Pacifier Holder Testing According to EN 12586:2025

On April 2, 2025, the European Committee for Standardization (CEN) officially released the new safety standard EN 12586:2025for pacifier holders (commonly known as "pacifier chains"). This standard will replace the current version EN 12586:2007+A1:2011and is scheduled to be fully adopted into the national standards of EU member states by the end of October 2025, achieving a complete replacement of the old version.

EN 12586:2025

Child care articles – Soother holder – Safety requirements and test methods

Target Groups and Products

Target Groups:

All businesses and suppliers involved in the manufacturing, sale, or import of pacifier holders within the EU and EEA regions.

Applicable Products:

Pacifier holders intended for infants and toddlers up to 36 months of age, including products with components such as chains, cords, clips, beads, etc.

Key Updates in EN 12586:2025

The new version of EN 12586:2025 introduces significant revisions and enhancements in terms of structural design, safety, durability, and chemical testing. It addresses both physical performanceand chemical safety:

(1) Physical Requirements:

1. Complete restructuring of the standard, aligned with the harmonized chapter structure of EU childcare product standards;

2. Clearly defined applicable age range: 0–36 months;

3. Specific size and strength limitations for connectors, chains, beads, packaging, and other components;

4. Enhanced testing requirements for potentially hazardous components such as batteries, small parts, and magnetic elements;

5. Updated and refined test methods for strap width and thickness, attachment strength, and seam durability;

6. New requirements covering sharp points/edges, outer packaging, and consumer information;

7. Specified color fastness testing method (EN ISO 105-E04, using artificial sweat) to evaluate the durability of dyed components.

(2) Chemical Requirements:

1. Newly introduced migration or release limits for 19 categories of potentially hazardous substances, including plasticizers, BISphenol A (BPA), formaldehyde, phenols, dyes, and flame retardants;

2. BPA limit reduced from 15 mg/L to 5 mg/L;

3. Mandatory formaldehyde emission testing for all materials used (including plastic, rubber, and thermoplastic elastomers);

4. Products with antifungal or antibacterial claims must comply with the EU Biocidal Products Regulation (BPR) (EU) No 528/2012;

5. Manufacturers and suppliers are encouraged to operate under an ISO 9001 quality management system.

EN 12586:2025not only strengthens safety and environmental requirements for pacifier holders but also reflects the EU’s ongoing commitment to enhancing the safety of children's products. Relevant enterprises are advised to promptly initiate compliance assessments, structural adjustments, and certification procedures to ensure a smooth transition before the new standard becomes mandatory.

By April 2026, EN 12586:2025 will fully replace the previous version. Products that do not comply with the new standard will face restrictions in the EU market.