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CEN published new EN 71-3 on migration of certain elements

Time : 2019-05-15 16:20:23

In 2019 April, the EN71-3:2019 had been published to support the chemical requirements of EU Toys Safety Directive (2009/48/EC).

1.The main changes and issues are as follows:
a.The limit value of hexavalent chromium for material category III, changed from 0.2mg/kg to 0.053mg/kg, will be effective from Nov 18, 2019.
b.For coating, sieving is no longer required and the corresponding annex with sieve requirements (former Annex C) has been deleted. the dewaxing procedure was changed from n-heptane extraction for 6 h to isooctane extraction for 60 min.
c.Revised the test method for hexavalent chromium.which can determine Chromium (VI) at the limit values for all material categories.
d.The test method for organic tin has been revised in appendix G. a new organotin-DMT (Dimethyl tin) has been added in this test method, which contain 11 organotins currently.

2.All significant technical changes between this document and the previous version are as below:

Clause/Paragraph
/Table/Figure
Change
3 New terms and definitions for sample and laboratory sample added and terms and definitions on limit of detection, limit of quantification and other material (whether mass coloured or not) removed.
4.2 table 2 the limit value for Chromium (VI) for material category III adapted to new legal limit values. Change from 0.2mg/kg to 0.053 mg/kg, will be effective from Nov 18, 2019.
6.2.6 The list of reagents and apparatus has been revised
7 Sampling and sample preparation have been revised and restructured to improve the user-friendliness of the standard. In particular sieving is no longer required and the corresponding annex with sieve requirements (former Annex C) has been deleted. the dewaxing procedure was changed from n-heptane extraction for 6 h to isooctane extraction for 60 min.
8.2.3 The migration procedure has been revised and more detailed procedures for checking the pH before and after migration has been introduced: for buffering effect by toy material, the PH value needs to be adjusted four times, and the control step of PH value after migration was added
9 The stabilization of the migration solution has been revised. The status of test methods (included in Annex E, Annex F and Annex G) has been changed to normative. Performance requirements concerning the use of modifications to the annexes and alternatives to the specified test methods have been introduced.
10 The calculation has been revised, in particular Chromium (III) is now calculated by subtracting the Chromium (VI) concentration from the total chromium concentration.
11 Data on method performance have been introduced based on the results of test method validation and in particular the results of an interlaboratory comparison.
Annex B A new informative annex containing information on the method development has been introduced.
Annex C A new informative annex with estimations of reproducibility has been added.
Annex D A new annex concerning the use of visual particle size comparison materials has been added.
Annex E Minor revisions of the test method for general elements have been made.
Annex F The test method for Chromium (III) and Chromium (VI) has been replaced by a test method for Chromium (VI) which can determine Chromium (VI) at the limit values for all material categories. The test methods for chromium (III) and chromium (VI) were changed from LC-ICP-MS to IC-ICP-MS
Annex G The test method for organic tin has been revised.
Annex H Various rationales have been revised and new rationales concerning sampling and dewaxing have been added.


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