EFSA's Scientific Committee has launched an open consultation on its draft EFSA Statement on the derivation of Health-Based Guidance Values (HBGVs) for regulated products that are also nutrients. This Statement describes the specific considerations that should be followed for regulated products (particularly food additives and pesticides) that are also nutrients to ensure an integrated and harmonised approach for the hazard and risk characterisation, considering the intake from all relevant sources. The Acceptable Daily Intakes (ADIs) and the Upper Levels (ULs) represent the chronic oral exposure HBGVs for regulated products and for nutrients respectively. Some regulated products are also nutrients; this can lead to a complex situation in which two assessments, requiring the establishment of HBGVs for the same substance (i.e. a nutrient), are carried out under different regulatory frameworks, using similar but not identical scientific methodological approaches. This is a recurrent issue for food additives and pesticides, and may occasionally occur for other regulated products. This document compares the conceptual and methodological approaches used by EFSA and presents a proposal for harmonising the establishment of HBGVs for regulated products that are also nutrients.
Interested parties are invited to submit written comments by 15/09/2020. Please use the electronic template provided to submit comments and refer to the line and page numbers. To submit additional data to support your comments or files, there is an upload function available in the tool (for a maximum size of 1Mb file). Otherwise you can also contact specific unit’s functional mailbox SCER.PublicConsult.EUS.008 [at] efsa.europa.eu. Please note that comments will not be considered if they:
- are submitted after the closing date of the consultation
- are presented in any form other than what is provided for in the instructions and template
- are not related to the contents of the document
- contain complaints against institutions, personal accusations, irrelevant or offensive statements or material
- are related to policy or risk management aspects, which are out of the scope of EFSA's activity.
EFSA will assess all comments which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.
Persons or organizations participating in a Public Consultation of EFSA are responsible for ensuring that they hold all the rights necessary for their submissions and consequent publication by EFSA. Comments should inter alia be copyright cleared5taking into account EFSA’s transparency policy and practice to publish all submissions. In case the submission reproduces third-party content in the form of charts, graphs or images, the required prior permissions of the right holder(s) should have been obtained by the PC respondent.
Publication of contributions
Contributions will be published and may be re-used by EFSA in a different context. It should be noted that contributions submitted by individuals in a personal capacity will be published as such, indicating the author’s first and family name, unless a substantial justification for protection is provided by the respondent. Contributions submitted on behalf of an organisation are also made publicly available and attributed to the organization in question.
Submit comments (deadline: 15 September 2020)