Health Canada Aligned Preservative Requirement With EC In Cosmetics
Following an adoption of Regulation (EU) No. 1003/2014 by European Commission (EC) to further restrict the use of a preservative mixture, 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one(CMIT/MIT) in cosmetic products, Health Canada follows the move and aligns the requirement with EC in the end of year 2015.
CHANGES IN HOTLIST
Cosmetic Ingredient Hotlist, which provides the prohibition and restriction of ingredients, has been updated in December 2015 by Health Canada. A new prohibition has been added and restrictions of four ingredients have been updated in the latest Hotlist. The table format has also been improved for the sake of consistency and clarity.
Methylisothiazolinone /Methylchloroisothiazolinone (MI/MCI), in combination (CAS RN 26172-55-4; CAS RN 2682-20-4), was permitted as a preservative in leave on products at 7.5ppm and rinse off products at 15ppm. After an internal review of scientific literature and in order to minimize the chance of skin sensitization, the preservative is proposed to have further restriction which is permitted to be used in rinse off products at a maximum concentration of 15ppm (0.0015%), e.g. shower gel,shampoo; while is prohibited in leave on products, e.g. cream and lotion. The proposal is adopted after an end of consultation period in August 2015 and is incorporated and published in Hotlist in December 2015.
METHYLISOTHIAZOLINONE / METHYLCHLOROISOTHIAZOLINONE, INCOMBINATION [CAS RN 26172-55-4; CAS RN 2682-20-4]
|maximum concentration permitted in cosmetics|
|rinse-off products||leave-on products|
|2015 cosmetics ingredient hotlist||15PPM (0.0015%)||PROHIBITED|
|2014 COSMETICS INGREDIENT HOTLIST||15PPM (0.0015%)||7.5PPM (0.00075%)|
OTHER CHANGES IN HOTLIST
Apart from MI/MCI, there are several updates through amendment or addition of restriction and requirement.
- Prostaglandins, their salts, derivatives and analogs.
- Peroxide and peroxide-generating compounds
- Cyanocrylate-based adhesives
- Methylisothiazolinone /Methylchloroisothiazolinone, in combination
- p-Phenyleendiamine and its salts
The same change of this preservative requirement in regulation (EU) No. 1003/2014 has been entered into force in September 2014 in all European Member states. With the first timeline on 16 July 2015, only cosmetic products in compliance with the new requirement shall be placed on the Union market. Starting from 16 April 2016, only cosmetic products in compliance with the new requirement shall be made available on Union market.
For enquries, please contact:
Customer Service Team
Cosmetics, Personal Care & Household
Tel: +852 2609 9611