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Regulatory consultant EAS Strategic Advice (Brussels) said it expects other member states to follow suit with their own guidelines in 2013.
Belgium has become the first EU member state to publish guidelines on the flexibility of health claims wording under the EU’s Nutrition and Health Claims Regulation. By December 14, 2012, companies selling product in the EU must ensure their health claims wording adheres to the EU regulation’s permitted claims list.
Belgium published its guidelines on October 31. Regulatory consultant EAS Strategic Advice (Brussels) said it expects other member states to follow suit with their own guidelines in 2013.
Among the topics covered in the Belgian guidelines is use of the wording 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),” EAS stated in a press release. The guidelines refer to both Article 13.1 health claims and Article 14 disease risk claims.
“The guidelines issued by Belgium provide an idea of the expected variations of permitted claims wording practices in national markets,” said EAS regulatory affairs manager Stefanie 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 authorized Article 13.1 claims wordings in line with related functions expressed by EFSA in its opinions.”
EAS is holding a workshop in Brussels on December 11 on the Nutrition and Health Claims Regulation.