New amendments to the Cosmetics Regulation

On 30th of April 2019 the Commission adopted  Regulation (EU) 2019/680, Regulation (EU) 2019/681 and Regulation (EU) 2019/698, amending Annexes VI, II and III and V of the Regulation (EC) No 1223/2009 (Cosmetics Regulation) respectively.  The amendments aim to address the recommendations of the Scientific Committee on Cosmetic Safety (SCCS), which provides opinions on healthy and safety risks of non-food consumer products, including cosmetics.

Amendment to Annex VI (allowed UV filters)

The amendment to Annex VI concerns the ingredient Phenylene Bis-Diphenyltriazine, which can now be used as a UV filter with maximum concentration of 5% in a cosmetic product. However, the ingredient cannot be used in applications that may lead to exposure of the end user’s lungs by inhalation.

Amendment to Annex II (prohibited ingredients)

Annex II to of the Cosmetic Regulation contains a list of substances, banned for use in cosmetic product. The Annex was amended by adding the ingredient 2-Chloro-p-Phenylenediamine, including its sulfate and dihydrochloride salts, when used as a substance in hair dye products, including eyebrow dye products, and eyelash dye products.

From 22 November 2019, hair dye products which contain 2-Chloro-p-Phenylenediamine cannot enter the EU market any longer. Products which are already on the market can still be sold until 22 February 2020. After this date the ban becomes fully applicable and no cosmetic products sold on the EU market may contain Surentain 2-Chloro-p-Phenylenediamine.

Amendment to Annexes III (restricted ingredients) and IV (allowed preservatives)?

Climbazole was added to both annexes and the restrictions applicable will depend on the function with which the ingredient was used. As a preservative, Climbazole can be used in hair lotions, face creams and foot care products with concentration of maximum 0.2% and in rinse-off shampoos with a maximum concentration of 0.5%. When used as an anti-dandruff agent in rinse-off anti dandruff shampoos, Climbazole can be used with maximum concentration of 2%.

Products containing Climbazole and not complying with the new restrictions cannot enter the EU market after 27 November 2019. As of 26 February 2020 they cannot be sold anymore in the EU.

Efrosina Zhivkova

Expert Consultant at Regulatory Affairs Department,

July 24, 2019

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