On June 26, 2020, the European Union issued (EU) Regulation 2020/878 in its official gazette, revising the requirements of Annex II of REACH Regulation (EC) No 1907/200 on the preparation of safety data sheets (SDS). This revised regulation will come into force on January 1, 2021 and will be directly applicable to EU member states. Considering that the update of SDS may impose burden on enterprises, the revised regulations provide enterprises with a 2-year transition period, that is, before December 31, 2022, enterprises can still provide SDS in accordance with the requirements of the revised regulations (EU) 2015/830 issued in 2015 in Annex II of REACH regulations. However, from January 1, 2023, enterprises must provide new versions of SDS in accordance with the requirements of Regulation (EU) 2020/878.
The requirements of the new version of SDS mainly include the following 7 items:
1. Inform PCN in Section 1.1 of SDS that the product reflects the unique formula identifier (UFI);
2. The nano products in Section 3 and Section 9 of SDS must state their nano morphology/particle characteristics and other information;
3. In Section 2.3, 11.2 and 12.6 of SDS, it must be stated whether the product has endocrine interference characteristics;
4. Indicate in Section 3 of the SDS the attributes contained in Annex VI of CLP (specific concentration limits, multiplier factors (M factors) and acute toxicity estimates);
5. It is necessary to disclose the ingredients that cause the supplementary hazard statement EUH208;
6. Update non hazardous and classified mixtures that must be disclosed:
◆ Lower concentrations of allergens, carcinogens (Category 2) and reproductive toxins.
◆ Substances with concentration ≥ 0.1% determined as having endocrine disrupting properties according to EU regulation EU 2017/2100 (3) or EU regulation EU 2018/605.
7. Be consistent with GHS.
The joint chemical property information requirements in SDS 9 are consistent with GHS requirements; Section 14.7 of the SDS details bulk shipping information, etc.
What is SDS?
SDS (Safety Data Sheet) is also called safety technical specification. It is a comprehensive technical document on chemical characteristics that chemical production, trade and sales enterprises must provide to downstream customers and the public according to legal requirements, including chemical composition information, physical and chemical parameters, combustion and explosion performance, toxicity, environmental hazards, as well as information on safe use, storage conditions, leakage emergency treatment, transportation regulations and requirements. SDS, as a carrier to transmit information about chemical physical and chemical hazards, has become more and more important in chemical safety management as countries around the world pay more attention to the legalization of chemical safety supervision and management, and has become a necessary technical document for chemicals. In many countries, chemicals and products containing chemicals have compliant SDS, and the use and transmission of SDS throughout the life cycle of such products is a regulatory requirement, such as European REACH regulations, China's Regulations on the Safety Management of Hazardous Chemicals and Measures for the Registration and Management of Hazardous Chemicals.
EU Recent Law Enforcement Plan
In the European Union, the enforcement inspection of SDS compliance has gradually become normalized. The European Union REACH Law Enforcement Forum has included the compliance inspection of SDS in the 11th Joint Law Enforcement Project (REF-11). This time, REF-11 will focus on checking whether SDS meets the new requirements in the revised REACH Annex II (effective in 2023). The Forum will prepare the project in 2022, conduct law enforcement review in 2023, and complete and publish the review report in 2024.
Tips
In view of the approaching end of the transition period of EU SDS revision regulations, ZRLK suggested that domestic chemical production or sales enterprises (such as printing ink, coating, paint, auxiliary materials, dyes, additives and other products) that have trade relations with the EU, or the production or sales enterprises (such as printer ink cartridges, lithium batteries and other products) of products containing chemicals should timely check and update the SDS of products to ensure that the SDS meets the requirements of the new EU regulations. Our company has rich experience in product testing, which can help you easily understand whether the products are safe and compliant. If you want to know more about SDS's compliance with the requirements of the new EU regulations or if there is a need for products to provide one-stop services for material analysis and SDS preparation, please feel free to contact us, and our engineers will serve you at the first time!
