Print version

Legal Spotlight: Intermediates: How to handle ECHA’s Article 36 requests?

Companies have recently begun receiving letters from ECHA asking them to submit documentation to prove their claims that substances qualify as intermediates. Jean-Philippe Montfort advises on their best course of action.

ECHA has recently adopted several decisions addressed to selected registrants of transported isolated intermediates under Article 36 of REACH (record keeping), asking for documentary evidence demonstrating that the substances in question a) qualify as intermediates and b) are used in strictly controlled conditions (SCCs). ECHA requests that information is sent preferably in the form of an “update” of the registration dossier, or by email.

Unexpected use of Article 36

The use of Article 36 by ECHA to request information is unexpected but there is no doubt that ECHA has the right to request documentary evidence of compliance under this article. It requires companies to assemble and keep available the information needed to carry out their duties under REACH and to submit it or make it available upon request to member state authorities or ECHA.

However, ECHA’s request in this case is very similar to a “compliance check” organised under Article 41 of REACH (dossier evaluation), even though the request in this case is limited to certain aspects of the registration dossier. The question therefore is why did ECHA select Article 36 to request that information, instead of starting a dossier evaluation?

The answer may be that ECHA is not on firm legal ground to instigate a compliance check of transported isolated intermediate dossiers, since Article 41 only refers to dossiers submitted pursuant to Article 10 of REACH, not pursuant to Article 18 (the article covering registration of intermediates). Also, even assuming the evaluation process could be lawfully followed by ECHA for transported intermediates, it is a much more formal process, imposing comment periods, publications and other procedural steps. In addition, intermediates do not necessarily fit the priority criteria of Article 41 to be picked up for dossier evaluation.

From there, one could possibly seek to argue that ECHA has selected the Article 36 route to by-pass the more complex, and possibly challengeable dossier evaluation process, and use this argument to challenge ECHA’s decision.

The “update” request

ECHA specifies that the information can be provided either as an update of the registration dossier under Article 22 of REACH or electronically. It notes that any confidential information can be marked as such, but it also specifies that sending an update via the designated IUCLID procedure is a more secure format.

We note that the submission of information to demonstrate compliance is not listed among the circumstances requiring an update under Article 22 of REACH, so submitting this information as an update is not an obligation. But is it then desirable? What are the risks involved, if any?

The direct consequence of submitting an update is that, as specified in Article 22.3 of REACH, the information submitted is then subject to a “completeness check”. The risk therefore exists that, if the information submitted as part of an update is considered “incomplete”, ECHA could reject the update. What happens then to the original registration?

Article 21.1 specified that in the case of an update, “a registrant may continue the manufacture or import of the substance… if there is no indication to the contrary from the Agency...within three weeks after the update date”. This means that if ECHA indicates to the submitter within three weeks of the update that the update is incomplete, the original registration itself may be deemed incomplete, therefore forcing the manufacturers to stop production or importation.

By contrast, the risk is much less imminent if the information is provided to ECHA under Article 36 of REACH. If ECHA considers that the information submitted is not sufficient, then in our view it should trigger the evaluation process, if that process indeed stands for transported isolated intermediates. Otherwise, only member states are eligible to take enforcement measures.

In view of the above, companies should think twice before responding to ECHA by means of an “update” of their registration dossiers.

The electronic route

ECHA is asking registrants to collect and send an extensive amount of information including a description of the chemical reactions that take place, and a description of all the measures taken to ensure strictly controlled conditions at all steps, as well as copy of letters sent to, or received from all downstream users confirming that they use the substance as an intermediate under SCCs. This information is obviously very confidential and it is important that it is protected.

In its request, ECHA provides that any information may be marked “confidential” but it also suggests that the update route (IUCLID format) may be safer to submit confidential information, recognising the risks of submitting this information by email. Companies should therefore be careful not to send an entire set of documents by email if they deem these documents to be confidential. Do they have another option?

In our view, Article 36 should be interpreted to allow competent authorities or ECHA to request any information required to demonstrate compliance, but not necessarily to receive copies of the entire set of business secrets of a company. For example one could argue that, while authorities should be able to ask companies to show letters sent to customers or ask about a particular customer, Article 36 does not necessarily allow them to collect and take with them an entire customer list.

In addition, Article 36 specifies that the companies “shall submit this information or make it available without delay upon request”. This should entail the right for companies to “make it available” at their premises, rather than “submit” the information requested by mail or through other forms of delivery, in particular if there are risks that confidential information be disclosed to third parties.

Member state laws on REACH enforcement may allow national authorities to take copies of any document they deem necessary for control purposes, but this is subject to administrative and judicial control under the national laws of the member state in question. This does not apply to ECHA.

Proposed response

Obviously, each company should consider the entire set of facts applicable to them before responding to ECHA’s request for information under Article 36. However, in view of the above, companies could contemplate responding to ECHA’s questions by sending sample or sanitised documents, and by indicating that, in order to protect confidentiality, they cannot send the entire set of information requested by email, but that this information will be made available to ECHA for consultation at the company site in the framework of Article 36 of REACH.

To comment on this article, click here: Chemical Watch Forum

© CW Research Ltd. You may circulate web links to our articles, but you may not copy our articles in whole or in part without permission.