Registration dossiers for substances and products: Chemical substances (REACh)

Registration dossiers for active substances and products Chemical substances (REACh) logo

Staphyt Regulatory team supports you in all regulatory procedures required to place your substances / chemicals on the European market according to REACH (Regulation (EC) No 1907/2006) and CLP (Regulation (EC) No 1272/2008).

Our team currently pools 30 scientists, whose backgrounds cover all areas needed to place substances or products on the European market: physico-chemistry, analysis, toxicology, ecotoxicology, biological efficacy, etc.

You need to

  • Carry out an inventory of your substances/products with regard to REACH to identify the specific requirements for each substance (registration, notification, authorisation and use restriction),
  • Prepare the joint or individual part of your substance registration dossier under the IUCLID format, including:
    • the technical dossier of the substance,
    • the Chemical Safety Report (CSR) including the risk assessment, exposure assessment and the risk characterization for human health and environment, depending on use and according to appropriate models (EASE, ConsExpo, EUSES, ECETOC TRA, etc.).
  • Conduct preliminary evaluations for PBT (Persistent Bioaccumulative and Toxic), vPvB (very Persistent and very Bioaccumulative), CMR (Carcinogenic, Mutagenic, Reprotoxic), and POPs (Persistent Organic Polluants),
  • Carry out literature searches on your substances,
  • Represent your company within exchange forums (SIEF),
  • Contact authorities to check on your dossier or respond to a particular request,
  • Update your registration dossiers (change of tonnage band, adaptation to technical progress, etc.),
  • Determine a strategy for substances subject to restriction or authorisation,
  • Notify SVHC substances contained in articles,
  • Prepare or revise Safety Data Sheet (SDS) according to new requirements (standard or extended SDS),
  • Determine/notify the classification according to CLP Regulation,
  • Determine or validate the labelling of your substances/products (mandatory labelling elements according to CLP regulations and specific regulations depending on the type of product),
  • Submit Anti-Poison Center declarations (Article 45 CLP Regulation) in Member States (including France via SYNAPSE / INRS).

Our expertise

  • Preparation of registration dossiers under IUCLID format,
  • Evaluation of the risk to Human Health (ECETOC TRA, Stoffenmanager, Riskofderm, etc.) and Environment (EUSES software), preparation of Chemical Safety Report (CSR),
  • Preparation or revision of Safety Data Sheet (standard or extended SDS),
  • Literature search and synthesis under IUCLID format,
  • Determination/notification of CLP classification for products/substances,
  • Submission of Anti-Poison Center declarations (Article 45 CLP Regulation) in any Member State (including France via SYNAPSE / INRS).

You want to build your registration dossier in another business area?