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Response from the European Coalition to End Animal Experiments (ECEAE) to the REACH Review February 2013

The European Commission has today published the long anticipated ‘Review of REACH’; which was to be a comprehensive assessment as to how REACH has worked in the EU since it began in 2007. REACH, the EU chemical testing regime, stands for Registration, Evaluation and Authorisation of Chemicals.

The ECEAE has been the leading animal protection organisation monitoring the implementation of the REACH legislation. We have been pleased to be a key stakeholder in the process, actively commenting on proposals to test on animals and observing, wherever possible, the decisions on these made by the Agency, ECHA. Since the start of it operations in 2008, the Agency has sought to be reasonably open to stakeholders and we have seen recent further improvements in the access to information arising from the work of the Agency. 

However, the ECEAE has experienced many problems related to animal testing and we are disappointed to see that the Commission’s REACH review appears not to have gone far enough to acknowledge these issues. 

One of the central goals of the legislation is the promotion of alternative methods with the requirement that animal testing would be a last resort. The Agency, the Commission and the Member States have however, failed, in our opinion, to uphold these principles. After all the promise of an ‘intelligent’, science-based approach, the Agency has reverted back to conservative, tick-box toxicology. We are seeing routine additional requests for animal tests in some areas, an almost complete failure to reject proposals to test on animals and a lack of leadership from the Commission or the Agency on the promotion of alternative methods that already exist.

In response to the Commission’s Review, the ECEAE has listed its own findings on the Implementation of REACH. The ECEAE findings are:

 

1. On the Agency responsible for the operation of REACH, ECHA:

  • The Agency has taken a narrow and we believe unlawful view of its role in terms of preventing unnecessary animal testing and is failing to reject testing proposals in all but very limited circumstances. The Review notes that” To date no testing proposal has been rejected on the basis of the third party information.”
  • The Agency is failing to promote alternative methods and is taking an increasingly conservative, unjustified tick-box approach in requesting additional animal testing.
  • The Agency already had a reasonably transparent mandate but, following pressure from NGOs, has further improved access to information and the results of its decision making.The Review acknowledges this.
  • However, stakeholder confidence in the Agency’s decision making process is being eroded by the procedures put in place to speed up decision making

 

2. On the European Commission:

  • The Commission is funding alternative methods through its support of ECVAM, Framework projects (such as ALXR8, SEURAT and OSIRIS) and the EPAA; with a budget that appears to far exceed that of overall national budgets (According to the REACH Review 330 million Euros over last 4 years)
  • However, the Commission has failed to take swift and decisive action to promote the use of alternatives (even those it has developed and validated) and to ensure that they are used as soon as they are validated, such as the Extended One Generation Reproductive Toxicity Study or the Reconstituted Human Epidermis skin irritation models, including by updating the REACH Annexes. The Review acknowledges that more needs to be done to promote the use of alternative methods.
  • The Commission has consistently failed, over a number of years to clarify the relationship between the REACH Regulation, which can require animal testing and the Cosmetic Directive which bans animal testing of chemical substances for cosmetics. The Industry has been left in limbo and we are disappointed that this has still not been resolved in the context of the Review.

 

3. On Member States:

  • Member States on the whole have failed to make an investment in alternative methods for REACH by either the promotion of existing alternative methods or in funding their development. The total reported investment in 2010 in alternatives was just over 8 million Euros across all 27 European countries, a paltry amount. (Article 117(1) report).

 

  • The investment by Member States in the REACH process does not appear to be consistent or fair; permitting a few more vocal, and generally toxicologically conservative, Member States to dominate decision-making.
  • Member States have shown little interest in enforcing REACH and the EU law related to animal testing (86/609/EC, now 2010/63) which states that an animal test must not be conducted if a scientifically appropriate alternative method is available.

 

4. On the Industry:

  • Only 2% of the tests used in 2010 registrations were newly-performed animal tests (Article 117(3) report). It is early days but the Industry appears to have avoided animal testing to a maximum degree for the first deadline. 
  • Most of the data gaps were filled with read across and not the use of non-animal tests. Even so, the Agency complain that this approach was often poorly justified, which will weaken the confidence in their future use. 
  • And, the ECEAE estimates that 37% of the new animal test that were done (using an estimated 200,000 animals) were done so unnecessarily- either pre-emptively, without submitting a testing proposal, ignoring validated alternatives or despite the Agency stating that they did not need to be performed (see Article 117(3) report).
  • Industry groups need to invest in greater promotion of alternative approaches and ensure that for the 2013 and 2018 deadlines even smaller companies are aware of their obligation to use alternatives to improve their dossiers and to avoid animal testing wherever possible.

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