REACH is a complex chemical regulation that aims to protect human health and the environment from substances that are hazardous, by using information about the substance to determine the risk and hence safe use. So this can be achieved there are many parts of the regulation that a manufacturer or importer of substances must comply with.

In 2018, manufacturers or importers of substances into the EU who do so at 1-100 tonnes per year must complete REACH registration. The requirements of registration vary according to; 1) the amount manufactured or imported; 2) the substance itself; 3) the use of the substance.  Understanding the data requirements can be a minefield.

A useful place to start is with a registration strategy, which will look at what is needed for registration for a particular substance. This can be tailored to the company and may include business costs and risks if the substance isn’t registered and therefore cannot be manufactured or imported, thus ensuring business continuity. The strategy can include information about the substance properties; its uses can be utilised to determine if registration is required or if it can be exempt, and the parts of the regulation that are required. This will inform on the information needed as part of a REACH registration, which is dependent on tonnage and substance type.

It may be possible to register the substance jointly as part of a Substance Information Exchange Forum (SIEF), which allows for data sharing with other registrants of the same substance, instead of generating data by an individual company which may be costly if this involves significant data generation, and that of agreement on the classification and labelling of the substance (and, if they agree to do so, jointly submit the guidance on safe use and the Chemical Safety Report, if above 10 tonnes).

The main part of a REACH registration is a REACH Technical dossier, which comprises:

  • General registrant information (Annex VI);
  • Identification of the substance (Annex VI);
  • Information on manufacture and use(s) of the substance(s) (Annex VI);
  • Classification and labelling (Annex VI);
  • Guidance on safe use (Annex VI);
  • Information on exposure for substances registered in quantities between 1 and 10 tonnes per year per manufacturer or import (Annex VI);
  • Study summaries (Annexes VII and VIII);
  • Robust study summaries (Annexes VII and VIII).

Particular data on potential human health and environmental hazards are required for study summaries and robust study summaries and registrants have to collect all available information. Existing data can be located via a literature search for public data, may include company data, and/or data that can be used in a read across/weight of evidence approach.

Considering the existing data and the information needs, any gaps in the data package can then be assessed. These may be addressed in a number of ways, for example, in vitro data, in vivo data, data from valid (Q)SARs and data from structurally related substances (read-across approach) or data waiving. Any additional information required to fill data gaps may take some time to generate, therefore starting early is recommended. When completing the dossier, information will also be required on classification and labelling and safe use of the substance, with those manufacturing or importing >10 tonnes per annum required to provide exposure scenarios and to ensure communication along the supply chain.

As the 2018 deadline captures those that manufacture or import lower quantities of substances, it is envisaged that more of these registrants will be SMEs. The European Chemicals Agency governs REACH and a large amount of information is available via its website (www.ECHA.europa.eu) which is specifically targeted at these groups. Expert help can also be used to assist with complying with this large piece of legislation and a registration strategy will help clarify what is required to ensure compliance.