Date: Jan 11, 2007
Effective June 1, 2007, a sweeping new law (849 pages in the Official Journal of the European Union) will become the cornerstone of European chemicals policy. After more than three years of negotiation, and shortly before last month's holidays, the European Council unanimously adopted "REACH" -- the new EU regulation covering the "Registration, Evaluation, and Authorization of CHemicals. Once REACH takes effect, it will replace approximately 40 different pieces of existing EU legislation on chemicals.
The European Council and European Parliament completed negotiations on a compromise package of provisions in REACH at the end of November so that legislation could be passed and the new regulation could be ready for implementation beginning June 1. The Parliament and Council adopted their compromise agreement on December 13, 2006, and December 18, 2006, respectively.
According to the European Council, the EU's chemicals policy is intended to avoid chemical contamination of air, water, soil, and the human environment, to preserve biodiversity, and to safeguard workers' and citizens' health and safety. The goal is to balance health and environmental benefits with the need to sustain a competitive, innovative, and job-creating EU industry and the proper functioning of the EU's Internal Market.
With this goal in mind, REACH:
REACH applies to all chemical substances and introduces special registration and evaluation requirements for substances manufactured or imported in the EU in quantities of over one ton per year. The new law is expected to affect approximately 30,000 substances.
An initial pre-registration phase will take about 18 months. During this period, the ECA will notify companies of REACH's provisions.
The registration of "phase-in substances" (i.e., existing substances) will begin three and a half years from REACH's entry into force (June 1, 2007). The registration schedule (referred to as "bands") depends on the risks of a particular chemical substance and the quantity produced. All covered substances will have to be registered by 2018.
During the first phase, substances "of high concern" or substances manufactured or imported in quantities of over 1,000 tons per year will be registered. The registration of phase-in substances manufactured or imported in quantities of between 10-100 tons per year will take place six years after REACH enters into force. The registration of low-volume substances (from 1 to 10 tons per year) will not begin for 11 years.
REACH includes rules on the role of distributors and downstream users in the supply chain, especially with respect to how manufacturers, importers, or downstream users should respond to information on identified uses provided by distributors and/or other downstream users. REACH also allows downstream users to participate in a "Substance Information Forum" and identifies the cases in which users should conduct a "Chemical Safety Assessment" and prepare a "Chemical Safety Report."
The ECA, based in Helsinki, is expected to play a key role in coordinating the evaluation of chemical substances by the EU Member States' regulatory authorities that have the required expertise in this area.
REACH's authorization procedures are intended to ensure that substances of high concern are controlled properly and eventually replaced by less dangerous substances (the "substitution requirement"). Authorizations will be granted when an applicant demonstrates that a substance can be adequately controlled or, if this is not the case, if the applicant can show that the socio-economic benefits from using the substance outweigh the risks to human health or the environment.
Final negotiations between the European Council and European Parliament focused on a number of issues, including the principle of a "duty of care," the communication of information, registration/data-sharing, organization of the ECA, and the authorization procedure, including the substitution requirement mentioned above.
With respect to registration requirements, the compromise provides that seven years after REACH's entry into force, the European Commission must review whether carcinogens, mutagens, or substances believed to be toxic for reproduction ("CMR substances") in the 1-10 tons per year band described above should be covered by a Chemical Safety Assessment. The Commission will review testing methods for reproductive toxicity 12 years after REACH enters into force.
With respect to the authorization procedure and substitution requirement, the compromise requires the following. Substances with persistent, bio-accumulative and toxic properties ("PBTs") or very persistent and very bio-accumulative properties ("vPvBs") identified under Article 56(f) of REACH are excluded from the "adequate control route" for authorization, meaning that these substances can only be authorized based on a socio-economic cost/benefit analysis. Six years after REACH enters into force, the European Commission will review whether to extend this provision to substances with endocrine disrupting properties. Further, when suitable alternatives are available, a substitution plan must be a mandatory part of an application for both the "adequate control route" and the "socio-economic route" for authorizing a chemical substance. If no substitute is available, then producers must present a research and development plan for finding one.
The compromise package also added a clause to the REACH provisions on the duty to inform the public about dangerous substances contained in products. The distribution chain must be informed of the presence of any chemical in an amount greater than 0.1 percent of the product's total weight.
Finally, as a result of the compromise, the European Parliament will appoint two representatives to the ECA's Managing Board and will confirm the appointment of the ECA's Executive Director.
Helpful Q&A guidance on REACH is available by clicking here.
Sources: European Council Press Release No. 16889/06 (Presse 368), December 18, 2006.