If you asked regulatory experts what they would like most, our guess is it would be a crystal ball that could predict exactly when and what regulatory changes are on the horizon—and how they will impact their operations. Though no such peek-into-the-future device exists, the Sphera regulatory team is constantly monitoring and evaluating changes around the globe that could impact your business.
While many organizations have aligned their resources and processes to manage the upcoming European Union Poison Centre Notification (EU PCN) regulatory changes, there are a few other evolving regulations that you may want to keep on your radar.
Responses to the UN GHS Purple Book
Countries continue to play catch up with the eighth edition of the Purple Book, which was issued in 2019, and are feeling increased pressure to update their regulations.
While waiting for the various countries to update their legislation, look at the changes and your product lines. It will be helpful to understand how these changes might affect you ahead of the country publications so that you can manage them proactively. Here are a few we are keeping an eye on:
• China REACH was updated with the publication of MEE 12 from China’s Ministry of Ecology and Environment, and those changes will take effect January 2021. There are changes to the tonnage bands for registration types as well as the types of information that must be communicated throughout the supply chain. The regulation itself wasn’t overly specific and additional draft guidance was just released for consultation through Sept. 6 and should be finalized soon to further clarify the requirements.
• New Zealand has launched a second consultation for adopting the Globally Harmonized System of Classification and Labeling of Chemicals (GHS), which is a strong sign that the country will finally have real GHS adoption.
• India has released draft chemical management initiatives, which could mean GHS adoption and potentially an inventory or registration like framework.
Titanium Dioxide Change
Earlier this year, the EU classified titanium dioxide in its powder form as a suspected carcinogen by inhalation under the EU’s Classification and Labelling (CLP) Regulation. This change is limited to certain powder forms and is scheduled to go into effect Oct. 1, 2021 and will require specific warning statements for SDSs and labels for products that contain more than 1% of TiO2 in the designated form.
As is often the case, Europe is often the first to institute new classifications, and it is reasonable to expect other countries to follow suit in the coming years.
Annex II
Annex II of REACH describes what information should be included under each of the 16 headings of Safety Data Sheets (SDS). With the amendment to Annex II, the Commission brought Annex II into line with the CLP Regulation. This amendment, which will go into effect on Jan. 1, 2021, details specific requirements for nanoforms and their inclusion on SDS. Nanoforms may have specific toxicological profiles and exposure patterns and may therefore require specific risk assessment and adequate sets of risk management measures. Manufacturers and importers should assess these requirements. Where relevant, they should generate the necessary information and documentation in the chemical safety report that the risks—arising from the identified uses of the substance with nanoforms they manufacture or import—are adequately controlled. It will be critical in the coming months to understand the new nanoform requirements and how they impact your current processes.
With all of these changes and the uncertainty of how they may be adopted in other regions, it’s important to understand the potential impacts and prioritize your compliance plans accordingly. While there may not be a crystal ball to predict the future of chemical compliance, Sphera will continue to provide you with regulatory information and impacts to help guide you through regulations evolving around the globe.
