Cosmeservice Newsletter November

29/11/2023

MOCRA: PREPARE FOR THE UPCOMING REGULATORY CHANGES IN THE US COSMETICS INDUSTRY

The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) represents the first major update to the United States Food and Drug Administration’s (FDA) oversight authority concerning cosmetic products in several years. This new law will help ensure the safety of cosmetic products many consumers use daily.

Small businesses with gross annual sales in the U.S. from cosmetic products totaling less than $1M over the past three years are exempt from GMP, registration, and product listing requirements.

Main changes

Facility Registration (updated    biennially)Labelling – US Contact information  
Product Listing (updated annually)  Adverse events reporting to the FDA  
Safety substantiation and record keeping  Compliance with GMP  
Labelling – professional use cosmetics  New regulations on talc, asbestos and PFAS, which will be issued by the FDA
Labelling –fragrance allergens   

These changes will impact all cosmetic companies involved in the manufacturing and distribution of cosmetics within the USA. Some new requirements will already come into force next month. We encourage your company to stay informed and proactively adapt to these evolving regulatory standards.

MOCRA UPDATE: DELAY ENFORCEMENT FOR COSMETIC PRODUCT FACILITIES REGISTRATION AND LISTING COSMETIC PRODUCT

On November 8th, the U.S. Food and Drug Administration (FDA) has issued guidance indicating its intention to postpone the enforcement of the obligations associated with cosmetic product facility registration and cosmetic product listing requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for six months.

This measure is implemented to ensure the industry has sufficient time to submit such facility registration and product listing information.

The FDA has communicated its decision not to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months post the statutory deadline of December 29, 2023, extending until July 1, 2024.

However, there isn’t any FDA publication relative to the extension for mandatory Safety Substantiation which will come into force next month.  Are you ready to face this challenge?

Additional information

BENZYL SALICYLATE EU OPINION

The Scientific Committee on Consumer Safety (SCCS) has released its final opinion on Benzyl Salicylate, a cosmetic ingredient with potential endocrine-disrupting properties. The Commission identified Benzyl Salicylate as one of 28 potential endocrine disruptors and initiated a data collection initiative in 2019. During this phase, stakeholders provided scientific evidence supporting the safety of Benzyl Salicylate as a cosmetic fragrance ingredient.

Based on a thorough assessment of physicochemical properties, toxicokinetics, exposure, and toxicological evaluations, the SCCS concluded that Benzyl Salicylate is safe for use in cosmetics at the specified concentrations (Table 1). Although there are indications of an endocrine mode of action, no evidence of adverse endocrine effects was found. However, it is important to note that the SCCS’s evaluation focused on human health and did not consider environmental safety.

Type of cosmetic product exposureMaximum %
concentration
used
Hydroalcoholic-based fragrances (spray and non-spray)4
Rinse-off skin & hair products (except rinse off body products)0.5
Rinse off body products1.3
Leave on skin & hair products (non-spray/non-aerosol)(except body
lotion)
0.5
Leave on hair products (spray/aerosol)0.5
Leave on body products (non-spray/spray/aerosol)0.7
Face make-up products and make-up remover0.2
Oral care0.004
Deodorant products (spray/aerosol)0.91

Additional information

NEW UK OPINION BHT AND KOJIC ACID

The UK’s Scientific Advisory Group on Chemical Safety (SAG-CS) has released two opinions regarding the use of Butylated Hydroxytoluene (BHT) and Kojic Acid. These ingredients are currently not regulated under the UK Cosmetic Products Regulation. However, concerns about their potential as endocrine disruptors have prompted discussions and industry responses.

To address these concerns, recommended maximum concentrations have been proposed. For BHT, the proposed limits are up to 0.1% in toothpaste, up to 0.001% in mouthwashes and direct oral care products, and up to 0.8% in other cosmetic products. As for Kojic Acid, it can be used up to 1% in face cream and hand cream, while other products will not contain it.

Despite initial worries about their endocrine-disrupting properties, the SAG-CS members do not consider BHT and Kojic Acid to be endocrine disruptors. Safety assessments have indicated that these ingredients are safe at the specified concentrations in cosmetic products.

We are now awaiting the final opinions and the dates for compliance with the new restrictions.
Additional information

REGULATION (EU) 2023/1490 ENTERS INTO FORCE ON 1ST DECEMBER

Cosmeservice would like to remind you about an upcoming regulatory change that will enter into force on 1 December. On 3 May 2022, the EU published Regulation (EU) 2022/692, which amends Regulation (EC) 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP Regulation, consolidated version until March 2022).

As a result of this amendment, all substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR substances) must be included in the list of banned substances in Annex II of the Cosmetics Regulation (EC) No 1223/2009. To ensure compliance with this law, a new EU Regulation 2023/1490, amending Regulation (EC) No 1223/2009, came into force on 19 July 2023.

You need to keep in mind that your cosmetic products are free from these CMR substances and that they are correctly labelled and notified in the European Cosmetics Products Notification Portal (CPNP).

To learn more about the specific substances that will be banned, we invite you to visit the following link.

References

If you have any questions, please do not hesitate to contact us, Cosmeservice will be happy to help you.

Please write an email to info@cosmeservice.com and subscribe to the Cosmeservice Newsletter to stay up-to-date

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