EFSA and health claims

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The European Food Safety Authority (EFSA) is ploughing its way through thousands of dossiers from companies to evaluate if the health and nutrition claims they wish to use are justified. EFSA will not meet its deadline of January 2010 and there are now calls that the companies who submit incomplete dossiers which waste EFSA’s time should get penalty fines. Alternatively, charges could be made for assessments, but this could threaten the EFSA’s independence.

So far EFSA has issued 540 opinions on adult foods and about 30 on claims for products for infants, young children and mothers. Up until now EFSA has required evidence (but not independent evidence) that a particular ingredient has a particular benefit for a particular population. Because of this approach the vast majority of claims for lipids, galacto-oligosaccharides (prebiotics), probiotics and nucleotides all claiming to help brain, eye, mental and cognitive development or to aid ‘serenity’ and ‘calming,’ have been rejected. This has infuriated industry who at a meeting with EFSA in June demanded more time and opportunity for consultation. Since then EFSA has allowed Danone more time to submit extra confidential evidence on a claim - submitted in January 08 - that “Immunofortis naturally strengthens your baby’s immune system,” This claim has already been rejected by the UK Advertising Standards Authority (see page 10).

Merk challenged a negative EFSA opinion on its claim that synthetic DHA supplements during pregnancy and lactation can benefit eye and brain development. EFSA has since clarified its opinion and approved a general claim about maternal DHA intake. EFSA also approved Mead Johnson’s claim, that its DHA and AHA in Enfamil follow-on formula helps visual acuity even though the Cochrane Review of research on adding such ingredients to formula did not find any benefit.

This image appears on the Mead Johnson website. As you pull the lever across to the right on the graphic (adding more DHA enriched formula) the toy duck comes more into focus. Similar adverts have been used in adverts in China. Such images are powerful and deceptive and very undermining of breastfeeding

Although product specific claims will probably not be allowed, this is not really a safeguard. Breastmilk substitutes compete with breast milk which contains over 100 fatty acids and over 130 prebiotics. And supplements for mothers invariably undermine confidence in breastmilk quality. So a claim of any sort will work. Indeed in1996, Hambrecht & Quist Spot Report on the Martek Bio-sciences Corporation said: “Even if Formulaide (DHA/AHA) had no benefit we think that it would be widely incorporated into most formulas as a marketing tool and to allow companies to promote their formula as ‘closest to human milk’.” Martek has cornered the market for its synthetic DHA, which is now added to 90% of US formula. But there also risks. In the US, 98 reports have been made to the Food and Drug Administration of adverse reactions to synthetic DHA enriched formulas - which some call ‘diarrhoea formulas’ and say should carry warnings rather than claims.1 Sadly, EFSA looks only at ‘efficacy,’ leaving risk management to the Committee on Food Chain and Animal Health (SCoFCAH), which decides whether and how a claim should be permitted. EC ratified opinions must be implemented in six months, so by July 2010 claims on the negative list might go.

1. Replacing mother - Imitating Breast Milk in the Laboratory.




Follow-on milks

The UK Government position is that follow-on formulas provide no health advantage over breastfeeding or infant formula, (which can only carry claims listed in the Infant Formula Directive (141/2006/EC). So claims on follow-on formulas are not only misleading and deceptive (there is no health advantage) but also contrary to UK policy. (See page 18)

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