compliance with health claim regulations

Health Claims and the Current Regulatory Environment for Weight Management Products in the EU

Communication to consumers concerning all food products—including those targeted to consumers trying to manage their healthy weight—need to comply with Regulation (EU) 1169/2011 on the provision of food information to consumers.

By Petr Mensik

The EU market offers a variety of food products designed to help consumers manage a healthy weight. From the standard food products with adjusted nutritional profile offering consumers lower calorie versions of their favourite foods to state-of-the-art nutritional products designed to help overweight and obese individuals effectively lower their weight, all products need to comply with European food legislation.

Communication to consumers concerning all food products—including those targeted to consumers trying to manage their healthy weight—needs to comply with Regulation (EU) 1169/2011 on the provision of food information to consumers. To inform consumers about the specifically designed nutritional profile of these products, manufacturers use nutrition and health claims on their packaging as well as in other commercial communication. To prevent misleading the consumer, all nutrition and health claims must comply with another piece of the EU legislation—Regulation (EC) 1924/2006 on nutrition and health claims made on foods.

Furthermore, for some products there is an additional regulatory framework in place with which these products and related commercial communication need to comply. This framework—introduced by Regulation (EU) 609/2013 on foods for specific groups—sets compositional and labelling rules for several categories of food. These include products specifically formulated for overweight or obese adults to replace their whole daily diet called ’total diet replacement for weight control’. Unfortunately, the delegated Regulation (EU) 2017/1522 which sets the compositional and information requirements for total diet replacement products prohibits the use of nutrition and health claims on these products, except the nutrition claim ’added fibre’ provided the dietary fibre content is not less 10g.

On the contrary, products which are aiming to replace only part of a daily diet are eligible to bear nutrition and health claims. This category of products called ’meal replacement products for weight control’ used to be part of the previous legislative framework for foodstuffs intended for particular nutrition uses (PARNUTS). In order to prevent confusion with products intended for the general population carrying similar statements presented as health claims for weight control, the category of meal replacement products has been taken out of the framework for foods for specific groups. The products belonging to this category are now regulated solely under Regulation (EC) 1924/2006.

There are two authorised health claims intended specifically for these products: ’Substituting one daily meal of an energy restricted diet with a meal replacement contributes to the maintenance of weight after weight loss.’ and ’Substituting two daily meals of an energy restricted diet with meal replacements contributes to weight loss.’  To bear one of these claims, the products must comply with Regulation (EU) 2016/1413 which sets the conditions of use of the two health claims.

As mentioned above all nutrition and health claims made on foods need to be in accordance with Regulation (EC) 1924/2006. The Regulation lists all permitted nutrition claims (e.g. high in protein) and sets an authorisation procedure for all health claims intended to be used on foods and related commercial communication in the EU. Within the authorisation procedure, all health claims are evaluated by the European Food Safety Authority (EFSA). Most health claims which received favourable opinion from EFSA were authorised by the European Commission and are available in the EU Register of Nutrition and Health Claims made on foods.

However, there is one exception concerning health claims related to plants and their preparations—the botanicals. As there is no consensus on what is 'the highest possible standard' of data which would allow for the scientific substantiation of a health claim relating to botanicals, for the time being these health claims are put on hold. This means these health claims may still be used by business operators until the situation is resolved.

To examine whether the current rules concerning health claims on botanicals are adequate and how the use of such claims interacts with the current applicable food regulatory framework, the European Commission is working on an evaluation of the Evaluation of Regulation (EC) 1924/2006 on nutrition and health claims made on food, inter alia, in this regard.

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