While not explicit in the document itself, industry sources have told NutraIngredients that if their concerns are not addressed by the European Commission and EU member states, as well as EFSA, legal teams are preparing for the possibility of challenging the controversial regulation in EU courts.
Responding to the publication of 523 article 13.1 health claim opinions by EFSA on October 1, EHPM (European Federation of Associations of Health Product Manufacturers), ERNA (European Responsible Nutrition Alliance) and EBF (European Botanical Forum) highlighted what they believe are several serious and damning flaws in the regulation and the manner of its implementation.
- Failure to communicate with applicants
- Inconsistent application of scientific criteria by EFSA
- Failure to publish substance characterisation guidelines
- Unclear distinction between sufficient and insufficient evidence
- Failure to discuss article 13.1 scientific principles with industry
- Preference for studies performed on healthy populations
- Failure to consider economic consequences of regulation
- Failure to consider health consequences of restricted consumer information
- Economic unfairness of staggered publication of opinions
The groups' full comments can be found here.
While the groups are holding out hope that dialogue can be opened about these issues with regulators, at a recent meeting they acknowledged this was increasingly unlikely and the legal challenge idea gained prominence.
This position followed a meeting with DG Sanco where industry concerns won little favour with EC representatives, who stated they were powerless to mediate the impact of the scientific opinions so far issued by EFSA.
As an example, the groups highlighted that glucosamine and chondroitin-related joint health claims may soon be wiped from EU markets, as these had drawn negative opinions from EFSA on October 1.
“The only ways to stop the course of this evaluation and avoid the disappearance of whole segments of claims for supplements will be through a combination of political action targeting member states and legal actions,” an EHPM member said in an email forwarded to NutraIngredients.
They will be hoping the paper, that took three weeks to prepare before being sent to the EC and member states, will go some way to energising political action, as it raises many detailed points.
In regard to EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) communication with applicants, the groups observe:
“We now see that EFSA rejects certain claims because of the same reason it has requested clarification for others. We fail to see the reasons or criteria EFSA has used to justify this difference and can only conclude that the approach seems arbitrary.”
On the fact that 171 of 181 probiotic dossiers failed because the strains were deemed to have been poorly characterised, EHPM/ERNA/EBF stated:
“[Among] the claims returned for clarification earlier this year there was none concerning the lack of characterisation of micro-organisms and, as far as we are aware, no further request has come to us to provide clarification on this aspect at another moment.”
The fact probiotic guidance was issued the day before the publication of the opinions on October 1, too late to be of use, also struck the groups as nonsensical.
They called on EFSA to reassess the opinions, adding that those probiotic strains and the products that contained them that had yet to be issued opinions would gain an unfair competitive advantage.
They also wondered why EFSA held a meeting on October 6 – after the article 13.1 publication - to discuss article 13.1 claims but only member states and not stakeholders were invited.
They therefore questioned the “commitment both by the EC and EFSA for transparency and involvement of stakeholders” and called on the EC and member states to meet to discuss the regulation’s, “terms of reference, current practice and proportionality, in the full acknowledgement of the potential serious economic consequences of decisions to be taken on the basis of inappropriate application of the law.”
On glucosamine/chondroitin and joint health claims, the groups noted claims were already approved in a number of member states including Belgium and Italy, and called for clarification of EFSA’s requirements in the area given healthy population assessments were not realistic.
“It must be observed that neither the terms of reference nor the Regulation itself explicitly require EFSA to judge the scientific evidence only for the general population. This is plainly obvious from the fact that claims on foods for particular nutritional uses (which are clearly not intended for the general population) fall under its scope.”
In the field of botanicals, EHPM/ERNA/EBF acknowledged that many dossiers were weak but queried why EFSA seemed to be utilising text book references in regard to some vitamins and minerals, but not for botanicals.
“We fail to see the point that these text books are used to characterise in detail the botanicals if the associated health effects are disregarded,” they said, adding:
“We would respectfully ask the EC and the Member States to consider the relevance of the EFSA approach as a justified basis to reject most botanical food supplements indications in the light of the principle of proportionality.”
The groups noted that while they had many issues with the opinions issued so far, only a few of the dossiers assessed so far related to a list of about 770 dossiers they had taken part in compiling and submitting.
Veteran US lawyer Jonathan Emord, who has successfully sued the FDA over its health claims system several times, will outline the grounds for challenging the EU system in the courts at the NutraIngredients Health Claims 2010 conference to be held in Brussels on 10th December. In addition, ERNA and the likes of Danone and Unilever will share their experiences with the process. For more information and to register, please click here .