Chemical Testing according REACH
REACH- Studies for old and new Chemicals
The new European Chemicals Directive REACH (Registration, Evaluation, Authorisation of Chemicals, EC No. 1907/2006) became effective on 01. June 2007. Its most important alteration compared with the old laws: Not the regulatory authorities must prove the hazards which are present in a chemical, but the chemical industry must prove that its products are produced and handled in a manner that dangers for human health or environment are avoided.
Who should be concerned about REACH?
All European producers and import companies handling substances with a yearly volume of more than 1 t/y (sum of all users). Except for those which were exempted from the registration duties, all substances have to be registered at the ECHA.
Formulations don’t have to be registered, but every ingredient which surpasses the limit of 1 t/y (sum of all users) has to be registered separately.
In order to guarantee independence (against European import companies and producers), a non-EU-producer may implement an Only Representative who will represent the respective company in the EU.
Downstream Users (DU) may have to observe REACH, too. They have to make sure that the amount of the substances which they use is part of the sum which is registered at the ECHA.
Substances which have not been registered on 01. Dec. 2008, are treated as new substances and may not be used, sold or otherwise handled before being fully registered and approved by the authorities!
Registration deadlines of Phase-In-Substances (Substances, which are already on the market):
- Production volume > 1000 t per year (REACH Annex X): September 2010
- Production volume 100 – 1000 t per year (REACH Annex IX): May 2013
- Production volume 1 – 100 t per year (REACH Annex VII / VIII): May 2018
The test requirements depend on the production volume as well as on the available data of the chemical substance. Together with our partner laboratories we provide you with all studies necessary for the registration according to REACH, but also registration following national guidelines in non-EU-countries:
- Substance Identification / Sameness
- Physico-chemical Properties
- in vitro / in vivo Toxicology
- Aquatic and Terrestrial Ecotoxicology
- Environmental Fate
- Analytical Chemistry
- Endocrine Properties
Requirements for Substance Identification (Sameness)
Sufficient spectral data are needed to confirm the structure and composition of the chemical substance. Several spectroscopic and analytical methods can be suitable. It is the responsibility of the registrant to present appropriate data depending on several substance information. We provide you with the necessary analyses and data:
- 1H-NMR/13C-NMR/solid NMR
- Mass spectrum: GC/MS with Headspace and LC-MS or LC-MS/MS
- GC/HPLC Chromatogram
- Water content (Gravimetric, Karl Fischer, Freeze Drying)