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Product Safety, REACH, CLP and National Chemical Regulations

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.  We take care that chemicals are classified, labelled and packaged appropriately and the safety data sheet (SDS) is prepared correctly.

Furthermore, article 45 and annex VIII, CLP, requires the notification of mixtures with hazardous ingredients, before they are placed on the EU market. Any such hazardous mixturs must be notified to the corresponding Appointed Body or 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 REACH 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 article 45 and
  •    Annex VIII, CLP
  • • Strategic consulting for the registration process of
  •    substances (Lead, Joint Submission/PPORD)
  • • Competent Person training for SDS

Registration of Chemicals as Lead or Co-registrant

  • • Verification of substance identity
  • • Identification of uses
  • • Identification of data gaps
  • • Preparation of inquiry and registration dossiers
  • • Communication with LEAD and ECHA
  • • Study initiation and monitoring
  • • Cost Sharing according to EC 2016/9
  • • Preparation of exposure scenarios and risk
  •    assessment for humans and environment

Authorisation under REACH

  • • Communication with ECHA for the preparation
  •    and follow up of authorisation applications
  • • Data purchase from the licence holder/access
  •    certificate
  • • Preparation and adaption of documents and reports
  •    (i.e. CSR, analysis of alternatives,  substitution plan,
  •     socio-economic analysis)
  • • Preparation and submission of application dossier
  •    for authorisation

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) SDS
  • • Development of company-specific exposure
  •    scenarios and communication with ECHA
  • • SVHC in articles – communication in supply chain

Seminars & Webinars

Product notification according to CLP and ChemG – UFI as central product Identifier

REACH 2020 – New challenges for manufacturers, importers and Downstream Users

IUCLID & REACH-IT

Competent Person training for safety data sheets REACH (Annex II (EC) 1907/2006)

 

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