The EU Emphasis on Enforcement
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For many reasons, the EU's emphasis on enforcement of non-compliance of chemical substances and products is about to be felt on a broader scale. Enforcement is one of the three pillars of the Chemicals Strategy for Sustainability, which was first introduced in October 2020. The commitment to enforcement outlined in the initial CSS documents (found here) is now being worked out in detail and given teeth in various acts and initiatives. However, the CSS early identified particular high-risk areas for non-compliance, such as online sales and imported substances and products.
One of the problems enforcers face in identifying non-compliant substances and products (e.g., at customs borders) is the absence of certification in proof of compliance. A Digital Product Passport is one proposal to get around this issue, in addition to the clarification of the roles and responsibilities of online retailers under the proposed Digital Services Act. The EU will begin rolling out Digital Product Passports focusing on key industries, such as textiles and construction products. However, until these measures are developed and generally in force, enforcers must rely on other indicators of compliance.
One such indicator is a Safety Data Sheet (SDS), which legally must accompany products containing:
hazardous substances or mixtures
substances classified as persistent bioaccumulative, toxic (PBT, or those that are vPvB)
substances of very high concern (SVHCs)
certain non-hazardous substances and mixtures
However, the non-compliance of Safety Data Sheets is notoriously high, as revealed by ECHA on their website: "the poor quality of the information in safety data sheets is a long-standing issue" - up to 52% were found to be deficient in 2013 (under REF2). One result of REF2 was an update to SDS legislation under AnnexII of REACH (2020/878). The deadline for compliance is December of this year.
A high-level roundtable held at the end of 2021 on the implementation of the CSS singled out enforcement and compliance of chemicals as a major issue and made ten recommendations in a Joint Report. These recommendations largely follow three themes: transparency and the sharing of information regarding non-compliance, penalties, and harmonised and coordinated enforcement, including internationally. Companies should particularly note the following recommendations:
Transgressors should be named and shamed–that is, they should be identified, publicised, sanctioned and have non-compliant substances or products removed from the market or brought into compliance. The recommendation includes the sharing of information about transgressors publicly and with consumer organisations.
The revocation of REACH registrations for non-compliant substances
Non-compliance should be costly
Harmonised and coordinated enforcement
The prioritisation of imports and online sales, along with the clarification of roles and responsibilities of online platforms and all of those actors in the supply chain
Enhanced cooperation with third countries, for example, the administrative arrangement between the EU and Canada, which allows increased cooperation on product safety including the exchange of data and joint investigation. In other words, being found non-compliant in one jurisdiction is likely to result in an investigation in other jurisdictions.
The combined emphasis on transparency of safety information, harmonisation of enforcement and the push toward zero tolerance for non-compliance has resulted in the latest round of REACH EN-FORCE (REF) choosing to focus on assessment of the quality of SDS information following the compliance deadline for updated SDS. REF11 is an EU-wide enforcement project that will begin in 2023.
In our experience, the most common elements of non-compliance found on SDS largely follow the 4 i’s: that is, information or sections that are incomplete (or missing), incorrect, inappropriate, or inconsistent. In a recent audit of over 6000 SDS that Yordas examined for compliance, we found that only 26.4% were fully compliant, 32.3% were partially compliant, and a further 28.6% were deemed non-compliant and required a full review and classification.
To find out more about SDS generation and to learn about our approach to authoring quality SDS, read our whitepaper here. You can also reach out to our team for all of your SDS related questions by sending us a message here.
