To prepare the updated guidance ESFA (Mandate EFSA-Q-2019-00687) will assess current authorised and assessed smoke flavouring products in the EU and in other scientific documents.
It will take into account applications on new smoke flavourings, renewals of existing ones and the provisions of Regulation 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment.
EFSA will finalise updating the guidance by March 21, 2021.
In a letter to Dr Bernhard Url, executive director, EFSA, on September 24, 2019, the European Commission said the current guidance is essentially based on a set of EFSA documents namely; Guidance on the submission of a dossier on a Smoke Flavourings Primary Product (EFSA 2005); Dietary exposure assessment methods for smoke flavouring Primary Products (EFSA 2009) and Statement on the interpretation of the Margin of Safety for Smoke Flavourings Primary Products (EFSA 2010).
This last statement clarifies the use of the margin of safety for smoke flavouring products on the basis of the available toxicological data.
EFSA is asked to update all the documents and compile them into a single document taking into account cross-sectional documents such as;
- Opinion on genotoxicity testing strategies applicable to food and feed safety assessment (EFSA Scientific Committee 2011)
- Opinion on the clarification of some aspects related to genotoxicity assessment (EFSA Scientific Committee 2017)
- Statement on the genotoxicity assessment of chemical mixtures (EFSA Scientific Committee 2019)
- Harmonised methodologies for human and animal health and ecological risk assessment of combined exposure to multiple chemicals (EFSA Scientific Committee 2019)
- Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Scientific Committee 2019).
“In addition, in the preparation of the new guidance, EFSA should also consider the latest updated version of the relevant OECD Test Guidelines (TG) such as OECD TG 488 (2011) Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays; OECD TG 474 (2016) In vivo mammalian erythrocyte micronucleus test and OECD TG 489 (2016) In vivo Mammalian Alkaline Comet Assay,” the European Commission said in the letter.
“A more refined exposure assessment could be also considered, based on actual use levels and on detailed food consumption data across different population groups and scenarios.
“Besides the safety aspects derived from the general requirements for flavourings, the protection of the environment should be considered where appropriate.”