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Hazardous Substances in RoHS
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Lead (0,1 %)
Mercury (0,1 %)
Cadmium (0,01 %)
Hexavalent chromium (0,1 %)
Polybrominated biphenyls (PBB) (0,1 %)
Polybrominated diphenyl ethers (PBDE) (0,1
%)
Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Di isobutyl phthalate (DIBP) (0,1 %)
July, 2019
Medical, In-Vitro Monitoring and ControlJuly, 2021
The 2 possible ways to demonstrate compliance to RoHS in Europe
Manufacturers options
4
RoHS
Directive
material
testing1
2
EN 50581
or
IEC 63000
Test
Report
TCF
EU DoC
Basic EN 50581 thinking-
Shit in-Shit out
9
Input-Material incl.
documentation
Your production
Ware-house
Production Package
Output-Product
Supplier Customer
Control Here
Selected items
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• 4 new substances into RoHS from July 22nd, 2019
• Scope expansion from July 2019.
• Update on exemptions
4 new substances into RoHS from July 2019
Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
Butyl benzyl phthalate (BBP) (0,1 %)
Dibutyl phthalate (DBP) (0,1 %)
Di-isobutyl phthalate (DIBP) (0,1 %)
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Consequences for Industry
Increased costs for Ban-free plastics
Increased costs for testing
Large maintenance job for updating all
technical files for RoHS
Updates of DoC’s
HAVE NOT STARTED???
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Introducing category 11 (catch all clause)
Removes discussions around- in scope or not. Like - are shoes with light inside or not ?
Carousels, Amusement park rides, USB...................
Covers veterinary and photovoltaic cells.
Scope expansion for RoHS –22 of July 2019
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