EFSA has now made available to applicants the new guides/guidelines for the preparation and submission of applications for the launching of novel foods in the European Union.
Three new guides are newly available on the EFSA’s website:
1) The guide on the scientific requirements for an application for authorisation of a novel food under Regulation (EU) 2015/2283
(2) The Guide on the scientific requirements for notifying and applying for authorisation of third-country country foods under Regulation (EU) 2015/2283
3) Guidelines on scientific principles and data requirements for assessing the safety and relative bioavailability of new sources of micronutrients.
Date of application of these new guidelines:
These updates take into account changes to the EU legal framework in the field of novel foods, progress in food innovation as well as the experience gained during the evaluations of applications for authorising novel foods since the entry into force of the regulation in 2018. The purpose of these updates is to clarify definitions and data requirements to help applicants prepare better quality dossiers.
What information must be provided?
Applicants will have to describe and identify the novel food, detail its production process, composition and specifications. Information on expected consumption, consumption history as well as data on its safety, absorption, metabolism, excretion and elimination, as well as data on toxicity, nutrition, potential allergens will also be provided.
These new explain what is expected.
To know more, you can find these new guides HERE
Orchidali can help you assess whether your product development is new or not.
Français
Novel food safety: EFSA guidelines updated
EFSA has now made available to applicants the new guides/guidelines for the preparation and submission of applications for the launching of novel foods in the European Union.
Three new guides are newly available on the EFSA’s website:
1) The guide on the scientific requirements for an application for authorisation of a novel food under Regulation (EU) 2015/2283
(2) The Guide on the scientific requirements for notifying and applying for authorisation of third-country country foods under Regulation (EU) 2015/2283
3) Guidelines on scientific principles and data requirements for assessing the safety and relative bioavailability of new sources of micronutrients.
Date of application of these new guidelines:
These updates take into account changes to the EU legal framework in the field of novel foods, progress in food innovation as well as the experience gained during the evaluations of applications for authorising novel foods since the entry into force of the regulation in 2018. The purpose of these updates is to clarify definitions and data requirements to help applicants prepare better quality dossiers.
What information must be provided?
Applicants will have to describe and identify the novel food, detail its production process, composition and specifications. Information on expected consumption, consumption history as well as data on its safety, absorption, metabolism, excretion and elimination, as well as data on toxicity, nutrition, potential allergens will also be provided.
These new explain what is expected.
To know more, you can find these new guides HERE
Orchidali can help you assess whether your product development is new or not.
Tags: