The European Chemicals Agency ECHA held its annual stakeholder conference on 21.-22.5.2019 at ECHA’s premises in Helsinki, Finland. As opposed to previous years, where the registration of chemical substances has been taking the spotlight, this year was all about risk management measures for the safe use of chemicals.
ECHA’s priorities in risk management and safe use
As presented by Bjorn Hansen, Executive Director of ECHA, the main strategic priority of the Agency is currently the identification and risk management of substances of concern. This, in turn, is followed closely by ensuring the safe and sustainable use of chemicals by industry.
Following the three big substance registration deadlines of 2010, 2013 and 2018 under the REACH regulation, the focus is therefore turning towards realizing necessary risk management measures based on the data gathered during registrations.
With the help of an elegant substance grouping strategy to target high priority substances, ECHA is aiming to have all substances of concern identified and respective regulatory actions initiated by 2027. In the meantime, more information will still need to be generated by registrants for a large number of substances. Compliance checks and substance evaluation programs are therefore continuously ongoing.
In general, the focus also seems to be turning more and more towards mixtures and articles, now that the substance registration deadlines have passed. Indeed, ECHA’s new work areas include, for example:
- The new portal for Poison Centre Notifications (PCN) of hazardous mixtures;
you can read more about obligations relating to the PCN in our previous blog post
- Occupational Exposure Limits (OELs), as backed by information gathered
via registrations on the hazards of known chemicals
- Persistent Organic Pollutants (POPs) as per the POP Regulation, and
- The upcoming SCIP Database to track chemicals of concern in articles;
a future notification obligation of SVHC substances in articles for potentially
all article suppliers as per the Waste Framework Directive
The subject of circular economy was also touched upon; hopefully this topic will receive some more attention during next year’s conference.
Industry well represented
The industry was again present at the conference, announcing its strong commitment to the safe use of chemicals. This time around especially the article producers seemed to be well represented, due perhaps to the imminence of the SCIP database. However, the SCIP database itself received very little attention during the conference, perhaps due to the work being at a preliminary stage despite schedule pressures, as a result of funding uncertainties.
Cefic, the European Chemical Industry Council, emphasized the tremendous effort that it has taken the industry to get this far. The safe use and handling of chemicals to protect both people and the environment, however, still requires a lot of work. More open dialogue with ECHA was especially called for, along with cooperation. To ensure a level playing field for all operators, more enforcement of the various requirements of the REACH regulation is also needed.
As was well put during the conference, being compliant with REACH is not only an obligation but also an act of social responsibility to use chemicals safely. Within such a topic as chemistry and hazardous chemicals, the confidence of the general public is not easy to instill; all actors need to play their parts properly.
REACH is by no means over – enforcement to be enhanced
Although the REACH registration deadlines for existing substances have passed, REACH is by far not over. The REACH regulation is undoubtedly the most ambitious chemical legislation in the world, encompassing several novel and complex features. Hence, there is still a lot of work to be done, regarding especially the enforcement of the regulatory requirements and the implementation of concrete safety measures at workplaces.
ECHA is indeed planning on increased resources within enforcement: their proposed new target for compliance checks on REACH registration dossiers is 20 % of all dossiers instead of the previous 5 % statutory target. This would correspond to roughly 30 % of all registered substances.
The main reasons for the non-compliance of existing dossiers have so far been:
- Data waivers not correctly justified
- Adaptations of standard information requirements incorrectly justified or documentation lacking (read-across, QSAR, Weight of Evidence)
- Insufficient documentation in e.g. robust study summaries
The majority of the dossiers have also never been updated, although this is a regulatory requirement. Some of the ways to avoid authority procedures in future compliance checks are therefore regular updates of the submitted dossiers, as well as a proactive re-assessment of the registration dossier content. Where data is found lacking, a proactive approach in generating further information in encouraged.
Substances with the biggest impact on the protection of people and the environment will be at the focus of most regulatory actions. That means especially high tonnage substances with high exposure potential.
Supply chain communication still an issue
Supply chain communication is especially a topic that was raised several times during the conference. Although an integral part of safe use, communication up and down the supply chain is still not working properly. Safety Data Sheets (SDS) especially have been an instrument of supply chain communication and safety measures for decades now. However, obligations relating to SDSs are not well known, nor the contents of SDSs understood.
Even more complexity to the issue is added via exposure scenarios as part of an extended SDS (eSDS). From a consultant’s point of view, exposure scenarios seem to be an entirely foreign concept to many operators, just as downstream user obligations in general. Indeed, there have been very few exposure scenarios in circulation, even though the highest tonnage band chemicals have been registered already in 2010. It is therefore not surprising that the complex format of PROCs, ERCs and endless matrices that are exposure scenarios is not fully embraced yet. However, this is an issue that ECHA has acknowledged and is working to solve together with the European Commission.
Exemplary authority work
The Health and Safety Authority of Ireland provided the conference guests with an excellent example of cooperation and communication between the inspecting authority and operators in the field. The local authorities have a system where they focus their inspection measures based on a profiling of the companies using chemicals. They have found that the vast majority of local actors are downstream users, with high numbers of SMEs and microenterprises.
The operators receive advance notice of an upcoming inspection and are asked to provide material beforehand as well. The inspection agenda is targeted and delivered well in advance, so that the actual inspection day can be spent efficiently.
The authority assumes the role of an advisor, rather than aiming at sanctions and penalties. In effect, they are helping operators understand their obligations under the REACH and CLP regulations, and thus helping improve the safe use measures at the workplaces via compliance actions. The target is on operators at the top of the supply chains, so as to facilitate correct information moving down the supply chains as well.
Similarly to ECHA’s strategies, the Irish authority also focuses inspection activities on high priority substances such as carcinogens. Surprisingly, of roughly 240 SDS’s and respective hazard labels inspected last year, only about 20 % passed the authority’s screen. More than half had deficiencies in the SDS section 8, especially with regard to personal protective equipment instructions and OELs, that were either wrong or missing. Classification issues were also common, and company-specific emergency numbers were missing in a quarter of the inspected SDS’s. As follows, hazard label elements were also incorrect in over 10 % of the cases. Clearly, more attention needs to be paid to SDS contents.
All in all, it seems that there are still a lot of gaps in knowledge with regard to roles and requirements of imported products under REACH and CLP Regulations. Operators’ awareness of the PIC regulation also needs improving. However, understanding what the main knowledge gaps to target are, in combination with e.g. inspector training and upskilling, has already led to some very positive results.
In case you wish to view the full conference material, it can be accessed here.