|
major changes
in SCOPE |
| |
Annex I is new:
Categories of covered EEE are
defined in the RoHS Directive itself (instead of referring back to
the WEEE Directive) |
| |
Category 8
equipment is included:
Effective July 22, 2014 for "medical
devices"
Effective July 22, 2016 for "in vitro medical devices"
(but not "active implantable medical devices") |
| |
Category 9
equipment is included:
Effective July 22, 2014 for "monitoring
& control instruments"
Effective July 22, 2017 for "industrial monitoring & control instruments" |
| |
Category 11 equipment is new:
Effective July 22, 2019 for "other electrical and electronic
equipment" not covered by any of the
other categories |
| |
Open Scope for RoHS is new:
Covers all electrical and electronic equipment except that which is
specifically excluded in Article 2(4): |
| |
|
Military equipment
Equipment sent into space
Large-scale stationary industrial tools
Large-scale fixed installations
Means of transport for persons or goods (except two-wheel)
Non-road mobile machinery exclusively for professional use
Active implantable medical devices
Photovoltaic panels producing energy in a fixed location
Equipment used only for research and development |
| |
Effective July 22, 2019 for "EEE that was outside the scope" of RoHS
Directive 2002/95/EC, such as: |
| |
|
Cables that connect EEE to other EEE or to electrical outlet
Electric two-wheel vehicles that are not type-approved
Equipment "dependent" on electric currents/electromagnetic fields to
fulfill at least one intended function |
|
No change
in Restricted
Substances |
| |
Annex II lists restricted substances and maximum concentration
values |
| |
|
Lead (0.1%)
Mercury (0.1%)
Cadmium (0.01%)
Hexavalent chromium (0.1%)
Polybrominated biphenyls (PBB) (0.1%)
Polybrominated diphenyl ethers (PBDE) (0.1%) |
| |
The Commission must
consider amendments to the list before July 22, 2014, so additions
should be expected in the future |
|
CHANGES to the EXEMPTION
PROCESS |
| |
Annex III is the same as the original
Annex:
Exemptions that are not specific to medical devices or monitoring
&
control instruments |
| |
Annex IV is new:
Exemptions
that are specific to medical devices or monitoring &
control instruments |
| |
Annex V is new:
Application information required for an exemption or renewal |
| |
Expiration dates
will be assigned to all exemptions:
Five-year maximum for Category 1-7 or 10-11 exemptions
Seven-year maximum for Category 8-9 exemptions |
| |
Exemptions may be
renewed
Application must be filed 18 months prior to expiration
Commission must issue its decision 6 months prior to expiration |
|
MAJOR CHANGES in COMPLIANCE |
| |
Module A is new:
Manufacturers must demonstrate compliance per Decision 768/2008/EC,
Annex II by maintaining technical documentation, citing relevant
harmonized standards, implementing internal production controls, and
keeping a register of nonconforming products |
| |
CE mark is
new:
Finished product must display CE mark, manufacturer's name, trademark, contact address,
and type/batch/serial number (to facilitate recalls) |
| |
EC declaration of conformity is more
rigorous:
Must
"accompany" the finished product, must contain elements listed in Annex VI,
and must be in the language of the local market |
| |
EEE not
manufactured in the EU must have an EU importer
Both manufacturer and importer are legally responsible for
compliance |
