aca24@aca-pharma.de/

+49 341 33 73 33 60

Registration of chemical substances according to REACH

The REACH regulation (EC) 1907/2006 defines the registration, evaluation, authorization and restriction of chemical substances within the EU. REACH has been adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. All manufacturers and importers are required to register chemical substances manufactured in or placed on the EU market at an amount of > 1 t/a. However, according to REACH the actors (manufacturer, importer, downstream user) within the supply chain of chemical substances, preparations (mixtures), and articles are subjected to many other obligations.

Based on expert knowledge on the registration of chemical substances and the verification and extension of exposure scenarios according to extended Safety data Sheets (eSDS), we support you – as manufacturer or downstream user – in identifying your obligations and the required measures to assure REACH conformity.

In the EU, the classification and labelling of hazardous chemicals is governed by Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the ‘CLP Regulation’). Take advantage of our experience concerning CLP of substances and mixtures as well as the preparation of eSDS.

It would be a pleasure to support you in the implementation of REACH and CLP.
Act now, with regard to the registration deadline at 31 May 2018 for substances with a tonnage band of maximally 100t/a

REACH conformity analysis

  • • Obligation check based on the substance/mixture
  •    /article portfolio to ensure REACH compliance
  • • Strategic advice and project management

Initial steps of a substance registration

  • • Verification of substance identity/
  •    substance sameness
  • • Establishing/participating in a substance information
  •    exchange forum (SIEF)
  • • Preparation of an inquiry dossier and submission
  •    to ECHA
  • • Identification of data gaps
  • • Testing proposals including alternative
  •    testing strategies
  • • Study initiation and monitoring
  • • Identification of uses and description according to
  •    the Use Descriptor System (UDS)
  • • Purchase of data (Letter of Access, LoA)

Substance registration as lead or co-registrant

  • • Cost sharing and cost transparency according to
  •    EC 2016/9
  • • Preparation of registration dossiers using IUCLID
  • • Preparation of exposure scenarios and risk
  •    assessment for human and environment
  • • Submission of registration dossiers to ECHA using
  •    REACH-IT

Services for Downstream Users (DU)

  • • Analysis of rights and obligations of DU under REACH
  • • Verification of uses according to the exposure
  •    scenarios as specified in the extended safety data
  •    sheets (eSDS)
  • • Development of company-specific exposure
  •   scenarios and communication with ECHA
  • • Support in the topic of substances of very high
  •    concern (SVHC) in articles

CLP services

  • • Classification and labelling of substances and
  •    mixtures according to EC 1272/2008

Seminars

Topics

REACH 2018

IUCLID 6.0 & REACH-IT

Use verification for DU according to the eSDS

Certificate of competence for the preparation of SDS

Comments are closed.