Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2014;12(1):3553 [37 pp.].
doi
10.2903/j.efsa.2014.3553
Acknowledgements

EFSA wishes to thank the members of: the Scientific Committee, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the Panel on Dietetic Products, Nutrition and Allergies (NDA), the Panel on Food Additives and Nutrient Sources Added to Food (ANS), the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), the Panel on Genetically Modified Organisms (GMO) for the preparatory work on this scientific output and EFSA staff: Per Bergman, Majlinda Lahaniatis, Maria Astridou, Daniela Maurici and Tobin Robinson for the support provided to this output.

Contact
Type
Scientific Report of EFSA
On request from
EFSA
Question Number
EFSA-Q-2013-00975
Approved
30 January 2014
Published
31 January 2014
Affiliation
European Food Safety Authority (EFSA) Parma Italy
Note
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Abstract

During the risk assessment of regulated products additional or supplementary information may be needed to be gathered and analysed by the European Food Safety Authority. This is performed, either through “calls for data” as prescribed through some sectoral legislation or through a mechanism of suspended timelines for the risk assessment. The timeline and specificities of use of suspended timelines for the risk assessment, is specified by the sectoral legislation and may diverge from one area to another. In this respect, the setting of indicative timelines for submitting additional or supplementary information needed to complete the risk assessment, aims at streamlining the interaction between EFSA and applicants.

Summary

The Scientific Evaluation of Regulated Products Directorate (REPRO) supports EFSA’s work in the evaluation of substances, products and claims intended to be used in the food chain in order to protect public, plant and animal health as well as the environment. Its units focus on the following specific areas: feed additives, food additives, food contact materials, food flavourings, enzymes, genetically modified organisms, nutrition, food allergies, novel foods and pesticides.

The regulatory processes that form the basis for EFSA’s evaluation activities of regulated products are defined in a number of sector-specific regulations with different requirements. The streamlining of certain steps under the legal acts governing the risk assessment of regulated products within EFSA aims at streamlining the interaction between EFSA and applicants.

A mapping exercise regarding the timelines used by different Panels to request additional or supplementary information during the risk assessment process was performed within EFSA in 2012. As an outcome of this exercise a proposal for the streamlining of these timelines was prepared. The proposal in form of this report was reviewed and consulted with the EFSA Scientific Panels (ANS, CEF, FEEDAP, GMO, NDA), as well as the Scientific Committee during first half of 2013. The Scientific Committee took note and supported this report during the final consultation in December 2013.

Keywords
indicative timelines, risk assessment, regulated products
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Number of Pages
37