Recent studies have highlighted the presence of heavy metals and metals in menstrual tampons. Many of these elements are ubiquitous, meaning they are widespread in our environment and detectable in everyday products such as food, toys, cosmetics, etc.
All substances have the potential to be toxic if given to humans and other living organisms under certain conditions and at specific doses or levels. With advancements in analytical technology, the detection limit has become extremely low, capable of identifying 1 particle in 100 million. Given the appropriate (low) detection limit, it is highly likely that all chemicals could be detected in any sample. Such extremely low values are therefore considered as ´unavoidable traces´. Regulators set product and material specifications based on toxicological evaluations. Currently, there are no regulatory limits set for heavy metals in hygienic products. However, products are placed on the EU market following Directive 2001/95/EC on general product safety and on the US Market according to FDA’s General and Special Controls for Medical Devices. These regulations ensure the products are safe for the end user when placed on the market.
Tosama prioritizes costumer safety highly. We are certified under ISO 9001 and ISO 13485 for quality management system. Before placing our menstrual tampons on the market, we conducted a risk assessment and decided to control residual chemicals. To ensure safety, we have implemented a testing plan that incorporates various regulations ((EU) 2018/1513, (EC) No 1907/2006), guidelines (EDANA Codex, CEN GUIDE 16, The International Cooperation on Cosmetics Regulation (ICCR)), and certifications (OEKO TEX 100 (Product Class 1 for Babies), GOTS). Furthermore, we are GOTS-certified for organic cotton menstrual tampons and OEKO-TEX 100-certified for all menstrual tampons.
Our suppliers are controlled through regular audits and evaluations, ensuring they hold at least OEKO-TEX 100 standard certifications.
Since menstrual tampons are considered medical devices in some parts of the world, we also conducted a biological evaluation. This evaluation was performed according to the ISO 10993 series that covers cytotoxicity, sensitization, acute systemic toxicity, intracutaneous irritation, and vaginal mucosa irritation.
To our knowledge, regulators such as the US FDA and EU surveillance authorities are reviewing the study results, including the methods used and quantities detected. They will issue additional legislation if necessary. Currently, based on recent scientific findings, they do not consider end-user health to be at risk.
We also want to highlight that manufacturer’s associations, such as:
- EDANA (European Disposables and Nonwovens Association) in the EU,
- INDA (Association of the Nonwoven Fabric Industry) in the USA, and
- AHPMA (Absorbent Hygiene Product Manufacturers Association) in the UK,
have examined the study results and issued a statement, which can be found at the link below:
https://www.edana.org/about-us/news/statement-on-tampons-as-a-source-of-exposure-to-metalloids
Our ongoing pursuit of knowledge and improvement ensures the highest safety and quality for our products. Given all the measures mentioned above, we can confidently assert that menstrual tampons produced by Tosama are safe for end users.
For further information, please do not hesitate to contact us.
Tosama d.o.o.
Quality Control Department
