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 Conflicting national standards are to be withdrawn by March 2019 at the very latest.
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standard is to be given the status of a national standard by March 2019 and conflicting national standards are to be withdrawn by this date at the latest.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 |
| PASS | ||
Table 1. Comparison of changes in Table 5
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