What is REACH
REACH is the European Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force in 2007, replacing the former legislative framework for chemicals in the EU. The main objective of REACH regulation is to provide a high level of protection to human health and the environment by imposing a greater responsibility on the industry to manage the risks from chemicals. The European Chemicals Agency (ECHA) manages the technical, scientific and administrative aspects of the implementation of REACH. ECHA run the databases necessary to operate the system, conduct an in-depth evaluation of the chemicals and provide a public database within which consumers and professionals can find relevant hazard information.
Scope of REACH
REACH covers all substances whether manufactured, imported or used in any form in the market. REACH applies to any person manufacturing, importing, using or placing a substance on its own or in a preparation on the EU market. Members states may exempt certain substances for defence purposes.
Other exemptions include:
- Radioactive substances like mineral ores
- Those subject to customs
- Non-isolated intermediaries
- Food or feeding items
- Plant protection products and biocides
- Medicinal products for humans of veterinary use
- Substances listed in Annex IV and V of REACH
Companies, or even individuals, that use chemical substances are called downstream users. Downstream users have a key role to play in advancing the safe use of chemicals by implementing safe use at their own site and communicating relevant information both to their suppliers and their customers. If the downstream user does not identify his use to the manufacturer/importer then, the user must inform ECHA and prepare their own CSA (Chemical Safety Assessment).
Manufactures or importers must prepare a registration dossier for all substances of a quantity more than one tonne per year manufactured/imported to ECHA. Information to be supplied includes physiochemical, toxicological and ecotoxicological data on the substance. Information on downstream users must also be provided. Other than this, all risk and safety assessments conducted must be submitted as well. For more than 10 tonnes per year manufactured or imported, a CSA must be documented in a Chemical Safety Report. However, a testing proposal is required at tonnages greater than 100 tonnes per year.
Member states choose which substances to evaluate out of the ones put on the Commissioner’s 3-year Community Rolling Action Plan. There are two types of evaluations:
- Dossier Evaluation: ECHA performs compliance checks of the testing proposals submitted by the industry and can decide if only a part of a dossier is to be investigated.
- Substance Evaluation: ECHA conducts this evaluation on a priority basis to clarify suspicions of risks to human health and the environment. Moreover, it also holds the authority to decide if any actions need to be taken under REACH.
Authorisation is applicable to all substances placed on the market or used between manufacturers, importers and downstream users. Sufficient control measures are already in place for certain substances. Hence, such substances are exempted from authorisation. For example, substances used in medicinal products.
A proposal to restrict the manufacture, marketing and use of the substance is made by the Commission or by a Member State. The intention is to provide a safety net to manage risks not addressed by other elements of REACH. Restriction can apply to a substance on its own or in a mixture.
The REACH deadline of 31 May 2018 is for companies that manufacture or import substances in low volume (Between 1-100 tonnes a year). ECHA’s estimate is that up to 60,000 registrations will be prepared for up to 15,000 substances. This is three times more than for either of the two previous deadlines (2010, 2013).
The 2018 deadline will create the most comprehensive chemical database in the world based on the information gathered on substances placed on the European market. The knowledge derived from this database will be potential drivers for future innovations. All manufacturers or importers of chemical substances from outside the European Union, above one tonne per year, will also be affected by the upcoming deadline and registration obligation under REACH.