Home > Nanotechnology Columns > Bergeson & Campbell, P.C. > OECD Tour de Table Includes Information on International Developments Regarding Nanomaterials
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Lynn L. Bergeson Managing Director Bergeson & Campbell, P.C. |
Abstract:
The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials -- Tour de Table.
July 11th, 2023
OECD Tour de Table Includes Information on International Developments Regarding Nanomaterials
The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials -- Tour de Table. See https://one.oecd.org/document/ENV/CBC/MONO(2023)7/en/pdf The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on international developments from the Tour de Table:
- Canada is developing a nanomaterial regulatory risk assessment framework to inform the assessment of manufactured nanomaterials under the Canadian Environmental Protection Act, 1999 (CEPA), including existing nanomaterials in commerce in Canada, and new nanomaterials notified prior to being manufactured or imported into Canada. The framework discusses the nanomaterial-specific considerations for risk assessment, such as the key physical and chemical properties specific for nanomaterial identification and used for grouping or classifying nanomaterials for information gathering; the data considerations used in a nanomaterial risk assessment, such as test data or modeling; and the behavior of nanomaterials throughout the lifecycle of the nanomaterial and characterizing those potential effects on human health and the environment. As reported in our June 21, 2022, blog item, the draft was published on June 17, 2022, for a 60-day public comment period. See https://nanotech.lawbc.com/2022/06/canada-publishes-draft-framework-for-the-risk-assessment-of-manufactured-nanomaterials-under-cepa/
- The Netherlands volunteered to initiate pilot inspections on registrations of nanomaterials under the European Union (EU) Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The main aim is to determine whether EU-wide enforcement action should be put in place to address the low level of information updates in dossiers for substances in nanoforms. The European Chemicals Agency (ECHA) will provide support with the REACH Competent Authority in the Netherlands. Based on a list provided by ECHA, companies will be selected to gain insight in the type of information companies use in their considerations to register the substances with nanoforms or not. With the project, the inspectors aim to build up knowledge and expertise on the (low number of) registrations of nanomaterials. According to the Tour de Table, France also showed interest in performing such pilot inspections. Depending on the results of the experiences in these pilot inspections, the ECHA Forum may discuss potential further action related to nanomaterials at a later stage.
- In the EU, compliance check processes addressing REACH registrations of three substances in nanoform are ongoing. Under the Cosmetic Products Regulation (CPR), a targeted revision of the regulation is taking place and is planned to address nanomaterials. Within the food sector, the European Food Safety Authority (EFSA) is implementing nano guidance documents published in 2021; the activity is mostly focused on novel foods and food and feed additives. According to the Tour de Table, in most cases, there is a need to request additional information from applicants to ensure that nanoscale considerations are addressed according to the new guidance. EFSA organized a 2021 stakeholder event to facilitate the implementation of these new challenges; presentations and recordings are available online. See https://www.efsa.europa.eu/en/events/stakeholder-event-update-guidance-submission-dossiers-food-enzymes#:~:text=EFSA%20organised%20a%20virtual%20meeting,fourth%20quarter%20of%20this%20year
- Malaysia launched a National Nano Product and Technology Roadmap on April 13, 2022, to support Malaysia's National Nanotechnology Policy and Strategy 2021-2030 (DSNN). The nano ecosystem has been mapped towards these jumpstart sectors: energy; environment; food and agriculture; medical and well-being; healthcare; and electronics and devices.
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