REACH

REACH is a regulation of the European Union, entered into force on 1 June 2007, to improve the protection of human health and the environment from the risks that can be posed by industrial chemicals.

The European Chemicals Agency (ECHA) in Helsinki is the driving force among regulatory authorities in implementing the four processes of REACH, namely the Registration, Evaluation, Authorisation and restriction of CHemicals.

The companies, manufacturers, importers and downstream users, must identify and manage the risks linked to the substances they manufacture and market in the EU, demonstrate to ECHA how the substance can be safely used, and must communicate the risk management measures to the users.

The Regulation calls for the progressive substitution of the most dangerous chemicals like Persistent Bioaccumulative and Toxic substances (PBT) and promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

Our Services

DERAC has previous experience in developing environmental risk assessment for more than 30 registration dossiers in the three phases of REACH (2010, 2013 and 2018). DERAC understanding of environmental sciences, industrial processes and regulatory authorities expectations enables to make the best use of existing information, to ensure that testing programmes are appropriate and to provide convicing justifications to the authorities.

DERAC offers its main and specific skills in support of REACH compliance with many aspects of the REACH requirements.

Registration: creation of technical dossiers and e-SDS (environmental sections)

Search for and analysis of existing data
Determination of the registration strategy including alternative methods
Determination of the testing strategy and generation of experimental and in-silico missing data
Creation of the environmental technical dossier (IUCLID) including classification and PBT assessment
Characterisation of life cycle and uses, definition of exposure scenario and risks assessment (Chesar)
Drafting of the Chemical Safety Report (CSR) and the e-Safety Data Sheet (e-SDS)
Technical representation within the SIEFs

Evaluation: Examination of testing proposals, Compliance check and Substance evaluation (CoRAP) phases

Communication with the environmental experts of ECHA and the evaluating Member States.
Collection of all available information and/or generation of new data depending on draft decisions case-by-case basis
Drafting of consolidated comments on the draft decisions and proposals for amendments on behalf of the registrant(s) respecting the regulatory deadlines
Representation at the Member State Committee meeting

Autorisation (application) and Restriction (Annex XV dossiers): environmental sections

Preparation of risk assessment for the applied uses(s) in the Chemical Safety Report (CSR)
Identification and risk assemment of alternative substances in the analysis of alternatives

Specific skills

Mixtures or multi-constituents: reaction mass and UVCB
Ionic substances
Inorganic substances: heavy metals, salts
Alternative methods: QSARs, read-across, Weight of evidence approach
Persistency and Bioaccumulation assessment
Marine risk assessment