CosmeticOBS - L'Observatoire des cosmétiques
June 26, 2017Ingredient of the month

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The Observatory of Cosmetics

Triclosan (2,4,4’-trichloro-2’-hydroxy-diphenylether) is an antibacterial preservative that is also used as a deodorant agent. Long criticised for its harmful effects on health and the environment, it has just been – after several evaluations by European scientific experts – more strictly regulated and its use in cosmetic products has been limited.

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Triclosan has a long history in cosmetics. Like many preservatives, it was first used widely in all kinds of products before arousing scientific suspicion and worry about its toxicity. Criticised more and more heavily, all around the world, it has been assessed several times by European experts, who decided to implement certain restrictive measures in order to better protect consumer safety. These measures have taken form in regulation 358/2014.

Suspicions aroused

Triclosan has long been known to persist in the environment. This bio-accumulative substance is accused of disrupting the development of flora and fauna, particularly in aquatic environments. Several studies have pointed to its endocrine-disrupting properties, which affect the natural regulation of oestrogenic and androgenic hormones and can have repercussions on human fertility. We also know that it is a potential skin irritant, and some cases of contact allergies have been reported. It is also reputed to be a photosensitiser.

Generating resistance

The main charge against triclosan, however, has to do with its formidable efficacy. As a broad-spectrum antimicrobial and bactericidal agent (it acts on a large number of germs), it has been targeted by several research teams due to its ability to trigger bacterial resistance (as is the case with antibiotics). Scientists and consumer groups joined forces to denounce a compound that is much too powerful to have a place in cosmetic products intended for daily use, and they recommended using it only when genuinely pertinent, such as in hospital operating rooms rather than in deodorants or liquid soaps.

Assessments

Triclosan’s dossier, which was already hefty, ended up on the desks of the European Commission, which sent it to its scientific experts for evaluation. In an opinion dated 19 January 2009, the European SCCP (Scientific Committee on Consumer Products, now the SCCS) stated that it lacked sufficient data to confirm the accusations against triclosan.

But things changed quickly, as in another opinion of 22 June 2010, the experts revealed that weak concentrations of triclosan can trigger bacterial resistance and cross-resistance in vitro. And even though no similar phenomena had been studied in our environment, the SCCP held that, given the concentration of triclosan that could trigger such resistance in vitro, it was probable that it could also prove to be harmful.  The Committee concluded by recommending new studies… and the use of triclosan with caution, for example by reserving it for applications where a benefit for health could be shown.

Questions about safety of use

The SCCP also pointed out that triclosan had the ability to cross the skin barrier in significant amounts (e.g. it was detected in the breast milk of women who had been exposed to it), which called into question the NOAEL (no-observed-adverse-effect level) that had been accepted up to that point. While it did not conclude that the compound was mutagenic or genotoxic as had been claimed, the SCCP did determine that its use in levels that were permitted, at the time, in all cosmetic products (0.3%) did not guarantee consumer safety. As a result, it recommended that the use of triclosan be limited to toothpastes, hand soaps, shower gels, and deodorants. Its use in some make-up products could be considered acceptable, but not in leave-on cosmetics such as body lotions, for example. The SCCS confirmed this opinion in March 2001.

Regulations

Using the various opinions provided by its experts, the Commission ratified the new rules for triclosan with the publication of a new regulation (no. 358/2014) in April 2014. ‘In light of the SCCS opinions,’ it states, ‘the Commission considers that maintaining the restriction on the use of triclosan at its current level would raise a potential risk to human health.’ As a result, the use of triclosan is now limited to certain categories of cosmetics (and it is forbidden in others), namely:
• toothpastes
• hand soaps
• body soaps and shower gels
• deodorants (but not spray-on deodorants)
• powders for the face
• foundations
• products intended for cleaning fingernails and toenails prior to the application of preparations for false nails.
In these products, the maximum concentration authorised in the finished product has been set at 0.3%. Triclosan is also authorised in mouthwashes, but at a maximum concentration of just 0.2%.

These new provisions took effect on 30 October 2014 for new products sold on the market. From 30 July 2015, products that do not comply with the new regulation must no longer be available on the market.

This is obviously not enough to eliminate the concerns: in June 2017, a new call for the ban of Triclosan, The Florence Statement on Triclosan and Triclocarban, was launched by 200 scientists and health professionals from 29 countries and published in The Environmental Health Perspectives. With a new global buzz araising…

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