Where are missing article 13 health claims? asks EHPM

The European Federation of Associations of Health Product Manufacturers (EHPM) put out a statement today which said, “conditions of use and examples of wording have been changed without explanation, and entries have been omitted completely.”​

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The criticism follows that from fellow Belgium-based trade group, the European Responsible Nutrition Alliance (ERNA), which on Friday issued a statement that also raised questions about missing and altered claims.

ERNA, EHPM and other European trade groups submitted more than 700 health claims list and it is believed some 80 of them are missing from the list of about 4000 the European Food Safety Authority (EFSA) now has in its possession.

In response, an EFSA spokesperson told NutraIngredients.com if claims were missing or altered it was because of intervention by any of the 27 member states that view all claims, or by the European Commission.

“If something is missing it is not the fault of EFSA,”​ she affirmed. “We simply receive the list and then we go about issuing scientific opinions about the claims on the list. It is a misunderstanding that EFSA has played a part in creating this list.”​

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Gold standards​

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That issue aside, the two groups have taken the opportunity to continue their attack on EFSA’s scientific processes that privileges “gold standard”​ studies and which it is applying to all the health claims it has received be they generic (article 13) or relating to children’s and disease reduction claims (article 14).

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Given EFSA’s stated position that it will apply the same criteria to all​ health claims, industry’s ongoing criticism in this area may be somewhat futile, but EHPM made the point of reiterating its case, as had ERNA last week.

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EHPM said applying the same across-the-board criteria flew in the face of the“​​original intention of the law”.​

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The group said the regulation was intended to respect national-level generic claims that were often based on generally-accepted scientific evidence. With member states, trade groups and companies believing this kind of science was required to back article 13 claims, it was unfair to now apply article 14 criteria.

“We believe that the task of EFSA as originally intended by the regulation should be to check and confirm that the evidence supporting article 13.1 claims is considered as generally accepted, by taking into account and weighing all of the existing evidence,”​ said Lorene Courrege, EHPM’s director of regulatory affairs.

“However, EFSA would have great difficulties in applying the same assessment process as that used for article 14 claims, as the regulation has not requested member states to provide the same detailed information, since the claims were deemed to be supported by long established and non controversial science. ​

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“We believe the insistence of EFSA to apply the same process of assessment simply does not make sense and could potentially decimate the final article 13.1 list. We hope to clarify this in further talks with EFSA.”​

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The EFSA spokesperson said many in industry supported EFSA’s approach to assessing health claims and said the Parma-based assessor had not closed down industry dialogue.

EFSA’s agenda​

EFSA has set out a timeline for assessing the article 13 claims as follows:

• End July 2009: Assess about 1000 main entries which have passed pre-screening and have not been substantially modified.

• End November 2009: Assess about 470 main claims that have been amended since their original submission in November 2008 but subsequently passed pre-screening

• Deadline to be determined: Assess the remaining 2700 claims.