Traditionally, regulations for industrial chemicals have been based on the assumption that "no data" means the same as "no danger". This is evidently no longer true, and the trend towards this erroneous conclusion implies a systematic underestimation of the risks.
After almost ten years of preparations, the decision was made in December 2006 to introduce REACH, and most of the regulations came into force in 2008. A considerable proportion of the discussions on the design of REACH referred to the amount of test data that shall be required for each substance. The cost of testing, the use of experimental animals, the need for knowledge and sufficient protection for the environment and human health are factors that were considered in these negotiations.
Table 1: Test requirements in REACH for different substance and classification categories.
Global system for hazard information
One way of analysing the need for data is to investigate what data, and how much, are needed for making an initial hazard assessment according to the rules for classification and labelling. The classification and labelling rules are a key element in chemical control. They comprise all industrial chemicals, and the system is just now undergoing global harmonisation. The results of hazard assessment are communicated through hazard warning on the product and in other product information. The objective of the system is to provide information for the users of the chemicals so that they can take relevant measures to limit exposure and to reduce risks.
The question is to what extent REACH will lead to the production of new data which will make it possible for hazard assessments to be made in accordance with the classification rules. And the answer is: This is still highly uncertain.
Unclear test requirements for low volume substances
For low volume substances in REACH, i.e. substances that are produced in quantities between 1 and 10 tonnes, different test requirements apply depending on whether or not the substance had been subject to regulation according to the previous European legislation. Fundamental test requirements will be specified for low volume substances that were introduced on the market after REACH came into force, but for the substances that were on the market already prior to REACH the test requirements will apply only if the substance is accorded special priority. The prioritisation criteria laid down are that the substance shall have wide use (in consumer products) and that there are "indications" that the substance may be carcinogenic, mutageneous or a reproductive toxicant (CMR), or toxic in some other way so that it is embraced by the classification criteria.
Examples of toxicity indications that are particularly named are data produced by structure activity relationships, Q(SAR). These are computer models that predict the properties of a substance on the basis of its molecular structure. This means that the test requirements that shall apply for low volume substances will in practice be determined both by the methods and (QSAR) models that may be used to produce indications of toxicity, and by the formulation of the criteria regarding the results which will cause the test requirements to come into force. Decisions regarding these models and criteria have not yet been made. Depending on what they will be like and how they will be applied, the outcome of REACH may range from no tests at all for low volume substances to tests for all low volume substances in accordance with the fundamental test package. Estimates suggest that low volume substances constitute two thirds of the number of substances regulated within REACH, and the test package comprises acute toxicity, skin allergy, skin and eye irritation, mutageneicity (in vitro), biotic degradability. as well as acute toxicity for algae and crustaceans.
Tests in volumes exceeding 10 tonnes
For the chemicals within REACH that are produced in volumes exceeding 10 tonnes annually, the requirements for testing will, apart from the studies required from 1 tonne upwards, also include an acute toxicity test (a second route of exposure), and an acute test with fish. A 28-day toxicity test may also be required. For volumes exceeding 100 tonnes annually, the 28-day test will be obligatory and further studies may also be required (a 90-day test, test for chronic toxicity and cancer, and further ecotoxicity data), but decisions regarding such testing will be made by the authorities on a case by case basis according to proposals by the manufacturer/importer.
To sum up, REACH will generate a limited quantity of data for the chemicals that are made in quantities exceeding 10 tonnes annually, data which enable a hazard assessment and classification for short term effects to be made. A 28-day study also makes possible classification for "repeated exposure", and such data will be be available for substances in the production category exceeding 100 tonnes, but also from 10 tonnes unless there are good reasons to the contrary. Long term data for ecotoxicity are required from 100 tonnes, but long term studies for health effects (chronic toxicity, cancer and reproductive toxicity properties) will not be automatically required for some substances. As pointed out, the situation for low volume substances is very confused. Depending on what methods and models will be permitted for data generation and what criteria shall be applied to these data, the test requirements may apply to none or all of these substances. (See the table).
REACH is not enough
REACH is an important step on the way towards a sustainable use of chemicals. However, the goal that no industrial chemicals shall be sold without fundamental testing will not be achieved with the present rules. Even if the results will be that all low volume substances shall be tested, there is still a lack of data regarding long term exposure for many substances. A large number of substances are not covered by the new rules at all, i.e. those substances that are produced in quantities less than 1 tonne annually. It is therefore essential to continue work on making the test requirements in the legislation more stringent. The research community can make important contributions to this process, for example through developing methods that can be used as prioritisation tools in test systems in accordance with the regulations.
Another important task wil be to monitor and evaluate the effects of REACH and the way in which the system contributes to the development of a non-toxic environment. Without fundamental testing of all industriasl chemicals according to the principle "no data, no market" we can never achieve a sustainable use of chemicals.
Author
:
Christina Rudén
is assistant professor in hazard assessment at KTH