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Companies failing to live up to EU chemical law

Companies are failing to provide the safety data required by Europe’s sweeping chemicals law REACH (registration, evaluation, authorization and restriction of chemicals), according to a study for the Centre for Alternatives to Animal Testing at the University of Konstanz in Germany.

The research looked at 400 documents drawn up by companies and detailing toxicity data for the chemicals they produce. REACH requires companies to produce these documents. The study found that “most” didn’t meet the requirements for providing safety data set by the European Chemical Agency (ECHA) — the REACH regulator based in Helsinki, Finland. In particular, documents lacked adequate data on the toxic effect of chemicals on reproduction and embryo development, the research found.

For example, nearly half the documents were found to have missing or inconclusive evidence of chemicals’ toxicity on embryo development. But in only around 11% of documents did companies propose conducting new tests to fill these gaps.

The study was led by Costanza Rovida, a consultant chemist based in Varese, Italy, and will be published in the journal Alternatives to Animal Experimentation.


We exclusively reported the preliminary results of the study in July (see ‘Data gaps threaten chemical safety law’). At that time, Jukka Malm, director of regulatory affairs at the ECHA, told Nature in an interview that “industry has not taken full responsibility for the quality of data”.

Rovida’s team also uncovered that companies had conducted a handful of illegal animal tests. All new animal tests must receive approval from ECHA before being carried out, but the research found that 24 tests were carried out after the law came into force but without regulatory approval.

The aims of REACH — to improve knowledge of chemical safety while reducing the number of animals used in tests by promoting alternative methods — could be in jeopardy, the study warns.

It suggests that up to 1.6 million animals may be used in tests to assess reproductive and development toxicity, which the team says is “very high”. But proposals for alternative in vitro tests in the documents are “completely absent”, the study finds.

Comments

  1. Report this comment

    Nicholas Ball said:

    I am not sure i completely agree with the report above, or at least the way that the information has been interpreted and reported. For instance, to claim that companies have conducted ‘Illegal animal tests’ is not possible without a detailed understanding of what the test is, and whetehr it was needed for a regulatory purpose in another geography. The EU REACH law has no authority to prevent a company from conducting a toxicological test it feels is necessary or required for legislation in another country. Also, with respect to the comments on the lack of proposals for ‘alternative in vitro tests’ or ‘non-animal methods’ for covering endpoints such as reproductive and developmental tests; there are no agreed guidelines that would cover this endpoint and in many cases where read across or waiving arguments based on exposure have been used, ECHA rejects them, requesting animal studies instead. As such ECHA shoudl also be held accountable for any failure to minimise animal testing.

    This type of article that vilifies the Industry will not help in the long run.

  2. Report this comment

    Stephen Friedeck said:

    Very good comments Nicholas. I would say that the author should have included more details about the statistics used or at least presented them in a more neutral way.

    Although I do not deal with the dossier or animal testing side of REACH, I do quite a lot of work with non-EU based customers and suppliers who know absolutely nothing about REACH (my employer is a US-based automotive supplier). They “certify” their materials as “REACH” compliant all the time when they have no understanding of which parts of the legislation they are or are not compliant. In these cases we educate until an “acceptable” level of understanding is indicated. I think that the heart of the article is that ECHA and individual companies need to do more to be compliant with the legislation; I would have to agree with that point at least.