Reach: Individual submissions threaten one substance, one registration
2:06 PM MDT | June 11, 2013 | By LISA ALLEN
Joint submissions of shared information is the mainstay of registration under the European Union’s Registration, Evaluation, Authorisation, and Restriction of Chemicals (Reach) program, reducing both costs and testing on vertebrate animals. For each substance, one company is appointed as lead registrant and submits an international uniform chemical information database (Iuclid) dossier containing shared information on classification, health, environmental, physical, and chemical properties on behalf of all registrants. Coregistrants confirm their membership of this joint submission by way of a Reach-IT token—normally after purchasing a letter of access to the company information—and then submit company-specific information in their own Iuclid dossier. Reach-IT is Reach’s central information technologies system that underpins the requirements of the legislation.
After the wake of the second Reach registration deadline, on 31 May, it seemed to be an appropriate time to review how this principle of one substance, one registration has been holding up.
For the vast majority of substances and companies the joint submission process seems to be working well. However, ReachReady, a wholly owned subsidiary of the Chemical Industries Association that provides support to companies affected by the Reach regulation, has seen problems arise when new registrants fail to reach agreement with the lead registrant over cost sharing and obtaining the token. In the weeks before the deadline, ReachReady’s subscribers highlighted cost sharing disputes related to a number of previously registered substances, such as charcoal and silica. Through our help desk, I learned that some of the new registrants, due to submit their dossier by 31 May, felt that the price for the letter of access charged by the consortium or lead registrant was disproportionate or was not fair, transparent, and nondiscriminatory. Rather than expressing disagreement over the value of the data required for the registration, these new registrants often did not agree with the costs incurred previously for a substance information exchange forum (SIEF) or consortium management and the administrative tasks related to the joint submission. Many of these new registrants felt that they could register more cost-effectively if they submitted data separately—a process known as opting out.
Let’s be clear on what opting out means. The basis of one substance, one registration is substance sameness. By confirming the membership of the joint submission, a registrant is indicating that his substance should be regarded as the same—although not necessarily identical—as that of the other registrants and that the lead registrant is submitting certain shared information on their behalf. A member company can, however, opt to submit this information separately in his Iuclid member dossier on the grounds of disproportionate cost, threat to confidential business information, or disagreement over the choice of data submitted by the lead registrant.
I believe that companies need to be clear regarding what information they are opting out of and to explain their reasons in writing to the lead registrant. When opting out, companies may have their own internal data to submit separately, or they may decide to gather the data from other sources. What must be stressed is that vertebrate animal data must be requested from the SIEF, and that the opt-out registrant must not commission new vertebrate animal studies on the substance where data already exist.
Remember that even if a manufacturer or importer opts out of all the shared data as allowed by Reach, it is still a part of the joint submission; the European Chemicals Agency (ECHA) guidance on registration makes this point clear. The snag for some of the new registrants spoken to by ReachReady is that, to confirm membership of the joint submission, they need a token, and that token is controlled by the lead registrant.
As part of their efforts to reach an agreement with the lead registrant, I suggest companies involved in a dispute should make a fair offer, in writing, for the Reach-IT token. Typically, the charge made to provide a token is €100–1000 ($133–1,331). For full substance registration, however, I have heard of few lead registrants selling only a token to registrants opting out of certain data, or who disagree with the price of the letter of access. The registrant is usually also expected to compensate the lead registrant or consortium for a fair share of reasonable costs incurred in the role, such as running the SIEF and maintaining the joint submission, even if the registrant is not party to shared data.
Failing to reach an agreement with the lead registrant usually means the company does not receive the token. So, for those companies the only option is to do it alone and submit an individual dossier if they want to continue to manufacture or import the substance. Submitting an individual dossier is not the same as opting out of the joint submission of shared information and was not foreseen in the regulation. Companies taking this route are wise to engage with ECHA and their national, competent authority to highlight the irresolvable dispute and the measures they have taken in trying to reach an agreement.
As with opting out, the risk for these registrants going it alone is having their dossier evaluated with the possibility of a subsequent decision potentially requiring further action or information. The risk for existing consortia and earlier registrants is a shortfall in income relating to the purchase of letters of access and fewer registrants to share ongoing costs for the joint submission. Of course, a lead registrant or consortium might consider legal action against lone registrants if it feels it is owed compensation, or perhaps it would report such companies to the Reach authorities if it feels the individual registration was not valid. However, the biggest risk is to one of the main principles of Reach itself—the joint submission.
The third and final deadline, on 31 May 2018, is expected to involve more companies, including more small and midsize enterprises. Given the lower tonnage band, many may feel unable to respect the ethos of one substance, one registration on the grounds of cost. Should the practice proliferate for the 2018 deadline, we expect multiple individual registrations of many more substances as companies look to register as cost effectively as possible. Perhaps, instead, the letter of access and Reach-IT token will become negotiable commodities with fluctuating prices as consortia and existing registrants seek to recover costs of joint registration and do all they can to support one substance, one registration.
Once ECHA starts to evaluate dossiers from the 2013 deadline we may see individual registrants being required to reengage or reunite with the joint submission. ReachReady will also be watching to see if any legal action can—and will—be taken by consortia or lead registrants against companies who go at it alone.
Lisa Allen is the technical manager of ReachReady.
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