Allison Tracy is a Chemicals Policy Fellow.
After many months of increasing the quantity but not the quality of dossiers available to the public for chemicals registered under REACH, the European Chemicals Agency (ECHA) has recently announced two improvements. (REACH is the European Union’s regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals.) According to the agency, the public will soon have access to more data from the dossiers that were submitted by companies as part of the first wave of REACH’s Registration process.
In a press release issued a couple of weeks ago, ECHA announced that it will publish information from registered chemicals’ Safety Data Sheets – including the identity of the registrant and whether the chemical was found to be Persistent, Bioaccumulative and Toxic (PBT). And last week, ECHA said it will also publish (by June) the aggregate production volume ranges (called “tonnage bands”) for chemicals registered under REACH. These decisions will improve ECHA’s record on disclosure and transparency by increasing the amount of both hazard and exposure data available to the public on chemicals in use.
In ECHA’s most recent newsletter, it notes that 92% of the more than 27,000 registration dossiers received have been disseminated so far. The disseminated dossiers cover more than 4,300 chemicals, while the dossiers yet to be published cover another 1,190 chemicals. Dossiers are being posted as they are released on ECHA’s website.
While ECHA has continued to publish dossiers on a regular basis, and they provide some helpful data, ECHA has repeatedly faced complaints that the dossiers do not tell consumers what they want to know (Chemical Watch, subscription required). Indeed, European NGOs have filed lawsuits (Chemical Watch, subscription required) against ECHA as a result of its refusal to release company identities and production volume data for a particular group of hazardous chemicals. Even with these two new proposals for greater disclosure, European NGOs have expressed skepticism about the completeness and timeliness of information that will become available.
Although some of the problems with the dossiers have more to do with ease of access than with the information itself, improving the quantity and quality of information is essential. In this respect, ECHA’s decision to publish information on the registrant identity, PBT status, and production volume will go a long way towards improving utility. Frankly, the dossiers have been lacking this crucial information since they began to be made available online more than a year ago.
Confidentiality and public disclosure under REACH
The lack of basic information in the dossiers is particularly puzzling, given the rather clear specifications in REACH as to what information received from companies is to be disclosed. Articles 118 and 119 of REACH delineate three categories into which data submitted in dossiers can fall:
- Information that is always confidential;
- Information that is never confidential and can be publicly disseminated;
- Information that shall be publicly disseminated unless the registrant has submitted a confidentiality claim and ECHA has accepted that claim.
Until recently, there was ambiguity as to where ECHA would place the registrant name, registration number, and the results of the PBT assessment (all of which are contained in Safety Data Sheets). A Q&A document that ECHA released with its first proposal clarifies that these data elements are to be publicly disseminated unless ECHA has received and approved a CBI claim. Hence, they are now squarely in the third category.
The subject of ECHA’s second proposal, the total tonnage band, is listed in the third category in the original text of REACH. I touch on the controversy surrounding the interpretation of this placement later in this post.
The first announcement: Welcome, if overdue
To date, the public has been unable even to find out which companies have registered which chemicals under REACH. As part of a larger effort to improve the flow of information between companies as well as to the agency and the public, ECHA is finally embarking on a project to add the registrant name, registration number, and the outcome of the required PBT assessment to the publicly available versions of the dossiers.
ECHA will derive this information from the Safety Data Sheets that are required to be submitted with the majority of chemicals registered to date. For chemicals without Safety Data Sheets, ECHA will still disseminate registrant identities (unless they have been claimed and approved as confidential). ECHA is in the process of refreshing its data dissemination portal to facilitate this process.
Of course, companies are allowed to claim some data as confidential business information (CBI) where they believe that dissemination would divulge a trade secret; ECHA must review and approve such claims for them to stand.
From the perspective of some in industry, namely the European Chemical Industry Council (Cefic), companies are becoming more amenable to being identified as a participant in REACH registration (Chemical Watch, subscription required). They may well perceive that evidence of their good-faith participation in making more information about chemicals available will improve their reputation in the eyes of customers and the public.
However, the degree to which CBI claims will impede ECHA’s efforts remains to be seen. There are relatively few claims thus far, which may be due in part to the fact that, unlike EPA under the Toxic Substances Control Act, ECHA imposes a fee for making confidentiality claims. Of course, that hasn’t solved the problem of invalid claims being asserted: In an article in Chemical Watch (subscription required), ECHA is quoted stating the following about the 1,750 claims it has received: “We have assessed more than half of these claims so far, and about half of the [reviewed] claims have had a positive outcome for the registrant and about half a negative outcome.”
Hopefully, ECHA will be able to deliver much more information through this first proposal. The agency has not yet published all of the expected guidance documents on confidentiality claims, so some uncertainty remains. And although the intention is to launch the project by July, it is unlikely that the public will actually see the information until the fall.
The second announcement: What is the public really getting?
Add to this first effort ECHA’s new proposal also to disseminate tonnage band information, and it seems like the public will be much closer to getting what it was supposed to get under REACH. ECHA has stated that the promised tonnage band information will be out by June. However, there are several caveats. For example, ECHA has provided a table of the tonnage bands that it will use, which are actually quite broad.
Additionally, European NGOs had requested that ECHA disseminate tonnage band information from the dossiers as reported by each registrant (Chemical Watch, subscription required). The agency has instead decided, for a given chemical, to report aggregate data for each joint submission, as well as to separately report the data for any other individual submissions. Hence, for joint submissions, the “tonnage band” for the dossier cannot be broken down by registrant.
The public will soon see the total tonnage band for each dossier – unless the tonnage band was claimed CBI. If companies wish to claim the tonnage band CBI in light of ECHA’s proposal, they may do so by providing the agency with a justification and the requisite fee; ECHA must review and approve the claims for them to hold. Hopefully these requirements will result in ECHA receiving and granting CBI claims only for data that warrant confidential status.
ECHA plans to deal with the “mosaic effect” (the concept that disclosing non-confidential information may inadvertently disclose CBI) in a novel manner. The agency has said it will disseminate the tonnage band information in a jointly submitted dossier even if some registrants have claimed the tonnage CBI. However, this will be done only if there are four or more registrants for a chemical. The agency reasons: “This is because the aggregation of tonnages of four or more registrants cannot reveal the individual tonnage of a specific registrant and as such will allow a fuller set of information on tonnages to be published without compromising commercially sensitive information.”
ECHA’s proposals seek to satisfy longstanding requests for access to more information from the registration dossiers, but there are several remaining problems and uncertainties. Despite the fact that the REACH regulation clearly identifies data that must be publicly disseminated, it clearly did not resolve all ambiguities and ECHA’s current efforts may still fall short.