By setting an unworkably high standard for claims substantiation, EFSA is threatening R&D not to mention health claims that have long been officially approved in many jurisdictions.
The opinions issued to date indicate that the research investments of many innovative companies over many years is failing to convince EFSA to issue a positive opinion.
Many companies and especially small to medium enterprises (SMEs) may abandon research initiatives in favour of safer brand marketing strategies. An idealistic EFSA approach could result in a steep fall in research projects funded by industry in the coming years.
One can only wonder how many millions were invested by Unilever in support of the only claim EFSA has approved – a plant sterol/cholesterol-lowering claim. Few will be able to match that level of investment.
Many innovative products stem from SMEs, so this would be particularly detrimental to their ability to invest in research and development.
Achievable gold standard?
EFSA was given the task of evaluating the scientific substantiation for article 14 claims dossiers (disease risk reduction claims and children’s health claims) and article 13.5 claims dossiers (claims based on new evidence or with the request for the protection of proprietary data).
If we take their first nine opinions as a precedent for how it will judge the remaining 220 article 14 applications received to date, its apparent ‘gold’ standard of substantiation (which follows current practice for clinical research) looks unlikely to be achievable in practice for foods.
To EFSA’s credit, its opinions are very detailed and clear and they contain lessons for industry.
To be successful, the ingredient or food must be sufficiently defined (a dairy claim was rejected because the types of dairy products were not, as EFSA terms it, ‘characterised’).
Also, the claim must be supported by well-designed human intervention studies performed on particular products, and a well-defined cause-effect relationship must be demonstrated.
These opinions, however, despite being well written and scientifically sound, raise a number of concerns. The future of generic disease risk reduction claims on, for example, fibre, oats, fruits and vegetables is a huge issue.
These foods may be deemed to be insufficiently characterised, with no cause-effect relationship demonstrated, despite the fact that such have been accepted by various national authorities and in some cases even recommended in nutrition advice.
Another concern is whether or not EFSA will apply the same evaluation standards to article 13 claims (claims based on generally accepted scientific evidence) and if so, the outlook for many claims could be bleak.
Initial indications are that EFSA does intend to use the same criteria. It would bring into question whether a generic description such as ‘antioxidants’ for example, would be considered as sufficiently characterised. But EFSA’s evaluationcriteriahave not been made publicly available, which has frustrated industry.
It could be argued that the the EFSA opinions do not, for example, fulfil the requirements of the law – which is to take into account the totality of the evidence and weigh it in order to provide advice on “the extent to which” a cause and effect relationship has been established.
It is unclear whether EFSA will disregard all evidence other than human interventions studies. And if so, one could question whether such criteria are appropriate for article 13 claims.
There seems to be a disproportionate focus on human intervention studies and surprising lack of appreciation for evidence based on epidemiological/observational studies. While it is agreed the latter provide only an association and not definitive proof of a cause and effect relationship, one should bear in mind that much of what we already know about human nutrition and health is based on epidemiological evidence, including several national and international dietary goals and programmes.
Many botanical ingredients claims, for example, are based on traditional use and knowledge – evidence which is accepted also for traditional herbal medicinal products.
Science does not exist in isolation. EFSA must consider the practical reality of the evidence available. Let’s hope the EFSA experts hear that rational call.
Article 14 reduction of disease risk claims
Plant Sterols and Blood Cholesterol
Soy and Flaxseed product and bone mineral density
Primarily because the only controlled intervention trial had weaknesses
Prickly pear cactus product and blood lipid parameters
Primarily because the only study did not establish a cause–effect relationship
Article 14 children’s claims
Mixed ingredients product and immune system of children
Primarily because of a lack of intervention trials and insufficient characterisation of the product and the claim
ALA and LA and growth and development of children.
The wording “essential fatty acids are needed for normal growth and development of children” is accepted but it is noted that no benefit is demonstrated by intakes that are higher than through a balanced diet.
Dairy products (milk and cheese) and dental health
Primarily because the evidence presented is insufficient (only observational, cross-sectional studies)
Dairy foods and healthy body weight
Primarily because cross sectional studies only indicate an association, not a cause-effect relationship, and the product is not well characterised
DHA and ARA and development of brain and eyes
Primarily because a cause and effect relationship has
not been established between the consumption of DHA and ARA starting at six months of age
and the neural development of the brain and eyes in infants and young children up to the age of
Article 13.5 claim based on new scientific data claims
CLA, plants and cocoa product and regulation of body composition
Primarily because the one randomised, double-blinded, placebo-controlled human intervention study showed an insignificant and transitory effect
Lorène Courrège, is the director of regulatory affairs at the European Federation of Associations of Health Product Manufacturers (EHPM).