The commitments of a company according to REACH result from its position within the supply chain. In general REACH distinguishes between producers and importers on the one and the downstream users on the other side.
Producers and importers are companies which actually produce a substance or import it in the customs territory of the EU. All substances which are produced or imported in quantities of ≥ 1 have to be registered. In case the produced or imported quantity exceeds 10 t per year an additional evaluation with regard to substance safety has to be carried out. Depending on the hazardous properties of the substance and its use this evaluation might become very complex and extensive. Target of this evaluation is to define clear frame conditions within which the application of a substance is regarded as safe. When leaving this frame the risk will exceed the advantage of the substance. The results of the evaluation regarding substance safety are measures to minimize the risk which the producer or importer has to observe himself and which he has to pass on to his customer in form of safety data sheets.
Depending on the determined risk the evaluation regarding substance safety must also include detailed indications on possible contact of the substance with man and environment. REACH calls these detailed indications "exposition scenarios". The evaluation of substance safety thus strongly depends on the intended use. In case a substance is subject to this exposition scenario it has to be communicated to all downstream users in form of an annex to the safety data sheet.
The evaluation with regard to substance safety can become very complicated. Especially, if one or even more exposition scenarios have to be developed. In that case the evaluation regarding product safety requires considerable know how of the company carrying out this evaluation. In general small or medium sized companies do not have the necessary resources to establish evaluations with regard to substance safety on their own. Therefore REACH explicitly encourages the formation of Substance Information Exchange For a (SIEF) by all the existing producers and importers of a substance in order to carry out these evaluations in common. Thus larger companies can considerably facilitate the registration for the small and medium participating companies of SIEF. Whether this will really be feasible will be shown in the future.
Downestream users are companies using a substance without carrying out any chemical modification. A typical example for a subsequent user is a formulator of lubricants. As an example we regard a typical lubricant: In the simplest case motor oils consist of a base oil and an additive package. The base oil as well as the substances in the additive package have to be registered by the corresponding producer. The formulator of the motor oil thus has nothing to do with the registration of the substances. He simply mixes the two components base oil and additive package without modifying them chemically. Downstream users therefore do not need to carry out the registration.
However, the downstream users are obliged to apply the measures for risk minimization which the producer or importer has derived from his evaluation regarding substance safety. Here it is of importance that the use of the substance by the downstream user has been considered during the evaluation of substance safety. This means, of course, that the producer knows for which application his customer needs the product. The downstream user must therefore reveal the application to the supplier. In case the user refuses the disclosure he has the possibility to establish an own evaluation of substance safety. But this is only possible if he has the corresponding resources.
In some cases a company can also play various parts within REACH. A good example for the clarification of this REACH phenomenon is the production of a lubricating grease. The grease consists of a base oil, a thickener, e.g. lithium-12-hydroxystearate, and additives. While the base oil and the additives have to be registered by the corresponding producers or importers, the grease producer often himself produces the thickener from corresponding precursor substances. In our case from lithium hydroxide and 12-hydroxy stearic acid. The generated substance must therefore be registered by the lubricant producer since it is not purchased from any pre-actor of the supply chain.
With reference to the base oil, the additives and the precursor substances of the thickener (lithium hydroxide and 12-hydroxy stearic acid) the grease producer is downstream user. With reference to the thickener, however, he is the producer. In case the base oil or one additive is imported from a state outside the EU into the EU, he additionally is the importer of the substance. Thus the allocation of roles within REACH can be very complicated.