EN 12586:2025 Published

The CEN has issued the 2025 version of EN 12586 on Child Care Articles – Soother Holders – Safety requirements and methods.

Requirement Summary and Effective Dates:

On April 2nd, 2025, the CEN issued EN 12586:2025 on Child Care Articles – Soother Holders – Safety requirements and methods, superseding the previous EN 12586:2007+A1:2011.

The document was almost entirely renewed and given a new structure. Significant technical changes for the physical part include:

• Inclusion of a new requirement of magnetic parts
• Prohibition of the use of button and coin batteries
• Addition of new requirements of suffocation by packaging
• Revision of the ventilation holes requirement and test method, for example, use of the Test spheres and 25 mm diameter Test Guide.

Significant technical changes for the chemical part include:

• Specified that products with claims of biocidal effects must comply with Regulation (EU) 528/2012
• Expansion of the list of materials used for soother holders (silicone elastomers, rubber, thermoplastic elastomers (TPE), leather and resin bonded materials)
• Removal of requirements for restricted substances regulated under REACH to reduce double testing (phthalate content and nickel release)
• Expansion of the list of heavy metals to be tested for migration: 19 heavy metals as for Toy Safety Directive 2009/48/EC but with more severe limits,
• New method for colour fastness
• For aromatic amines evaluation, the preliminary step with colour fastness is limited to specific materials (textiles, silicone, wood) 
• Revision of limits and test methods for formaldehyde release,
• Revision of migration limits for BPA (now 0.04 mg/L) and phenol (now 5 mg/L)
• Addition of requirements for preservatives in leather
• Addition of requirements for N-nitrosamines and N-nitrosatable substances in rubber, TPE and silicone elastomer, refer to EN 71-12:2016
• Added new restrictions for 14 solvents for decorative items, coatings and resin bonded materials
• Specified in Annex B rationale for the specific migration limits listed

The new standard is expected to be harmonized by the end of October 2025.

How Does this Impact You? Contact Us to Discuss
If you have any questions, please contact your customer service representative or email: info@us.bureauveritas.com
25B-061