REACH

With REACH Regulation (EC) No 1907/2006 the different approaches of the European Chemical laws was harmonized. REACH stand for "Registration, Evaluation and Authorisation of Chemicals". The Regulation is continuously actualised. A consolidated version is available from the Öffnet externen Link in neuem Fenster website of the European Commission.

Until 1st June 2013 all chemicals produced or imported in amounts above 100 t/a had to be registered. Now, the next deadline is 1st June 2018, where all chemicals above 1 t/a have to be registered. The companies concerned are well advised to prepare in time for this deadline, since experience shows, that at the end of this period the testing capacities of the laboratories are scarce.

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:

Öffnet externen Link in neuem FensterEuropean Chemicals Agency (ECHA)
The ECHA, situated n Helsinki, is leading European regulatory authority on the safety of chemicals.

Öffnet externen Link in neuem FensterREACH website EC DG Environment

Öffnet externen Link in neuem FensterREACH website of the German Federal Environmental Agency

Öffnet externen Link in neuem FensterREACH-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 Öffnet externen Link in neuem FensterECHA-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
Annex

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