ADVERTORIAL
KEEPING YOU IN THE KNOW
Alex Fotheringham, Operations Director at MSL Solution Providers, updates on the latest regulatory changes in the cosmetics industry
As regulatory requirements continue to change and evolve, compliance can often feel like a moving target. The best way to keep up with regulations is to stay informed about what changes are happening or coming up.
The UK SCPN Portal When the UK Cosmetic Regulation came into force in January 2021, it brought with it some significant changes in the way products are regulated in the UK, including the introduction of the ‘Submit Cosmetic Product Notifications’ (SCPN) portal. This platform has recently undergone some major changes to enhance its functionality and make it easier to submit cosmetic product notifications. Users can now upload formulations with
exact concentrations via a new CSV function, which was difficult to do with the previous PDF upload option. This new feature is initially available when entering ingredients by exact concentration. Functionality to upload ingredients with shades and concentration ranges will be available later in 2023. Instructions on how to develop the CSV
file can be found at:
https://submit.cosmetic-product-
notifications.service.gov.uk/help/csv.
USA Modernization of Cosmetic Regulation Act of 2022 (MoCRA) In December 2022, President Biden signed into law the Modernization of Cosmetic Regulations Act of 2022 in the USA.
The first major update to the US Food
and Drug Administration’s (FDA) authority over cosmetic products since 1938, it increases their powers and funding and brings the legislative environment closer in line with other major regions, such as the UK and EU.
Alex Fotheringham, Operations Director at MSL Solution Providers
As part of MoCRA, the FDA will also be
establishing regulations for: Good Manufacturing Practice (GMP): This will align US GMP with international standards and is expected to be completed in 2025. • Fragrance allergen labelling: Cosmetic labels will be required to identify every fragrance allergen in a product. This requirement will take effect at the end of 2024.
By December 2023, cosmetic brands and manufacturers will need to amend their practices to comply with the new law. Key points to address include:
• Mandatory Facility Registration: Cosmetic brands and manufacturers must register their facilities with the FDA and renew their registration every two years.
• Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, place of manufacture, product listing number, and provide any updates annually. This registration must be complete before December 2023 for existing products on the market and 120 days for new products.
• Adverse event reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA within 15 business days after receiving the report and certain additional information, such as new medical information, within one year of the initial report. The FDA will also have access to adverse event reports during an inspection.
• Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products.
• Talc: The FDA will be issuing regulations to establish and require standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
• Perfluoralkyl and polyfluoralky substances (PFAs): The FDA is required to issue a public report, no later than three years after MoCRA is enacted, to assess the use of PFAs in cosmetic products. For small businesses, there are
exemptions from GMP, registration, and product listing requirements. More guidance will be issued in the coming months, with updates posted on the FDA’s website
www.fda.gov/cosmetics/cosmetics-laws- regulations/modernization-cosmetics- regulation-act-2022.
CONTACT US
As the UK’s largest 3rd party Responsible Person and offering ISO 9001 and insurance backed regulatory services, MSL Solution Providers is ideally placed to support cosmetic businesses’ compliance needs internationally. For further information or advice, please visit
www.msl.io
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60
