Food Law News - EU - 2003

FSA Letter and News, 30 July 2003

CLAIMS - Seeking views on nutrition and health claim proposals

The following are items taken from FSA documents issued on 30 July. They include:

See also Commission news item on these pages at: 16 July 2003

News Item: Seeking views on nutrition and health claim proposals

The Food Standards Agency is consulting on a European Commission proposal to regulate nutrition and health claims on food labels.

The proposed regulation, which is supported by the Agency, aims to harmonise nutrition and health labelling requirements across the EU to protect consumers from inaccurate and misleading labelling.

Under the proposal, health claims will be approved for use on labels only after assessment by the European Food Safety Authority (EFSA) and approval by the Standing Committee on Food and Animal Health. A summary of decisions will be published on a website register and will be fully open to public scrutiny.

For the first time it also establishes statutory criteria for nutrition claims, such as low-fat, low energy, fat free and low sodium/salt.

The proposal will mean that non-specific claims, such as 'good for you' or 'will improve your wellbeing' will be prohibited.

Claims that are misleading due to the way they are expressed will also be prohibited. This will include claims such as '90% fat free', which in fact means the product contains 10% fat - significantly higher than low fat products conforming to the regulations.

Rosemary Hignett, Head of the Food Standards Agency's Labelling Division, said: 'This proposal will make labels more consistent and clearer for the consumer. It is another step forward in creating a labelling system that everyone can trust.'

The consultation, which starts today, ends on 24 October 2003.

The Agency has also published research it commissioned on options for controlling health and nutrition claims on foods that are high in fats, sugars or salt.

This is because nutrition or health claims, such as 'with added vitamins', on these products could undermine healthy eating messages that are aimed at achieving diets lower in these nutrients.

The FSA research examined the situation in other countries and examined a number of options for criteria that could be used to control the use of claims on these foods.

This research is currently available on the FSA web site at:

Consultation Letter: Proposal to regulate nutrition and health claims made on foods

Consultation details

The European Commission has now formally adopted a proposal to regulate nutrition and health claims made on foods. This differs from previous discussion papers and informal proposals in a number of ways. Previous comments on other documents have been noted, but this consultation invites your views on this proposal.

The proposed Regulation sets a positive list of permitted nutrition claims, contained in an annex to the regulation. It also sets out the procedure for making additions to this list. Health claims are also to be regulated and the proposed Regulation sets out procedures for doing this as follows:

Prior approval will be required for all health claims. The European Food Safety Authority (EFSA) will give an opinion following submission of an application and a decision will be taken under the regulatory procedure involving the Standing Committee on the Food Chain and Animal Health.

For a period of 3 years, a list of 'well established' claims will be developed based on proposals from Member States. As a transitional measure, over this period these claims may continue to be used, subject to this regulation and national rules.
In addition, a number of specific restrictions on the use of nutrition and health claims are proposed. These will be made (a) on the basis of nutritional profiles, or (b) for health claims, on general non-specific claims, psychological effects, slimming claims, and use of charity and professional recommendations.


The initial Regulatory Impact Assessment highlights some key areas for comment and asks specific questions on costs and benefits of this proposal (see below).

A first Council Working Party met on 25 July to consider this proposal and the European Commission underlined the importance of the provisions under Article 4 on nutritional profiling. See also the research done on behalf of the Agency entitled Nutrition Profiles for Foods to which Nutrients could be added or on which Health Claims could be made available on the FSA web site (address above).

Negotiations on this proposal are scheduled to resume on 8 September. It is possible that there could be 2 or 3 Council Working Party meetings before the end of the formal FSA consultation.. For the meeting on 8 September we will need to receive comments by 1 September.

European negotiations

While all Member States welcomed this proposal as meeting an important need for community-wide legislation on nutrition and health claims, all made the point that they had to consult widely before making substantive comments.

Extract from Draft Regulatory Impact Assessment

(Note that this provide some further details but does focus on the UK issues)



The objective of the proposed Regulation is to harmonise Community rules on the use of nutrition and health claims on food. The aims of the proposed Regulation are to achieve a high level of consumer protection in the provision of voluntary information; to improve the free movement of goods within the Community; and ensure fair competition. This will be achieved through the prior approval and listing of permitted nutrition and health claims.


Once in force, the Regulation will be directly applicable in all EU Member States.


The European Community has detailed rules on labelling (Directive 2000/13/EC) and nutrition labelling (Directive 90/496/EEC) of foods. With regard to claims there is the basic provision that claims should not mislead the consumer. Also, Article 2(1)(b) of Directive 2000/13/EC prohibits attributing to food the property of preventing, treating or curing a human disease, or referring to such properties. In the absence of detailed rules on the use of nutrition or health claims on food, Member States' rules may vary widely. Some Member States have legislation regulating these claims where manufacturers choose to make them, while others may have guidelines or industry codes of practice. The UK operates a voluntary system via the Joint Health Claims Initiative (JHCI) which has an agreed code of practice and a system to authorise health claims manufacturers wish to use.

Consumers are increasingly aware of the relationship between diet and health and therefore take a greater interest in food composition. Manufacturers have responded to this by providing more information, including claims about the nutritional or health properties of food and/or its ingredients. A major concern is that this information can as easily mislead as inform, especially by lack of context in relation to a balanced diet. This can be exacerbated when comparative claims are made. While general food labelling rules seek to protect consumers from being misled, the absence of a harmonised approach on nutrition and health claims may undermine this general protection.

Risk assessment

The proposed Regulation sets a positive list of permitted nutrition claims, contained in an annex to the regulation. It also sets out the procedure for making additions to this list. Health claims are also to be regulated and the proposed Regulation sets out procedures for doing this as follows:

In addition, there are a number of specific restrictions on the use of nutrition and health claims proposed. These will be made (a) on the basis of nutritional profiles, or (b) for health claims, on general principles covering general nonspecific claims, highlighting of certain effects, on slimming products, and charity and professional recommendations.

Business sectors and charities affected

The Regulation will affect all food manufacturing businesses or retailers with their own labelling wishing to make a claim on the nutritional or health benefits of the food. Where there is no intention of making a nutrition or health claim, these regulations will have no effect. As currently drafted, some associations between health charities and manufacturer's products may be restricted.

Issues of equity and fairness

The FSA would welcome views on how this proposed Regulation might place unfair burdens on any particular group, for example on specific groups (e.g. the elderly, ethnic minorities, those with disabilities), or on one group where another reaps any benefits.



This is a proposed Regulation of the European Parliament and Council, and if agreed, it would be directly applicable in the UK. Some discretion is given Member States as regards monitoring of foods making claims (Article 24). It would be necessary to make subordinate legislation in the UK to provide for the enforcement of the proposed Regulation.

Key issues for discussion

We consider it important to ensure this proposed Regulation achieve its objectives while minimising the impact on business, particularly small and medium sized businesses. As this proposal seeks to regulate in areas previously unregulated and as it introduces a fairly novel concept in European legislation with nutritional profiles, consideration of each Article will be important. Some of the main issues will be:


The FSA require specific information to calculate the effect this proposed Regulation is likely to have on consumers, businesses, charities or the voluntary sector, including financial benefits or costs where appropriate. The FSA are interested in hearing the views of all concerned, including small businesses.

Competition assessment

The FSA will begin preparing the competition assessment now and will invite specific comments in the future.

Enforcement and sanctions

After implementation, this Regulation will be enforced by relevant food authorities.

Monitoring and review

Article 25 of the proposed Regulation provides for future evaluation of the impact of the proposal and the Commission will present a report to the European Parliament and Council 6 years after implementation.

To go to main Foodlaw-Reading Index page, click here.