EAS: EU Member State Flexibility on Health Claims Wordings is Key

The Belgian guidelines are the first final guidelines officially published in the EU, and it is expected that these might be followed by further Member State 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’.

30 Nov 2012 --- Belgium’s guidelines on the flexibility of wording for health claims formulated differently to those listed in the EU Nutrition and Health Claims Regulation show that acceptable wording will vary considerably on national markets, EAS Strategic Advice has said.

Commenting on the guidelines published on 31 October 2012, 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 might be followed by further Member State 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 refer to both Article 13.1 claims and the permitted reformulation of Article 14 disease risk factor claims.

“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’.

The workshop, which is limited to a small group to enable participants to get actionable answers to questions, will cover in detail how national authorities will address divergent claims wordings, how product claims need to change, what will happen to issues still open to interpretation, and the extent to which communications to health care professionals and business-to-business communications will be permitted.

It will also cover timeframes for certain claims still ‘on hold’ and how these will be dealt with; how the national enforcement agencies will keep control of all of the new rules in practice, and the decisions likely to be taken on botanicals.

For more information about the workshop or to register, visit http://www.eas.eu/Event/32