Restriction of MI in rinse-off products in 2017

© CosmeticOBS-L'Observatoire des Cosmétiques

The European Union has just transmitted to WTO a draft regulation aimed at restricting the use of methylisothiazolinone as a preservative in rinse-off cosmetic products from the currently authorised concentration of 100 ppm to 15 ppm. The text should enter into force during 3rd quarter 2017.

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Notification date

28 November 2016

Content

The draft Commission regulation aims at amending Annex V to Regulation No 1223/2009 on cosmetic products and restricting the use of methylisothiazolinone as a preservative in rinse-off cosmetic products from the currently authorised concentration of 100 ppm to 15 ppm.

The text of the future regulation

Whereas

1. The substance 2-Methyl-2H-isothiazol-3-one, which has been assigned the name Methylisothiazolinone under the International Nomenclature of Cosmetic Ingredients (INCI), CAS number 2682-20-4, is currently authorised as a preservative in rinse-off cosmetic products at a concentration up to 0.01% weight/weight (100 ppm) through entry 57 of Annex V to Regulation (EC) No 1223/2009.

2. The Scientific Committee on Consumer Safety (SCCS) adopted an Opinion on the safety of Methylisothiazolinone on 15 December 2015. The SCCS concluded that for rinse-off cosmetic products, a concentration up to 0.0015% (15 ppm) Methylisothiazolinone is considered safe for the consumer from the point of view of induction of contact allergy.

3. In light of that SCCS opinion, it is important to address the increased incidence of allergies induced by Methylisothiazolinone and that substance should therefore be further restricted in rinse-off products.

4. Regulation (EC) No 1223/2009 should therefore be amended accordingly.

5. The industry should be allowed a reasonable period of time to make the necessary adjustments to product formulations in view of their placing on the market and for the withdrawal of non-compliant products from the market.

6. The measures provided for in this regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products.

Articles

Article 1
Annex V to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this regulation.

Article 2
From [date = 6 months after the date of entry into force] only cosmetic products which comply with this Regulation shall be placed on the Union market.
From [date = 9 months after the date of entry into force] only cosmetic products which comply with this Regulation shall be made available on the Union market.

Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.

Proposed modification of Annex V to Cosmetics Regulation

In Annex V to Regulation (EC) No 1223/2009, entry 57 is replaced by the following:

• Chemical name/INN: 2-Methyl-2H-isothiazol-3-one
• Name of Common Ingredients Glossary: Methylisothiazolinone
• CAS number: 2682-20-4
• EC number: 220-239-6
• Product type: Rinse-off products
• Maximum concentration in ready for use preparation: 0.0015%*
*Methylisothiazolinone is also regulated in entry 39 of Annex V in a mixture with methylchloroisothiazolinone. The two entries are mutually exclusive: the use of the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone is incompatible with the use of Methylisothiazolinone alone in the same product.