Regulatory Solution Ensure Continuous Compliance with the Latest Information Available
Atrion International announces the availability of Intelligent Authoring (IA) release 4.1, which is part of the Atrion Product Compliance Solution. This version features updates to its Managed Regulatory Content to facilitate localized regulatory compliance for formula-based companies. Additions include localized GHS support for Taiwan, Thailand and New Zealand, as well as regulation updates specific to the Paint & Coatings and Flavors & Fragrances industries.
Atrion’s IA application is a cost-effective and scalable solution that requires minimal additional resources or investments in sophisticated systems. The application facilitates product compliance by automating the creation of globally compliant and multi-lingual Material Safety Data Sheets MSDS/SDS, labels, hazard summary sheets, documents related to transportation and inventory reports.
GHS support has been added for Taiwan, Thailand and New Zealand, in addition to the existing support for Japan and Korea. New forms, sentences and logic were added enabling users to create compliant safety data sheets and labels for these countries. Atrion will continue to track the GHS schedule and will add support as additional countries announce their plans for GHS adoption.
Other enhancements in IA 4.1 include updates addressing VOC regulations for Australia, Canada, the United States (CARB, EPA and OTC) and Hong Kong. Users can now determine the VOC content of a paint or a consumer product in accordance with the different calculation methods specified in these countries. In addition, exempt lists (substances that are not VOC) will be supplied through Atrion’s data products, providing a greater degree of automation. Existing support for EU, UK and Switzerland VOC regulations have been revised, improved and integrated with new content addressing this complex requirement.
IA 4.1’s Managed Regulatory Content also features several new additions that are pertinent to the flavors and fragrances industry sector:
- IFRA Certificate Implementation — IA 4.1 facilitates the production of IFRA certificates by implementing the concentration limits for all substances — in every category — that are restricted and/or prohibited by IFRA. Rules are also included to determine the MAC for any substance or mixture of fragrance material, taking into account all the limitations set by IFRA.
- EFFA Code of Practice — In support of EFFA’s proposed ‘commonly used substances’ classification scheme that aims to comply with Europe’s current Dangerous Substances Directive, IA 4.1 includes Risk and Safety phrases that can be leveraged by standard rules calculating the classification for simple substances or complex mixtures (calculation compliant with the Dangerous Preparation Directive).
- EU Cosmetics Directive — Full implementation of the ‘EU Cosmetics Directive (76/768/EEC)’ has been provided in IA 4.1, in addition to the ‘Fragrance Safety Evaluation Form’ prescribed by COLIPA.
Atrion monitors any changes to the IFRA CoP and EFFA CoP and data is kept up-to-date to ensure continuous compliance with the latest information available.