The European Food Safety Authority (EFSA) last month published its first batch of article 13.1 claim evaluations, and it looks like most products will lose the ability to make use of claims for other ingredients and botanicals that have been used on the market for many years with no concern from governments or consumer groups.
In comparison to the United States and Asia, Europe has long struggled with the concept of innovation in the food sector. The novel food regulation dramatically increased the costs of bringing new ingredients to market, and the nutrition and health claims regulation would appear to be the killer blow.
Not because there is no evidence to support such claims but because the process being followed for the development of the article 13.1 claims list has been flawed with interpretation issues and lacking the transparency and legal certainty companies are entitled to expect.
The impact is huge, especially on the food supplement market, where bioactive ingredients and botanicals represent more than half of the products available and where consumers need information to make appropriate use of products. EHPM has always supported the goals of the nutrition and health claims regulation to protect consumers against misleading information and provide a level playing field and incentive to innovation for all companies across the European Union.
But we cannot support the fact that well-known and sufficiently substantiated claims will disappear from the market.
Playing the claim game
Article 13.1 claims are by their nature generic claims based on generally accepted scientific evidence. The Article 13.1 procedure was in itself developed to ensure well-accepted claims could continue to exist, thus enabling companies, particularly SMEs (small-to-medium enterprises), to make use of them without investing in lengthy and costly authorisation procedures.
Therefore the regulation provides for less detailed data to be submitted for their evaluation, as opposed to the more stringent data required for other types of claims, specifically those relating to disease risk reduction and children’s development and health (Article 14 claims). The result is that the information provided to EFSA for article 13.1 is less extensive and more generic than that for Article 14.
EFSA’s decision to evaluate all health claims according to the same criteria therefore, is damaging, as many of its article 13.1 negative opinions acknowledge supporting evidence but not enough to meet the article 13.5 and 14 criteria that has been established.
But this is a highly unfair situation as the regulation does not require that kind of information.
Handicapped
There has been a serious lack of guidance and transparency about how EFSA would evaluate the information received and this has essentially handicapped the efforts of companies when providing information to the member states. We have raised serious concerns regarding both the procedure and the scientific assessment.
It is unclear why, despite many calls from our sector, there has been no formal opportunity for all stakeholders to discuss the article 13.1 approach and the principles adopted by the scientists, given its serious impact on the sector. A public discussion on these EFSA standards and their impact is essential before any further decisions are taken.
As it stands, only very highly resourced, major brand multinationals are likely to benefit from the regulation as they can recoup of the costs of investing huge sums to gain claims approval. For SMEs, many of which drive market innovation, the economics simply don’t stack up.
This is a sad day for European competitiveness and consumers, who will also suffer as health claims are essential for informing them about the appropriate use of food supplements as well as functional foods. This restrictive application of the 2006 nutrition and health claims regulation will inevitably drive them towards other unregulated sources of information, which the enforcement agencies do not have the resources to control.
This approach leaves very little in the way of options for affected companies in our sector and potential legal action may appeal to some, even though this is a long term, costly effort with no guarantee of success.
Peter van Doorn is the chairman of EHPM (European Federation of Associations of Health Product Manufacturers), a trade group representing food supplements makers across Europe.
Health claims will be discussed at the NutraIngredients Health Claims 2010 conference to be held in Brussels on 10th December where the likes of Danone and Unilever will share their experiences with the process. For more information and to register, please click here .