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

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.

Butylphenyl Methylpropional (Lilial) ban in cosmetics comes into force in Great Britain

Ingredients: BUTYLPHENYL METHYLPROPIONAL

Date of application: 15/12/2022

Due to its classification as toxic to reproduction, Butylphenyl Methylpropional is prohibited in cosmetic products placed in the Great Britain market as of December 15, 2022.

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.

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.

French labelling requirement for leave-on products containing Phenoxyethanol repealed

Ingredients: PHENOXYETHANOL

The EU Court of Justice repealed the French requirement for the labelling of the precautionary measurement “Not to be used on the nappy-skin area of children under 3 years of age” on leave-on cosmetic products containing Phenoxyethanol. Therefore, the labelling restriction related to Phenoxyethanol is officially not mandatory for products imported into France.

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.