 Downstream User Obligations |
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Downstream users will need to apply appropriate measures to adequately control the risks arising from their use of substances meeting the criteria for classification as dangerous, PBT, or vPvB.
A downstream user is any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.
Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.
REACH requires downstream users to identify and apply appropriate measures to adequately control the risks identified in safety data sheets received from their suppliers and follow the instructions in it or in exposure scenarios which will be attached to some safety data sheets. In addition to REACH, other law on chemicals, such as Directive 98/24/EC on chemical agents requires assessment and control of substances.
If the substance was registered in their supply chain by a manufacturer or importer in quantities of 10 tonnes or more per year then their use of the substance will need to have been assessed in a CSA to ensure it can be adequately controlled.
Two possibilities are foreseen in REACH for the generation of a CSA, to give downstream users a choice:
(1) Downstream users will have to develop their own appropriate risk management measures in a chemical safety assessment in accordance with Annex I, if they use a substance outside the conditions described in an exposure scenario communicated to them in a safety data sheet annex. This will particularly be the case if the downstream users want to use a substance for uses which are not foreseen or not even thought of by their suppliers, and the downstream users prefer to keep these uses confidential. In this case they will have to report certain information to the Agency.
However, there is no obligation for the downstream users to perform a CSA, if they do not receive a safety data sheet with exposure scenarios in the Annex, for one of the following reasons:
. the manufacturer or importer who supplies them with the substance registered less than 10 tonnes per year, and therefore did not need to perform a CSA, or
. the substance is not dangerous, not PBT and not vPvB, so that there is no obligation to compile a SDS.
(2) Downstream users do not need to perform their own chemical safety assessments, if they use substances within the conditions described in exposure scenarios communicated to them in a safety data sheet. In this case, they will have to apply the risk management measures communicated to them and therefore, they need to make sure that the safety data sheets in fact contain information that is appropriate to adequately control the risks arising from their uses. If he does not agree that the identified risk management measures are appropriate, he will need to inform his supplier and will have to resolve the matter with him or carry out a chemical safety assessment (CSA) himself.
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If downstream users supply substances on their own or in dangerous preparations to other downstream users, or distributors, further down the chain, they will also need to pass on information on recommended risk management measures for the further downstream uses in a safety data sheet. |
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