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).

Key Stages

REACH Processes

• Pre-registration

  This stage was carried out from 1 June 2008 and 1 December 2008 for substances that were already on the EU market (so-called phase-in substances), in order to have benefits from transitional arrangements that allow registering them at a later stage. Pre-registration also enabled registrants to contact each others in order to share data and avoid repeating animal tests.
  To comply with pre registration, Companies realised inventories identifying their manufactured /imported substances, intermediates, as well as the ones used during their production process. Also Nr of affected Legal Entities were assessed. Although required information for this pre registration was small.

• Registration

  REACH requires manufacturers and importers of chemical substances (≥1 tonne/year),a registration dossier with detailed information on the physicochemical, health and environmental properties of their substances, as well as how they are used it, and most cases a risk assessment is required (Chemical Safety Report), covering all identified uses.
  Dossier information and registration deadlines depend on Substance Classification and tonnage bands. First substances to be registered before 1 December 2010 are the ones produced/imported >1000 T/y, and dangerous substances classified as carcinogens, mutagens or toxic for reproduction category 1 or 2, or R50/53, and produced/imported> 100 T/t.
  Currently, Chemical Industry is doing a big effort in order to comply with this stage, joining efforts in most cases in Consortia.
  

• Evaluation

  The Agency will perform dossier evaluation to assess testing proposals made by the registrant or to check that the registration dossiers comply with the requirements. The Agency will also co-ordinate substance evaluation, which will be conducted by the Member States to investigate chemicals of concern.

• Authorisation

  Authorisation will be required for the prioritised substances of very high concern (SVHC) that are included in Annex XIV, this means carcinogens or can have other serious and irreversible effects on human health or the environment.
  Companies applying for authorisation will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.
  Applicants will also have to investigate the possibility of substituting theses substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.

• Restriction

  The European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified