Methylisothiazolinone (MI) is listed in Annex V/57 of the Cosmetic Regulation (EC) 1223/2009, as amended, meaning it can be used as a preservative in cosmetics. It is contained in products such as makeup, moisturisers, baby wipes, sun creams, shampoos and shower gels as well as household products and paints.
Preservatives are important in cosmetics as they protect consumers from harmful pathogens that would otherwise invade the cosmetic products people use on a daily basis. Without preservatives, the majority of cosmetics would have a very short shelf life and would, for the most part, have to be stored in a fridge.
While the vast majority of people are not sensitive (allergic) to MI, the continued use of this preservative can result in sensitivity in a small percentage of the population. Indications are that the level of sensitivity to MI is increasing. Because of this, European regulations have been, and are currently being, drafted aimed at reducing the risk from MI and the incidence of skin sensitivity.
Changes in European Regulations
(1) Methylchloroisothiazolinone (MCI) / Methylisothiazolinone (MI) Mixture
MI often forms part of a mixture with a similar substance, Methylchloroisothiazolinone (MCI), which is used as a preservative in cosmetics. The mixture is deemed not to pose a risk to the health of the consumer when used as a preservative up to a maximum concentration of 0.0015% in rinse-off cosmetic products.
With effect from 16 July 2015:
- The European Commission has banned the mixture of MCI/MI from leave-on cosmetic products that are placed on the EU market;
- Only cosmetic products containing the restricted levels of 0.0015% MCI/MI mixture in rinse -off products will be allowed to be placed on the market.
With effect from 16 April 2016:
- Only cosmetic products containing the restricted levels of 0.0015% MCI/MI mixture in rinse- off products will be allowed on the market.
(2) Methylisothiazolinone (MI)
MI is also used alone as a preservative, normally at a concentration of 0.01%. The European Commission has proposed a change in the law to remove MI from leave-on cosmetic products. This will be available for public consultation over the coming weeks.
A review is currently taking place of the scientific evidence relating to the continued use of MI in rinse-off cosmetic products. Following this process, new proposals for changing the current levels may be made.
Consumer Advice
The HPRA strongly advises anyone who experiences any undesirable effects relating to a cosmetic product, to stop using the product immediately. These effects will normally disappear but if they persist or you are concerned, you should report these to your healthcare professional. You should also report the effects to the responsible person (whose contact details are on the product packaging) and to cosmetics@hpra.ie.
The HPRA advises consumers to purchase cosmetic products through reputable sources only. In addition, consumers are advised of the following:
- to ensure that the product is labelled with a European address;
- to pay attention to the product information and directions for use;
- if you have a known allergy or sensitisation to an ingredient, read the list of ingredients where this information will be available.
Further information on the regulation of cosmetic products is available from the Cosmetics section of our website.