SCCS issues Final Opinion on Methylparaben
Ingredients: METHYLPARABEN

Date of publication: 14/12/2023

On December 14 2023, the Scientific Committee on Consumer Safety (SCCS) published the Final Opinion on Methylparaben.

BACKGROUND

Methylparaben (CAS No. 99-76-3, EC No. 202-785-7) with the chemical name ‘Methyl 4- hydroxybenzoate’ is currently regulated as a preservative in a concentration up to 0.4 % (as acid) when used on its own or up to 0.8% for mixtures of esters. Methylparaben is produced naturally in a variety of plants, but it is also synthesised for use in a range of products including cosmetics. 

Methylparaben has been subject to different safety evaluations by the SCCP in 2005 (twice), 2006 and 2008 and by the SCCS in 2010 and 2011. 

In 2019, the European Commission issued a call for data on a list of potential substances with endocrine disrupting (ED) properties in cosmetics, a list containing Methylparaben. Methylparaben is currently regulated under Annex V (entry 12) of the Cosmetics Regulation No. 1223/2009, with specific maximum concentrations. 

During the call for data, stakeholders submitted scientific evidence to demonstrate the safety of Methylparaben as a preservative in cosmetic products. The Commission requested the SCCS to carry out a safety assessment on Methylparaben in view of the information provided. 

WHAT’S NEW?

In light of the data provided and considering the potential endocrine-disrupting properties of Methylparaben, the SCCS is of the opinion that:

  • that the use of Methylparaben as a preservative in cosmetic products at concentrations of up to 0.4% (expressed as acid) is safe.

The assessment did not cover the safety of Methylparaben for the environment.

REFERENCES

Scientific Committee on Consumer Safety Opinion on methylparaben (CAS No. 99-76-3, EC No. 202-785-7), preliminary version of 6-7 June 2023, final version of 14 December 2023, SCCS/1652/23

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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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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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.

Read More »

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.

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