During 2010, the implementation of the new EU chemical regulatory system, including REACH registration and CLP classification and labelling started full scale. For substances already registered, the focus of REACH activities is shifting towards the maintenance of the registrations. REACH transition in the supply chain will take place until at least 2018, when the last phase-in substances will be registered and their new extended safety data sheets will be used by both industry and professionals throughout the supply chain.
ALFE REACH Consortium
The ALFE REACH Consortium registered 11 Joint Submissions before 1 December 2010 (and referred to several other similar substances not registered in parallel).
They included classification and labelling proposals and a joint chemical safety report template, which each registrant needs to maintain individually according to Article 22 of REACH.
In early 2011, the Consortium finalised the financial reporting, cost compensation and reimbursements of 2008 - 2010, and calculated the final prices of the Letters of Access. Task forces on chemical safety reports and extended safety data sheets were established to facilitate the implementation among member companies. Special focus has been on the classification and labelling of possible metal impurities according to the CLP regulation and upgrading their chemical safety assessment.
Dossier maintenance
After the initial submission of the registrations, each Legal Entity has the duty to keep their information up to date. For example, in case of changes in the substance composition, identified uses or applicable risk management measures, or other changes specified by REACH Article 22, each registering Legal Entity is responsible to keep their registrations up to date.
The ALFE Consortium will carefully evaluate the need to update the Joint Submissions by sharing common work in a cost effective manner and minimising the joint maintenance work of companies. Any major changes in the key studies, classification and labelling or joint chemical safety reporst will naturally require an update of the Joint Submission. The Consortium can also provide a collaboration platform, for example for preparing examples for the extended safety data sheets, for companies willing to share their experiences and work.
The annual ECHA progress report of 2010 also highlights the importance of pro-active updating of the dossiers. Substance identity, quality and consistency of argumentation, study summaries and chemical safety assessments are mentioned as the key areas of improvement based on available evaluation experience by ECHA.
Evaluation process
After having gone through the submission pipeline, the registrations will proceed to the evaluation process. Unless the substance contains testing proposals or is selected to undergo compliance check evaluation (dossier evaluation) by EHCA, they will be allocated to the Member States for evaluation (substance evaluation). Substance evaluations will start in 2012, based on annual Community Rolling Action Plans (CoRAP) agreed by ECHA and Member States. The first CoRAP is to be published by the end of 2011, and thereafter established annually for prioritisation of the substances selected for evaluation.
When a substance undergoes evaluation, a draft decision of the Member state should be made available within one year. It will be communicated to the registrant, with a commenting period of 30 days, which includes the possibility to provide further information or update the dossier. Registrants are provided an additional possibility for informal discussion on the scientific and legal background, to be initiated within 10 days of the draft decision. In exceptional cases additional time (maximum 3 months) can be allowed for the registrant to provide the information. Due to the short reaction time, the Lead Registrant and Consortium must be ready to react timely.
During the evaluation process, the registrant will have another possibility to comment or update a modified proposal, and also to participate in the initial discussions in the Member State Committee. A functioning Consortium therefore forms a sound basis for timely reactions during the process.
Contact: Aluminium and Iron Salts REACH Consortium Manager jti@reachcentrum.eu
Did you know?
For substances already on the EU market and pre-registered by 1.12.2008, a transition period of 3 - 11 years will be granted for preparing registrations. Therefore, not all substances have yet received registration numbers or have extended safety data sheets available. Any non phase-in substance needs to be registered as manufactured or imported into the EU.
Companies are currently working hard to prepare extended safety data sheets for the registered substances. The work proceeds slowly, due to extensive changes on the content, format, methods and IT tools. The REACH transformation of the supply chain communicaiton process will continue until 2018 and even beyond.
A registration dossier is an electronic submission package containing basic information about the physicochemical, health and environmental properties (hazard information) as well as exposure and risk assessments for the identified uses of these substances. Any new users not yet registered need to either request to be included in the original registration or be notified to ECHA by the downstream user. The request for 2013 registrations should be made by June 2012.
Downstream users should have identified their uses to manufacturers by December 2009 of the first substances which were registered by 1.12.2010.
Any change in the registrations as specified by REACH Article 22 triggers an update. Each registrant is individually responsible for the maintenance of the registration of his specific substance.
The impact of CLP Regulation on impurities needs special attention.
Substance evaluations will start this year (2012), possibly triggering new testing and updates of the Joint Submissions.
