With REACH Regulation (EC) No 1907/2006 the different approaches of the European Chemical laws was harmonized. REACH stands for "Registration, Evaluation and Authorisation of Chemicals". The Regulation is continuously actualised. A consolidated version is available from the website of the European Commission.
Until 1st June 2013 all chemicals produced or imported in amounts above 100 t/a had to be registered and until 1st June 2018 all chemicals prduced or imported in amounts above 1 t/a had to be registered (Annex VII). Actually new chemicals have to be registered and additional claims from ECHA from earlier deadlines have to be completed.
The main objectives of REACH are:
For the implementation of REACH comprehensive websites have been established by the European Commission, DG Environment and the German authorities:
European Chemicals Agency (ECHA)
The ECHA, situated n Helsinki, is leading European regulatory authority on the safety of chemicals.
The test methods to be used are described in Regulation (EC) No 440/2008 laying down the test methods pursuant to REACH. A consolidated version may be downloaded from the ECHA-Website. The test methods are based on the former Annex V of the Directive 67/548/EEC and the corresponding OECD guidelines.
The standard information requirements for substances depend on the quantities manufactured or imported and are laid down in Annexes VII to X of the REACH-Regulation. Examples for studies performed by Hydrotox are given in the following:
REACH reference number
Corresponding guideline (EG) Nr. 440/2008
In vitro gene mutation study in bacteria
440/2008, B. 13/14
Further mutagenicity studies should be considered in case of a positive result
In vitro cytogenetic study in mammalian cells
Does not need to be conducted if adequate data from reliable tests are available. Further mutagenicity studies should be considered in case of a positive result.
In vitro gene mutation study in mammalian cells
Mouse Lymphoma assay
9.1 Aquatic ecotoxicity
Short-term toxicity testing on Daphnia
Does not need to be conducted for highly insoluble or high molecular weight substances
Growth inhibition study on algae
Short term toxicity test on fish
Activated sludge respiration inhibition test
Does not need to be conducted for highly insoluble or readily biodegradable substances
Long-term toxicity testing on Daphnia
Does not need to be conducted for high molecular weight substances or if direct or indirect exposure of the aquatic compartment is unlikely
Fish early-life stage toxicity test (FELS)
Fish short-term test on embryo and sac-fry stages
Fish, juvenile growth test
440/2008, C.4. A-D
Does not need to be conducted for inorganic substances, simulation studies may be required by competent authorities
Annex VII: ≥ 1 t; Annex VIII: Annex VIII : ≥ 10 t ; Annex IX : ≥ 100 t