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CEN Publishes Amendment 2 to EN 1400 for Soothers

Photo: Baby Products
Photo: Baby Products

In September 2018, the European Committee for Standardization (Comité Européen de Normalisation, CEN) published EN 1400:2013+A2:2018, 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).

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. 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 the table below and amending some of these migration limits. 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).

    • 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 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standard is to be given the status of a national standard by March 2019 and conflicting national standards are to be withdrawn by this date, at the latest.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 below between the A1:2014 and A2:2018.

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/kgNot applicable
Chromium (VI), (Cr (VI))≤ 0.001 mg/kg*Not applicable
Nickel (Ni)≤ 28 mg/kg≤ 100 mg/kg
Organic tin≤ 1.3 mg/kgNot 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’

Changes of limit of Element Migration from Soothers

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