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  Health Claims - Further assessment of Article 13 health claimsslide

Please note that data collection in relation to the further assessment process for certain Art.13 claims referred to below (deadline 30th September 2011) has now been completed

When evaluating health claims submitted for inclusion in the permitted list of Article 13 health claims, in certain cases, EFSA concluded that due to the incomplete nature of the data submitted, it could not provide a conclusive assessment in relation to their scientific substantiation. The Commission has looked at this, and has agreed with EU countries that, as risk managers, they would not be able to take a final decision on whether or not to include these claims in the list of permitted health claims and a further assessment should therefore be considered. The two categories of claims for which EFSA's assessment is considered as not conclusive are:

  • Health claims on micro-organisms which EFSA considered as insufficiently characterised to proceed with the assessment of the evidence since they were not properly characterised by genotypic identification of the strain using appropriate methodology.
  • Health claims for which EFSA concluded that "the evidence provided is insufficient to establish a cause and effect relationship".

EU countries' competent authority will be responsible for submission of additional data to the Commission, which will then forward it to EFSA. In order to facilitate the further assessment process, a guidance document pdf on the submission format has been prepared in cooperation with EFSA.

Any stakeholder who has an interest in submitting additional data for one of the claims qualifying for this process will be able to identify through a [ table of responsible Member States] which EU country is responsible for each claim and to whom this data should be submitted before 30 th September 2011. The table of responsible Member States EXCEL will be updated as necessary to allow stakeholders to keep track of the progress.

Stakeholders should make contact with national authorities for further information at the earliest opportunity. Claims for which the responsible EU country does not receive any interest from stakeholders will not be included in the process.



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