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Home > Products > EU Certificate > EU pacifier holder EN 12586:2025 new standard safety requirements and test methods
EU pacifier holder EN 12586:2025 new standard safety requirements and test methods
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Product Description
EU pacifier holder EN 12586:2025 new standard safety requirements and test methods
EU pacifier holder EN 12586:2025 new standard safety requirements and test methods
I. Background
On April 2, 2025, the European Committee for Standardization (CEN) released a new version of the safety standard EN 12586 for soother holders: EN 12586:2025 "Child Care Articles - Pacifier Holders - Safety Requirements and Test Methods", replacing the previous version EN 12586:2007+A1:2011. The new standard will be given the status of a national standard by publishing the same text or by recognition before October 2025, and conflicting national standards should be invalidated by April 2026 at the latest.
EN 12586:2025: The standard specifies the material, structure, performance, physical and mechanical, chemical, product packaging, labeling and age requirements for pacifier holders.
2. Scope of application of EN 12586:2025
Scope of application of EN 12586:2025: pacifier holders for children aged 0-36 months (anti-dropping). Note: pacifier holders with significant playfulness should also comply with the EU Toy Safety Directive 2009/48/EC
3. Updated test items of the new standard EN 12586:2025:
(1) Physical update: -- Testing and certification consultant Zhang Gong: 1382796O869+V
1. Update the structure and chapters of the entire standard
2. Delete the separate supplementary component requirements section and split the supplementary component requirements into relevant chapters.
3. Update the scope of Section 1 to add an age limit to cover pacifier clips for children from birth to 36 months old.
4. Update the detailed description of terms and definitions in Section 3, and add additional sections 3.5: Connecting devices, 3.5.3: Chains, 3.5.4: Beaded elements, and 3.10: Outer packaging.
5. Add requirements and figures for test equipment and tolerances in Section 5.
6. Update the general requirements in Section 6.1, and add requirements for magnetic components, button and coin batteries, and small parts testing.
7. Retain the 220 mm length limit for pacifier clips without buttons in Section 6.2, and add additional requirements for the entire pacifier clip length not exceeding 300 mm, the loop length not exceeding 110 mm, and related restrictions on adjustable connecting devices.
8. Retain the requirements for strap width and rope thickness in Section 6.3, and add additional requirements for connecting device width/thickness, including chain width, rope exposed greater than 15 mm, rope used for or as part of a pacifier fastener, and rope thickness less than 6 mm.
Define the entrapment test equipment in Section 6.5, and test with a 5.5 mm test ball and a 12 mm test ball.
9. Keep the ventilation hole requirements in Section 6.6, and add additional requirements for permanent attached components (such as beads). If these components are not supplementary components but are only part of the connecting device, ventilation holes are not required even if they cannot fully cover the 25 mm diameter range.
10. Add the requirements for packaging suffocation hazards in Section 6.8.
11. Update the requirements for consumer packaging in Section 8.
12. Update the requirements for product information in Section 9.
(2) Chemical updates:
1. Add additional materials (silicone elastomers, rubber, thermoplastic elastomers (TPE), leather, resin bonding materials).
2. Change the number of elements in the element migration test from 8 to 19.
3. Change the formaldehyde emission test to the entire product with a limit of 0.75 mg/L instead of testing plastics, textiles, and wood separately.
4. Reduce the migration limit of bisphenol A (BPA) from 0.1 mg/L to 0.04 mg/L, and reduce the migration limit of phenol from 15 mg/L to 5 mg/L.
5. Add restrictions on 6 preservatives in leather parts.
6. Add restrictions on 14 solvents in decorative items, coatings and resin bonding materials.
7. Add restrictions on N-nitrosamines and N-nitroso substances in silicone elastomers, rubbers and thermoplastic elastomers (TPE).
8. Removed the requirements for phthalate content and nickel release because the relevant test items are already in the EU REACH Regulation (EC) No 1907/2006.
9. Emphasize that products claiming to have biocidal effects or expected biocidal effects must comply with the EU BPR Regulation (EU) No 528/2012.
IV. EN 12586:2025 new standard certification process for pacifier holders:
1. Fill out the application form
2. Send samples
3. Sample testing
4. Test passed
5. Produce a draft and confirm that the information is correct
6. Issue a formal report
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