Sweden submitted its intention to classify Carvone as toxic to reproduction (CMR Cat. 2)

Carvone to be classified as Toxic to Reproduction Cat. 2

Date of publication: 27/03/2023

On 27 March 2023, Sweden submitted to the European Chemicals Agency (ECHA) its intention of harmonized classification and labelling (CLH) of Carvone, a fragrance ingredient, to be classified as a reprotoxic substance of category 2 (CMR 2 - Carcinogenic, Mutagenic, and Toxic to Reproduction).

BACKGROUND

Carvone (CAS 6485-40-1 / 99-49-0 / 2244-16-8) is a monoterpene present in high amounts in caraway, dill, and spearmint essential oils. Carvone is not currently regulated by the EU Cosmetics Regulation No. 1223/2009, and can therefore be used as a fragrance ingredient in cosmetic products.

WHAT’S NEW?

On 27 March 2023, Sweden submitted to the European Chemicals Agency (ECHA) its intention of harmonized classification and labelling (CLH) of Carvone, a fragrance ingredient, to be classified as a reprotoxic substance of category 2 (CMR 2 – Carcinogenic, Mutagenic, and Toxic to Reproduction).

If the process is completed, this could pose a risk to the use of Carvone in cosmetics.

WHAT NOW?

After Sweden submits a dossier containing comprehensive information about Carvone, its properties, and any available data on its hazards, it will undergo an acceptance check by ECHA. In case the dossier is accepted, data provided to support the CMR 2 classification will undergo an assessment by the Risk Assessment Commitee (RAC). The outcome of this assessment might lead to an official CMR 2 classification of Carvone.

Depending on the outcome of RAC opinion, the use of Carvone in cosmetics might be threatened in the future, considering that cosmetic ingredients, classified as CMR substances, of category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be either directly prohibited or may be allowed where the substance has been evaluated by the SCCS (in the context of the new classification) and found safe for use in cosmetic products.

References:

European Chemicals Agency (ECHA) – Registry of CLH intentions until outcome

other REGULATORY UPDATES

Update on the classification and labelling of Titanium Dioxide in powder form

Ingredients: TITANIUM DIOXIDE

Date of publication: 23/11/2022

The EU General Court annuls the Commission Delegated Regulation of 2019 in so far as it concerns the harmonised classification and labelling of Titanium Dioxide as a carcinogenic substance by inhalation in certain powder forms.

Regulation (EU) 2022/2195 – Updates to cosmetic ingredients use requirements

Ingredients: BHT, ACID YELLOW 3, HOMOSALATE, HAA299 and RESORCINOL

Date of publication: 11/11/2022

Date of application: 01/07/2023

Commission Regulation (EU) 2022/2195 of November 2022 amends Regulation (EC) No 1223/2009, restricting the use of BHT, Acid Yellow 3, Homosalate, HAA299 and Resorcinol, in cosmetic products.

SCCS Revision of the Scientific Opinion on Vitamin A

Ingredients: RETINOL, RETINYL PALMITATE, RETINYL ACETATE, RETINYL LINOLEATE, RETINAL

Date of publication: 25/10/2022

The Scientific Committee on Consumer Safety has issued a final version of the Scientific Opinion on Vitamin A, concluding that exposure to Vitamin A derived from cosmetics can be a concern for higher exposure consumers, and since cosmetics alone do not exceed the upper limit the SCCS cannot suggest maximum concentration limits that take into account contributions from other sources.

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.

Italy and France – Environmental Labelling of Cosmetic Products

PACKAGING WASTE MANAGEMENT

Date of application:01/01/2023

Although the European Cosmetics Regulation is applicable to every cosmetic product made available in the European Union market, some national legislations may also apply. Environmental regulations in Italy and France specify mandatory labelling requirements applicable to packaged products marketed in these countries.

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.