FoBiG - Work Areas: Chemicals legislation


Some of our major REACH clients

Chemicals legislation

REACH, Registration, Evaluation, Authorisation and Restriction of chemicals

The first hurdle is taken. Thousands of substances were registered by 31 October 2010. And despite the enormous efforts dedicated, REACH is seen as a success by many.

But time is ticking again. Many more phase-in substances are due to be registered by 1 June 2013. While the information requirements are slightly lower (compared to high production volume substances), less data are often available for the substances with tonnages below 1000 tons per year. Conducting new tests involves high costs and – in particular – is very time consuming.

Therefore, using all available instruments to fill data gaps is all the more important. In many of FoBiG’s projects on registration of substances in phase I, category building and read-across turned out to be the best instruments.

FoBiG’s experience from the early phase of REACH – with involvement in many preparatory projects (for the German Chemical Manufacturers Association (VCI): exposure-based waiving, “practical guide”), in the SPORT project, in REACH Implementation Project (RIP) 4.1/4.2 and in the REACH Baseline Study – has been extended by the work for many large European companies of the chemical industry during REACH phase I and registration of numerous substances.

FoBiG offers in relation to REACH:

Support for registration of phase-in substances:
Support in SIEF and consortia discussions
Data searches and data gap analyses
Preparation of IUCLID files (physico-chemical data, human and ecotoxicological data, quality assurance by „Good Evaluation Practice")
Classification and labelling, DNEL and PNEC derivation
Preparation of Chemical Safety Reports (including exposure assessment and risk characterisation)
Support for registration of new substances:
Preparation of inquiry dossiers
Data searches and data gap analyses
Preparation of IUCLID files (physico-chemical data, human and ecotoxicological data, quality assurance by „Good Evaluation Practice")
Classification and labelling, DNEL and PNEC derivation
Preparation of Chemical Safety Reports (including exposure estimation, drafting of exposure scenarios and risk characterisation)
Support for application for authorisation of substances in REACH Annex XIV
Updating/differentiation of the chemical safety report
Assessment of alternatives
(in cooperation with pertners) socio-economic analysis
Assistance in supply chain communication and support of downstream users in meeting their REACH obligations
Assistance for extended safety data sheets
Checking compliance with registered uses
Assessment of mixtures
Notifications of classification and labelling according to Regulation (EC) No 1272/2008 (CLP)

FoBiG provides the expertise in toxicological risk assessment to make full use of the flexible tools of REACH for your benefit: use of intelligent testing strategies (by category building and read-across), exposure-based waiving of information requirements (e.g. according to Annex XI, No 3 and documentation of strictly controlled conditions), tailored exposure assessment and derivation of DNELs.

For REACH and chemicals legislation please contact:
Dr. Klaus Schneider

FoBiG flyer on REACH-related services (1.6 MB)