As the GHS wave continues and more countries adopt it, one thing has become clear - each implementation has its own unique shade leading to challenges around:
Different implementations of GHS can have an impact on the marketability of your products.
Fortunately, the ‘Shades of purple’ between some countries can be immaterial to their product lines. At Sphera, we believe in giving our customers as much flexibility as possible so that they can design a system that works for them. With our ‘GHS by Design’ feature you can exercise the option of creating SDSs and Labels for many countries with a single classification while still respecting the ‘worst case’ building blocks.
With GHS by Design you can:
Primary implications of REACH include the registration of chemicals, the reduction and end of use of Substances of Very High Concern (SVHC), and the obligation to produce an Extended Safety Data Sheet (extSDS) detailing exposure scenarios and risk management measures according to each specified use of a product.
Sphera’s solutions were developed keeping REACH requirements in mind to help you comply with these requirements comprehensively.
Sphera’s product compliance solution is designed with REACH requirements in mind and includes all elements required to produce an extSDS. We take into account the SDS requirements as per REACH Annex II, including REACH registration numbers, and all supporting elements to produce an exposure scenario per use. In addition, Sphera experts are collaborating with CEFIC (the European Chemical Industry Council) and ECHA for the development of standards to facilitate the exchange of exposure scenario information.
Sphera’s Product Compliance solution includes:
In 2018 the REACH thresholds triggering registration and reporting to ECHA will be lowered to 1 Ton. This greatly lowered threshold poses a challenge for companies dealing with SVT obligations, whether inside or outside the EU. Sphera has developed a turn-key solution to help you with your SVT needs.
We can help you:
Sphera continuously monitors global regulations, including REACH and GHS, interprets changes, and delivers application ready updates to data, rules, templates and logic to truly automate the classification process of your products and the production of your Safety Data Sheets and other compliance related documents.
We employ experts in a variety of fields to monitor and analyze regulatory changes. Combined with our software expertise, we deliver a set of rules and logic which automate the classification and assessment of products according to regulatory jurisdiction.
We monitor, maintain and update an extensive data set on lists of regulated chemicals. This includes a wide range of data to support screening and classification of products—from very specific chemical property data to international standards.
We have rigorous quality and validation processes, which we apply to our content elements to ensure the reliability of documents. We also deliver and update a standard translated phrase library and ESCom phrases in support of REACH, and a wide array of templates, forms and labels.
Our extensive team of over 50 product compliance experts, many with over 20 years of experience, are key in enabling Sphera to effectively deliver our managed regulatory content, software, and managed services.
Francis Trudeau has worked for nearly 20 years in product compliance and chemical management. He has significant experience in solutions management and development, global regulations and industry standards enforced worldwide. He has worked on a wide variety of projects that support Sphera's integrated information management solutions, and address legal compliance challenges and the implementation of regulations in databases and software applications.
Francis is a recognized industry expert, serving both as a featured speaker at international conferences and leading multi-organization task forces in establishing industry best practices for regulatory compliance.
Mary Rudolph has more than 25 years of international environmental, health and safety experience, including technical and business implementations of authoring services. She offers Sphera customers an in-depth and often sought after understanding of the needs of global EHS departments.
Mary has a very strong network of international regulators and experts who provide regulatory insight and interpretation. In addition to being an SCHC (Society for Chemical Hazard Communication) Board member and Product Stewardship Society member, she has also managed the development of EHS-related databases, including RTECS®, a recognized toxicology database.
Scott Harter has more than 25 years of experience in EH&S. He has worked for 15 years in implementation, SDS authoring service, and content development. Previously he managed an EH&S department in a consulting business and worked for industry.
In industry Harter managed extensive environmental investigations, the Industrial Hygiene Department, and the Radiation Protection Program for Eastman Kodak Company. He is a board certified industrial hygienist or “CIH”
Carrie Decatur is an internationally recognized expert in GHS at the United Nations and individual country level. She has been with Sphera Solutions for over 10 years. In her role as Senior Regulatory Analyst she is responsible for the analysis and implementation of global chemical regulations into the Sphera Product Stewardship offerings and the web based Intelligent Authoring™ training program. She is the Chair the Global Regulatory Focus Group which is a monthly client-based forum where regulatory updates and issues and new system implementations are discussed.
Carrie has worked in the Services group as a consultant where she utilized her experience in authoring SDSs and industry to assist clients in implementing Intelligent Authoring™ in an efficient and cost effective manner. She has also worked in the chemical manufacturing arena where she was responsible for HSE and quality programs. Carrie often speaks at international conferences and at industry trade association meetings.
Rosemary Feiter has over 25 years of experience in a variety of fields that are correlated to product stewardship activities such as R&D, production, quality control, distribution and EH&S assessments. She leads the Product Stewardship Services team which provides Sphera clients with safety document authoring and consulting services.
The Sphera authors and project managers are regulatory experts that have substantial experience and knowledge of global regulations and industrial best practices having worked on multiple authoring projects for clients with diverse product portfolios.