REACH Services

Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (EC) No 1907/2006

reach


The REACH regulation applies to anyone manufacturing or importing chemical substances into Europe. Substances placed on the EU market in quantities of 1 tonne or more per year must be registered by the relevant deadlines or they may not be placed on the market.

There are many steps to the registration process and our experts are helping many clients to comply with the requirements of REACH. Our Third Party Representative and Only Representative services are key to helping clients register their substances before the applicable deadlines.

Key points of the REACH regulation

  • It is being implemented in several phases up to 2018.
  • It affects everyone in the supply chain – manufacturers, importers and end-users. 
  • Hazard assessment, risk assessment, product classification and labelling information are required. 
  • This information must be submitted to the European Chemicals Agency (ECHA) in a dossier for all substances placed on the EU market in quantities of 1 tonne or more per year.
  • The greater the tonnage, the greater the amount of information required. 
  • It restricts the use of some harmful chemicals.

Key steps and obligations

The REACH regulation has a 'no data, no market' policy. This means that, for manufacturers and importers, there is a need to 'sign up', and generate dossiers of chemical information for REACH registration. The REACH regulation has three key deadlines (2010, 2013 and 2018) based on quantity produced. The amount of data required is also scaled, with the least amount of detail required for the final deadline in 2018.

The key steps for REACH are:

  • Pre-registration – which had to be completed by 2008 to sell to market straight away.
  • Late pre-registration – available up to 1 year prior to a submission deadline provided the product has never been sold in the EU.
  • Communication with other companies registering the same substance.
  • Submission of a REACH registration dossier to complete registration.
  • Above 10 tonnes per year, completion of al chemical safety report (CSR).
  • Generation of an extended safety data sheet (ESDS) with a new exposure scenario (ES) section required for some substances.
  • Additional measures for substances requiring authorisation or substances of very high concern (SVHC).

Manufacturers and importers

Manufacturers and importers (or Only Representatives, where applicable), will be required to have already carried out pre-registration if they wish to sell to market straight away. It is possible to carry out a late pre-registration for new products provided that they are still more than a year away from the deadline. Once this has been completed, manufacturers/importers enter the Substance Information Exchange Forum (SIEF), where they are able to communicate with other companies registering the same substance. A lead registrant will be chosen and will act as the main player in developing the appropriate dossier, to which all of the other registrants will have access once they purchase a 'letter of access'. Completion and submission of the dossier will then end the registration process and grant the manufacturers/importers a REACH registration number, which can be quoted on their SDS. The level of effort required and number of documents necessary for registration will reflect the volume of production, and whether the chemical has any specific issues such as being a SVHC.

Downstream users

Downstream users (DU) have obligations under the REACH regulation. Typically, a DU is a company that purchases a chemical from an EU manufacturer or from a distributor that has already imported the goods into the EU. The DU will need to keep a copy of a compliant SDS (REACH/Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation)), which their supplier should provide. They must also keep track of how much of the product they buy and use each year, and should ensure that their supplier is REACH compliant. This latter point is important because if, at a later date, it becomes apparent that a supplier has not followed the rules regarding the REACH regulation, it can mean that their goods are prohibited from being sold. This would affect the supply of products to the DU.