The European Commission has unveiled a White Paper laying out a plan for the future regulation of chemical substances. The requirement for testing and notifying "new" substances, introduced in 1981, excluded over 100,000 "existing" substances already on the market. As a result, there is a lack of knowledge about the environmental and health impacts of many of these existing substances. The White Paper addresses this disparity, along with other shortcomings of the current system, such as the lack of incentives for innovation to develop less hazardous substitutes. In addition the onus for assessment is shifted from the competent authority to industry.
The White Paper introduces a new system for assessing both existing and new chemicals called REACH, for the Registration, Evaluation and Authorisation of CHemicals. It will require:
- Registration of basic information for substances exceeding a production volume of 1 tonne (around 30,000 substances) by 2012. The suggested registration deadlines for production volumes exceeding 100 tonnes and 1,000 tonnes are 2008 and 2005, respectively.
- Evaluation of the registered information for substances exceeding a production volume of 100 tonnes, and at lower volumes for substances of particular concern. The manufacturer has to supply information about the chemical, including a testing strategy, to the competent authority to decide the appropriate course of action. Increased responsibility will also pass to users in the manufacturing chain (formulators and downstream users) who will have to supply data on the particular uses they make of a substance
- An Authorisation procedure will apply to the most dangerous substances that will require specific permission for particular uses. This could lead to widespread restrictions in the use of many carcinogenic, mutagenic and reprotoxic chemicals (CMRs), plus a few persistent organic pollutants (POPs), unless industry could prove that they were safe.
- Substances that are persistent, bioaccumulative or toxic (PBTs) (excluding the above mentioned POPs) will be identified through further research which will determine how they are treated.
Comment
Implementation of the proposals would herald a regulatory revolution for the chemical industry. The chemical industry body CEFIC are unhappy with the authorisation process, which could see a ban on the use of many substances, and estimates it could cost the industry Euro 20 - 30 billion over the 11 years to 2012. The lack of proposed sanctions for companies failing to register their products is unpopular with environmentalists. Similarly, the proposal for raising the current marketing threshold for testing new chemicals from 10 kilograms to one tonne, has caused some concern among this group.
For further information, please contact Mark Rutter at mark.rutter@cms-cmck.com or on +44 (0)20 7367 3182.
