary in order to achieve the objectives pursued; also principle of subsidiarity applies, according to which where objectives cannot be sufficiently achieved by the Member States and would therefore, by reason of their complexity, trans-border character and, with regard to food imports, international character, be better achieved at Community level, the Community may adopt measures. These objectives have been inserted within the Lisbon Strategy addressing the aim at promoting better regulation and maintain/support competitiveness.

These objectives have been implemented by means of the Hygiene Package which consists of a number of EU legal acts[13] laying down main provisions as regards food hygiene 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” (Article 2, litt. a) of Reg. (EC) No 852/2004 laying down general hygiene rules for foodstuffs).

One of the key concept in the EU Food Law is that Food Business Operators (hereinafter, FBOs) at all stages of production, processing and distribution within the business “are responsible for ensuring the fulfilment of food law which are relevant to their activities”[14]. This is one of the cornerstones in EU regulation since the involvement of public authorities in food safety assurance was a key point in the first phase of harmonisation in the EEC food market. On the other side, Public Authorities (rectius, Competent Authorities) are called to test compliance of products marketed within the Single Market. EU Hygiene Laws requires a radical change of mind for civil servants operating within the framework of official control for foodstuffs. Additionally, as enforcement  of EU Food Law is at a large extent under the competence of Member States, execution may be hampered by a number of factors as: i) shortcomings in assessing EU Food Law Requirements; ii) misunderstanding of roles of FBO and CA within the Food Chain; iii) Misuse of Traceability and poor Crisis Management enhancement, iv) lack of knowledge about rights and obligations addressed by EU regulation; v) uncertainty about legal status of norms in case o coexistence of National and EU food related provisions; vi) Low financial resources in respect of (bigger) trading flow; vii) Low capacity in recovering incompliance. Another important shortcomings in the light of a proper enforcement of EU food regulation is the diaphragm between Regulatory Framework and Product Liability System as it is addressed by Regulation no. 178/2002.

Daniele Pisanello

[2] Article 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.

[3] Pisanello D., What do Food Safety and Fair Trade stand for? Reconciling the twofold objective of EU Food Law, European Food and Feed Law Review, 5/2009 and Van der Meulen B., The Function of Food Law, On the objectives of food law, legitimate factors and interests taken into account, Food and Feed Law Review 2/2010.

[4] It is to be noted that the mentioned features are given in respect of pharmaceutical, from one side, and substances covered by REACH as well, but a lower level of integration in respect of Food Law.

[5] European Communities, The EU Veterinarian, Animal Health, welfare & veterinary public health  developments in Europe since 1957, 2008.

[6] Article 14 of GFL.

[7] Article 17.1 of GFL.

[8] Article 18 of GFL.

[9] Article 19 of GFL.

[10] Article 16 of GFL.

[11] Article 17.2 of GFL.

[12] Articles 11 to 13 of GFL.

[13] The main EC legal acts providing the legal framework for the hygiene rules and official controls (so called Hygiene Package) are: Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs; Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin; Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules; Regulation (EC) No 854/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption. Other pieces of legislation related to hygiene rules within the Single Market are: Directive 2004/41/EC of the European Parliament and of the Council of 21 April 2004 repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC; and Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption. Further legislation in the field of food control should consider the specific rules on certain aspects or products (for example Veterinary law, microbiological criteria (Reg. (EC) No 2073/05), safety requirements for contact-materials (Reg. (EC) No 1935/04), Implementing rules listed under Reg. (EC) No 882/04, Annex VIII and those rules still in force by virtue of the transitional provision Article 61 Reg. (EC) No 882/04; in addition: specific rules for Intra-Community control; contingency plans as referred to Article 55 of Reg. (EC) No 178/02; specific rules on Import Conditions (for example: Dir. (EC) No 97/78 on principles governing the organisation of veterinary checks on products entering the EU from third countries; specific rules on an animal welfare and others. Recently, the Commission Regulation (EC) No 669/2009 of 24 July 2009 introduced implementing rules to Regulation (EC) No 882/2004 as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC.

[14] Article 17.1 of GFL.