Posted: 2 August 2011. Updated: 2 August 2011
The European Chemicals Agency (ECHA) has published the first of the reports, which it is required to submit to the European Commission every three years, on “The Use of Alternatives to Testing on Animals for the REACH Regulation”.
This describes how companies are using non-animal alternatives to provide information on chemicals, demanded by the REACH requirements.
One of the main aims of the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation, which came into force on 1st June 2007, is to understand the impact of chemicals on human health and the environment.
Although this is a commendable goal, many of the requirements, to demonstrate that a substance is safe, include unreliable animal tests. In order for industry to make a better assessment of the risks posed by different chemicals, the gaps in knowledge need to be filled by testing chemical substances, but the ECHA states that “Some of these are studies using experimental animals”.
There are a number of measures, highlighted in the ECHA report, which allow data on the hazards of chemicals to be gathered by means other than by testing on animals. These include comparing similar substances, computer modelling, using weight of evidence and by using validated alternative tests. In addition to this, companies holding information about chemicals must also share it with other companies making the same substance, so that duplication of tests is avoided.
ECHA analysed the information provided by companies about the properties of their substances and showed the extent to which they are using the alternatives provided by REACH.
Dossiers of evidence submitted by each manufacturer or importer on the safety of their registered chemicals were used for the analysis; a total of 24,560 dossiers were submitted by 28th February 2011. The assessment focused on substances which are manufactured in, or imported into, the EU at or above 100 tonnes per year, as volume is used as a way of measuring likely exposure and these dossiers have the greatest amounts of information.
The analysis found that data sharing mechanisms are being used and are working. However there were cases in which the ECHA received either multiple joint submissions or a joint submission and one or more individual submissions on the same substance. This is something which the Agency comments that they are “currently examining”.
Data with a reference year of 2009, or later showed that 1,849 tests have been carried out, which involved tests on vertebrate animals, with 107 of these, carried out without the submission of prior testing proposals. This is important as the testing proposals for new studies involving vertebrate animals must be submitted to the ECHA before they are carried out, in order for the proposals to be published. This allows third parties to submit scientifically valid information on the end points of the proposed test, with a view to avoiding them.
Clearly, if some companies are going ahead with new testing on animals and skipping this step, experiments which could have been avoided may have been carried out.
Of the new testing proposals to gather additional data on long-term hazards, 711 were submitted for vertebrate animal studies. These included repeat dose toxicity via the dermal, oral and inhalation routes, genetic toxicity, carcinogenicity, reproductive and developmental toxicity and long-term studies in fish and birds. Although the report states that “The Agency received far fewer testing proposals than had been anticipated”.
Most disappointingly, the conclusion from the evaluation of the dossiers found that justifications for the use of alternatives, provided by the companies, fell short of the legislative requirements. As a result “the Agency will need to ask for some new animal tests to ensure that the information necessary for ensuring the safe use of chemicals is available, unless registrants can improve their scientific justifications".
It is unfortunate that any requests by ECHA for further studies on vertebrate animals are not included in the report. This displays an unsatisfactory lack of transparency.
Animal use for “Toxicological and other safety evaluations” in the EU increased by 15,867 animals for “Toxicological and other safety evaluations” from 2005, before REACH legislation was in place, to 2008, when it had been in place for a year. In the same time frame, the number of animals used in tests required by EC legislation rose by 119,140.
The continued reliance on animal data for the protection of human heath does not put Europe at the forefront of scientific advancement. It is acknowledged that the whole animal approach to toxicity testing is “time-consuming and resource-intensive, it has had difficulty in meeting many challenges encountered today, such as evaluating various life stages, numerous health outcomes, and large numbers of untested chemicals”.
Considering that one of the aims of REACH is to “enhance innovation in the competitiveness of the EU chemicals industry”, it is unfortunate that the ECHA do not acknowledge the unreliable and unnecessary use animals in scientific testing, as other scientists already have.