On 25 January, 2022 the EFSA organized a webinar to introduce new services, processes for the health claim procedure following the implementation of the EU’s Transparency Regulation (2019/1381) (TR). The replay will be available soon.
The new Regulation on the transparency and sustainability of the EU risk assessment in the food chain became applicable on 27 march 2021. All scientific data, studies and other information supporting applications will be made public proactively, with the exception of duly justified confidential information. Confidentiality requests may only be submitted with respect to information falling within the closed positive lists of confidential items, set out in the Transparency Regulation. Applicants will have to substantiate their requests and provide verifiable justification that public disclosure of the relevant information would potentially harm their interests to a significant degree. Confidentiality requests will be mainly assessed by EFSA, in accordance with the applicable Union provisions.
In addition, the TR empowers EFSA to develop detailed practical arrangements (i.e. binding rules) on new provisions and procedures specified in the Regulation. To help stakeholders better understand and prepare for the new arrangements, EFSA has produced a range of supporting materials such as a questions and answers document, animated tutorials and held a series of training sessions and webinars including the one organized on January 25, 2022.
We would like to share with you the definition of study under the notification obligation:
This definition goes beyond the studies conducted to demonstrate the safety of a substance or a product and includes all studies carried out for regulatory purposes and for which, pursuant to Union law, EFSA may or shall be requested to provide a scientific output, including a scientific opinion. EFSA must therefore ensure the effectiveness of this objective, while also taking into account the close links with the broader transparency requirement and the new Article 61a of the General Food Law (GFL) on fact-finding missions, whereby the Commission is to verify compliance of the laboratories with the applicable standards and the notification obligation. To increase legal clarity the definition of study introduced in EFSA’s Practical Arrangements is based on Directive 2004/10/EC on good laboratory practices (GLP Directive): “study” means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data with respect to the properties and/or the safety of that test item, which is relevant for submission to appropriate regulatory authorities.
To know more on the practical arrangements, you can consult the Q and A document.
Orchidali can help you to submit a health claim application dossier.
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EFSA practical arrangements related to the health claim procedure
On 25 January, 2022 the EFSA organized a webinar to introduce new services, processes for the health claim procedure following the implementation of the EU’s Transparency Regulation (2019/1381) (TR). The replay will be available soon.
The new Regulation on the transparency and sustainability of the EU risk assessment in the food chain became applicable on 27 march 2021. All scientific data, studies and other information supporting applications will be made public proactively, with the exception of duly justified confidential information. Confidentiality requests may only be submitted with respect to information falling within the closed positive lists of confidential items, set out in the Transparency Regulation. Applicants will have to substantiate their requests and provide verifiable justification that public disclosure of the relevant information would potentially harm their interests to a significant degree. Confidentiality requests will be mainly assessed by EFSA, in accordance with the applicable Union provisions.
In addition, the TR empowers EFSA to develop detailed practical arrangements (i.e. binding rules) on new provisions and procedures specified in the Regulation. To help stakeholders better understand and prepare for the new arrangements, EFSA has produced a range of supporting materials such as a questions and answers document, animated tutorials and held a series of training sessions and webinars including the one organized on January 25, 2022.
We would like to share with you the definition of study under the notification obligation:
This definition goes beyond the studies conducted to demonstrate the safety of a substance or a product and includes all studies carried out for regulatory purposes and for which, pursuant to Union law, EFSA may or shall be requested to provide a scientific output, including a scientific opinion. EFSA must therefore ensure the effectiveness of this objective, while also taking into account the close links with the broader transparency requirement and the new Article 61a of the General Food Law (GFL) on fact-finding missions, whereby the Commission is to verify compliance of the laboratories with the applicable standards and the notification obligation. To increase legal clarity the definition of study introduced in EFSA’s Practical Arrangements is based on Directive 2004/10/EC on good laboratory practices (GLP Directive): “study” means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data with respect to the properties and/or the safety of that test item, which is relevant for submission to appropriate regulatory authorities.
To know more on the practical arrangements, you can consult the Q and A document.
Orchidali can help you to submit a health claim application dossier.
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