The European Federation of Associations of Health Product Manufacturers (EHPM), the European Responsible Nutrition Alliance (ERNA) and the European Botanical Forum (EBF) have expressed deep concerns about the way in which article 13 of the EU nutrition and health claims is being implemented.
They agree that issues with the process should be urgently addressed before the European Food Safety Authority (EFSA) releases its first article 13 claims evaluation at the end of July.
The three federations represent more than 2,500 food supplement manufacturers, of which 80% are small- and medium-sized companies.
“We fear that the current process will lead to dismissal of a majority of the article 13 entries, not because of insufficient substantiation but because of a lack of clarity on an important number of issues that should first be addressed,” said Gert Krabichler, chairman of ERNA. “Therefore, we believe that the EC should take the time to carefully clarify all issues in a formal dialogue with stakeholders.”
Echoing his comments, Peter van Doorn, chairman of EHPM, said: “The nutrition and health claims regulation is of crucial importance for our member companies, as food supplement products need to indicate their effect and intended use in order to allow consumers to make an informed choice. These indications are considered as health claims, and the vast majority are based on generally accepted scientific evidence covered by the article 13 claims list. Many of these have been on the market for decades. We’ve entered a crucial phase now with the publication of the first EFSA opinions on these claims expected by the end of July, and we’re extremely concerned that the process followed isn’t working.”
The federations highlighted that despite several rounds of consultation over the last year between the Commission and member states, EFSA has sent back about half of the 4,000 claims initially submitted by the Commission for clarification.
All three federations provided input into the clarification process, and stressed the need for dialogue with stakeholders as a number of issues surrounding EFSA’s method of evaluation still remain unclear. They regret that the EFSA technical meeting with stakeholders of 15 June isn’t scheduled to address article 13.1 claims issues.
Manfred Ruthsatz, chairman of the European Botanical Forum, said: “We have identified a number of significant issues that need to be addressed to ensure that all article 13 claims are subject to an evaluation by EFSA based on the totality of available evidence, including traditional usage for botanicals, and that the Commission and member states are able to fulfil their role as risk managers. We believe that a constructive dialogue among all parties involved before the first opinions are published is the only way forward to avoid further confusion.”
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