REACH REGULATION

In this section you will learn about how CEPSA Quimica is preparing to fulfill its obligations under REACH Regulation, in order to properly register its products (our deadline, November 2010).

Product Uses

Communication in the supply chain

REACH foresees communication in the supply chain in two directions:

1. Communication down the supply chain (from suppliers to downstream users)

   REACH requires manufacturers and importers of a substance on its own or in a preparation to communicate how their substances or preparations can be used safely for humans and environment.

   The main instrument for this communication down the supply chain is the Safety Data Sheet (SDS).

   The manufacturer, importer or downstream user will prepare the SDS according to a similar principle as he did before REACH came into force. The main difference is that when required, the SDS will also have an annex including Exposure Scenarios specifying the conditions under which the substance or preparation can be used safely, for uses that have been identified. The quality of the SDSs is expected to improve due to REACH as more information will be available as a result of the registration process.

   If an SDS is not required, the supplier still has to communicate key risk information about the substance, in particular stating if the substance is subject to authorisation or restriction, together with any other available and relevant information to enable appropriate risk management.

   Furthermore, suppliers of articles shall inform their customers about substances of very high concern contained in concentrations above 0.1%. Also consumers can request such information.

   Distributors are not considered as downstream users under REACH but should pass on information received from their suppliers to their customers to ensure they can use the substance or preparation safely.

2. Communication upstream (from downstream users to suppliers)

   Upstream communication by an actor in the supply chain is mandatory in a number of situations. This includes the communication of new information on the hazardous properties that become available as well as of information that may call into question the appropriateness of the risk management measures recommended by the supplier. Distributors have a general obligation to pass on information received to the next actor in the supply chain.

   Downstream users have a right to make their use known to the supplier and in doing so have to provide sufficient information to prepare an exposure scenario. This upstream communication will play an important role when a registrant will prepare a chemical safety report, including exposure scenarios if required, as a part of the registration dossier. The manufacturers and importers often do not know what the substance is used for, and how it is used, and therefore need to collect such information from customers in order to assess how risks can be adequately controlled for the different identified uses. The downstream users have on the other hand the detailed knowledge on their uses and also an interest in having these covered by the suppliers’ exposure scenarios thus being able to continue the use and receiving relevant information on how to control possible risks.

Consequences of registration for downstream users

You are not required to register the substances that you use, but the registration of these substances by their manufacturers and importers will affect you in a number of ways:

• Substances which are not registered will no longer be available on the EU market.
• The classification and labelling of some substances may change and, if you are a formulator using such substances, you will need to review the classification of your products and their safety data sheets accordingly.
• Safety data sheets will also be updated or extended with information generated through the registration process. If you receive an exposure scenario attached to a safety data sheet, this will trigger additional obligations for you.

Exposure Scenario is a new feature under REACH. It will depend on whether the substance is dangerous and the quantity produced by the manufacturer or importer who registers it. An Exposure Scenario describes how a substance or preparation can be used safely and the risk management measures which should be applied to control risks to humans or the environment. If you receive an exposure scenario, you must check whether your current use is covered and whether you comply with the conditions described in that exposure scenario.

If you use a substance or preparation outside the conditions described in the exposure scenario, or if your use is not covered by the exposure scenario, you have several options:

• you may make your use/use conditions known to your supplier so that the supplier can prepare an exposure scenario covering your use conditions
• you may change your conditions of use so they comply with the supplier’s exposure scenario
• you may find another supplier who provides an exposure scenario covering your conditions of use
• you may prepare your own chemical safety report5 , or
• you can find an alternative substance, preparation or process and stop using the sub-stance/preparation in question.

Thus, it is very important downstream users submit detailed information on use and use conditions about substances supplied to them.

The obligation to comply with the exposure scenario developed by the supplier (or to develop them for uses not covered) applies twelve months after the downstream user has received a safety data sheet with a registration number