the 2018 lvd guide - compliance & risks...• the lvd applies to all forms of supplying...
TRANSCRIPT
The 2018 LVD GuideWhat suppliers of electrical equipment to the EU need to know
C&R Webinar, 27 November 2018
Presented by Dr Alex Martin
Agenda
• Background
• Scope-related guidance
• Advice pertaining to overlaps in legislation
• Guidance on economic operator obligations
• Conclusion
RINA overview
• Originally established in 1861, RINA is an Italian-owned business active across
testing, inspection and certification as well as in engineering consultancy.
• In recent years it has grown through acquisitions, including Edif ERA (ERA
Technology Ltd) in 2016.
• As of 2018, RINA has a global network of 3,700 professionals across 65
countries.
• At Leatherhead in the UK, RINA’s Industry service includes consultancy on
technical and environmental regulation affecting electrical and electronic
equipment.
Product Regulatory Compliance
Support with product-related requirements, including:
Circular Economy
Global Market
Access
Chemicals
Responsible
Sourcing
New law, new guidelines
• The Low Voltage Directive is a longstanding EU law – it dates back to
1973. This means it predates the “New Approach” (i.e. the LVD was not
a CE marking Directive when first adopted as CE marking had yet to be
developed).
• In its 45 year history it has experienced two revisions, each initiated by
the European Commission:
• Codification in 2006; and
• A recast in 2014.
• Over the years, the European Commission has also published non-
legally binding guidelines (e.g. in 1997, 2001, 2007).
• The Commission published provisional guidance in support of the LVD
recast in 2015/6. An updated set of guidelines was expected to follow.
Article 1 of the LVD
The purpose of this Directive is to ensure that electrical equipment on the
market fulfils the requirements providing for a high level of protection of
health and safety of persons, and of domestic animals and property, while
guaranteeing the functioning of the internal market.
This Directive shall apply to electrical equipment designed for use with a
voltage rating of between 50 and 1 000 V for alternating current and
between 75 and 1 500 V for direct current, other than the equipment and
phenomena listed in Annex II.
LVD Guide interpretation regarding
scope
• The voltage rating is for voltage of the electrical input or output, and not
to voltages that may appear inside the equipment.
• The extent to which electrical components are within the scope of the
LVD requires careful consideration.
• Please refer to the LVD Guide for indicative examples of basic
components that fall outside the scope of the LVD, but also components
that are in scope.
• Unless the battery provides a DC power supply between 75 and 1 500
V, battery operated electrical equipment falls outside the scope of the
LVD.
LVD Guide interpretation regarding
scope (cont.)
• The LVD applies to all forms of supplying electrical equipment intended
to be placed on the EU market, regardless of the selling technique.
• Specific advice is given on the CE marking of power cord sets.
• The LVD Guide’s Annex VII, Section A lists circa 30 example products
within or outside the scope of the LVD.
• Annex VII also discusses a socket outlet with switch; the guidance
varies depending on the type of socket outlet.
When EU safety legislation other
than the LVD applies
This is when electrical equipment falling in scope of the LVD is also:
• An item of radio equipment; or
• A machine; or
• A part for a passenger or goods lift; or
• Intended for use in potentially explosive atmospheres.
When the LVD applies together with
other EU product safety legislation
• When LVD in-scope electrical equipment is to be permanently
incorporated in construction works:
• Then the Construction Products Regulation will also apply.
• When LVD in-scope electrical equipment is intended to be a gas
“fitting”:
• Then the Gas Appliance Regulation will also apply, although the LVD
Guide explains that this Regulation’s requirements are specific to “…gas
related risks due to the hazards of electrical origin of the appliances or
of the fittings.”
• When LVD in-scope electrical equipment is intended for consumer use:
• Then specific provisions of the General Product Safety Directive apply,
although the LVD maintains precedence as the EU product safety law
that must be complied with.
Economic operator
Manufacturer Authorised
representativeImporter Distributor
Makes the electrical
equipment
Alternatively, has the
electrical equipment
designed or
manufactured
Markets the electrical
equipment under his
name or trademark
The authorised
representative of the
manufacturer
This means an entity
that has received a
written mandate from a
manufacturer to act on
his behalf, specifically
with regards to meeting
certain legal obligations
Entity established
within the EU that
places electrical
equipment from a
third country (e.g.
US, Canada) on
the EU market
Entity that makes
electrical
equipment
available on the
EU market other
than the
manufacturer or
the importer
Provision of information/documentation
to a national authority upon request
• Any economic operator placing LVD in-scope electrical equipment on the EU
market faces the obligation to provide a competent national authority with “all
the information and documentation in paper or electronic form necessary to
demonstrate the conformity of the electrical equipment.”
• This should follow a “reasoned request” (undefined in the LVD).
• Economic operators are also to “cooperate with [the] authority, at its request, on
any action taken to eliminate the risks posed by electrical equipment which they
have placed on the market.”
• There is no specific timeline when it comes to providing requested
information and documentation.
• The LVD Guide suggests that a possible default period is 10 working
days.
• The LVD Guide also says that Member States are “free to fix a default
period in their national laws.”
Translation of instructions and safety
information
• Manufacturers, importers and distributors share the obligation to ensure that
LVD in-scope equipment is accompanied by instructions and safety information
in “a language which can be easily understood by consumers and other end-
users, as determined by the Member State concerned.”
• However, the LVD does not state which of the three economic operators is
responsible for translating the information.
• Advice given in the LVD Guide:
• It is for each economic operator that makes in-scope electrical
equipment available in an EU Member State to ensure that instructions
are available in all the languages required.
• Economic operators may wish to share meeting the obligation via
contractual arrangements.
• Consider the worked example.
Translation of the Declaration of
Conformity (DoC)
• Upon request by a national authority, the DoC is to be made available in
the language required by the Member State in whose territory the
electrical equipment is placed on the market.
• However, the LVD does not state which economic operator is to fulfil
this obligation.
• With that in mind, the LVD Guide suggests that the fulfilment of the
obligation is addressed through contractual arrangements between
relevant entities.
Formal non-compliance /
Presumption of conformity
• Addressing formal non-compliance.
• Article 22 of the LVD identifies various non-compliance issues (e.g.
absence of a CE marking, no DoC) that “the relevant economic
operator” may be obliged to address. Nothing is said about response
times however.
• Unfortunately, the LVD Guide offers little additional direction here (it is
said that it is for the authorities to judge, case-by-case).
• Presumption of conformity
• The LVD Guide clarifies that this is only conferred when the reference of
the harmonised standard is published in the EU Official Journal. Also, it
is just the harmonised standard that is relevant – guidance documents
on harmonised standards cannot confer the presumption of conformity.
Equipment modification and/or own
labelling by importer / distributor
Under these circumstances, the LVD Guide is quite clear that the importer
or distributor is considered the manufacturer and should assume the
corresponding obligations. This means replacing/updating the DoC (it
should be in the importer’s or distributor’s name and signed by a suitable
representative of the business) but not necessarily replacing test reports,
certificates and other accompanying documentation provided this remains
relevant.
In conclusion
• For economic operators, the most salient advice given in the new LVD Guide
arises in discussion of the Directive’s scope, overlap with other EU product
legislation, and legal obligations.
• Concerning scope, interpretation is offered on the LVD’s voltage rating,
components and distance selling. Annex VII gives helpful examples.
• When an EU safety law takes precedence over the LVD, LVD harmonised
standards may still be applied to demonstrate electrical safety. If used, the LVD
harmonised standard(s) can be referenced in the DoC, but the DoC should
refer to the legislation that takes precedence (e.g. the Machinery Directive).
• Various legal obligations are stated in the LVD and it is important to determine
which apply to you if you are involved in the supply of electrical equipment to
the EU. Many obligations fall upon manufacturers, but sometimes it is unclear
who is responsible for meeting administrative requirements like the translation
of instructions and safety information.
Further information
• RINA Product Regulatory Compliance Team
[email protected] +44(0)1372 367 032
• Compliance & Risks – C2P
• European Commission (DG GROW)