Home » Blog » The Regulatory Gap in Menstrual Health: A Case for Reclassification Under South African Law

The Regulatory Gap in Menstrual Health: A Case for Reclassification Under South African Law

Authored By: Kgotlello

University of the Western Cape

Introduction: Sanitary Dignity Beyond Access

Over the years, we have seen a major change in the policies covering topics about menstrual health and hygiene. They have changed the approach from shaming and silencing to a right focused one mostly grounded in dignity and equality. To tackle issues surrounding period poverty, the government introduced movements such as the Sanitary Dignity Implementation Framework (SDIF) and the zero rating of Value Added Tax (VAT) on sanitary pads.[1] However, the laws governing these products are still mostly focused on their affordability and access over their biological safety.

Currently, sanitary pads are considered to be consumer goods rather than medical ones and as a result, regulation of these products focuses mainly on performance and quality rather than chemical safety or ingredient transparency. Recent research done by the University of Free State has identified traces of potentially harmful chemicals known as endocrine disrupting chemicals (EDCs) in commonly used menstrual products in South Africa. This raises significant constitutional concerns under Sections 10 and 27 of the Constitution relating to the right to dignity and access to healthcare services as exposure to these EDCs has been linked to diseases and abnormalities such as endometriosis, premature puberty onset, ovulation disorders and many more.[2]

This essay argues that South Africa’s current regulatory framework prioritizes performance over safety and is failing to reach the constitutional standard of reasonableness. It will make use of constitutional, legislative, court jurisprudence, and recent research to determine how reclassifying menstrual products as medical devices under the South African Health Products Regulatory Authority (SAHPRA) would close this regulatory gap and strengthen protection of women’s health and dignity.

The Current Legal Framework: Consumer Protection and No Chemical Transparency

South Africa makes use of the Consumer Protection Act 68 of 2008 (CPA), rules from the South African Bureau of Standards (SABS), and general public health laws to control how sanitary pads are manufactured and sold. According to section 55 of the CPA, consumers have the right to safe and good quality goods. Section 61, on the other hand, imposes strict liability for harm caused by unsafe products.[3] However, the Act neither offers a detailed definition of safety for menstrual products, nor does it require full ingredient disclosure.

The SABS standard SANS 1812:2020 marked progress in standardizing reusable sanitary towels. Nevertheless, it remains fundamentally a performance standard.  Its requirements focus on the practicality of the product, i.e. absorbency, liquid retention, adhesive strength, and durability rather than chemical composition. Following this, manufacturers are not legally obliged to reveal what goes into their products including plastics, fragrances, adhesives, or leftover chemicals like dioxins from bleaching processes.[4]

Since menstrual products are not classified as medical devices, they are not subject to pre-market clinical evaluation, toxicological thresholds, or mandatory ingredient transparency. This allows potentially harmful substances including EDCs, fragrances, and plasticizers to remain undisclosed and largely unregulated.[5]

Performance Versus Safety

It is important to distinguish between performance standards and safety standards. Performance standards assess whether a product works; safety standards evaluate whether it is biologically safe for long-term use.

Women are exposed to menstrual hygiene products for more than 3500 days (about 9 and a half years) during their lives.[6] Global research has associated exposure to EDCs such as phthalates and bisphenols with reproductive disorders, hormonal disruption, and microbiome imbalance. Even where concentrations appear to be low, it was established that constant exposure raises a legitimate public health concern.[7]

Without required ingredient labels, people struggle to make clear choices about what they use. Dignity means control over your body. We see this in C v Department of Health and Social Development, where the Constitutional Court emphasized that dignity includes bodily integrity and self-determination.[8] When consumers cannot identify the substances to which they are exposed, meaningful consent is compromised, so is personal freedom over physical well-being.

Constitutional Obligations: Health, Dignity, and the Reasonableness Standard

Section 27(1)(a) of the Constitution guarantees the right of access to healthcare services. Section 10 protects the inherent dignity of every person.[9] These provisions impose positive obligations on the country to adopt reasonable legislative and policy measures to protect public health. In Government of the Republic of South Africa v Grootboom, the Constitutional Court ruled that government actions on social and economic rights must be reasonable, comprehensive, and responsive to the needs of people who are struggling.[10] When rules about period care only look at getting products out but ignore whether those products are safe, it might not meet what the Constitution requires.

The principle was reinforced in Minister of Health v Treatment Action Campaign, where the Court ruled that government programmes must be balanced, flexible, and responsive to those most at risk.[11] The SDIF hands out free sanitary products to learners and students who can’t afford them.[12] Suppose those supplies carry hidden chemicals, then the very help meant to protect might quietly cause harm instead. Following the Treatment Action Campaign‘s approach, simply offering something does not count if it comes with unseen threats. How people are treated in law ties closely to their physical autonomy. In S v Makwanyane, the Court described dignity as a foundational constitutional value.[13] When period supplies risk someone’s reproductive well-being, it weakens what the SDIF aims to protect.

Consumer Protection and the Limits of Post-Market Remedies

Although the CPA provides remedies for harm caused by unsafe goods, litigation is an inadequate mechanism for addressing the risks posed by menstrual products. Harm caused by EDCs or chronic chemical exposure is often cumulative, sub-clinical, and difficult to trace to a single product.

In Halstead-Cleak v Eskom Holdings Ltd, the court examined how hard it is for people to show real damage arising from corporate actions.[14] In the context of menstrual products, tying chemicals found in them to long-lasting effects on reproductive health outcomes would be even more complex. This reinforces the need for checking safety before things hit shelves makes far more sense than waiting for lawsuits after release.

Comparative Regulatory Approaches

Comparative analysis reveals that other jurisdictions adopt a precautionary approach to menstrual product safety. In the United States, the Food and Drug Administration treats tampons and similar products as medical tools, so they must pass health checks and follow strict production steps. Several U.S. states have introduced legislation authorising clear labels showing the ingredients of these items.[15]

Within the European Union, rules such as REACH limit dangerous chemicals. Because of this, companies must reveal risky ingredients found in everyday items. Starting with future well-being, the system acts before harm occurs. Protection stretches ahead, built into how these laws work. [16]

South Africa’s regulatory regime, by contrast, remains largely performance-based, leaving consumers without comparable safeguards. This approach puts people at a disadvantage when compared to stronger systems elsewhere.[17]

Proposed Reform: Reclassification under SAHPRA

To close the regulatory gap, the Minister of Health should consider declaring menstrual products medical devices under the Medicines and Related Substances Act 101 of 1965, thereby bringing them under the regulatory authority of South African Health Products Regulatory Authority.

Reclassification would provide several regulatory benefits:

  1. Mandatory Ingredient Disclosure

    Firms making products must list every ingredient used – plastics, glues, scents, and bleach included. Hidden ingredients won’t be allowed anymore under these rules

  2. Chemical Threshold Standards

    One way to handle safety might be setting caps on certain chemicals through SAHPRA. Limits for things like phthalates, or hormone-interfering substances, could protect health. These rules would aim at keeping exposure within a range that the body can tolerate. Keeping people safe means knowing how much is too much. Levels set by authorities may prevent harm before it starts

  3. Pre-Market Safety Evaluation

    A closer look at safety comes first when it’s time to clear a product for stores. Before anything reaches shelves, experts check how it might affect health. Getting the green light means passing strict checks on possible harm. Only after a thorough review does a product move forward. Safety proof is required, otherwise there’s no go-ahead

  4. Reporting systems for harmful events

    Consumers and healthcare providers could report allergic reactions or systemic health concerns, which could help shape later safety rules. Sometimes reactions get logged by clinics, feeding into how guidelines shift over time. When patients speak up about symptoms, that info slowly builds a clearer picture down the line

  5. Enhanced Protection for State-Procured Products

    Government procurement under the SDIF would be subject to safety compliance standards, protecting vulnerable beneficiaries. Not just rules on paper, safety checks would back every purchase made through the SDIF. Instead of users chasing proof, makers must show their products won’t cause harm. Responsibility flips quietly but firmly toward those who produce. Laws wouldn’t float alone – they’d tie into rights already promised by the Constitution. Global examples help shape how strictly things are done here.

Conclusion: From Period Poverty to Product Safety

Having pads isn’t enough if they harm the body. It is undeniable that South Africa has moved forward on menstrual access, however, its laws focuses only on cost and miss something deeper. Following the studies made by the UFS, it is apparent that the ingredients of the producst matters too. When rules ignore toxins, basic rights start cracking: health wavers, dignity slips, control over one’s self frays. Safety must shape policy, not just supply

The current performance-focused regulatory metrics falls short when applied to items people rely on closely and regularly across many years. Looking at constitutional law, especially how fairness was defined in cases like Grootboom and the Treatment Action Campaign, shows government must act so that period care solutions remain within reach and free from harm

Imagine a world where pads and tampons fall under the same watchful eye as medicines. That shift could quietly fix long-standing gaps in how these items are monitored. Instead of slipping through regulatory cracks, they’d face real scrutiny on what chemicals go into them. Safety matters more when something touches bodies month after month, year after year. Dignity isn’t just about getting products it also means knowing they won’t harm you over time.

BIBLIOGRAPHY:

Table of Legislation

Constitution of the Republic of South Africa, 1996

Consumer Protection Act 68 of 2008

Medicines and Related Substances Act 101 of 1965

National Health Act 61 of 2003

Table of Cases

C v Department of Health and Social Development

Government of the Republic of South Africa v Grootboom

Halstead-Cleak v Eskom Holdings Ltd

Minister of Health v Treatment Action Campaign (No 2)

S v Makwanyane

Government & Institutional Reports

Competition Commission South Africa, Competition Commission of South Africa: Contribution to the Inquiry into the Supply of Sanitary Pads (Competition Commission South Africa 2021)

Department of Women, Youth and Persons with Disabilities, Sanitary Dignity Programme (Media Statement, 12 February 2024)

Department of Women, Youth and Persons with Disabilities, Sanitary Dignity Implementation Framework (2019)

South African Bureau of Standards, SANS 1812:2020 Washable, Reusable Sanitary Towels (SABS 2020)

Journal Articles & Academic Sources

Blignaut J, Visser HG, Erasmus E et al, ‘Review: sanitary pads—composition, regulation, and ongoing research to address associated challenges’ (2025) 60 Journal of Materials Science 13109

Chenwi L, ‘The Right to Health Care Services’ in Socio-Economic Rights in South Africa (2nd edn, Juta 2024)
Scorgie F, ‘Period Poverty and the Law in South Africa’ (2021) 12 South African Journal of Bioethics and Law 45

van der Merwe MS, ‘Chemical Hazards in Menstrual Products: A South African Regulatory Gap’ (2023) 15 South African Journal of Law and Health 112

Zungu L and Govender N, ‘Menstrual Hygiene Management Among Adolescent Girls in South Africa’ (2023) 5(1) African Journal of Inter/Multidisciplinary Studies

Research & Scientific Studies

University of the Free State, Chemical Analysis of Menstrual Products in South Africa (2023)

[1] Department of Women, Sanitary Dignity Implementation Framework (2019) 3–5.

[2] M S van der Merwe and others, ‘Chemical Analysis of Volatiles and Plasticizers in Commercial Sanitary Pads in South Africa’ (2023) University of the Free State study, 7–12

[3] Consumer Protection Act 68 of 2008 ss 55(2)(a), 61.

[4] South African Bureau of Standards, SANS 1812:2020 Washable, Reusable Sanitary Towels (2020) 4–9.

[5] F Scorgie, ‘Period Poverty and the Law in South Africa’ (2021) 12 SAJBL 45, 48–50.

[6] J Blignaut, HG Visser, E Erasmus et al, ‘Review: sanitary pads—composition, regulation, and ongoing research to address associated challenges’ (2025) 60 Journal of Materials Science 13109.

[7] M S van der Merwe and others, ‘Chemical Analysis of Volatiles and Plasticizers in Commercial Sanitary Pads in South Africa’ (2023) University of the Free State study, 7–12.

[8] C v Department of Health and Social Development [29]–[31].

[9] Constitution of the Republic of South Africa, 1996.

[10] Government of the Republic of South Africa v Grootboom [41]–[44].

[11] Minister of Health v Treatment Action Campaign [68]–[79].

[12] Department of Women, Youth and Persons with Disabilities, Sanitary Dignity Programme (Media Statement, 12 February 2024).

[13] S v Makwanyane [144].

[14] Halstead-Cleak v Eskom Holdings Ltd [23]–[27].

[15] US Food and Drug Administration, Menstrual Tampons and Pads: Regulatory Requirements (FDA Guidance) 2–4.

[16] European Chemicals Agency, REACH Regulation (EC) No 1907/2006 arts 57–59.

[17] Author(s), ‘Title of Article’ (Year) Volume(Issue) African Journal of Inter/Multidisciplinary Studies page https://journals.dut.ac.za/index.php/ajims/article/view/1588/1038 accessed 24 February 2026.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top