Bibra Toxicology Advice and Consulting | Toxicology and Regulatory…

July’s Toxicology and Regulatory News brings together key developments across medical device toxicology, chemical safety, food contact materials and occupational exposure.

In this month’s update:

Does metal found in tampons pose a health risk?

At a glance

Topic: metals found in tampons
Organisation: US Food and Drug Administration (FDA)
Key reference: ISO 10993
Method used: Estimated Exposure Dosage (EED)
Main takeaway: the analysis indicated the metals found in tampons that may leach during using are not expected to result in adverse health effects

Metals may be detected in tampons due to intentional addition (e.g., titanium dioxide as a pigment), or contamination of raw natural and/or plant-based materials or during the manufacturing process.

Although there is currently no evidence of any metal-related safety concerns, given the widespread use of tampons, researchers at the US Food and Drug Administration (FDA) measured the levels of leaching of 21 metals from eleven tampon products under exaggerated extraction conditions (relative to normal use). Following this, the researchers conducted a Toxicological Risk Assessment (TRA) based on International Organization for Standardization (ISO) 10993 precepts.

Comparison of worst-case Estimated Exposure Dose (EEDmax) values against parenteral or oral long-term tolerable intakes, assuming 100% systemic bioavailability via the vaginal mucosa, resulted in Margin of Safety (MoS) values of >10 for 16 metals, indicating a lack of toxicological concern. Beryllium and mercury were not identified above the method detection limit and, as such, were not subject to TRA. Antimony, lead, and calcium had MoS values of 7, 8 and 9, respectively. Given the known toxicities of antimony and lead, additional consideration was given to the bioavailability of these elements before the conclusion was reached that the values for these three metals were also adequately protective.

Overall, the researchers concluded that the levels of metals that may leach from tampons during use are not expected to result in adverse health effects.

Reference: Toxicological Sciences Journal

Learn more about bibra’s Extractables and Leachables service.

IARC evaluation of three phthalates' cancer risk

In June 2026, the International Agency for Research on Cancer (IARC) discussed the carcinogenicity of butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisononyl phthalate (DiNP).

According to the initial summary published in Lancet Oncology, all three were classified as “possibly carcinogenic to humans” (Group 2B). For BBP and DiNP, this was based on “sufficient” evidence for cancer in experimental animals and “strong” mechanistic evidence in experimental systems.

For DBP, this classification was based on “limited” evidence in experimental animals and “strong” mechanistic evidence in experimental systems. Regarding cancer in humans, the evidence was “inadequate” for all three phthalates.

Reference: The Lancet

EFSA statement on mercury

Having reviewed the 2024 toxicological profile for mercury issued by the US Agency for Toxic Substances and Disease Registry (ATSDR), EFSA concluded that the available evidence, including a 28-day rat study (dated 2016) on inorganic mercury (Hg), does not warrant revision of its 2012 risk assessment.

The current Tolerable Weekly Intakes (TWIs) of 4 µg/kg bw for Hg and 1.3 µg/kg bw for methylmercury (also expressed as Hg) remain valid. Although the ATSDR derived a lower Minimal Risk Level (MRL) for methylmercury (0.1 µg Hg/kg bw/day, corresponding to 0.7 µg Hg/kg bw/week), EFSA concluded that the disparity primarily reflected different methodological approaches between itself and the ATSDR (in the selection of the critical neurodevelopmental endpoint, the dose-response assessment and the uncertainty factor applied).

EFSA could see no clear indication that the ATSDR’s MRL was scientifically more robust than its own TWI set in 2012 (0.7 and 1.3 µg Hg/kg bw/week, respectively). However, it did note that advances in risk assessment methodology, and the new data on mercury published since 2012, would suggest that an update of its 2012 opinion is merited.

Reference: EFSA

Learn more about bibra’s Food + Food Contact toxicology services.

BfR considers energy drink effects on children

Last month (see July issue of Toxicology and Regulatory News), we reported on a Swedish evaluation of caffeine intake by children consuming energy drinks. This topic has also recently been scrutinised by BfR, which did not anticipate any adverse health effects in adults consuming 200 mg of caffeine as a single dose from energy drinks and could find no evidence to suggest that an equivalent caffeine dose of 3 mg/kg bw would be harmful to children or adolescents.

Whilst a daily dose of 3 mg/kg bw of caffeine was also deemed likely to be safe over a prolonged period, higher levels can result in a range of effects, including:

heart palpitations
rapid heartbeat
shortness of breath
nausea
anxiety
Headaches, and
poor sleep.

BfR recommended better communication of the health risks of excessive energy drink consumption by children and adolescents. No particular concerns were raised about other ingredients of energy drinks including taurine, glucuronolactone and inositol.

References: BfR

Dutch Health Council recommends total abstinence from alcohol

The Dutch Health Council has concluded that there is no safe lower limit for the use of alcohol, such that every glass consumed poses health risks at a population level. Alcohol use increases the risk of organ damage, and the evidence was considered strong for an increased risk of seven cancer types without a practical threshold:

oesophageal
oral
throat and laryngeal
liver
colon
postmenopausal breast
premenopausal breast, and
stomach

In a broader sense, alcohol use poses other risks to health such as addiction, an increased risk of traffic accidents, and injury from aggression or violence. Consumption was considered a public health issue, and the Dutch government was advised to focus on denormalisation and discouraging its use.

Reference: Dutch Health Council