On March 15, 2024, the European Commission (EC) published in the Official Journal of the European Union an amendment to the Cosmetics Regulation. The following nanomaterials have been added to Annex II (substances prohibited in cosmetic products). From February 1, 2025, cosmetic products containing these substances shall not be placed on the European Union (EU) market. From November 1, 2025, cosmetic products containing these substances shall not be made available on the EU market: The...
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October 12, 2023
FDA Seeks Comment on Cosmetics Direct and Forms Regarding Registration of Cosmetic Product Facility and Cosmetic Product Listing
On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form...
September 21, 2023
Austrian Academy of Sciences Publishes NanoTrust Dossier on the Regulation and Safety Assessment of Nanomaterials in Cosmetics in the EU
In August 2023, the Institute of Technology Assessment of the Austrian Academy of Sciences published a NanoTrust Dossier entitled “Nanomaterials in cosmetics — regulation and safety assessment in the EU.” The dossier states that to ensure “the highest possible level of consumer protection,” the European Union (EU) Cosmetics Regulation was adapted in 2009, with special provisions introduced for nanomaterials. These provisions include requiring the notification of cosmetic products...
August 16, 2023
UK Calls for Data on Nanomaterials in Cosmetics
On August 14, 2023, the United Kingdom’s (UK) Office for Product Safety and Standards (OPSS) called for the submission of any scientific information relevant to the safety assessment of nanomaterials used in cosmetics. Article 16 of the UK Cosmetics Regulation requires that cosmetic products containing nanomaterials be notified to the Secretary of State at least six months prior to being placed on the market. These notifications may be completed via the Submit Cosmetic Product Notification...
On June 26, 2023, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published the second revision of its Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The Guidance covers the main elements of safety assessment, i.e., general considerations (Section 2), material characterization (Section 3), exposure assessment (Section 4), hazard identification and dose-response characterization (Section 5), and risk assessment (Section 6). SCCS states...
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) has begun a public consultation on its preliminary opinion on fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes (nano). The EC asked SCCS if it considers fullerenes, hydroxylated fullerenes, and hydrated forms of hydroxylated fullerenes safe when used in cosmetic products according to the maximum concentrations and specifications as reported via the Cosmetic Product...
February 15, 2022
EC Notifies WTO of Draft Amendment to Cosmetics Regulation to Prohibit Certain Nanomaterials
The European Commission (EC) notified the World Trade Organization (WTO) on February 11, 2022, of a draft amendment to the Cosmetics Regulation regarding the use of certain nanomaterials in cosmetics products. The EC states that the amendment is required to enact the prohibition to use in cosmetic products certain nanomaterials for which the Scientific Committee on Consumer Safety (SCCS) identified a basis of concern. The draft amendment would revise Annex II to the Cosmetics Regulation (list...
November 19, 2021
EPA Denies TSCA Section 21 Petition Seeking the Elimination of Hazardous Chemicals Used in Mixtures in Cosmetics
On November 17, 2021, the U.S. Environmental Protection Agency announced the availability of its response to an August 16, 2021, petition filed under Section 21 of the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 64129. William D. Bush requested that EPA determine that the “chemical mixtures contained within cosmetics present an unreasonable risk of injury to health and the environment,” and issue a rule or order under TSCA to “eliminate the hazardous chemicals used in...
October 7, 2020
Public Consultation Begins on SCCS Scientific Advice on Safety of Nanomaterials in Cosmetics
The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) began a public consultation on October 5, 2020, on a preliminary opinion entitled Scientific Advice on the Safety of Nanomaterials in Cosmetics. The EC requested that SCCS determine the nanomaterials, as published in the 2019 catalogue of nanomaterials, for which specific concerns can be identified and justified to establish a priority list of nanomaterials for risk assessment (Article 16(4)...
March 24, 2020
EC Committee Posts Fact Sheet on Guidance on Safety Assessment in Nanomaterials in Cosmetics in French, German, Italian, and Spanish
On March 23, 2020, the European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) announced that the fact sheet on the SCCS Guidance on the safety assessment of nanomaterials in cosmetics is now available in French, German, Italian, and Spanish. The guidance provides recommendations for the safety assessment of nanomaterials intended for use in cosmetics and covers the main elements of risk assessment of nanomaterials in relation to possible use as cosmetic...