An anticipated final opinion from the SCCS (Scientific Committee on Consumer Safety) on Methylisothiazolinone (MI) was published a few weeks ago.
- MI at a concentration of 100ppm (0.01%) is not safe
- No safe level of MI has been demonstrated for leave-on cosmetics (including ‘wet wipes’) – for either sensitisation to MI, or triggering of symptoms in those already sensitised
- MI at 15ppm (0.0015%) in rinse-off products should not sensitise – but may well trigger symptoms in those already sensitised
Following this previous opinion, the cosmetic industry was concerned that the level of 15ppm for MI in rinse-off products would be ineffective as a preservative, and provided the SCCS with additional information on methylisothiazolinone in rinse-off products at a higher level it considered would be both safe and effective. It was this evidence that the SCCS has been reviewing for the last several months.
Conclusion of the new opinion
Essentially, the SCCS stuck to their previous view following the review, and were not swayed by industry’s additional evidence. In summary, the SCCS said:
- There is no evidence to support safe use of MI in rinse-off cosmetic products or leave-on haircare products up to 100ppm
- The results of a recent study from Scandinavia do not support safe use of MI at 50ppm
- Reiterating their previous view: for rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for consumers not sensitised to MI.
Where are we now?
It’s important to remember that MI and the MCI/MI preservative blend are treated differently.
MCI/MI will be banned from leave-on cosmetics from 16th April 2016 in the EU.
MI has not yet been banned from leave-on cosmetics, but industry body Cosmetics Europe has asked members to voluntarily remove it, ahead of legislation which will come, but has not been finalised.
Both MCI/MI and MI can continue to be used in rinse-off products.
What happens next?
Nothing has changed in practice yet.
We asked Dr Christopher Flower, Director-General of the Cosmetic Toiletry & Perfumery Association (CTPA), for his perspective. He acknowledged that MI should not be used in specific products, but that “its use in other products can be continued without undue risk to consumers”, adding that “the SCCS does not agree but is only looking at MI in isolation rather than the wider issue of an effective preservation strategy”.
As MI may be ineffective in low doses, this proposed use in combination with other preservatives, if effective, could potentially save it from cosmetic extinction. This paper from 2011 suggests that the preservative phenoxyethanol enhances the anti-microbial potency of MI, without enhancing its reactivity. (It also notes that almost 1 in 5 with MI allergy react to a mere 5ppm.) However, a comment on the Allergy to IT, MI and BIT Facebook page suggests 15ppm MI in combination with phenoxyethanol would be ineffective.
“The next step will be for the European Commission to reflect upon both points of view and, if it feels it is appropriate since it is solely the Commission’s prerogative, propose amending the Cosmetics Regulation to restrict or prohibit MI,” says Flower.
“The Commission is aware that whenever a preservative is removed from the palette of available choices, exposure to the remaining ones must increase … Consequently, the risk of sensitising someone to one of the remaining preservatives also increases with that increased use. The Commission must balance this risk against the risk of allowing restricted access to MI and it is not a simple choice to make.”
Once again, it seems, the MI-allergic community must wait patiently for the next development …