EFSA Proposes New Qualification System for Nanomaterials Risk Assessment Using New Approach Methodologies (NAMs)

Background and Purpose

NAMs have gained traction in risk assessments for their ability to provide faster, more informative insights than traditional animal tests. Despite their potential, only a few NAMs have been validated and incorporated into regulatory frameworks like OECD Test Guidelines (TGs). EFSA's proposal seeks to establish a qualification system that allows for a structured and efficient evaluation of NAMs, specifically targeting the food and feed sector's need for assessing nanomaterials​.

The Need for a Qualification System

Currently, non-guideline studies are used for NM risk assessments, necessitating complex case-by-case evaluations. This new qualification system aims to simplify this process by enabling expert opinions on the adequacy of NAMs for specific contexts. The system is designed to provide guidance for method readiness, ensuring the scientific validity, reliability, and relevance of NAMs for regulatory applications​.

Proposed Framework

The proposed system involves a sequential process starting with a Letter of Intent (LoI) to evaluate the suitability of a NAM for a specific context-of-use. The system covers all phases, including submission, evaluation, and outcome, providing clear criteria for assessment. This interim proposal focuses initially on NM risk assessment, aligning with the EFSA framework to address specific considerations such as NM physicochemical characterization, toxicity screening, and other relevant evaluations​.

Implementation and Testing

The proposal suggests that the system be initially tested with selected NAMs in the context of NM risk assessment case studies. This testing phase aims to fine-tune and finalize the approach through broader discussions among experts and stakeholders. The document is open for feedback until 31 December 2024, encouraging a collaborative effort to enhance the regulatory use of NAMs​.

Current Challenges with NAMs

The limited regulatory implementation of NAMs is attributed to unclear regulatory applications, incomplete data interpretation procedures, and lack of quality systems. Additionally, for nanomaterials, challenges such as dispersion stability and dosimetry make validation more complex. The proposed qualification system aims to address these challenges by providing a structured approach for assessing method readiness​.

Advantages of the Qualification System

By establishing this system, EFSA aims to facilitate the international use of test methods under the Mutual Acceptance of Data (MAD) principle. The qualification system is intended to support the optimization of NAMs, allowing them to be applied for qualified use without the need for repetitive evaluations. This approach could lead to a more harmonized risk assessment process for nanomaterials in the food and feed sector​.