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Science versus politics.

Of the three DHA (docosahexaenoic acid) Article 14 claims authorized for use in Commission Regulation (EU) No. 440/2011 of 6 May 2011 on the authorization and refusal of certain health claims made on foods and referring to children's development and health, none sparked more debate than the claim "DHA intake contributes to the normal visual development of infants up to 12 months of age."

Under the co-decision process that health claims approvals go through in the EU, various parliamentary committees have the right to object to a claim, which then allows the full parliament to vote whether to approve or deny the claim. On 16 March 2011, the European Parliament (EP) Committee on the Environment, Public Health and Food Safety (ENVI) voted against authorizing the health claim that had already received a positive opinion from the European Food Safety Authority (EFSA) and proposed by the European Commission (EC) and the EU Standing Committee for the Food Chain and Animal Health (SCFCAH). The resolution incorrectly asserted that there was a lack of scientific consensus on the effect of DHA-fortified formula on infants, that more research was needed on the possible effects, both beneficial and harmful, of DHA supplements and that the health claim could be misleading.

The results of the vote were 30 in favour and 28 against the proposal that the EP should not authorize the health claim. Given the co-decision process, the ENVI vote in favour of the resolution meant that it (the claim) would be the subject of a plenary vote by the full European Parliament on 6 April. In advance of the 6 April Strasbourg Plenary Session, there were lobbying efforts from both those opposed to the claim and those in favour of the claim. Included in those lobbying efforts were those from GOED who wrote an open letter to members of the EP urging them to recognize the scientific consensus and rigorous review conducted by EFSA, and vote in favour of the claim by not supporting the resolution.

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On 6 April 2011, the full European Parliament (EP) supported the claim when they rejected the move to block it. The resolution opposing the claim did not achieve the necessary qualified majority of votes (388), so it was not passed. The vote was 328 in favour, 323 against and 26 abstentions. By default, with one more hurdle to go, the EP approved the plan under which the health claim could be added to the annex of permitted health claims. Fortunately, any last attempts to kill the health claim by the 21 April deadline did not happen. Thus, the science prevailed and the claim has been authorized for use since 26 May on foods on the EU market. According to the Regulation published on 6 May 2011, the claim is associated with the following conditions of use:

* information shall be given to the consumer that the beneficial effect is obtained with a daily intake of 100 mg of DHA.

* when the claim is used on follow-on formula the food shall contain at least 0.3% of the total fatty acids as DHA.

Although the resolution to oppose the authorization of the health claim was authored by MEP Glenis Wilmott and three other members of ENVI, the campaign against the claim appears to have been initiated by breast milk advocates, including Baby Milk Action. This organization has repeatedly criticized the industry saying that the science does not support the role of added or "synthetic" DHA in infant formula and only supports a benefit when delivered via mother's milk. The basis for such an erroneous assertion was the conclusion of a 2008 Cochrane Review -- "feeding term infants with milk formula enriched with LCPUFA had no proven benefit regarding vision, cognition or physical growth." However, the Cochrane Review did not consider the dosage level of DHA in infant formula; EFSA specifically evaluated this aspect and found that 0.3% of fatty acids from DHA was necessary to obtain a visual benefit, and that lower doses had no clear effect. In addition to Baby Milk Action's criticism, Wilmott claimed a lack of consistent peer-reviewed evidence demonstrating a benefit, but EFSA's favourable opinion suggested otherwise. That is, every randomized, controlled trial conducted with 0.3% DHA or higher has shown a benefit for visual acuity in infants.

Clearly, this was an emotionally charged political issue, rather than one grounded in science. Had the resolution to block the health claim received enough support, not only would parents have lost out on receiving critical nutritional information that is relevant to the development of their babies, but EFSA's credibility as an adviser to the Commission would have been undermined. Not authorizing the extensively vetted claim would have established a precedent by which the EP is able to overrule scientific opinions, essentially rendering EFSA's ability to advise obsolete.

For more information

Adam lsmail, Executive Director and Harry Rice, VP,

Regulatory and Scientific Affairs

Global Organization for EPA and DHA Omega-3 (GOED)

1075 East Hollywood Avenue

Salt Lake City, Utah 84105, USA

Tel. +1 801 746 1413

www.goedomega3.com
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Title Annotation:GOED report; Global Organization for EPA and DHA Omega-3
Author:lsmail, Adam
Publication:Nutraceutical Business & Technology
Geographic Code:4EUUK
Date:Jul 1, 2011
Words:844
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