February 8, 2025

Congratulations, Dr. McGuinness, on your appointment as executive director of the European Chemicals Agency (ECHA).

ECHA plays an important role in the enforcement of European Union legislation on chemicals, and biocidal products. In addition, the agency’s approach to this mandate will be particularly important under the ambitious European Green Deal commitments and Chemical Strategy for Sustainability (CSS).

In our changing geopolitical, social, economic and technological landscape, it is important to consider ECHA’s core mandates of ensuring safety, promoting the substitution of animal testing, and promoting competition and innovation. ohan as connected rather than competing, and guided by a unified vision and strong. strategy to achieve the laudable objectives of the EU under the CSS.

It is important to think of ECHA’s core mandates of ensuring safety, promoting the replacement of animal testing, and promoting competitiveness and innovation as connected rather than competing.

The European Parliament observed that “the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) have put in place strategies to actively reduce and replace animal testing, but the European Chemical Agency (ECHA) still needs to be put in place. a strategy of reduction and replacement”. Examples of ambitious targets for stopping animal testing and phasing in new methods of approach (NAM) and next-generation risk assessment (NGRA) methods in chemical space declared in Canada, South Korea, and the United States. They were also requested by the majority of MEPs and more than 1.4 million respondents in a recent European Citizens Initiative.

Now is the time for ECHA to develop an ambitious strategy, structure, system and culture that removes barriers to the preferred use and acceptance of appropriate NAM and NGRA methods, in line with EU law. As a stakeholder organization accredited by ECHA, Humane Society International/Europe (HSI) welcomes the opportunity to collaborate with the agency and interested parties on future-oriented planning, capacity building, and other activities. solution to support ECHA in fulfilling its legal obligations. protect people and the environment while ensuring that animal testing is truly done only as a last resort.

Humane Society International/Europe (HSI) welcomes the opportunity to work with the agency and interested parties on future-oriented planning, capacity building, and other solutions to support ECHA in fulfilling its legal obligations.

HSI recently published a peer-reviewed article with proposals for modernizing the EU’s overall approach to chemical safety and regulation. These include changes to the structure of REACH that require a political agreement through the upcoming legislative process, as well as changes to the existing process that ECHA has the power to implement. The latter include:

  • Establish a new scientific committee on the use of NAMs
    A committee composed of independent experts on the NAM/NGRA-based safety assessment of chemicals would better equip ECHA and member countries to deal with topics related to animal testing, such as test proposal, review of waiver requests, and review of current practices to ensure that they. in accordance with the principle of last-resort. Such a committee could also contribute to the development and implementation of an ambitious reduction and replacement strategy and roadmap and provide independent advice and recommendations to develop and increase the use of non-animal methods by registrants.
  • Better grouping and read-through
    Grouping and reading across are often cited as a success story because they are the most frequently used adaptations. However, ECHA’s Read-Across Assessment Framework sets the bar too high, and the extent to which these methods contribute to reducing the use of animals, or cause additional animal testing due to properties of concern -an of one or more members of a chemical group, requires further investigation. It should go without saying that the use of alternative trigger-increased animal testing methods is against the letter and spirit of EU law.

    One way to improve the current method of grouping and read-across would be for ECHA to encourage and facilitate the sharing of data on similar substances where relevant information can be read-across. For example, EFSA has proposed a method in which low-priority chemicals are identified using a poor result pathway known as NAM in order to reduce the number of chemicals in an assessment group, thus reducing the animal testing in general. It can be analyzed and reproduced under REACH.

  • Increasing reporting criteria
    Every three years, ECHA publishes a report on the use of alternatives to animal testing. This report could be developed to include: ECHA’s work in promoting alternatives to animal testing; the rate of regulatory acceptance of the alternatives submitted, per endpoint; recommendations for registrants and ECHA itself to improve the regulatory acceptance rate; and the number and type of new vertebrate tests performed and requested, along with corresponding guidelines for in vitro tests (to determine potential non-compliance).

In 2019, the Administrator of the US Environmental Protection Agency issued an encouraging memo to all staff that read: “Through scientific innovation and strategic partnerships, we can protect human health and the environment by using the latest -or, good ethical behavior in our decision- making it efficient and cost-effective to evaluate the potential effects without animal testing.” In doing so, he ordered “all the leaders of agency to take actions consistent with this vision and to raise our efforts to the next level”.

We hope, Dr. McGuinness, that your leadership will encourage a similar change in ECHA’s internal culture around animal-free safety science — from a widespread negative bias that seems to regard NAMs as inferior and lead to reduced safety, to in a more positive and constructive perspective that recognizes the benefits of new methods, takes an objective approach to uncertainty, and is motivated to work together with all stakeholders to get a ‘yes’ to change or reducing the animal if possible.

Our best wishes as you begin your new role.

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