Europe Amends Regulation for Soothers Used by Babies and Young Children
11/01/2018

Europe's CEN has published amendment two to its safety standard for soothers - EN 1400:2013. Existing national standards must be withdrawn by March 2019.

Online PR News – 01-November-2018 – Geneva, Switzerland – The European Committee for Standardization (CEN) has published a second amendment to its safety standard for soothers designed to be used by babies and young children.

The new standard, EN 1400:2013+A2:2018, was published in September 2018 and it contains several important changes:

• Overview of the requirements and the related test methods for different materials (listed in Table 4) is amended and the category 'Thermoplastics' is now divided into 'All Thermoplastics' and 'Polycarbonate and Polysulphone'
• List of soluble elements from 17 to 19 in Table 5 is expanded and amended, in the case of some migration limits:
o Arsenic (As) - ≤ 2.5 mg/kg becomes ≤ 5.0 mg/kg
o Barium (Ba) - ≤ 200 mg/kg becomes ≤ 2,000 mg/kg
o Chromium (Cr) - no longer applicable as this category has been split into:
o Chromium (III), (Cr (III)) - ≤ 50 mg/kg, previously not applicable
o Chromium (VI), (Cr (VI)) - ≤ 0.001 mg/kg, previously not applicable
o Nickel (Ni) - ≤ 100 mg/kg becomes ≤ 28 mg/kg
o Organic tin - ≤ 1.3 mg/kg, previously not applicable
• Migration limit for bisphenol A (BPA) in Table 10 has been strengthen to 0.01 mg/L (previously 0.125 mg/L). This regulation will not apply in the following Europe Union (EU) States due to national legislation:
o Austria - Federal Law from the Ministry of Health Regulation Number 327 of October 6, 2011 prohibits the use of BPA in soothers and teething rings
o France - Article 2 of French Law Number 2012-1442 of December 24, 2012 relating to the 'ban on manufacturing, importation, exportation and placing on the market of food containers containing BPA', and modifying Article L. 5231-2 of the French Health Code by prohibiting BPA in teethers as well as shields in teats and soothers
• French translation of Table A1 of Annex A for warnings in a set form and order is updated

Stakeholders should be aware that for Cr (VI) the detection limit from EN 71-3 test method is applied. If the measured value of Cr (VI) in the sample is below the Limit of Quantification (LOQ) of the valid version of EN 71-3, then the sample is considered to have 'Passed'

The new version of EN 1400:2013 'Child Use and Care Articles - Soothers for Babies and Young Children - Safety requirements and Test Methods' will be given the status of a national standard by March 2019. Conflicting national standards must be withdrawn by this date.

The standard is already commercially available from national standards organizations, such as the British Standards Institution.

SGS Juvenile Products & Childcare Article Services
SGS's global network of laboratories and experts provide a range of services, including analytical testing and consultancy for toys, teats and soothers for the EU and international markets. Learn more about SGS's Juvenile Products & Childcare Article Services [www.sgs.com/en/consumer-goods-retail/toys-and-juvenile-products/juvenile-products-and-childcare-articles]

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