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Substance Restricted in Face Creams, Hair Lotions, Foot Care Products and Rinse-off Shampoos

The Official Journal has published Commission Regulation 2019/698, which will restrict the substance known as “Climbazole” in certain cosmetic preparations placed on the EU market after a transition period laid down in the Regulation. This substance is frequently used as a preservative in cosmetic products, but can also be used for other purposes, such as an anti-dandruff agent in rinse-off shampoos. The EU’s Scientific Committee on Consumer Safety (the SCCS) has presented revised concentration limits in its latest opinion on the substance. The Regulation therefore restricts the substance further for use in a variety of cosmetic products.

On 27 May 2019, Commission Regulation 2019/698 entered into force, amending Annexes III and V to Regulation 1223/2009 of the European Parliament and of the Council on cosmetic products. The latter, i.e., Regulation 1223/2009 is the framework Regulation applicable in all Member States, and concerns the safety of cosmetic products placed on the EU market. Annex III is a “List of substances which cosmetic products must not contain except subject to the restrictions laid down”, i.e., subject to the conditions mentioned therein. Annex V, on the other hand, is a “List of preservatives allowed in cosmetic products”. Both these annexes have now been amended, pursuant to new Commission Regulation 2019/698.

The substance which has the technical name 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one, commonly referred to as “Climbazole” under the International Nomenclature of Cosmetic Ingredients (INCI), is currently allowed as a preservative in cosmetic products at a maximum concentration of 0.5% in ready-for-use preparations. It is listed as entry 32 of Annex V (i.e., in the allowed list of preservatives) to Regulation 1223/2009. Climbazole may also be contained in cosmetic products for an intended use other than as preservative, but only within the concentration limit laid down in said entry 32 of Annex V.

The Scientific Committee on Consumer Safety (SCCS) concluded in June last year, adding to its earlier opinions on Climbazole, that, under an aggregate exposure scenario, Climbazole is safe when used as a preservative in face cream, hair lotion and foot care products, but at a maximum concentration of 0.2%. It is still safe when used as a preservative in rinse-off shampoo at a maximum concentration of 0.5%.

The SCCS furthermore concluded that, under an aggregate exposure scenario, Climbazole is safe when used as an anti-dandruff agent in rinse-off shampoo at a maximum concentration of 2%.

In light of the addition to its earlier opinions, there is felt to be a potential risk to human health arising from the use of Climbazole as a preservative or as a non-preservative at the currently allowed maximum concentration of 0.5% in all cosmetic products. The European Commission has therefore stipulated in new Regulation 2019/698 that use of Climbazole as a preservative should therefore only be allowed in face cream, hair lotion, foot care products and rinse-off shampoo. The maximum concentration should be 0.2% for face cream, hair lotion and foot care products and 0.5% for rinse-off shampoo.

Moreover, it is also stipulated in the new Regulation that the use of Climbazole as a non-preservative should be restricted to rinse-off shampoo, when the substance is used as an anti-dandruff agent. For such use, the maximum concentration should be 2%.

The new Regulation also notes that industry must be allowed a reasonable period of time to adapt to the new requirements by making the necessary adjustments to product formulations, so as to ensure that only products complying with the new requirements are placed on the market. The industry should also be allowed a reasonable period of time to withdraw products which do not comply with the new requirements from the market. Therefore, Hong Kong suppliers of cosmetic products to EU consumers should take careful note of the following deadlines:

  • From 27 November 2019, cosmetic products containing Climbazole for other than preservation purposes and not complying with the restrictions laid down in the Regulation shall not be placed on the Union market.
  • From 27 February 2020 cosmetic products containing Climbazole for other than preservation purposes and not complying with the restrictions laid down in this Regulation shall not be made available on the Union market.
  • From 27 November 2019 cosmetic products containing Climbazole for preservation purposes and not complying with the conditions laid down in this Regulation shall not be placed on the Union market.
  • From 27 February 2020 cosmetic products containing Climbazole for preservation purposes and not complying with the conditions laid down in this Regulation shall not be made available on the Union market.

Framework Regulation 1223/2009 on the safety of cosmetic products has therefore been amended in accordance with the stipulations set out in new Regulation 2019/698.

Content provided by Picture: HKTDC Research
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