- Moving forward at cruising speed
- Want to stay on the market with your biocidal product after 1 September 2015?
- Implementing biocides in a Member State - a Dutch perspective
- An industry perspective: Challenges for generating safe use information for mixtures
- What happens after a decision has been made on a dossier?
- Helping SMEs
- Improving quality of nanomaterial registrations
- Checking compliance - lessons learnt and recommendations
- Working for scientifically sound opinions
- New Head of Unit for ICT Infrastructure and IT Security
- A shock that led to a documentary: "Products on the shelves are not tested for safety"
- Guest column: Nanotechnology Industries Association's view on nanomaterials under REACH
- "Protecting health and the environment is a global goal"
- Advocating for transparency of chemical data
Send your feedback to:echanewsletter (at) echa.europa.eu
Article related to: news from echa
Checking compliance - lessons learnt and recommendations
The final report on the outcomes of the second EU wide harmonised enforcement project was published in September.
The enforcement project (REF-2) organised by the Forum of national enforcement authorities focused on checking the compliance of downstream users – mainly formulators of mixtures. The report found two thirds of the inspected 1 181 companies incompliant with one or more provisions of REACH and CLP. ECHA Newsletter spoke with Ms Natali Promet from the Forum and Ms Magdalena Tloczek from ECHA's Forum secretariat on the report outcomes and follow up.
Invest in knowledge-building
One of the main findings in the project was that awareness of REACH and CLP duties can be very low or even non-existent among smaller downstream user companies. Given the complexity of the new chemicals legislation, a learning phase is to be expected. "We encourage companies to be active, to participate in training and to focus on further knowledge-building within the company," prompts Ms Natali Promet, the Chair of the Forum REF-2 working group and an Estonian member of the Forum.
"Well trained staff is a good investment and may even be cheaper in the long run than using the services of an external contractor," she notes. Interestingly, one fifth of the checked companies had outsourced the preparation of safety data sheets to an external contractor.
Ms Promet points out that ECHA and many stakeholder organisations provide lots of useful information for companies. "On a national and international level, stakeholder organisations could do even more to involve companies in their activities and to attract new members. This support should especially target smaller companies and downstream users."
Look for structure
One of the crucial provisions in the new chemicals legislation is the need to keep an archive of all required information for a period of 10 years. Inspectors found that 20% of the companies had issues in the long-term storing of information on their substances. "The results indicate that companies with good systems and structures in place were also more likely to provide good quality information on the properties of chemicals downstream to fulfil their duty along the supply chain," Ms Promet says. "Archiving structures, for example an established document management system, were missing more frequently among smaller companies."
"As we see an increasing amount of safety data sheets distributed in electronic format, this could further help companies to store their information electronically to successfully meet this duty," Ms Promet says.
Advice to get on track
The most frequent measure used by the inspectors when they found compliance issues with companies was to provide written or oral advice on how to comply. Fines were rarely imposed. "The inspectors advised companies on where to find the information they needed to comply. They for example gave reference to specific ECHA guidance documents or the registered substances database," Ms Promet stresses, and continues, "advice on how to correct the available information was also mainly given in cases of single, less significant misdemeanours, for example remarks on one section of the safety data sheet or small remarks concerning a label."
"When measures like orders were imposed, these were accompanied by explanations on the responsibilities of the company."
Improvements in safety data sheets
Magdalena Tloczek from ECHA's Forum Secretariat.
Nearly all of the inspected companies (97%) had the required safety data sheets available on site. Moreover, 86% of companies had their safety data sheets available in the national language. "Although the availability of safety data sheets in inspected companies was very high, the quality of these was insufficient in 52% of the cases," says Ms Magdalena Tloczek from ECHA's Forum Secretariat. "This is a matter of concern for us," Ms Promet adds, "and we hope to encourage companies to increase their attention to communication along the supply chain."
Inspectors noticed, however, an improvement in the formats and availability of safety data sheets in comparison to the previous enforcement project (REF-1) which was run in 2009 (although the results are not fully comparable due to the difference in the amount of inspected data).
"Between the first and second enforcement projects, a lot of information had been produced, such as the REF-1 project report and the ECHA Guidance on the compilation of safety data sheets," says Ms Tloczek and continues, "the increased awareness amongst companies on the provisions of safety data sheets is very welcome and we look forward to further improvements." Currently, ECHA is working on both an update to the guidance on the compilation of safety data sheets and on new guidance in a nutshell on the same topic.
Forum: monitoring compliance will continue
The Forum will continue to monitor the level of compliance among companies by organising enforcement projects on a regular basis. "The Forum plans to enter into a new, three year cycle for harmonised enforcement projects with each project consisting of a planning, operation and reporting phase. In this way, we will run the operational phase of a different project every year with inspections in the Member States," Ms Tloczek concludes.
Some of the main recommendations from the REF-2 project could also be implemented in the Forum's Multi Annual Work Programme. The Forum is, for example, organising further training for national inspectors on exposure scenarios in extended safety data sheets and identified uses. "Following the training, the inspectors will also be able to provide inspected companies with more detailed advice during the inspections," Ms Promet says.
The Forum will also continue raising awareness about REACH and CLP obligations.
Interviews by Veera Saari
The Downstream Users of Chemicals Coordination Group (DUCC) read the final report of the second REACH enforcement project with interest. The inspection phase lasted from May 2011 until March 2012, which was quite early in the transitional period of REACH. The report showed that the implementation of risk management measures was not yet sufficient.
On the other hand, many extended safety data sheets were either not received or only just received at that time, and many issues were - and still are - pending for downstream users. We are pleased to see that already two thirds of the companies had a system in place to prepare, store and distribute safety data sheets and that 86% of companies inspected had safety data sheets available in their national language.
We look forward to improving towards a 100% compliance target, since the safety data sheets are the most important tool for safe use of chemicals. DUCC fully recognises the importance of the extended safety data sheets as a central risk management tool with a view of demonstrating good practice within the supply chain. This is why DUCC called for and now actively participates in the activities of the ECHA CSR/ES Roadmap. With regard to exposure scenarios, we also welcome the suggestion made in the report that training on exposure scenarios for inspectors should be considered.
Sylvie Lemoine, DUCC
- Final report of the second REACH enforcement project published, press release with a link to the report, 4 September 2013
- Guidance on the compilation of safety data sheets
- Update to the guidance on the compilation of safety data sheets (on-going consultation)
- Practical Guide 13 – How downstream users can handle exposure scenarios
- Leaflet on exposure scenarios and safety data sheets
- Registered substances database
Facts and figures
Types of measures imposed by authorities on non-compliant companies.
Companies checked according to the statistical classification of economic activities.
Sign in to comment and/or rate this article.
Biocidal Products Committee:
30 November-4 December (tentative)
Committee for Risk Assessment:
6-8 October (RAC-52B);
30 November-4 December (tentative);
7-11 December (tentative)
Committee for Socio-Economic
30 November-4 December (tentative);
7-11 December (tentative)
Member State Committee:
7-11 December (tentative)
Management Board meeting: