The EU REACH Regulation entered into force on 1 June 2007 replacing several other EU chemical laws. The core aim of this legislation is to improve the protection of human health and the environment from the hazards of chemicals, including metals and their compounds.
REACH places the burden of proof upon industry to:
- demonstrate that the effects of their substances on human health and the environment are fully understood,
- provide risk management measures to ensure the safe use of substances throughout their life cycle
To achieve this goal the EU requires all manufacturers in Europe and/or importers into Europe of chemicals substances, to register detailed technical dossiers about each substance with the European Chemicals Agency (ECHA) within certain timeframes.
Facts and consequences:
- As an EU-based manufacturer or importer, if you need to register but fail to do so then your must suspend your EU business until Registration is completed - "no data no market".
- REACH is substance based and compliance is the responsibility of each EU legal entity involved in the manufacture or import of that substance.
- All EU manufacturers and EU importers of a substance at ≥1 mt per registrant per year will need to submit a comprehensive registration to the European Chemicals Agency (ECHA) based in Helsinki.
- For existing substances, pre-registration will allow a temporary exemption period of up to mid 2018, the timing of which depends on the registrant's annual tonnage of the substance.
- Authorisation and, ultimately, restriction of substances of high concern for specific uses, where the risks can be demonstrated to be controlled.
- Ongoing review and update of individual registrations as tonnage, identified uses or risk profiles change
What is involved in registering?
In very broad terms, per substance, REACH prescribes an extensive list of human health, environment and physico-chemical endpoints about which it first requires data. Secondly, it requires the data to be used to make risk assessment, and thirdly it requires the provision and use of risk management measures for safe use of each substance throughout its life cycle.
- June 1 2007 - REACH entered into force
- June 1 2008 - start of pre-registration
- December 1 2008 - end of pre-registration
- Early 2009 - publication of SIEF membership
- December 1 2010 - registration deadline for substances ≥1000 t/a
registration deadline for CMR ≥1 tpa and PBT/vPvB (R50:53) ≥100 t/a
- June 1 2013 - registration deadline for substances ≥100 t/a
- June 1 2018 - registration deadline for substances ≥1 t/a