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In September 2018, the European Committee for Standardization (CEN) published new standard EN 1400:2013+A2:2018, safety requirements and test methods for soothers for babies and young children.
The new standard is to be given the status of a national standard by March 2019 and conflicting national standards are to be withdrawn by this date at the latest.
EN 1400:2013+A2:2018 contains a number of important changes, the details are as follows:
1. Abstract/Scope: This European Standard specifies safety requirements relating to the materials, construction, performance, packaging and product information for soothers. This European Standard is applicable to products that resemble or function as a soother. Some soothers may be marketed with other functions.
This European Standard does not apply to products designed for specialist clinical medical applications. The standard is not applicable to feeding teats.
2. The following table summarizes a comparison of changes for soluble elements between A1:2014 and A2:2018 versions of EN 1400.
3. The new standard strengthens the migration limit for bisphenol A (BPA) 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
MTS reminds related companies to timely follow upon new laws and regulations, produce and export according to requirements, and pay attention to the requirements of the declaration of conformity. Scientific safety assessments must be carried out during the product design phase to the bulk production phase to ensure that relevant products meet the new regulatory requirements and avoid export risk.
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