Brussels, 25 June 2008

Ref:   FILENAME   \* MERGEFORMAT  20080616  

DG ENTR/I/4

supplier’s declaration of conformity (SDoC) – a cross-atlantic
single market for electrical and ict products

The European Commission submits the rationale for its request to the
Occupational Safety and Health Agency (OSHA) to review its conformity
assessment procedures in the area of electrical and electronic products.

Resulting from discussions between the EU and the US under the
Transatlantic Economic Council, OSHA announced that it will issue a new
Request For Information (RFI) seeking to review its National Recognised
Testing Laboratory (NRTL) programme, in view of promoting transatlantic
trade and regulatory convergence.

Rationale

The EU has a long experience with conformity assessment regimes that do
not oblige manufacturers to demonstrate compliance with essential public
interest requirements through obligatory 3rd party certification of
their products.  Such certification is considered as a barrier to trade
that should be justified.  The choice of the conformity assessment
regime is made on the basis of an assessment of the risk to consumers,
workers and the general interest that non-compliant products would reach
the market place that would pose danger.  In many areas it was concluded
that these risks are at a level that they can be satisfactorily managed
by obliging manufacturers to demonstrate compliance and to keep such
proof at the disposal of public authorities for inspection at all times.
 These rules, together with horizontal liability, consumer protection
legislation and an appropriate enforcement guarantee a high level of
safety for European consumers.  In the area of electrical safety the Low
Voltage Directive that covers all products between 50-1000 V AC and
75-2500 V DC and which was adopted in 1973 is based on this principle. 
Products below the voltage limits of the LVD are covered by the General
Product Safety Directive, which does also not require 3rd party
certification.  In many cases manufacturers rely on the expertise of
certification bodies of their choice to assess the conformity of their
products.

The United States have a long standing tradition with this approach
(informally referred to as self-declaration of conformity or SDoC) and
in many areas have made similar assessments as the EU.  The area of
electrical safety is a notable exception.  Because of the specific legal
situation in the US, the rules that were designed in the early 70's for
ensuring the safety of electrical products used in the workplace have
become the de facto market access rule for most electrical products for
the US market.

At the time it was considered that 3rd party certification for these
products was necessary, even though this decision was not the result of
an in-depth risk assessment.  This principle has since then been
continued and has been applied to all new types of electrical and
electronic products that appeared on the market, regardless of their
level of compliance or their risk to workers and consumers.

The European Commission considers that it is pertinent for OSHA to
review the proportionality of its approach.  It firstly causes an
imbalance in market access regimes governing transatlantic trade in
electrical products.  Secondly they create an imbalance in market access
for the certification industry as US certifiers can without any barrier
offer their services to US industry to comply with EU rules, whereas EU
certifiers require either recognition as a NRTL by OSHA or be accepted
as a test house by NRTLs. Thirdly maintenance by the US of its approach
is providing little incentive for 3rd countries importing products from
the US and the EU to refrain from requiring local testing and approval. 
The European Commission recalls the discussions in the WTO-TBT, which
demonstrate that SDoC is widely perceived as an alternative to
conformity assessment systems that create de facto trade barriers
through mandatory certification.

A rule change is justified by the fact that European consumers and
workers experience a high if not higher level of electrical safety as
their counterparts in the US.  This is on the one hand brought about by
the high level of safety of electrical and electronic devices but also
by other factors that contribute to electrical safety, notably
electrical installation codes that prescribe amongst others the use of
Residual Circuit Breakers.  Statistics furthermore demonstrate that
accidents can seldom be attributed to products, but are normally the
result of "live" wires and neglect.  Where they can be attributed to
products, there are no indications that in the EU there is a
relationship between non-compliance and incidents.  On the contrary,
statistics show that they are the result of misuse or simply incidents
caused by other factors (e.g. electrical devices falling of shelves). 
In reviewing the current system, OSHA should collect such statistics as
part of a risk assessment.

The experience in the EU does not support the sometimes voiced fear,
that without a 3rd party certification system the market would be
swamped with dangerous products, notably from China.  Whilst EU market
surveillance authorities pay specific attention to the low price/low
technology segment of the market, following some incidents over the last
years, market mechanisms ensure that most electrical and electronic
products and especially high technology products and high volume
products follow rigid quality controls and have an excellent record of
compliance.

Elements for consideration in a Request for Information

The objective of this RFI is to gather information that will enable OSHA
to do an informed assessment of the effects of a system that would not
further rely on obligatory 3rd party certification.  It should asses
which elements such a system should contain in order to attain the level
of compliance that is to be obtained.  It does not seem appropriate for
the Commission to suggest to OSHA the exact scope of products that
should be considered for an SDoC system or whether such a system should
be operated in parallel with the current NRTL system to build up
experience.  Whilst having the experience for SDoC to operate successful
for equipment operating in and below the voltage ranges covered by the
EU Low Voltage Directive, the Commission would understand a segmented
approach in which product areas are given priority, where US and EU
industry have explicitly suggested a move towards SDoC.

The RFI should seek information from stakeholders on the state of the
art of production processes, the factual risks of products in different
product segments and should seek statistics on incidents with electrical
and electronic products and their causes.  Since horizontal legislation
(liability, consumer protection, workplace legislation) already are a
deterrent for placing non-compliant products on the market, it should be
asserted whether sector specific legislation remains necessary to
protect workers and consumers and what such legislation should ensure.

A revised rule making would need to propose a complete regulatory
system.  The RFI would hence need to seek comments on:

The objectives and the evidence demonstrating the need for sector
specific regulation;

The obligations on manufacturers and other market players in terms of:

Safety objectives to be reached and technical requirements to be met;

Tests or risk assessments that have to be done;

Documentation that is to be produced;

The location at which such documentation is to be kept;

Ensuring traceability of products in case of non-compliance (marking and
labelling);

Enforcement

(Where needed) sector specific liability and consumer protection
legislation

Access to product information and information on production, including
for foreign produced products;

Effective enforcement tools: means for recall, fines, market control
(CPSC, Customs, OSHA workplace inspections)

It would not be proper for the Commission to suggest specific approaches
to these elements, but recalls the provisions of EU legislation, which 

gives preference to using global standards as a basis for compliance
(with safeguards to take account of specific local conditions);

does not oblige the use of accredited tests, even though they are
strongly recommended;

does recognise the results of tests done in reputable test laboratories
around the world without requiring their explicit recognition under EU
law;

oblige manufacturers to label equipment so as to make it possible to
trace the manufacturer and to keep a technical file at the disposal of
authorities at all time.

	EUROPEAN COMMISSION

ENTERPRISE AND INDUSTRY  DIRECTORATE-GENERAL





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