Abstract
Endorsement date21 January 2021Implementation date27 March 2021 Upon request from the European Commission, the scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim initially published in 2007 and subsequently revised in 2011 and 2016 has been updated. This guidance document presents a common format for the organisation of information for the preparation of a well‐structured application for authorisation of health claims which fall under Articles 13(5), 14, and 19 of Regulation (EC) No 1924/2006. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs, and the key issues which should be addressed in the application to substantiate the health claim. This guidance has been revised in 2020 to inform applicants of new provisions in the pre‐submission phase and in the application procedure set out in Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain, that are applicable to all applications submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
Highlights
ScopeThe guidance presented in this document is for preparing and presenting applications for authorisation of health claims which fall under Article 14 of the Regulation, i.e. reduction of disease risk claims and claims referring to children’s development and health.The guidance is applicable to applications for authorisation of health claims which fall under Article 13(5) of the Regulation, i.e. which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data.Applications for the modification of existing authorisations of health claims in accordance with Article 19 of the Regulation shall be presented, as appropriate, in the format outlined in this document.http://www.efsa.europa.eu/en/efsajournal/pub/2170 6 http://www.efsa.europa.eu/en/efsajournal/pub/2170 www.efsa.europa.eu/efsajournal
The Nutrition and Allergies (NDA) Panel has gained considerable experience in the evaluation of health claims, and has increased interactions and exchange of views with stakeholders. Lessons learnt from these experiences have been translated into a General scientific guidance for stakeholders on health claim applications
The updated guidance has been aligned with the General scientific guidance for stakeholders on health claim applications and adapted to include claims that are based on the essentiality of nutrients
Summary
ScopeThe guidance presented in this document is for preparing and presenting applications for authorisation of health claims which fall under Article 14 of the Regulation, i.e. reduction of disease risk claims and claims referring to children’s development and health.The guidance is applicable to applications for authorisation of health claims which fall under Article 13(5) of the Regulation, i.e. which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data.Applications for the modification of existing authorisations of health claims in accordance with Article 19 of the Regulation shall be presented, as appropriate, in the format outlined in this document.http://www.efsa.europa.eu/en/efsajournal/pub/2170 6 http://www.efsa.europa.eu/en/efsajournal/pub/2170 www.efsa.europa.eu/efsajournal. The NDA Panel has translated the lessons learnt from these experiences into a revised General scientific guidance for stakeholders on health claim applications,[4] which was recently published and represents a step forward in assisting applicants to compile their applications for health claims authorisation. In this context, it is noted the need to adapt the existing scientific and technical guidance for stakeholders[5] to the new scientific and technical developments in this area
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