Upholding the Last Resort: A Call to Action under REACH Regulation

Dear Reader,

Today, I come to you with a recommendation: delve into the insightful paper titled "The Last Resort Requirement under REACH: From Principle to Practice" by Macmillan et al. This paper, published in the Regulatory Toxicology and Pharmacology journal, sheds light on a critical aspect of the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation in the European Union.

Why Should You Read This Paper?

REACH stands as a beacon of protection for human health and the environment against the potential hazards of chemicals. At its core, Article 25 distinctly declares that animal testing must only be considered as a last resort. However, the reality portrayed in this paper, based on meticulous research and first-hand experiences, reveals a different tale.

A Discrepancy: Theory versus Practice

Despite the clear stipulation of minimizing animal testing, the authors of this paper present evidence showing that animal studies are still predominantly used to fulfil REACH's information requirements. This raises crucial concerns about the implementation of the "last resort" principle in practice.

Challenges and Proposed Solutions

Through meticulous case studies and thoughtful analysis, the paper identifies six key issues contributing to this discrepancy:

1. Non-acceptance of existing data, both animal and non-animal.

2. Reluctance to embrace read-across methodologies.

3. Inflexible administrative processes hindering progress.

4. Redundancy in testing procedures.

5. Testing despite concerns for animal welfare.

6. Conducting tests for cosmetic-only ingredients.

The authors, members of the Animal-Free Safety Assessment (AFSA) Collaboration, do not merely stop at highlighting the challenges. They offer a roadmap forward, proposing actionable recommendations. These recommendations are intended to guide the European Commission, the European Chemicals Agency (ECHA), and registrants towards a future where human health and the environment are safeguarded without unnecessary animal testing.

Embracing a New Paradigm

One of the most compelling conclusions drawn in this paper is the assertion that a scientific approach to substance safety assessment can indeed exist without reliance on animal testing. The authors advocate for a paradigm shift where non-animal approaches are the norm, not the exception. This shift, they argue, is not only feasible but also essential for ethical and scientific progress.

Join the Conversation

For those eager to dive deeper into this discussion, the AFSA Collaboration offers the recording of a webinar on this very topic that was held on the 28th of March. The agenda promises a wealth of insights from industry experts, including discussions on specific case studies.

• Webinar Agenda Highlights:

• Introduction to AFSA & webinar by Jay Ingram (HSI)

• Overview of the "Last Resort" paper by Carl Westmoreland (Unilever)

• Case Studies:

• C12-15 alkyl benzoate by James Dawick (Innospec)

• Pyrrolo[3,4-c]pyrrole-1,4-dione, 3,6-bis[4-(1,1-dimethylethyl)phenyl]-2,5-dihydro by Xiaoling Zhang (P&G)

• Aziridine Aluminium chloride, aluminium chloride basic and aluminium sulphate by Xiaoling Zhang (P&G)

In Closing

In a world where scientific progress must go hand in hand with ethical considerations, the "Last Resort" paper offers a compelling narrative. It is a call to action for regulators, agencies, and industry stakeholders to uphold the principles of REACH, ensuring that animal testing truly becomes the last resort, not the default.

Let us embark on this journey towards a future where innovation and compassion intersect, where the protection of human health and the environment stands at the forefront of chemical safety assessments.

Read the paper here and explore the webinar here.

Yours in advocacy for progress,

Elena Fioravanzo