REACH Regulation – Balancing Chemical Safety and Animal Welfare

Introduction

While the EU’s cosmetics testing ban was a resounding victory for animal welfare, the regulatory landscape in Europe is far from simple. The very same year that the final phase of the cosmetics ban came into effect, another, far more comprehensive piece of legislation was already in force: the REACH regulation. Standing for Registration, Evaluation, Authorisation and Restriction of Chemicals, REACH is the most ambitious and far-reaching chemical safety regulation in the world. Its primary goal is to protect human health and the environment from the risks posed by chemicals. However, in its pursuit of this goal, REACH has created a complex and often contradictory situation for animal-free testing. In this installment of our series, we unravel the complexities of REACH and explore the ongoing challenge of balancing chemical safety with the ethical imperative to replace animal testing.

The Aims of REACH

REACH, which came into force in 2007, was designed to address the fact that for the vast majority of chemicals in daily use, there was little to no safety information. The regulation places the burden of proof on companies to demonstrate that the chemicals they produce, import, or use are safe. To do this, companies are required to gather or generate data on the properties and hazards of their chemicals and to register this information with the European Chemicals Agency (ECHA).

The Animal Testing Dilemma

The data requirements of REACH are extensive, and for many of the required endpoints, animal tests have traditionally been the default method. This has created a significant dilemma. On the one hand, REACH is a crucial piece of legislation for protecting public health and the environment. On the other hand, it has the potential to lead to a massive increase in the number of animals used in testing.

To address this, the REACH regulation includes a number of provisions that are designed to promote the use of alternative methods. The regulation explicitly states that animal testing should only be used as a last resort. It also encourages the use of a range of non-animal methods, including:

  • In silico methods: The use of computer models to predict the properties of chemicals.
  • In vitro methods: The use of cell and tissue cultures to assess the effects of chemicals.
  • Read-across: The use of data from similar chemicals to predict the properties of a target chemical.

The Reality of REACH

Despite these provisions, the reality of REACH has been mixed. While the use of alternative methods has certainly increased, animal testing has not been eliminated. In many cases, companies have found it easier and less risky to simply conduct the animal tests rather than to invest in the development and validation of alternative methods. The read-across approach, while widely used, has also been a source of controversy, with concerns about its scientific validity and its potential to underestimate the risks of some chemicals.

The conflict between REACH and the cosmetics testing ban has been a particularly contentious issue. While the cosmetics ban prohibits animal testing for cosmetic ingredients, the same ingredients may still need to be tested on animals to meet the requirements of REACH if they are also used in other products, such as paints or detergents. This has created a legal and ethical loophole that has been a source of frustration for animal welfare organizations and a source of confusion for consumers.

The Way Forward

The challenges posed by REACH are significant, but they are not insurmountable. The European Commission, ECHA, and a wide range of stakeholders are working to address these challenges and to accelerate the transition to animal-free chemical safety assessment. The development of New Approach Methodologies (NAMs), which integrate a range of non-animal methods to provide a more holistic and human-relevant assessment of chemical safety, is a particularly promising area of research.

As we will explore in the next installment of our series, the Netherlands has taken a leading role in this effort, with its ambitious goal of becoming a world leader in animal-free innovation. The story of REACH is a reminder that the path to a truly animal-free world is not a straight one. It is a complex and challenging journey that requires a constant balancing of competing interests and a relentless commitment to scientific innovation and ethical progress.

References

  1. European Chemicals Agency. (n.d.). Alternatives to animal testing under REACH. Retrieved from https://echa.europa.eu/animal-testing-under-reach
  2. Knight, J. (2021). Continuing animal tests on cosmetic ingredients for REACH in the EU. ALTEX, 38(1), 143-154. Retrieved from https://www.altex.org/index.php/altex/article/view/2291

 

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