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What is
the New Legislative Framework?
Regulation (EC) 765/2008
Decision 768/2008/EC
The
EU's New Legislative Framework (NLF) is the modernization of its
New Approach to technical harmonization. Under the New Approach, directives specify only
the "essential elements" for safe products; optional technical requirements
for compliance are specified in the "harmonized standards" developed
by non-profit
European standards organizations (ESO).
Adopted July 9,
2008 and effective January 1, 2010,
Regulation (EC) 765/2008
requires Member States to establish accreditation and market
surveillance systems under rules designed to increase product
compliance and promote uniformity among the Member States.
Each Member
State must appoint a single national
accreditation body (NAB) responsible for accrediting all
"conformity assessment bodies" operating within its borders.
NABs
must not offer conformity assessment services themselves, they must
be not-for-profit, and they must be audited annually.
The national
accreditation bodies must be members of the
European cooperation for Accreditation (EA) which is
to coordinate a rigorous and transparent system of peer review.
Conformity
assessment bodies (CAB) are third-party organizations who
perform testing and inspection of manufacturing products and
processes for the purpose of certifying conformity with specified
requirements (such as an EU directive or an international standard)
While CABs must be
accredited by the national accreditation body (NAB) for the Member
State in which they are established, a single accreditation is good for the whole EU territory.
Each Member State
must carry out market surveillance
activities
(such as documentary checks and sample testing) on an adequate
scale, based upon established principles of risk assessment,
complaints and other information. Also included is the right to
enter the manufacturer/importer/distributor's place of business and
request additional documentation of compliance.
Market
surveillance is required for all products covered by EU
"harmonization" legislation, except for these
products which are specifically excluded: food,
feed, living plants and animals, products of human origin, products
of plants and animals relating directly to their future
reproduction.
Member states
should pay particular attention to enforcing the compliance of
imported products. Customs authorities must carry out
checks at external borders on an
adequate scale.
Member States may
order recall or destruction of
products that present a serious risk.
The
CE mark
may be affixed to products only when its use is
required by specific EU legislation and only by the
manufacturer of the product. Member States must ensure the correct
application of the CE mark and provide penalties for its misuse.
Also
adopted July 9, 2008, Decision 768/2008/EC provides an extensive
legislative "toolkit" to be used in
drafting future directives. Annex II contains 16 different modules
for conformity assessment. Variables include manufacturer declaration of
conformity with either the essential requirements or an approved type
(standard); tests on specific aspects of the product or random checks on the
final product; product testing by accredited in-house body or a third party "notified
body" (i.e. CAB accredited for this requirement); ISO certified quality
system for design, production and/or final inspection/testing.
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.
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.
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