Health claims rejected in EU have year of breathing room

Health claims rejected in EU have year of breathing room

Hundreds of Article 13.1 health claims rejected by the European Food Safety Authority (EFSA) are unlikely to be officially banned until well into 2012, according to Brussels-based EAS.

Hundreds of Article 13.1 health claims rejected by the European Food Safety Authority (EFSA) are unlikely to be officially banned until well into 2012, according to Brussels-based EAS.

The regulatory consultancy, which specializes in nutrition, said the European Commission had indicated that it intended to present its proposal for an Article 13.1 ‘Union list’ of approved claims by the end of this year at the earliest.

EAS said this meant itwas now unlikely that any ban on rejected claims – by way of a ‘negative register’ – would come into force before spring or summer next year.

Stefanie Geiser, regulatory affairs manager at EAS, said: “If the Commission’s proposal is adopted at the end of the year, there must still be a final adoption process, which includes a three-month European Parliament scrutiny procedure.

“In addition, the Commission will most likely also provide a post-Article 13 list transition period of some months. Therefore it’s unlikely that we will see a ban on any Article 13.1 claims before summer 2012.

“However, the ban is imminent and companies should be carefully monitoring the EFSA opinions and planning future strategies for marketing products that currently bear Article 13.1 claims.”

EFSA is assessing all health claims applications submitted under the EU’s Nutrition & Health Claims Regulation. Two last batches of Article 13.1 opinions are expected in June and September, after which the Commission will set about finalizing its proposal for the Union List. Claims on this list will be available for any company to utilize provided they meet the necessary conditions of use.

EFSA has now completed 80 percent of its Article 13.1 claims assessments for all substances excluding botanicals, with around 600 claims still to be assessed. The scientific agency issued a set of 442 Article 13.1 claims opinions in April, of which only 22 percent were positive.

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