In our health-conscious society, food products which claim to be good for you - or perhaps, more modestly, not all that bad for you - are attractive to consumers and have added value for businesses. Their importance in the market has inevitably attracted the attention of the regulatory authorities, in the shape of a new European Regulation.
The Regulation on Nutrition and Health Claims (EC No. 1924/2006), which came into force on 20 January, is one of the most important recent developments in European food law. It regulates the claims that can be made by food businesses about the nutritional content or health effects of their products. For the first time there is now a fully-harmonised regime for the claims that can be made in all member states of the European Union. Although the Regulation removes some old restrictions on claims, it adds a great many new ones. Most importantly, it creates lists of permitted claims - in most cases, if a claim is not on the list, it cannot be made. And even claims on the list can be made only if they meet strict criteria.
This briefing note explores in outline what the Regulation requires, when it requires it, and what businesses need to do in order to ensure that they comply.
Transition to the new law
Businesses which are not yet familiar with the Regulation have some time to get ready for it. But they will need to start right away. Although legally in force now, the Regulation will not take effect until 1 July 2007 - a short window of opportunity for those who are not yet prepared - and further transitional provisions provide some protection for existing products.
On the other hand, even for those who are well prepared, the Regulation may bring surprises. It provides a framework within which the European Commission will be able to impose new prohibitions on claims for products that fail to meet a “nutrient profile” - in essence, those products which are judged so basically unhealthy that they should not be capable of carrying any claim at all.
The profiles, which have yet to be developed, are the secret weapon of the Commission, the scope for which is buried in the detail of the Regulation. If used to their potential at a later date, they may prove to be a very powerful regulatory tool.
A claim is any representation - in writing, by way of a picture, or in any other form - which states or suggests that a food has certain characteristics. The Regulation applies to claims made in general advertising as well as to those made on a product itself. It prohibits absolutely certain types of claim, and places restrictions on others.
There are a number of general conditions which apply to the form, presentation and content of all claims.
The claim must not:
(a) be false, ambiguous or misleading;
(b) give rise to doubts about the composition of other foods;
(c) encourage excessive consumption;
(d) state or imply that a balanced diet cannot provide all of the nutrients a person needs;
(e) refer to changes in bodily functions in an alarming way.
The claim must:
(a) be expressed in terms that the average consumer is able to understand;
(b) be substantiated by generally accepted scientific evidence; and
(c) be capable of being justified by the food business making it.
Nutrition claims are claims that state, or imply, that a food product has nutritional properties that are beneficial to consumers, eg “fat free”, “reduced energy” or “high in fibre”.
Until the Regulation, the restrictions on nutrition claims in the UK were relatively light. The main requirement in relation to a nutrition claim was simply that it was factually accurate. More specific requirements applied only to a subset of claims that related to reduced/low energy foods, proteins, vitamins, minerals and cholesterol.
The Regulation marks a step change in the regulation of these claims and introduces a more detailed scheme. In particular, it establishes a positive list of permitted claims, all of which are set out in an Annex to the Regulation. The list may be added to by the Commission, but it is intended to be exhaustive at any given time. Any claim made must fall within the list, and any claim that is not on the list will be unlawful.
Health claims are claims that state, or imply, that there is a connection between a food and health, eg “contains calcium which promotes strong bones and teeth”.
Under UK law before the Regulation, health claims which suggested that a food has a role in preventing, treating or curing disease were prohibited outright. Under the Regulation they are not - one of its few liberalising effects.
On the other hand, certain types of health claims will now become prohibited, eg those in which an individual health professional provides an endorsement of the health benefits of a particular food. And other health claims can only be made if they are on a ‘permitted’ list and they comply with other provisions of the Regulation.
There are effectively two categories of permitted lists - one relating to claims which refer to the reduction of disease risk and children’s development and health, and the other to the remainder of the health claims.
Claims which refer to the reduction of disease risk or the role of the food in children’s development and health can be made only if they have been authorised in accordance with detailed procedures laid down in the Regulation. In summary, they must have been authorised by the Commission on the recommendation of the European Food Safety Authority, following a consultation process.
Other health claims do not need to go through this authorisation procedure, but can only be made if they are based on generally accepted scientific information, are well understood by the average consumer and are on a permitted list. Unlike the list of allowed nutrition claims, the list of health claims does not yet exist, but one will be adopted by the Commission by 31 January 2010 (and in the meantime existing rules will apply). The list may be amended by the Commission over time, but as with the list of permitted nutrition claims, it is meant to be exhaustive at any point in time.
In addition, permitted claims can only be made if certain information is provided on the label (or in the presentation and advertising) of the food, eg a statement indicating the importance of a balanced diet and a healthy lifestyle.
Checklist for businesses
The following is a very basic checklist for businesses considering whether a nutrition and/or health claim that they wish to make about a product can properly be made under the new Regulation. This is inevitably just a brief synopsis of the law, and not a substitute for product-specific legal advice.
Nutrition and Health Claims
- Is the product already on the market or labelled with the claim?
If so, it does not have to be withdrawn so long as the claim was lawful at the time of labelling. This transitional provision runs out on the expiry date of the product, with an absolute backstop date of 30 months from 20 January 2007.
- Does the claim take the form of a trade mark?
Trade marks may amount to claims in themselves - eg “Fruit and Fibre®” is a trade mark which clearly indicates that the product is a good source of fibre - a nutrition claim. If so, and if the trade mark was in use before 1 January 2005, it can continue to be used for a period of 15 years after the Regulation comes into force. Even if not in use before that date, the trade mark can still be used so long as the product is also labelled with a related (nutrition or health) claim that is compliant.
- Is the product an alcoholic beverage with a greater than 1.2 per cent abv?
If so, the only permissible claim is a nutrition claim which refers to low or reduced alcohol content or to reduced energy content. A health claim will not be allowed in any circumstance in relation to such a product
- Is the content of the product capable of justifying the claim? The claim must be justified in a number of different senses:
(a) The presence/absence or reduction in/of the relevant nutrient or substance (as the case may be) must have a beneficial nutritional or physiological effect.
(b) The nutrient/substance must be present or absent in the product in a quantity capable of having beneficial effects.
(c) The quantity of the product likely to be consumed must be such as to be capable of having a beneficial effect.
- Is there a nutrient profile for the product, and does the product comply with it?
This is not an issue at the present time, as no nutrient profiles have been established. However, if and when nutrient profiles has been established in relation to a product, the product will be unable to bear a nutrition claim unless it is consistent with that profile.
There is a derogation for products which:
(a) bear a nutrition claim relating only to a reduction in fat, saturates, trans-fatty acids, sugars or salt/sodium, or
(b) fail to meet the profile only because a single nutrient exceeds the permitted level.
The former do not have to comply with the nutrient profile. The latter can bear a claim so long as there is an accompanying statement that the product is high in the relevant nutrient. Nutrition claims only
- Was the nutrition claim being used, lawfully, before 1 January 2006?
If so, it can continue to be used for a period of three years after the Regulation comes into force, even if it does not meet the other criteria.
- Is the nutrition claim of a type on the permitted list?
The claim must be capable of categorisation as one of those listed in the Annex to the Regulation, and must comply with any conditions attached to it.
- Does the nutrition claim involve a comparison with other products?
If so, the comparison must be based on a range of foods of the same category, including those of different brands.
Health claims only
- Is the health claim describing or referring to the role of a nutrient/substance in the growth, development or function of the body?
The claim can be made until 31 January 2010 as long as it complies with existing rules (but thereafter only if on the permitted list).
- Is the health claim describing or referring to (i) psychological and behavioural functions or (ii) slimming or weight loss matters (including hunger and energy issues), and has it been made before 20 January 2007?
If the claim has been subject to evaluation and authorisation in a member state, it can be made until it is authorised and adopted by the Commission or until six months after the decision of the Commission not to authorise and adopt. If the claim has not been subject to evaluation and authorisation in a member state, it can be used provided an application for authorisation is made within 12 months and if the claim is not subsequently authorised until six months after the decision not to authorise.
The new Regulation has been a very long time in the making, and like all such documents reflects a series of political compromises. Embarrassingly for its promoters, the version that was published in the Official Journal on 20 December 2006 does not reflect the latest changes that were made to the draft, and is therefore incorrect on a number of key points. Until the necessary corrections are published, that version should be treated with caution.
Nonetheless, the Regulation is a substantial and important piece of law-making which for the first time harmonises European law in this area and lays down a detailed set of rules for any business wishing to attach health and nutrition claims to food products. Just as importantly, the Regulation contains a framework for continuing detailed regulation of claims in the future. By its ability to amend the permitted lists of claims, and to establish nutrient profiles for foods in the case of which no claims can be made, the Commission has been granted a powerful regulatory tool. It will be some time before we see the full effect of these powers in action. The Regulation is only the beginning of an important new phase in the law relating to health and nutrition claims