BUTYLPARABEN

US FDA substance register · UNII 3QPI1U3FV8 · registered name BUTYLPARABEN · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Butylparaben is an organic molecular entity.

Source: PubChem

Butylparaben is the ester of butyl alcohol and p-hydroxybenzoic acid. It conforms to the formula:

Restricted

China · Japan · South Korea

Allowed preservative

United Kingdom

Source: MFDS (Korea) cosmetic regulatory information · EU Cosmetics Regulation · Taiwan FDA cosmetic ingredients · UK cosmetics regulations (OPSS)

Argentina · Brazil

• Maximum concentration permitted at final product : (a) 0,14% (expresso como ácido) para a soma das concentrações individuais. (b) 0,8% (expresso como ácido) para a soma das concentrações individuais das substâncias mencionadas nos itens 11 e 11-A contidos no produto; neste caso a soma das concentrações individuais de butil e propilparabeno e seus sais não devem superar 0,14% (expresso como ácido).
• Other limitations and requirements : Não usar em produtos que não se enxáguem destinados a área de fraldas em crianças menores de 3 anos.
• Use conditions and warnings that must appear on the label : Em produtos que não se enxáguem desenhados para crianças menores de 3 anos: "Não usar nas áreas das fraldas".

ASEAN

• Maximum authorised concentration in the finished cosmetic product : 0.4% (as acid) for single ester 0.8% (as acid) for mixtures of esters

Taiwan

• (a) 0.14%

European Union

• Maximum concentration in ready for use preparation : - 0,14% (as acid) for the sum of the individual concentrations - 0,8% (as acid) for mixtures of substances mentioned in entry 12 and 12a, here the sum of the individual concentrations of butyl and propylparaben and their salts does not exceed 0,14%
• Other : Not to be used in leave-on products designed for application on the nappy area of children under three years of age.
• Wording of conditions of use and warnings : For leave-on products designed for children under three years of age: "Do not use on the nappy area"

Not classified under Korea’s toxic-substance GHS list · existing chemical substance · priority-management substance

Source: Korea toxic substances GHS register (NIER)

Restriction V/12a · Other restriction: ban substances that deplete the ozone layer · SCCS opinion: Extended Opinion on the Safety Evaluation of Parabens; Opinion concerning Restrictions on Materials listed in annex VI of Directive 76/768/EEC on Cosmetic Products; Opinion on Parabens; Opinion on Parabens updated request for a scientific opinion on 'propyl-and butylparaben'; Opinion on Parabens, underarm cosmetics and breast cancer

Source: EU CosIng ingredient list

Reviewed by CIR: Final Amended Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben and Benzylparaben as used in cosmetic products

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Final Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, and Butylparaben

Source: US Cosmetic Ingredient Review (CIR)

Reviewed by CIR: Amended Safety Assessment of Parabens as Used in Cosmetics

Source: US Cosmetic Ingredient Review (CIR)