DoH Interested Parties Letter, 25 March 2011
Nutrition claims – discussion on revision of the list of permitted nutrition claims (current draft proposal is attached at the end of this note)
‘No added salt’
Two member states (MS) reiterated the suggestion that the claim should be permitted on products including additives containing salt/sodium; others argued against on grounds that this would be misleading and that it was not possible to distinguish analytically between sources of sodium.
‘No added sugars’
Several MS spoke in support of the current proposed wording and in support of introducing a transition period to allow food business operators (FBOs) time to comply with the changed criteria. The Commission asked if a six-month transition would be long enough.
‘Now contains X% less’
There appears to be increased opposition to the claim, several MS reiterated concerns that the claim did not comply with Article 9 of the nutrition and health claims regulation (NHCR), that it would be misleading to consumers and that it would be difficult to enforce. Others supported the claim at the same time indicating that they would prefer the minimum reduction to be 10% rather than 15%. There was some concern about allowing products that had been labelled and placed on the market before the end of the one-year period to be sold until stocks were exhausted.
Discussions on health claims opinions received from EFSA recently
None of these three claims (Q-2010-00950: L. plantarum TENSIA in the semihard Edam-type ‘heart-cheese’ and maintenance of normal blood pressure (Article 13.5); Q-2008-05014: Water and reduced risk of development of dehydration and concomitant decrease of performance (Article 14); Q-2009-00501: calcium-containing fruit juices and reduction of tooth demineralisation (Article 14)) had received a positive opinion from EFSA. MS had no comments.
Q-2009-00776: oat beta-glucan and lowering blood cholesterol and reduced risk of heart disease (Article 14)
The Commission proposed setting a minimum content of 1g oat beta-glucan (OBG)/quantified portion for a food to bear the claim arguing that this figure takes into account the OBG content of a reasonable range of foods currently on the market; there was some support for this. The Commission reminded MS that viscosity affects the cholesterol-lowering effect of OBG and that it is determined by the molecular weight (MW), solubility and concentration of OBG.
After a difficult discussion on how best to reflect this in the conditions of use (COU) for the claim the Commission concluded that it would draft COU that required the OBG to be viscous and that excluded low MW OBG. Two MS commented that this was not in complete agreement with the EFSA opinion and might unjustifiably prevent certain products from carrying the claim. The claim is likely to go for a vote at the 2 May meeting of the standing committee on the food chain and animal health.
Q-2010-00784: ”Toothkind” drinks and reduction of tooth demineralisation (Article 13(5))
The Commission is having internal discussions about the validity of this claim and how it might be perceived by consumers.
List of article 13 health claims.
The document under discussion was the Commission’s spreadsheet of Article 13(1) claims with positive EFSA opinions. The discussion covered much old ground so this note only mentions new points.
Claims for fibres such as glucomannan / pectin / guar gum
The Commission is consulting colleagues to ensure coherence with legislation on additives and novel foods; it noted that these substances are already on sale as foods rather than additives (e.g. pectin for jam making). There is likely to be further discussion about whether any of these substances present a choking risk at the quantities required for health claims. Several MS would like EFSA to conduct a safety assessment of these substances before considering these claims further.
Claims such as ‘pectin contributes to a reduction in blood glucose rise after meals’ where the target population is adults willing to reduce their post-prandial glycaemic responses
Some MS considered that the target population was diabetic patients and that authorising such a claim would go against national policies preventing the marketing of such foods. EFSA commented that impaired glucose tolerance is common in the general population and thus supported the Commission’s view that non-diabetic members of the general population may be interested in managing their blood glucose levels.
‘Psychological’ claims (mental or cognitive performance) expressed as ‘x has a role in the function of the brain’ to make them less emotive
One MS asked whether, in making use of flexibility of wording, FBOs would be permitted to mention some of the specific functions cited in EFSA’s opinions thereby giving claims more weight than warranted; the Commission agreed that this could be a problem and invited MS to propose solutions.
Melatonin, lactulose considered medicinal in some MS
Some MS are concerned that authorising claims for these substances might appear to harmonise their categorisation as foods rather than as medicinal substances. Ideas for possible ways of addressing this were floated: a recital to the authorising Regulation could state that this was not the case; or annex three in regulation 1925/2006 could somehow be used. The Commission will check the novel food status of melatonin.
DHA – options for claims with high intake requirements e.g. DHA and EPA contributes to maintenance of normal blood pressure (3g/day; DHA and EPA contribute to maintenance of normal triglyceride concentrations (2g/day)
There was a reiteration of concerns over high intakes. The Commission suggested options: authorise both types of claims along with safety warnings; authorise the triglyceride claim since the 2g/day was not risky; authorise neither since the claim ‘DHA and EPA contribute to the normal function of the heart’ (250mg required daily) was likely to be authorised. Several MS would like EFSA to do a safety assessment of high intakes before considering the claims further.
Is a ‘reduced cholesterol’ claim permitted?
Several MS objected to such a claim on policy grounds. As to legal considerations: one MS thought that cholesterol was neither a ‘nutrient’ nor a ‘micronutrient’ under the NHCR and therefore could not satisfy the COU for the ‘reduced’ claim however several other MS disagreed. One MS argued that since dietary cholesterol does not have a significant negative impact on health for most people a ‘reduced cholesterol’ claim would not indicate that a food had beneficial nutritional properties and therefore would not be a nutrition claim as defined in the NHCR. However, another argued against this point of view on grounds that dietary cholesterol is important for a small proportion of the population.
Double efficacy campaign from Benecol
Benecol has announced the results of a meta-analysis which it claims shows that high doses of plant stanol esters have twice the cholesterol-lowering power of plant sterol esters. This is on an area of a website declared to be for healthcare professionals but which can be accessed by other consumers. In this context does the health claim fall within the scope of the NHCR and, if so, is it a permitted claim? Those MS who spoke agreed that the claim was within scope. They also appeared to agree that it does not comply with the authorised claim for cholesterol reduction by suggesting a potential reduction of 17% with a daily consumption of 9g plant stanols.
For an ‘energy-reduced’ claim on an alcoholic beverage do the COU in the annex or do national provisions apply?
Articles 4.3 and 4.4 NHCR appear to be contradictory. The issue of which rules apply to nutrition claims for alcoholic drinks may be discussed at the ad hoc working group later in the year.
The Commission said that discussions might begin at the end of the year.
Next batch of EFSA opinions and next working group meeting
EFSA is likely to issue the next batch of opinions on Article 13 claims before the next working group meeting which will be on Friday 29 April.