2023-07-03 Reference source : ECHA
On 8 June 2023, the EU’s Scientific Committee on Consumer Safety (SCCS) published preliminary opinions on the use of methylparaben and butylparaben in cosmetics. The European Commission has opened public consultation on the 2 preliminary opinions and the deadline for comments is 21 August 2023.
Methylparaben and butylparaben have been assessed to rule out potential endocrine-disrupting properties and to ensure their safe use in cosmetics. The EU’s Cosmetics Regulation (Regulation (EC) No 1223/2009) does not have explicit provisions for the management of endocrine disruptors (EDs) therefore the European Commission requested the SCCS to conduct safety assessments on the two substances.
The conclusion of the SCCS in the two preliminary opinions was that methylparaben and butylparaben are safe for use as preservatives in cosmetics when used as summarized in the following table.
Common name |
Systematic name |
CAS No. |
Restrictions |
Methylparaben |
Methyl 4-hydroxybenzoate |
99-76-3 |
0.4 % as acid when used individually |
0.8 % for mixtures of esters |
|||
Butylparaben |
Butyl 4-hydroxybenzoate |
94-26-8 |
0.14 % as acid |
According to the SCCS, methylparaben and its salts are widely used in cosmetics, food products, and pharmaceutical formulations. In cosmetics it is the one used most frequently. It is either used alone ore in combination with other parabens or other antimicrobial agents. Butylparaben has been widely used as a preservative in cosmetics and pharmaceutical preparations for 70 years.
The preliminary opinion for methylparaben can be found here and the one for butylparaben can be found here.
Global Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
© Copyright 2024 | Global Product Compliance