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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:

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businesses to ensure that only safe food/feed is placed on the market, and that foods/feedingstuffs that are unsafe are withdrawn from the market.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:

  1. the name under which the product is sold;
  2. the list of ingredients;
  3. the quantity of certain ingredients or categories of ingredients where the name or depiction draws attention to such ingredients;
  4. in the case of prepackaged foodstuffs, the net quantity;
  5. the date of minimum durability or, in the case of foodstuffs which, from the microbiological point of view, are highly perishable, the �use by� date;
  6. any special storage conditions or conditions of use;
  7. the name or business name and address of the manufacturer or packager, or of a seller established within the Community.
  8. particulars of the place of origin or provenance where failure to give such particulars might mislead the consumer to a material degree as to the true origin or provenance of the foodstuff;
  9. instructions for use when it would be impossible to make appropriate use of the foodstuff in the absence of such instructions;
  10. with respect to beverages containing more than 1.2 % by volume of alcohol, the actual alcoholic strength by volume.

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:

  • the labelling of beef and beef products (Regulation (EC) No 1760/2000);
  • products containing quinine and caffeine (Directive 2002/87/EC);
  • GMOs or products containing GMOs (Regulation (EC) No 1830/2003);
  • GM seeds (Directive 98/95/EEC);
  • food supplements (Directive 2002/46/EC);
  • dietetic foods (Directive 89/398/EC as amended by Directive 1997/41/EC);
  • infant and follow-on foods (Directive 2006/141/EC);
  • mineral waters (Directive 80/777/EC amended by Directive 96/70/EC and Directive 2003/40/EC); and
  • foods and food ingredients with added phytosterols, phytosterol esters, phytostanols and/or phytostanol esters (Regulation (EC) No 608/2004).

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

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:

  • The clarification of the responsibilities regarding food labelling for the different food business operators along the supply chain;
  • To improve the legibility of the information provided on the labelling a minimum print size (3mm) for the mandatory information is introduced (it remains to be seen whether that seemingly impracticable minimum print size will survive consultation and negotiation among Member states) ;
  • The introduction of a requirement that information on allergenic ingredients should be available for non-prepacked foods sold through retail and catering outlets;
  • Given the specificities of wine, spirits and beer, the proposal provides for the Commission to report on the application of current rules on ingredient listing and mandatory nutrition labelling on these products with the possibility of specific measures to be adopted.
  • With respect to the labelling of the country of origin or place of provenance of a food, the basic requirement in the legislation remains the same. Therefore, such labelling is voluntary, but if the failure to give such information might mislead the consumer, the labelling becomes mandatory. Either the mandatory or the voluntary indication of the country of origin or place of provenance of a food as a marketing tool, should not deceive the consumer and should be based on harmonised criteria. The country of origin should be determined in accordance with the provisions on non-preferential origin following the Community Custom Code. The place of provenance would refer to any place that is not the country of origin as determined by the Community Customs Code. Rules for determining the place of provenance will be adopted following �Comitology procedure�*. In addition, criteria are introduced for the declaration of country of origin or place of provenance of multi-ingredient products and the country of origin or place of provenance of meat, other than beef and veal. These criteria would equally apply to the voluntary declaration of "EC" origin labelling;
  • The proposal clarifies the conditions under which Member States may adopt national rules on origin labelling.
  • The rules on nutrition labelling are recast with the horizontal food labelling provisions. The proposal makes nutrition labelling mandatory in the principal field of vision of a food label; allows for the development of best practice in the presentation of nutrition information, including alternative forms of expression of the nutrition information in relation to overall daily nutrient requirements or graphical forms of presentation.

As regards nutrition labelling the main new aspects of the proposal are:

  • The mandatory declaration is for energy, fat, saturates, carbohydrates with specific reference to sugars and salt expressed as amounts per 100g or per 100 mL or per portion in the principal field of vision (front of pack) whilst nutrients from a defined list may be declared voluntarily. In selecting the mandatory elements account has been taken of: research indicating that consumers can feel overwhelmed by excessive information; the scientific advice about the most important nutrients bearing a relationship to the risk of development of obesity and noncommunicable diseases; while avoiding excessive burden on food businesses, in particular small and medium size enterprises;
  • In the case of alcoholic drinks, derogations are provided for wine, spirits and beer, and will be subject to a future Commission report.

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:

  • edible carbohydrate polymers naturally occurring in the food as consumed;
  • carbohydrate polymers, which have been obtained from food raw material by physical, enzymatic or chemical means; or
  • synthetic carbohydrate polymers. For the material considered as fibre a beneficial physiological effect should be demonstrated by generally accepted scientific evidence except in the case of nondigestible edible carbohydrate polymers naturally occurring in foods as consumed.

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:

  1. the quantities of certain nutrients and other substances contained in the food, such as fat, saturated fatty acids, trans fatty acids, sugars and salt/sodium;
  2. the role and importance of the food (or of categories of food) and the contribution to the diet of the population in general or, as appropriate, of certain risk groups including children
  3. the overall nutritional composition of the food and the presence of nutrients that have been scientifically recognised as having an effect on health.

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 (

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:

  • the substance and/or the ingredient containing the substance shall be placed in Annex III, Part A and its addition to foods or its use in the manufacture of foods shall be prohibited; or
  • be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
  • if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C. Food business operators, or any other interested parties, may at any time submit for evaluation to the Authority a file containing the scientific data demonstrating the safety of a substance listed in Annex III, Part C, under the conditions of its use in a food or in a category of foods and explaining the purpose of that use.

Issued in February 2008, Regulation (EC) No 108/2008 amends Regulation (EC) No 1925/2006. It provides additional powers for the Commission:

  • to adopt modifications to Annexes I and II to Regulation (EC) No 1925/2006;
  • to establish additional foods to which particular vitamins or minerals may not be added;
  • to take decisions to establish and/or amend the lists of authorised, prohibited or restricted other substances;
  • to define the conditions under which vitamins and minerals may be used, such as purity criteria, maximum amounts, minimum amounts and other restrictions or prohibitions on the addition of vitamins and minerals to food; and
  • to establish derogations from certain provisions of that Regulation.

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:

  • centralise the procedure for assessment and authorisation for novel foods;
  • develop an assessment system for traditional food from third (non-European Union) countries, which has not been consumed in the EU, but which has a history of safe food use elsewhere to gain authorisation via a simplified assessment and authorisation process;
  • provide an updated definition of a novel food to clarify that new technologies not currently being used in the food chain, such as nanotechnology and animal cloning, will require a pre-market safety assessment; a clearer definition of a novel food intended to reduce the current ambiguity, where a food is considered novel only if the food was not significant consumed in the EU before 15 May 1997 and it results in significant changes in the composition or structure of the foods which affect their nutritional value, metabolism or level of undesirable substances compared with similar products from existing processes. The proposed revised definition takes account of the general food law Regulation EC 178/2002, which includes a general definition of 'food'.
  • update the scope of the novel food regulation in relation to parallel legislation on specific categories of foods;
  • provide a degree of protection for innovative food.

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:

  • Directive 86/362 on maximum levels for pesticide residues in and on cereals;
  • Directive 86/363 on maximum levels for pesticide residues in and on foodstuffs of animal origin; and
  • Directive 90/642 on maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables.
  • These MRLs are now covered by Annex II to Regulation 396/2005 as regards the products covered by Annex I to that Regulation.

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.

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.

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.

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.

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.

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.

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.

European Commission. Proposal to revise the Novel Foods Regulation.

Commission Regulation (EC) No 1441/2007 of 5 December 2007 amending Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs.

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.

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.

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: