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Opportunities for NAMs



Exploring the Gaps: A Closer Look at Chemical Safety Assessments


In the realm of chemical safety, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) framework stands as a pivotal system for safeguarding human health and the environment. However, what if I told you that the current approach might be overlooking crucial aspects of chemical exposure?

A recent paper caught my attention as it delved into this very topic. The study, which analysed the mandated studies required under REACH for different annual tonnage bands, shed light on an intriguing aspect of chemical safety assessments.


Digging Deeper into Chemical Safety Data

The cornerstone of REACH assessments has been the annual tonnage of chemicals manufactured or imported into the European Union. It's a logical starting point, considering that tonnage can be a proxy for human exposure levels. But, as the study points out, this metric might not paint the full picture.

The paper notes that while REACH mandates data collection on a range of health concerns such as skin effects, sensitization, and genetic impacts, the actual information available often falls short. In fact, the analysis revealed that a significant portion—nearly 81%—of registered substances lacked comprehensive datasets covering all areas of health concern.


Addressing the Data Deficit

So, what does this mean for chemical safety? It underscores a critical gap, particularly for substances in the lower tonnage bands. These chemicals, while less voluminous in production, still merit a thorough assessment, especially regarding issues like repeat and extended exposure, as well as carcinogenic potential.

Here's where the discussion takes an intriguing turn. The study proposes the use of New Approach Methodologies (NAMs) for assessing these overlooked health concerns. By deploying NAMs, which are alternative methods to traditional animal testing, a more comprehensive understanding of chemical risks could emerge.


Looking Towards the Future

The notion of incorporating NAMs into the assessment framework is not just theoretical—it's already gaining traction. Projects across Europe are actively working on developing NAM-based assessment frameworks. These could potentially offer a solution for filling the information gap for low tonnage chemicals.

What strikes me as particularly exciting is the idea that these NAMs could find their initial application precisely where they are needed most—assessing chemicals in the lower tonnage bands. It presents an opportunity for both registrants and regulators to gain valuable experience in utilizing these innovative methodologies.


Final Thoughts

As someone intrigued by the intersection of science and policy, this study opens up a fascinating discussion on the evolution of chemical safety assessments. It's a reminder that while frameworks like REACH are robust, there's always room for refinement and adaptation.


Botham, P.; Cronin, M. T. D.; Currie, R.; Doe, J.; Funk-Weyer, D.; Gant, T. W.; Leist, M.; Marty, S.; Van Ravenzwaay, B.; Westmoreland, C.

Analysis of Health Concerns Not Addressed by REACH for Low Tonnage Chemicals and Opportunities for New Approach Methodology.


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