CEN Issues EN 12586:2025 for Soother Holders

SafeGuardSToys and Juvenile ProductsJune 18, 2025

SG 084/25

CEN has published the 2025 version of EN 12586 for soother holders. Conflicting national standards are to be withdrawn by April 2026.

In April 2025, the European Committee for Standardization (Comité Européen de Normalisation, CEN) issued EN 12586:2025 ‘Childcare articles – Soother holder – Safety requirements and test methods’. This standard specifies the safety requirements relating to materials, construction, performance, packaging and labeling for soother holder products for children from birth to 36 months of age.

EN 12586:2025 supersedes EN 12586:2007+A1:2011 and is a completely revised standard with a new structure. Highlights of several important changes in this new standard are summarized in Table 1.

Section to EN 12586:2025	Highlights of change
Introduction	Emphasizes that chemicals regulated under Regulation (EC) No 1907/2006 (REACH, current consolidated version to April 2025), such as phthalates, polycyclic aromatic hydrocarbons (PAHs) and nickel release, are not indicated in this standard to avoid double testing
Clause 3 ‘Terms and definitions’	Revises existing definitions and adds new terminologies, including ‘connecting device’, ‘chain’, ‘beaded elements’, ‘touch-and-close device’ and ‘outer packaging’
Clause 4 ‘Description of a soother holder’	Amends pictorial representations/descriptions for different types of soother holders and their design features
Clause 6 ‘Mechanical requirements and test methods’	Improves the description of the requirements and test methods to better cover all different designs on the market and to ensure better reproducibility of test results and safety assessments: Adds a requirement for hygiene concerns Adds a requirement related to magnets (in line with EN71-1 requirements) Emphasizes that button and coin batteries are not allowed Addresses suffocation hazard requirements for plastic packaging
Clause 7.2 , Table 2 ‘Tests to be carried out on materials’	Expands the set of defined materials that must be tested for specified chemicals to include 1) leather, 2) resin-bonded materials, 3) rubber and thermoplastic elastomer (TPE) and 4) silicone elastomer Stresses that manufacturers are responsible for the risk evaluation of materials not listed in Table 2 and address them accordingly New requirements for N-nitrosamines and N-nitrosatable substances for 1) silicone and 2) rubber and TPE materials New requirements for the migration of 14 solvents for 1) decoration and coating and 2) resin-bonded materials
Clause 7.3, Table 3 ‘Limits of element migration from soother-holder materials	Expands the number of migratory elements from eight to 19 elements (see Table 2 below)
Clause 7.4 ‘Color fastness’	Revises and divides the test into ‘first action’ and ‘final action’ methods
Clause 7.7 ‘Formaldehyde’	≤ 0.75 mg/L (formaldehyde per liter of migrate) using the migration procedure as described in the standard and EN 71-11:2005
Clause 7.8, Table 6 ‘Monomers (migration)’	Strengthens requirements for the migration of bisphenol A (BPA) and phenol: ≤ 0.04 mg/L BPA migration (from 0.1 mg/L) ≤ 5.0 mg/L phenol migration (from 15 mg/L)
Clause 7.10 ‘Leather preservatives’	Adds new section for the determination and requirements for six restricted leather preservatives
Clause 9.2 ‘Purchase information’	Visible information on the packaging or at the point of sale to include instructions for use and warnings (clauses 9.4 and 9.3), or if these are included within the packaging, an indication that this is the case (symbol 1641 in ISO 7000:2019 may be used) Requires information disclosure for products made of natural rubber latex
Clause 9.5 ‘Supply chain for product that contain vulcanized rubber’	The phrase ‘Keep away from sunlight and heat’ and/or symbol 0624 from ISO 7000:2019 must be provided on any outer packaging used for storage of products that contain vulcanized rubber

Table 1. Highlights of changes in EN 12568:2025

Element	Limit value (mg/kg)	Element	Limit value (mg/kg)
Aluminum (Al)	18,750	Lead (Pb)	16
Antimony (Sb)	375	Manganese (Mn)	1,875
Arsenic (As)	31	Mercury (Hg)	63
Barium (Ba)	12,500	Nickel (Ni)	175
Boron (B)	10,000	Selenium (Se)	313
Cadmium (Cd)	11	Strontium (Sr)	37,500
Chromium (Cr (III))7	313	Tin (Sn)	125,000
Chromium (Cr (VI))	0.006¹	Organic tin	8
Cobalt (Co)	88	Zinc (Zn)	31,250
Copper (Cu)	5,188	--	--
¹Sample is considered a ‘Pass’ if result is below the limit of quantification in EN 71-3:2019+A1:2021

Table 2. Limits of element migration from soother-holder materials as per Table 3 in EN 12596:2025

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