On 2 April 2025, the European Committee for Standardization (CEN) published a new version of the European Standard EN 12586: EN 12586:2025, Child care articles - Soother holder - Safety requirements and test methods, which supersedes the previous standard EN 12586:2007+A1:2011.

The main physical technical changes are as follows:

1. Renewed the structure and sections of the whole standard.
2. Deleted the individual requirement section for supplementary components and divide requirements for supplementary components into relevant sections.
3. Updated the scope in Section 1 to include an age grade limit covering products for children from birth to 36 months of age.
4. Updated the detailed descriptions of terms and definitions in Section 3, add Sections 3.5: connecting devices, 3.5.3: chain, 3.5.4: beaded elements and 3.10: outer packaging additionally.
5. Added requirements and figures of test equipment and tolerance in Section 5.
6. Updated the general requirements in Section 6.1, add requirements for magnetic parts, button and coin batteries and small parts test.
7. Retained the 220 mm length limit for soother holders without garment fastener in Section 6.2, add additional requirements for the whole soother holder length not exceeding 300 mm, the loop length not exceeding 110 mm, and the relevant limit for adjustable connecting devices.
8. Retained the strap width and cord thickness in Section 6.3, and add additional requirements for connecting device width/thickness, including chain width, exposed cords more than 15 mm, cords used to form or as part of soother fastener, cords with thickness less than 6 mm.
9. Defined the test equipment for entrapments in Section 6.5 to test with 5.5 mm test sphere and 12 mm test sphere.
10. Retained the ventilation holes requirements in Section 6.6, add additional requirements for permanent attached components (e.g. beads) which are not supplementary components but are only part of the connecting device and cannot fully cover a 25 mm diameter do not require ventilation holes.
11. Added requirements for suffocation hazard by packaging in Section 6.8.
12. Updated the requirements for consumer packaging in Section 8.
13. Updated the requirements for product information in Section 9.
14. Changed colour fastness method from EN ISO 105-E04 (test solution: artificial perspiration) to “Prüfung von eingefärbten Bedarfsgegenständen aus Kunststoffen und anderen Polymeren auf Farblässigkeit” (“Testing coloured consumer goods made of plastics and other polymers for colour fastness”) (test solution: artificial saliva simulant). Changed appliable materials from textile components and wooden parts of the soother holder to components which have been coloured or printed.

The main chemical technical changes are as follows:

1. Included additional materials (silicone elastomer, rubber, thermoplastic elastomer (TPE), leather and resin-bonded materials).
2. Modified the number of elements in the element migration test from 8 to 19.
3. Changed to conduct formaldehyde release test on the entire product, and set the limit as 0.75 mg/L, instead of on plastic, textile and wood components separately.
4. Lowered bisphenol A (BPA) migration limit from 0.1 mg/L to 0.04 mg/L, and lowered phenol migration limit from 15 mg/L to 5 mg/L.
5. Restricted 6 entries of preservatives in leather components.
6. Restricted 14 entries of solvent in decorations, coatings and resin-bonded materials.
7. Restricted N-nitrosamines and N-nitrosatable substances in silicone elastomers, rubber and thermoplastic elastomers (TPE).
8. Removed phthalates content and nickel release requirements since there are related test items in EU REACH Regulation (EC) No 1907/2006.
9. Emphasized products with claimed biocidal effect or intended biocidal action shall comply with EU BPR Regulation (EU) No 528/2012.
10. Recommended manufacturers and suppliers operate to EN ISO 9001 for quality management systems

The new standard EN 12586:2025 is scheduled to be given the status of a national standard at the latest by October 2025 and the conflicting national standards will be withdrawn by April 2026 at the latest.

The standard EN 12586:2025 applies to soother holders for children from birth to 36 months of age. Soother holders are articles that consist of a soother fastener, a garment fastener and a connecting device in between, e.g., a strap. The standard has laid down mechanical and chemical safety requirements relating to materials, construction, performance, packaging and labelling of soother holders. Soother holders that have significant play value shall additionally comply with the EU Toy Safety Directive 2009/48/EC.

Intertek China Hardlines labs are capable of providing you with testing services and technical support in compliance with the EU juvenile products-related regulations and standards.

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