EU Commission Suggests New Definition for Nanomaterials in Food

Overview of the Proposed Changes

The draft act proposes significant updates to the existing definition of engineered nanomaterials, as outlined in Regulation (EU) 2015/2283. This revision aims to align the definition with the latest scientific knowledge and international standards, specifically reflecting the technical elements of the general nanomaterial definition established in Commission Recommendation 2022/C 229/01.

Key Points of the Draft Act

• Adjustment of Definition: The draft seeks to modify the definition of 'engineered nanomaterial' to encompass the latest state-of-the-art technical and scientific developments.
• Inclusion of Size Limits and Applicability: The revised definition will include a size limit of less than 100 nm, applicable to the external dimensions and shape of the material.
• Exclusion Criteria: Materials with a surface to volume ratio above a certain value will be excluded from the definition.
• Clarity on Manufactured Materials: The new definition will only include manufactured materials, distinguishing them from natural or incidental materials, and will incorporate materials in solid state only.
• Objective Thresholds: A default threshold value of 50% of particles at the nanoscale will be used to determine if a material is considered a nanomaterial.

Public Participation and Feedback

The Commission invites stakeholders, industry experts, and the general public to provide feedback on this draft regulation. The feedback period is open from 30 November 2023 to 28 December 2023 (midnight Brussels time).

Consultations and Legal Elements

Prior to adopting this act, the Commission engaged in extensive consultations with national experts, the European Parliament, and the Council. The legal elements of the delegated act are geared towards ensuring regulatory coherence within the EU legal framework and addressing implementation issues of the current definition.

Transitional Measures and Implementation

Transitional measures have been proposed to limit administrative burdens and provide sufficient time for business operators to comply with the new requirements. Foods falling within the amended definition can continue to be marketed until a specified period post-regulation enforcement.

This initiative represents the European Commission's commitment to adapting food safety regulations to evolving scientific standards. Stakeholders are encouraged to participate in this open feedback process, contributing to the safe and responsible development of novel foods in the EU market.