Earlier this year you may remember us telling you that Inspectors in EU Member States would be investigating the quality of Safety Data Sheets (SDSs) as they launched their fifth REACH Enforcement Project (REF-5) in January 2017. It is understood that the sixth coordinated enforcement project – also known as REACH-EN-FORCE-6 (REF-6) – is now underway, and will focus on the classification and labelling of mixtures – which will include checking relevant parts of the SDS.
The Forum for Exchange of Information on Enforcement (Forum) is a network of authorities responsible for the enforcement of the REACH, CLP and PIC regulations in the EU, Norway, Iceland and Liechtenstein. The Forum coordinates various enforcement projects, with one of the main ones being the REACH-EN-FORCE (REF) projects, which are designed to harmonise enforcement in each Member State, and monitor the current level of compliance with certain obligations imposed on industry by REACH, CLP and PIC.
The REF-projects are carried out by inspectors based in the national authorities of participating Member States, with resulting information collected by ECHA and the Forum Working Group. The ultimate goal of the REF-projects is to improve the quality of enforcement in Member States, but also to increase industry compliance with chemical hazard regulations.
The scope of the enforcement project is being defined over the course of this year, and with training of competent authorities scheduled for this October, enforcement is set to kick off at the beginning of 2018.
What can Companies Expect from the REF-6 Project?
Whilst the exact details of the REF-6 project are not publicly available, areas which are going to be targeted can be projected by reference to publicly available information, including the open day at the Forum-25 meeting, minutes of the closed sessions at Forum-25 and Forum-26, and findings of concern from the previous enforcement projects.
Companies can expect key areas of focus to include:
- The quality of sections 2 and 3 of the Safety Data Sheet;
- Compliance of the classifications with the CLP requirements, especially
- Cases where a substance has various classifications notified by industry, and
- Checking of mixture classifications;
- Coherence of labels with the SDS
Optional modules for the competent authorities will address:
- Obligations related to notifying classification to the C&L Inventory
- The duty to apply harmonised classification and labelling
- Application of labelling and packaging exemptions
- New rules for packaging of liquid laundry detergent caps
The inadequate quality of safety data sheets and lack of harmonisation of substances notified to the Classification and Labelling inventory were specific reasons given when the proposal for the REF-6 project was advanced, which suggests that these two aspects will be closely targeted by enforcement authorities.
In addition, it seems that the REF-projects are already beginning to return some concerning results, as 17% of safety data sheets reviewed during the first enforcement project were found not to have the required headings or be available in the language required.
What are the Consequences of Non-Compliance?
Whilst the competent authorities have a variety of mechanisms available to respond to non-compliance, evidence from previous enforcement projects helps us shed some light on the likely consequences for companies found to be in violation of the CLP criteria once enforcement for REF-6 begins.
In the majority of cases, the initial reaction often involves “corrective measures”. This includes verbal or written advice on how to correct the issues, and administrative orders that provide a more enforceable mandate on the scope of correction(s) required.
However, the first inspection can in some cases result directly in “sanctioning measures”, including fines/penalties or referral for criminal prosecution. Furthermore, in cases where the softer “corrective measures” have not been implemented in follow-up inspections, the likelihood of “sanctioning measures” being imposed on companies is much higher.
The full scope of sanctioning measures from previous enforcement projects is not yet known as the majority of these cases are still ongoing.
What are the Penalties for Non-Compliance?
The scope of penalties issued in specific enforcement cases is not readily available. However, the legislation requires that penalties should be “effective, proportionate and dissuasive” (REACH Article 126 and CLP Article 47).
According to a report on penalties applicable for infringement of chemical regulations in EU Member States, it was stated that:
“Overall, the fine is the sanction most commonly provided for in the legislation. Most countries provide for fines between 50,000 and 1,000,000 Euros maximum for the first infringement. A few countries have adopted significantly lower or higher fines. In Latvia and Lithuania, on the one hand, the maximum fine is below 5,000 Euros. However, in Belgium, the fine can be as high as 55,000,000 Euros under the federal legislation, and in the UK the fine is unlimited.”
If you are a chemical manufacturer, chemical importer, downstream user, chemical distributor or chemical retailer, it is important that you are aware of the ongoing REF-projects, and the potential consequences it could have on your business.
At UL Safeware Quasar we have an experienced team of Regulatory Consultants who have a comprehensive understanding of both the REACH and CLP regulations, and are constantly monitoring the legislation to ensure that our software solutions are fully up to date, and to help hundreds of companies sustain compliance.
EU Enforcement Authorities To Investigate Quality Of SDSs (January 2017)
The Forum for Exchange of Information on Enforcement (Forum)
Forum Enforcement Projects
ECHA Slides From The Forum-25 Meeting (PDF)