For many companies who manufacture or import lower tonnage substances into Europe, registration under REACH is a complex and challenging process. However, one of the main principles of REACH is ‘one substance, one registration’, meaning that companies manufacturing or importing the same substance should work together. This saves the individual companies time and money and prevents the duplication of testing.
For each substance, a Substance Information Exchange Forum (SIEF) was set up to enable data sharing. A SIEF is formed automatically through REACH-IT¹ based on pre-registrations. Within the SIEF a lead registrant will be identified who makes the initial dossier submission to ECHA. All other co-registrants can then register using the same hazard dataset.
For companies manufacturing or importing a substance in the EU at a tonnage ≥1 tpa (but < 100 tpa), registration under REACH is required by May 31st 2018. Even if you have not been actively involved in your SIEF up until now you can still register using the dataset and be a co-registrant.
As REACH is based on the principles of data sharing, if a dossier for the same substance has already been submitted in 2010 or 2013, registration in 2018 can be completed by purchasing access. Once the Lead Registrant in the SIEF has submitted a dossier to ECHA you can buy a letter of access (LOA) to the dossier. The following stages outline the process for registering as a co-registrant by buying a LOA and are vital for ensuring compliance under REACH.
1. 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.
2. Identify the Lead Registrant for the dossier that has been submitted. If you have a pre-registration, you should be able to identify the Lead Registrant within the SIEF or the SIEF manager representing your substance via REACH IT. If that doesn’t work, lots of REACH consortia have useful websites, many of which are listed on the ChemicalWatch website.
3. Check that the current dossier completely covers your substance. It is very important to make sure that your substance would be covered by the current dossier. In particular, check for the following:
a) Substance composition: A REACH dossier will define the composition of the substance that it covers. This includes the level of purity and the percentage of impurities that a substance may contain. For example, a dossier may state that it covers the named substance provided it has <20% impurities (criteria regarding impurities vary between dossiers). You must check that your substance falls within these limits before purchasing a LOA.
b) Substance uses: A REACH dossier will cover a particular set of uses, as declared by those registering the substance. You must check whether this list covers your uses and all of your downstream users uses of the substance. If it doesn’t, new exposure scenarios may be required for any additional uses that you or any of your downstream users require.
4. Complete the company-specific sections of IUCLID. A number of IUCLID² sections will still need to be completed even if a LOA is purchased. These include information about your company and specific details relating to the substance to be registered. Analytical data must be supplied to demonstrate that your substance is the substance that you are registering. Such information may already be available in-house. If not, analytical testing of the substance must be carried out.
5. Check if any additional information is required. Depending on the SIEF, some Lead Registrants may complete items that others may not. For example, a “Part A” document is needed, confirming that the Risk Management Measures (RMM) identified to ensure safe use are complied with and that these RMMs are communicated to your customers. Some Lead Registrants complete this on behalf of all registrants, others do not. If it is not already completed, a Part A will need to be produced. If you have extra uses that require additional RMMs then the Part A document needs to be updated to reflect this.
6. Submit the dossier using REACH-IT. Once all of the above stages are complete, the IUCLID dataset must be submitted to ECHA using REACH-IT. This will require your REACH-IT username and password (generated when you pre-registered).
At wca, we offer a full package of services to assist with REACH compliance, building on our wealth of knowledge and expertise to help your REACH registrations to go smoothly. We have completed many IUCLID hazard datasets as part of successful 2010 and 2013 REACH registrations and can assist you with completion of the required company specific sections of IUCLID for your substance. We are experienced exposure modellers who can generate additional exposure scenarios if your uses, or the uses of your downstream users, are not covered by the Lead Registrant’s dossier. We are experienced users of REACH IT and have helped a number of our clients to submit their completed dossiers via REACH-IT.
Please contact us for more information or a quote by emailing or contact us today on +44 (0)1367 246026.
¹ REACH IT is the IT system specifically set up for pre-registering and submitting registration dossiers under REACH.
² IUCLID (International Uniform ChemicaL Information Database) is a key software application to capture, store, maintain and exchange data on intrinsic and hazard properties of chemicals, essential for compliance with REACH.