New guidelines issued by Belgium hint at the extent to which health claims wording may vary across the EU, says international regulatory consultancy EAS.
The wording of article 13.1 claims under the Nutrition & Health Claims Regulation is seen by many in industry as both commercially restrictive and overly technical. Hopes have therefore been pinned on individual EU member states allowing for a more flexible ‘reformulation’ of wording at a national market level.
EAS regulatory affairs manager Stefanie Geiser said that member state flexibility will be a key determining factor for acceptable practices that deviate from the regulation.
The Belgian guidelines are the first final guidelines officially published in the EU, and it is expected that these will be followed by further national guidelines in 2013. They cover a number of aspects, in particular permitted and prohibited principles with concrete examples related to reformulations of the terms ‘contributes to’ and ‘normal’. They also cover how the claims wording related to a health function may be reformulated and/or enriched with certain additional information (mainly from European Food Safety Authority opinions).
“The guidelines issued by Belgium provide an idea of the expected variations of permitted claims wording practices in national markets,” said Geiser. “They also illustrate that there may be space for negotiations with national authorities on specific product cases based on acceptable market practice in other EU countries. An overall positive trend is that the Belgian authorities show some flexibility on the permission to enrich/amend authorised Article 13.1 claims wordings in line with related functions expressed by EFSA in its opinions. It is hoped that this concept will also be taken on in the future guidelines of other EU Member States.”
• To help companies navigate national interpretation differences and plan for marketing and regulatory compliance after the Article 13.1 list becomes applicable, Geiser and fellow EAS expert Patrick Coppens will host a workshop on 11 December in Brussels, titled ‘The Nutrition and Health Claims Regulation: Dealing with the present – Planning for the future’. For more information about the workshop or to register, visit http://www.eas.eu/Event/32