EU Food Legislation
In simplified outline, at present food legislation is formed by recommendations from the EU Commission�s Directorate General for Consumer Policy and Consumer Health (familiarly referred to as �DG Sanco�) based on scientific advice from the European Food Safety Authority (EFSA). The recommendations are considered at a succession of meetings of officials from all the Member countries, where, ideally, differences in approach are resolved; in practice these meetings often involve "horse trading" and compromises, and are the main reason why the process is sometimes lengthy. The revised recommendations go to the European Parliament for a "first reading"; thence to the Council of Ministers; and finally a second reading in the European Parliament before returning the final version to the Council of Ministers. During this period, drafts (and often a succession of drafts) are widely circulated within their respective countries by the national government departments for public consultation.
The main forms of legislation, including food legislation, are EU Directives and EU Regulations. When adopted, the full text of the Directive or Regulation is published in that day's "L" issue of the Official Bulletin of the European Communities (quoted as "OJ L" followed by volume number date and page(s)). All food-related legislative texts are accessible on-line via: http://ec.europa.eu/food/food/index_en.htm
The difference between a Directive and a Regulation should be appreciated. The measures in a Directive must, within a limited time from the date of its adoption, be given legal effect by the promulgation of national legislation in each Member country. In contrast, a Regulation takes immediate force in all Member countries. Although national legislation is not necessary to bring a Regulation into force, it is customary for national legislators to develop national regulations mirroring it, to provide for national enforcement machinery and penalties for non-compliance.
Overarching all EU food law is Regulation EC 178/2002 which sets out general objectives. A key element is the responsibility of food and feed businesses to ensure that only safe food/feed is placed on the market, and that foods/feedingstuffs that are unsafe are withdrawn from the market. It equally includes rules imposing the traceability of all foodstuffs, animal feed and feed ingredients, and procedures for developing food law and dealing with food emergencies. It also set up a Rapid Alert System for Feedingstuffs by integrating information on contaminated feed into the existing Rapid Alert System for Food. It allows for rapid communication between the Member States on dangerous substances found in feed and possible recalls. It became operational early spring 2002:
Food Labelling Proposals
Several of the recent developments fall into the area of food labelling.
As background, the main existing labelling legislative provision is Council Directive 2000/13/EC, as amended by Directive 2003/89/EC and Directive 2007/68/EC. The main provisions relate to:
There are other requirements for indicating the presence of sweeteners, for warnings on foods containing aspartame or more than 10% of polyols, the use of modified atmosphere packing and the declaration of any of a specified list of food allergens (now brought together in amending Directive 2008/5/EC).
Additionally there are specific Directives and Regulations affecting:
In 2003 DG SANCO in close co-operation with stakeholders, launched an evaluation of the food labelling legislation in order to reassess its effectiveness and legal basis, and to identify the needs and expectations of today's consumers for food information, taking into account the technical and logistical constraints. The conclusions, published in 2004, identified the focus for a future proposal. Based on the conclusions, the EU Commission has now issued a proposal for a new �Food Information� Regulation. The text may be accessed at http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/publications/3359-en.pdf
The proposal brings together general and nutrition labelling for all pre-packed foods and also covers the requirements for foods sold non-pre-packed (loose and pre-packed for direct sale). The aims of the proposal are simplification and consolidation of existing texts, while ensuring consumers have sufficient information to make informed choices. The Regulation will replace Directive 2000/13/EC on general labelling and Directive 90/496/EC for nutrition labelling and recast a number of other Directives. As a Regulation it will be directly applicable in all Member States.
In addition, it introduces clear principles to draw a clearer borderline between mandatory and voluntary information. The main changes with respect to general labelling issues are:
As regards nutrition labelling the main new aspects of the proposal are:
However, and somewhat confusingly, the European Commission has also produced a separate working document of a draft Directive (the 'Amending Directive') to amend the Nutrition Labelling Directive 90/496/EEC in relation to: recommended daily amounts (RDAs), energy conversion factors and definitions.
Once the Amending Directive is adopted, a consequential amendment will be created to the proposed Food Information Regulation. The Amending Directive provides a definition of dietary fibre for labelling, to ensure nutrition claims made about, and nutrition labelling of, dietary fibre are on a consistent basis across Europe. In this definition 'fibre' means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the small intestine. Dietary fibre consists of one or more of:
The Amending Directive provides new energy conversion factors for fibre (2kcal/8kJ per g) and erythritol (0kcal/0kJ per g) and updates the list of vitamins and minerals and associated RDAs to ensure coherence between Community legislation.
Nutrition and Health Claims are Governed by Regulation EC 1924/2006
This Regulation, adopted in December 2006 provided harmonised rules for the use of health or nutritional claims (such as �low fat�, �high fibre� and �helps lower cholesterol�) on foodstuffs based on nutrient profiles. It was amended by Regulation (EC) No 107/2008 as regards the implementing powers conferred on the Commission. It is intended to ensure that any claim made on a food label in the EU is clear, accurate and substantiated. In doing so, it will enable consumers to make informed and meaningful choices when it comes to food and drinks. This should also contribute to a higher level of human health protection, as it ties in with the Commission�s campaign for healthier lifestyle choices by allowing citizens to know exactly what they are consuming. It also aims to ensure fair competition and promote and protect innovation in the area of food. Only products offering genuine health or nutritional benefits will be allowed to refer to them on their labels.
The requirements regarding nutrition claims were set out in Chapter III of the Regulation.
However, as regards health claims, while it laid down procedures by which applications for approval of health claims can be made, the actual process of submitting, and gaining approval for, health claims is a lengthy and ongoing one.
Different types of health claims are dealt with under Articles 13, 14 and 18.
Article 13 covers health claims other than those referring to the reduction of disease risk and to children's development and health. Member States had to collect applications within their countries and submit them to EFSA by 31 January 2008, accompanied in each case by references showing that the claim was based on generally accepted scientific evidence and �well understood by the average consumer�. Overall, 43,082 Article 13 applications have been sent in by Member States to EFSA, which has the task of evaluating and recommending so that the EU Commission can prepare a list of all permitted claims and the conditions for their use by 31 January 2010 at the latest. Although there is inevitably some replication among the applications it will be a huge task to complete in the time. On 3 June 2008 the Commission issued to Member States a working document on how they proposed to go about consolidating the national lists into the list which will form the basis for the EFSA consultation. A database has been developed. In addition, with the aim to ensure a consistent handling of the national lists, to facilitate the possibility to make accurate comparisons and queries in the database, i.e. between and in Member States submissions, a coding system has been developed. Member States have co-operated in the task of assigning the codes to the national lists.
In order to facilitate the input of Member States in the process of consolidating the national lists an ad hoc working group consisting of 9 volunteer Member States has been set up. This group met on 27 February 2008 and 28 May 2008. In addition, the Commission facilitated discussions with Member States in the standing working group on claims on 12 February and 21 April 2008.
The Regulation provides that the Community list of permitted health claims shall be adopted by 31 January 2010 at the latest. Given the tight timetable it is intended to give EFSA one year to do the scientific assessment and in order to leave sufficient time to the following Regulatory Committee procedure the Commission will send before the summer break 2008 the consolidated list to EFSA. Article 13(5) states that any additions of claims to that list based on newly developed scientific evidence and/or which include a request for the protection of proprietary data shall be adopted following the procedure laid down in Article 18, except claims referring to children's development and health.
Article 14 covers reduction of disease risk claims and claims referring to children�s development and health, and specifies more stringent requirements, set out in Articles 15, 16, 17 and 19.
Parallel with all this, Article 4 requires that by 19 January 2009, the Commission shall establish specific nutrient profiles, including exemptions, which food or certain categories of food must comply with in order to bear nutrition or health claims and the conditions for the use of nutrition or health claims for foods or categories of foods with respect to the nutrient profiles. The nutrient profiles for food and/or certain categories of food shall be established taking into account in particular:
The nutrient profiles shall be based on scientific knowledge about diet and nutrition, and their relation to health.
In setting the nutrient profiles, the Commission shall request the Authority to provide within 12 months relevant scientific advice, focusing in particular on: (i) whether profiles should be set for food in general and/or categories of food. The Commission shall carry out consultations with interested parties. [where is part (ii)?}
Addition of Vitamins, Minerals and Certain Other Substances to Food
Regulation (EC) No 1925/2006 was adopted in December 2006 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1925:EN:NOT).
It deals with vitamins and minerals added to foods other than food supplements (which are covered by Directive 2002/46/EC). "Other substance" is defined as a substance other than a vitamin or a mineral that has a nutritional or physiological effect. The Regulation specifies foods that may not have added vitamins and minerals, notably beverages containing more than 1.2 % by volume of alcohol and unprocessed food such as fruit, vegetables, meat, poultry and fish. Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods. When a vitamin or a mineral is added to a food, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts that shall be set in accordance with the procedure referred to in Article 14(2). The Commission may, to this end, submit proposals for the maximum amounts by 19 January 2009. For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.
�Certain other substances� are the subject of an as yet empty Annex III. The provisions relate to where a substance other than vitamins or minerals, or an ingredient containing a substance other than vitamins or minerals, is added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers. Annex III is intended to consist of three parts. If a harmful effect on health has been identified:
Issued in February 2008, Regulation (EC) No 108/2008 amends Regulation (EC) No 1925/2006. It provides additional powers for the Commission:
Amending of the Novel Foods Regulation EC 258/97
On 14 January 2008 the European Commission published a proposal to revise the Novel Foods Regulation with a view to simplifying the regulatory process thereby reducing the administrative burden and improving the competitiveness of the European food industry:
Preliminary discussions in Brussels are currently taking place at Council Working Party level under the Slovenian Presidency.
The key elements of the proposal are:
Commission Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs
This Regulation was applicable from 1 January 2006. It lays down food safety criteria for certain important foodborne bacteria, their toxins and metabolites. These criteria are applicable to products placed on the market during their entire shelf-life. In addition, the Regulation sets down certain process hygiene criteria to indicate the correct functioning of the production process. In December 2007 Regulation (EC) No 1441/2007 was adopted, amending Regulation (EC) No 2073/2005. It sets out microbiological criteria for certain micro-organisms and the implementing rules to be complied with by food business operators when addressing the general and specific hygiene measures referred to in Article 4 of EC Regulation No 852/2004. Regulation 2073/2005 also provides that food business operators are to ensure that foodstuffs comply with the relevant microbiological criteria set out in Annex I to that Regulation, Chapters 1 and 2 of which set out food safety criteria and process hygiene criteria regarding dried infant formulae and dried dietary foods for special medical purposes intended for infants below six months of age (dried infant formulae and dried dietary foods).
Regulation (EC) No 396/2005 on Maximum Pesticide Levels for Food Products for Human Consumption and Animal Feedingstuffs
This Regulation becomes fully applicable on 2 September 2008. Until then, chapters II, III and V to the Regulation are not applicable; and the national maximum residue levels (MRLs) of each Member State for each pesticide/crop combination remain in force and operators/stakeholders should comply with the relevant national legislation. Meanwhile in January 2008 Regulation (EC) No 149/2008 was adopted amending Regulation 396/2005 by establishing Annexes II, III and IV which set maximum residue levels of pesticides in or on food and feed of plant and animal origin for products covered by Annex I thereto. Running to almost 400 pages, this completes the introduction of Regulation 396/2005, though as stated implementation is not until 1 September 2008. As regards the MRLs provided for under the new regime, these supersede those currently set out in the following Directives:
Regulation (EC) No 299/2008 further amends Regulation (EC) No 396/2005, permitting the EU Commission to define the scope of Regulation (EC) No 386/2005 and the criteria for establishment of MRLs.
Production and Labeling of Organic Food Products
Regulation (EC) No 834/2007 repeals and replaces Regulation E(EC) No 2092/91, in order to define more explicitly the objectives, principles and rules applicable to organic production, and in order to contribute to transparency and consumer confidence as well as to a harmonised perception of the concept of organic production.
Proposed Directive on Indicating the Absence of Gluten in the Labelling of Certain Foods
The EU Commission has issued for consultation a working document proposing a Directive on measures for the use of terms concerning the absence of gluten on the labelling of certain foodstuffs. It proposes definitions (including for �gluten�, �gluten-free�, and �very low gluten�), compositional requirements and labelling rules to describe the products referred to in Article 1 of Directive 89/398/EEC as they have been specially formulated, processed or prepared to meet the special dietary needs of people intolerant to gluten; and in Article 3(2) of that Directive as they are by nature suitable to meet those special dietary needs.
European Commission, DG Health and Consumer Protection, Food and Feed Safety. http://ec.europa.eu/food/food/index_en.htm
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January2002 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.
Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs. http://eur-lex.europa.eu/pri/en/oj/dat/2000/l_109/l_10920000506en00290042.pdf
Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs. http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/fl_com2003-89_en.pdf
Commission Directive 2007/68/EC of 27 November 2007 amending Annex IIIa to Directive 2000/13/EC of the European Parliament and of the Council as regards certain food ingredients. http://eur-lex.europa.eu/LexUriServ/site/en/oj/2007/l_310/l_31020071128en00110014.pdf
Commission Directive 2008/5/EC of 30 January 2008 concerning the compulsory indication on the labelling of certain foodstuffs of particulars other than those provided for in Directive 2000/13/EC of the European Parliament and of the Council.
EU Commission proposal for a new �Food Information� Regulation. http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/publications/3359-en.pdf
Corrigendum to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1924R(01):EN:NOT
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32006R1925:EN:NOT
European Commission. Proposal to revise the Novel Foods Regulation. http://ec.europa.eu/food/food/biotechnology/novelfood/COM872_novel_food_proposal_en.pdf
Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:322:0012:0029:EN:PDF
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC.
Regulation (EC) No 299/2008 of the European Parliament and of the Council of 11 March 2008 amending Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin, as regards the implementing powers conferred on the Commission. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:097:0067:0071:EN:PDF
Commission Regulation (EC) No 273/2008 of 5 March 2008 laying down detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards methods for the analysis and quality evaluation of milk and milk products. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:088:0001:0115:EN:PDF
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91.
* Comitology procedure: a legally-provided system of committees consist of representatives from Member States, chaired by the Commission. They enable the EU Commission to establish dialogue with national administrations before adopting implementing measures and provide for post-adoption scrutiny of how implementation is carried out. For more detail see: http://europa.eu/scadplus/glossary/comitology_en.htm