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Fred Lebreux

How to deal with a shrinking list of preservatives and without MIT in particular?

Most cosmetic products need to be protected from microorganisms and this is why preservatives are so incredibly useful. Despite their usefulness, many preservatives are now at risk because of toxicological properties: endocrine disruption, carcinogenicity, mutagenicity, reprotoxicity, skin sensitization - the list of safety concerns raised is almost endless.

As far as regulatory compliance and consumer safety are concerned, preservatives are a major issue in the cosmetics Industry. In Europe, the list of allowed preservatives (Annex V of the European Union Cosmetics Regulation EC No 1223/2009) is constantly shrinking and almost nothing comes to replace removed substances.

First of all, I will address the complex issue of Methylisothiazolinone here below and will focus on other preservatives (and notably on Article 15 of the EU Cosmetics Regulation) in my next article.

Methylisothiazolinone

Methylisothiazolinone (MIT) is a very efficient preservative, which had a huge (but short) success when the use of Methylparaben became less and less popular. The problem is that, beyond its antimicrobial properties, MIT is also a strong skin sensitizer that caused an unprecedented skin allergy outbreak in Europe over the last years. The EU Commission had to promptly react to this public health issue but, given the expected economic impact on the cosmetics industry, also had to adopt a stepwise approach.

First, they started to focus on the Methylchloroisothiazolinone (MCI) and Methylisothiazolinone (MIT) mixture, regulated in the EU Cosmetics Regulation by entry 39 of Annex V (at 15 ppm in a ratio 3:1). After consultation of the Scientific Committee on Consumer Safety (SCCS) [1], the Commission banned this mixture in all leave-on cosmetic products (EU No 1003/2014) with a pretty long transition period, which is currently coming to an end and from April 16th, 2016, only cosmetic products complying with this piece of legislation shall be made available on the European Union market.

In a second step, the Standing Committee on Cosmetic Products [2] of the EU Commission voted to ban of MIT alone, when used in leave-on cosmetic products (including hair leave-on products). The substance being extensively used in the industry, and currently restricted at 100 ppm (0.01%) in all cosmetic products (via entry 57 of Annex V), we could have thought that this ban would come with comfortable transition periods to allow the industry to make the necessary adjustments to product formulations but this does not seem the case. This amendment expected from one day to the other will get enforced 20 days after its publication and then a six-month transition period will start. At the end of this period, only cosmetic products complying with the new regulation shall be placed and made available on the EU market.

Finally, the SCCS released a last Scientific Opinion on MIT recommending that MIT be further restricted in rinse-off products from the current 100 ppm to only 15 ppm (0.015%). The EU Commission took these recommendations on board and released a regulatory proposal reflecting the SCCS Opinion. In addition to this severe restriction, the warning “Contains Methylisothiazolinone” will probably have to be labelled. Although MIT is not effective at such a low concentration, the industry made a point of preserving a limited use of this ingredient since many raw materials are preserved with MIT (which is therefore frequently present below 10 ppm in the finished product).

Currently under public consultation, this regulatory proposal should be submitted for vote at the Standing Committee in early 2017. Once voted, we can reasonably expect 3 to 6 months for the EU Commission to prepare and publish the corresponding regulation. Twenty days after the publication of this piece of legislation will start the transition period, which should be 6 months for placing on the market and 9 months for withdrawing from the market.

How to cope with a shrinking list

First, I would therefore recommend to start immediately the reformulation of your leave-on products (if not done already) and check that your raw materials suppliers are aware of this upcoming changes and ready to provide you with MIT-free alternatives.

More generally, three workarounds can be considered: do with what you have (easier to say than to do), rethink your packaging to include technological solutions (e.g. airless dispensers, single-use products) and use non-official preservatives recognized for other functions (essential oils, alcohol, etc.).

Footnotes

[1The scientific advisory committee of the EU Commission.

[2The Standing Committee on Cosmetic Product is made of representatives of the EU Member States to whom the EU Council and the EU Parliament delegated the power to pass amendments of the EU Cosmetics Regulation to update its annexes.

© 2016 - Brazil Beauty News - www.brazilbeautynews.com

about Fred Lebreux

Ph.D. in Organic and Medicinal Chemistry, post-doc from the École Polytechnique (Paris), and master in management from UCL (Belgium), Fred Lebreux first joined IFRA (the International Fragrance Association) where he spent five years at the successive positions of Scientific & Regulatory Manager and Scientific Projects Manager. Recruited in 2014 by BIORIUS, the world leader of scientific and regulatory consultancy services dedicated to the Cosmetic and Dietary Supplements Industries, he worked in the scientific department before being appointed Chief Operating Officer end of 2015 to embrace more management-related functions.

Contact: frederic.lebreux@biorius.com

Website: www.biorius.com

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