Cosmeservice Newsletter September

29/09/2023

Navigating the world of cosmetic regulations?

We’ve got the latest industry buzz. Let’s embark together!

2nd Edition of “Safe Cosmetics for young children” guideline

The 2nd Edition of “Safe Cosmetics for Young Children” by The European Committee for Cosmetics and Consumer Health addresses concerns about children’s skin sensitivity to certain substances.

The Committee sets standards and aids market surveillance via OCCLs. The surge in kids’ cosmetics strains safety reporting through Safety Gate in EU states. The guide bans or limits toxic ingredients and caters to children’s unique sensitivity, preventing risks like poisoning. It covers nanomaterials, endocrine disruptors, safety margins, product-specific advice (e.g., fluoride, baby wipes), and updated references.

Additional information

MOCRA Update: New submission platform for listing and registration facilities.

On the 15th of September, the U.S Food and Drug Administration continues its implementation of the Modernization of Cosmetics Regulation Act’s (MoCRA) following on the FDA’s Draft Guidance on Facility Registration and Product Listing.

FDA is looking for feedback on its newly draft guidance for the cosmetic product listings and registration facility registrations added Section 607 of the federal Food, Drug and Cosmetic Act (FD&C Act). The U.S Food and Drug Administration is promoting the use of electronic submissions to enhance the efficiency and promptness of data submission and management.

The draft guidance also contains information about a new electronic registration and listing submission platform, along with specific exemptions from the registration and listing prerequisites. FDA expects this new portal to begin accepting submissions in October 2023, in advance of the December 29, 2023 statutory deadline for Facility Registration and product listing.

More information

CRUELTY FREE: Commit to a Europe Without Animal Testing.

The ‘Save Cruelty-Free Cosmetics – Commit to a Europe Without Animal Testing’ initiative was submitted to the Commission on the 25th of January 2023, after having gathered 1,217,916 verified statements of support. The Commission adopted a Communication on the 25th of July 2023, setting out its response to this initiative.

Animal testing was banned for cosmetic products by the EU Regulation 1223/2009 since its publication, in 2009. It unequivocally prohibits the marketing of cosmetic products tested on animals. Consequently, products marketed in the EU are “cruelty-free” and “Not tested on animals”.

However, there it’s important to note that there was a lack of specific legislative measures on chemicals (e.g. REACH, Biocides Regulation, Regulation on Plant Protection Products and Medicinal Products for Human and Veterinary Use). The EU Commission will launch a new roadmap with a set of legislative and non-legislative actions to further reduce animal testing, and promoting alternative methods to animal testing in these fields.

Read more

SCCS Final Advice: Children’s Exposure to Methyl Salicylate.

On the 22nd of September, the final SCCS advice on the safety of children’s exposure to Methyl Salicylate in cosmetic products was published.

In light of potential differences in metabolism between newborns/infants/toddlers up to six years olds, 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.
  • Up to 2.52% for toothpaste.

Nevertheless, according to Annex III entry 324 on the ingredient Methyl Salicylate, can’t be used in cosmetic preparations for children unless the exception of toothpaste. Following the advice issued by the SCCS it is not possible to confirm that in the future, the entry of this ingredient in the EU Regulation 1223/2009 will be amended to adapt it to the new findings.

Additional information

A new version of the Cosmetic Regulation was published.

new version of the EU Cosmetic Regulation 1223/2009 was published in August, including important additions to the lists of restricted substances, known as allergens.

Annex III now contains the substances restricted by Regulation 2023/1545, adding 56 substances to be controlled when added to cosmetic products and declared on the ingredient lists.

With regard to the new restrictions, cosmetic companies and manufacturers are allowed a reasonable time to adapt to them by adjusting product formulations and containers.

It is confirmed the transition period mentioned before for beauty brands to adapt the labels, is 3 years for new cosmetic products, until 31 July 2026, and 5 years for cosmetic products that are already on the EU market, until 31 July 2028.

More information

GREEN AND SUSTAINABILITY CORNER

MICROPLASTICS IN THE EU & UK: A Shift Towards Sustainability

European Commission takes action against microplastics intentionally added to products under the EU chemical legislation REACH.

The adopted restriction uses a broad definition of microplastics – it covers all synthetic polymer particles below five millimetres that are organic, insoluble and resist degradation.

Cosmetics where microplastics is used for multiple purposes, such as exfoliation (microbeads) or obtaining a specific texture, fragrance or colour are restricted.

The restriction will come into force 20 days after the 25th September 2023 adoption. The first measures are for example, the ban on loose glitter and microbeads.

For cosmetics containing microbeads (small plastic beads used for exfoliation) the sale ban applies immediately. For rinse-off and leave-on cosmetic products without microbeads is proposed a 4-year and a 6-year transitional period.

However, for microparticles encapsulated in fragrances, the transitional period is from 5 to 8 years.

Restriction will be enforced within both the EU and Northern Ireland. There is currently no restriction proposal for microplastics under UK REACH for the GB market. Nevertheless, the Health and Safety Executive is going to start an evidence project that will inform any Regulatory Management Option Analysis under UK REACH.

Find more information HERE

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

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