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EU Published EN71-3:2019 under toys safety directive

EU Published EN71-3:2019 under toys safety directive

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.

歐盟正式發佈最新EN71-3:2019版本

2019年4月,歐洲標準化委員會(CEN)發佈了玩具安全標準EN 71第3部分:特定元素的遷移的2019版。

1.主要修訂內容:
a. 第三類材料的六價鉻的限值,由0.2mg/kg更改至0.053mg/kg,於2019-11-18生效。
b. 對於塗層樣品,取消了過篩的要求,相關篩網的要求(前附錄C)也已經刪除,除蠟程式由正庚烷抽提6h更改為異辛烷抽提60min。
c. 修訂了鉻(VI)的測試方法,修訂後的方法可以滿足所有類別材料的限量。
d. 附錄G修訂了有機錫的測試方法。該方法所涉及的有機錫物質由10種變更為11種。Table G.1有機錫新增了一項DMT。

2.新版本所有修訂內容:

章節號

變更內容

3

新增術語定義:樣品和實驗室樣品;刪除以下術語定義:檢出限,定量限和其他材料。

4.2 table 2

修訂第三類材料的六價鉻限量,由0.2mg/kg更改至0.053mg/kg,於20191118日生效

6.2.6

修訂試劑和儀器清單

7

新版把舊版的樣品製備的章節7拆分為7~8章樣品製備和遷移程式,樣品製備表述更加容易理解,對於塗層樣品,取消了過篩的要求,相關篩網的要求(前附錄C)也已經刪除,除蠟程式由正庚烷抽提6h更改了異辛烷抽提60min

8.2.3

修訂遷移程式中有關PH值的調節過程,對於有緩衝體系的樣品,需要經過四次調節PH值的操作,增加了對於遷移後PH的控制步驟

9

新增了對於不同元素(一般元素,六價鉻,有機錫)遷移溶液的穩定性要求和測試儀器

10

更改了三價鉻的計算方式,三價鉻=總鉻-六價鉻

11

新增了實驗方法驗證的結果,特別是實驗室間的比對結果,列舉了有關方法性能的資料

附錄B

新增了資料性附錄B,方法驗證的資訊

附錄C

新增了資料性附錄B,對於再現性的評價

附錄D

新增了資料性附錄D,關於不同類別材料的粒徑的指引

附錄E

對一般元素的測試方法進行了少量的修訂

附錄F

修訂了六價鉻測試方法,修訂後的方法已經能包含所有類別的限量

附錄G

修訂了有機錫的測試方法

附錄H

基本原理的資料性附錄新增採樣和除蠟程式的相關原理,並修訂了部分原理

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