By Alison Sharper - 23 October 2017

Recent changes to the regulatory landscape

The majority of 'sports' products including protein powders and drinks are now regulated as ‘normal’ foods. Until recently, sports foods were classified as ‘foods intended for particular nutritional uses’ if they complied with the provisions of the Foods for Particular Nutritional Uses legislation (Directive 2009/39/EC). Regulation (EU) No. 609/2013 on foods for specific groups came into force on 20 July 2016: it abolishes the concept of food intended for particular uses and repealed Directive 2009/39/EC. It replaced the Directive with a framework covering only foods for certain vulnerable groups of consumers - for example infant formulas, baby foods, foods for special medicinal purposes and total diet replacement products - for which specific composition and information rules were justified.

So, since 20 July 2016 sports foods are now exclusively governed by horizontal food law, such as the legislation on:

• nutrition and health claims,
• addition of vitamins and minerals and other substances to foods
• food information
• food supplements
• novel foods

Also, article 14 of the EU General Food Law Regulation 178/2002 requires that food must not be placed on the market if it is unsafe. It is the responsibility of the sports food manufacturer to ensure compliance and Member States are responsible for enforcement. In some countries sports foods may require notification for monitoring purposes.

Vitamins, minerals and food supplements

As mentioned above, the majority of ‘sports’ products - including protein powders and drinks - are now regulated as ‘normal’ foods. The exception is a product, containing concentrated sources of vitamins and minerals or nutrients and other substance with a nutritional or physiological effect and marketed as a food supplement.

Such a product falls within the scope of Directive 2002/46/EC on food supplements; this specifies compositional and labelling requirements of food supplements, including the vitamin formulations and mineral substances permitted to be used. It also provides for the setting of maximum permitted levels for nutrients. At present these have not been laid down in law, however, safety is an overriding consideration, so upper safe levels as recommended by industry groups, EFSA and the UK Expert Group on Vitamins and Minerals can be used as a guide when formulating products.

Novel foods

The use of any new or novel ingredient must satisfy the Novel Food Regulations; this requires that any substance that has not been used to a significant degree in the EU since May 1997 (when the Regulations were enforced) has to gain approval before it can be used in a product and marketed in the EU.

Nutrition and health claims

Any claims made for a food product must comply with Regulation (EU) No 1924/2006 on nutrition and health claims. This covers any statement made on a label, in advertising material or commercial communication relating to a product aimed at the final consumer. The EU has produced a list of authorised nutrition and health claims which may be used on a food product. These may only be used if the product satisfies the conditions laid down for each claim. For instance:

• a claim that a product is high in protein may only be made for a product where at least 20% of the energy value of the food is provided by protein.
• a claim that a product is a “source of” a particular vitamin or mineral is only permitted if it provides at least 15% of the daily nutrient reference value for the nutrient in a quantity of the product that can reasonably be expected to be consumed in a day.

A particular issue with vitamins and minerals is that in sports foods, vitamins and minerals are sometimes added at a lower level than the 15% significant amount, and the fortification legislation provides for the possibility of granting a derogation to this requirement in justified cases for certain categories of food.

The EU Nutrition and Health Claims Register lists authorised health claims and specifies the conditions that must be met in order to use them. The wording for each claim is very precise and whilst a certain flexibility of wording is permitted it must not alter or strengthen the intended meaning of the claim. Health claims targeting sportspeople should be backed by scientific evidence specific for this target group.

Information for consumers

Another key piece of legislation is Regulation (EU) No 1169/2011 on food information for consumers. This lays down the general principles, requirements and responsibilities for food information, in particular food labelling to ensure consumers are provided with clear, accurate and not misleading information about the products they are buying. The instructions for use must be indicated in such a manner as to enable appropriate use.

Enforcement responsibilities

Enforcement of the legislation in the UK is the responsibility of the Competent Authority. In the UK the Food Standards Agency (FSA) is the government body responsible for food safety and hygiene and the Department of Health covers health and nutrition. Local Authority Environmental Health Officers and Trading Standards Officers deal with a wide range of issues including consumer protection and fair information practices such as labelling and claims. They can ultimately instigate prosecutions against food business operators in breach of the legislation. Medicines are the responsibility of the Medicines and Health products Regulatory Agency (MHRA), whose Borderline section look at any food products that fall between the two areas either in terms of composition or claims made for them.

Next steps

If you are involved with the design or marketing of healthy products and need help to ensure your products comply with food labelling and nutrition and health claims legislation then you may be interested in our one day specialist nutrition and health claims course.

Alison Sharper, Principal Food Law Advisor
+44(0)1386 842282
alison.sharper@campdenbri.co.uk