REACH
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:
- To improve the protection of human health and the environment.
- To harmonise the assessment system for existing and new substances.
- To register substances which are produced or imported in amounts above 1 ton/year, whereas data requirements depend on the quantity and the consideration of risks.
- To shift the responsibility for risk assessment from authorities to industry whereas the relevant data will be evaluated by experts from a central EU authority.
- To establish an authorisation system for substances of very high concern, in particular for so-called CMR-substances (carcinogenic, mutagenic and toxic to reproduction), PBT-substances (persistent, bioaccumulative and toxic) and vBvP-substances (very bioaccumulative and very persistent).
- To include downstream users into responsibility, e.g. with regard to the flow of information or the safe handling and use of chemicals.
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.
REACH website EC DG Environment
REACH website of the German Federal Environmental Agency
REACH-CLP-Helpdesk of the German Federal Authorities
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 | REACH | Method | Corresponding guideline (EG) Nr. 440/2008 | Comments |
|---|---|---|---|---|
8.4 Mutagenicity | ||||
8.4.1 | VII | In vitro gene mutation study in bacteria | Ames-assay 440/2008, B. 13/14 | Further mutagenicity studies should be considered in case of a positive result |
8.4.2 | VIII | In vitro cytogenetic study in mammalian cells | Chromosome-aberration assay 440/2008, B.19 | 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. |
8.4.3 | VIII | In vitro gene mutation study in mammalian cells | Mouse Lymphoma assay 440/2008, B.17 | |
9.1 Aquatic ecotoxicity | ||||
9.1.1 | VII | Short-term toxicity testing on Daphnia | 440/2008, C.2 | Does not need to be conducted for highly insoluble or high molecular weight substances |
9.1.2 | VII | Growth inhibition study on algae | 440/2008, C.3 | |
9.1.3 | VIII | Short term toxicity test on fish | 440/2008, C.1 | |
9.1.4 | VIII | Activated sludge respiration inhibition test | OECD 209 ISO 8192 | Does not need to be conducted for highly insoluble or readily biodegradable substances |
9.1.5 | IX | Long-term toxicity testing on Daphnia | 440/2008, C.20 | Does not need to be conducted for high molecular weight substances or if direct or indirect exposure of the aquatic compartment is unlikely |
9.1.6.1 | IX | Fish early-life stage toxicity test (FELS) | OECD 210 | |
9.1.6.2 | IX | Fish short-term test on embryo and sac-fry stages | 440/2008, C.15 | |
9.1.6.3 | IX | Fish, juvenile growth test | 440/2008, C.14 | |
9.2 Degradation | ||||
9.2.1.1. | VII | Ready biodegradability | 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