A new EU regulation on nutrition and health claims, such as 'low fat', 'helps your body resist stress' or 'purifies your organism', entered into force on 1 July 2007.
In the food sector producers sometimes use claims such as "low fat", "helps your body resist stress" or "purifies your organism", which either cannot be scientifically substantiated or contain only a partial truth regarding the health effects of food products. For example, a product may be low in fat but contain high quantities of sugar or salt. This can be misleading to consumers.
In order to prevent unfounded claims on food packages and to ensure effective functioning of the internal market as regards to nutrition and health claims, the Commission adopted in July 2003 a new legislative proposal aimed at tackling unsubstantiated claims made on food. This proposal builds on the international guidelines of Codex Alimentarius, which sets out that food cannot be described or presented in a misleading manner and that the person marketing the food should be able to justify the claim made. The Codex Guidelines prohibit a list of claims, such as unsubstantiated claims, as well as claims regarding the suitability of foods for use in the prevention, treatment or cure of a disease (with exceptions).
The proposal covers two categories of claims: nutrition claims (such as "rich in vitamin C" and "low in fat") and health claims (such as "good for your beauty and your inner harmony") and proposes allowing a category of previously prohibited claims relating to the reduction of disease risk.
It only covers food products for human consumption and does not deal with cosmetics, medicine and pet food products.
After years of discussion, the Regulation was adopted in October 2006. Two articles in the Commission's proposal proved to be particularly controversial:
After years of discussion, the Regulation was adopted in October 2006. Two articles in the Commission's proposal proved to be particularly controversial:
- Article 4, which lays down the conditions for restricting the use of nutrition and health claims. It calls on the Commission to establish nutrient profiles (with reference to fat, sugar and salt/sodium content) for each food category within 18 months from the adoption of the regulation.
- Article 15, which requires certain health claims to go through an authorisation procedure and stipulates that "the proposed wording of the health claim is substantiated by scientific data".
New rules on health and nutrition claims made on food products entered into force on 1 July 2007. Food producers launching new products on the internal market, if they wish the product to carry a nutrition or health claim, must now have the claim approved by the European Food Safety Authority (EFSA).
The Commission will, by 2010, draw up a 'positive list' of permitted health claims already approved in member states. These types of health claims include those referring to: growth, development and the functions of the body; psychological and behavioural functions, and weight control.
Any claims referring to the reduction of disease risk or to children's development and health will have to be examined by the EFSA and approved by the Commission as well as any other new claims not already included in the positive list. The authorisation will thus be required on a case-by-case basis, following the submission of a scientific dossier to the EFSA for assessment.
The products already on the market and bearing such claims will be allowed a two-year transition period to allow industry time to adapt to the new rules, either by phasing out products that do not meet the new criteria, or by applying for claim authorisation.
Initially, no transition period was allowed for claims referring to the health and development of children, meaning that from 1 July 2007 such claims must be removed from all products on the market. However, the Commission adopted, on 28 June 2007, a proposal to allow a two-year transitional period for the claims referring to the health and development of children as well. According to the Commission, "this was unintentionally omitted from the main regulation during the last phase of the adoption of the text".
The regulation also mandates the EFSA to define the basic nutrient criteria or nutrient profiles to set the conditions under which a nutrition or health claim may be made. This could change the current practice that still allows a food high in fat, salt and/or sugar to use claims such as "rich in vitamin C" or "high in fibre" to attract consumers, even if the overall health and nutritional benefits of the product are low.
In order to facilitate the application of this measure, a derogation was agreed in discussions between the Parliament and Council, which will allow nutrition claims to be used if just one nutrient doesn't meet the required profile. However, the high level of this nutrient must be clearly marked on the label, close to and with the same prominence as the claim. If two or more of the nutrients exceed the limit, no nutritional claim can be made.
As the Regulation entered into force on 1 July 2007, food-industry officials have highlighted the need to ensure that the EFSA has the necessary resources to swiftly deal with all the claims dossiers it will receive in order to prevent long delays.
The European Snacks Association (ESA) is urging the Commission to give some kind of encouragement that the industry can keep on investing in innovation with the aim of introducing reformulated products, including products reduced in fat, saturated fat and/or salt, onto the market.
"Currently, there's still a degree of uncertainty within what we know so far about how the process is going to work. There's still a possibility that whole categories, such as savoury snacks, confectionary and soft drinks, might be exempt from making any claims whatsoever. That is why we were against the establishment of nutrient profiles in the first place. Once such a categorisation is made, it may be used in the future for things like additional taxation measures and further restrictions on advertising or promotion of our goods," said Stave Chandler, ESA secretary-general.
"As an industry, we have spent a lot of time and resources in terms of developing new ingredients, and new technologies bringing new products to market. At the end of the day, we need to be able to get consumers to be aware of these products and if we're not allowed to do so it is a big problem for us, as well as for the consumers as they will not know about our 'better for you' products carrying a reduction claim [such as 30% reduced in sugar or fat]," he added pledging for the need to allow the savoury-snacks sector to make reduction claims.
The British Retail Consortium (BRC) points out that "the regulations will make it harder for retailers and manufacturers to make recipes healthier by, for example reducing salt or fat. Products can only be labelled 'reduced fat' or 'reduced salt' if the content is 25 or 30% less than in a previous product that is still available. This change does nothing to help customers make healthier choices. Producers often make reductions in stages to allow customers time to adapt and customers need labelling that explains a noticeable difference in the taste of a product has arisen because it has been made healthier."
A European Basic Foods Platform, launched in February 2007, aims to ensure that "the inherent characteristics of basic foods [such as dairy products, vegetable oils, sugar, flours, meat, eggs and fish] are acknowledged by the EU legislator". The platform strongly believes that the new regulation on nutrition and health claims should authorise basic foods to claim scientifically recognised health benefits of particular nutrients, such as omega-3 fatty acids.
The European Consumers' Organisation (BEUC) welcomed the fact that new, previously unknown, claims will have to be substantiated before they can be used in marketing. "We are pleased that health claims will be phased out for sugary, fatty and salty foods," said BEUC Director Jim Murray. BEUC also believes that nutrient profiles could be applied to health and nutrition claims, fortification, marketing of foods to children, shape and support nutritional policy, and improve the content of vending machines.
Reactions to the final Council-Parliament compromise on the nutrition and health claims regulation:
The European Association of Craft, Small and Medium-sized Enterprises (UEAPME) "mildly welcomes" the compromise. It says that "European SME producers will now have to deal with additional registration procedures through the EFSA if they wish to inform consumers on the nutritional benefits of their foodstuffs. This will increase the bureaucratic burden, limit the number of possible claims and ultimately reduce the amount of information that is available for the consumer," said UEAPME Adviser on Food issues, Ludger Fischer.
"This legislation will guarantee truthful and science-backed information for European consumers. Food labels have a huge influence over consumers' choices and it is only reasonable to expect that the claims on them are not false or misleading. [...] It will also create a fairer market for producers making genuine and substantiated health or nutrition claims. Like any compromise, each side would have liked to go further, but this is a good compromise which takes account of all positions in a balanced way," said Health and Consumer Protection Commissioner Kyprianou.
To see initial stakeholder views on the issue expressed in a public hearing held in the European Parliament on 8 January 2004 click here.
- May 2005: European Parliament Plenary delivered its opinion and voted to delete Article 4 on nutrient profiles.
- June 2005: The Council reached a common position on the issue on and rejected Parliament's Article 4 amendments - thus backing Commission's initial proposal.
- May 2006: In its second reading the EP voted to back the Commission proposal.
- 12 Oct 2006:The Council adopted the regulation.
- 18 Jan 2007: The regulation was published in the Official Journal of the EU.
- 16 May-17 June 2007: EFSA consultation on draft guidance for health claims applications.
- 1 July 2007: The regulation entered into force.
- By end July: EFSA is set to publish its guidelines on the submission of health claims dossiers.
- 1 July 2007-1 July 2009: Transition period for products already on the market.
- July 2007: Industry is expected to present the industry list (Article 13 list) of health claims for authorisation.
- By end Jan 2008: EFSA will give scientific advice on nutrient profiles that will be the basis for the establishment of profiles by the Commission and member states.
- By end Jan 2008: Member states need to submit their lists of current functional claims to the Commission.
- Jan 2010: Commission will present its list of functional claims.
EU official documents
- Commission:Questions and Answers on Health and Nutrition Claims(28 June 2007)
- EFSA:Draft Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies on the scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim(16 May 2007)
- EFSA:Nutrition and Health Claims
- Commission:Questions and Answers on Health and Nutrition Claims(16 May 2006)
- Commission press release:Commissioner Kyprianou welcomes Council agreement on Health Claims(3 June 2005)
- Commission:The proposed Regulation on health & nutrition claims: Myths & Misunderstandings(1 October 2003) [FR] [FR] [DE]
- DG Health and Consumer Protection:Discussion Paper on Nutrition Claims and Functional Claims(May 2001)
- Commission:White Paper on Food Safety(12 January 2000)
- Commission:Health & Nutrition Claims
- Parliament News:Food safety: MEPs vote on health claims and additions to food(16 May 2006)
- Parliament - Committee on the Environment, Public Health and Food Safety:Draft recommendation for the second reading on the Council common position for adopting a regulation on nutrition and health claims made on foods(19 January 2006) [FR] [FR] [DE]
- Parliament - Committee on the Environment, Public Health and Food Safety:Amendments for the second reading(20 February 2006) [FR] [FR] [DE]
- Amendments 69 A and 160 A [FR] [FR] [DE]
- European Parliament:Draft Report on the proposal on nutrition and health claims made on foods (COM(2003) 424 – C5-0329/2003 – 2003/0165(COD))(Rapporteur: Mauro Nobilia) FIRST READING [FR] [FR] [DE]
- European Parliament:Amendments to the Draft Report of Mauro Nobilia - Nutrition and health claims made on foods(9 February 2004) FIRST READING [FR] [FR] [DE]
- Codex Alimentarious:General Guidelines on Claims
- Joint Health Claims Initiative of the UK Food Standards Agency:Health Claims report(17 December 2003)
- UK Food Standards Agency:Nutrition, Functional and Health Claims made on foods(25 June 2002)
- US Federal Trade Commission:'Miracle' Health Claims: Add a Dose of Scepticism
- US Food and Drug Administration:Claims That Can Be Made for Conventional Foods and Dietary Supplements
- UK Food Standards Agency:Health Claims on Food Packaging - Consumer-Related Qualitative Research
EU Actors positions
- European Consumers' Organisation (BEUC) press release:The proposal on nutrition and health claims survives (nearly) intact(16 May 2006)
- Which?:Victory on food claims in EU(16 May 2006)
- European Consumers' Organisation (BEUC) press release:BEUC’s Black Book on health claims(15 March 2006) [The Black Book on health claims]
- European Community of Consumer Co-operatives - EuroCoop:Vote on Nutrition & Health Claims Proposal - 21 March 2006(15 March 2006)
- EPHA, EHN, PGEU, Eurocare and EURO COOP joint press release:Health and nutrition claims on food: EU health ministers support nutrient profiles for foods(9 December 2005)
- EPHA, EHN, PGEU, Eurocare and EURO COOP joint press release:"Destroying myths and misunderstandings of the claims regulation" - a further clarification by health and consumer groups(13 May 2005)
- European Consumers' Organisation (BEUC) press release:Consumers rely on marketing claims for food choices(1 September 2005)
- European Consumers' Organisation (BEUC):A simplified labelling scheme(26 August, 2005)
- European Consumers' Organisation (BEUC):Report on European Consumers’ Perception of Foodstuffs Labelling - Results of Consumer Research conducted on behalf of BEUC from February to April 2005(31 August 2005)
Business & Industry
- British Retail Consortium:Days to go but concerns remain of food claims law(29 June 2007)
- European Basic Foods Platform:For a legislation that acknowledges the unique characteristics of basic foods in food labelling(February 2007)
- European Association of Craft, Small and Medium-sized Enterprises (UEAPME) press release:New rules on health claims: good for consumers, good for SMEs?(17 May 2006)
- UEAPME - European Association of Craft, Small and Medium-Sized Enterprises:Health Claims: much remains to be done after Parliament’s Committee vote(28 March 2006)
- European Breakfast Cereal Association (CEEREAL) press release:CEEREAL welcomes Environment Committee Vote on Health Claims and Fortification(27 March 2006)
- Confederation of the food and drink industries of the EU (CIAA):CIAA Principles of Food and Beverage Product Advertising(27 April 2004)
- UEAPME - European Association of Craft, Small and Medium-Sized Enterprises:UEAPME Position paper on the Proposal for a Regulation of the European Parliament and of the Council on Nutrition, Functional and Health Claims Made on Foods COM(2003) 424 final(2004)
- Confederation of the food and drink industries of the EU (CIAA):Position on the proposal for a Regulation on nutrition and health claimsmade on foods(22 October 2003)
- American Chamber of Commerce to the European Union:Position Paper on the Proposal for an EU Regulation on Nutrition and Health Claims made on Food(2003)
NGOs and Think-Tanks
- Which? Consumers' Association (UK) press release:Which? calls on MEPs to stop misleading health food claims(14 March 2006)
- Which? Consumers' Association (UK):The whole truth? - Health and nutrition claims 2nd reading (Which?'s briefing to UK MEPs)(March 2006)
- Which? Consumers' Association (UK):Food Labelling
Think tanks & Academia
- The European Policy Centre:European Parliament Public Hearing "Proposal for a Regulation on Nutrition and Health Claims Made on Foods" - Position Paper by the Better Regulation Programme of the European Policy Centre(8 January 2004)
- The European Policy Centre:British Medical Association (BMA) Position Statement on Health Claims Legislation
- Nutraingredients.com:Correct version of health and nutrition claims legislation published
- EURO COOP - EPHA - EHN and EURO CARE Press Release:Open Letter to Members of the European Parliament on the Proposal for a Regulation on nutrition and health claims(22 January 2004)
- The European Public Health Alliance (EPHA):Position paper on nutrition and health claims(7 January 2004)
- The European Public Health Alliance (EPHA):EPHA's Response on the Commission Proposal for a Regulation on Nutrition and Health Claims Made on Foods COM(2003) 424 final(December 2003)
- European Community of Consumer Co-operatives - EuroCoop:Position paper - Why and How can European Consumers benefit from a strict EU legislation on claims?(27 October 2003)
- European Heart Network (EHN):Response to a Commission Proposal for a Regulation on Nutrition and Health Claims(October 2003)