Product Compliance Regulations

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Product manufacturers often need to track thousands of regulations across various jurisdictions to ensure products are compliant globally. In addition to the many regional and country-specific laws, various industries have set out guidelines and standards in the marketing, shipping, and use of products within their domain. Interpreting these regulations and the related implications on your product classifications can place a big burden on your current resources.

Get the most comprehensive regulatory information

A key aspect of Sphera’s Product Compliance solution is its managed regulatory content. It is designed to support your product compliance program providing comprehensive and current information that can help you avoid compliance-related risk and maintain ongoing access to key markets. More importantly, our in-house experts interpret the regulations to deliver a set of rules and logic that is seamlessly integrated with our software. This allows the automation and classification of your products according to regulatory requirements in each jurisdiction.

Sphera content coverage includes all the needed elements for REACH and GHS compliance in implemented countries, however it goes beyond these broad based regulations and includes other key content such as:

  • Country-specific regulations such as WGK, TSCA, CFRs, Maladies Professionelles
  • Marketability data lists such as national inventories and lists of banned and controlled substances including U.S. (TSCA), Australia (AICS), China (IECSC), Japan (ISHL, METI), Korea (KECI), New Zealand (NZIoC), Philippines (PICCS), Taiwan (CSNN)
  • Occupational Exposure limits such as: U.S. ACGIH and OSHA PELs, All E.U. Member States, Canadian Provinces, Australia, Japan, Hong Kong, Korean Republic
  • Transport regulations such as IATA and IMDG
  • Substance physical, toxicological and ecotoxicological data from ECHA REACH Registration dossiers, RTECS and AQUIRE

Industry-specific guidelines such as:

  • International Fragrance Association (IFRA) Code of Practice
  • CEPE Guidelines
  • RoHS
  • E.U. Detergents Regulation
  • Global Automotive Declarable Substance List (GADSL)
  • FIFRA: Inert ingredients permitted for use in nonfood use pesticide products
  • California EPA ARB Architectural coatings VOC exclusions
  • FEMA (Flavor and Extract Manufacturers Association) – FEMA Numbers
  • E.U. Cosmetic products Directive (76/768/EEC)
  • Inventory and Common Nomenclature of Ingredients Employed in Cosmetic Products(INCI)
  • US National Volatile: Organic Compound Emission Standards for Consumer Products

Sphera managed regulatory content is global in scope and consists of:

  • Rules automating hazard assessment and Safety Data Sheet (SDS) authoring
  • Elements enabling compliance for industry guidelines and standards
  • An extensive set of peer reviewed data lists of regulated chemicals
  • Substance physical, toxicological and ecotoxicological data
  • Thousands of translated phrases
  • Templates respecting legal requirements and regulatory tracking of major jurisdictional documents