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Annex V Entry 12 a 02/08/2021

BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN

Butyl 4-hydroxy­benzoate and its salts Propyl 4-hydroxy­benzoate and its salts

BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN appears in Annex V as a positive-list preservative entry for EU cosmetics. Maximum concentration in this record: - 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%.

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Permitted preservative— Annex V, EU Regulation 1223/2009
Max conc.: - 0,14% (as acid) for the sum of the individual concen…
Entry: 12 a

Record details

Maximum concentration

- 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 restrictions

Not to be used in leave-on products designed for application on the nappy area of children under three years of age.

Warnings

For leave-on products designed for children under three years of age: "Do not use on the nappy area"

INCI glossary name

BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN

Chemical name

Butyl 4-hydroxy­benzoate and its salts Propyl 4-hydroxy­benzoate and its salts

Chemical / IUPAC name

Butyl 4-hydroxy­benzoate and its salts Propyl 4-hydroxy­benzoate and its salts (Butylparaben, propylparaben, sodium propylparaben, sodium butylparaben, potassium butylparaben, potassium propylparaben)

Regulatory information

Regulation

(EC) 2014/1004

SCCS opinions

Identified ingredients

Key data

CAS
94-26-8/ 94-13-3/ 35285-69-9/ 36457-20-2/ 38566-94-8/ 84930-16-5
EC
202-318-7/ 202-307-7/ 252-488-1/ 253-049-7/ 254-009-1/ 284-597-5
Annex
V
Entry number
12 a

Inventory links for BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN

Inventory Identified ingredient
Ref 31734

BUTYLPARABEN

CAS: 94-26-8
EC: 202-318-7
Inventory Identified ingredient
Ref 37312

PROPYLPARABEN

CAS: 94-13-3
EC: 202-307-7

Direct matches are limited for this record, so nearby entries from Annex V are shown as well.

Annex V 11
Nearby record in the same annex

CHLOROBUTANOL

CAS: 57-15-8
EC: 200-317-6
Annex V 16
Nearby record in the same annex

THIMEROSAL

CAS: 54-64-8
EC: 200-210-4

What Annex V means for BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN

BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN is an approved preservative listed in Annex V of EU Cosmetics Regulation 1223/2009. Only substances on this positive list may be used as cosmetic preservatives in the EU.

Each preservative entry specifies maximum permitted concentrations and applicable product scope. Concentrations must not exceed the listed maximum. Some preservatives require warning statements on the product label.

This record is linked to 6 CosIng inventory ingredients for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Use concentration must not exceed: - 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%
  • Verify the preservative is effective at the permitted concentration for your matrix.
  • Apply required label warning statement.

Frequently asked questions

Yes. BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN is listed in Annex V of EU Cosmetics Regulation 1223/2009 as a permitted preservative. It may be used in cosmetics up to the maximum concentration specified above, within the permitted product scope.

CAS 94-26-8/ 94-13-3/ 35285-69-9/ 36457-20-2/ 38566-94-8/ 84930-16-5 is the unique numerical identifier assigned to BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

The maximum concentration of - 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% applies to the concentration of the substance in the ready-to-use cosmetic product. When the substance is supplied as part of a blend or mixture, the calculation must account for the contribution of all sources in the formulation. The combined concentration must not exceed the stated limit.

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Source note for Annex V record BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN

This page summarizes one Annex V record for BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex V conditions for BUTYLPARABEN/PROPYLPARABEN/SODIUM PROPOYLPARABEN/SODIUM BUTYLPARABEN/POTASSIUM BUTYLPARABEN/POTASSIUM PROPYLPARABEN, but confirm any final regulatory decision against the current official annex wording and source files.

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