Global Chemical Notification Programs

Areas in which we advise clients include the following:

• New Substance Notification Services –
  • Analyze notification schemes and develop notification strategies on a product-specific and market-specific basis.
  • Design and coordinate testing programs to comply with notification requirements across markets, including developing non-testing methods such as Quantitative Structure Activity Relationship (QSAR) and read-across where possible
  • Prepare notification dossiers
  • Assist with reporting obligations for new and existing chemicals
• General Compliance Reviews –
  • Assess whether client facilities are sufficiently staffed and equipped; prepare compliance manuals and standard operating procedures (SOP); conduct in-house training seminars
• Specific Regulatory Reviews –
  • Assist clients with adherence to:
    • PMN/Microbial Commercial Activity Notice (MCAN) requirements
    • Voluntary Children`s Chemical Evaluation Program (VCCEP) requirements
    • PMN requirements pertinent to products of nanotechnology and engineered nanoscale materials
    • Section 5 Significant New Use Rules (SNUR)
    • Section 6 chemical restrictions, including bans
• Recordkeeping and Reporting Assistance –
  • Assist clients with their recordkeeping and reporting requirements, SOPs, and systems development issues
  • Update notification dossiers and fulfill other post-notification obligations as required in markets where a product has been certified

• Acta routinely collects, prepares, and performs new chemical substance notifications (NCSN) for a variety of countries.
• Acta regularly counsels prominent multinational chemical manufacturers on the legal, regulatory, policy, and business implications of evolving TSCA, REACH, China NCSN, and other rulemaking initiatives to ensure product stewardship alignment.
• Acta has negotiated dozens of Enforcement Consent Agreements (ECA) under TSCA Section 4, resulting in diminished testing requirements.
• Acta, along with its affiliates Bergeson & Campbell, P.C. (B&C^®) and B&C® Consortia Management, L.L.C. (BCCM), routinely counsels TSCA testing consortia on TSCA Sections 4 and 5 testing obligations and on voluntary product stewardship testing initiatives.
• Acta routinely counsels on issues pertinent to the management of confidential business information (CBI) under TSCA.
• Acta counsels clients on harmonizing global chemical product approval and testing programs under TSCA, REACH, China NCSN, and related chemical management programs.