European Parliament votes a mixed result on REACH
The main points (for an in-depth analysis of the main changes, see our pdf):
- Authorization (strengthened)
The criteria for granting an authorisation were made stricter, including time limits (Amendment 235 – maximum of 5 years), and introducing the principle of substitution should suitable alternatives be available. (Amendment 232, Article 57).
- Registration (weakened)
The Sacconi-Nassauer compromise package severely watered down the basic health and safety information required for low-volume chemicals; in addition excessive derogations have been permitted for medium and high-volume chemicals (waiving).
A strong role has been given to the use of crude exposure categories in determining the amount of information to be provided.
- One Substance One Registration (introduced)
The OSOR block of amendments were passed making sharing of testing and registration costs for registrants mandatory, albeit with the possibility of exceptions. There is proportional division of costs on the basis on each party’s production volume. This addresses the interests/concerns of the small and medium-sized companies.
- Access to Information (strengthened)
Amendment 366, Article 31a – Manufacturers have a duty to provide information on effects of substance on human health and the environment at request of downstream users. In addition, safety data sheets follow the substance down the chain of supply even after it has entered into an article. Consumers’ right to information in accordance with the Aarhus convention has been introduced.
- Duty of care (introduced as an article)
A ‘Duty of Care’ has been written into the legislation giving manufacturers and importers a responsibility for chemicals’ harmful effects that he/she could have ‘reasonably foreseen’.
- Substances in articles (strengthened)
The Manufacturer or importer must notify the Agency of dangerous substances contained in articles in accordance with certain criteria, including exposure that could result during the entire lifecycle of the article.
Numerous other amendments were voted through, including on the role of the Chemicals Agency, including the Evaluation phase; the communication of risk; and Animal Tests. For more information, please contact our office.
The next step in the legislative process is a common position from the Council of Ministers. The UK Presidency has expressed its desire to achieve this position before its term finishes at the end of the year. Following this, the European Parliament will again be voting on REACH in its second Reading in 2006.
At the time of writing, it seems as if a decision on REACH will be taken in Council in December. There have been negotiations taking place between the new German chancellor Angela Merkel and Tony Blair concerning some changes Germany will be tabling in exchange for supporting an agreement whilst still under the UK presidency. The indications are that the German changes would further weaken the rules set out by the so-called UK-compromise text – particularly with regard to substitution and the application of use and exposure categories. However, several delegations are pushing for a strengthening of authorisation rules, such as France, Denmark, Belgium and Sweden.
More in depth analysis of vote (pdf, 130kB)