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Regulatory News

August/September 2023 Reg News for EU & US

EU

On July 27th, 2023, the European Commission published Regulation (EU) 2023/1545 amending Regulation (EC) No 1223/2009 as regards labelling of fragrance allergens in cosmetic products. 

This Regulation adds 56 new fragrance allergens to the existing list of 24 allergens, and updates some existing entries about fragrance allergens.

The presence of such fragrance allergens shall be indicated in the list of ingredients when their concentration exceeds:

  • 0,001 % in leave-on products
  • 0,01 % in rinse-off products.
 

New cosmetic products placed on the market after July 31st, 2026 must be compliant to the new requirements.

Cosmetic products already placed on the market before July 31st, 2026 could be sold until July 31st, 2028. After this date, their label must be compliant to the new regulation.

Ref.: Regulation (EU) 2023/1545

On June 22nd, 2023, the European Commission notified a draft amendment to Annex XVII of REACH. 

As regards cosmetic products, the draft amendment proposes to limit the use of Decamethylcyclopentasiloxane (D5) and Dodecamethylcyclohexasiloxane (D6) to 0,1% in all cosmetic product categories (rinse-off and leave-on products).

The amendment should be adopted by the end of 2023.

Ref.: European Commission

  • On September 14th, 2023 the SCCS published a Scientific Advice on methyl salicylate (methyl 2-hydroxybenzoate) for children exposure (SCCS/1654/23). 

In the previous SCCS/1633/21 Opinion, the Committee concluded that Methyl Salicylate in toothpaste is safe for children under 6 years of age when used up to the maximum concentration of 2.52%.

In view of the conclusions of SCCS/1633/21 and the aggregate exposure, the SCCS considers the use of Methyl Salicylate as safe in cosmetic products:

  • intended for children of age 0.5-3 years when used up to a maximum concentration of 0.02% in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products and hair conditioner. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.
  • intended for children of age 3-6 years in shower gel, hand soap, shampoo, body lotion, face cream, hand cream, lip products, and hair conditioner up to the allowed maximum concentrations indicated in Table 1 of Opinion SCCS/1654/23. For toothpaste up to a maximum concentration of 2.52% methyl salicylate is considered safe.

 

Ref.: SCCS/1654/23

US

On August 7th, 2023 the FDA issued a draft guidance on registration and listing of cosmetic products and facilities, which describes:

  • The requirement to submit cosmetic product facility registrations and product listings
  • Who is responsible for making the registration and listing the submissions
  • What information needs to be included
  • How and when to make the submissions
  • Exemptions to the registration and listing requirements

When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA.

Ref.: FDA

Cosmetics companies selling products in California shall report to California Safe Cosmetics Program (CSCP) if they use ingredients identified on designated hazard lists. .

CSCP published its latest data report: “Hazardous Ingredients in Personal Care Products – Data Reported to the CSCP 2009-2022”.

It summarizes information reported by cosmetics companies to CSCP since the launch of the online reporting system in 2009 through the cut-off date for the report (December 31st, 2022).

Ref.: CSCP

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