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Article related to: People and perspectives
Stopping products sidestepping enforcement through rebranding
Sometimes products that we buy online are not what they claim to be, and sometimes they turn out to be harmful to our health. Marilin Lutsoja and Annemari Linno tell us more about how the Estonian Health Board took action on such a case in 2018, taking a potentially toxic product, branded as the 'Miracle Mineral Solution', off the market.
Miracle Mineral Solution, or MMS, was first concocted in the late 1990s and has been marketed as a miracle cure for various illnesses within Europe and throughout the world ever since.
What you actually get when you buy the product is an industrial bleach made using sodium chlorite solution and an acid, such as hydrochloric acid. When mixed together, these ingredients produce chlorine dioxide, water and salt. In addition to being toxic in the doses recommended by the manufacturers of the solution, chlorine dioxide is covered by several harmonised classification and labelling entries: for example, it is toxic if swallowed, and can cause severe skin burns and eye damage.
|Marilin Lutsoja. |
Image: Marilin Lutsoja.
“MMS first came to our attention in 2015, when it was being advertised and sold as a biocide to purify water. In Estonia, biocides have to be registered, and as this product was not, we were able to easily remove it from the market,” says Ms Linno.
“It reappeared on the market in 2018 as a mouthwash, and as such was being branded as a cosmetic product. Its re-emergence came to our attention because journalists started to ask us about the product and our position on it,” Ms Lutsoja adds.
The role of social media
In Estonia, MMS was first sold hand-to-hand as a mouthwash and as its popularity spread it became available in several online and New Age shops. The product also began to receive more attention on social media, especially through a private Facebook group, which peaked at 8 000 members in August 2018. The Health Board asked Facebook to close the group in September 2018 as it was promoting harmful ways of using the product. Facebook did so within a week.
Some examples of harmful uses that the producers were promoting through the group included drinking the solution, using it as eye drops and applying it to wounds. It was even recommended for children and animals.
“There was also further promotion through YouTube videos and an Estonian television talk show. One of the main promoters for the product gave an interview on the show and the host supported the product by promoting their own personal experience,” Ms Lutsoja adds.
The Estonian poison centre has received 23 calls related to MMS since 2015. The majority of those came in 2018 when the substance was most heavily being promoted and sold.
Getting the product off the market
The Health Board had to navigate several legislative issues to find a way to get the product off the market. Since the product had previously been marketed as a biocide and was subsequently being manufactured as a cosmetic product, identifying the legislation that the product fell under was not straightforward.
Several cosmetic specialists indicated that if the manufacturer claimed the product to be a cosmetic, then it should be dealt with in that way. The sodium chlorite component has a heavy classification under the CLP Regulation. It is fatal in contact with skin, toxic if swallowed, causes skin burns and eye damage, is damaging to organs through prolonged and repeated exposure, and has long-lasting, harmful effects on aquatic wildlife.
“Despite the classification under the Classification, Labelling and Packaging Regulation, use of the component is not forbidden under the Cosmetics Regulation. However, chlorine, which is one of the reaction products, is prohibited under the Cosmetics Regulation, and this gave us our first path to pursue,” Ms Lutsoja says.
There is also an implementing decision by the Commission on safety reports that links cosmetics with the CLP Regulation, stating that safety assessors need to take the CLP classification of components and the end product into account.
As well as this, national legislation allowed the Health Board to take samples and ban the product from being marketed until a safety report was presented.
Looking for answers in the safety report and sample analysis
The low concentrations made it difficult to separate the different chlorine compounds from the samples taken. After contacting the main universities in Estonia dealing with chemical analysis, the Health Board was only able to get inconclusive results that could not be used as proof that chlorine was present in the solution.
“We could prove that MMS contained different harmful chlorine compounds above a safe limit, but this in itself didn’t give us a sure way to ban the product,” Ms Lutsoja tells.
However, the safety report had not considered the CLP classifications, it falsely claimed that there are no restrictions for chlorine under the Cosmetics Regulation, and it did not take into account chlorine compounds being absorbed into the skin.
“The safety report was fundamentally flawed and it allowed us to see which chemical analyser the manufacturers were using. This information and other literature allowed us to prove that the end product contained chlorine,” Ms Linno explains.
The findings allowed the Health Board to remove the product from the market as:
- It contained chlorine, which is forbidden in cosmetic products in any concentration.
- The safety report provided was inaccurate and the CLP classification had not been taken into account.
- The concentration of active chlorine compounds was 214 times higher than the limit for drinking water and 70 times higher than the limit for pool water.
A wider issue?
Given that the manufacturers already succeeded in rebranding MMS twice – first as a biocide, then as a cosmetic product – the Health Board sees that there is a risk of this happening again in the future, and calls for enforcement actions to be taken at the EU level.
“We have heard that the manufacturer is now attempting to obtain the permission they were missing to market the product as a biocide. They are also pursuing other means to market it as a medical device to disinfect dentures. We presented this case to ECHA’s Enforcement Forum as we feel that it is important that this information is shared at a European level,” Ms Lutsoja tells.
“We would like to see a harmonised and cross-legislative approach so that products like MMS would be unable to escape regulation through rebranding. For this to work, cooperation and finding common ground between authorities dealing with different regulations would be key,” Ms Linno concludes.
The Estonian Health Board is a governmental authority that operates under the Ministry of Social Affairs and implements a population health policy in the fields of healthcare, health protection, chemical safety and medical devices to shape a healthy living and learning environment.
Interview by Paul Trouth
Published on: 16 May 2019
Top image: © iStock.com/MadamLead
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Committee for Risk Assessment:
25-28 November 2019 and
3-5 December 2019
Committee for Socio-Economic
26-28 November 2019 and
3-5 December 2019
Member State Committee:
9-11 December 2019
3-7 February 2020 (tentative)
Biocidal Products Committee:
10-11 December 2019
Management Board meeting:
12-13 December 2019