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EU revises CLP regulations to lower the concentration limits of certain boron compounds
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Time:2021-07-15
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        On May 28, 2021, the European Commission issued the Authorization Regulation (EU) 2021/849, amending Regulation (EC) No1272/2008 "Regulations on                      Classification, Labeling and Packaging of Substances and Mixtures" (CLP Regulation).


   The amendment will take effect on June 17, 2021, and will be implemented from December 17, 2022.


   The regulation amended Table 3 ("Uniform Classification and Labelling List of Hazardous Substances") in Part 3 of Annex VI of the CLP Regulation, and deleted the specific concentration limit values (SCL) of 7 boron compounds.


   These boron compounds will be applied to a lower general concentration limit (GCL) than before: 0.3% (Class 1B reproductive toxicants (Repr.1B)).


"If the concentration of these boron compounds in another substance or mixture as impurities, additives or individual components is greater than or equal to this concentration limit (0.3%), the other substance or mixture will be classified as a reproductive toxicant.


   EU Toy Safety Directive 2009/48/EC prohibits the use of CMR substances in toys (that is, substances that are classified as carcinogenic, mutagenic or toxic to reproduction).


   However, as an exemption, if the individual concentration of these substances or mixtures is less than or equal to the relevant concentration specified in the CLP regulations for the classification of mixtures containing these substances, these CMR substances or mixtures are allowed to be used in toys.


   Therefore, the concentration limit of these boron compounds in toys and toy parts will be reduced to 0.3% (that is, the general concentration limit value for the classification of mixtures caused by category 1B reproductive toxicants)


   (Note: Toys and toy components must also comply with the boron element (B) migration limit specified in Point 13 of Part III of Annex II of the Toy Safety Directive 2009/48/EC.)


  The boron compounds involved in the revision are as follows:


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   Boron compounds are often used as raw materials to produce Slime and Putty toys to make them more elastic and malleable.


   Ingestion of medium to high doses of boron compounds may cause nausea and vomiting.


   Long-term intake of boron compounds will adversely affect fertility. Toy manufacturers should control the content of boron compounds in toys to ensure the safety of children.


  In addition to boron compounds, Regulation (EU) 2021/849 also added, revised, and deleted other substances in Table 3 of Part 3 of Annex VI of the CLP Regulation.


   For a detailed list of these substances, please refer to the following official website link:


  Https://eur-lex.europa.eu/eli/reg_del/2021/849/oj