Our team would like to remind you about the most significant changes that have taken place in the cosmetic industry in the last few months.
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New version of the Regulation (EC) 1223/2009 published
The new version of the cosmetic regulation was published on the 17th of December 2022.
Now, it can be found all formats updated and all languages available. Since the las amendment, no ingredients were included, as it was not published any amendment of the annexes of the Regulation (EC) 1223/2009.
You can find the newest version of the document here:
FDA Cosmetics Reform Expected to Become Law Soon
On December 23, 2022, The Congress of the United States passed the Food and Drug Omnibus Reform Act of 2022 (“FDORA”) as part of the Consolidated Appropriations Act of 2023. FDORA includes, as subtitle E, the Modernization of Cosmetics Regulation Act of 2022, called MoCRA.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), as it has been titled, will add significant new authorities to chapter VI of the Federal Food, Drug, and Cosmetic Act (“FDCA”)—the first major amendments to FDA’s cosmetics authorities since 1938.
It will include new requirements for cosmetics. MoCRA focuses on safety of cosmetics and, among other things, FDA is to develop and issue good manufacturing practice, industry will become subject to registration and listing requirements, must have records to substantiate safety of its products, and must report serious side effects to FDA.
MoCRA also gives FDA mandatory recall authority and expands FDA’s access to certain records. The requirements for registration and listing and new enforcement provisions become effective one year after enactment of the legislation.
The 18th ATP and Omnibus Act VI will apply will apply from December 1, 2023.
The corrigendum to Commission Delegated Regulation (EU) 2022/692 of May 25, 2022, includes the substances recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). There are 30 substances that are used as cosmetic ingredients, but not widely used, as the industry was not defending them. Benzophenone or Cumene, among other substances will become prohibited for use in cosmetic products from the 1st December 2022.
If you need help to review your products or if you need the complete list, just contact us!
Omnibus Act V came into force as of 17 December 2022.
Omnibus V will be fully applicable since 17th December 2022 and the 14 substances listed will be prohibited at cosmetic products. Moreover, Methyl Salicylate will be added to Annex III to the EU Cosmetics Regulation, limiting its use.
Hence, as 17th December 2022, cosmetics cannot be placed on the EU market if they are not compliant with Omnibus Act V, and the existing ones on the market must be recalled.
UK RP data: the deadline (which was scheduled for January 1, 2023) has been extended to the 1st January 2026.
Cosmetic products marketed in the UK must bear the Responsible Person information, the name and address located in the UK. Name, address and country of origin requirements are satisfied if the labelling is in compliance with Article 19 of the EU Cosmetics Regulation.
Therefore, there is a 5-year grace period, until 31st December 2025 to label cosmetic products under the rules of the Article 19 (1)(a) transitional arrangements UKCR. In September 2022, the original 2-year grace period has been extended to 5 years.
Thus, the products with the EU RP on the labelling can be made available on the UK market until December 2025 and from the 1st of January 2026, the UK Responsible Person data must appear on the labelling of the cosmetic products.
Draft Community Rolling Action Plan (CoRAP) update for years 2023-2025 published
The draft is for an annual update of the CoRAP and covers the three subsequent years 2023-2025. It contains substances suspected of posing a risk to human health or the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows generation of information for clarification of such potential risks.
The draft CoRAP contains 24 substances, including 6 new substances compared to the current CoRAP 2022-2024; 5 substances are being planned for evaluation in 2023, and 19 are divided for evaluation in 2024 and 2025.
By publishing this draft now, ECHA wishes to inform the stakeholders of the progress made and to facilitate early communication between the involved registrants and the relevant evaluating Member State Competent Authority.
If you have any questions, please do not hesitate to write to us, our team will be happy to help you.