Joerg Gruenwald01.01.11
The Health Claim Regulation, meant to unify all of Europe as far as product labeling is concerned, continues to make headlines. Most recently, the widespread rejection of generic article 13.1 claims are causing the stir. These claims were in use before the new regulation came into effect, e.g. “calcium is good for bones.” Of the 44,000 claims originally submitted to the national authorities, 4185 claims ended up on the Commission’s consolidated list—the rest were considered duplicates or badly documented claims. The consolidated claims are currently being evaluated by the European Food Safety Authority (EFSA) based on “generally accepted scientific evidence”—the goal being to evaluate all non-botanical claims by June 2011.
The evaluation of claims on botanicals or herbal extracts will be postponed for the time being, since the present EFSA criteria on scientific evidence for claim substantiation are conflicting with the low requirements for claim substantiation for traditional herbal medicines. This would lead to an absurd situation in which claim substantiation for an herbal supplement would have to fulfill higher scientific standards compared to herbal drugs. The industry is awaiting a resolution for this discrepancy, which will hopefully come by next fall.
The third batch of generic article 13.1 claims was published last October, again with a devastating result for the industry. With each batch of published opinions, it has become clearer that EFSA is applying the same strict criteria it does for article 13.5 and 14 claim opinions. Of about 500 claim opinions published in October 2009, 105 opinions were positive. Of 416 claim opinions published in February 2010, only six were positive. Of 808 health claims assessed in October 2010, 162 were positive. It is important to know, however, that the evaluations by EFSA are not yet legally binding. The positive list of generic claims has to be enforced by the EU Commission, which is expected to happen by the end of 2011. The transition period for negatively evaluated claims will therefore end by mid-2012.
The consequences of the many rejections are far-reaching for the industry. Labeling needs to be changed, as no longer permissible claims must be removed. In many cases, packages need to be redesigned. The compositions and formulations of products must be changed. All this will incur costs that will lead to a shake-up in the market and put certain products at a competitive disadvantage.
The industry is responding with heavy lobbying activities, headed by food associations such as CIAA, ERNA and EHPM. Their efforts are directed toward the submission of additional scientific material, the stop of batch-wise approval of article 13.1 claims, for a better dialogue with EFSA and the Commission, and for more transparency of the evaluation criteria.
But criticism directed toward EFSA’s handling of claim applications does not originate from within the industry alone. Voices being raised from within EFSA point out that the EC’s guidance on article 13.1 claim evaluation has been inadequate. While for articles 13.5 and 14 claims the applicant submits a full dossier with all the available evidence, the article 13.1 claims are generic. This means that there is no “full body of scientific evidence” readily available to the EFSA panel that evaluates the claims, and the EC never clearly stated what level of evidence would be considered sufficient. Also, since no single applicant submitted the claims, EFSA had no point of contact for follow-up questions.
The key issue here is the “full body of evidence.” With articles 13.5 and 14 claims, it is the applicant’s responsibility to submit complete evidence, but what is the complete body of evidence for generic claims? Is it really the EFSA panel’s responsibility to “guess what is out there,” as Seppo Salminen, a member of the NDA panel at EFSA, put it in a recent statement? He went on to say, “Sometimes there were discrepancies between what data is available [to support a claim] and what was actually submitted to us for assessment.”
True, the high rejection rate sounds devastating. But, as Mr. Salminen said, “Looking at the data for the 4600+ article 13.1 claims, I don’t think many people would come to different conclusions than the [NDA] panel.”
There is also an issue with the woeful quality of applications. In fact, references provided to support them were in many cases far from “academic” (i.e., excerpts from the Old Testament, Wikipedia, a Tea Association press release, a Royal Air Force report and the American Heritage Dictionary, to name a few).
Some critics even go so far as to say that EFSA’s approach to assessing scientific evidence is not consistent with the wording of the legislation. “The Health Claims Regulation states that we should look at the totality of the available data. It also says that you have to weigh the evidence, and look at the extent to which a causal relationship between a food and a health benefit has been demonstrated, rather than seeking absolute proof,” one critic said.
In any case, implementation of the new Regulation is causing a lot of money to be spent, and another point raised against it is the fear that it will stifle innovation. At the same time, supporters are claiming the exact opposite (i.e., that innovation will be stimulated). Regardless, it is a highly controversial situation.
The EU commission has meanwhile stated that it will ditch the batch-wise assessment of article 13.1 claims. Still, the next opinions will only be issued in June, 2011. This means that, in addition to all other criticism directed at it, EFSA is way behind schedule.