Regulatory Developments

REACH Enforcement: Notes from ANSI Chemical Network Presentation

February 4, 2016

On January 21, 2016, the American National Standards Institute (ANSI) hosted a presentation on enforcement under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Regulation. The topics covered included "Enforcement -- the Actors and the Activities"; "[the European Chemicals Agency (ECHA) Forum for Exchange of Information on Enforcement (ECHA Forum)]'s Role and Initiatives"; "Enforcement Targeted to Importers"; and "Enforcement of [Substances of Very High Concern (SVHC)] in Articles."

Dr. Eugen Anwander, the Austrian Vice-Chair of the ECHA Forum led the discussion and was introduced by The Acta Group's (Acta®) Gyöngyi (Pearl) Németh, M.Sc. Németh appropriately expressed in her introduction of Dr. Anwander that Acta personnel routinely participate in ANSI's regularly scheduled discussions, conveyed the value these discussions provide, and urged listeners to participate regularly. Németh and other participants on the call appreciated Dr. Anwander's useful insights on how Austria and other European Union (EU) Member States will manage enforcement under REACH.

The Actors and the Activities segment of the presentation covered several topics including REACH evaluation competence of ECHA and Member State Competent Authorities (CA), the ECHA Forum's competence for "coordination of national enforcement," and the "borderline competencies" of ECHA and national enforcement authorities. Various organizational structures for REACH enforcement were addressed, including one central enforcement authority (e.g.: Slovenia), regional enforcement authorities (e.g.: Poland), one enforcement authority competent for REACH, and split or parallel competencies among several national enforcement authorities (e.g.: United Kingdom).

The ECHA Forum's Role and Initiatives segment of the discussion addressed several important issues. Regarding joint efforts of the ECHA Forum with CAs, Dr. Anwander discussed training, guidance, and manuals for inspectors; coordinated inspection projects; enforceability advice to the regulators; and IT tools. A number of on-going and upcoming areas for harmonization of enforcement were addressed, including enhanced practical documentation covering a summary of safe use information for substances/uses being authorized; planning for the inspection project in 2017 on extended Safety Data Sheets (SDS), exposure scenarios, and safe use in the supply chain; and targeted inspector training in 2016. Dr. Anwander further addressed "[Harmonization] 'in a world of changes,'" including new Classification, Labelling, and Packaging (CLP)/Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria replacing old criteria in the REACH Regulation (based on dangerous substance/preparation directives); the Board of Appeal ruling on the specific status of ECHA's Statements of Non-Compliance (SONC) issued in context of the REACH evaluation instrument; the General Court ruling on intermediate status; and frequent changes in Annex II of REACH for SDSs (last amendment in Regulation (EU) No 830/2015).

The penultimate topic addressed by Dr. Anwander was Enforcement Targeted to Importers. His remarks addressed cooperation with customs authorities and use of customs' data. The REACH duties relevant for importers, including those under Articles 5, 7, 31, and 33 of REACH were evaluated. The duties under Article 62 (Annex XIV) and Article 67 (Annex XVII) were also noted. The various enforcement activities focused on importers were analyzed, including REACH-EN-FORCE 3 and REACH-EN-FORCE 4. Dr. Anwander noted high rates of non-compliance among Only Representatives in relation to REACH-EN-FORCE 3.

The final topic of the presentation, relating to SVHCs, is of particular interest and has received much attention. In September 2015, the European Court of Justice (ECJ) ruled that the obligation to notify SVHCs in articles applies to "each of the articles incorporated as a component of a complex product," rather than to the entire product. Several industry associations, including those representing retailers and the automotive industry, have encouraged Member State CAs not to enforce ECJ's ruling until ECHA has updated its guidance.

The ruling, which took immediate effect, related to two Articles of REACH:

  • Article 7(2) that states "producers and importers" must notify ECHA if an SVHC totalling over one tonne per producer or importer per year, in a concentration higher than 0.1 percent by weight, is present in an article; and
     
  • Article 33 that requires "suppliers" of articles containing an SVHC above this threshold to inform the recipient of the article.

Following the ruling, the ECHA Forum stated it was "committed to coordinating enforcement" of the provisions. ECHA's Johan Nouwen stated that ECHA's revised guidance would not be available until the end of 2016 "at the earliest," making it clear that the guidance is voluntary and the updated version "is not a prerequisite for enforcement."

Dr. Anwander expressed his view that since REACH's enactment, differing views have prevailed across the EU on the definition of an "article." He made it clear that the duty holder's obligations are always relevant for the article supplied by them, addressing this both in the context of Articles 7 and 33 of REACH. Dr. Anwander examined how individual Member State control activities related to Article 33 have been conducted in the past and suggested they will continue, stating that clarity on the definition of an "article" is critical to enhance enforcement activities meaningfully. Dr. Anwander stated that the ECHA guidance on "substances in articles" will need a full update and that the ECHA Forum Pilot Project for Enforcement of SVHCs in Articles is prepared for 2017.

Discussion

As always, this ANSI call was both informative and highly useful. REACH, its interpretation, and its enforcement are consistently evolving. With highly qualified speakers such as Dr. Anwander providing important guidance to professionals participating in these calls, industry can remain up-to-date with the latest developments and the repercussions for various actors in the complex supply chains under the REACH Regulation.

Since REACH's inception, Acta professionals have actively assessed the legislation and its implications, and have prepared clients for its requirements and those of the emerging REACH-like regulatory systems around the world. From offices in North America, Europe, and Asia, Acta professionals have the technical and regulatory know-how, the commercial sense, and the strategic resources to help companies develop and market chemical-based products successfully worldwide. Visit Acta's website for more information about Chemical Regulation under REACH.

If you have specific questions about how best to ensure your compliance obligations under REACH are met, call or e-mail Gyöngyi (Pearl) Németh, M.Sc. at +44(0)3302230614 or pnemeth@actagroupeu.com. Alternatively, contact Zameer Qureshi at +44(0)7496272129 or zqureshi@actagroupeu.com.


 
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