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What is
RoHS2?
RoHS is short for
Restriction
of Hazardous Substances.
RoHS2 refers to the proposed revision of the original RoHS Directive.
Proposed Directive - RoHS2
Decision 768/2008/EC - New Legislative Framework
Decision 1999/468/EC
- Implementing Powers
The
proposed directive incorporates the European Union's
New Approach to legislation which aims to
make its regulation less burdensome to business, more enforceable, and more
nimble in adapting to technical progress. It does so by separating the
"essential elements" of a directive from its technical requirements, which
are to be developed by non-profit
European standards
organizations (ESO).
In
July 2008, the New Approach was modernized and expanded with the issuance of
Decision 768/2008/EC and Regulation EC/765/2008 on the marketing of
products, commonly known as the
New
Legislative Framework (NLF). It is intended that these documents provide a common
legal framework
for all subsequent directives through common definitions and
a "toolbox of measures" for implementation. Rules governing the
CE mark, accreditation of conformity
assessment bodies (CAB), and market surveillance by Member States
were strengthened.
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major changes
proposed under RoHS2: |
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Category 8 & 9
electrical and electronic equipment (currently excluded due to
concerns about reliability) will be included in the scope of RoHS,
with appropriate transition periods provided.
-- Category 8 equipment
Medical devices, covered effective Jan 1,
2014
In vitro medical devices, covered effective Jan 1, 2016
Active implantable medical devices, not covered but under review
-- Category 9 equipment
Monitoring & control instruments, covered
effective Jan 1, 2014
Industrial monitoring & control instruments, effective Jan 1, 2017 |
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Exemptions will be granted for a maximum
period of four years;
if renewal of the exemption is desired, a new application must be
filed 18 months prior to the expiration date (currently exemptions
are granted with no expiration date). |
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RoHS2
compliance measures are specified in Module A
of the New Legislative Framework (NFL) Decision 768/2008/EC,
Annex II (guidance for compliance procedures
is currently provided by each Member State, creating a patchwork of
often
conflicting rules). |
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Module A conformity assessment
procedures specifies the type of technical documentation that must
be maintained by the manufacturer. In addition, testing of the final
product (or of specific aspects of the product) is required and must
be performed by either an accredited
in-house body or by a
notified body of the manufacturer's choosing
(notified bodies are CABs that have been accredited by the Member
States). |
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Products must have
an EC declaration of conformity
from the manufacturer; they must bear the
CE mark; and they must be marked with a
type, batch or serial number to
facilitate identification and recalls (not currently required,
except for a few types of electrical and electronic equipment
covered by other directives which require the CE mark). |
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When products are
manufactured outside the EU, both the manufacturer located outside
the EU and the importer established within
the EU have legal liability for product compliance (this
strengthens enforcement by requiring there to be an accountable EU
entity and follows the definition of "importer" set out in REACH). |
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no change under
RoHS2: |
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No change in the list of
prohibited
substances
(or their maximum concentration values):
Lead, 0.1% by weight
Mercury, 0.1% by weight
Cadmium, 0.01% by weight
Hexavalent chromium, 0.1% by weight
PBB (polybrominated biphenyls), 0.1% by weight
PBDE (polybrominated diphenyl ethers), 0.1% by weight |
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Still excludes equipment specifically designed as part of another type of
equipment that is not within the scope of RoHS (such as
automotive
electronics). |
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No change in the list of thirty-two
exemptions, with no new exemptions proposed
for the existing categories of equipment. However, there are new exemptions proposed for category 8
& 9 equipment. |
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NEW ANNEXES proposed
for RoHS2: |
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Covered categories
of equipment are specified in Annex I (no longer tied to the
WEEE directive) |
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Annex II
provides a binding list of products for each category of equipment
covered by RoHS |
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Annex III
provides a list of substances under review for eventual inclusion in
RoHS |
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Prohibited
substances are specified in Annex IV (no longer specified in
the directive itself) |
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Exemptions for
specific applications which were contained in the
original Annex
are now specified in Annex V |
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Exemptions for
Category 8 & 9 applications are specified separately in Annex VI |
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Annex VII
lists the required elements for an EC Declaration of Conformity |
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Annex VIII
lists the legislation which RoHS2 will obsolete (i.e. repeal)
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Annex IX provides a
correlation table for RoHS and RoHS2 |
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The annexes contain
"non-essential elements" that may be
amended by committee procedure as specified in Article 18(2) |
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COORDINATION with
other EU directives/regulations: |
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RoHS2 follows
guidelines specified in the
New Approach and the
New Legislative Framework
for:
CE mark requirements
Manufacturer compliance
Member State market surveillance
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RoHS2 follows the
Medical Directives in the
following:
Definition of medical device per Directive 93/42/EC;
Definition of in vitro diagnostic device per Directive 98/79/EC;
Definition of active implantable medical device per Dir.
90/385/EEC;
RoHS2 exemption is automatically approved if a "notified body"
performing a conformity assessment has certified that the safety of
a potential substitute is not demonstrated |
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Coordination with
REACH:
Product applications with RoHS2 exemptions are automatically exempted from
the REACH authorization requirement;
Identification of additional RoHS2 prohibited substances will
utilize data and deliberations submitted under REACH |
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Coordination with
Decision 1999/468/EC - Implementing Powers:
RoHS2 "non-essential elements" may be amended by the committee
procedure specified in this decision |
If you need assistance
in implementing or managing your company's RoHS compliance, we stand ready
to help you. Just
email
us or give us a call at 972-679-8996 for a timely and personalized response.
This summary is intended to give you an easy-to-understand overview and does
not constitute legal advice. The actual standard in the original language
should be reviewed and used for all business, legal, and product compliance
purposes.
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Technical Consulting
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