On 19 January 2007 a European Regulation (Regulation EC No.1924/2006) establishing the first fully harmonised regime on the use of nutrition and health claims made on foods in the European Union became law. It provides detailed regulation of the circumstances in which claims such as “low fat” or “helps lower cholesterol”may andmay not bemade. The Regulation establishes general principles which will apply to all claims, and detailed rules in relation to specific types of claim. Further detail is to be developed by the Commission, for example in establishing a list of permitted health claims, in consultation with interested parties over the coming years. Producers should take advantage of the consultation processes.
This is amajor piece of consumer protection legislation, which aims to preventmanufacturers frommisleading consumers through ensuring claims are linked to specific conditions whichmust be capable of substantiation. It is also designed to facilitate consumer choice, contribute to a higher level of health protection, and ensure fair competition across the EU. The Regulation is binding in its entirety and will have direct effect in allMember States. As such it will be directly enforceable by citizens in theMember States’ national courts.
The Regulation is stated to take effect from1 July 2007, although in fact the requirements will be phased in over an extended period through detailed transitional provisions. For example, food placed on themarket or labelled prior to 1 July 2007 need not be withdrawn so long as the claim was lawful at the time of labelling until that product reaches its expiry date or 31 July 2009, whichever is sooner. Clearly producers of products with a short shelf life will need to ensure compliance as fromJuly of this year. In this article we consider:
- The scope of the Regulation
- The key principles which will apply to all nutrition and health claims
- Conditions specific to health claims
- Conditions specific to nutrition claims
- The impact of the Regulation on trademarks and “name claims”
- Practical issues formanufacturers
Application of the Regulation
The Regulation applies to all food and drink products produced for human consumption to be sold on the EU/Member Statesmarket. This includes food supplements,mineral water, and non-pre packaged foods such as fruit, vegetables and bread, although there are someminor exceptions for non-pre packaged foods. The Regulation applies to “claims”made in relation to such products. A claimis any representation in writing by picture or any other formwhich states or suggests that a food has certain characteristics. This applies to claimsmade in commercial communications, on the product itself, in labelling, presentation or in general advertising.
Health claims are claims which state or imply that there is a relationship between a specific food and improved health eg, “contains calciumwhich is good for strong bones and teeth”. Nutrition claimsmake an assertion that a product has nutritional properties which are beneficial to consumers such as “fat free”, “high fibre” or “high in Vitamin C”.
The Regulation sets down some overarching principles which apply to all nutrition and health claims which are set out below:
- Be false, ambiguous, ormisleading
- Give rise to doubt about the safety of other foods
- Encourage or condone the excessive consumption of food
- Suggest a balanced diet cannot provide appropriate quantities of nutrients
- Refer to changes in bodily functions which could create or exploit fear
- Comply with any relevant “Nutrient Profiles” and their attached conditions of use. The Commission is to establish these profiles by January 2009 following a consultation process with interested parties. The profiles will for example take into account the permitted levels of fat, salt, sugar etc whichmay be contained in that particular food, and will be based on scientific opinion of the European Food Safety Authority, “EFSA”. There will be a transitional period of up to 2 years for compliance after adoption of these profiles.
- Be expressed in terms that the average consumer is able to understand
- Also detail nutritional information regarding energy value and the amounts of protein, carbohydrates, sugars, fats, saturates, fibre and sodium, with the exception of generic advertising
- Where applicable, the nutrient or other substance for which the claimismademust be in a formavailable to be used by the body
- Be substantiated by generally accepted scientific evidence - producers shall justify their use of the claim. The competent authoritiesmay request the operator or person placing the product on themarket to produce all relevant elements and data establishing compliance with the Regulation.
- Be capable of justification by generally accepted scientific evidence that:
- The presence, absence or reduced presence in a food of a nutrient or other substance in respect of which the claimis made has been shown to have a beneficial nutritional or physiological effect
- The nutrient or substance for which the claimismade must be present or absent in such quantity as to have the beneficial effects claimed
- The quantity of the product likely to be consumed must be capable of having the beneficial effects claimed There are also specific conditionswhich will apply depending on whether the claimis a health or nutrition claim, which we set out below:
Specific conditions for Health Claims
These claimsmust include information as to how much or how often the product is to be consumed to result in the beneficial effect, include a statement as to the importance of a balanced diet and healthy lifestyle, warn where there are health risks of excessive consumption, and, if appropriate, advise as to those who should avoid the product.
To consider the requirements under the Regulation for making heath claims, it is useful to consider these claims in four categories as identified below:
The following types of health claims are prohibited to the extent set out below:
• Non-specific well being claims such as “helps your body to resist stress” will not be allowed unless there is also a more specific, positive listed health claim.
- Claims that healthmay be affected by not consuming the food
- Health claims whichmake reference to rate/amount of weight loss
- Claims in which an individual health professional or association endorse the health benefits of a food, for example “as recommended by the British Heart Foundation” and which are not regulated by Community or national law will generally be prohibited.
- drinks containingmore than 1.2%alcohol by volume shall not bear health claims. The only permissible claimis a nutrition claimwhich refers to low or reduced alcohol content or to reduced energy content.
Health claims which are not prohibitedmay only bemade if they are on a ‘Permitted List’ and comply with the other provisions of the Regulation. Unlike nutrition claims, the list of permitted health claims has not yet been drawn up, and will be prepared on the basis of claims submitted by the Member States.Member States will provide the Commission with a positive list of these claims plus scientific evidence provided by industry by 31 January 2008. The Commissionmust then adopt a list of permitted claims together with their conditions for use by 31 January 2010. In the interimexisting rules will apply.
Claims on the List will not require specific authorisation, but will be allowed if the key principles have been complied with, for example the producer can verify the link between the claimand the product based on generally accepted scientific information, and the food complies any relevant Nutrient Profile.
Claims relating to slimming (eg, reduces calorie intake); growth, development and functions of the body (eg, good for bones); psychological or behavioural functions (eg, improvesmemory) and hunger reduction or reduction of available energy (energy restricted diets)must be on a Permitted List to be used without prior authorisation.
New claims are those which are essentially those which are not prohibited and which are not on the Permitted List. Prior authorisation is required for new claims, and formost claims therewill be a fast track rather than the full authorisation procedure to encourage innovation. The authorisation procedure requires submission of a dossier to the EFSA who issue a risk assessment (within 5 months subject to extension) prior to Commission’s final decision. The level of substantiation required in relation to claims is unclear. Health claims based on new scientific datamust be submitted to the EFSA for evaluation before they can be authorised for use. If the EFSA opinion is positive the Commission will take a decision on whether to authorise after simple consultation with theMember States.
Otherwise the standard comitology procedure will be used under whichmember state experts will vote on a commission proposal in the Standing Committee on the Food Chain and Animal Health.
d) Claims requiring full authorisation
These claimsmust be authorised by the Commission on a case by case basis following submission of a scientific dossier to the EFSA. Full authorisation will be required in the following cases:
- Claims referring to the reduction of the risk of disease eg, “helps reduce risk of osteoporosis”. Such claimsmust be accompanied by a statement that altering one ofmultiple risk factorsmay ormay not have a beneficial effect.
- Claims relating to children’s development and health. Before the Regulation any health claims which suggested a food had a role in preventing, treating or curing disease were prohibited. This is no longer the case under the Regulation.
Specific conditions for Nutrition claims
In relation to nutrition claims, generally accepted scientific datamust substantiate the beneficial nutritional or psychological effect claimed.
Such claims will only be permitted if they are listed in the Annex to the Regulation and the conditions set out for that claimare complied with. For example:
- “Low sugars” may only be claimed where the product contains no more than 5g of sugars per 100g for solids or 2.5g per 100ml for liquids.
- “Fat free” may only be claimed where the product contains no more than 0.5g fat per 100g or 100ml. Claims of X%fat free are completely prohibited.
- No other claims will be permitted unless the Annex is amended to include them. This introduces a farmore detailed regime into the UK than was previously in place.
There is a derogation for products which:
- bear a nutrition claimrelating only to a reduction in fat, saturates, trans-fatty acids, sugars or salt/sodiumwhich do not have to comply with the nutrient profile, and • those which fail tomeet the profile because a single nutrient exceeds the permitted level. These can bear a claimso long as there is a statement that the product is high in that nutrient.
The transitional arrangements for nutrient claims are that if the claimwas being used lawfully before 1 January 2006 it can continue to be used for 3 years after the Regulation comes into force.
TradeMarks and Name Claims
Trademarks or brand names whichmay be seen as claims in themselves such as “Vitalite” or “Fruit and Fibre” will only be permitted without prior authorisation if accompanied by a related and scientifically justifiable nutrition or health claim. There is a transitional period until 19 January 2022 during which products which had name claims before 1 January 2005 may continue to bemarketed.
Member State authorities have already begun the task of collating the list of permitted health claims. Food manufacturers should therefore start considering the claims they wish to submit to ensure they have sufficient time to gather the requisite supporting scientific evidence before the deadline of 31 January 2008. The food industry must review which new health claimsmay require approval. There will clearly be a period in whichmanufacturers will remain in limbo regarding which claims will be allowed under nutrient profiling, what claims will appear on the positive lists of generally accepted claims, and which claims will require authorisation.Where authorisation is required and therefore a dossiermust be submitted, this will require careful formulation includingmeasures to protect proprietory data. Food/drink manufacturers should ensure that they protect their interests by participating effectively in the Commission consultations regarding nutrient profiles.
In some casesmanufacturers will need to consider whether current claimsmade, particularly generic claims or “name claims” are of sufficientmarketing importance to warrant either reformulation of the product to satisfy the profile requirements or an application for authorisation of the claim.
The Regulation establishes a detailed framework for the continuing regulation of claims in the future, and it is clear that it will have a significant impact on the composition of food products and how they aremarketed.
This provides the Commission with a potentially powerful method of regulation particularly through the ability to amend the permitted lists of claims and through the establishment of the nutrient profiles with which specific foods will need to comply. There will therefore be further developments in the future as these areas are developed. We understand theremay also be further amendments in the future to include changes to EUadministrative procedures