09.29.10
Two moves by the European Commission regarding Article 13 and Article 14 health claims will affect omega 3 claims that have already received positive opinions from the European Food Safety Agency (EFSA), according to the Global Organization for EPA and DHA Omega-3.
Instead of adopting claim opinions on a rolling basis as they were received from EFSA, the list of permitted health claims for all non-botanicals will be adopted in a single step by the end of June 2011. Subsequently, claims regarding botanicals will be considered separately.
According to GOED, since EPA and DHA have received positive opinions for Article 13 triglyceride and blood pressure claims, the move means these claims would not be adopted until the June 2011 deadline at the earliest.
“GOED views this as a positive development,” the organization said in its newsletter, “because there has been considerable debate by the Commission on the conditions of use for the claims and the extra time should allow for a more scientific treatment of the EFSA opinions. At issue is whether high doses of EPA and DHA are needed for a triglyceride benefit. GOED originally submitted a robust dossier of evidence that supported a claim for the maintenance of healthy triglyceride levels that are already within normal ranges, but the Commission and EFSA have treated the submission like a pharmaceutical claim saying high doses were required for a clinically significant reduction in triglycerides. The differences between ‘maintenance’ and ‘reduction’ claims may seem subtle, but highlight the difference between nutritional claims for the general population and drug claims for a diseased population.”
EFSA has said it is currently evaluating another claim on blood fats that considers new evidence from a meta-analysis funded by GOED that more clearly demonstrates that a maintenance benefit can be obtained at nutritional dosage levels.
As for Article 14 claims, GOED said notes from the U.K.’s Food Standards Agency on the last Commission Working Group on claims indicate the Commission is getting frustrated by its lack of progress on DHA claims for visual acuity and children's brain development.
“The Commission has been trying to implement EFSA’s positive scientific opinions for over a year now, but because they have approved ALA claims in areas where seemingly less scientific support existed, the Commission has tried to apply a consistent approach to all omega 3 claims in brain and eye development,” GOED said. “The resolution and path forward are not clear, but it was suggested the Commission revert back to the original claims language rather than try to reconcile the claims with the various statements from EFSA in correspondence to the Commission or the language of EFSA opinions on similar claims for ALA.”
Instead of adopting claim opinions on a rolling basis as they were received from EFSA, the list of permitted health claims for all non-botanicals will be adopted in a single step by the end of June 2011. Subsequently, claims regarding botanicals will be considered separately.
According to GOED, since EPA and DHA have received positive opinions for Article 13 triglyceride and blood pressure claims, the move means these claims would not be adopted until the June 2011 deadline at the earliest.
“GOED views this as a positive development,” the organization said in its newsletter, “because there has been considerable debate by the Commission on the conditions of use for the claims and the extra time should allow for a more scientific treatment of the EFSA opinions. At issue is whether high doses of EPA and DHA are needed for a triglyceride benefit. GOED originally submitted a robust dossier of evidence that supported a claim for the maintenance of healthy triglyceride levels that are already within normal ranges, but the Commission and EFSA have treated the submission like a pharmaceutical claim saying high doses were required for a clinically significant reduction in triglycerides. The differences between ‘maintenance’ and ‘reduction’ claims may seem subtle, but highlight the difference between nutritional claims for the general population and drug claims for a diseased population.”
EFSA has said it is currently evaluating another claim on blood fats that considers new evidence from a meta-analysis funded by GOED that more clearly demonstrates that a maintenance benefit can be obtained at nutritional dosage levels.
As for Article 14 claims, GOED said notes from the U.K.’s Food Standards Agency on the last Commission Working Group on claims indicate the Commission is getting frustrated by its lack of progress on DHA claims for visual acuity and children's brain development.
“The Commission has been trying to implement EFSA’s positive scientific opinions for over a year now, but because they have approved ALA claims in areas where seemingly less scientific support existed, the Commission has tried to apply a consistent approach to all omega 3 claims in brain and eye development,” GOED said. “The resolution and path forward are not clear, but it was suggested the Commission revert back to the original claims language rather than try to reconcile the claims with the various statements from EFSA in correspondence to the Commission or the language of EFSA opinions on similar claims for ALA.”
