Penman Consulting

Regulatory Services - REACH and GHS

Illustration

With the onset of the EU's REACH regulation and the United Nation's Globalised Harmonised Systems initiative (GHS) , practical toxicological, regulatory and IT skills are in high demand. Penman Consulting can provide advice and assistance in the following areas:

  • Comprehensive guidance on REACH requirements and its timelines
    • Exemptions and ways to minimise liabilities
    • Training in aspects of REACH regulation
  • Business impact studies and development of business strategies to aid compliance at minimal cost, but without compromising business flexibility
  • Advice on science aspects in particular; Toxicology (mammalian and environmental), exposure and special considerations e.g. Carcinogen Mutagens or Reprotoxins or PBT categorisation
  • Direction and training on the IT aspects of REACH such as the data entry programme and database for REACH, set up and use of IUCLID and legal entities, and use of IUCLID to record data on categories
  • Pre-registration
    •  Potential Category formation and set up in IUCLID
  • Representation on Substance Information Exchange Fora (SIEF)
  • Development of the Chemical Safety Assessment and reporting in Chemical Safety Report as required
  • Development of the Registration Dossier (in or out of a consortia , lead company or joint registrant)
  • Classification and Labelling of Substances (GHS and EU classic)
  • Oversight of the Registration process within the prescribed timelines
  • Project management of the process as required

To complement these services, strategic partnerships are at an advanced stage of development with key service providers. These include,

  • Environmental expertise – assessment of PBT / vPvB
  • Literature services, (searching and data collection / interpretation)
  • High quality, low cost, toxicology, environmental, and Physchem testing
  • Exposure Sciences