FDA Issues Draft Guidance on Registration and Listing of Cosmetic Product Facilities and Products
On 7 August 2023, The U.S. Food and Drug Administration, today, issued draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
MoCRA provided new authorities to FDA including:
Facility Registration: Cosmetic product manufacturers and processors must register their facilities with FDA, update content within 60 days of any changes, and renew their registration every two years.
Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
The draft guidance also contains information about a new electronic registration and listing submission portal. FDA intends to make the new electronic submission portal available in October 2023. FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency. FDA is also developing a paper form as an alternative submission tool to the electronic submission portal.
As described in the draft guidance, FDA intends to use the FDA Establishment Identifier (FEI) as the required facility registration number. To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, send a request to feiportal@fda.hhs.gov.
EU Amends the Ecolabel Criteria for Cosmetic Products
On 25 July 2023, the European Commission amended the Ecolabel criteria for cosmetic products through Commission Decision (EU) 2023/1540, which came into effect on July 26, 2023. The amendments update the wording and provisions within the existing criteria to clarify and refine the requirements for cosmetic products to qualify for the EU Ecolabel.
EU Amends Labelling of Fragrance Allergens in Cosmetic Products
On 26 July 2023, the European Union finalized a new regulation extending labeling requirements for fragrance allergens in cosmetics. The regulation expands the list of fragrance allergens that must be individually labeled on cosmetic products from 26 to 82. Cosmetic products containing that substance that do not comply with the restrictions may, provided that they comply with the restrictions applicable on 15 August 2023, be placed on the Union market until 31 July 2026 and made available on the Union market until 31 July 2028.
Indonesia to Ban Imported Goods Below $100 on E-commerce Platforms
On 28 July 2023, Indonesia Trade Minister Zulkifli Hasan announced that the country will restrict online sales of imported goods valued under $100.
The new policy will affect both major e-commerce platforms as well as social media retailers. According to Minister Zulkifli, the goal is to safeguard domestic small and medium-sized businesses from foreign competition.
The Trade Ministry is coordinating with other government agencies to finalize changes to current regulations by August 1st. Under the new rules, imported products sold online will also need to obtain an Indonesian National Standard (SNI) certification, which sets product quality standards.
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