Category: International

November 16, 2023

NanoHarmony Releases Tool to Guide Stakeholders through OECD TG/GD Development Process

NanoHarmony announced on November 10, 2023, the release of the NanoHarmony OECD TG/GD Process Mentor, an interactive web-based tool to guide stakeholders through the development process of Organization for Economic Cooperation and Development (OECD) Test Guidelines (TG) and Guidance Documents (GD). NanoHarmony states that it developed the NanoHarmony OECD TG/GD Process Mentor to highlight the involvement of key institutions in the OECD Test Guidelines Programme, and their incentives to take part...
October 11, 2023

EC Recommends Carrying Out Risk Assessment on Biotechnologies

The European Commission (EC) announced on October 3, 2023, that it adopted a Recommendation on critical technology areas for the European Union’s (EU) economic security, for further risk assessment with EU member states. According to the EC, the Recommendation relates to the assessment of technology risk and technology leakage. The EC states that the risk assessment “will be objective in character, and neither its results nor any follow-up measures can be anticipated at this stage.”...
September 18, 2023

Canada Will Hold Information Sessions in October 2023 on Right to a Healthy Environment Amendments to CEPA

As reported in our June 23, 2023, memorandum, on June 13, 2023, Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act, became law. The bill made a number of changes to the Canadian Environmental Protection Act, 1999 (CEPA), including recognizing that every individual in Canada has a right to a healthy environment as provided under CEPA. Environment and Climate Change Canada (ECCC) and Health Canada (HC) will hold information sessions in October 2023 for...
August 17, 2023

Health Canada Begins Consultation on Proposed New Requirements for Consumer Chemical Products under the CCPSA

Health Canada has begun a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). Health Canada states that many substances found in consumer chemical products, like household cleaning products, have been linked to human health hazards of concern (HHHOC) such as carcinogens, mutagens, and reproductive toxicants. The proposed new requirements include the introduction of classification criteria for...
August 2, 2023

Canada Issues Mandatory Information Request for 850 Chemical Substances

Canada published a notice in the Canada Gazette on June 24, 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. Canada is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (for example, releases), and uses of these substances in Canada, pursuant to Section 71 of the Canadian Environmental Protection Act (CEPA)....
July 25, 2023

OECD Will Hold Webinar on Test Guideline No. 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement

On September 20, 2023, the Organization for Economic Cooperation and Development (OECD) will hold a webinar on Test Guideline No. 126: Determination of the Hydrophobicity Index of Nanomaterials Through an Affinity Measurement. The webinar will present the method to determine the hydrophobicity index (Hy) of nanomaterials, through an affinity measurement, described in the OECD Test Guideline (TG) No. 126. According to OECD, webinar attendees will be able to learn the use and limitation...
July 11, 2023

OECD Publishes New, Corrected TGs for Nanomaterials and Workshop Report on How to Prepare TGs for Emerging Technologies

The Organization for Economic Cooperation and Development (OECD) announced on July 4, 2023, that it published a number of new, updated, and corrected Test Guidelines (TG), including the following for nanomaterials: On July 4, 2023, OECD also released a corrected version of its Report on the WNT Workshop how to prepare the Test Guidelines Programme for emerging technologies. The Working Party of the National Coordinators of the TG Program (WNT) held a workshop in December 2022 on...
July 6, 2023

EuropaBio Offers Recommendations on Biomanufacturing

By Lynn L. Bergeson and Carla N. Hutton   On June 30, 2023, EuropaBio announced that it “set[] in stone the first European recommendations on biomanufacturing with the publication of its Biomanufacturing Policy Summit 2023 report.” On March 15, 2023, EuropaBio hosted its inaugural Biomanufacturing Policy Summit in Brussels, “marking the first major milestone from its newly established Biomanufacturing Platform.” The Summit captured priorities of 80 industry leaders,...
July 5, 2023

OECD Working Party on the Harmonization of Regulatory Oversight in Biotechnology Met in April 2023

By Lynn L. Bergeson and Carla N. Hutton   The July 2023 issue of the Organization for Economic Cooperation and Development’s (OECD) Chemical Safety and Biosafety Progress Report includes a summary of the April 2023 meeting of the Party on the Harmonization of Regulatory Oversight in Biotechnology (WP-HROB). During the meeting, WP-HROB agreed on next steps for preparing several consensus documents: “Environmental Considerations for Risk/Safety Assessment for the Release of...