2018 REACH/CLP Enforcement: EU inspectors start safety data sheet and label quality checks
ECHA has announced that EU and EEA Member State inspectors have begun enforcement controls intended to improve the quality and harmonisation of CLP labels and ensure consistency between labels and the information in the safety data sheet.
The new inspections targets have been defined as part of the sixth coordinated enforcement project, going by the code name REACH-EN-FORCE-6 (REF-6). These enforcement programs are planned by the Forum for Exchange of Information on Enforcement (Forum), a network of authorities responsible for the enforcement of the REACH, CLP and PIC regulations in the EU, Norway, Iceland and Liechtenstein. For the first time this year, the Forum’s Biocidal Products Regulation Subgroup (BPRS) has joined in the enforcement project.
The timing comes shortly after the end (in June 2017) of the final transition period allowing products not yet updated with CLP labels to remain in commerce. This means that inspectors can expect labels and SDSs to be fully compliant with CLP as they start their enforcement efforts.
What can companies expect?
The exact details being covered in the project guidance and checklists are not publicly available, but target areas can be projected by reference to the publicly available information including the open day at the Forum-25 meeting , and the minutes of the closed sessions at Forum-25 and Forum-26, as well as findings of concern in previous enforcement projects.
Companies can expect the key areas of focus to include:
- 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
Member State inspectors may choose to address compliance on additional topics set out in optional modules. These include:
- obligations related to notifying classification to the C&L Inventory,
- the duty to apply harmonised classification and labelling,
- application of labelling and packaging exemptions as well as
- new rules for packaging of liquid laundry detergent caps.
Inadequate safety data sheet quality and lack of harmonization of substances notified to the Classification and Labelling inventory were specific reasons given when the CLP proposal was advanced, suggesting that these two aspects will be of concern to enforcement authorities.
17% of Safety Data Sheets reviewed in 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?
Past enforcement projects can shed some light on the consequences for companies found to be in violation of the CLP criteria after this project launches.
The competent authorities have a variety of mechanisms available to respond to non-compliance. In the vast majority of cases, the initial reaction involves only “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 result directly in “sanctioning measures” including fines/penalties or referral for criminal prosecution. In cases where the softer “corrective measures” have not been implemented in follow-up inspections, the risk of “sanctioning measures” is higher. The full scope of sanctioning measures from the projects is not known because the majority of the cases may still be in on-going activities at the time the summary report was issues.
Penalties for non-compliance
The scope of penalties issued in specific enforcement cases is not readily available. The text of the regulations requires that penalties should be “effective, proportionate and dissuasive” (REACH Article 126 and CLP Article 47).
According to a study of EU Member State provisions notified to the Commission in accordance with article 126 of REACH :
“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. In Belgium, on the other hand, the fine can go up to 55 000 000 Euros under the federal legislation and in the UK the fine is unlimited.”