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Synthetic polymer microparticles on a beach, indicating that REACH Restriction 78 can reduce environmental pollution.
EU Microplastics Restriction 2026 Update: What to know
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The REACH restriction on Synthetic Polymer Microparticles (“SPM”) entered into force on October 17 2023....
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April Regulatory Updates
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Medical Device: Manual on borderline and classification for medical devices: Fifth Version released New clarifications...
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Food Supplement safety assessment and how it starts with characterization
Safety Assessment in Food Supplement Production
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When discussing the safety of a food supplement ingredient, the focus often shifts immediately to...
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The European Association on Medical devices Notified Bodies warns about the new MDR/IVDR Revision as it might reduce the safety of Class I and Class II Medical Devices
MDR/IVDR Revision: Team-NB concerns over MD regulation shift
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The European medical device landscape is at a critical juncture. In its comprehensive position paper...
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Biocide Task Force: how to make your Regulatory Life easy
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Biocide task forces are collaborative industry groups formed to bring together companies in the registration...
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March Regulatory Updates
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Biocides: UK-EU SPS Alignment for PPPS & Biocides The new UK-EU SPS Agreement (targeted for...
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Extractable and Leachables material composition and supply chain for ICH Q3E compliance
ICH Q3E: E&L risks with Material Variability and Supply Chain
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ICH Q3E places strong emphasis on understanding and controlling extractables and leachables (E&L) risks throughout...
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USP Class VI
USP Class VI: New Approach to Polymer Safety in Medical Devices
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For decades, many medical device manufacturers have relied on USP Class VI certification when selecting...
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Food supplement products can be novel or non-novel food, regardless of its ingredient.
Novel Food in Ingredients and Food Supplements: Key Differences
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Did you know that in the EU an ingredient can be classified as a Novel...
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Regulation (EU) 2026/405 shifts detergents compliance into...
Regulation EU 2026/405: New Detergents and Surfactants Compliance
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Regulation (EU) 2026/405 is the new European Union regulation on detergents and surfactants, published in...
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