The ECHA Nanomaterials Expert Group (NMEG)

Creation of NMEG and brief history

In October 2012, ECHA created the Nanomaterial Working Group (NMWG) with the aim to discuss scientific and technical questions relevant to REACH and CLP processes dealing with nanomaterials and to provide recommendations on strategic issues. This group also aimed at improving the exchanges between industry and regulators on nanomaterials, similarly to the Group Assessing Already Registered Nanomaterials (GAARN) which organised meetings in 2012 and 2013 and published several recommendations. (In 2012, 2013 and 2014, the GAARN published recommendations on substance identity, on human health and environmental hazards, and on exposure assessment and risk characterisation of nanomaterials.)

At that time, there were no explicit requirements for nanomaterials under the REACH or CLP regulations. However, as nanomaterials were covered by the REACH substance definition they were subject to REACH and CLP. Moreover, the publication in 2011 of the European Commission recommendation on the definition of nanomaterials highlighted the need of a focused expert group to address scientific and technical issues relating to their registration under REACH and their further evaluation.

At the beginning of 2017, the name of the group was changed from Nanomaterial Working Group (NMWG) to Nanomaterials Expert Group (NMEG), which is the current name of the group. The name was changed in order to align with the names of two other groups coordinated by ECHA: the PBT Expert Group and the Endocrine Disruptors Expert Group.

Role and organisation of the NMEG

The NMEG is coordinated and hosted by ECHA. Participants of the NMEG are nominated experts from EU Member State competent authorities, the European Commission (DG Environment, DG GROW, and Joint Research Centre, JRC), the European Food Safety Authority (EFSA), industry associations, non-governmental organisations, as well as other stakeholder organisations. There have generally been two NMEG meetings per year.

The mandate of the NMEG has regularly been reviewed and the latest update was published on the NMEG webpage in January 2021. The current mandate of this group is to provide informal and non-binding scientific and technical advice on questions related to nanomaterials or nanoforms of substances in the frame of the implementation of REACH, CLP, BPR, EUON and other issues of relevance to ECHA’s work. The activity of the NMEG will not interfere with REACH, CLP or BPR formal regulatory processes. The NMEG improves the understanding of specific issues concerning nanomaterials/nanoforms of substances which leads to more informed and efficient discussions in ECHA’s Committees.

The meeting agenda items are proposed by ECHA and by the expert group members, and may be developed in consultation with the Member State competent authorities (MSCAs), Member State Committee (MSC), Committee for Risk Assessment (RAC) and Biocidal Products Committee (BPC) members or European Commission. Sessions have usually been open to all participants, but closed sessions, with authority representatives only, have also taken place. Among the main topics that have been addressed by the NMEG are: technical challenges of registering and characterising substances covering nanoforms; practical reporting in IUCLID for nanoforms; assessment of environmental or human health hazards for nanomaterials; updates on specific dossier evaluation or substance evaluation cases (in closed sessions). The NMEG has also discussed issues related to the development of REACH guidance documents for nanomaterials (NMEG contributed to the preliminary preparation of several guidance documents on nanoforms/nanomaterials: Registration and Substance Identification (2019), QSARs and Grouping (2019), information requirements (draft under commenting round). The agendas and the summary reports/minutes of the latest NMEG meetings are available on the NMEG webpage.

Future direction after the mandate update in 2021

In 2019 and 2020, the activity of the NMEG was put on hold. This period corresponds to the update of the REACH Annexes and 1) the appearance in the legal text of the words nanomaterials/nanoforms, and 2) the introduction of specific data requirements for nanoforms. The new requirements entered into force on the 1st of January 2020; since then, registrants of substances covering nanoforms have to characterise and address information requirements that are specific for nanoforms.

In January 2021, the NMEG mandate was updated in order to fully align the NMEG with the PBT and the Endocrine Disruptors expert groups. The main change is that a NMEG meeting will be organised only when 1) critical scientific issues or operational issues (individual cases from e.g. REACH or BPR) have been proposed by one of the NMEG members, and 2) robust documentation (clear, comprehensive and mature enough to allow a conclusive discussion) is provided. Moreover, the NMEG outcomes should be useful to support decision making, and the connection between the NMEG, the MSCAs and ECHA Committees should be ensured. The NMEG could for instance provide recommendations on specific dossier evaluation or substance evaluation cases that the Member State Committee may take into account in their decision making.

In that way, the refreshed NMEG is expected to deliver the most efficient and effective support to regulatory decision-making.

 

About the author

Frank Le Curieux, Senior Scientific Officer - European Chemicals Agency (ECHA)

I have been working at ECHA since 2010. My main field of expertise is genotoxicity and I coordinate ECHA mutagenicity activities in my role of Directorate C Scientific Area Leader for Genotoxicity. I am a nominated EU expert in OECD expert groups on genotoxicity test guidelines and have participated in external genotoxicity expert groups (EFSA, EMA, IARC). I have chaired the Nanomaterials Expert Group since its creation. Before ECHA, I was Professor of Toxicology (Faculty of Pharmacy, Lille/France) and one of my research projects was on the genotoxicity of nanoparticles; I was also a study director in a genotoxicology CRO (Laboratory of Toxicology, Pasteur Institute of Lille). Connect with me on LinkedIn.

 

If you would like to leave a comment, you first need to sign in or create an account if you are a new user.
Note: trying to submit a comment without signing in will cause you to lose your comment text.

0 0

More Blog Entries

0 Comments