5 September, 2018, The European Committee (CEN) published a second amendment to the safety standard for soothers for babies and young children. The new standard EN 1400:2013+A2:2018 Child use and care articles - Soothers for babies and young children - Safety requirements and test methods is applicable to products that resemble or function as a soother. This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers.


Amendments to the new standard include:

1. Reduce the limitation of bisphenol A (BPA) migration in infant pacifier products from 0.125 mg/L to 0.01 mg/L;

2. An amendment of the overview of the requirements and related test methods for different materials. The category 'thermoplastics' is divided into two new categories: 'all thermoplastics' and 'polycarbonate and polysulpfone';

3. Expansion of the list of soluble elements to 19 from 17;

4. Migration of total chromium divided into two types: chromium III and chromium VI. A new migration limit for chromium VI and a new entry for organic tin have been added;

5. New migration limits for arsenic, barium and nickel. For nickel, the limit has been strengthened nearly four-fold, whereas those for arsenic and barium have become less stringent;

All conflicting standards are to be withdrawn from March 2019 at the latest, CEN has said.

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