What are the main obligations of a downstream user under REACH?
The role, responsibilities and rights of downstream users are mostly covered under Title V of the REACH Regulation.
The DU must comply with the safety precautions recommended in his suppliers’ safety data sheet. For substances which are manufactured or imported in quantities of greater than 10 tonnes per annum, the SDS should have one or more exposure scenarios attached and the downstream user must ensure that his use of the substance is covered by the exposure scenarios(s) and that he is applying the recommended operational conditions and risk management measures If a downstream user finds he is not covered by his suppliers safety data sheet and exposure scenario, he has a number of options available to him:
- The DU will be able to make his use of the chemical substance known to his manufacturer/importer with the aim of having the manufacturer/importer address it as an ‘identified use’ and incorporate it in the chemical safety assessment which the manufacturer/ importer will be required to do as part of his registration requirements.
- The DU may change to a supplier who has an exposure scenario which covers his use.
- If he cannot source an alternative supplier, and he chooses not inform his supplier of his use, perhaps for confidential business reasons, then he will have to notify the European Chemicals Agency (ECHA) and may have to prepare his own chemical safety assessment, in accordance with Annex XII of the Regulation.
A downstream user may also need to inform his supplier of any new information on the hazardous properties of the chemical he uses and also of information regarding the appropriateness of the recommended risk management measures.
There is a possibility in the future that if a DU uses substances of very high concern such as carcinogens, mutagens, reproductive toxins (CMRs), PBT and vPvB substances, they may be phased out by the authorisation system under REACH. If such substances are currently in use by a DU, every effort should be made to source safer alternative substances.
Downstream users will not be required to pre-register or subsequently register, the substances that they use. However, DUs should now start communicating with their suppliers and check that the substances they receive are phase in substances, whether the supplier plans to pre-register and then register the substances, if a chemical safety report will be required, and if so, if the use of the DU will be included. Contacting the suppliers before registration can help to ensure that the use of the DU, and the risk management measures that he has in place, are taken account of in the registration. It is largely up to those in the supply chain to decide how this communication will work most effectively, and where relevant trade associations exist, they may have a role to play here.
Title V of the REACH Regulation outlines the roles and duties of Downstream Users. This Title will enter into force on 1st June 2008. DU will then have the right to identify their use in writing to their suppliers and to ask them to address this as an identified use in their registration and chemical safety report (where this is required). It is anticipated that some suppliers may react immediately, whereas others may not react until they are approaching the relevant registration deadline for the substance and have to develop their exposure scenarios. Where a number of alternative suppliers are available for a substance, it may be possible to determine which of them are more advanced in their REACH preparations and have started to consider identified uses and development of appropriate exposure scenarios. However, a manufacturer or importer will not be compelled to disclose the uses he intends to cover, and the exposure scenarios he has developed, until the registration deadline that is relevant to him, his substance and his tonnage has passed. In some cases, the exact plans for a particular substance may not be clear until after pre-registration and SIEF formation has taken place.
Downstream users can participate in the substance information exchange forum (SIEF) that may be formed for a pre-registered substance that they use. In order to participate in the SIEF's, DUs will need to have relevant data that is required within the SIEF to complete the registration. Article 28(7) of the REACH Regulation states that downstream users and third parties holding information may submit the information to the European Chemicals Agency (ECHA) for those substances, with the intention of being part of the SIEF. Downstream users may be in possession of large sets of data and so, may have a lot to contribute in the collection of data to be used for registration, such as that for classification and labelling, exposure and estimation of risks. Therefore, DUs are considered a category of ‘data holders’. DUs become involved in pre-registration and registration once the list of pre-registered substances is published. They may submit information to ECHA on pre-registered substances, with the intention of becoming a member of the corresponding SIEF. They will need to identify themselves and lodge a request to the European Chemicals Agency (ECHA), with a view to participating in a SIEF for a particular substance for which they hold data (e.g. data regarding safety, hazard data and uses). This will be completed through REACH IT. Such information from DUs may, for example, help potential registrants to waive certain tests based on lack of exposure.
In addition the European Chemicals Agency has published a Guidance Document for Downstream Users