The Joint Occupational Safety, Health and Environment Committee, a joint project of FEMA and FMA, released this letter, stating the changes made to REACH since the December 2005 version.
The European Union Parliament adopted the compromise text for the European chemicals regulation—REACH (Registration, Evaluation and Authorization of Chemicals). The REACH regulation will enter into force in June 2007 and the six month time frame for pre-registration for substances currently in use will be between June and December 2008.
The relevant changes compared to the December 2005 version of the REACH text are summarized as follows:
- Much more emphasis on alternative testing methods; animal testing proposals will be published by the European Chemicals Bureau;
- An explicit reference to the chemical industry's legal duty of care;
- Adoption of substitution principle for authorized substances; authorization period is time limited on a case-by-case basis; if suitable alternatives exist a substitution plan must be submitted;
- Deadline for the first phase in period extended to 42 months;
- Intellectual property protection extended from 10 to 12 years;
- List of pre-registered substances includes phase-in registration date
According to Parliament, the direct costs of supplying safety information about a substance range from 20,000 Euros to 400,000 Euros ($26,528 to $530,560), depending on the volume of data requirements. However, the overall costs of compliance are incalculable, but could be enormous, particularly since manufacturers will be required to substitute safer alternatives to the 1,500 most dangerous chemicals known or suspected to cause cancer, birth defects and other serious illnesses. If alternatives don't exist, industry is expected to fund research and development to find them. Under the compromise passed, regulators will be able to make exceptions for chemicals whose use in certain instances is considered more beneficial than detrimental to public health. More information about the adoption of REACH can be found here. The consolidate compromise text for the REACH regulation can also be obtained from the EFFA Secretariat and further communications on the REACH Road Map and Time Line will be provided early next year.