EuroFIR - New EU regulation on nutrition and health claims

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New EU regulation on nutrition and health claims:

A growing number of foods now carry nutrition and health claims and the European Commission (EC) has taken the decision to introduce a Regulation to harmonise the provision of this type of information. The new legislation has been adopted by the EC by the end 2006 and has come into force in June 2007. The stated objectives of the Regulation are to achieve a high level of consumer protection, to improve the free movement of goods within the internal market, to increase legal security for economic operators, and to ensure fair competition in the food sector. The Regulation covers voluntary nutrition and health claims made on foods; labelling, presentation and advertising; trademarks and brand names.

Nutrition claims

In this context, examples of nutrition claims are: low fat, no added sugar, high in fibre. Nutrition claims are covered in Articles 8 and 9 of the legislation and a list of permitted claims appears as an Annex to the Regulation. For example, a claim that a product is low in fat can only be made if it contains no more than 3g of fat per 100g (or 1.5g fat per l00ml for liquids, note that an exception exists for semi skimmed milk which can be classed as low fat at 1.8g/100ml). For a low sugars claim to be legal, the product must contain no more than 5g of sugars per 100g for solid foods or 2.5g of sugars per 100ml for liquids. For micronutrients, at least 15% (per 100g) of the labelling RDA for a micronutrient needs to be present in order to make a ‘contains’ claim and at least 30% per 100g of the food needs to be present to make a ‘rich in’ claim. A food can be claimed to be a source of fibre if it provides 3g per l00g or 1.5g fibre per 100kcal, and can be claimed as rich in fibre if it provides 6g/100g or 3g/100kcal.

Health claims

A health claim is a statement on food packaging, food marketing or advertising that health benefits can result from consuming a particular food, for example reduce blood cholesterol level, enhance learning ability or reinforce the body’s natural defences. Health claims are covered in Articles 10-19 of the Regulation and are of two main types. Firstly, there are those health claims covered in Article 13 (‘functional claims’) that are based on generally accepted scientific evidence and that: (a) describe the role of a nutrient or other substance in growth, development and the functions of the body, or (b) describe psychological or behavioural functions, or (c) refer to slimming, weight control, reduction in sense of hunger, increase in satiety. Claims approved by the EC under Article 13 will be available for general use provided conditions listed in the Regulation are met, including conditions linked to nutrient profiling (see below). Article 13 does not include claims referring to reduction in disease risk or those referring to children’s development and health (both of these types are covered in Article 14).

The processes for substantiation of claims falling under Articles 13 and 14 are different, as is described below. The process for Article 13 is that member states are now compiling lists of claims in current use that are based on generally accepted evidence and that fall within the boundaries defined for Article 13 (see above). In the UK this is the responsibility of the Food Standards Agency and these lists will be sent to the EC. The time frame for submission of Article 13 claims to the EC is 12 months after the Regulation comes into force. Once this deadline has been met, it will still be possible to submit new Article 13 functional claims and the process for this is covered in Article 18 and has been described as ‘fast track’. The time frame for publication by the EC of the ‘positive list’ of permitted functional health claims is within three years of the Regulation coming into force.

Article 14 claims (disease risk reduction and those referring to children) require submission of a detailed dossier of evidence to substantiate the claim that the manufacturer wishes to make. In due course, technical guidance and tools to assist manufacturers in compiling these dossiers is expected (as described in Article 15).

Role of the European Food Safety Authority

Clearly, it is essential that all claims are based on reliable scientific evidence and not misleading to consumers. One of the Commission’s key objectives is to ensure that consumers will be able to rely on the truth and accuracy of information. Even from this short summary it will be clear that a number of protocols still need to be developed. The European Food Safety Authority (EFSA) is to have the lead role in implementing the legislation. EFSA will have four main tasks:

1. EFSA will give scientific advice on nutrition profiles

EFSA is to provide scientific advice to the Commission that will be the basis for the establishment of the nutrient profile criteria by the EC and Member States. The deadline for this work by EFSA is 12 months after the Regulation comes into force and the nutrient profiles will be in place 2 years after the Regulation comes into force.

2. EFSA will be consulted on establishing a Community ‘positive list’ of permitted health claims

This list will be derived form the various lists of claims based on generally accepted evidence that are being compiled by member states. The precise meaning of ‘generally accepted’ still needs clarification, for example is information from a text book sufficient, is an expert scientific report needed?

3. EFSA will give an opinion on individual applications for health claims not on the permitted claims list

Any article 13 claims submitted after the positive list has been established will be examined by EFSA prior to a decision by the Commission. EFSA will be responsible for verifying that any proposed health claims are substantiated by the scientific evidence. If its opinion is favourable, it will make a proposal for the wording of the claim. A time frame of 5 months will operate for an EFSA opinion on each application, followed if successful by EC authorisation.

4. EFSA will provide detailed advice to the Commission on Community guidance for the preparation of applications for health claims not included on the positive list. EFSA will be involved in compiling technical guidance for food companies wishing to submit evidence for a particular heath claim.

In readiness for implementation of the Regulation in early 2007, EFSA has indicated that it will be developing guidance for Member States, industry and consumers, as apriority. Work on nutrient profiles will follow.

Figure 1: Milestones and transition periods following introduction of the Regulation on Nutrition and Health Claims.

More detailed information about the new EU regulation on nutrition and health claims can be found in the 5^th EuroFIR Synthesis Report “Nutrition and Health Claims: the Facts on your Food”. This report can be downloaded below. To see a full copy of the new regulations click here.

More Information:

Nutrition and health claims: the facts on your food Download

Fifth synthesis report pdf