Preliminary SCCS opinion on Hydroxyapatite (nano)
Ingredients: HYDROXYAPATITE (NANO)

Date of publication: 31/03/2022

On 11 January 2023, the SCCS published the preliminary opinion on Hydroxyapatite (nano). The deadline for comments was set for 1 March 2023.

On January 11, 2023, the EU Scientific Committee on Consumer Safety (SCCS) published the preliminary opinion SCCS/1648/22 on Hydroxyapatite (CAS No. 1306-06-17) in nano form. The opinion is open for comments until March 1, 2023.

BACKGROUND

Hydroxyapatite is a mineral obtained from pearl oyster shells, salmon bones, phosphate rock, or derived synthetically. Hydroxyapatite is used in cosmetic products as abrasive, bulking, skin conditioning and oral care agent.

Article 2(1)(k) of EU Cosmetics Regulation (EC) No. 1223/2009 states that ‘nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.

The nanomaterials definition covers materials in the nano-scale that are intentionally made and are insoluble/partially-soluble or biopersistent. It does not cover those that are soluble or degradable/non-persistent in biological systems.

Article 16 of the EU Cosmetics Regulation requires cosmetic products containing nanomaterials other than colourants, preservatives and UV-filters and not otherwise restricted by the Cosmetics Regulation to be notified to the European Commission six months prior to being placed on the market. If there are concerns over the safety of a notified nanomaterial, the European Commission shall refer it to the Scientific Committee on Consumer Safety (SCCS) for a full risk assessment.

WHAT’S NEW?

Based on the data submitted via the Cosmetic Products Notification Portal (CPNP), additional information provided by the industry, and other relevant information in scientific literature, the SCCS conducted a safety assessment on Hydroxyapatite (nano), and published its preliminary opinion.

In the opinion, SCCS considers Hydroxyapatite (nano) as safe if used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash. The opinion conclusions only apply to the substance with the following characteristics:

  • Composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9.
  • The particles are not coated or surface modified.

References:

1. Scientific Committee on Consumer Safety (SCCS) – Preliminary opinion on Hydroxyapatite (nano), SCCS/1648/22, January 4, 2023.

other REGULATORY UPDATES

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

Ingredients: BENZOPHENONE, TEOPHYLLINE, MELAMINE, AZADIRACHTA EXTRACTS, TRIMETHYLOLPROPANE TRIACRYLATE, PENTETIC ACID, PENTASODIUM PENTETATE

Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

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SCCS Preliminary Opinion on Sodium Bromothymol Blue (C186) as hair dyeing

Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.

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SCCS Final Opinion on the Safety of Triclocarban and Triclosan

Ingredients: TRICLOCARBAN and TRICLOSAN

Date of publication: 25/10/2022

During the plenary meeting on 24-25 October 2022, the Scientific Committee on Consumer Safety (SCCS) presented its final opinion on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products.

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Any REGULATORY QUESTION?

Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

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French Anti-Waste Law – Impact in Cosmetics Packaging and Labelling

PACKAGING WASTE MANAGEMENT

Date of application: 01/01/2023, with a transition period until 09/03/2023 for packaging produced or imported before 09/09/2022.

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. From January 2023 the requirements of the law became mandatory, including specific symbols on the packaging or labelling of cosmetic products.

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