Product Safety, REACH & CLP
The REACH regulation (EC) 1907/2006 outlines how chemical substances ≥ 1 t/a are to be marketed and used within the EU. Manufacturers, importers and downstream users must fulfil comprehensive legal obligations when marketing chemicals and mixtures, also when communicating within the supply chain.
We offer registrants and downstream users bespoke and solution-oriented support, starting from helping them to identify and implement their REACH obligations, including for example the registration of substances and preparation of exposure scenarios, ensuring all-round REACH conformity and marketability.
The CLP regulation (EC) 1272/2008 lays down the responsibilities of companies concerning the classification, labelling and packaging of chemicals and mixtures before placing them on the EU market.
Furthermore, article 45 and annex VIII, CLP, requires the notification of mixtures containing as hazardous classified substances, before they are placed on the EU market. Any such hazardous mixtures must be notified to the corresponding Appointed Body via the Poison Centre Notification Portal (PCN) of ECHA. ACA-pharma concept GmbH will consult you on all aspects concerning the submission of information of your hazardous mixtures. We help you to submit all necessary data to the authorities, be it for the whole of the EU or on a national level.
ACA-pharma concept GmbH will assist you in all matters to implement REACH and CLP correctly in your company. As ECHA is intensifying examinations of dossiers, we will also help you with completeness and quality checks of your existing dossiers to ensure that they fulfil the recent ECHA requirements.
Product safety and conformity
- • Identification of your legal rights and obligations
- based on your substance or product portfolio
- • Classification and labelling of substances
- and mixtures according to CLP
- • Product notification according to CLP
- • SCIP notification
Authorisation under REACH
- • Communication with ECH
- • Data purchase from the licence holder/access
- • Preparation and adaption of documents/reports
- (i.e. CSR, analysis of alternatives, substitution plan,
- socio-economic analysis, dossier)
Registration of Chemicals as Lead or Co-registrant
- Verification of substance identity
- Preparation of inquiry, PPORD and registration dossiers; Communication with LEAD and ECHA
- Identification of data gaps; Study initiation and monitoring
- Cost Sharing according to EC 2016/9
- Preparation of exposure scenarios and risk assessment for humans and environment