IngredientsEuropean Union
Methylparaben in EU cosmetics: status and maximum concentration
INCI METHYLPARABEN · CAS 99-76-3
EU status: Allowedsingle and shared caps
Data from Certo’s regulatory database as of
Some rows corrected against the legal texts on
The short answer
Methylparaben is allowed in cosmetic products sold in the European Union (single and shared caps). The binding limits are set in Regulation (EC) No 1223/2009, Annex V, entries 12 and 12a.
EU legal requirements
| Product type or use | Limit | Conditions and label wording | Applies from |
|---|---|---|---|
| EU Cosmetics Regulation, Annex V 12 — Every use, whatever its function. Legal text | |||
| Every product type | ≤ 0.4 % as acid | Each of 4-hydroxybenzoic acid, methyl- and ethylparaben, and their salts, on its own. | In force |
| Every product type | ≤ 0.8 % as acid, for methylparaben, 4-hydroxybenzoic acid, potassium ethylparaben, potassium paraben, sodium methylparaben, sodium ethylparaben, ethylparaben, sodium paraben, potassium methylparaben and calcium paraben combined | Count together: 4-hydroxybenzoic acid, methyl- and ethylparaben, and their salts. | In force |
| EU Cosmetics Regulation, Annex V 12a — When the product also contains propyl- or butylparaben or their salts. Legal text | |||
| Every product type | ≤ 0.14 % as acid, for propylparaben, butylparaben, sodium propylparaben, potassium propylparaben, sodium butylparaben and potassium butylparaben combined | Count together, as acid: propyl- and butylparaben and their salts. | In force |
| Every product type | ≤ 0.8 % as acid, for methylparaben, 4-hydroxybenzoic acid, potassium ethylparaben, potassium paraben, sodium methylparaben, sodium ethylparaben, ethylparaben, sodium paraben, potassium methylparaben, calcium paraben, propylparaben, butylparaben, sodium propylparaben, potassium propylparaben, sodium butylparaben and potassium butylparaben combined | Count together, as acid: 4-hydroxybenzoic acid, methyl-, ethyl-, propyl- and butylparaben, and their salts. Allowed only if propyl- and butylparaben and their salts stay within 0.14 % in total. | In force |
| Nappy-area leave-on, children under 3 | — | Propyl- and butylparaben and their salts are not allowed in these products. | In force |
| Leave-on for children under 3 | — | If the product contains propyl- or butylparaben, the label must state ‘Do not use on the nappy area’. | In force |
Standards, advice and watch lists
| Product type or use | Limit | Conditions and label wording | Applies from |
|---|---|---|---|
| Endocrine-disruptor lists (national authorities), ED List II Source | |||
| Endocrine Disruptor Lists, List II (latest update 2026/04), rows 73 to 75: Methyl 4-hydroxybenzoate (Methylparaben) | |||
| ECHA substance evaluation (CoRAP), CoRAP Source | |||
| ECHA CoRAP substance evaluation list: methyl 4-hydroxybenzoate (France) | |||
| ECHA classification proposal, CLH intention Source | |||
| ECHA Registry of CLH intentions until outcome: methyl 4-hydroxybenzoate (France) | |||
What the texts say
Reference number: 12 Chemical name/INN: 4-Hydroxybenzoic acid and its Methyl- and Ethyl-esters, and their salts Name of Common Ingredients Glossary: 4-Hydroxybenzoic acid methylparaben potassium ethylparaben potassium paraben sodium methylparaben sodium ethylparaben ethylparaben sodium paraben potassium methylparaben calcium paraben CAS number: 99-96-7 99-76-3 36457-19-9 16782-08-4 5026-62-0 35285-68-8 120-47-8 114-63-6 26112-07-2 69959-44-0 EC number: 202-804-9 202-785-7 253-048-1 240-830-2 225-714-1 252-487-6 204-399-4 204-051-1 247-464-2 274-235-4 Maximum concentration in ready for use preparation: 0,4 % (as acid) for single ester 0,8 % (as acid) for mixtures of esters
12a Butyl 4-hydroxybenzoate and its salts Propyl 4-hydroxybenzoate and its salts Butylparaben propylparaben sodium propylparaben sodium butylparaben potassium butylparaben potassium propylparaben 94-26-8 94-13-3 35285-69-9 36457-20-2 38566-94-8 84930-16-5 202-318-7 202-307-7 252-488-1 253-049-7 254-009-1 284-597-5 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, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 % Not to be used in leave-on products designed for application on the nappy area of children under three years of age. For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’
Methyl 4-hydroxybenzoate (Methylparaben) | 99-76-3 | 202-785-7 | Yes | Commission EDC list | 2019 | Cosmetics | List II | List III Methyl 4-hydroxybenzoate (Methylparaben) | 99-76-3 | 202-785-7 | Yes | Yes | Corap List | 2014 | REACH | List II | List III Methyl 4-hydroxybenzoate (Methylparaben) | 99-76-3 | 202-785-7 | Yes | Yes | List III National Authority evaluation | 2025 | List II | List III
Methyl 4-hydroxybenzoate | Evaluating member state: France | Initial grounds for concern: CMR; Potential endocrine disruptor | Status: Concluded | Latest update: 20-Apr-2026
Methyl 4-hydroxybenzoate | Submitter: France | Status: Intention | Date of intention: 21-May-2026 | Expected date of submission: 31-Mar-2027 | Proposed classification: To be further specified
On the horizon
- Coming: An EU draft notified to the WTO in July 2026 (G/TBT/N/EU/1219), not yet adopted, would give butylparaben its own entry 12b and count entries 12, 12a and 12b together for the 0.8 % mixture cap, still with propyl- and butylparaben within 0.14 %.
- Watch: On ED List II (under EU evaluation as an endocrine disruptor, for health and environmental effects) and on List III (identified as an endocrine disruptor by a participating national authority, 2025).
- Watch: REACH substance evaluation by France, for suspected CMR and endocrine-disrupting properties, concluded in April 2026.
- Watch: France intends to propose a harmonised CLP classification (intention of 21 May 2026, submission expected by 31 March 2027). The hazard classes are not specified yet.
Sources
- Reg. (EC) No 1223/2009, Annex V, entry 12
- Endocrine Disruptor Lists, List II (latest update 2026/04), rows 73 to 75: Methyl 4-hydroxybenzoate (Methylparaben)
- ECHA CoRAP substance evaluation list: methyl 4-hydroxybenzoate (France)
- ECHA Registry of CLH intentions until outcome: methyl 4-hydroxybenzoate (France)
This page is general regulatory information, not legal advice. Rely on the legal texts linked above and on your own regulatory experts before making a compliance decision.