Theophylline is a natural alkaloid from the methylxanthine group, found primarily in tea leaves (at the highest concentration in green tea) and—to a much lesser extent—in cocoa beans. For centuries, it has been a regular part of the daily diet for millions of people worldwide.
In cosmetics, its use has been limited—primarily for its lipolytic and draining properties and its beneficial effects on skin microcirculation. For this reason, theophylline has mainly been used in anti-cellulite and massage products.
It is also important to note that theophylline has medicinal uses and is applied in the treatment of chronic respiratory diseases.
It has never been a widely used ingredient in cosmetics, so there has never been a concern about any significant impact on the health of the general population (where the “contribution” to health risk would stem from cosmetic use).
In fact, exposure to theophylline is significantly higher through the consumption of green tea. According to this source, global tea consumption in 2023 was around 7.3 billion kilograms! Assuming a theophylline content of 1% (though in reality it is much lower), it is clear that the primary source of exposure to this substance comes from infusions, not cosmetics.
In 2020, theophylline received a harmonized CLP classification as a category 1B reproductive toxicant (H360D). What are the consequences of this chemical legislation for cosmetics?
Article 15 of Regulation (EC) No 1223/2009 prohibits the use of CMR substances (carcinogenic, mutagenic, or toxic to reproduction). Exceptions to this rule are possible, but obtaining an exemption requires meeting very strict conditions—including submitting a full toxicological dossier and receiving a positive opinion from the Scientific Committee on Consumer Safety (SCCS) confirming the safe use of the CMR substance in cosmetics.
Due to the marginal use of theophylline in cosmetics, the industry did not pursue defending its use, and since December 2023, the use of theophylline in cosmetic products has been banned 🙁
But have you heard of any restrictions on the consumption or sale of green tea as a result of this classification?
This raises a question: why 🤔? If the use of theophylline (in trace amounts) in cosmetics has been banned, shouldn’t its presence in a commonly consumed beverage raise even greater concerns?
Apparently not—I can calmly enjoy green tea several times a day, but under current regulations, I cannot use that same ingredient in a cosmetic product 🤔🤔🤔
“Dosis sola facit venenum” – “Only the dose makes the poison”
This entire situation illustrates that CLP classification refers solely to the hazard assessment of a substance—regardless of the actual exposure conditions.
Whether a substance poses a health risk depends not only on its properties but also on how and in what context it is used. This is precisely why we should always remember Paracelsus’ maxim—though it seems EU lawmakers may have forgotten it.
I can safely drink green tea without health risks. Until recently, theophylline in cosmetics was also used safely—the exposure levels in those products were negligible and harmless.
Until recently, the practical consequences of Article 15 of the Cosmetics Regulation were not particularly problematic—the ban on CMR substances mostly covered synthetic ingredients or a small percentage of natural compounds with significant health risks.
Today, however—with the European Commission’s increasingly “green” agenda—we’re seeing heightened legislative activity from ECHA. More and more natural ingredients, used for centuries, such as essential oils or their components, are being subjected to harmonized classifications (including CMRs). There is growing concern over the fate of ethanol, tea tree oil, talc, and fragrance compounds from the terpene group, among others.
Conclusions?
The current system of cosmetic regulation—although designed with consumer protection in mind—is beginning to work against the industry and defy toxicological logic. Bans are being applied to substances that are completely safe under real-world usage conditions.
Moreover, the basic function of the skin as a protective barrier has been completely overlooked—its primary purpose is to shield the body from external factors. If transdermal absorption of substances were truly so effective, there would be no need for oral or injectable medications.
The current legal framework is leading to the disappearance of valuable ingredients from the cosmetic market—ingredients that have been used for centuries. This realistically limits innovation and the availability of natural raw materials, and it makes the European cosmetics industry less competitive compared to markets where the Green Deal has not yet taken hold.
