CEN has published EN 1400:2013+A2:2018 for soothers for babies and young children. Conflicting national standards are to be withdrawn by March 2019 at the very latest.

SAFEGUARDS | Hardlines NO. 141/18

SafeGuardS orig baby crawling with pacifier

In September 2018, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 1400:2013+A2:2018 [1], the new safety standard for ‘Soothers for Babies and Young Children’. This new standard is now available on a commercial basis at national standards organizations, such as the British Standards Institution (BSI [2])

EN 1400:2013+A2:2018 contains a number of important changes, including the following:

  • Amending the overview of the requirements and the related test methods for different materials as listed in Table 4. The category ‘Thermoplastics’’ is divided into two new categories: ‘All Thermoplastics’ and ‘Polycarbonate and Polysulphone’
  • Expanding the list of soluble elements from 17 to 19 in Table 5 and amending some of these migration limits (see Table 1 below for the changes). These changes include dividing the migration of (total) chromium into two types of chromium: chromium (III) and chromium (VI), a completely new entry for organic tin, and new limits for arsenic, barium and nickel. It is interesting to note that the migration limit for nickel has been strengthened approximately 4-fold, but limits for arsenic and barium have become less stringent.
  • Strengthening the migration limit for bisphenol A (BPA) in Table 10, from 0.125 mg/L to 0.01 mg/L. It is important to note that this limit is not applicable to certain member states in the EU due to national legislation, including:
    • Austrian Federal Law from the Ministry of Health Regulation Number 327 of October 6, 2011 prohibiting the use of BPA in soothers and teething rings (Safeguard 3/12 [3])
    • 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.
  • Amending the French translation in Table A1 of Annex A for warnings in a set form and order.

According to EN 1400:2013+A2:2018, this standard is to be given the status of a national standard by March 2019 and conflicting national standards are to be withdrawn by this date at the latest.

Highlights of a comparison of changes for soluble elements in Table 5 between the A1:2014 and A2:2018 versions of EN 1400 are summarized in Table 1.

EN 1400:2013 ‘Child Use and Care Articles – Soothers for Babies and Young Children – Safety requirements and Test Methods
Table 5 ‘Limits of Element Migration from Soothers’
A2:2018 A1:2014
Arsenic (As) ≤ 5.0 mg/kg ≤ 2.5 mg/kg
Barium (Ba) ≤ 2,000 mg/kg ≤ 200 mg/kg
Chromium (Cr) Not applicable ≤ 50 mg/kg
Chromium (III), (Cr (III)) ≤ 50 mg/kg Not applicable
Chromium (VI), (Cr (VI)) ≤ 0.001 mg/kg* Not applicable
Nickel (Ni) ≤ 28 mg/kg ≤ 100 mg/kg
Organic tin ≤ 1.3 mg/kg Not applicable
*The actual detection limit of EN 71-3 test method is to be 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, the sample is considered ‘Passed’

Table 1. Comparison of changes in Table 5

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