Sweden: Regulatory and ESG challenges of innovative menstrual hygiene products in the Fem-Tech industry

1. Fem-Tech: a growing industry for women’s health and wellness

In recent years, the market has seen the emergence of new products and services targeting women’s health and wellbeing – an industry commonly referred to as “Fem-Tech”. Fem-Tech is distinguished by the use of new technologies, such as the use of AI in apps where women can track their fertility and other health conditions, as well as product innovations, such as alternatives to traditional menstrual hygiene products.

A recent example of product innovation is period underwear, a garment designed to securely absorb menstrual blood. Period underwear is often marketed as a comfortable, economical, and sustainable option to single-use products like tampons or pads. The surge of this product group during the fall of 2022 led the Swedish Chemicals Agency to initiate an audit, which highlighted both regulatory and ESG challenges as it was published in the fall of 2023.

2. Regulatory risks of innovative menstrual hygiene products

As period underwear became a more common product on the market, the Swedish Chemicals Agency noticed that many of the products were marketed as “anti-bacterial” or “anti-odour”.

These claims indicate that articles may be treated with an active biocidal substance, which are subject to the EU Biocidal Products Regulation (EU No 528/2012, “BPR”). The BPR defines biocidal products as products containing one or several active biocidal substances or microorganisms “intended to destroy, deter, render harmless, or exert a controlling effect on any harmful organism”. Biocidal products are heavily regulated under the BPR and must be formally approved, as they can have a significant effect on living organisms. Biocidal substances are used on a wide range of everyday articles such as home appliances, shoes, and clothing, to enhance performance and/or service life. Treated articles are regulated in Article 58 of the BPR, which is applicable to all parties involved in placing a treated article on the market, meaning the entire supply chain (manufacturers, suppliers, importers, and retailers). Under Article 58, these parties are required to provide consumers certain information on the treated article, and to correctly label the article. Furthermore, they must ensure that the article is treated with approved active biocidal substances. A summary of the requirements under Article 58 can be found here.

In their audit, the Swedish Chemicals Agency found that many retailers of period underwear failed to meet the requirements under Article 58 of the BPR, and that some did not even know about them at all. It does not come as a surprise that retailers find the regulatory landscape for menstrual hygiene products uncertain, as specific regulation governing the composition, manufacture and use of these products currently doesn’t exist. Instead, these products are regulated as any other consumer product, meaning that retailers must individually assess if other regulations apply besides from general legislation on product safety, marketing, and consumer rights. This creates a special risk profile for these products, that is especially prevalent if the products are considered as treated articles under the BPR. Non-compliance with the BPR may result in market exclusion, environmental penalties, and in some cases criminal sanctions under Swedish environmental crime legislation.

3. ESG risks: greenwashing and pinkwashing

The risk profile for menstrual hygiene products also includes ESG risks. Over the past few years, ESG considerations has increasingly taken centre stage in the retail industry. Retailers are now, driven by both consumer- and regulatory demands, focusing on how to have a positive impact on society and the environment. Selling chemically treated goods pose several ESG risks, since the process of chemically treating articles can expose both workers, the environment, and the end-customer to hazardous substances.

ESG risks are particularly prevalent for companies in the Fem-Tech industry given that they often profile themselves and their products as a better option for women’s health and the environment. An example of the ESG risks in relation to the end-consumer is a recent class-action lawsuit in the US against the company Thinx. Thinx allegedly sold period underwear containing both nano-silver, a biocidal product, and “PFAS”, short for per- and polyfluoroalkyl substances. PFAS is known as “forever-chemicals” as their strong chemical bindings make them virtually non-degradable both in the environment and in living organisms. PFAS-exposure is linked to a range of health problems, such as decreased fertility, increased risk of certain cancers, hormonal disruption, high cholesterol levels, development delays and low birthweight in children, high blood pressure in pregnant women and reduced effectiveness of the immune system. In its case against Thinx, complainants did not claim that they had been inflicted bodily harm by the product. Instead, the action merely stated they had been misled by Thinx to believe that the products were safe, healthy, and sustainable, when they instead contained health- and environment hazardous chemicals. The lawsuit was settled, and Thinx committed to make changes to its marketing and production, as well as to pay up to $5 million in reimbursements.

The Thinx lawsuit can be seen as a cautionary example of how deficient ESG-work can pose serious reputational risks to Fem-Tech companies. From an EU perspective, the lawsuit also highlights how the regulatory landscape may vary for different menstrual hygiene products. PFAS are, similarly to biocidal products, found in many everyday products within the EU, often as a treatment to make a surface water-repellent, or in the case of Thinx, to give the period underwear moisture-wicking and leak-resisting qualities. Products on the internal market containing PFAS are subject to Regulation (EC) No 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), adding yet another possibly applicable regulation to the list regulatory framework for innovative menstrual hygiene products.

4. Outlook – the future of innovative menstrual hygiene products

There are currently no legislative drafts on EU level regarding product-specific regulation for menstrual hygiene products. The European Commission has recently stated that the product safety of this product group is expected to be enhanced as the new General Product Safety Regulation is adopted.

However, there is currently an ongoing process to develop an ISO standard for menstrual hygiene products, as the member countries of the ISO have voted to set up a committee to develop common and clear safety requirements for the product group. The committee (ISO/TC 338 Menstrual Products) is Swedish-led and expected to develop the standard over about two years. ISO standards often make for best practice over time, and it is likely that the upcoming standard will clarify ESG aspects of the composition, manufacture, and use of menstrual hygiene products. The drafting may draw inspiration from the EU Ecolabel Criteria, which is an EU-initiated voluntary eco-labelling scheme. As for now, the EU Ecolabel Criteria includes both reusable menstrual cups and absorbent menstrual products (the criteria can be found here).

5. Key takeaways

• The Fem-Tech industry is experiencing rapid growth, presenting significant business opportunities. Expect substantial product innovation in this space.
• Companies operating in Fem-Tech often position themselves as strong ESG candidates. However, this branding strategy comes with heightened reputational risks if they fail to comply with regulatory requirements. For smaller companies, their entire business may hinge on this image.
• While menstrual hygiene products are not specifically regulated, they are not entirely unregulated. Instead, they may fall under unexpected regulations from a retailer’s perspective. This is crucial to consider if the products undergo chemical treatments, or are marketed with claims of special function, as these products may be subject to the BPR or other regulations like REACH.
• As for chemical treatment of products, it should be avoided unless necessary. Chemical treatment increases compliance-costs and is not necessarily the way of the future. More chemicals are likely to be banned in the future as part of the EU’s chemicals strategy, which aims to create a toxic-free environment. For instance, PFAS are under consideration for phasing out and may potentially be prohibited in all products where it is non-essential.
• Companies in the Fem-Tech industry, especially for innovative menstrual hygiene products, now have an opportunity to strengthen their market position by staying informed about the impending ISO standard before its adoption. It is likely that certain chemical treatment will not be allowed under the upcoming ISO standard and that other product specific requirements may apply.