Global Notification of New Chemicals

Exponent offers a full suite of services to help companies achieve global regulatory compliance. The strong, diverse scientific and regulatory experience of our staff means we can provide assistance in regions around the world, including (but not limited to):

  • Australia
  • Canada
  • China
  • EU
  • Eurasia
  • Japan
  • Korea
  • New Zealand
  • Philippines
  • Switzerland
  • Taiwan
  • Turkey
  • USA

Our staff has extensive knowledge and experience of chemical regulatory systems in all major territories including:

  • Network of local agents – Translation of documents into native language, effective liaison with regulatory authorities.
  • Regulatory strategy and advice – Both for chemicals and the specific requirements for polymers.
  • Project management services.
  • Inventory searches and amendments or additions to inventories.
  • Bona fide intent to supply submissions including Article 26 inquiry submissions in the EU.
  • Data evaluation and gap analysis – Determination of availability of data and evaluation of their suitability (Klimisch rating), literature searches, and identification of data gaps.
  • Use of intelligent testing strategies (ITS) – Grouping and read across, data waivers, expert statements, and (Q)SAR modelling.
  • Development of harmonised notification strategies and testing programmes – To meet worldwide requirements for a single product.
  • Pre-notification consultations with competent authorities.
  • Study placement and monitoring – All studies required for chemical notifications including “in-country” studies to comply with certain regulatory requirements or preferences.
  • Dossier preparation and submission – For all types of exemptions and notifications at all levels of supply.
  • Risk assessments – Including Chemical Safety Reports.
  • Classification and labeling.
  • Safety data sheets – Including extended safety data sheets.
  • Post notification support.
  • Only representative and third-party representative services for EU and Swiss sole representative services.
  • Tracking of emerging issues and developing notification schemes.

How Exponent Can Help

With 30 offices and over 1,000 staff worldwide, Exponent is a leading scientific and regulatory consulting firm, having provided services to the chemical industry for more than 50 years. Our experts in the UK, EU, US, and Asia offer a wide range of technical and regulatory expertise to help companies of all sizes meet their new chemical regulatory obligations worldwide. Exponent’s large industrial chemical notification team includes regulatory affairs professionals, project managers, risk assessors, and technical specialists in all relevant scientific disciplines necessary to help achieve the successful registration of a product. These scientists have varying backgrounds in industry, government, and contract research, giving us unparalleled expertise in solving complex regulatory problems. Many of our consulting staff have been working in the field of chemical regulations for over 10 years and have extensive experience with all worldwide chemical regulatory schemes, enabling us to play a vital role in facilitating this process for companies.

With dedicated offices experts in the UK, EU, US, and Asia, Exponent is well placed to help companies meet their regulatory requirements.

With dedicated offices experts in the UK, EU, and Switzerland, Exponent is well placed to help companies meet their European regulatory requirements.

With offices and experts in the UK, EU, US, and Asia we offer a comprehensive range of technical and regulatory expertise to help companies meet their REACH obligations.