Several health claims rejected by the European Food Safety Authority (EFSA) could have previously been returned to Member States for more information - but were not pinpointed during pre-screening, the European Commission has admitted.
A substantial number of the article 13.1 claims were issued with negative opinions earlier this month because the substances in question had not been properly characterised. This caused huge frustration among some ingredients suppliers, who felt the claims should therefore have been sent back to the Member States without being assessed, along with scores of others last year.
In particular, several probiotics suppliers argued they had the information EFSA required, but did not know now what to do as these claims had already been assessed. That was according to Lorène Courrège at the European Federation of Associations of Health Product Manufacturers. “We are puzzled that EFSA has not asked for further clarification on those claims to Member States, as it has done for so many other claims.”
There were six criteria for returning claims to Member States during the Commission’s ‘pre-screening’ (before claims collated by Member States were passed to EFSA). One was that ingredients were characterised, said a spokeswoman for the Commission.
But, in practice, claims had only been returned where it was immediately obvious they did not meet this criterion, “for example claims about ‘foods in general’ or ‘dairy products’”, she said. “It only became obvious during the detailed scientific assessment of the claims by EFSA that a number of other substances were also not sufficiently characterised.”
However, there was no official means by which firms could submit missing information once a negative opinion had been issued, she said. “It was the responsibility of Member States to ensure information allowing a scientific assessment accompanied the claims submitted. Re-submission of claims with the missing information on probiotics [for example] is therefore not possible.”
A spokeswoman for EFSA said that if companies were unhappy about this issue, “they should speak to the Commission”
Dr Julian Stowell, regulatory affairs supreme at Danisco, praised EFSA’s scientific rigour. But he said the key problem had been a failure of communication at the beginning of the process as to what information was required. “As a result, some claims appear to have been rejected on technicalities.”
Christian Artaria, marketing director at natural extracts specialist Indena, said he also had concerns about whether “the filed documentation with EFSA actually included all the science available for each product in the list”. However, companies could re-apply by conducting proprietary studies on these ingredients and submitting applications under article 13.5 or 14 of the health claims Regulation, he said.
Patrick Coppens, secretary general of the European Responsible Nutrition Alliance (ERNA), said it was a “complete mystery” why some probiotics and botanicals claims had not been returned to Member States - especially if EFDA felt ingredients had not been properly characterised.