Chemical testing in Europe
Sarah Tomlin
Wednesday, 19 August 2009 18:06 UTC
An Opinion article calling for an urgent review of European regulations on chemical testing and consumer safety is published in Nature this week
The REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) regulation aims to determine the toxicity of tens of thousands of existing chemicals that are sold in Europe in quantities of more than one tonne per year. REACH came into force two years ago but the number of chemicals that have now been pre-registered by industry vastly exceeds expectations.
A new analysis from toxicologists Thomas Hartung and Costanza Rovida shows that compliance with REACH may use 20 times more animals and cost 6 times as much as previously estimated. The authors argue that a moratorium on the most costly tests — in terms of both money and animals lives — would be wise, until alternatives are approved.
Hartung and Rovida support the aims of REACH – calling it “the biggest investment into consumer safety ever.” But they fear that regulatory toxicology has neither the high-throughput methods nor the alternatives to animal testing to cope. They plan to release their full analysis at the meeting of the World Congress on Alternatives & Animal Use in the Life Sciences in Rome at the end of August.
Please contribute to this online discussion. Was this crisis avoidable? What can European authorities do now to rescue REACH from the burden of too many animal tests and too high costs? Does it worry you whether the chemicals you use every day are safe to use?
We especially want to hear from you if you are a working toxicologist with ideas for how to improve consumer safety testing. For the next two weeks the authors of the Nature article will be joining in the conversation and can answer your questions.
For more discussion check out Nature’s podcast and news coverage
Updated 26 August 2009 17:22 UTC
-
Replies
-
We can reduce the analysis to a very small critical part, which is the reproductive toxicity testing for high-production volume chemicals, i.e. those required to submit a preliminary safety assessment by December 2010. EChA replied to Nature in response to our study that they expect 8.730-9.000 chemicals to be notified next year, repeated in yesterday’s press release. Our estimate is based only on 6.286, noteworthy the earlier estimates of the Commission on 2.704.
The only really relevant test requirement for our analysis is reproductive toxicity. For this group of chemicals this means a two-generation study in rats and in case of negatives, i.e. the majority, in a second species to be considered. Animal numbers for one species are between 2.600 and 3.200 animals, so about 6.000 for two species. Costs in one species are about 328.000 Euro in rats and 481.000 in rabbits as the most likely second species.
It is no rocket science to calculate that this alone results in 37 million animals (6.286 multiplied by 6.000). Adding the positives of screening tests for lower tonnage levels etc. quickly amounts to 54 million as shown in our study.
We very clearly show that exactly for this test no data exist, no alternative method be it (Q)SAR, read-across or in vitro exist and that the published guidance to test for industry does not foresee relevant waiving opportunities.The costs for a two species two-gen-study for chemicals at 1000+ tons is 6.286 × 809 thousand Euro is 5.1 billion Euro.
This shows simply that these alone bring us close to the numbers deduced.Certainly, we will not arrive at our scenario, because it is simply not feasible – we only show where the current guidance for the minimum number of substances arrives, i.e. non-feasibility.
Costs and animal numbers are in the end indicative of this non-feasibility. We simply do not have the testing facilities. About 70 two-generation studies in one species have been carried out for industrial chemicals over the last 28 years; the overall capacity in Europe is 50-60 substances per year, block-booked for drugs and pesticides. We resulted in 14.000 such studies requested at this moment for REACH…
I would very much like to see what is wrong in our calculation. We want REACH to happen. We identified the reasons for higher numbers of chemicals (data basis 1991-1994, i.e. EU-12 only and 5% annual growth) and higher testing demands (second species added at late stage of legislation) as well as correct statistics (inclusion of off-spring). We pinpointed a single animal test as the bottle-neck for REACH. This can be taken as a start for amending this. But this will not work if simply refusing relatively simple calculations.
-
Two very different blog discussions have been sparked by the publication of Hartung and Rovida’s study and by the official response of the European Chemical Agency
First by Richard Denison on the Environmental Defense Funds’ Chemicals and Nanomaterials blog
And second by Derek Lowe on his blog In the Pipeline
The reactions couldn’t be more different – a sign of the polarising nature of the debates over chemical and animal testing? Or simply reflecting the splintering of discussions in the blogosphere?
-
countries use way too many chemicals for things.
-
