Experts from leading South African research and clinical institutions have moved to assure the public that it remains safe to use sanitary pads.
Health Minister Dr Aaron Motsoaledi on Sunday led a joint media briefing to respond to public concerns on the safety of sanitary pads. This after a study conducted by the Department of Chemistry at the University of Free State, entitled ‘The presence of endocrine disrupting chemicals in sanitary pads: A study done in South Africa’ was published in the Science of the Total Environment Journal last month.
Motsoaledi said: “It is not surprising that EDCs were found in sanitary pads both because they are found in many products, and their presence in sanitary pads has previously been documented.
“The levels of ECDs were low. The regulatory authorities in South Africa will continue to play their role in regulating the products as they were doing prior to this study.
“Most important is that this or any other study has not established a causal relationship between the detected chemicals and adverse health outcomes in women or girls.
“Women and girls can be reassured that it remains safe to use sanitary pads.”
The briefing took place as South Africa marks International Women’s Day, a day that helps to refocus the spotlight on issues such as gender equality, reproductive rights, and violence and abuse against women.
Background
The Free State University study was conducted on 16 sanitary pads and seven pantyliners that were bought online. Small quantities of EDCs were present in the
tested samples, with all products tested containing at least two types of EDCs. This included products that were marketed as being chemical-free.
The study concluded that menstrual products are a significant but overlooked source of exposure to EDCs. In a news story published on the university’s website, the exposure to EDCs in sanitary pads found in the study was linked to hormonal imbalances, fertility problems, endometriosis, and certain types of reproductive cancer.
In response, the National Department of Health (NDOH) has engaged with scientific and clinical experts from a number of institutions and organisations in order to understand whether there is any risk to users of these products and whether any action needs to be taken.
Experts from the following institutions were consulted:
• The South African Medical Research Council (SAMRC).
• The South African Society of Obstetricians and Gynaecologists (SASOG), together with the South African Society of Reproductive Medicine and Gynaecological Endoscopy (SASREG).
• The National Health Laboratory Service (NHLS).
• The South African Health Products Regulatory Authority (SAHPRA).
• World Health Organisation (WHO).
What the experts have to say
The South African Medical Research Council (SAMRC)
President: Prof Ntobeko Ntusi
The SAMRC said the following six important points should be shared with the public.
“The first is to understand what endocrine disrupting compounds are, what the different classes are, their mechanisms of actions, their human effects, and most importantly, the fact that they are found almost everywhere you look.
“The second to emphasise is that the exposure to EDCs is actually much higher in men than it is in women. Most of the exposure in women comes from cosmetic exposure, including sanitary pads, whereas most of the reported exposure in men comes from occupational exposure, which tends to be much, much higher.
“Thirdly, it is important to understand the scientific method and how we link exposures to outcomes through clinical trials or observation studies, which is something that has not been done at all in this study.
“Fourthly, it is critical for scientists in the country to be reminded of the avenues for reporting perceived adverse events or concerns from post-marketing surveillance, either through the NDOH or SAHPRA.
“Point five is to address the fact that the detection of EDCs, most importantly and critically, does not translate to evidence of harm to South Africans. Just because a chemical is present does not mean that it represents a risk.
“Finally, the industry for manufacture of sanitary products is a universal one. It’s not an industry that is unique to South Africa. The market standards for manufacture are the same all around the world, and not only in this country, but all over the world, there’s been no evidence or signal of harm for use of these products,” said the SAMRC.
SAMRC concluded that there is no causality and no evidence of clinical harm. “We need to reassure the South African public that there is no signal of harm.”
Obstetricians and Gynaecologists
Prof Ismail Bhorat: President of the South African Society of Obstetrics and Gynaecology (SASOG);
Dr Jack Biko: President of the South African Society of Reproductive Medicine
and Gynaecological Endoscopy (SASREG), and
Prof Zozo Nene: President: College of Obstetrician and Gynaecologists (CMSA)
and Head Clinical Unit: Reproductive Endocrinology and Infertility, University of Pretoria
Experts in the obstetrician and gynaecological field said EDCs only have a potential to interfere in the action of hormones, including reproductive hormones and thyroid hormones, as opposed to established risk.
“There is a difference between the ‘potential to interfere’ and ‘actual risk’. At this point in time, EDCs only represent a ‘potential to interfere’ and not an ‘actual risk’. The incidental finding of these chemicals, which is widespread in almost everything we are exposed to and which is not confined to menstrual products, does not translate to risk,” the experts said.
Further, they said the concentrations of EDCs found in the study were very low, “much lower than permissible concentration levels further minimising the potential to cause harm”.
“The permissible concentration levels are determined by the Cosmetic Ingredients Expert panel (an international body), and their decisions are used by the relevant regulatory bodies, such as the Food and Drug Administration (FDA) in the US to set practice guidelines.
“The contribution of EDCs in menstrual products to the total pool of EDCs from daily exposure to other sources is also low, which is around 6.8%. The majority comes from foodstuffs (40%) and other personal care products (40%), like toothpaste, shampoo and conditioners, body lotions, lipsticks and also clothing.
“Thus, perspective and context is needed when interpreting this data,” the experts said.
The study from the Free State did not establish causation between the presence of the endocrine disruptors in menstrual products and infertility, hormone dysfunction or cancer.
“To prove causation, you would need to control for (or exclude) other causes or risk factors for the particular condition or disease – in this instance infertility, cancer, endometriosis. In this case, you would have to prove that the EDCs from sanitary pads only directly cause cancers and infertility, and show that you have excluded other sources of EDCs and other risk factors for cancers and infertility.
“No causation was established. The evidence at present does not support a change of usual practice,” said the experts.
“In the absence of comprehensive and reliable data on the cumulative effect of these chemicals with only the ‘potential to interfere’, the small contribution of menstrual products to the overall total pool of EDC exposure, the small concentrations found below permissible levels and the small sample size, which limits generalisability, the implication to the general public of harm has not been proven in this study and based on the available data and evidence, we cannot draw any conclusions that will inform a change in usual practice.”
According to WHO, data for the past decades have not linked EDCs to particular disease conditions.
South African Health Products Regulatory Authority (SAHPRA)
Dr Boitumelo Semete – CEO
Under the Medicines and Related Substances Act 101 of 1965, sanitary products are regarded as low-risk medical devices. Thus, exempting the manufacturers from a need for a licence.
“While this is said, manufacturers must still comply with global standards. There has been no causality determined for the EDCs found in these sanitary products linking them to cancer, infertility and endometriosis to name but a few.
“Further, SAHPRA has not received any reports of adverse events from the public. The public can contact SAHPRA to report any adverse events. SAHPRA will continue to monitor these products in partnership with other regulators. It is our considered view that these products remain to be safe for use by the public,” the regulatory authority said.
World Health Organization
Ms Shenaaz El-Halabi (Country Representative)
Dr Richard Brown (Technical Officer responsible for chemical safety projects at
WHO Headquarters)
“WHO recognises that access to menstrual products is an important part of universal health coverage. This means that products which contribute to this important public health benefit should not be withdrawn, unless there is good reason to do so, such as evidence of harm which outweighs the public health benefits.
“No clear evidence of harm to health from these types of products has been identified to date. It is known, including from WHO assessments, that exposure to endocrine disrupting chemicals can arise from the use of many different types of personal care products, which are widely used. This is a global issue.
“Regulatory decisions have to take into account all relevant considerations, including the public health context. WHO understands that balancing the presence of chemicals against the public health benefits of products, including of these types of menstrual products, is factored into regulatory policy decisions in other jurisdictions elsewhere in the world, for example in the European Union.
“WHO is not aware of any cases globally where access to these important health products has been withdrawn because of concerns over health effects arising from endocrine disrupting chemicals,” WHO said.
University of Free State
The University of Free State has also issued a statement indicating that the research does not claim that short-term use of menstrual products causes specific health conditions.
Similarly, the study published in February was not designed to establish a direct causal relationship between the detected chemicals and diseases in women.
“The research findings and their publication are not intended to constitute medical advice, consumer directives, or product usage recommendations: they present peer-reviewed scientific data and identify areas warranting further scientific and clinical enquiry. The research does not recommend that current products be withdrawn from the market,” Motsoaledi said.
Regulators
A number of institutions play a role in ensuring that the sanitary pads and other products meet the required standards and are safe to use. In addition to SAHPRA, role-players include:
• The South African Bureau of Standards.
• The National Compulsory Standards Regulator.
• The National Consumer Council.
“Whilst these regulators play an important ongoing role in ensuring the safety and quality of sanitary products, the findings of the UFS study do not require any additional actions or response on the part of the regulators,” Motsoaledi concluded. – SAnews.gov.za
