EFSA release first batch of 94 health claim opinions

At last EFSA has released 94 opinions on a small batch of 523 health claims relating to over 200 food components. With 66% of the claims rejected (negative opinion) including the likes of glucosamine, the industry is again in turmoil - but it gets worse…

According to Directorate-General for Health and Consumers (DG SANCO) the body which helps make sure traders, manufactures and food producers observe their legal obligations, commented that those given a negative opinion by EFSA have 6 months to comply and be removed from the market.

In a recent exclusive interview with EU Food Law Weekly, Robert Madelin, director general of DG SANCO gave his opinion that, “those claims that EFSA says are bad have six months.” Although no time line has been given for the commission to make a comment the pace of enforcement of the rulings is concerning.

Although it looks like 66% of claims have been rejected, closer inspection of the wording within the text highlights additional positives. In some cases structure function comments have been made, which maybe useful to manufactures looking to imply a connection between an ingredient and an effect. These are cause and effect relationships rather than health claim per se.

The biggest concern from the opinions so far is the continual push that the claims made are “vague”. In an example Probi a leading manufacture of probiotics was told,

“The Panel considers that the claimed effect “immune system” is not sufficiently defined.”

EFSA, October 1^ST 2009

As such the associated claims are rejected not because of the science behind the product (Lactobacillus plantarum 299v), rather the claimed effect is too broad. This is concerning for 2 reasons, 1. The commission had already pushed back many claims to member states asking for clarifications on wording of claims not sufficiently defined and amended, 2. Media are likely to look at these opinions as proving these products/ingredients don’t work, when in many cases is will be a situation of resubmitting the dossiers with tighter wording which can then be thrown back to member states for interpretation of marketing flexibility. The additional concerns are that these opinions could be seen as “proof” of false marketing to the consumer, opening up legal risk for manufacturers to be taken to court due to misleading claims and a requirement for consumer compensation. This has recently been the case with Danone in the US.

Whilst industry take time to digest the opinions, and prepare for the October the 6^th stakeholder meeting over these claims, we wait with interest to see just what the fall out will be. The next scheduled list of opinions are February 2010 (700 claims), July 2010 (500 claims), and the final batch in summer 2011.

Given EFSA’s opinions carry no legal weight it will not be until the final adoption and publication of the “community list” will we know what the real impact could be. The future for these opinions now lie in the hands of the European Parliament and council, member states and ultimately external lawyers.