Scope of the system:
- Polymers have been exempted from registration, but may still be subject to authorisation and restriction; the Commission can amend this provision once sound scientific criteria have been developed to define which polymers should be registrered;
- The requirements for substances in articles have been watered down;
- The requirement to undertake chemical safety assessments has been considerably reduced;
Legal certainty
- The "duty of care" provision for industry has been more clearly defined as companies feared they would be confronted with open-ended liability claims;
- The European Chemicals Agency (to be set up) will have a Board of Appeal;
Costs
- For downstream users, the obligation to undertake chemical safety assessments and produce chemical safety reports has been strictly limited;
- Registration obligations for production of 1-10 tonnes have been simplified;
- Intermediates transported under strict control face less severe requirements;
Bureaucracy / Powers of the Agency
- Streamlined legislation: the Agency will be the sole responsible;
- Evaluation: the Agency has more and clearer responsibility;
- The system of chemicals safety reports has been better coordinated with the existing system of safety data sheets;
- The Agency will have more powers as to decisions on data sharing, R&D exemptions and confidentiality;
Confidentiality
- Stricter protection for sensitive and confidential business information ; all information that is non-confidential will be available on request;
Substitution
- Stronger provision for substitution: companies will be encouraged to present substi tution plans; this may influence decisions on authorisations;
Animal testing
- No increased animal testing.
Together with the legislative proposals, the Commission will present a new impact assessment, which will, according to sources in the Commission, be more accurate than the industry studies prepared in France and Germany.
