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Recent changes in the Annexes of the Regulation 1223/2009



The year 2017 quickly approaches its end and legal requirements for cosmetic products are changing constantly. As an overview, we would like to present the most recent changes in regards to particular ingredients:

Prohibition of 4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC/Lyral), Atranol and Chloratranol

The fragrance substance “3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC/Lyral)”, known with the INCI name Hydroxy¬isohexyl-3-Cyclohexene Carboxaldehyd (CAS No. 51414-25-6 / 31906-04-4) is a component of many commercially available fragrance mixtures. During the last 20 years, its characteristics as contact allergen have been derived from several studies (1). Therefore, the substance belongs to the 26 fragrance substances that must be additionally declared on the ingredient lists when its concentration is above 0.001% (for leave-on products) or 0.01% (for rinse-off products).

Since September 2017, the substance is considered as prohibited according to Annex II No. 1380 of the European Cosmetics Regulation 1223/2009, together with 2,6-Dihydroxy-4-methyl-benzaldehyde (Atranol, No. 1381) and 3-Chloro-2,6- Dihydroxy-4-methyl-benzaldehyde (Chloroatranol, No. 1382).

From 23 August 2019 on, cosmetic products containing the above substances shall not be placed on the European market. From 23 August 2021 on, none of these products shall be made available on the European market.

It must be noted that the fragrance allergen Butylphenyl Methylpropional (CAS No. 80-54-6, BMIHCA, Lilial) is also expected to be added to Annex II in a foreseeable future due to similar allergenic properties.

It is strongly recommended to check the compositions of fragrance mixtures used for cosmetic products and, where appropriate, reformulate the affected products in a timely manner.


Restriction of Methylisothiazolinone

The substance known with the INCI name Methylisothiazolinone (CAS No.2682-20-4) is currently authorized as a preservative limited for rinse-off products through Annex V No. 57 of the Regulation 1223/2009. The former maximum concentration of 0.01% has been significantly decreased to 0.0015 % on the basis of studies evaluated by the SCCS (2). Therein, it has been outlined that the increased incidence of allergies induced by Methylisothiazolinone must be further restricted and a concentration up to 0.0015 % for rinse- off products will be considered safe for human use in regards to induction of contact allergy.

From 27 January 2018 on, only cosmetic products that comply with the above requirement shall be placed on the European market. From 27 April 2018 only cosmetic products which comply with the requirement shall be made available on the Union market.

If you have questions, please feel free to contact us via cosmetics@mdss.com.


Sources:
1. SCCS Opinion 1459/11 of December 2011

2. SCCS Opinion 1557/15 of December 2015