REACH | User obligations

Under REACH downstream users must communicate certain information to the next actor (who may be a distributor1) up and down the supply chain. Any actor who receives such information may also be required to pass it in the supply chain.

A downstream user of a substance or a preparation is required to communicate to his immediate supplier new information on hazardous properties, regardless of the uses concerned. ‘New’ information means information that is not communicated to the downstream user by his supplier and that is not available in public data bases or literature. It may relate either to substances or to preparations. However there is no precise definition in REACH of what constitutes new information. Examples of new information may be observations on acute human health effects at workplaces or results of tests carried out by the downstream user.
The downstream user may first want to communicate only the fact that he has new information and the result. He does not have to forward the test report; if his supplier is interested in obtaining the full study report, the downstream user may wish to negotiate the conditions for providing such information.
There are no specific deadlines for communicating information on hazards upstream. The downstream user should do so as soon as he becomes aware that, compared to the information received from his supplier, he has new information.

The downstream user is also required to report2 to the European Chemicals Agency if his classification of a substance is different to that of his supplier. The reason for differences in classification may be the use of new data or a different interpretation of existing data. In this last case, the downstream user only needs to report to the Agency.

A downstream user must communicate to his supplier information that might call into question the appropriateness of the risk management measures recommended in a safety data sheet supplied to him (recommendations for identified uses only). This requirement relates to the main body of the safety data sheet as well as the exposure scenario(s)3 given in the annexe.
REACH does not specify what information the downstream user should forward, or in what format. The downstream user needs to provide sufficient information to justify why he considers that the recommendations are not appropriate. If he regards the measures as ineffective or overprotective, he needs to indicate why this is the case, perhaps with reference to his own operational conditions and the results of his risk assessments. If the recommendations contradict classification and labelling or existing legislation, reference to this is sufficient.

Any professional customer has the right to make a use known in writing (on paper or electronically) to his immediate supplier of a substance or preparation, with the aim of making this an identified use. This is particularly important for substances or preparations which are supplied with exposure scenario(s)3 (see Compliance with the safety data sheet). In these cases, if the immediate supplier is a downstream user, he may decide to identify the use and to prepare a downstream user chemical safety report for it or he may pass the request to the next actor up the supply chain. He may also advise against this use, if he cannot identify safe conditions of use and decide not to include this use in his chemical safety report; he has then to pass the request upstream or he cannot continue to supply his customer.

Any downstream user must provide his customers with information on hazards, safe conditions of use and appropriate risk management advice for substances on their own, in preparations or in articles (see Communication down the supply chain).

In some cases, when the downstream user formulates a preparation and put it on the market, this may require him to consolidate or develop exposure scenario(s)3,4 covering uses of substances in the preparation further down the supply chain and to attach them to his own safety data sheet. Safety data sheets of preparations could have:

For customers who are end-users, the formulator may choose to merge and consolidate the exposure scenarios received from his supplier(s) – and covering all or some of substances in the preparation – into new exposure scenario(s) for the preparation rather than just forwarding them. However, if the formulator supplies another formulator, forwarding the scenarios without changes could be the preferred option, as it provides the customer with sufficient information to carry out a chemical safety assessment, if required, or merge the information for the end-user, if necessary. In any case, the exposure scenario(s) submitted should be consistent with the information provided in the body of the safety data sheet of the preparation.
When merging the exposure scenarios received from his supplier(s), the formulator has to select the ones of relevance for the uses of his preparation. He has to identify the risk-determining substances of the preparation for each route of exposure with the aim to select the most appropriate risk management measures.
If his own conditions of use or the conditions of use down the supply chain indicated by his customers are not covered, he may make a downstream user chemical safety assessment and develop exposure scenario(s) for them.

1. A distributor under REACH is an actor established within the Community who only stores and places on the market substances and preparations.

2. A report to the Agency is not required if the downstream user uses less than 1 tonne per year of the substance as such or contained in a preparation. However if he has relied on the exemption from developing a downstream user chemical safety report on the basis that he uses in total less than 1 tonne per year of the substance or preparation, he does need to report his classification (downstream users may have to make a downstream user chemical safety report when their use is outside the conditions described in the annexe of the safety data sheet they have received or when their use is not covered by this annexe).

3. An exposure scenario describes how a substance (as such, in a preparation or in an article) is used during its life-cycle and how the downstream user controls or recommends controlling exposure of humans and the environment. It includes the appropriate risk management measures and operational conditions that, when properly implemented, ensure that the risks from the uses of the substance are adequately controlled. Exposure scenario(s) are developed in the framework of chemical safety assessment, for substances manufactured or imported at 10 tonnes or more per year and which meet any criteria for classification as dangerous (in accordance with Directive 67/548/EEC) or are assessed to be PBT (persistant, bioaccumulative and toxic) or vPvB (very persistent and very bioaccumulative) substances (in accordance with criteria of annexe XIII of REACH). Exposure scenarios covering all or some of the substances in a preparation may be merged into a single exposure scenario for the preparation.

4. No chemical safety assessment (and therefore no exposure scenario) is required for substances contained in a preparation below the lowest of the concentration thresholds specified in article 14(2) of REACH.