EU health claims conversation must continue
The general consensus among health claim applicants from the EFSA Technical Stakeholders meeting in Brussels last week was that is was definitely a step in the right direction.
Most of those I talked to felt that the meeting was far better than they had expected with plenty of time for questions, even if we did not like some of the answers. There was an occasional murmur that “actions speak louder than words” and so everybody is hoping that the promised increases in dialogue and transparency materialise. But few doubt EFSA is earnest and open to debate on how it can improve, as all good scientitific bodies are.
The good news is that we get more dialogue and transparency but the bad news is the underlying problem still exists. There is still so little time to engage in this debate and conclusions are reached at such a late stage that withdrawals are not possible when more data/studies etc may be required.
In truth, EFSA can only delay their opinions by up to 15 days or two months (depending on which article it is submitted under) with “stop clocks”, and so scope for dialogue remains limited. Ominously, EFSA noted all its opinions to-date have met their legal deadline.
A potential solution could lie in the new Common Authorisation Procedure (Regulation 1331/2008) that has been adopted for new food improvement aids and will also most likely be adopted for novel foods in the future.
Here EFSA must produce an opinion within nine months of application receipt but variations are permitted and determined case-by-case.
The reason you do not see many negative food additives or novel food opinions from EFSA is that a scientific negotiation process occurs with the applicant who has the option of an inconclusive/negative opinion, withdrawal or submission of additional data as issues arise. They take longer but on balance I think industry would accept this, especially as it is clear there are too many applications, too few experts and precious little time.
The bad news is EFSA will not change its “cause-effect” principles for evaluation of claims. The good news is that we may be able to ask EFSA to evaluate “might/may” type health relationships if we ask for them up front.. We will need a test case or two to see if this is a genuine option, but at least there is an apparent open mind from EFSA.
That said, it is still down to the Commission and member states to accept such principles. It is interesting to note that a statement adopted in the new additives legislation Regulation 1333/2008 (Annex V) states “‘name or E number of the colour(s)’: may have an adverse effect on activity and attention in children.”.
Clearly the EC feels the term ‘may’ is understandable to the consumer, at least in a safety context. How this could be applied to health claims 8is unknown. In fairness, with 27 member states all with their own opinions to take into account it is difficult to get agreement on any judgement on wording that deviates from the exact scientific language used in EFSA opinions. Member states recognise that they need guidance on this.
We now have two definition issues in the Regulation. Firstly what is ‘health’? EFSA states that it has to evaluate whether a claim is beneficial to health, for example it stated that breast enlargement (“push up” capsules) is not.
But taking this in a wider context, there are many interpretations on what health is. For example does beauty = health, or is a resculptured profile really meant to be interpreted as a reduction in abdominal fat (i.e. of disease relevance) rather than simply to make a person have a nicer figure/appearance?
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The second issue is what is ‘proprietary data’? There still exists no legal definition and it seems the onus is on the competitors of the applicant to challenge them rather than the Commission to formally decide. This will be an issue for the new novel food regulation as well if adopted, so it needs “sorting” soon.
But the real concern that industry has, shared among regulators and enforcers, is the presence of a Refused Claims Annex in the Regulation. Refused claims are a real downer for all applicants and it is pure commercial sense that they would rather withdraw claims than deal with the fall-out of a refused claim.
This may also be true for an enforcer. For example take the plethora of omega-3 claims in relation to brain, eye and cognitive function. In the not-to-distant future we should have one approved claim across the EU for visual development along with several refused claims with similar wordings.
Surely all the enforcer needs to do is check whether a claim is on a positive list, not try to figure out whether it is on both annexes and then figure out which one applies. Its very confusing for them as well, so this would surely not benefit the protection of the consumer.
I have not discussed the 4000+-claim containing article 13.1 list because it may turn out to be a “white elephant” in the end and it was not up for discussion last week in Brussels.
But when you take this into account and all the issues above, it seems a logical conclusion that we need to simplify the regulation a bit now we know where the problems are.
At the same time, we do have to recognise industry is also responsible for some of the problems, such as the tight timelines and with saturating the system with too many claims that arguably have insufficient evidence (at least as far as EFSA’s requirements go).
And I don’t think it benefits anyone to lose momentum on the good aspects of the regulation but ongoing dialogue with EFSA is vital if this is to happen.
It may be we need to sit down with EFSA again sooner rather than later.
Nigel Baldwin is a senior scientific and regulatory consultant and EU manager for Cantox Health Sciences International.