On 2015-June-4, European Commission published (EU) No. 2015/863 to amend Diretive 2011/65/EU (Recast) , the new amendment added 4 phthalates into the hazardous substance list. The new requirements shall be enforced on 2019-July-22. New Restriction and its limit is shown below:
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New Restricted Substance List
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Hazardous Substance
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Limit
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Lead
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0.1 %
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Mercury
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0.1 %
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Cadmium
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0.01 %
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Hexavalent Chromium
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0.1 %
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Polybrominated biphenyls (PBB)
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0.1 %
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Polybrominated diphenyl ethers (PBDE)
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0.1 %
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Bis(2-ethylhexyl) phthalate (DEHP)
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0.1 %
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Butyl benzyl phthalate (BBP)
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0.1 %
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Dibutyl phthalate (DBP)
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0.1 %
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Diisobutyl phthalate (DIBP)
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0.1 %
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The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.
The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.