Polyhexamethylene biguanide (PHMB)-DalBac BG is a polymeric disinfectant and antiseptic agent widely used in medical, cosmetic, and industrial applications. Its regulatory approvals and certifications vary depending on its specific use and the region. Here’s an overview:
1. European Union (EU)
- Biocidal Product Regulation (BPR): PHMB is subject to regulation under the Biocidal Products Regulation (EU) No 528/2012. It includes PHMB in various product types (PTs), such as disinfectants, preservatives, and antifouling products. Companies using PHMB in biocidal products must obtain approval for its use from the European Chemicals Agency (ECHA).
- REACH Registration: PHMB may also need to comply with REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) for specific chemical substances if manufactured or imported in the EU in quantities exceeding certain thresholds.
- Cosmetic Products: Regulation (EC) No 1223/2009 allows PHMB in cosmetics, but only in concentrations of up to 0.1% (as a preservative). Annex V of this regulation lists it as a restricted substance due to concerns about potential health risks, particularly skin sensitivity.
2. United States (US)
- The Environmental Protection Agency (EPA) regulates PHMB used in disinfectants, sanitizers, and preservatives under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Products containing PHMB must meet safety and efficacy standards and be registered with the EPA.
- Food and Drug Administration (FDA): For PHMB used in medical devices (e.g., wound care products, contact lens solutions), the FDA regulates it under the Food, Drug, and Cosmetic Act. It must have approval as part of a 510(k) premarket notification. Other appropriate FDA submissions, depending on its intended use.
- Cosmetics: The FDA monitors PHMB in cosmetics for safety, but the use of PHMB in cosmetics is not pre-approved by the FDA. It is the responsibility of the manufacturers to ensure safety under the Fair Packaging and Labeling Act.
3. Canada
- Health Canada: PHMB is regulated in disinfectants under Health Canada’s Pest Control Products Act (PCPA). Like the US EPA, Health Canada requires that products containing PHMB undergo registration to assess their safety, efficacy, and environmental impact.
- Cosmetic Ingredient Hotlist: Health Canada lists PHMB in its Cosmetic Ingredient Hotlist, restricting its use in cosmetics to a concentration of up to 0.1%.
4. Australia
- The Therapeutic Goods Administration (TGA) approves PHMB when it is used in medical products (such as wound care products or antiseptics).
- The TGA lists the product in the Australian Register of Therapeutic Goods (ARTG) and assesses it for safety and efficacy.
- The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates PHMB as a biocide under the Agricultural and Veterinary Chemicals Code Act 1994.
5. China
- China Food and Drug Administration (CFDA): The CFDA regulates PHMB when used in medical devices and healthcare products.
- Cosmetic Ingredient Restrictions: The National Medical Products Administration (NMPA), which oversees cosmetics, restricts PHMB use in cosmetic formulations. Typically limiting it to a concentration of 0.1% due to potential risks.
6. Japan
- Pharmaceuticals and Medical Devices Agency (PMDA): The PMDA, Japan’s regulatory authority for medical products, must approve PHMB used in medical devices.
- Ministry of Health, Labour, and Welfare (MHLW): For biocides and disinfectants, PHMB products must adhere to regulations from the MHLW. PHMB may be subject to restrictions depending on its intended use.
7. World Health Organization (WHO)
- WHO Prequalification for Medical Devices: PHMB-containing products (especially those used in wound care) may also need to meet WHO standards for international distribution in low- and middle-income countries.
Key Certificates and Compliance
- ISO 13485: Medical devices containing DalBac BG must often comply with ISO 13485, which ensures quality management systems are in place.
- CE Marking: For products sold in the EU, a CE Mark is necessary for medical devices or biocidal products containing PHMB.
- Good Manufacturing Practice (GMP): DalBac BG used in pharmaceutical and cosmetic products must comply with GMP requirements for safe manufacturing processes.
The regulatory landscape for PHMB is strict due to potential health concerns. So manufacturers must ensure compliance with local and international regulations to bring products to market.
For more information visit: https://pubmed.ncbi.nlm.nih.gov/36630111/
To learn more about DalBac BG visit: https://phmb.co.za/2024/08/20/is-phmb-environmentally-friendly/
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