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Why Aren’t Menstrual Products Classified as Medical Devices in the EU? (Feminine Hygiene Rules Explained)
When you buy tampons, pads, or menstrual cups, you expect them to be safe. But in 2023, a petition to the European Parliament questioned whether the EU is doing enough to guarantee that. The petitioner, Clarisse Le Court, argued that these feminine hygiene products should be classified as medical devices, pointing to risks such as toxic shock syndrome (TSS) and potential exposure to harmful chemicals. She also noted that in the United States, tampons and pads already fall under medical device rules, which require more rigorous testing before they reach consumers.
EU regulators, however, explained why menstrual products remain regulated as consumer goods rather than medical devices. This post looks at that reasoning, covering how the General Product Safety Regulation (GPSR), REACH, and new testing standards apply, and what this means for both consumers and the industry.
Not Medical Devices: Understanding the EU’s Stance on Feminine Hygiene Products
Why doesn’t the EU treat tampons, pads, or menstrual cups as medical devices? The answer lies in how the law defines “medical.” Under the EU Medical Devices Regulation (MDR), a product must be intended to diagnose, treat, or prevent a disease or injury. Menstruation, however, is not an illness—it’s a natural process. That’s why menstrual products are considered hygiene items, not medical devices.
The MDR does extend to some non-medical products if their risks closely resemble those of medical devices. Examples include cosmetic contact lenses or implants, which appear in Annex XVI. But menstrual products don’t have a medical device “equivalent” to compare them with. Since there is no medical device that serves the same purpose as a tampon or pad, the legal criteria for adding them to Annex XVI aren’t met. For that reason, the European Commission has said it sees no basis to amend the law to include them.
Sanitary Pads, Tampons and Menstrual Cups under the GPSR: A New Safety Net
If menstrual products are not regulated as medical devices, how does the EU ensure their safety? The answer lies in general consumer product law. For many years, items like tampons, pads, and menstrual cups were governed by the General Product Safety Directive (2001/95/EC). That framework has now been replaced by the General Product Safety Regulation (GPSR, Regulation (EU) 2023/988), which has applied in full since 13 December 2024. The GPSR establishes a much stronger safety net for consumer goods, including feminine hygiene products.
Under the GPSR, manufacturers must take a proactive, documented approach to safety. Before placing products on the market, they are required to:
- Carry out a risk assessment, including foreseeable misuse.
- Maintain technical documentation explaining identified hazards and mitigation measures (e.g., TSS risk and user guidance for tampons).
- Ensure an EU-based “responsible person” is designated for every product.
- Strengthen traceability with tools like batch coding to enable rapid recalls.
The GPSR also extends oversight to online marketplaces and gives national regulators greater enforcement powers. Authorities can now conduct test purchases (including online), issue stop-sale orders, and mandate recalls more efficiently. Through the EU’s Safety Gate system, alerts about unsafe products are shared across all Member States, ensuring coordinated action.
In short, even though tampons, pads, and menstrual cups are not classified as medical devices, the GPSR ensures they are subject to strict safety requirements, backed by stronger market surveillance and EU-wide cooperation.
Managing Chemical Risks: REACH and New Testing Initiatives for Menstrual Products
One of the biggest drivers behind calls for tighter rules on menstrual products has been concern about chemical safety. Consumers often ask what might be in tampon cotton, the fragrances or additives in pads, or the materials used in menstrual cups. In its response, the European Commission pointed to the REACH Regulation (EC 1907/2006) as the EU’s primary safeguard. REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), is a wide-ranging law that restricts or bans substances hazardous to human health or the environment. It applies across all sectors, from electronics and toys to feminine hygiene.
Under REACH, certain chemicals are already prohibited in menstrual products. For example:
- Organotin compounds such as dioctyltin (DOT), once used as stabilisers, are banned due to their toxic effects.
REACH is also built to adapt. A new restriction is currently in development that would target skin-sensitising substances in absorbent hygiene products, aiming to eliminate common allergens and irritants. More broadly, if scientific evidence shows a substance in menstrual products is risky, REACH provides a mechanism to restrict it across the EU. On top of this, the General Product Safety Regulation (GPSR) acts as a catch-all: even if a harmful chemical is not yet formally banned, products containing it can still be pulled from the market for being unsafe.
The EU is also investing in better testing methods. The European Committee for Standardization (CEN) is finalising a harmonised protocol for detecting trace chemicals in menstrual and other absorbent hygiene products. This work, carried out through a fast-track CEN Workshop Agreement, responds to years of debate about chemical residues in pads and tampons. Published in 2024, the new method now provides:
- A consistent standard for testing trace chemicals in menstrual and other absorbent hygiene products.
- Comparable results across countries, reducing the risk of conflicting findings.
- A recognised tool companies can use to demonstrate compliance under the GPSR.
In practice, this harmonised testing framework gives both regulators and industry a clearer, more reliable way to assess safety, and helps strengthen consumer trust.
What about Toxic Shock Syndrome and other health risks?
No discussion of tampon safety is complete without mentioning Toxic Shock Syndrome (TSS). This is a rare but serious condition historically linked to high-absorbency tampon use. This concern was central to the petition and continues to resonate with consumers. EU authorities have examined it closely. In 2020, France’s national health agency (ANSES) published a detailed review of menstrual products and TSS. Researchers tested tampons and menstrual cups for a wide range of chemicals and evaluated their safety. The findings were reassuring overall: while some trace substances were detected, they were well below levels of concern, and no evidence was found that product materials themselves increase the risk of TSS. Instead, the condition is primarily associated with misuse. For example, leaving a tampon in place for too long, which can allow bacteria to multiply. Even so, ANSES urged manufacturers to keep improving product quality and reduce any chemical residues, reflecting the EU’s broader policy of driving safety standards ever higher.
Another step in that direction is the EU Ecolabel, a voluntary certification scheme that sets strict environmental and safety requirements. In September 2023, the European Commission updated the Ecolabel criteria for absorbent feminine hygiene products, including tampons, pads, and menstrual cups. To qualify, products must meet performance benchmarks for absorbency and comfort while also avoiding a long list of substances, such as:
- Antibacterial agents
- Formaldehyde
- Parabens
- Phthalates
- Known endocrine disruptors
- Added fragrances or common allergens
While not every brand will pursue certification, the scheme establishes a higher bar that can influence the market more broadly. For consumers, the Ecolabel’s flower logo is an easy way to identify products that have been independently assessed and certified against some of the toughest standards in Europe.
Implications for Consumers and the Feminine Hygiene Industry
For consumers, the absence of a “CE” medical device mark on tampons or pads does not mean weaker protection. These feminine hygiene products fall under general consumer safety and chemical laws, which now include stricter requirements through the GPSR. Companies must perform risk assessments before launching products, and regulators have stronger powers to remove unsafe items from the market. Market surveillance is active and coordinated across the EU: for example, a 2022 campaign tested hygiene items, including menstrual products, and any unsafe findings can trigger rapid alerts and recalls across all member states. In practice, this means consumers benefit from a broad safety net, even if products are not classified as medical devices. Proper use remains important, however, especially when it comes to reducing the risk of Toxic Shock Syndrome (TSS) by following usage guidelines.
For the industry, the EU’s approach offers both flexibility and responsibility. Not classifying menstrual products as medical devices spares companies from the most stringent medical device rules, such as notified body approvals or clinical trials, which lowers barriers to entry and supports innovation. At the same time, the GPSR places clear obligations on manufacturers, requiring:
- Thorough risk assessments and safety documentation
- Strong quality control systems
- Transparent supply chain management
Chemical compliance is equally critical. Under REACH, materials such as fibers, additives, and dyes must be continually reviewed against evolving restrictions. The new CEN Workshop Agreement on trace chemical testing is set to become a benchmark, giving regulators and industry a common reference point for demonstrating compliance.
Market dynamics are also shifting. The updated EU Ecolabel criteria raise expectations for both chemical safety and sustainability. While certification is voluntary, brands that achieve it can signal stronger safety and eco-friendly standards, earning consumer trust and competitive advantage. Overall, the EU’s framework is steering the industry toward greater accountability and transparency. For consumers, this means confidence in product safety. For manufacturers, it means adapting to a stricter but more future-proof regulatory environment.
Final Takeaway
The debate over how menstrual products should be regulated in the EU comes down to balance: strong protection for users without unnecessary red tape. Tampons, pads, and menstrual cups are not treated as medical devices. That does not mean they are left unchecked. The EU has built a solid system to keep them safe. The GPSR raises standards for manufacturers, REACH chemical rules keep harmful substances out, and extra measures like standardised testing methods and the EU Ecolabel add further safeguards. Together, these create several layers of protection, covering product design, chemical safety, and quality, without relying on the “medical device” label.
The 2023 petition helped put these issues in the spotlight and pushed regulators to strengthen protections. For consumers, the takeaway is reassuring: menstrual products on the EU market are closely regulated and monitored. Regulators run market checks, issue recalls when needed, and act quickly if risks are found. Safe use still matters, especially following tampon guidance to reduce the risk of TSS, but the products themselves are subject to strict safety rules. If you want extra peace of mind, the EU Ecolabel is a good sign that a product meets even tougher standards.
For manufacturers and brands, the current rules bring both challenges and opportunities. That’s where Euverify can help. We support companies in the feminine hygiene products sector by making sense of GPSR and REACH requirements, preparing the risk assessments and documentation regulators expect, and staying ahead of new standards like CEN testing methods and the EU Ecolabel. With the right mix of compliance expertise and practical tools, Euverify makes it easier for businesses to stay on track, protect their reputation, and build lasting trust with consumers.
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