From the 29th of July 2015 to the 23rd of October 2015 public consultation on the restriction of the use of the preservative Methylisothiazolinone (MI) in cosmetics products is open. The EC proposes to ban MI in leave-on products and to wait for the final SCCS opinion on rinse-off and hair leave-on products, expected at the end of September 2015, before reducing the concentration from 100ppm to 15ppm in other products.
The scientific background
Methylisothiazolinone (MI) can be used in beauty products at maximum concentration of 0.01% according to the Annex V/57 of Regulation (EC) No 1223/2009. The mixture of Methylchloroisothiazolinone (MCI) and Methylisothiazolinone (MI) is currently allowed as a preservative only for rinse-off cosmetics products at a maximum concentration of 0.0015% (15ppm) of a mixture in the ratio 3:1 of the two substances, according to the Annex V/39 of Regulation (EC) 1223/2009, as modified by the Regulation (EU) No 1003/2014, that has become applicable on 16th July 2015.
With two different Opinions in 2003 and 2004, the Scientific Committee on Consumer Safety concluded that the use of MI as a preservative at a maximum concentration of 0.01% (100ppm) in the finished cosmetic product did not pose a risk to the health of the consumer. However, in 2011, concerns have been raised by Belgium, Denmark and France since data demonstrating that the ingredient is a sensitizer in animals and a contact allergen to humans was released. Other literature and clinical data shows an increasing sensitisation in young children from moist toilet tissue/hygiene moist tissue (wet wipes) or cosmetics.
On the 12th of December 2013, the SCCS adopted a new opinion concluding that:
Current clinical data indicate that 100 ppm MI in cosmetic products is not safe for the consumer. For leave-on cosmetic products (including ‘wet wipes’), no safe concentrations of MI for induction of contact allergy or elicitation have been adequately demonstrated.
In the Opinion of the 25th of June 2015, open for comments until September 8th 2015, the SCCS observed that “the information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy”.
Modifications proposed to Annex V of the EU Cosmetic Regulation
- Banning MI in leave-on products. The deadline for placing compliant products and removing non-compliant products from the EU beauty products market will be short;
- Waiting for the finalisation of the SCCS opinion on rinse-off and hair leave-on products before reducing the concentration from 100ppm to 15ppm. This choice follows the need to assess other data and the opinion of the beauty products industry according to which, at a concentration of 15 ppm, MI would not be effective as a preservative, with the risk to threaten the product preservation.
Any interested parties, including authorities of the Member States, manufacturers of beauty care products, producers of the substances concerned and relevant make-up industry and consumers associations can submit comments and propose measures. Inter alia, comments on the following topics should be provided: feasibility of the proposed changes, competitiveness, markets and trade, direct and indirect costs imposed on businesses – including SMEs, innovation and research, specific regions, sectors or workers, third countries and international relations, macroeconomic environment.
It is also important to read the specific privacy statement attached to the consultation for information on how your personal data and contribution will be dealt with.
How to submit your contribution
Any comments should be sent with the reference: ‘Methylisothiazolinone – Public Consultation’ by post or e-mail by 23 October 2015 at the latest to:
Directorate General Internal Market, Industry, Entrepreneurship and SMEs
Unit D/4, Health Technology and Cosmetics,
Av. D’Auderghem 45, BREY 12/10
Cosmetic industry manufactures and their designated EU Responsible person should closely follow the outcome of the consultation as this might imply for them the revision of formulas for purpose of regulatory compliance.
If you want to know more about regulatory compliance requirements and product safety regulations please contact us.