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Laws and regulations

European Commission plans to restrict the use of MCI and MI

The European Commission envisages restricting the use of methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI). The use of the mixture of MCI/MI should be limited to rinse-off cosmetic products. Further more, using the mixture together with MI alone should no be permitted. Recently, the two preservatives have been pointed out for their allergenic effects.

Dermatologists, in particular in France and in the United Kingdom, have raised the alarm on a “contact allergy epidimedic” allegedly caused by two cosmetic ingredients, methylisothiazolinone (MI) and a mixture of methylchloroisothiazolinone and methylisothiazolinone (MCI/MI), used as preservatives in some cosmetic products as well as in certain household products.

Increased number of allergies

A study released at the British Association of Dermatologists’ Annual Conference, which was held in Liverpool in July, showed a sharp rise (up to 6.2 per cent sensitivity) in contact allergy to MCI/MI and MI over the past three years. [1]

This was also reported by a team of researchers at St John’s Institute for Dermatology at St Thomas’ Hospital in London who had seen a rapid rise in contact allergy to MI in the last two years going from one case in 2010 to 33 cases in 2012. [2]

According to the British Association of Dermatologists, other dermatology centres across the UK are also noticing rapid rises in numbers of acute allergic contact dermatitis related to MI exposure. British researchers suspected that the recent use of MI as a single agent preservative in quantities up to 100 ppm in personal care products may be a major contributor to this outbreak of MI allergy.

Calls for immediate ban

Across the large patch test centres in the UK, data suggest that rates of allergy to these two preservatives are now nearing 10 per cent – and in some cases higher – this is clearly far too high and is an unacceptable situation,” said David Orton, President of the British Society of Cutaneous Allergy. “The last time a preservative had this type of effect it was banned by the EU,” he added.

In the wake of the release of these two study, reports in the British press also called for immediate ban on methylisothiazolinone.

This is a complex issue and the cosmetics industry is committed to working in partnership with dermatologists, the broader scientific community and regulatory authorities to find out what this means for the population at large and how it can be most effectively managed in a timely manner. Preservatives are essential in many consumer products, including cosmetics. Simply banning MI could have unforeseen consequences, so whatever action is taken it must be done with all the facts in front of us to ensure it is the most appropriate in the circumstances,” commented the Cosmetic, Toiletry and Perfumery Association (CTPA), the voice of the cosmetic, toiletry and perfumery industry in the UK.

Rinse-off products only

For its part, the Commission proposed to amend Annex V of Regulation (EC) No 1223/2009 on cosmetic products in order to limit the use of the mixture of methylchloroisothiazolinone and methylisothiazolinone (MCI/MI) to rinse-off products and clearly indicate that the use of this mixture is incompatible with the use of methylisothiazolinone (MI) alone, because the 3:1 ratio in the mixture would be affected (see document here below). The proposed implementation dates are: six months, after the date of entry into force of the restriction, to place on the market compliant products, and twelve months, after the date of entry into force of the restriction, to withdraw from the market non-compliant products after the entry into force of this Regulation.

Public consultation on  Methylchloroisothiazolinone and methylisothiazolinone

Public consultation on Methylchloroisothiazolinone and methylisothiazolinone

Interested parties can send their comments regarding the proposed ruling to the European Commission by mail or e-mail by 8 October 2013 at the latest.

Vincent Gallon

Footnotes

[1] “Methylchoroisothiazolinone and methylisotiazolinone contact allergy: a new epidemic”, R. Urwin and S.M Wilkinson, The Leeds Centre for Dermatology, Leeds. UK

[2] “Outbreak of contact allergy to cosmetic preservative: history repeats itself (again)”, J.Mann, I.White, J.White, P.Bannerjee and J. McFadden, St John’s Institute of Dermatology, St Thomas’ Hospital, London, UK

© 2013 - Premium Beauty News - www.premiumbeautynews.com
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