Ramped up enforcement is planned for EU Importers around REACH registrations and Only Representative as part of the Ref-3 Enforcement Project. Plus increased assessment and scrutiny of reduced registration dossier for intermediates is in full swing and will eventually include completion of on-site assessments by Member States.

Ref-3 is the third in a series of enforcement projects initiated from the REACH mandated Forum and represents what are the next REACH and CLP enforcement areas. On-going broad enforcement of all obligations of REACH and CLP, e.g. safety data sheets, is still a major activity at the national level but ECHA’s Enforcement Forum establishes targeted and prioritized enforcement projects aimed at focusing compliance at pre-defined and high concern obligations. The enforcement projects also coordinate enforcement efforts in a harmonized and consistent manner across the national enforcement authorities (NEAs).

The 3rd Forum Enforcement Project (Ref-3) adopted at the 10th Forum meeting will focus on:

  • registration obligations in general,
  • an increased emphasis on checking that the Only Representatives (ORs) are complying with their various duties and,
  • elaborating and piloting the cooperation with customs in as many countries as possible.

Ref-3 will focus on registration obligations in a broader sense but including customs is a significant step in strengthening and expanding the breadth of REACH and CLP enforcement activities for imported substances (on their own or as a mixture). In fact customs is not new to REACH enforcement with stoppages of goods based on “lack of proper REACH documentation” having been reported. One of the goals of Ref-3 is to foster cooperation and networking between customs and the national inspectors, helping to identify importers, matching importers covered by ORs, and providing a screening process. So if you are a Non- EU Company sending goods to the EU, national custom authorities will be helping national chemical inspectors in looking closely at your REACH obligations and compliance. Make sure your OR is doing what REACH requires of them because Ref-3 is going to check that your OR is doing what he should be doing.

In addition the Forum is looking at compliance with the reduced registration obligations for intermediates. Since 2009 ECHA has been investigating registration dossiers with about half of those focused on intermediate registrations. In 2010 ECHA began flagging deficiencies to intermediate registrants and through Article 36 letters asking for additional clarification and information. As recently as last month ECHA reinforced its increased focus of intermediates dossiers by announcing they have completed an IT-based screening of all REACH intermediate registration dossiers and have found significant quality and potential compliance concerns. The screening first culled out dossiers submitted as an intermediate and then screened the “use coding” (process categories (PROC) listed in iuclid section 3.5). ECHA identified of the 5500 intermediate dossier that about one-half did not have “uses” (PROC codes) that would typically be associated with intermediate uses. ECHA has sent the screened registrants, via REACH-IT, their findings and asked that the registrants review and update their dossiers after which ECHA plans to screen these dossiers again and identify those that will be subject to further regulatory actions.

As part of Forum enforcement activities, ECHA asked that the NEAs get involved by conducting on-site investigations of dossier data, e.g. strictly controlled conditions, in order to attain a final decision on the acceptability of the intermediate registration and impose measures to address compliance. ECHA indicated that the on-site assessments at the registrants and/or at the downstream user’s site(s) are necessary as the quality of the dossiers is not fulfilling the legal requirements. One can infer that those deficient dossiers subject to “further regulatory actions” could be targeted for the on-site assessments.

Remember that enforcement is the key to making REACH sustainable and registrations will remain an enforcement priority for ECHA for years to come. Also don’t forget that the national enforcement agencies at the member states may have their own enforcement spotlights so make sure you know what your REACH and CLP responsibilities are and that you stay on top of them.

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