SCCS Revises Its Position on  Silver in Cosmetics: New Evidence Confirms Dermal Safety

The European Union’s Scientific Committee on Consumer Safety (SCCS) has released new preliminary scientific advice on the use of micron-sized particulate silver in cosmetic products, marking a significant regulatory development for the cosmetics industry. The updated assessment reverses earlier safety concerns and confirms that micron-sized silver can be safely used within defined concentration limits, based…

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Regulatory & Standards Update 2025 (Key ISO Medical Device and Healthcare Standards Revised or Published)

The year 2025 has seen an extensive update to international ISO standards affecting the medical device, healthcare, and life sciences sectors. These revised and newly published standards span biological safety, cleanroom operations, sterilization, implants, dentistry, respiratory care, ophthalmics, health informatics, and additive manufacturing, reinforcing global expectations for patient safety, performance, and risk-based compliance. Biological Evaluation…

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ECHA Updates Guidance to Expand Use of In Vitro Methods for Skin Sensitisation Testing

The European Chemicals Agency (ECHA) has released updated guidance on the use of OECD Test Guidelines (OECD TG 442 C–E) and Defined Approaches (OECD GL 497) for Skin Sensitisation, further strengthening the transition toward non-animal testing under REACH. The updated guidance clarifies when in chemico, in vitro, and in silico approaches can be used to…

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FDA Issues Draft Guidance to Reduce Non-Human Primate Testing for Monoclonal Antibodies

December 2, 2025 — The U.S. Food and Drug Administration (FDA) has released new draft guidance aimed at significantly reducing, and in some cases eliminating, six-month non-human primate (NHP) toxicity studies for certain monoclonal antibody (mAb) products. The move marks a major step in the agency’s ongoing efforts to modernize nonclinical drug evaluation and transition…

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