EU GPSR Compliance for Menstrual & Intimate Hygiene Products
GPSR risk assessment, technical documentation and label review for pads, liners, tampons, menstrual cups and period underwear sold in the EU and Northern Ireland.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Most menstrual and intimate hygiene products are consumer products under the EU General Product Safety Regulation (EU) 2023/988, which requires an internal risk analysis, technical documentation and traceability labelling. Some products, such as certain menstrual cups or products with medical claims, may be classed as medical devices, and some countries add their own rules. We prepare the GPSR risk assessment and technical documentation and review your labels and listings. £350 per product.
What's included in your hygiene product GPSR documentation
| Document | What it is |
|---|---|
| GPSR risk assessment | Internal risk analysis covering materials, skin contact, foreseeable use and misuse, and vulnerable users |
| Classification check | Whether your product and its claims fit GPSR, or may fall under medical device or other rules |
| Chemical review | Your supplier data checked against relevant REACH restrictions, with any testing you may need identified |
| Technical documentation | A file describing the product, the risks identified and how they are controlled |
| Label and listing review | Traceability details, instructions and warnings such as toxic shock syndrome (TSS) information for tampons, and online listing information |
Who this service is for
- Brands selling sanitary pads, liners, tampons, menstrual cups or period underwear in the EU or Northern Ireland
- Intimate hygiene accessory brands launching a new product
- Marketplace sellers asked for GPSR information by Amazon, Etsy or eBay
- Non-EU brands preparing to sell into the EU
What this service does not include
- Acting as your EU responsible economic operator. We explain the role and check the details on your label; the operator must be established in the EU.
- Laboratory testing. If the risk assessment shows testing is needed, it is arranged and paid for separately.
- Medical device conformity. If your product is a medical device, it needs a separate conformity route, which this service does not cover.
- Several different products. Each product needs its own risk assessment.
How it works
- Send your product details Product description, materials, supplier safety and test data, photos of the product, packaging and label, and your manufacturer and EU contact details.
- Classification and risk analysis We check how your product is likely to be regulated and assess hazards, foreseeable use and users.
- Documentation and label review We write the technical documentation and review your label and listing information.
- File delivered The documentation is delivered by email for you to keep on file.
What is GPSR compliance for menstrual and intimate hygiene products?
The General Product Safety Regulation (EU) 2023/988 (GPSR) has applied since 13 December 2024 to consumer products placed on the EU market and in Northern Ireland. Most pads, liners, tampons and period underwear are regulated as general consumer products, so manufacturers must carry out an internal risk analysis, keep technical documentation and label products so they can be traced. Classification is not always the same everywhere: some products, such as certain menstrual cups or products with medical claims, may be treated as medical devices, and some countries have specific national rules for menstrual products. Where other EU law covers a risk, such as REACH for chemicals, GPSR applies alongside it.
What your risk assessment covers
Product and use:
- Materials: Absorbent cores, fabrics, plastics, silicones and any fragrance.
- Foreseeable use: Wear time, insertion and removal, and reasonably foreseeable misuse.
- Users: Including teenagers and other vulnerable users.
Risks and controls:
- Hazards: Skin irritation, chemical exposure and, for tampons, toxic shock syndrome.
- Controls: Instructions, wear-time guidance and warnings. TSS warnings on tampon packs are an established labelling practice.
Traceability:
- Identification: Type, batch or serial number on the product or packaging.
- Contact details: Manufacturer and EU responsible economic operator.
- Online sales: The information Article 19 requires on distance-selling listings.
What your documentation contains
- Product description, intended use and classification note
- Internal risk analysis and its conclusions
- Chemical review summary and any recommended tests
- Risk controls, instructions and warnings
- Label, traceability and online listing checklist
Legal framework
- Regulation (EU) 2023/988, Article 5 — only safe products may be placed on the market
- Article 9 — internal risk analysis and technical documentation, kept for 10 years, plus traceability and contact details
- Article 16 — a responsible economic operator established in the EU
- Article 19 — required information for products sold online
- Regulation (EC) No 1907/2006 (REACH) — chemical restrictions that may apply to materials
- Regulation (EU) 2017/745 — applies instead where a product qualifies as a medical device
- Directive (EU) 2019/904 — plastic marking requirements for some pads, liners and tampons
- National rules — some countries have specific requirements for menstrual products
Official sources:
Why brands choose Phoenix
- Written for your product — a risk analysis based on your materials, use and users.
- Classification flagged early — we tell you if your product may need a different route.
- Label and listing checks — traceability, warnings and contact details reviewed together.
Prepare your GPSR file before you list. Order above, or message us on WhatsApp on +44 7346 009332 if you are unsure how your product is regulated.
Frequently asked questions
Does GPSR apply to menstrual products?
Most pads, liners, tampons and period underwear sold in the EU or Northern Ireland are consumer products covered by GPSR. Some products, such as certain menstrual cups or products with medical claims, may be regulated as medical devices instead.
Are menstrual cups medical devices?
It depends on the product, its claims and the country. Some menstrual cups have been treated as medical devices. We check this as part of the service and tell you if a different route may apply.
Do tampons need a TSS warning?
Toxic shock syndrome information on tampon packs and leaflets is an established labelling practice, and some countries have specific rules. We review your warnings as part of the label check.
How much does this service cost?
£350 per product, covering the risk assessment, technical documentation and label and listing review. Laboratory testing is separate.
What do you need from me?
A product description, materials, supplier safety and test data, photos of the product, packaging and label, and your manufacturer and EU contact details.
Do you act as my EU responsible economic operator?
No. We explain the role and check the details on your labels; the operator must be a business established in the EU.