Regulatory News
REACH REGULATION PUBLISHED IN DECEMBER
Following the vote of the European Parliament of December 13th, the new chemical policy on Registration, Evaluation, Approval and restrictions of Chemical Substances, known as REACH, was published on December 30th 2006 as Regulation 1907/2006/EC and will come into force on June 1st 2007. REACH represents a revolution in the management of safety of chemicals by replacing 40 previously issued legal provisions. Also it reverses the burden of proof from regulatory authorities demonstrating that a substance is unsafe to producers having to demonstrate that it is safe. Under REACH, about 30,000 substances have to undergo the Registration process.
The initial phase lasting 3.5 years will deal with substances of high concern (about 1,500), and substances produced in or imported into Europe in a quantity exceeding 1000 tons per year. Substances of high concern such as Carcinogens, Mutagens or those Toxic for Reproduction will be subjected to an Authorization and to restrictions. They will not be allowed in consumer products unless authorized. Authorization will be granted if the applicants can demonstrate that the substance can be adequately controlled or the benefits outweigh the risks for health or for the environment. If the applicant is not able to demonstrate the above, they have to submit a substitution plan in conjunction with the authorization’s request.
Substances produced or imported into Europe in quantities between 100 and 1000 tons per year shall be registered to REACH by 1st June 2013 (6 years), while substances between 1 and 10 tons will be registered by 1st June 2018 (11 years).
Some other points worth noting in the Regulation are the following:
- REACH is creating a new European Chemical Agency, based in Helsinki, responsible for the entire procedures of registration, evaluation and authorization of substances.
- Polymeric materials are exempt from Registration and Evaluation, but may not be exempt from Authorization if they contain substances of concern. On the other hand starting substances composed of polymers (e.g. monomers, additives and others) fall within the scope of REACH, and they shall undergo the Registration, Evaluation and Authorization as appropriate.
- Food Contact Materials are exempted from REACH in relation to their impact on human health. They are not exempted in relation to the risk to the environment; this means that substances composing Food Contact Materials shall undergo environmental risks evaluation.
- Articles, including articles imported into Europe from other regions, are exempted unless they contain substances of concern.
- Practical implementation of REACH can only be done by setting up a communication system within the supply chain aimed at circulating the appropriate information needed by business operators to carry out their duties to comply with the Regulation.
For more information, please follow these links:
|
