EU - SCCS Opinions on Methyl Salicylate, Salicylic Acid and Butylparaben
On 2nd May 2025, the EU SCCS (Scientific Committee on Consumer Safety) published Opinions on children’s exposure to Methyl Salicylate, Salicylic Acid and Butylparaben.
The SCCS commented that the maximum safe use concentration of Methyl Salicylate is 0.4% in toothpaste and 0.02% in other products when used in products intended for children of age 0-3 years.
The SCCS deemed Salicylic Acid not safe when used as a preservative up to a concentration of 0.5% for children between 3-10 years of age, nor was it found to be safe at the following concentrations, when used for purposes other than inhibiting the development of microorganisms:
- Up to 3.0% for the cosmetic rinse-off hair products used by children (shampoo, conditioner).
- Up to 2.0% for selected other dermally applied products used by children (face moisturizer, hand cream, liquid soap, shower gel).
- Up to 0.5% for body lotion.
With the exception of body lotion, Salicylic Acid was found to be safe in single dermal and oral product categories, when used only in the respective product category.
SCCS commented that reducing the concentration, for example to 0.1% in dermal products, would make the use safe for dermal products and toothpaste.
During public consultation, the SCCS received a proposal to keep rinse-off products at 0.5% and reduce Salicylic Acid in leave-on products to 0.15%, and oral care products to 0.1%. These concentrations of Salicylic Acid are safe for children 3-10 years old.
The SCCS concluded that Butylparaben is not safe for children when used as a preservative up to a maximum concentration of 0.14%. The SCCS could consider Butylparaben safe for children, provided that its maximum concentration is reduced in some product types so that the aggregate exposure does not exceed 245 μg/kg bw/day.
During public consultation, the SCCS received a proposal to keep the maximum safe use concentration of Butylparaben at 0.14% in rinse-off products, and reduce it to 0.002% in leave-on products and 0.092% in oral care products. The SCCS considers these reduced concentrations safe for children.
Public Consultation Open for EU Cosmetics Regulation
As previously reported, the EU Commission is conducting a fitness check of the ‘Cosmetic Products Regulation’, (EC) 1223/2009. Following a comment period running from February to March 2025, a consultation period has now begun, running from 5th May - 28 July 2025. Feedback received during the comment period will now be taken into account and summarised in a synopsis report.
Click here for information on the initiative.
Defra Gives Updates on Extended Producer Responsibility for Packaging
On 6th May 2025, GB’s Defra (Department for Environment Food & Rural Affairs) notified the CTPA (Cosmetic Toiletry and Perfume Association) of a Statutory Instrument Amendment sent to the European Union on Extended Producer Responsibility for packaging (pEPR).These amendments will be laid before Parliament in November 2025 so that changes can come into force ahead of year two of the scheme.
You may read about the key changes here.
Thai FDA Announces Titanium Dioxide Powder Requirements
On 21st April 2025, the Thai FDA (Food and Drug Administration) released an announcement stipulating requirements for use in cosmetic products of Titanium Dioxide in powder form, containing 1% or more of particles with aerodynamic diameter ≤10 μm at risk of being inhaled into the lungs.
You may find the announcement here.
