Regulatory Developments

REACH 2018: Registrants that Initiate Laboratory Testing by March 31, 2018, May Be Granted Extension for Complete Dossier Submission

March 22, 2018

The European Chemicals Agency’s (ECHA) Directors’ Contact Group (DCG) recently posted guidance for companies that are required to register under the European Union’s (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation by May 31, 2018.  This guidance focuses on specific important issues for companies managing compliance under the 2018 REACH deadline, and should be read in conjunction with DCG’s “Summary Paper on [Four] Issues.”  The guidance provides eight pragmatic solutions for companies facing difficulty in submitting registration dossiers for the upcoming deadline, and seeks to assist companies in overcoming common challenges under REACH.  Among the most helpful aspects of the guidance is “DCG Issue 10.3 -- Completeness of Registration Dossiers -- Data required in Annexes VII and VIII of REACH not yet available by the registration deadline” addressed to companies “which have ordered tests in a timely manner but have not received the results in due time to complete their registration dossier.”  This DCG Solution is particularly important due to the number of substances being registered by May 31, 2018, extensive REACH data requirements, and limited laboratory capacity to meet industry’s compliance needs.

The guidance asks submitters to contact ECHA if submitters “believe [their] situation is covered by this issue.”  Although a timeframe for when tests would have to be ordered by to qualify as being ordered in a “timely manner” is not specified in the guidance,  ECHA’s “Notice on Contacting ECHA to Provide Information About Being in an Exceptional Situation as Identified by the DCG” (Notice) indicates “missing tests must have been ordered before [March 31, 2018]” to benefit from this DCG Solution. 
 
The Notice specifies that registrants must be able to provide written justification and documentary evidence related to the testing (e.g., copy of testing contract) to rely on the DCG Solution and display that the tests were ordered timely.  The Notice also indicates that Substance Information Exchange Forum (SIEF) members “must have communicated with each other about the situation,” and that documentary evidence is required in this regard (e.g., SIEF communication).  If required documentation is not provided when relying on DCG Solution 10.3, the lead dossier for the joint submission will not pass ECHA’s completeness check. 

As a consequence of the aforementioned ECHA documents and discussions at ECHA’s Stakeholders’ Day, partial dossiers “will be accepted if companies can demonstrate they have ordered tests ‘in a timely manner.’” Companies wanting to rely successfully on the DCG Solution should file a notification to ECHA, including evidence and timelines for completion of testing, before March 31, 2018, indicating clearly that tests have been ordered.  This is an important and increasingly relevant issue that global supply chains facing testing issues must address appropriately to demonstrate compliance.
 
The seven other DCG solutions posted, ranging from “DCG issue 10.2 – Completeness of registration dossiers – Difficulties for importers to obtain data on substances in mixtures,” to “DCG issue 21 -- SIEF without an EU manufacturer,” also encourage the submitter to contact ECHA.  Each solution also states the following, which further indicates that submitters should still attempt to submit their registration by the May 31 deadline, even if it is imperfect:

You will receive an acknowledgment of receipt as soon as your enquiry has been recorded in our system, followed by a separate communication with further instructions.  To benefit from the DCG solution we advise you to submit your registration dossier taking into consideration ECHA’s instructions.  Please note that in order to continue the uninterrupted manufacture or import of your substances under Article 21 of REACH you must submit your registration by 31 May 2018.

Commentary

Industry faces significant compliance challenges as the final REACH registration deadline looms.  DCG Solution 10.3 has attracted mixed responses from chemical companies, consultants, and others.  While the Solution is plainly a measure to assist industry in meeting regulatory obligations in light of limited laboratory capacity, certain Small- and Medium-sized Enterprises (SME) have expressed that the March 31, 2018, deadline presents challenges because the SMEs were unaware of the cut-off date previously.  Others state that these “exceptional cases” are, in fact, quite numerous -- and that the situation is very complicated.
 
Entities registering chemical substances under REACH are urged to review immediately the documents referenced in this memorandum and follow closely ECHA’s communications.  The DCG Solutions indicate clearly ECHA’s intentions to cooperate with industry and facilitate compliance, and are an important instrument for those facing some of the most common challenges under REACH.  Companies that wish to rely on any of the DCG Solutions should ensure that all procedural rules are followed closely and provide comprehensive evidence to support their cases and maintain compliance.

 


 
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