October 12, 2011 by wca Staff
After the first REACH registration deadline in 2010, European industry now has to prepare for the second registration deadline of the 31st of May 2013. This deadline is for the registration of all phase-in substances manufactured or imported in the EU above 100 tonnes per year.
The lessons learned in 2010 tell us that all the companies involved in this phase have to be prepared and start work now to make sure that they have time to fulfill all the obligations required for the registration.
To remind everyone of this, ECHA is promoting its “REACH 2013 – Act Now!”campaign on its website. Here registrants will find all the information needed as well as the services and tools that the Agency provides to help companies to comply the REACH registration requirements.
Steps and timeline for submission
Here are the main steps and the suggested timeline for a successful submission:
- SIEF work. Substance Information Exchange Fora help registrants of the same substances by facilitating data sharing, avoiding unnecessary studies and leading to agreed classification and labelling. A SIEF should be a shared effort: be active and communicate with other co-registrants.
- Substance identification. Check with other SIEF members that you have the same substance.
- Hazard data and data sharing. Collect all the available information on the intrinsic properties of the substance to be registered from published sources or within the SIEF. Avoid when possible new testing (consider the use of alternative methods, like QSARs, to fill data gaps) and agree on a transparent cost-sharing mechanism.
- Chemical assessment. Carry out a Chemical Safety Assessment (CSA) of the substance to be registered and document it in a Chemical Safety Report (CSR). The CSA shall include all the information on the physico-chemical, human health and environmental hazard properties (hazard assessment), information on the uses (exposure assessment) and risk characterization.
- Lead submission. The lead registrant of the SIEF has to submit the “joint submission dossier” via REACH-IT, which includes the joint information for the registration. The dossier should be submitted at least two months before the final deadline (31 May 2013) since it has to be accepted for processing before other SIEF-member’s submission can take place.
- Member submission. Other co-registrants, once they have confirmed their membership of the joint submission, have to submit the member registration dossier through REACH-IT.
However, you may not need to undertake all these steps. As REACH is based on the principles of data sharing, if a dossier for the same substance has already been submitted in 2010, registration in 2013 can be completed by buying a letter of access (LOA) from the Lead Registrant in the Substance Information Exchange Fora (SIEF). The general process for registering as a co-registrant by buying a LOA is as follows:
- Check that you have pre-registered. The first step is to check that a pre-registration was made for your substances by your company. If no pre-registration was made, you must cease manufacture (if > 1 tpa) and submit an inquiry to ECHA.
- Identify the Lead Registrant for the dossier that has been submitted: It should be possible to identify the Lead Registrant or SIEF manager for the SIEF containing your substance within REACH IT.
- Check that the current dossier completely covers your substance: In particular check that the substance composition and all your uses and your downstream users uses are covered.
- Complete the company-specific sections of IUCLID: Specific details about your company and the substance to be registered need to be entered into IUCLID.
- Check if any additional information is required: Some Lead Registrants will complete certain items that others will not. It is important to check that all of the required information is available and to complete it if it is not.
- Submit the dossier using REACH-IT: Once complete, the IUCLID dataset will need to be submitted via REACH-IT.
How wca can help you
Need help? At wca REACH experts are ready to help and assist your company in the full registration process. We have experience in aspects of REACH registration from chemical safety assessment (CSA) to dossier submission. We can support you in different activities, such as:
- Literature searches;
- Data gap analysis and development of test strategies;
- Data review and interpretation;
- Preparation of IUCLID dossiers;
- Hazard assessment and PBT/vPvB assessment;
- PNEC and DNEL derivation;
- Evaluation and application of in silico alternative methods (QSAR and read-across);
- Classification and labeling;
- Exposure assessments;
- CSR preparation;
- Assistance with dossier submission;
- Strategic advice on cost-effective approaches to Registration.
We have been involved in hundreds of dossiers that have been successfully submitted to ECHA in 2010, and we are now ready to assist companies that are involved in 2013 deadlines.
Remember, companies that don’t register the substance they manufacture or import on time cannot place it on the EU market.
The 2013 Deadline is coming...
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