,"On November 10, 2025, the Draft Uganda Standard DUS 2863:2022 – Tampon Specification (First Edition) entered into force, as notified by the WTO. The standard sets mandatory requirements for tampon safety, quality, materials, packaging, labelling, sampling, and test methods in Uganda, aligned with international best practices. Tampons are defined as single-use internal menstrual products designed to safely absorb menstrual fluid.
- Product Description & Components: Tampons must include an absorbent core, overwrap, and mandatory removal string (≥80 mm; ≥28 N strength), with optional cardboard/non-irritant applicator. Materials include cotton, viscose, or blends (preferably organic), chlorine-free bleaching, and non-woven/perforated overwrap. Restricted materials include polyester foam, CMC, modified rayon, fragrances, and antimicrobials unless declared.
- Performance & Safety: Products must be clean and free from foreign matter, non-irritant and non-sensitizing (ISO 10993-5/10), non-linting, and classified for light/moderate/heavy absorbency (Syngina, 21CFR801.430). They must be free from dioxins, pesticides, heavy metals, phthalates, formaldehyde, carcinogens, acrylic monomers, etc. Microbial count must be ≤10 CFU/g and free from E. coli, S. aureus, C. albicans, and P. aeruginosa. - Wear time: 4–8 hours. Vaginal pH must remain 5.5–8.5 (ISO 3071).
- Packaging & Labelling: Each tampon must be individually wrapped in hygienic, biodegradable, non-plastic material; primary packs hold 15–40 units. Labels must show product name, manufacturer details, absorbency, batch/lot, dates, ingredients, and license number. IFU must include usage, insertion/removal, disposal, precautions (TSS warning, no use during infection/sex, do not flush), and multilingual guidance with pictograms/QR codes.
- Regulatory Standards: Compliance with ISO 9001 (min), ISO 13485 (recommended), ISO 14001 (preferred). Absorbency testing: NWSP 350.1, 21CFR801.430. Microbiology: ISO 6887, 6888, 21149, 22717, 22718, 18416. Products must have ISO 17025-accredited lab reports and comply with FDA Class II (21CFR884.5470) and EU 2001/95/EC requirements.
Environmental Requirements: Preference for biodegradable/compostable materials certified under ISO/EN 17088-2021, EN 13432; sustainable packaging compliant with the EU Single-Use Plastics Directive; FSC and EU Ecolabel recommended.
- Documentation: Manufacturers must supply engineering drawings, ingredient lists, ISO 17025 test reports matching the actual SKU, and multilingual IFUs (six UN languages). Sustainability and certified materials receive higher weightage in procurement.
Additional Requirements: Provide biocompatibility test criteria, Syngina absorbency ranges, microbiology testing and sampling plans, ISO 17025 report formats, and draft IFU pictograms/QR content."
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