CELEX: 52014PC0258
Language: en
Date: 2014-05-12
Title: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on appliances burning gaseous fuels

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		52014PC0258
		
			Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on appliances burning gaseous fuels /* COM/2014/0258 final - 2014/0136 (COD) */
			
				
		
		
			
			   	EXPLANATORY MEMORANDUM
1.           CONTEXT OF THE PROPOSAL
General context, reasons for and
objectives of this proposal 
Directive 2009/142/EC on appliances burning
gaseous fuels[1]
is the codification of Directive 90/396/EEC[2]
that was adopted on 29 June 1990 and became applicable as from 1 January 1992.
Directive 2009/142/EC is an example of
Union harmonisation legislation, ensuring the free movement of appliances
burning gaseous fuels. It has contributed considerably to the completion and
operation of the Single Market with regard to appliances burning gaseous fuels.
It harmonises the conditions for the placing on the market and/or putting into
service of appliance burning gaseous fuels covered within its scope with regard
to gas safety risks and rational use of energy.
Directive 2009/142/EC sets out essential
requirements that appliances burning gaseous fuels must comply with in order to
be made available on the EU market. 
Directive 2009/142/EC is based on Article
114 of the Treaty on the Functioning of the European Union (hereinafter
"the Treaty") and is one of the first harmonisation Directives based
on the “New Approach” principles, according to which manufacturers must ensure
compliance of their products with the mandatory performance and safety
requirements provided for in the legislative instrument, without out however
imposing specific technical solutions or specifications.
This proposal intends to replace Directive
2009/142/EC on appliances burning gaseous fuels by a Regulation, in line with
the Commission’s simplification objectives.
Experience from the implementation of
Directive 2009/142/EC made necessary to update and clarify some of its
provisions, without however modifying its scope. Those provisions concern
mainly some sector specific definitions, the content and the form of the Member
States communications of their gas supply conditions, the relationship with
other Union harmonisation legislation applying to gas appliances (for other
aspects) and some essential requirements in order to complete them and reduce
thus the need for interpretation.
The proposed Regulation does not change the
current scope of Directive 2009/142/EC, it however, modifies some of its
provisions in order to clarify and update their content. The proposed
Regulation is also aligned to the provisions of Decision No 768/2008/EC
establishing a common framework for the marketing of products (NLF Decision).
The proposed Regulation clarifies also the
relationship between its provisions and other more specific EU harmonisation
legislation. It also clarifies that the rational use of energy essential
requirement in point 3.5 of Annex I to this Regulation will not apply with
regard to the energy efficiency aspect concerning appliances burning gaseous
fuels falling within an implementing measure of Directive 2009/125/EC
establishing a framework for the setting of ecodesign requirements for
energy-related products[3].
To this date the implementing measures under Directive 2009/125/EC are
Directive 92/42EEC on efficiency requirements for new hot-water boilers fired
with liquid or gaseous fuels[4],
Commission Regulation (EU) No 813/2013 implementing Directive 2009/125/EC with
regard to ecodesign requirements for space heaters and combination heaters[5], Commission Regulation
(EU) No 814/2013 implementing Directive 2009/125/EC with regard to ecodesign
requirements for water heaters and hot water storage tanks[6] and Commission
Regulation (EU) No 932/2012 implementing Directive 2009/125/EC with regard to
ecodesign requirements for household tumble driers[7].The rational use of
energy requirement of this Regulation will not apply to appliances burning
gaseous fuels which will be covered by future Ecodesign implementing measures
under Directive 2009/125/EC. In the absence of Ecodesign implementing measures,
the rational use of energy requirement continues to apply. However, this does not
affect the obligations of Member States to adopt national measures with regard
to the promotion of the use of energy from renewable sources and to the energy
efficiency of buildings in accordance with Directive 2009/28/EC on the
promotion of the use of energy from renewable sources[8], Directive 2010/31/EU
on the energy performance of buildings[9]
and Directive 2012/27/EU on energy efficiency[10].
Such measures, which may in certain circumstances, limit the installation of
gas appliances which comply with the rational use of energy requirement of this
Regulation, must be compatible with the Treaty and take into account of the
need to ensure the coherent implementation of the all aspects of Union law.
The proposal intends also to align
Directive 2009/142/EC to the
“goods package” adopted in 2008 and in particular to
the NLF Decision.
The NLF Decision sets out a common
framework for EU product harmonisation legislation. This framework consists of
the provisions which are commonly used in EU product legislation (e.g.
definitions, obligations of economic operators, notified bodies, safeguard
mechanisms, etc.). These common provisions have been reinforced to ensure that
the legislation can be applied and enforced more effectively in practice. New
elements, such as obligations on importers, have been introduced, which are
crucial for improving the safety of products on the market. 
The Commission has already proposed the
alignment of nine Directives to the NLF Decision within an NLF implementation
package adopted on 21 November 2011.
In view of ensuring consistency across Union harmonisation legislation for industrial products, in accordance with the political
commitment resulting from the adoption of the NLF Decision and the legal
obligation provided for in Article 2 of the NLF Decision, it is necessary that
this proposal is in line with the provisions of the NLF Decision.
The proposal takes into account Regulation
(EU) No 1025/2012 of the European Parliament and of the Council on European
Standardisation[11].
The proposal also takes into account the
proposal of the Commission of 13 February 2013 for a Regulation on market
surveillance of products[12],
which intends to set out a single legal instrument on the market surveillance
activities in the field of non-food goods, consumer or non-consumer products
and products covered or not by Union harmonisation legislation. This proposal
merges the rules on market surveillance of Directive 2001/95/EC on general product
safety[13],
Regulation (EC) No 765/2008 of the European Parliament and of the Council
setting out the requirements for accreditation and market surveillance relating
to the marketing of products[14]
and of sector-specific harmonisation legislation in order to increase the
effectiveness of market surveillance activities within the Union. The proposed
Regulation on market surveillance of products contains also the relevant
provisions on market surveillance and safeguard clauses. Therefore, provisions
in existing sector specific harmonisation legislation that relate to market
surveillance and safeguard clauses should be removed from that harmonisation
legislation. The overacting objective of the proposed Regulation is to simplify
the Union market surveillance framework fundamentally so that it works better
for its main users: market surveillance authorities and economic operators. Directive
2009/142/EC provides for a safeguard clause procedure for gas appliances. In
line with the framework intended to be established by the proposed Regulation
on the market surveillance of products, this proposal does not include the
provisions on market surveillance and safeguard clause procedures provided for
in the NLF Decision. However, in order to ensure legal clarity, it makes a
reference to the proposed Regulation on market surveillance of products.
Consistency with other policies and
objectives of the Union
This initiative is in
line with the Single Market Act[15],
which stressed the need to ensure consumer confidence in the quality of
products on the market and the importance of reinforcing market surveillance.
It is consistent with the Union energy policy as it does not affect the
application and implementation of Union legislation in the field of energy
efficiency and renewable energy. 
It complements and is
coherent with Union policy on energy supply and energy efficiency by not
applying where more specific Union acts apply.
Furthermore it supports
the Commission’s policy on Better Regulation and simplification of the regulatory
environment.
2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
Consultation of interested parties
The revision of Directive 2009/142/EC has been
discussed with national experts responsible for the implementation of the Directive,
the conformity assessment bodies’ forum, the administrative cooperation group
on market surveillance as well as in bilateral contacts with industry
associations. 
The consultation included meetings with the
Member States Working Group Gas Appliances (WG-GA), the Working Group GAD
Revision (WG GAD REV) and the Gas Appliances Directive Advisory Committee
(GAD-AC). 
An Ex-post Evaluation Study was carried out
in 2010-2011, intending to evaluate the results of the implementation of
Directive 2009/142EC[16].
The study assessed the effectiveness of Directive 2009/142/EC, its impact on
companies and users, possible trade barriers limiting the free movement of
appliances, innovation and whether the provisions of the Directive are
sufficient to ensure that appliances burning gaseous fuels and fittings placed
on the market and/or put into service in accordance with it, are designed and
manufactured so as to operate safely and present no gas related risks.
Although the Ex-post evaluation study
concluded that Directive 2009/142/EC was functioning well and contributed to
the improvement of safety of appliances burning gaseous fuels, it also
highlighted some areas for possible improvements.
From December 2011 to March 2012, a public
consultation was organised with as main objective to have the views and
opinions of authorities, manufacturers, associations, standardisation
organisations, notified bodies, consumer organisations and citizens on various
issues that needed to be addressed in preparing the options for the revisions
of Directive 2009/142/EC.
The participation in the public
consultation was important and the Commission services received 90 replies with
contributions from public authorities, industry associations, notified bodies,
standardisation and consumer organisations, both big enterprises and SMEs and
consumers.
The results of the public consultation are published
at: 
http://ec.europa.eu/enterprise/sectors/pressure-and-gas/files/gad/publ-cons-summary_en.pdf.  
The consultation process in all related
fora revealed widespread support for the revision.
There is unanimity on the need to align to
the NLF and thus to improve the existing general regulatory framework.
Authorities fully support the exercise because it will strengthen the existing
system and improve cooperation at EU level. Industry expects a more level
playing field resulting from more effective actions against products that do
not comply with the legislation, as well as a simplification effect from the
alignment of legislation. Certain concerns were expressed on some obligations
which are, however, indispensable for increasing the efficiency of market
surveillance. These measures will not entail significant costs for industry and
the benefits resulting from improved market surveillance should by far outweigh
the costs.
Collection and use of expertise - Impact
assessment 
An impact assessment on the revision of
Directive 2009/142/EC has been conducted. The impact assessment sets out
extensively the different options of revision of the sector related aspects of
Directive 2009/142/EC.
With regard to the NLF alignment aspects,
the impact assessment report for the revisions of Directive 2009/142/EC refers
to the general impact assessment conducted in the framework of the NLF
Implementation package of 21 November 2011[17].
In particular, the modifications due to the
alignment to the NLF Decision and their impacts are expected to be the same as
for the nine product harmonisation Directives included in the Alignment
Package.
The Impact Assessment Report on this
Alignment Package has already examined in depth the different options, which
are exactly the same with regard to Directive 2009/142/EC. The Report contained
also an analysis of the impacts resulting from the legislative alignment to the
provisions of the NLF Decision.
Therefore, the Impact Assessment Report on
the revision of Directive 2009/142/EC did not examine those aspects and it
focussed on specific issues relating to Directive 2009/142/EC as well as on the
ways to address them.
Based on the information collected, the impact
assessment carried out by the Commission examined and compared three options
with regard to problems and issues relating to Directive 2009/142/EC.
Option 1 – “Do nothing” - No changes to
the existing situation
This option proposes no changes to Directive
2009/142/EC.
Option 2 – Intervention by non-legislative
measures
Option 2 considers the possibility of
encouraging voluntary interventions to resolve the identified issues, e.g.,
guidance documents containing a commonly agreed interpretation of Directive
2009/142/EC.
Option 3 – Intervention by legislative
measures
This option consists in modifying Directive
2009/142/EC.
Option 3 was
found to be the preferred option because:
–                        
it is considered more effective than option 2:
due to the lack of enforceability of option 2 it is questionable that the
positive impacts would materialise under that option;
–                        
it does not entail significant costs for
economic operators and notified bodies; for those who are already acting
responsibly, no extra costs or only negligible costs are expected, as the scope
and the provisions remain in substance unchanged and only legal clarifications
are inserted;
–                        
not any significant economic or social impacts
could be identified;
–                        
options 1 and 2 do not provide answers to legal inconsistencies
or ambiguities and therefore will not lead to a better implementation of
Directive 2009/142/EC.
The proposal includes:
·              
The removal of the outdated temperature limit of
105°C from the definition of the scope;
·              
The introduction of currently missing
definitions for the sector specific terminology under Directive 2009/142/EC;
·              
The introduction of a harmonised content and
form of the communications of the Member States under Article 2(2) of Directive
2009/142/EC, of the types of gas and corresponding supply pressures used on
their territory;
·              
The clarification of the relationship between
Directive 2009/142/EC and other EU harmonisation legislation, including Ecodesign
implementing measures under Directive 2009/125/EC and other Union energy policy
instruments;
·              
The improvement of the readability of some of
the provisions of Directive 2009/142/EC.
The impact of the proposal will lead to
strengthening the competitiveness of European enterprises as a result of guaranteeing
a level playing field for the economic operators and to enhanced safety
protection for consumers and other end-users.
3.           LEGAL ELEMENTS OF THE
PROPOSAL
3.1. Scope and definitions
The scope of the proposed Regulation
corresponds to the scope of Directive 2009/142/EC, and covers “appliances” and
“fittings”.
The proposal introduces some definitions
relating to sector specific issues, in order to improve its readability.
Additionally, the general definitions
resulting from the alignment to the NLF Decision have been inserted.
3.2. Member States communications on
gas supply conditions on their territory
The proposed Regulation contains current
Article 2(2) of Directive 2009/142/EC, according to which Member States must
communicate the types of gas and corresponding supply pressures used on their
territories and any changes in their gas supply conditions to other Member States and the European Commission. Subsequently, this information is published in
the Official Journal of the European Union (OJEU)[18].
This information is very important for manufacturers
as the gas supply conditions at the place where an appliance burning gaseous
fuels is put into service are very important for its safe and correct
functioning. Therefore, this aspect has to be taken into account by the
manufacturer already in the design phase.
The availability of adequate information is
also the prequisite for the determination of the "appliance category” marking
or markings that must be indicated on the appliance and are
defined by the European Committee for Standardisation (CEN). Cureently, this
information is provided in harmonised standard hEN 437:2003+A1:2009 and in
product specific European harmonised standards.
However, as the
currently published information is not sufficient, there is a need to better
determine the parameters which should be communicated by the Member States in
order to ensure the adequacy and comparability of this information.
Additionally, the gas
supply conditions in the Union are currently under rapid development. This is
due, amongst others, to the general Union objective to increase the proportion
of energies from renewable sources. As a result, more and more gases from
non-conventional sources[19]
will be supplied both through isolated local networks and by injecting them
into natural gas distribution networks.
Despite the attempts to
achieve a higher degree of harmonisation of gas qualities across Europe[20], the
gradual depletion of the sources of gas extracted from some gas fields and
their replacement with biogas will lead to an increasing diversity of gas
qualities.
As the types of gas and
their supply pressures are not subject to harmonisation
in the framework of Directive 2009/142/EC and cannot be subject to such
harmonisation under this proposal, the gas quality
issue has to be taken into account in the proposal in order to ensure the link
with the safety and performance of the appliances.
It is therefore important that this proposal ensures that manufacturers have adequate
information about the types of gas and supply pressures available as gas
appliances are very sensitive to the composition of the fuel. Inadequate or
missing pieces of information during the design phase would lead to unsafe
and/or not correctly performing (e.g. significantly reduced energy efficiency
level) appliances being placed on the market.
Therefore the proposal defines the
parameters that should be included in the communications, in order to better
ensure the compatibility of the appliances with the gas supply conditions and provides
for a harmonised form for those communications.
3.3. Making available on the market of
gas appliances and fittings, obligations of economic operators, CE marking,
free movement
The proposal contains the typical
provisions for product-related Union harmonisation legislation and sets out the
obligations of the relevant economic operators (manufacturers, authorised
representatives, importers and distributors), in accordance with the NLF
Decision.
According to Directive 2009/142/EC,
fittings do not bear the CE marking (as also they are not subject to a
safeguard clause procedure). Fittings are not appliances
burning gaseous fuels, but intermediate products made separately available only
between professionals and intended to be incorporated into an appliance before
the latter is placed on the market. According to
Directive 2009/142/EC, fittings must however been accompanied by a certificate
declaring their conformity with the provisions of the Directive and stating
their characteristics and how they should be incorporated into an appliance or
assembled to assist compliance with the essential requirements applicable to
finished appliances. As the appropriate design of a
fitting contributes to the correct and safe functioning of a finished appliance
and as the gas related risks of an appliance can only be assessed after
incorporation of the fitting, the proposed Regulation keeps the existing
provision according to which fittings do not bear the CE marking. However, in order to improve clarity, the certificate accompanying fittings
under Directive 2009/142/EC has been qualified as “Fitting conformity
certificate”, in order to better define its content and clarify its
relationship with the EU declaration of conformity requirement under other
possibly applicable Union harmonisation legislation.
3.4. Harmonised standards
Compliance with harmonised standards
provides for a presumption of conformity with the essential requirements.
Regulation (EU) No 1025/2012 sets out a horizontal legal framework for European
standardisation. The Regulation contains inter alia provisions on
standardisation requests from the Commission to the European Standardisation
Organisation, on the procedure for objections to harmonised standards and on
stakeholder participation in the standardisation process. Consequently the
provisions of Directive 2009/142/EC which cover the same aspects have not been
reintroduced in this proposal for reasons of legal certainty.
3.5. Notified bodies
Proper functioning of notified bodies is
crucial for ensuring a high level of health and safety protection and for the
confidence of all interested parties in the New Approach system.
Therefore, in line with the NLF Decision,
the proposal reinforces the notification criteria for notified bodies and
introduces specific requirements for notifying authorities. 
3.6. Conformity assessment
The proposal keeps the conformity
assessment procedures provided for under Directive 2009/142/EC. It however
updates the corresponding modules in line with the NLF Decision.
In particular, it keeps the requirement for
a notified body intervention in the design and production phase of all
appliances and fittings.
Furthermore, it keeps the current approach
for the design phase, according to which the type examination of the product by
the notified body takes the form of examination of the complete appliance or
fitting.
Therefore, in accordance with Article 4(6)
of the NLF Decision, it provides only for the EU-type examination – production
type, as the examination of the technical documentation in conjunction with the
examination of the complete type is considered, as in Directive 2009/142/EC, to
better correspond with the high risks related to gas safety.
3.7. Implementing and delegated acts
The proposal empowers the Commission to
adopt, where appropriate, implementing acts to ensure the uniform application
of this Regulation in respect of notified bodies that do not meet or no longer
meet the requirements for their notification. Those implementing acts will be
adopted in accordance with the provisions on implementing acts laid down in
Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16
February 2011 laying down the rules and general principles concerning mechanisms
for control by the Member States of the Commission's exercise of implementing
powers.
The proposal empowers the Commission to
adopt, where appropriate, delegated acts in accordance with Article 290 of the
Treaty in respect of the content and the form of the Member States
communications relating to the gas supply conditions on their territory, in
order to take into account technical developments.
3.8. Final provisions
The proposed Regulation will become
applicable two years after its entry into force to allow manufacturers,
notified bodies, Member States and European Standardisation Bodies, time to
adapt to the new requirements.
However, the designation of notified bodies
pursuant to the new requirements and process needs to start shortly after the
entry into force of this Regulation. This will ensure that by the date of
application of the proposed Regulation, sufficient notified bodies will have
been designated in accordance with the new rules so as to avoid problems with
production continuity and market supply.
A transitional provision is foreseen for
the certificates issued by notified bodies under Directive 2009/142/EC so as to
allow stocks to be absorbed and ensure a smooth transition to the new
requirements.
Directive 2009/142/EC will be repealed and
replaced by the proposed Regulation.
3.9. Union competence, legal basis,
subsidiarity principle and legal form
Legal basis
The proposal is based on Article 114 of the
Treaty.
Subsidiarity principle
The subsidiarity principle arises in
particular with regard to the newly added provisions aiming at the improvement
of effective enforcement of Directive 2009/142/EC, namely, the economic
operators’ obligations, the traceability provisions, the provisions on the
assessment and notification of conformity assessment bodies. 
Experience with the enforcement of the
legislation has shown that measures taken at national level have led to
divergent approaches and to a different treatment of economic operators inside
the Union, which undermines the objectives of Directive 2009/142/EC. If actions
are taken at national level to address the problems, this risks creating
obstacles to the free movement of goods. Furthermore action at national level
is limited to the territorial competence of a Member State. Coordinated action
at Union level can much better achieve the objectives set, and will in
particular render market surveillance more effective. Hence it is more
appropriate to take action at Union level.
Proportionality
In accordance with the principle of
proportionality, the proposed modifications do not go beyond what is necessary
to achieve the objectives set. 
The new or modified obligations do not
impose unnecessary burdens and costs on industry - especially on small and
medium sized enterprises - or administrations. Where modifications have been
identified to have negative impacts, the analysis of the impacts of the option
serves to provide the most proportionate response to the problems identified. A
number of modifications concern the improvement of clarity of the existing
Directive without introducing new requirements that entail added cost. 
Legislative technique used
The proposal takes the form of a
Regulation.
The proposed change from a Directive to a
Regulation takes into account the Commission's general objective to simplify
the regulatory environment and the need to ensure a uniform implementation
throughout the Union of the proposed legislation.
The proposed Regulation is based on Article
114 of the Treaty and aims to ensure the proper functioning of the internal market
for gas appliances. It imposes clear and detailed rules which will become
applicable in a uniform manner at the same time throughout the Union.
In accordance with the
total harmonisation principles, Member States are not allowed to impose more
stringent or additional requirements in their national legislation for the
placing on the market of gas appliances. In particular, the mandatory essential
requirements and the conformity assessment procedures to be followed by
manufacturers must be identical in all Member States.
The same applies with
regard to the provisions that have been introduced as a result from the
alignment to the NLF Decision. Those provisions are clear and sufficiently
precise to be applied directly by the actors concerned.
The obligations
provided for the Member States, such as the obligation to assess, appoint and
notify the conformity assessment bodies are, in any case, not transposed as
such into national law but implemented by the Member States by means of the
necessary regulatory and administrative arrangements. This will not change when
the obligations concerned are set out in a Regulation.
Therefore, Member
States have almost no flexibility in transposing a Directive into their
national law. The choice of a Regulation will however allow them to save the
costs associated with the transposition of a Directive.
Additionally, a Regulation avoids the risk
of possible diverging transpositions of a Directive by the different
Member States, which might lead to different levels of safety protection and
create obstacles to the internal market, undermining thus its effective
implementation.
The change from a
Directive to a Regulation will not lead to any change in the regulatory
approach.
The characteristics of
the New Approach will be fully preserved, in particular the flexibility given
to manufacturers in the choice of the means employed to comply with the
essential requirements and in the choice of the procedure used, amongst the
available conformity assessment procedures, to demonstrate compliance of gas
appliances. The existing mechanisms supporting the implementation of the
legislation (standardisation process, working groups, administrative
cooperation, the development of guidance documents etc.) will not be affected
by the nature of the legal instrument.
Furthermore, the choice of a Regulation
does not mean that the decision-making process is centralised. Member States
retain their competence e.g. as regards the designation and accreditation of
notified bodies, market surveillance and enforcement action and of defining
their gas supply conditions as far as the gas qualities are not harmonised at
Union level.
Finally, the use of
Regulations in the area of internal market legislation, allows, in accordance
also with the preference expressed by stakeholders, to avoid the risk of ‘gold
plating’. It also allows manufacturers to work directly with the Regulation
text instead of needing to identify and examine 28 transposition laws.
On this basis, it is
considered that the choice of a Regulation is the most appropriate solution for
all involved parties as it will allow a more rapid and coherent application of
the proposed legislation and will establish a clearer regulatory environment
for economic operators.
4.           BUDGETARY IMPLICATION
This proposal does not have any implication
for the Union budget.
5.           ADDITIONAL INFORMATION
Repeal of existing legislation
The adoption of the proposal will lead to
repeal of Directive 2009/142/EC.
European Economic Area
The proposal concerns the EEA and should
therefore be extended to the European Economic Area.
2014/0136 (COD)
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL
on appliances burning gaseous fuels
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE
COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the
European Commission,
After transmission of the draft legislative
act to the national Parliaments,
Having regard to the opinion of the
European Economic and Social Committee[21],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       Directive 2009/142/EC of
the European Parliament and of the Council relating to appliances burning
gaseous fuels[22]
lays down rules for the placing on the market and the putting into service of
appliances burning gaseous fuels.
(2)       Directive 2009/142/EC is
based on the New Approach principles, as set out in Council Resolution of 7 May
1985 on a new approach to technical harmonisation and standards[23]. Thus, it sets out
only the essential requirements applying to appliances burning gaseous fuels,
whereas technical details are adopted by the European Committee for
Standardisation (CEN) and the European Committee for Electrotechnical
Standardisation (Cenelec) in accordance with Regulation (EU) No 1025/2012 of
the European Parliament and of the Council on European Standardisation[24]. Conformity with the
harmonised standards so set, the reference numbers of which are published in
the Official Journal of the European Union, provides a presumption of
conformity with the requirements of Directive 2009/142/EC. Experience has shown
that those basic principles have worked well in this sector and should be
maintained and even further promoted.
(3)       Experience from the
implementation of Directive 2009/142/EC has shown the need to modify some of
its provisions in order to clarify and update them and ensure thus legal
certainty as regards the definitions relating to its scope, the content of the Member
States' communications of their gas types and supply pressures and certain
essential requirements.
(4)       As certain aspects of
Directive 2009/142/EC should be revised and enhanced, in the interests of
clarity that Directive should be repealed. Since the scope, essential
requirements and conformity assessment procedures must be identical in all
Member States, there is almost no flexibility in transposing a Directive based
on the New Approach principles into national law. In order to simplify the regulatory
framework, Directive 2009/142/EC should be replaced by a Regulation, which is
the appropriate legal instrument as it imposes clear and detailed rules which
do not give room for divergent transposition by Member States and ensures thus
a uniform implementation throughout the Union.
(5)       Decision No 768/2008/EC of
the European Parliament and of the Council on a common framework for the
marketing of products [25]
lays down a common framework of general principles and reference provisions
intended to apply across the legislation harmonising the conditions for the
marketing of products in order to provide a coherent basis for revision or
recasts of that legislation. In order to ensure consistency with other sectoral
product legislation, Directive 2009/142/EC should be adapted to that Decision. 
(6)       Regulation (EC) No
765/2008 of the European Parliament and of the Council setting out the
requirements for accreditation and market surveillance relating to the
marketing of products [26]
lays down horizontal provisions on the accreditation of conformity assessment
bodies [,market surveillance of products and controls on products from third
countries,] and the CE marking.
(7)       Regulation (EU) No […/…]
of the European Parliament and of the Council[27]
[on market surveillance of products] provides detailed rules on market
surveillance and on controls of products entering the Union from third
countries, including appliances burning gaseous fuels. It also sets out a
safeguard clause procedure. Member States should organise and carry out market
surveillance, appoint market surveillance authorities and specify their powers
and duties. They should also set up general and sector-specific market
surveillance programs.
(8)       The scope of Directive
2009/142/EC should be maintained. This Regulation should apply to appliances
burning gaseous fuels and to fittings incorporated into an appliance burning
gaseous fuels. Appliances burning gaseous fuels are domestic and non-domestic
appliances intended for a number of specified applications.
(9)       This Regulation should aim
to ensure the functioning of the internal market of appliances burning gaseous
fuels and of fittings as regards the gas safety risks and energy efficiency.
(10)     This Regulation should not
apply where other Union harmonisation legislation covers more specifically the aspects
covered by this Regulation. This includes the measures issued under Directive
2009/125/EC of the European Parliament and of the Council[28] establishing a
framework for ecodesign requirements.
(11)     Article 6 of this
Regulation prevents Member States from imposing stricter requirements on
health, safety and energy conservation which would prohibit, restrict or impede
the making available on the market and the putting into service of appliances
which comply with this Regulation. However, this provision does not affect the
possibility for Member States, when implementing other EU Directives, to impose
requirements which affect the energy efficiency of products, including gas
appliances, as long as such measures are compatible with the Treaty. 
(12)     Directive 2009/28/EC of the
European Parliament and of the Council[29]
on the promotion of the use of energy from renewable sources requires Member
States to introduce in their building regulations and codes appropriate measures
in order to increase the share of all kinds of energy from renewable sources in
the building sector. Directive 2010/31/EU of the European Parliament and of the
Council on the energy performance of buildings[30]
requires Member States to set minimum energy performance requirements for
buildings and building elements and system requirements in respect of the
overall energy performance of the technical building systems which are
installed in existing buildings. Directive 2012/27/EU of the European
Parliament and of the Council on energy efficiency [31]
requires Member States to take sufficient measures to progressively reduce
energy consumption in different areas including in buildings.
(13)     This Regulation does not
affect the obligation for Member States to adopt national measures with respect
to the promotion of the use of energy from renewable sources and to the energy efficiency
of buildings in accordance with Directives 2009/28/EC 2010/31/EU and 2012/27/EU.
It is consistent with the objectives of these Directives that national measures
may in certain circumstances limit the installation of gas appliances which
comply with the rational use of energy requirement of this Regulation, provided
that such requirements do not constitute an unjustifiable market barrier. 
(14)     Member States should take
the necessary steps to ensure that appliances burning gaseous fuels are made
available on the market and put into service only where they do not compromise
the safety of persons, domestic animals and property, when normally used.
(15)     The provisions of this
Regulation do not affect the Member States’ entitlement to lay down rules
concerning commissioning or periodic inspections of appliances burning gaseous fuels
in order to ensure their correct installation, use and maintenance.
(16)     The provisions of this
Regulation do not affect the Member States’ entitlement to lay down
requirements as they may deem necessary concerning installation aspects, space
ventilation conditions and aspects relating to the safety of the building itself
and its energy performance, provided that those provisions do not impose design
requirements on appliances burning gaseous fuels.
(17)     As this Regulation does not
cover such risks caused by appliances burning gaseous fuels in case of
incorrect installation, maintenance or use, Member States are encouraged to
take measures to ensure that public is made aware of the risks related to combustion
products and in particular to carbon monoxide.
(18)     Although this Regulation does
not regulate the gas supply conditions in the Member States, it should take
into account the fact that different conditions as regards types of gas and
supply pressures are in force in the Member States in the absence of
harmonisation of the technical characteristics of the gaseous fuel. The
composition and specifications of the types of gas and the supply pressures at
the place where an appliance burning gaseous fuels is put into service is very
important for its safe and correct functioning and therefore this aspect should
be taken into consideration already at the design phase of the appliance in
order to ensure its compatibility with the gas type(s) and supply pressure(s)
it is intended for.
(19)     In order to avoid barriers
to trade with regard to appliances burning gaseous fuels on grounds relating to
the fact that the gas supply conditions are not yet harmonised and ensure thus
a sufficient information of economic operators, Member States should
communicate to the other Member States and to the Commission the gas types and
supply pressures used in their territory and any changes thereof in good time.
(20)     The communication of the
gas types and supply pressures by Member States should contain the relevant
necessary information for economic operators. In this framework, the primary
source of the gaseous fuel supplied is not relevant for the characteristics,
the performance and the compatibility of appliances burning gaseous fuels with
the communicated gas supply conditions.
(21)     When determining the gas
families and gas groups used on their territory, Member States are encouraged
to take into account the on-going standardisation work concerning gas qualities
and ensure thus across the Union, a coherent and coordinated approach towards
harmonisation of the gaseous fuels via standardisation.
(22)     When in accordance with
Directive 2009/73/EC of the European Parliament and of the Council concerning
common rules for the internal market in natural gas[32] and the on-going
standardisation work of CEN on the gas quality specifications, Member States take
concrete measures for a wider use of biogas by injecting such gas into the gas
distribution network or by distributing such gas through isolated systems, they
should ensure to timely update their communication of gas types in case the
quality of the supplied gas does not remain within the already communicated
quality range.
(23)     When Member States
establish their national action plans in accordance with Directive 2009/28/EC
in order to comply with their obligation to increase the percentage of renewables
energies and in particular biogas in the total energy consumption, they are encouraged
to consider the possibilities of injecting such gases in the gas distribution
network.
(24)     Member States should take
the necessary measures to ensure that the gas supply conditions do not
constitute barriers to trade and that they do not restrict the putting into
service of appliances burning gaseous fuels that are compatible with the local
gas supply conditions.
(25)     Appliances burning gaseous
fuels covered by this Regulation and complying with its provisions should
benefit from the principle of free movement of goods. Such appliances should be
allowed to be put into service provided that they are compatible with the local
gas supply conditions.
(26)     The appliance category
marking indicated on the appliance data plate establishes a direct link with
the gas families and/or gas groups for which an appliance burning gaseous fuels
has been designed to burn safely at the desired performance level and thus ensures
the compatibility of the appliance with the local gas supply conditions.
(27)     The essential safety, health
and rational use of energy requirements should be observed in order to ensure
that appliances burning gaseous fuels are safe when normally used at the desired
performance level.
(28)     The essential requirements
should be interpreted and applied so as to take account of the state of the art
at the time of design and manufacture as well as of technical and economic
considerations which are consistent with a high degree of health, safety
protection and rational use of energy.
(29)     Economic operators should
be responsible for the compliance of appliances burning gaseous fuels and of
fittings with the requirements of this Regulation, in relation to their
respective roles in the supply chain, so as to ensure a high level of
protection of public interests, such as health, safety, rational use of energy and
the protection of consumers and other users, domestic animals and property and
to guarantee fair competition on the Union market.
(30)     All economic operators
intervening in the supply and distribution chain should take appropriate
measures to ensure that they only make available on the market appliances
burning gaseous fuels which are in conformity with this Regulation. It is
necessary to provide for a clear and proportionate distribution of obligations
which correspond to the role of each economic operator in the supply and
distribution chain.
(31)     The manufacturer, having
detailed knowledge of the design and production process, is best placed to
carry out the complete conformity assessment procedure. Conformity assessment
should therefore remain solely the obligation of the manufacturer.
(32)     The manufacturer should
provide sufficient and detailed information on the intended use of the
appliance burning gaseous fuels so as to allow its correct and safe installation
and putting into service, use and maintenance. Such information may need to
include the technical specifications of the interface between the appliance and
its installation environment.
(33)     In order to facilitate the
communication between economic operators, national market surveillance
authorities and consumers, Member States should encourage economic operators to
include a website address in addition to the postal address.
(34)     It is necessary to ensure
that appliances burning gaseous fuels and fittings from third countries entering
the Union market comply with the requirements of this Regulation, and in
particular that appropriate conformity assessment procedures have been carried
out by manufacturers with regard to those appliances and fittings. Provision
should therefore be made for importers to make sure that the appliances burning
gaseous fuels and fittings they place on the market comply with the requirements
of this Regulation and that they do not place on the market appliances and
fittings which do not comply with such requirements or present a risk.
Provision should also be made for importers to make sure that conformity
assessment procedures have been carried out and that appliance marking and
documentation drawn up by manufacturers are available for inspection by the competent
supervisory authorities.
(35)     The distributor makes an
appliance burning gaseous fuels or a fitting available on the market after it
has been placed on the market by the manufacturer or the importer and should
act with due care to ensure that its handling of the appliance or fitting does
not adversely affect its compliance.
(36)     When placing on the market
an appliance burning gaseous fuels or a fitting, every importer should indicate
on the appliance or fitting his name, registered trade name or registered trade
mark and the postal address at which he can be contacted. Exceptions should be
provided for in cases where the size or nature of the appliance or fitting does
not allow it. This includes cases where the importer would have to open the
packaging to put his name and address on the product.
(37)     Any economic operator that
either places an appliance burning gaseous fuels or a fitting on the market
under his own name or trademark or modifies an appliance burning gaseous fuels
or a fitting in such a way that compliance with the requirements of this Regulation
may be affected should be considered to be the manufacturer and should assume
the obligations of the manufacturer.
(38)     Distributors and importers,
being close to the market place, should be involved in market surveillance
tasks carried out by the competent national authorities, and should be prepared
to participate actively, providing those authorities with all necessary
information relating to the appliance burning gaseous fuels or fitting concerned.
(39)     Ensuring traceability of an
appliance burning gaseous fuels or a fitting throughout the whole supply chain
helps to make market surveillance simpler and more efficient. An efficient
traceability system facilitates market surveillance authorities' task of
tracing economic operators who made non-compliant appliances burning gaseous
fuels or fittings available on the market.
(40)     This Regulation should be limited
to the expression of the essential requirements. In order to facilitate
conformity assessment with those requirements it is necessary to provide for
presumption of conformity for appliances burning gaseous fuels or fittings which
are in conformity with harmonised standards that are adopted in accordance with
Regulation (EU) No 1025/2012 of the European Parliament and of the Council on
European Standardisation[33]
for the purpose of expressing detailed technical specifications of those
requirements, especially with regard to the design, manufacture, operation, testing
the rational use of energy and installation of appliances burning gaseous fuels.
(41)     Regulation (EU) No
1025/2012 provides for a procedure for objections to harmonised standards where
those standards do not entirely satisfy the requirements of this Regulation.
(42)     In order to enable economic
operators to demonstrate and the competent authorities to ensure that appliances
burning gaseous fuels or fittings made available on the market conform to the
essential requirements, it is necessary to provide for conformity assessment
procedures. Decision No 768/2008/EC establishes modules for conformity
assessment procedures, which include procedures from the least to the most
stringent, in proportion to the level of risk involved and the level of safety
required. In order to ensure inter-sectoral coherence and to avoid ad-hoc
variants, conformity assessment procedures should be chosen from among those
modules.
(43)     Manufacturers of appliances
burning gaseous fuels should draw up an EU declaration of conformity to provide
information required under this Regulation on the conformity of an appliance with
the requirements of this Regulation and of other relevant Union harmonisation
legislation.
(44)     To ensure effective access
to information for market surveillance purposes, the information required to
identify all applicable Union Acts for an appliance burning gaseous fuels should
be available in a single EU declaration of conformity.
(45)     Manufacturers of fittings
should issue a Fitting conformity certificate to provide information required
under this Regulation on the conformity of the fitting with the requirements of
this Regulation. In case the fitting is subject also to other Union
harmonisation legislation, manufacturers of fittings should also, where relevant,
issue an EU declaration of conformity in accordance with that legislation.
(46)     The CE marking, indicating
the conformity of an appliance burning gaseous fuels is the visible consequence
of a whole process comprising conformity assessment in a broad sense. General
principles governing the CE marking and its relationship with other markings are
set out in Regulation (EC) No 765/2008. Rules governing the affixing of the CE
marking should be laid down in this Regulation.
(47)     Fittings are not appliances
burning gaseous fuels, but intermediate products made available between
professionals and intended to be incorporated into an appliance. As the
appropriate design of a fitting contributes to the correct and safe functioning
of a finished appliance and as the gas related risks of an appliance can only
be assessed after incorporation of the fitting, it is appropriate that fittings
do not bear the CE marking.
(48)     A check of compliance of
appliances burning gaseous fuels and of fittings with the essential
requirements provided for in this Regulation is necessary in order to provide
effective protection for users and third parties.
(49)     In order to ensure
compliance of appliances burning gaseous fuels with the essential requirements,
it is necessary to lay down appropriate conformity assessment procedures to be
followed by the manufacturer. Those procedures should be set from the
conformity assessment modules laid down in Decision No 768/2008/EC.
(50)     The conformity assessment
procedures set out in this Regulation require the intervention of conformity
assessment bodies, which are notified by the Member States to the Commission.
(51)     Experience has shown that
the criteria set out in Directive 2009/142/EC that conformity assessment bodies
have to fulfil to be notified to the Commission are not sufficient to ensure a
uniformly high level of performance of these bodies throughout the Union. It is, however, essential that all conformity assessment bodies perform their
functions to the same level and under conditions of fair competition. That
requires the setting of obligatory requirements for conformity assessment
bodies wishing to be notified in order to provide conformity assessment services.
(52)     In order to ensure a
consistent level of conformity assessment quality, it is also necessary to set
requirements for notifying authorities and other bodies involved in the
assessment, notification and monitoring of notified bodies.
(53)     If a conformity assessment
body demonstrates conformity with the criteria laid down in harmonised
standards, it should be presumed to comply with the corresponding requirements
set out in this Regulation.
(54)     The system set out in this Regulation
should be complemented by the accreditation system provided for in Regulation
(EC) No 765/2008. Since accreditation is an essential means of verifying the
competence of conformity assessment bodies, it should also be used for the
purposes of notification.
(55)     Transparent accreditation
as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of
confidence in conformity certificates, should be considered by the national
public authorities throughout the Union as the preferred means of demonstrating
the technical competence of conformity assessment bodies. However, national
authorities may consider that they possess the appropriate means of carrying
out that evaluation themselves. In such cases, in order to ensure the
appropriate level of credibility of evaluations carried out by other national
authorities, they should provide the Commission and the other Member States with the necessary documentary evidence demonstrating the compliance of the
conformity assessment bodies evaluated with the relevant regulatory
requirements.
(56)     Conformity assessment
bodies frequently subcontract parts of their activities linked to the
assessment of conformity or have recourse to a subsidiary. In order to
safeguard the level of protection required for the appliances burning gaseous
fuels to be placed on the Union market, it is essential that conformity
assessment subcontractors and subsidiaries fulfil the same requirements as notified
bodies in relation to the performance of conformity assessment tasks.
Therefore, it is important that the assessment of the competence and the
performance of bodies to be notified and the monitoring of bodies already
notified cover also activities carried out by subcontractors and subsidiaries.
(57)     It is necessary to increase
the efficiency and transparency of the notification procedure and, in
particular, to adapt it to new technologies so as to enable online
notification.
(58)     Since conformity assessment
bodies may offer their services throughout the Union, it is appropriate to give
the other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period
during which any doubts or concerns as to the competence of conformity
assessment bodies can be clarified before they start operating as notified
bodies.
(59)     In the interests of
competitiveness, it is crucial that conformity assessment bodies apply the
conformity assessment procedures without creating unnecessary burdens for
economic operators. For the same reason, and to ensure equal treatment of
economic operators, consistency in the technical application of the conformity
assessment procedures needs to be ensured. That can best be achieved through
appropriate coordination and cooperation between conformity assessment bodies.
(60)     In order to ensure uniform
conditions for the implementation of this Regulation, implementing powers
should be conferred to the Commission. Those powers should be exercised in
accordance with Regulation (EU) No 182/2011 of the European Parliament and of
the Council laying down the rules for the Commission’s exercise of implementing
powers[34].
(61)     The advisory procedure
should be used for the adoption of implementing acts requesting the notifying Member State to take the necessary corrective measures in respect of notified bodies that
do not meet or no longer meet the requirements for their notification.
(62)     In order to take into
account the technical developments, the power to adopt acts in accordance with Article
290 of the Treaty should be delegated to the Commission in respect of
amendments to the content and the form of the Member State communications on
the gas supply conditions on their territory.
(63)     The Commission, when
preparing and drawing-up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament
and to the Council.
(64)     It is necessary to provide
for transitional arrangements that allow the making available on the market or the
putting into service of appliances burning gaseous fuels and fittings that have
already been placed on the market in accordance with Directive 2009/142/EC.
(65)     Member States should lay
down rules on penalties applicable to infringements to this Regulation and
ensure that they are implemented. Those penalties should be effective,
proportionate and dissuasive.
(66)     Since the objective of this
Regulation, namely to ensure that appliances burning gaseous fuels on the
market fulfil the requirements providing for a high level of protection of
health and safety of users and protection of domestic animals or property and for
rational use of energy, while guaranteeing the functioning of the internal
market cannot be sufficiently achieved by the Member States and can therefore,
by reason of its scale and effects, be better achieved at Union level, the
Union may adopt measures, in accordance with the principle of subsidiarity as
set out in Article 5 of the Treaty on European Union. In accordance with the principle
of proportionality, as set out in that Article, this Regulation does not go
beyond what is necessary in order to achieve that objective.
(67)     Directive 2009/142/EC
should therefore be repealed.
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL
PROVISIONS
Article 1
Scope
(1)                   
This Regulation shall apply to appliances and
fittings.
(2)                   
For the purposes of this Regulation, an appliance
shall be considered to be ‘normally used’ where the following conditions are
met:
(a)         
it is correctly installed and regularly serviced
in accordance with the manufacturer’s instructions.
(b)         
it is used with a normal variation in the gas
quality and a normal fluctuation in the supply pressure.
(c)         
it is used in accordance with its intended
purpose or in a way which can be reasonably foreseen.
(3)                   
This Regulation shall not apply to:
(a)         
Appliances specifically designed for use in
industrial processes carried out on industrial premises.
(b)         
Appliances specifically designed for use on
aircrafts and railways.
(c)         
Appliances specifically designed for research
purposes for temporary use in laboratories.
(4)                   
Where, for appliances or fittings, the aspects
covered by this Regulation are covered more specifically by other acts of Union
harmonisation legislation, this Regulation shall not apply or shall cease to
apply to such appliances or fittings in respect of those aspects.
(5)                   
The rational use of energy essential requirement
in point 3.5 of Annex I to this Regulation shall not apply to appliances
covered by a measure issued pursuant to Article 15 of Directive 2009/125/EC.
Article 2
Definitions
For the
purposes of this Regulation the following definitions shall apply:
(1)                   
‘appliances’ means appliances burning gaseous
fuels used for cooking, refrigeration, air-conditioning, space heating,
hot water production, lighting and washing, as also forced draught burners and
heating bodies to be equipped with such burners;
(2)                   
‘fittings’ means safety devices, controlling
devices or regulating devices and sub-assemblies thereof, separately marketed
for trade use and designed to be incorporated into an appliance burning gaseous
fuels or to be assembled to constitute such an appliance;
(3)                   
‘burning’ means a process in which gaseous fuel
reacts with oxygen producing heat or light;
(4)                   
‘washing’ means the entire washing process,
including drying and ironing;
(5)                   
‘gaseous fuel’ means any fuel which is in a
gaseous state at a temperature of 15 °C under a pressure of 1 bar;
(6)                   
‘industrial process’ means the extraction,
growth, refining, processing, production, manufacture or preparation of
materials, plants, livestock, animal products, food or other products with a
view to its commercial use;
(7)                   
‘specific design’ means a design for an
appliance when that design is only intended to address a specific need for a
specific process;
(8)                   
‘industrial premises’ means any place where the
main activity carried out is an industrial process that would be subject to
specific national health and safety regulations;
(9)                   
‘gas family’ means a group of gaseous fuels with
similar burning behaviour linked together by a range of Wobbe indices;
(10)               
‘gas group’ means a specified range of Wobbe
index within that of the family concerned;
(11)               
‘Wobbe index’ means an indicator of the
interchangeability of fuel gases used to compare the combustion energy output
of different composition fuel gases in an appliance;
(12)               
‘appliance category’ means the identification of
gas families and/or gas groups that an appliance is designed to burn safely and
at the desired performance level, as indicated by the appliance category
marking, determined by CEN;
(13)               
‘making available on the market of appliances’
means any supply of appliances for distribution or use on the Union market in
the course of a commercial activity, whether in return for payment or free of
charge;
(14)               
‘making available on the market of fittings’
means any supply for trade use of fittings for distribution on the Union market
in view of incorporation into an appliance or assembled to constitute such an
appliance, whether in return for payment or free of charge;
(15)               
‘energy efficiency’ means the ratio of output of
performance of an appliance, to input of energy;
(16)               
‘placing on the market’ means the first making
available of an appliance or a fitting on the Union market;
(17)               
‘putting into service’ means the first use of an
appliance or its first use for the manufacturer’s own purposes;
(18)               
‘manufacturer’ means any natural or legal person
who manufactures an appliance or a fitting or who has such an appliance or
fitting designed or manufactured, and markets that product under his name or
trademark;
(19)               
‘authorised representative’ means any natural or
legal person established within the Union who has received a written mandate
from a manufacturer to act on his behalf in relation to specified tasks;
(20)               
‘importer’ means any natural or legal person
established within the Union who places an appliance or a fitting from a third
country on the Union market;
(21)               
‘distributor’ means any natural or legal person
in the supply chain, other than the manufacturer or the importer, who makes an
appliance or a fitting available on the market;
(22)               
‘economic operators’ means the manufacturer, the
authorised representative, the importer and the distributor;
(23)               
‘technical specification’ means a document that
prescribes technical requirements to be fulfilled by an appliance or a fitting;
(24)               
‘harmonised standard’ means harmonised standard
as defined in Article 2(1)(c) of Regulation (EU) No 1025/2012;
(25)               
‘accreditation’ means accreditation as defined
in Article 2(10) of Regulation (EC) No 765/2008;
(26)               
‘national accreditation body’ means national
accreditation body as defined in Article 2(11) of Regulation (EC) No 765/2008;
(27)               
‘conformity assessment’ means the process
demonstrating whether the essential requirements of this Regulation relating to
an appliance or a fitting have been fulfilled;
(28)               
‘conformity assessment body’ means a body that
performs conformity assessment activities including calibration, testing,
certification and inspection;
(29)               
‘recall’ means any measure aimed at achieving
the return of an appliance that has already been made available to the end-user;
(30)               
‘withdrawal’ means any measure aimed at
preventing an appliance or a fitting in the supply chain from being made
available on the market;
(31)               
‘CE marking’ means a marking by which the
manufacturer indicates that the appliance is in conformity with the applicable
requirements set out in Union harmonisation legislation providing for its
affixing;
(32)               
‘Union harmonisation legislation’ means any
Union legislation harmonising the conditions for the marketing of products.
Article 3
Making
available on the market and putting into service
(1)                   
Member States shall take all appropriate
measures to ensure that appliances may be made available on the market and put
into service only if they satisfy the requirements of this Regulation.
(2)                   
Member States shall take all appropriate
measures to ensure that fittings may be made available on the market only if
they satisfy the requirements of this Regulation.
(3)                   
This Regulation shall not affect Member States’
entitlement to lay the requirements which they may deem necessary to ensure
that persons, domestic animals and property are protected during the normal use
of the appliances, provided that this does not mean modifications to such
appliances.
Article 4
Gas supply
conditions
(1)                   
Member States shall communicate to Commission
and the other Member States, the types of gas and corresponding supply
pressures of gaseous fuels used on their territory and in good time any changes
thereof, in accordance with the requirements set out in Annex II.
(2)                   
The Commission shall ensure that this
information is published in the Official Journal of the European Union.
Article 5
Essential
requirements
Appliances and fittings shall comply with
the essential requirements which apply to them set out in Annex I.
Article 6
Free
movement
(1)                   
Member States shall not, on grounds relating to
the aspects covered by this Regulation, prohibit, restrict or impede the making
available on the market and the putting into service of appliances which comply
with this Regulation.
(2)                   
Member States shall not, on grounds relating to the
risks covered by this Regulation, prohibit, restrict or impede the making
available on the market of fittings which comply with this Regulation.
(3)                   
This Regulation shall not affect the obligation for
Member States to provide for measures with respect to the promotion of the use
of energy from renewable sources and to the energy efficiency of buildings, in
accordance with Directives 2009/28/EC, 2010/31/EU and 2012/27/EU. Such measures
shall be compatible with the Treaty.
CHAPTER II
OBLIGATIONS
OF ECONOMIC OPERATORS
Article 7 [Article R2 of Decision No
768/2008/EC]
Obligations
of manufacturers
(1)                   
When placing their appliances or fittings on the
market, manufacturers shall ensure that they have been designed and
manufactured in accordance with the essential requirements set out in Annex I.
(2)                   
Manufacturers of appliances or fittings shall
draw up the technical documentation referred to in Annex III and carry out the relevant
conformity assessment procedure referred to in Article 14 or have it carried
out.
Where compliance of an appliance with the applicable
requirements has been demonstrated by the procedure referred to in the first
subparagraph, manufacturers shall draw up an EU declaration of conformity and
affix the CE marking.
Where compliance of a fitting with the
applicable requirements has been demonstrated by the procedure referred to in
the first subparagraph, manufacturers shall draw up a Fitting conformity
certificate.
(3)                   
Manufacturers shall keep the technical
documentation and the EU declaration of conformity for 10 years after the appliance
has been placed on the market.
Manufacturers shall keep the technical documentation
and the Fitting conformity certificate for 10 years after the fitting has been
placed on the market.
(4)                   
Manufacturers shall ensure that procedures are
in place for series production to remain in conformity. Changes in appliance or
fitting design or characteristics and changes in the harmonised standards or in
other technical specifications by reference to which the conformity of the
appliance or the fitting is declared shall be adequately taken into account.
When deemed appropriate with regard to the risks
presented by an appliance or a fitting, manufacturers shall, to protect the
health and safety of consumers and other end-users, carry out sample testing of
the appliance made available on the market, investigate, and, if necessary,
keep a register of complaints of non-conforming appliances and fittings, and
recalls of such appliances, and shall keep distributors informed of any such
monitoring.
(5)                   
Manufacturers shall ensure that their appliances
or fittings bear a type, batch or serial number or other element allowing their
identification.
Where the size or nature of the appliance or the
fitting does not allow it, manufacturers shall ensure that the required
information is provided on the packaging.
(6)                   
Manufacturers shall indicate their name,
registered trade name or registered trade mark, the postal address at which
they can be contacted on the appliance or, where that is not possible, on the
packaging and in the instructions accompanying the appliance. The address must
indicate a single point at which the manufacturer can be contacted. The contact
details shall be in a language easily understood by consumers and other users
and the market surveillance authorities as determined by the Member State concerned.
Manufacturers shall indicate their name,
registered trade name or registered trade mark, the postal address at which
they can be contacted on the fitting or, where that is not possible, on the
packaging and in the instructions accompanying the fitting. The address must
indicate a single point at which the manufacturer can be contacted. 
(7)                   
Manufacturers shall ensure that the appliance is
accompanied by instructions and safety information in accordance with point 1.5
of Annex I, in a language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned. Such instructions and
safety information shall be clear, understandable and intelligible.
Manufacturers shall ensure that the fitting is
accompanied by the Fitting conformity certificate containing, amongst others, instructions
for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I, in a language which can be easily
understood by appliance manufacturers. The instructions shall be clear,
understandable and intelligible.
(8)                   
Manufacturers who consider or have reason to
believe that the an appliance or a fitting which they have placed on the market
is not in conformity with this Regulation shall immediately take the necessary
corrective measures necessary to bring that appliance or fitting into
conformity, to withdraw it or recall it, as appropriate. Furthermore, where the
appliance or the fitting presents a risk, manufacturers shall immediately
inform the competent national authorities of the Member States in which they made
the appliance or the fitting available on the market to that effect, giving
details, in particular, of the non-compliance and of any corrective measures
taken.
(9)                   
Manufacturers shall, further to a reasoned
request from a competent national authority, provide it with all the
information and documentation necessary to demonstrate the conformity of the appliance
or the fitting with this Regulation, in a language which can be easily
understood by that authority. That information and documentation may be provided
in paper or electronic form. They shall cooperate with that authority, at its
request, on any action taken to eliminate the risks posed by the appliances or
fittings which they have placed on the market. 
Article 8 [Article R3 of Decision No
768/2008/EC]
Authorised
representatives
(1)                   
A manufacturer may, by a written mandate,
appoint an authorised representative.
The obligations laid down in Article 7(1) and
the drawing up of technical documentation shall not form part of the authorised
representative's mandate.
(2)                   
An authorised representative shall perform the
tasks specified in the mandate received from the manufacturer. The mandate
shall allow the authorised representative to do at least the following:
(a)         
keep the EU declaration of conformity and the
technical documentation at the disposal of national surveillance authorities
for 10 years after the appliance has been placed on the market;
(b)         
keep the Fitting conformity certificate and the
technical documentation at the disposal of national surveillance authorities for
10 years after the fitting has been placed on the market;
(c)         
further to a reasoned request from a competent
national authority, provide that authority with all the information and
documentation necessary to demonstrate the conformity of the appliance or fitting;
(d)        
cooperate with the competent national
authorities, at their request, on any action taken to eliminate the risks posed
by appliances or fittings covered by the authorised representative’s mandate.
Article 9 [Article R4 of Decision No
768/2008/EC]
Obligations
of importers
(1)                   
Importers shall place only compliant appliances
or fittings on the market.
(2)                   
Before placing an appliance on the market,
importers shall ensure that the appropriate conformity assessment procedure in
accordance with Article 14 has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
appliance bears the CE marking and is accompanied by instructions and safety
information in accordance with point 1.5 of Annex I, and that the manufacturer
has complied with the requirements set out in Article 7(5) and (6) respectively.
Before placing a fitting on the market,
importers shall ensure that the appropriate conformity assessment procedure in
accordance with Article 14 has been carried out by the manufacturer. They shall
ensure that the manufacturer has drawn up the technical documentation, that the
fitting is accompanied by the Fitting conformity certificate containing,
amongst others, instructions for incorporation or assembly, adjustment,
operation and maintenance in accordance with point 1.7 of Annex I, and that the
manufacturer has complied with the requirements set out in Article 7(5) and (6)
respectively.
Where an importer considers or has reason to
believe that an appliance or a fitting is not in conformity with the essential
requirements set out in Annex I, he shall not place the appliance or the fitting
on the market until it has been brought into conformity. Furthermore, where the
appliance or the fitting presents a risk, the importer shall inform the
manufacturer and the market surveillance authorities to that effect.
(3)                   
Importers shall indicate their name, registered
trade name or registered trade mark and the postal address at which they can be
contacted on the appliance or where that is not possible, on its packaging and in
the instructions accompanying the appliance. The contact details shall be in a
language easily understood by consumers and other end-users and of the market
surveillance authorities as determined by the Member State concerned.
Importers shall indicate their name, registered
trade name or registered trade mark and the postal address at which they can be
contacted on the fitting or where that is not possible, on its packaging. The
contact details shall be in a language easily understood by appliance
manufacturers and the market surveillance authorities as determined by the Member State concerned.
(4)                   
Importers shall ensure that the appliance is
accompanied by instructions and safety information in accordance with point 1.5
of Annex I, in a language which can be easily understood by consumers and other
end-users, as determined by the Member State concerned.
Importers shall ensure that the fitting is
accompanied by the Fitting conformity certificate containing, amongst others, instructions
for incorporation or assembly, adjustment, operation and maintenance in
accordance with point 1.7 of Annex I, in a language which can be easily
understood by appliance manufacturers, as determined by the Member State
concerned.
(5)                   
Importers shall ensure that, while an appliance
or a fitting is under their responsibility, storage or transport conditions do
not jeopardise their compliance with the requirements set out in Annex I.
(6)                   
When deemed appropriate with regard to the risks
presented by an appliance or a fitting, importers shall, to protect the
health and safety of the users, upon a duly justified request of the competent
authorities, carry out sample testing of appliances or fittings made available
on the market, investigate, and, if necessary, keep a register of complaints of
nonconforming appliances or fittings and recalls of such appliances, and shall
keep distributors informed of any such monitoring.
(7)                   
Importers who consider or have reason to believe
that an appliance or a fitting which they have placed on the market is not in
conformity with this Regulation shall immediately take the corrective measures
necessary to bring that appliance or the fitting into conformity, to withdraw
it or recall it, if appropriate. Furthermore, where the appliance or the
fitting presents a risk, importers shall immediately inform the competent
national authorities of the Member States in which they made the appliance or the
fitting available on the market to that effect, giving details, in particular,
of the non-compliance and of any corrective measures taken.
(8)                   
Importers shall, for 10 years after the appliance
has been placed on the market, keep a copy of the EU declaration of conformity
at the disposal of the market surveillance authorities and ensure that the
technical documentation can be made available to those authorities, upon
request.
Importers shall, for 10 years after the fitting
has been placed on the market, keep a copy of the Fitting conformity
certificate at the disposal of the market surveillance authorities and ensure
that the technical documentation can be made available to those authorities,
upon request.
(9)                   
Importers shall, further to a reasoned request
from a competent national authority, provide it with all the information and documentation
necessary to demonstrate the conformity of an appliance or a fitting in a
language which can be easily understood by that authority. That information and
documentation may be provided in paper or electronic form. They shall cooperate
with that authority, at its request, on any action taken to eliminate the risks
posed by appliances or fittings which they have placed on the market. 
Article 10 [Article R5 of Decision No
768/2008/EC]
Obligations
of distributors
(1)                   
When making an appliance or fitting available on
the market distributors shall act with due care in relation to the requirements
of this Regulation.
(2)                   
Before making an appliance available on the
market distributors shall verify that the appliance bears the CE marking and it
is accompanied by instructions and safety information in accordance with point 1.5
of Annex I, in a language which can be easily understood by consumers and other
end-users as determined by the Member State in which the appliance is to be
made available on the market, and that the manufacturer and the importer have
complied with the requirements set out in Article 7(5) and (6) and Article 9(3)
respectively.
Before making a fitting available on the market
distributors shall verify that the fitting is accompanied by the Fitting conformity
certificate containing, amongst others, instructions for incorporation or
assembly, adjustment, operation and maintenance in accordance with point 1.7 of
Annex I, in a language which can be easily understood by appliance
manufacturers, and that the manufacturer and the importer have complied with
the requirements set out in Article 7(5) and (6) and Article 9(3) respectively.
Where a distributor considers or has reason to
believe that an appliance or a fitting is not in conformity with the essential requirements
set out in Annex I, he shall not make the appliance or the fitting available on
the market until it has been brought into conformity. Furthermore, where the appliance
or the fitting presents a risk, the distributor shall inform the manufacturer or
the importer to that effect as well as the market surveillance authorities.
(3)                   
Distributors shall ensure that, while an
appliance or a fitting is under their responsibility, storage or transport
conditions do not jeopardise their/its compliance with the essential
requirements set out in Annex I.
(4)                   
Distributors who consider or have reason to
believe that an appliance or a fitting which they have made available on the
market is not in conformity with this Regulation shall make sure that the
corrective measures necessary to bring that appliance into conformity, to
withdraw it or recall it, if appropriate, are taken. Furthermore, where the appliance
presents a risk, distributors shall immediately inform the competent national
authorities of the Member States in which they made the appliance available to
that effect, giving details, in particular, of the non-compliance and of any
corrective measures taken.
(5)                   
Distributors shall, further to a reasoned
request from a competent national authority, provide it with all the information
and documentation necessary to demonstrate the conformity of an appliance or a
fitting. That information and documentation may be provided in paper or
electronic form. They shall cooperate with that authority, at its request, on
any action taken to eliminate the risks posed by the appliance or the fitting which
they have made available on the market. 
Article 11 [Article R6 of Decision No
768/2008/EC]
Cases in
which obligations of manufacturers apply to importers and distributors
An importer or distributor shall be
considered a manufacturer for the purposes of this Regulation and he shall be
subject to the obligations of the manufacturer under Article 7, where he
places an appliance or a fitting on the market under his name or trademark or
modifies an appliance or a fitting already placed on the market in such a way
that compliance with the requirements of this Regulation may be affected.
Article 12 [Article R7 of Decision No
768/2008/EC]
Identification
of economic operators
Economic operators shall, on request,
identify the following to the market surveillance authorities:
(a)         
any economic operator who has supplied them with
an appliance or a fitting;
(b)         
any economic operator to whom they have supplied
an appliance or a fitting.
Economic operators shall be able to present
the information referred to in the first paragraph for a period of 10 years
after they have been supplied with the appliance or the fitting and for a
period of 10 years after they have supplied the appliance or the fitting.
CHAPTER III
CONFORMITY
OF APPLIANCES AND FITTINGS
Article 13 [Article R8 of Decision No
768/2008/EC]
Presumption
of conformity of appliances and fittings
Appliances and fittings which are in conformity with
harmonised standards
or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential
requirements covered by those standards or parts thereof, referred to in Annex
I. 
Article 14
Conformity
assessment procedure for appliances and fittings
(1)                   
Before an appliance or a fitting is placed on
the market, the manufacturer shall submit it to a conformity assessment
procedure in accordance with paragraphs 2 or 3.
(2)                   
The conformity of series-manufactured appliances
and fittings with the requirements of this Regulation shall be certified
through EU-type examination (Module B – production
type) referred to in point 1 of Annex III, combined with either of the
following conformity assessment procedures, at the choice of the manufacturer:
(a)         
conformity to type based on internal production
control plus supervised appliance or fitting checks at random intervals (Module
C2), set out in point 2 of Annex III;
(b)         
conformity to type based on quality assurance of
the production process (Module D), set out in point 3 of Annex III;
(c)         
conformity to type based on appliance or fitting
quality assurance (Module E), set out in point 4 of Annex III;
(d)        
conformity to type based on appliance or fitting
verification (Module F), set out in point 5 of Annex III.
(3)                   
In the case of production of an appliance as a
single unit or in small quantities, conformity based on unit verification
(Module G), set out in point 6
of Annex III, may be chosen by the manufacturer.
(4)                   
After completion of the procedures referred to
in points (a) to (d) of paragraph 2 or in paragraph 3, the appliance manufacturer
shall, in accordance with Article 18, affix the CE marking on the conforming
appliance and draw up an EU declaration of conformity.
After completion of the procedures referred to
in points (a) to (d) of paragraph 2, the fitting manufacturer shall issue a
Fitting conformity certificate.
(5)                   
Records and correspondence relating to conformity
assessment of an appliance or a fitting, shall be drawn up in the official
language(s) of the Member State where the notified body carrying out the
procedures referred to in paragraphs 2 and 3 is established or in a language
accepted by that body.
Article 15
EU
declaration of conformity [Article R10 of Decision
No 768/2008/EC]
(1)                   
The EU declaration of conformity shall state
that the fulfilment of essential requirements set out in Annex I has been
demonstrated.
(2)                   
The EU declaration of conformity shall have the
model structure set out in Annex V and shall contain the elements specified in
the relevant conformity assessment procedures set out in Annex III and shall be
continuously updated. It shall be translated into the language or languages
required by the Member State in whose market the appliance is placed or made
available on the market.
(3)                   
Where an appliance is subject to more than one Union acts requiring an EU declaration of conformity, a single EU declaration of conformity
shall be drawn up in respect of all such Union acts. That declaration shall
contain the identification of the acts concerned including the publication references.

(4)                   
By drawing up the EU declaration of conformity,
the manufacturer shall assume responsibility for the compliance of the appliance
with the requirements laid down in this Regulation.
Article 16
Fitting
conformity certificate
(1)                   
The Fitting conformity certificate shall state
that the fulfilment of the applicable essential requirements set out in Annex I
has been demonstrated.
(2)                   
The Fitting conformity certificate shall have
the model structure set out in Annex VI. In order to assist compliance with the
essential requirements applicable to finished appliances set out in Annex I,
the Fitting conformity certificate shall state the characteristics of the
fitting and it shall contain instructions on how it should be incorporated into
an appliance or assembled to constitute such an appliance. It shall contain also
the elements specified in the relevant conformity assessment procedures set out
in Annex III and shall be continuously updated. It shall be in a language which
can be easily understood by appliance manufacturers.
(3)                   
The Fitting conformity certificate shall be
supplied with the fitting.
(4)                   
Where a fitting is covered by other Union
legislation covering other aspects which require the CE marking, the latter
shall indicate that the fitting is presumed to conform to the provisions of
those other acts. In such a case, the publication reference of the said acts in
the Official Journal of the European Union shall be given in the
documents, notices or instructions required by those acts and accompanying the
fitting.
(5)                   
By drawing up the Fitting conformity
certificate, the manufacturer shall assume responsibility for the compliance of
the fitting with the requirements laid down in this Regulation.
Article 17 [Article R11 of Decision No 768/2008/EC]
General
principles of the CE marking
The CE marking shall be subject to the
general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 18 [Article R12 of Decision No 768/2008/EC]
Rules
and conditions for affixing the CE marking and inscriptions
(1)                   
The CE marking and the inscriptions referred to
in Annex IV shall be affixed visibly, legibly and indelibly to the appliance or
to its data plate.
(2)                   
The inscriptions referred to point 2 of Annex IV
shall be affixed, visibly, legibly and indelibly to the fitting or to its data
plate, as far as relevant.
(3)                   
The CE marking and/or the inscriptions referred
to in Annex IV shall be affixed before the appliance or the fitting is placed
on the market.
(4)                   
The CE marking shall be followed by the
identification number of the notified body involved in the production control
phase of the appliance.
(5)                   
The identification number of the notified body
involved in the production control phase shall be affixed on the fitting.
(6)                   
The CE marking and/or the identification number
referred to in paragraphs 4 and 5 may be followed by any other mark indicating
a special risk or use.
CHAPTER IV
NOTIFICATION
OF CONFORMITY ASSESSMENT BODIES
Article 19 [Article R13 of Decision No 768/2008/EC]
Notification
Member States shall notify the Commission
and the other Member States of bodies authorised to carry out third-party
conformity assessment tasks in accordance with Article 14. 
Article 20 [Article R14 of Decision No 768/2008/EC]
Notifying
authorities
(1)                   
Member States shall designate a notifying
authority that shall be responsible for setting up and carrying out the
necessary procedures for the assessment and notification of conformity
assessment bodies and the monitoring of notified bodies, including compliance
with Article 24.
(2)                   
Member States may decide that the assessment and
monitoring referred to in paragraph 1 shall be carried out by a national
accreditation body within the meaning of and in accordance with Regulation (EC)
No 765/2008.
(3)                   
Where the notifying authority delegates or
otherwise entrusts the assessment, notification or monitoring referred to in
paragraph 1 to a body which is not a governmental entity that body shall be a
legal entity and shall comply mutatis mutandis with the requirements laid down
in Article 21 (1) to (6). In addition it shall have arrangements to cover
liabilities arising out of its activities.
(4)                   
The notifying authority shall take full
responsibility for the tasks performed by the body referred to in paragraph 3. 
Article 21 [Article R15 of Decision No 768/2008/EC]
Requirements
relating to notifying authorities
(1)                   
A notifying authority shall be established in
such a way that no conflict of interest with conformity assessment bodies
occurs.
(2)                   
A notifying authority shall be organised and
operated so as to safeguard the objectivity and impartiality of its activities.
(3)                   
A notifying authority shall be organised in such
a way that each decision relating to notification of a conformity assessment
body is taken by competent persons different from those who carried out the
assessment.
(4)                   
A notifying authority shall not offer or provide
any activities that conformity assessment bodies perform or consultancy
services on a commercial or competitive basis.
(5)                   
A notifying authority shall safeguard the
confidentiality of the information it obtains.
(6)                   
A notifying authority shall have a sufficient
number of competent personnel at its disposal for the proper performance of its
tasks.
Article 22 [Article R16 of Decision No 768/2008/EC]
Information
obligation of notifying authorities
Member States shall inform the Commission
of their procedures for the assessment and notification of conformity
assessment bodies and the monitoring of notified bodies, and of any changes
thereto.
The
Commission shall make that information publicly available.
Article 23 [Article R17 of Decision No 768/2008/EC]
Requirements
relating to notified bodies
(1)                   
For the purposes of notification, a notified
body shall meet the requirements laid down in paragraphs 2 to 11.
(2)                   
A conformity assessment body shall be
established under national law of a Member State and have legal personality.
(3)                   
A conformity assessment body shall be a
third-party body independent of the organisation or the appliance or the fitting
it assesses.
A body belonging to a business association or
professional federation representing undertakings involved in the design,
manufacturing, provision, assembly, use or maintenance of appliances or
fittings which it assesses, may, on condition that its independence and the
absence of any conflict of interest are demonstrated, be considered such a
body.
(4)                   
A conformity assessment body, its top level
management and the personnel responsible for carrying out the conformity
assessment tasks shall not be the designer, manufacturer, supplier, installer,
purchaser, owner, user or maintainer of the appliances or the fittings which
they assess, nor the representative of any of those parties. This shall not
preclude the use of assessed appliances or fittings that are necessary for the
operations of the conformity assessment body or the use of such appliances or
fittings for personal purposes.
A conformity assessment body, its top level
management and the personnel responsible for carrying out the conformity
assessment tasks shall not be directly involved in the design, manufacture or
construction, the marketing, installation, use or maintenance of those
appliances or fittings, or represent the parties engaged in those activities.
They shall not engage in any activity that may conflict with their independence
of judgement or integrity in relation to conformity assessment activities for
which they are notified. This shall in particular apply to consultancy
services.
Conformity assessment bodies shall ensure that
the activities of their subsidiaries or subcontractors do not affect the
confidentiality, objectivity or impartiality of their conformity assessment
activities.
(5)                   
Conformity assessment bodies and their personnel
shall carry out the conformity assessment activities with the highest degree of
professional integrity and the requisite technical competence in the specific
field and shall be free from all pressures and inducements, particularly
financial, which might influence their judgement or the results of their
conformity assessment activities, especially as regards persons or groups of
persons with an interest in the results of those activities.
(6)                   
A conformity assessment body shall be capable of
carrying out all the conformity assessment tasks assigned to it by Annex II and
in relation to which it has been notified, whether those tasks are carried out
by the conformity assessment body itself or on its behalf and under its
responsibility.
At all times and for each conformity assessment
procedure and each kind or category of appliances or fittings in relation to
which it has been notified, a conformity assessment body shall have at its
disposal the necessary:
(a)         
personnel with technical knowledge and
sufficient and appropriate experience to perform the conformity assessment
tasks;
(b)         
descriptions of procedures in accordance with
which conformity assessment is carried out, ensuring the transparency and the
ability of reproduction of those procedures. It shall have appropriate policies
and procedures in place that distinguish between tasks it carries out as a
notified body and other activities;
(c)         
procedures for the performance of activities
which take due account of the size of an undertaking, the sector in which it
operates, its structure, the degree of complexity of the appliance or fitting technology
in question and the mass or serial nature of the production process.
A conformity assessment body shall have the
means necessary to perform the technical and administrative tasks connected
with the conformity assessment activities in an appropriate manner and shall
have access to all necessary equipment or facilities.
(7)                   
The personnel responsible for carrying out
conformity assessment activities shall have the following:
(a)         
sound technical and vocational training covering
all the conformity assessment activities in relation to which the conformity
assessment body has been notified;
(b)         
satisfactory knowledge of the requirements of
the assessments they carry out and adequate authority to carry out those
assessments;
(c)         
appropriate knowledge and understanding of the
essential requirements set out in Annex I, of the applicable harmonised
standards and of the relevant provisions of Union harmonisation legislation and of national
legislation;
(d)        
the ability to draw up certificates, records and
reports demonstrating that assessments have been carried out.
(8)                   
The impartiality of the conformity assessment
bodies, their top level management and of the personnel responsible for
carrying out the conformity assessment tasks shall be guaranteed.
The remuneration of the top level management
and of the personnel responsible for carrying out the conformity assessment
tasks of a conformity assessment body shall not depend on the number of
assessments carried out or on the results of those assessments.
(9)                   
Conformity assessment bodies shall take out
liability insurance unless liability is assumed by the State in accordance with
national law, or the Member State itself is directly responsible for the
conformity assessment.
(10)               
The personnel of a conformity assessment body
shall observe professional secrecy with regard to all information obtained in
carrying out their tasks under Annex III or any provision of national law
giving effect to them, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be
protected.
(11)               
Conformity assessment bodies shall participate
in, or ensure that their personnel responsible for carrying out the conformity
assessment tasks are informed of, the relevant standardisation activities and
the activities of the notified body coordination group established under the
relevant Union harmonisation legislation and shall apply as general guidance
the administrative decisions and documents produced as a result of the work of
that group.
Article 24 [Article R18 of Decision No 768/2008/EC]
Presumption
of conformity of notified bodies
Where a conformity assessment body
demonstrates its conformity with the criteria laid down in the relevant
harmonised standards or parts thereof the references of which have been
published in the Official Journal of the European Union it shall be
presumed to comply with the requirements set out in Article 23 in so far as the
applicable harmonised standards cover those requirements. 
Article 25 [Article R20 of Decision No 768/2008/EC]
Subsidiaries
of and subcontracting by notified bodies
(1)                   
Where a notified body subcontracts specific
tasks connected with conformity assessment or has recourse to a subsidiary, it
shall ensure that the subcontractor or the subsidiary meets the requirements
set out in Article 23 and shall inform the notifying authority accordingly.
(2)                   
Notified bodies shall take full responsibility
for the tasks performed by subcontractors or subsidiaries wherever these are
established.
(3)                   
Activities may be subcontracted or carried out
by a subsidiary only with the agreement of the client.
(4)                   
Notified bodies shall keep at the disposal of the
notifying authority the relevant documents concerning the assessment of the
qualifications of the subcontractor or the subsidiary and the work carried out
by them under Annex III.
Article 26 [Article R22 of Decision No 768/2008/EC]
Application
for notification
(1)                   
A conformity assessment body shall submit an
application for notification to the notifying authority of the Member State in which it is established.
(2)                   
The application for notification shall be
accompanied by a description of the conformity assessment activities, the
conformity assessment module or modules and the appliance/fitting or
appliances/fittings for which that body claims to be competent, as well as by
an accreditation certificate, where one exists, issued by a national
accreditation body attesting that the conformity assessment body fulfils the
requirements laid down in Article 23.
(3)                   
Where the conformity assessment body concerned
cannot provide an accreditation certificate, it shall provide the notifying
authority with all the documentary evidence necessary for the verification,
recognition and regular monitoring of its compliance with the requirements laid
down in Article 23.
Article 27 [Article R23 of Decision No 768/2008/EC]
Notification
procedure
(1)                   
Notifying authorities may notify only conformity
assessment bodies which have satisfied the requirements laid down in Article 23.
(2)                   
They shall notify the Commission and the other
Member States using the electronic notification tool developed and managed by
the Commission.
(3)                   
The notification shall include full details of
the conformity assessment activities, the conformity assessment module or
modules and the appliance/fitting or appliances/fittings concerned and the
relevant attestation of competence.
(4)                   
Where a notification is not based on an
accreditation certificate as referred to in Article 26(2), the notifying
authority shall provide the Commission and the other Member States with
documentary evidence which attests to the conformity assessment body's
competence and the arrangements in place to ensure that that body will be
monitored regularly and will continue to satisfy the requirements laid down in
Article 23.
(5)                   
The body concerned may perform the activities of
a notified body only where no objections are raised by the Commission or the
other Member States within two weeks of a notification where an accreditation
certificate is used or within two months of a notification where accreditation
is not used.
Only such a body shall be considered a notified
body for the purposes of this Regulation.
(6)                   
The Commission and the other Member States shall be notified of any subsequent relevant changes to the notification. 
Article 28 [Article R24 of Decision No 768/2008/EC]
Identification
numbers and lists of notified bodies
(1)                   
The Commission shall assign an identification
number to a notified body.
It shall assign a single such number even where
the body is notified under several Union acts.
(2)                   
The Commission shall make publicly available the
list of the notified bodies under this Regulation, including the identification
numbers that have been allocated to them and the activities for which they have
been notified.
The Commission shall ensure that that list is
kept up to date.
Article 29 [Article R25 of Decision No 768/2008/EC]
Changes
to notifications
(1)                   
Where a notifying authority has ascertained or
has been informed that a notified body no longer meets the requirements laid
down in Article 23 or that it is failing to fulfil its obligations, the
notifying authority shall, as appropriate, restrict, suspend or withdraw the
notification, depending on the seriousness of the failure to meet those
requirements or fulfil those obligations. It shall immediately inform the
Commission and the other Member States accordingly.
(2)                   
In the event of restriction, suspension or
withdrawal of notification, or where the notified body has ceased its activity,
the notifying Member State shall take appropriate steps to ensure that the
files of that body are either processed by another notified body or kept
available for the responsible notifying and market surveillance authorities at
their request.
Article 30 [Article R26 of Decision No 768/2008/EC]
Challenge
of the competence of notified bodies
(1)                   
The Commission shall investigate all cases where
it doubts, or doubt is brought to its attention regarding, the competence of a
notified body or the continued fulfilment by a notified body of the
requirements and responsibilities to which it is subject.
(2)                   
The notifying Member State shall provide the
Commission, on request, with all information relating to the basis for the notification
or the maintenance of the competence of the notified body concerned.
(3)                   
The Commission shall ensure that all sensitive
information obtained in the course of its investigations is treated
confidentially.
(4)                   
Where the Commission ascertains that a notified
body does not meet or no longer meets the requirements for its notification, it
shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including withdrawal of notification if
necessary.
The implementing act referred to in the first
subparagraph shall be adopted in accordance with the advisory procedure
referred to in Article 36(2).
Article 31 [Article R27 of Decision No 768/2008/EC]
Operational
obligations of notified bodies
(1)                   
Notified bodies shall carry out conformity
assessments in accordance with the conformity assessment procedures provided
for in Annex III.
(2)                   
Conformity assessments shall be carried out in a
proportionate manner, avoiding unnecessary burdens for economic operators.
Conformity assessment bodies shall perform
their activities taking due account of the size of an undertaking, the sector
in which it operates, its structure, the degree of complexity of the appliance
or fitting technology in question and the mass or serial nature of the production
process.
In so doing they shall nevertheless respect the
degree of rigour and the level of protection required for the compliance of the
appliance or the fitting with the provisions of this Regulation.
(3)                   
Where a notified body finds that essential requirements
set out in Annex I or corresponding harmonised standards or other technical
specifications have not been met by a manufacturer, it shall require that
manufacturer to take appropriate corrective measures and shall not issue a
conformity certificate.
(4)                   
Where, in the course of the monitoring of
conformity following the issue of a certificate, a notified body finds that an
appliance or a fitting no longer complies, it shall require the manufacturer to
take appropriate corrective measures and shall suspend or withdraw the
certificate if necessary. 
(5)                   
Where corrective measures are not taken or do
not have the required effect, the notified body shall restrict, suspend or
withdraw any certificates, as appropriate.
Article 32
Appeal
against decisions of notified bodies
Member States shall ensure that an appeal
procedure against decisions of notified bodies is available.
Article 33 [Article R28 of Decision No 768/2008/EC]
Information
obligation of notified bodies
(1)                   
Notified bodies shall inform the notifying authority
of the following:
(a)         
any refusal, restriction, suspension or
withdrawal of a certificate;
(b)         
any circumstances affecting the scope of or the conditions
for notification;
(c)         
any request for information which they have
received from market surveillance authorities regarding conformity assessment
activities;
(d)        
on request, conformity assessment activities
performed within the scope of their notification and any other activity
performed, including cross-border activities and subcontracting.
(2)                   
Notified bodies shall provide the other bodies
notified under this Regulation carrying out similar conformity assessment
activities covering the same appliances or fittings with relevant information
on issues relating to negative and, on request, positive conformity assessment
results.
Article 34 [Article R29 of Decision No 768/2008/EC]
Exchange
of experience
The Commission shall provide for the
organisation of exchange of experience between the Member States' national
authorities responsible for notification policy.
Article 35 [Article R30 of Decision No 768/2008/EC]
Coordination
of notified bodies
The Commission shall ensure that
appropriate coordination and cooperation between bodies notified under this Regulation
are put in place and properly operated in the form of a sectoral group or
groups of notified
bodies.
Member States shall ensure that the bodies
notified by them participate in the work of that or those group or groups,
directly or by means of designated representatives.
CHAPTER V
COMMITTEE
PROCEDURE
Article 36
Committee
procedure
(1)                   
The Commission shall be assisted by the
Committee on appliances burning gaseous fuels. That committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.
(2)                   
Where reference is made to this paragraph,
Article 4 of Regulation (EU) No 182/2011 shall apply.
Article 37
Amendment
of Annexes
The Commission shall be empowered to adopt
delegated acts in accordance with Article 38 concerning modifications to the
content and the form of the communications of the Member States of the gas supply
conditions used in their territory, set out in Annex II, in order to take into
account the technical developments with regard to the gas supply conditions.
Article 38
Exercise
of the delegation
(1)                   
The power to adopt delegated acts is conferred
on the Commission subject to the conditions laid down in this Article.
(2)                   
The delegation of power referred to in Article 37
shall be conferred for an indeterminate period of time.
(3)                   
The delegation of powers referred to in Article 37
may be revoked at any time by the European Parliament or by the Council. A
decision to revoke shall put an end to the delegation of the power specified in
that decision. It shall take effect the day following the publication of the
decision in the Official Journal of the European Union or at a later date
specified therein. It shall not affect the validity of any delegated acts
already in force. 
(4)                   
As soon as it adopts a delegated act, the
Commission shall notify it simultaneously to the European Parliament and to the
Council. 
(5)                   
A delegated act adopted pursuant to Article 37 shall
enter into force only if no objection has been expressed either by the European
Parliament or the Council within a period of two months of notification of that
act to the European Parliament and the Council or if, before the expiry of that
period, the European Parliament and the Council have both informed the
Commission that they will not object. That period shall be extended by two
months at the initiative of the European Parliament or of the Council.
CHAPTER VI
TRANSITIONAL
AND FINAL PROVISIONS
Article 39
Penalties
The Member States shall lay down the rules on
penalties applicable to infringements by economic operators of this Regulation and
shall take all measures necessary to ensure that they are enforced. Such rules
may include criminal penalties for serious infringements.
The penalties provided for shall be
effective, proportionate and dissuasive.
The Member States shall notify those
provisions to the Commission by [3 months prior to the date of application
of this Regulation] and shall notify it without delay of any subsequent amendment
affecting them.
Article 40
Transitional
provisions
(1)                   
Member States shall not impede the making
available on the market or the putting into service of appliances covered by
Directive 2009/142/EC which are in conformity with that Directive and which
were placed on the market before [the date referred to in Article 42(2)].
(2)                   
Member States shall not impede the making
available on the market of fittings covered by Directive 2009/142/EC which are
in conformity with that Directive and which were placed on the market before [the
date referred to in Article 42(2)].
Article 41
Repeal
Directive 2009/142/EC is repealed from [the
date referred to in Article 42(2)].
References to the repealed Directive shall
be construed as references to this Regulation and shall be read with in
accordance with the correlation table laid down in Annex VII.
Article 42
Entry
into force and date of application
(1)                   
This Regulation shall enter into force on the
twentieth day following that of its publication in the Official Journal of
the European Union.
(2)                   
It shall apply from [two years after entry into
force].
(3)                   
By way of derogation from paragraph 2, Articles
19 to 35 shall apply from [six months after entry into force].
This Regulation shall be binding
in its entirety and directly applicable in all Member States.
Done at Brussels,
For the European Parliament                        For
the Council
The President                                                 The
President
[1]               OJEU
L 330, 16.12.2009, p.10.
[2]               OJEU
L 196, 26.7.1990, p.15.
[3]               OJEU L 285, 31.10.2009, p.10.
[4]               OJ L 167, 22.6.1992, p.17.
[5]               OJ L 239, 6.9.2013, p.136.
[6]               OJ L 239, 6.9.2013, p.162.
[7]               OJ L 278, 12.10.2012, p.1. 
[8]               OJ L 140, 5.6.2009, p.16.
[9]               OJ L 153, 18.6.2010, p.13.
[10]             OJ L 315, 14.11.2012,p.1.
[11]             Regulation (EU) No 1025/2012 of the European Parliament
and of the Council of 25 October 2012 on European Standardisation and amending
Council Directives 89686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and
2009/105/EC of the European Parliament and of the Council and repealing Council
Decision 87/95/EEEC and Decision No 1673/2006/EC of the European Parliament and
of the Council (OJ L 316, 14.11.2012).
[12]             Proposal for a Regulation of the European Parliament
and of the Council on market surveillance of products and amending Council
Directives 89/686/EEC and 93/15/EEC, and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 1999/5/EC, 2000/9/EC, 2000/14/EC, 2001/95/EC, 2004/108/EC,
2006/42/EC, 2006/95/EC, 2007/23/EC, 2008/57/EC, 2009/48/EC, 2009/105/EC,
2009/142/EC, 2011/65/EU, Regulation (EU) No 302/2011, Regulation (EC) No
764/2008 and Regulation (EC) No 765/2008 of the European Parliament and of the
Council (COM(2013) 75 final).
[13]             OJ L 11, 15.1.2002, p.4.
[14]             OJ L 218, 13.8.2008, p.30.
[15]             Communication from the Commission to the European
Parliament, the Council, the Economic and Social Committee and the Committee of
the Regions, COM(2011) 206 final.
[16]             Ex-post evaluation of Directive 2009/142/EC on
appliances burning gaseous fuels (GAD), Final Report, Risk & Policy
Analysts Limited, March 2011,
http://ec.europa.eu/enterprise/dg/files/evaluation/03_2011_finalreport_gas_en.pdf.
[17]             New Legislative Framework (NLF) Alignment Package
(Implementation Goods Package), Commission Staff Working Paper – Impact
Assessment accompanying document to the 10 Proposals to Align Product
Harmonisation Directives to Decision No 768/2008/EC, SEC(2011) 1376 final. 
[18]             http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2004:296:0002:0007:EN:PDF

[19]             For example, gaseous fuel produced from biomass where ‘biomass’
means the biodegradable fraction of products, waste and residues from
biological origin from agriculture (including vegetal and animal substances),
forestry and related industries including fisheries and aquaculture, as well as
the biodegradable fraction of industrial and municipal waste.
[20]             Mandate M400 - Phase I: Standardization in the field of
gas qualities, Final report, CEN/BT/WG 197 (2012) evaluating the impact of H
gas quality variations on the behaviour of GAD compliant appliances.
Mandate M475:
Mandate given to CEN for standards for biomethane for use in transport and injection
in natural gas pipelines.
[21]             OJ C […], […], p.[…].
[22]             Directive 2009/142/EC of the European Parliament and of
the Council of 30 November 2009 relating to appliances burning gaseous fuels
(OJ L 330, 16.12.2009, p.10).
[23]             OJ C 136, 4.6.1985, p.1.
[24]             Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012 on European
Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and
Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the
Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council (OJ L 316, 14.11.2012, p.12).
[25]             Decision No 768/2008/EC of the European Parliament and
of the Council of 9 July 2008 on a common framework for the marketing of
products and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p.82).
[26]             Regulation (EC) No 765/2008 of the European Parliament
and of the Council of 9 July 2008 setting out the requirements for
accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p.30).
[27]             OJ L […], […], p. […].
[28]             Directive 2009/125/EC of the European Parliament and of
the Council of 21 October 2009 establishing a framework for the setting of
ecodesign requirements for energy-related products (OJ L 285, 31.10.2009,
p.10).
[29]             Directive 2009/28/EC of the European Parliament and of
the Council of 23 April 2009 on the promotion of the use of energy from
renewable sources and amending and subsequently repealing Directives 2001/77/EC
and 2003/30/EC (OJ L 140, 5.6.2009, p.16). 
[30]             Directive 2010/31/EU of the European Parliament and of
the Council of 19 May 2010 on the energy performance of buildings (OJ L 153,
18.6.2010, p.13).
[31]             Directive 2012/27/EU of the European Parliament and of
the Council of 25 October 2012 on energy efficiency, amending Directives
2009/125/EC and 2010/30/EU and repealing Directives 2004/8/EC and 2006/32/EC
(OJ L 315, 14.11.2012, p.1).
[32]             Directive 2009/73/EC of the European Parliament and of
the Council of 13 July 2009 concerning common rules for the internal market in
natural gas and repealing Directive 2003/55/EC (OJ L 211,14.8.2009, p.94).
[33]             Regulation (EU) No 1025/2012 of
the European Parliament and of the Council of 25 October 2012 on European
Standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and
Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC,
2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the
Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC
of the European Parliament and of the Council (OJ L
316, 14.11.2012, p.12).
[34]             Regulation (EU) No
182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control
by the Member States of the Commission’s exercise of implementing powers (OJ
L 55, 28.2.2011, p.13).
ANNEX I
ESSENTIAL
REQUIREMENTS
PRELIMINARY OBSERVATIONS:
1. The essential requirements laid down in
this Regulation are compulsory.
2. The essential requirements are to be
interpreted and applied in such a way as to take into account the state of the
art and current practice at the time of design and manufacture as well as of
technical and economic considerations which are consistent with a high degree
of energy efficiency, of health and safety protection.
1.         GENERAL REQUIREMENTS
1.1. Appliances shall be so designed and
constructed as to operate safely and present no danger to persons, domestic
animals or property when normally used at the desired performance level.
Fittings shall be so designed and
constructed as to fulfil correctly their intended purpose when incorporated
into an appliance or assembled to constitute such an appliance.
1.2. The manufacturer is under an
obligation to analyse the risks in order to identify those which apply to his
appliance or fitting. He shall then design and construct it taking into account
its analysis.
1.3. In selecting the most appropriate
solutions, the manufacturer of an appliance or a fitting shall apply the
principles set out below, in the following order:
(a)          
eliminate or reduce risks as far as possible
(inherently safe design and construction);
(b)         
take the necessary protection measures in
relation to risks that cannot be eliminated;
(c)          
inform users of the residual risks due to any
shortcomings of the protection measures adopted and indicate whether any
particular precautions are required.
1.4. When designing and constructing the
appliance, and when drafting the instructions, the manufacturer shall envisage
not only the intended use of the appliance, but also the reasonably foreseen
uses.
1.5. When placed on the market, all appliances
shall: 
(a)          
be accompanied by technical instructions
intended for the installer;
(b)         
be accompanied by instructions for use and
servicing, intended for the user;
(c)          
bear appropriate warning notices, which shall
also appear on the packaging.
The instructions and warning notices shall
be in a language which can be understood by consumers and other end-users as
determined by the Member State concerned.
1.6.1. The
technical instructions intended for the installer shall contain all the
instructions for installation, adjustment and servicing required to ensure that
those operations are correctly performed and that the appliance may be used
safely.
The
instructions for installation shall include also information on the technical
specifications of the interface between the appliance and its installation
environment allowing its correct connection to the gas supply network, the
supply of auxiliary energy, the combustion air supply and the flue gas
evacuation system.
1.6.2. The instructions for use and
servicing intended for the user shall contain all the information required for
safe use and in particular shall draw the user's attention to any restrictions
on use.
The manufacturer of the appliance shall
include in the instructions accompanying the appliance, all necessary
information for adjustment, operation and maintenance of the fittings as part
of the finished appliance, as appropriate.
1.6.3. The warning notices on the appliance
and its packaging shall clearly state the type of gas used, the gas supply
pressure, the appliance category and any restrictions on use, in particular the
restriction whereby the appliance shall be installed only in areas where there
is sufficient ventilation so as to ensure that the risks presented by it are
minimised.
1.7. The instructions for incorporation or
assembly, adjustment, operation and maintenance shall be provided with the
fittings concerned as part of the Fitting conformity certificate.
2.         MATERIALS
2.1. Materials for appliances or fittings
shall be appropriate for their intended purpose and shall withstand the
mechanical, chemical and thermal conditions to which they will foreseeably be
subjected.
2.2. The properties of materials that are
important for safety shall be guaranteed by the manufacturer or by the supplier
of the material.
3.         DESIGN AND CONSTRUCTION
The obligations arising for appliances from
the essential requirements set out in this point apply also to fittings, as far
as relevant.
3.1. General
3.1.1. Appliances shall be so designed and
constructed that, when used normally, no instability, distortion, breakage or
wear likely to impair their safety may occur.
3.1.2. Condensation produced at the
start-up and/or during use shall not affect the safety of appliances.
3.1.3. Appliances shall be so designed and
constructed as to minimise the risk of explosion in the event of a fire of
external origin.
3.1.4. Appliances shall be so designed and
constructed that water and inappropriate air penetration into the gas circuit
does not occur.
3.1.5. In the event of a normal fluctuation
of auxiliary energy, appliances shall continue to operate safely.
3.1.6. Abnormal fluctuation or failure of
auxiliary energy or its restoration shall not lead to an unsafe situation.
3.1.7. Appliances shall be so designed and
constructed as to obviate any gas related risks due to hazards of electrical
origin. As far as relevant, the results of the conformity assessment in
relation to the safety requirements of Directive 1999/5/EC of the European
Parliament and of the Council[1]
on radio equipment or the safety objectives of Directive 2006/95/EC of the
European Parliament and of the Council relating to electrical equipment
designed for use within certain voltage limits[2]
shall be taken into account.
3.1.8. Appliances must be so designed and
constructed as to obviate any gas related risks due to hazards originating from
electromagnetic phenomena. As far as relevant, the results of the conformity
assessment in relation to the electromagnetic compatibility requirements of
Directive 1999/5/EC or Directive 2004/108/EC of the European Parliament and of
the Council relating to electromagnetic compatibility[3] shall be taken into
account.
3.1.9. All pressurized parts of an
appliance shall withstand the mechanical and thermal stresses to which they are
subjected without any deformation affecting safety.
3.1.10. Appliances shall be so designed and
constructed that failure of a safety, controlling or regulating device may not
lead to an unsafe situation.
3.1.11. If an appliance is equipped with
safety and controlling devices, the functioning of the safety devices shall not
be overruled by that of the controlling devices.
3.1.12. All parts of appliances which are
set or adjusted at the stage of manufacture and which should not be manipulated
by the user or the installer shall be appropriately protected.
3.1.13. Levers and other controlling and
setting devices shall be clearly marked and give appropriate instructions so as
to prevent any error in operation/use. Their design shall be such as to
preclude accidental operation.
3.2. Unburned gas release
3.2.1. Appliances shall be so designed and
constructed that the gas leakage rate is not dangerous.
3.2.2. Appliances shall be so designed and
constructed that gas release at any state of operation is limited in order to
avoid a dangerous accumulation of unburned gas in the appliance.
3.2.3. Appliances intended to be used in
indoor spaces and rooms shall be so designed and constructed to prevent the
release of unburned gas in all situations which could lead to a dangerous
accumulation of unburned gas in such spaces and rooms.
3.2.4. Appliances designed and constructed
to burn gas containing toxic components shall not present a danger to the
health of persons and domestic animals exposed.
3.3. Ignition
Appliances
shall be so designed and constructed that, when used normally, ignition and
re-ignition is smooth and cross-lighting is assured.
3.4. Combustion
3.4.1. Appliances shall be so designed and
constructed that, when used normally, the combustion process is stable and
combustion products do not contain unacceptable concentrations of substances
harmful to health.
3.4.2. Appliances shall be so designed and
constructed that, when used normally there will be no accidental release of
combustion products.
3.4.3. Appliances connected to a flue for
the dispersal of combustion products shall be so designed and constructed that
in abnormal draught conditions there is no release of combustion products in a
dangerous quantity into the indoor spaces or rooms concerned.
3.4.4. Appliances shall be so designed and
constructed that, when used normally, they do not cause a concentration of
substances harmful to health, such as they would be likely to present a danger
to the health of persons and domestic animals exposed.
3.5. Rational use of energy
Appliances must be so designed and constructed
as to ensure rational use of energy, reflecting the state of the art and taking
into account safety aspects.
3.6. Temperature
3.6.1. Parts of appliances which are
intended to be installed or placed in close proximity to surfaces shall not
reach temperatures which present a danger.
3.6.2. The surface temperature of parts of
appliances intended to be handled during normal use shall not present a danger
to the user.
3.6.3. The surface temperatures of external
parts of appliances, with the exception of surfaces or parts which are
associated with the transmission of heat, shall not under operating conditions
present a danger to persons exposed and in particular to children and elderly
people, for whom an appropriate reaction time shall be taken into account.
3.7. Contact with food and water intended
for human consumption
Without prejudice to Regulation (EC) No
1935/2004 of the European Parliament and of the Council[4] on materials and
articles intended to come into contact with food and Regulation (EU) No
305/2011 of the European Parliament and of the Council[5] on construction
products, materials and parts used in the construction of an appliance, which
may come into contact with food or water intended for human consumption as defined
in Article 2 of Council Directive 98/83/EC on the quality of water intended for
human consumption[6],
shall not impair quality of the food or water. 
 ANNEX II
CONTENT OF THE MEMBER STATES
COMMUNICATIONS OF THE GAS SUPPLY CONDITIONS
(1)                   
The communications of the Member States to the Commission and the other Member States provided for in Article 4 shall have the
following content:
(a)         
(i)         Gross Calorific Value (GCV) in MJ/m3         Minimum/Maximum;
(ii)     Wobbe Number
in MJ/m3          Minimum/Maximum.
(b)         
Gas composition by volume in % of the total content:
–              
C1 to C5 content in % (sum)     Minimum         Maximum;
–              
N2 + CO2 content in %   Minimum         Maximum;
–              
CO content in %            Minimum         Maximum;
–              
Unsaturated HC Minimum         Maximum;
–              
Hydrogen content in %  Minimum         Maximum. 
(c)         
Information on toxic
components contained in the gaseous fuel.
That communication shall also include either of
the following:
(a)          
Supply Pressure at the inlet of appliances in
mbar:        Nominal/Minimum/Maximum;
(b)         
(i) Supply Pressure at the point of delivery in
mbar: Nominal/Minimum/Maximum;
ii) Admissible Pressure loss in the end user
gas installation in mbar: Nominal/Minimum/Maximum.
(2)                   
The reference conditions for Wobbe Index and
Gross Calorific Value shall be the following:
(a)         
Combustion reference temperature: 15°C;
(b)         
Volume measurement reference temperature: 15°C;
(c)         
Volume measurement reference pressure: 1013,25 mbar.
ANNEX III
CONFORMITY ASSESSMENT PROCEDURES FOR
APPLIANCES AND FITTINGS
1. MODULE B: EU-TYPE
EXAMINATION – PRODUCTION TYPE
1.1. EU-type examination is the part of a
conformity assessment procedure in which a notified body examines the technical
design of an appliance or a fitting and verifies and attests that the technical
design of the appliance or the fitting meets the requirements of this
Regulation.
1.2. EU-type examination is carried out by assessment
of the adequacy of the technical design of the appliance or the fitting through
examination of the technical documentation and supporting evidence referred to
in point 1.3, plus examination of a specimen, representative of the production
envisaged, of the complete appliance or fitting (production type).
1.3. The manufacturer shall lodge an
application for EU-type examination with a single notified body of his choice.
1.3.1. The application shall include the
following:
(a)         
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
(b)         
a written declaration that the same application
has not been lodged with any other notified body,
(c)         
the technical documentation. The technical
documentation shall make it possible to assess the appliance’s or fitting's
conformity with the applicable requirements of this Regulation and shall
include an adequate analysis and assessment of the risk(s). The technical
documentation shall specify the applicable requirements and cover, as far as
relevant for the assessment, the design, manufacture and operation of the
appliance or the fitting. The technical documentation shall contain, wherever
applicable, at least the following elements:
(1)         
a general description of the appliance or the
fitting;
(2)         
conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.;
(3)         
descriptions and explanations necessary for the
understanding of those drawings and schemes and the operation of the appliance
or the fitting;
(4)         
a list of the harmonised standards and/or other
relevant technical specifications the references of which have been published
in the Official Journal of the European Union, applied in full or in part, and
descriptions of the solutions adopted to meet the essential safety requirements
of this Regulation where those harmonised standards have not been applied. In
the event of partly applied harmonised standards, the technical documentation
shall specify the parts which have been applied;
(5)         
results of design calculations made,
examinations carried out, etc.;
(6)         
test reports;
(7)         
the specimens representative of the production
envisaged. The notified body may request further specimens where needed for
carrying out the test programme; 
(8)         
the supporting evidence for the adequacy of the
technical design solution. This supporting evidence shall mention any documents
that have been used, in particular where the relevant harmonised standards
and/or technical specifications have not been applied in full. The supporting
evidence shall include, where necessary, the results of tests carried out by
the appropriate laboratory of the manufacturer, or by another testing
laboratory on his behalf and under his responsibility.
(9)         
instructions for installation and use of the appliance.
(10)     
the Fitting conformity certificate containing
the instructions on how the fitting should be incorporated into an appliance or
assembled to constitute such an appliance.
1.3.2. Where appropriate, the design
documentation shall contain the following elements:
(a)                   
the EU type-examination certificate and the
Fitting conformity certificate relating to the fittings incorporated into the
appliance;
(b)                   
attestations and certificates relating to the
methods of manufacture and/or inspection and/or monitoring of the appliance or
the fitting;
(c)                   
any other document making it possible for the
notified body to improve its assessment.
1.4. The notified body shall:
For the appliance or the fitting:
1.4.1. examine the technical documentation
and supporting evidence to assess the adequacy of the technical design of the
appliance or the fitting.
For the specimen(s):
1.4.2. verify that the specimen(s) have
been manufactured in conformity with the technical documentation, and identify
the elements which have been designed in accordance with the applicable
provisions of the relevant harmonised standards and/or technical
specifications, as well as the elements which have been designed without
applying the relevant provisions of those standards;
1.4.3. carry out appropriate examinations
and tests, or have them carried out, to check whether, where the manufacturer
has chosen to apply the solutions in the relevant harmonised standards and/or
technical specifications, these have been applied correctly;
1.4.4. carry out appropriate examinations
and tests, or have them carried out, to check whether, where the solutions in
the relevant harmonised standards and/or technical specifications have not been
applied, the solutions adopted by the manufacturer meet the corresponding
essential requirements of this Regulation;
1.4.5. agree with the manufacturer on a
location where the examinations and tests will be carried out.
1.5. The notified body shall draw up an evaluation
report that records the activities undertaken in accordance with point 1.4 and their
outcomes. Without prejudice to its obligations towards the notifying
authorities, the notified body shall release the content of that report, in
full or in part, only with the agreement of the manufacturer.
1.6. Where the appliance or the fitting type
meets the requirements of this Regulation, the notified body shall issue an
EU-type examination certificate to the manufacturer. The certificate shall
contain the name and address of the manufacturer, the conclusions of the
examination, the conditions (if any) for its validity, the necessary data for
identification of the approved type and, if relevant, descriptions of its
functioning. The certificate may have one or more annexes attached. 
The certificate and its annexes shall
contain all relevant information to allow the conformity of manufactured
appliances or fittings with the examined type to be evaluated and to allow for
in-service control.
The certificate shall have a maximum validity
period of ten years from the date of its issue. Where
the type does not satisfy the applicable requirements of this Regulation, the
notified body shall refuse to issue an EU-type examination certificate and
shall inform the applicant accordingly, giving detailed reasons for its
refusal.
1.7. The notified body shall keep itself apprised
of any changes in the generally acknowledged state of the art which indicate
that the approved type may no longer comply with the applicable requirements of
this Regulation, and shall determine whether such changes require further
investigation. If so, the notified body shall inform the manufacturer
accordingly. 
The manufacturer shall inform the notified
body that holds the technical documentation relating to the EU-type examination
certificate of all modifications to the approved type that may affect the
conformity of the appliance or the fitting with the essential requirements of
this Regulation or the conditions for validity of the certificate. Such
modifications shall require additional approval in the form of an addition to
the original EU-type examination certificate.
1.8. Each notified body shall inform its
notifying authorities and the other notified bodies concerning the EU-type
examination certificates and/or any additions thereto which it has issued.
The notified body which refuses to issue or
withdraws, suspends or otherwise restricts an EU type-examination certificate
shall inform its notifying authorities and the other notified bodies
accordingly, giving the reasons for its decision.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination
certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the
examinations carried out by the notified body. The notified body shall keep a copy
of the EU-type examination certificate, its annexes and additions, as well as
the technical file including the documentation submitted by the manufacturer,
until the expiry of the validity of the certificate.
1.9. The manufacturer shall keep a copy of
the EU-type examination certificate, its annexes and additions together with
the technical documentation at the disposal of the national authorities for 10
years after the appliance or the fitting has been placed on the market.
1.10. The manufacturer's authorised
representative may lodge the application referred to in point 1.3 and fulfil
the obligations set out in points 1.7 and 1.9, provided that they are specified
in the mandate.
2. MODULE C2:
CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED APPLIANCE
OR FITTING CHECKS AT RANDOM INTERVALS
2.1. Conformity
to type based on internal production control plus supervised appliance or
fitting checks at random intervals is the part of a conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points
2.2 and 2.3 and point 2.4 or 2.5, and ensures and declares on his sole
responsibility that the appliances or the fittings concerned are in conformity with
the type described in the EU-type examination certificate and satisfy the
requirements of this Regulation.
2.2.
Manufacturing
The
manufacturer shall take all measures necessary so that the manufacturing
process and its monitoring ensure conformity of the manufactured appliances or
fittings with the type described in the EU-type examination certificate and
with the requirements of this Regulation.
2.3. Appliance
or fitting checks
A notified body, chosen by the
manufacturer, shall carry out appliance or fitting checks or have them carried
out at intervals of one year or less, in order to verify the quality of the
internal checks on the appliance, taking into account, inter alia, the
technological complexity of the appliances or the fittings and the quantity of
production. An adequate sample of the final appliances or fittings taken on
site by the notified body before the placing on the market, shall be examined
and appropriate tests as identified by the relevant parts of the harmonised
standards and/or technical specifications, or equivalent tests, shall be
carried out in order to check the conformity of the appliance or the fitting
with the relevant requirements of this Regulation. Where a sample does not
conform to the acceptable quality level, the notified body shall take
appropriate measures to prevent the placing on the market of the concerned
appliances or fittings.
The acceptance sampling procedure to be
applied is intended to determine whether the manufacturing process of the appliance
or the fitting performs within acceptable limits, with a view to ensuring
conformity of the appliance or the fitting.
The
manufacturer shall, under the responsibility of the notified body, affix the
notified body's identification number during the manufacturing process.
2.4. CE marking
and EU declaration of conformity
2.4.1. The
manufacturer shall affix the CE marking and the inscriptions provided for in
Annex IV to each individual appliance that is in conformity with the type
described in the EU-type examination certificate and satisfies the applicable
requirements of this Regulation.
2.4.2. The
manufacturer shall draw up a written EU declaration of conformity for an
appliance model and keep it at the disposal of the national authorities for 10
years after the appliance has been placed on the market. The EU declaration of
conformity shall identify the appliance model for which it has been drawn up.
A copy of the
EU declaration of conformity shall be made available to the relevant
authorities upon request.
2.5. Fitting
conformity certificate
2.5.1. The
manufacturer shall affix the inscriptions provided for in point 3 of Annex IV
to each individual fitting that is in conformity with the type described in the
EU-type examination certificate and satisfies the applicable requirements of
this Regulation.
2.5.2. The
manufacturer shall draw up a written Fitting conformity certificate for a
fitting model and keep it at the disposal of the national authorities for 10
years after the fitting has been placed on the market. The Fitting conformity
certificate shall identify the fitting model for which it has been drawn up and
shall accompany the fitting.
2.6. Authorised
representative
The
manufacturer's obligations set out in point 2.4 or 2.5 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
3. MODULE D:
CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS
3.1. Conformity
to type based on quality assurance of the production process is the part of a
conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in point 3.2 and points 3.5 or 3.6, and ensures and
declares on his sole responsibility that the appliances or fittings concerned
are in conformity with the type described in the EU-type examination
certificate and satisfy the requirements of this Regulation that apply to them.
3.2.
Manufacturing
The
manufacturer shall operate an approved quality system for production, final
instrument inspection and testing of the appliances or fittings concerned as
specified in point 3.3, and shall be subject to surveillance as specified in
point 3.4.
3.3. Quality
system
3.3.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the appliances or fittings concerned.
The application
shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
(b)                   
a written declaration that the same application
has not been lodged with any other notified body,
(c)                   
all relevant information for the appliance or
the fitting approved under module B,
(d)                  
the documentation concerning the quality system,
(e)                   
the technical documentation of the approved type
and a copy of the EU-type examination certificate.
3.3.2. The quality system shall ensure that
the appliances or fittings are in conformity with the type described in the
EU-type examination certificate and comply with the requirements of this Regulation
that apply to them.
All the elements, requirements and
provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions.
The quality system documentation shall permit a consistent interpretation of
the quality programmes, plans, manuals and records.
It shall, in particular, contain an
adequate description of:
(a)                   
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to
appliance quality;
(b)                   
the corresponding manufacturing, quality control
and quality assurance techniques, processes and systematic actions that will be
used;
(c)                   
the examinations and tests that will be carried
out before, during and after manufacture, and the frequency with which they
will be carried out;
(d)                  
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc. and
(e)                   
the means of monitoring the achievement of the
required appliance quality and the effective operation of the quality system.
3.3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in point 3.2.
It shall presume conformity with those
requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the
relevant harmonised standard and/or technical specifications.
In addition to experience in quality
management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant appliance or fitting field and the
appliance or fitting technology concerned, and knowledge of the applicable
requirements of this Regulation. The audit shall include an assessment visit to
the manufacturer's premises. The auditing team shall review the technical
documentation referred to in point 3.3.1(e), to verify the manufacturer's
ability to identify the relevant requirements of this Regulation and to carry
out the necessary examinations with a view to ensuring compliance of the
appliance or the fitting with those requirements.
The decision shall be notified to the
manufacturer. The notification shall contain the conclusions of the audit and
the reasoned assessment decision.
3.3.4. The
manufacturer shall undertake to fulfil the obligations arising out of the
quality system as approved and to maintain it so that it remains adequate and
efficient.
3.3.5. The manufacturer shall keep the
notified body that has approved the quality system informed of any intended
change to the quality system 
The notified
body shall evaluate any proposed changes and decide whether the modified
quality system will continue to satisfy the requirements referred to in point
3.3.2 or whether a reassessment is necessary.
It shall notify
the manufacturer of its decision. The notification shall contain the
conclusions of the examination and the reasoned assessment decision.
3.4.
Surveillance under the responsibility of the notified body
3.4.1. The
purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
3.4.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:
(a)                   
the quality system documentation and
(b)                   
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.
3.4.3. The notified body shall carry out
periodic audits of at least once every two years to make sure that the
manufacturer maintains and applies the quality system and shall provide the
manufacturer with an audit report.
3.4.4. In addition, the notified body may
pay unexpected visits to the manufacturer. During such visits the notified body
may, if necessary, carry out appliance or fitting tests, or have them carried
out, in order to verify that the quality system is functioning correctly. The
notified body shall provide the manufacturer with a visit report and, if tests
have been carried out, with a test report.
3.5. CE marking and EU declaration of
conformity
3.5.1. The manufacturer shall affix the CE
marking and the inscriptions provided for in Annex IV,
and, under the responsibility of the notified body referred to in point 3.3.1,
the latter's identification number to each individual appliance that is in
conformity with the type described in the EU-type examination certificate and satisfies
the applicable requirements of this Regulation.
3.5.2. The manufacturer shall draw up a
written EU declaration of conformity for each appliance and keep it at the
disposal of the national authorities for 10 years after the appliance has been
placed on the market. The EU declaration of conformity shall identify the
appliance model for which it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
3.6. Fitting conformity certificate
3.6.1. The
manufacturer shall affix the inscriptions provided for in point 3 of Annex IV
and, under the responsibility of the notified body referred to in point 3.3.1,
the latter's identification number to each individual fitting that is in
conformity with the type described in the EU-type examination certificate and
satisfies the applicable requirements of this Regulation.
3.6.2. The
manufacturer shall draw up a written Fitting conformity certificate for a
fitting and keep it at the disposal of the national authorities for 10 years
after the fitting has been placed on the market. The Fitting conformity
certificate shall identify the fitting model for which it has been drawn up and
shall accompany the fitting.
3.7. The
manufacturer shall, for a period ending at least 10 years after the appliance
or the fitting has been placed on the
market, keep at the disposal of the national authorities:
(a)                   
the documentation referred to in point 3.3.1,
(b)                   
the change referred to in point 3.3.5, as
approved,
(c)                   
the decisions and reports of the notified body
referred to in points 3.3.5, 3.4.3 and 3.4.4.
3.8. Each notified body shall inform its
notifying authorities of quality system approvals withdrawn, and shall,
periodically or upon request, make available to its notifying authorities
information related to quality system assessments. 
Each notified body shall inform the other
notified bodies of quality system approvals which it has refused, suspended,
withdrawn or otherwise restricted, giving the reasons for its decision.
3.9. Authorised representative
The manufacturer's obligations set out in
points 3.3.1, 3.3.5 and point 3.5 or 3.6 and point 3.7 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
4. MODULE E:
CONFORMITY TO TYPE BASED ON APPLIANCE OR FITTING QUALITY ASSURANCE
4.1. Conformity
to type based on appliance or fitting quality assurance is that part of a
conformity assessment procedure whereby the manufacturer fulfils the obligations
laid down in points 4.2 and 4.5 or 4.6, and ensures and declares on his sole
responsibility that the appliances or fittings concerned are in conformity with
the type described in the EU-type examination certificate and satisfy the
requirements of this Regulation that apply to them.
4.2.
Manufacturing
The
manufacturer shall operate an approved quality system for final appliance or
fitting inspection and testing of the appliances or fittings concerned as
specified in point 4.3 and shall be subject to surveillance as specified in
point 4.4.
4.3. Quality
system
4.3.1. The
manufacturer shall lodge an application for assessment of his quality system
with the notified body of his choice, for the appliances or fittings concerned.
The application
shall include:
(a)                   
the name and address of the manufacturer and, if
the application is lodged by the authorised representative, his name and
address as well,
(b)                   
a written declaration that the same application
has not been lodged with any other notified body;
(c)                   
all relevant information for the appliance
category envisaged;
(d)                  
the documentation concerning the quality system,
and
(e)                   
the technical documentation of the approved type
and a copy of the EU-type examination certificate.
4.3.2. The quality system shall ensure
compliance of the appliances or the fittings with the type described in the
EU-type examination certificate and with the applicable requirements of this
Regulation.
All the elements, requirements and
provisions adopted by the manufacturer shall be documented in a systematic and
orderly manner in the form of written policies, procedures and instructions.
The quality system documentation shall permit a consistent interpretation of the
quality programmes, plans, manuals and records.
It shall, in particular, contain an
adequate description of the following:
(a)                   
the quality objectives and the organisational
structure, responsibilities and powers of the management with regard to product
quality;
(b)                   
the examinations and tests that will be carried
out after manufacture;
(c)                   
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.;
(d)                  
the means of monitoring the effective operation
of the quality system.
4.3.3. The notified body shall assess the
quality system to determine whether it satisfies the requirements referred to
in point 4.3.2.
It shall presume conformity with those
requirements in respect of the elements of the quality system that comply with
the corresponding specifications of the national standard that implements the
relevant harmonised standard and/or technical specification.
In addition to experience in quality
management systems, the auditing team shall have at least one member with
experience of evaluation in the relevant appliance or fitting field and appliance
or fitting technology concerned, and knowledge of the applicable requirements
of this Regulation. The audit shall include an assessment visit to the
manufacturer's premises. The auditing team shall review the technical
documentation referred to in point 4.3.1(e), in order to verify the
manufacturer's ability to identify the relevant requirements of this Regulation
and to carry out the necessary examinations with a view to ensuring compliance
of the appliance or the fitting with those requirements.
The decision shall be notified to the
manufacturer. The notification shall contain the conclusions of the audit and
the reasoned assessment decision.
4.3.4. The manufacturer shall undertake to
fulfil the obligations arising out of the quality system as approved and to
maintain it so that it remains adequate and efficient.
4.3.5. The manufacturer shall keep the
notified body that has approved the quality system informed of any intended
change to the quality system.
The notified body shall evaluate any
proposed changes and decide whether the modified quality system will continue
to satisfy the requirements referred to in point 4.3.2 or whether a
reassessment is necessary.
It shall notify the manufacturer of its
decision. The notification shall contain the conclusions of the examination and
the reasoned assessment decision.
4.4.
Surveillance under the responsibility of the notified body
4.4.1. The
purpose of surveillance is to make sure that the manufacturer duly fulfils the
obligations arising out of the approved quality system.
4.4.2. The
manufacturer shall, for assessment purposes, allow the notified body access to
the manufacture, inspection, testing and storage sites and shall provide it
with all necessary information, in particular:
(a)                   
the quality system documentation;
(b)                   
the quality records, such as inspection reports
and test data, calibration data, qualification reports on the personnel
concerned, etc.
4.4.3. The notified body shall carry out
periodic audits out of at least once every two years to make sure that the
manufacturer maintains and applies the quality system and shall provide the
manufacturer with an audit report.
4.4.4. In
addition, the notified body may pay unexpected visits to the manufacturer.
During such visits the notified body may, if necessary, carry out appliance or
fitting tests, or have them carried out, in order to verify that the quality
system is functioning correctly. The notified body shall provide the
manufacturer with a visit report and, if tests have been carried out, with a
test report.
4.5. CE marking
and EU declaration of conformity
4.5.1. The
manufacturer shall affix the CE marking and the
inscriptions provided for in Annex IV and, under the responsibility of
the notified body referred to in point 4.3.1, the latter's identification number
to each individual appliance that is in conformity with the type described in
the EU-type examination certificate and satisfies the applicable requirements
of this Regulation.
4.5.2. The
manufacturer shall draw up a written EU declaration of conformity for each
appliance model and keep it at the disposal of the national authorities for 10
years after the appliance has been placed on the market. The EU declaration of
conformity shall identify the appliance model for which it has been drawn up.
A copy of the
EU declaration of conformity shall be made available to the relevant
authorities upon request.
4.6. Fitting conformity
certificate
4.6.1. The
manufacturer shall affix the inscriptions provided for in point 3 of Annex IV
and, under the responsibility of the notified body referred to in point 4.3.1,
the latter's identification number to each individual fitting that is in
conformity with the type described in the EU-type examination certificate and
satisfies the applicable requirements of this Regulation.
4.6.2. The
manufacturer shall draw up a written Fitting conformity certificate for each
fitting model and keep it at the disposal of the national authorities for 10
years after the fitting has been placed on the market. The Fitting conformity
certificate shall identify the fitting model for which it has been drawn up and
shall accompany the fitting.
4.7.The manufacturer shall, for a period
ending at least 10 years after the appliance or the fitting has been placed on
the market, keep at the disposal of the national authorities all of the
following:
(a)                   
the documentation referred to in point 4.3.1;
(b)                   
the change referred to in point 4.3.5, as
approved;
(c)                   
the decisions and reports of the notified body
referred to in points 4.3.5, 4.4.3 and 4.4.4.
4.8. Each notified body shall inform its
notifying authorities of quality system approvals issued or withdrawn, and
shall, periodically or upon request, make available to its notifying
authorities the list of quality system approvals refused, suspended or
otherwise restricted.
Each notified body shall inform the other
notified bodies of quality system approvals which it has issued. Each notified
body shall inform the other notified bodies of quality system approvals which
it has refused, suspended or withdrawn, providing the reasons for its decision.
4.9. Authorised representative
The manufacturer's obligations set out in
points 4.3.1, 4.3.5 and 4.5 or 4.6 and point 4.7 may be fulfilled by his
authorised representative, on his behalf and under his responsibility, provided
that they are specified in the mandate.
5. MODULE F:
CONFORMITY TO TYPE BASED ON APPLIANCE OR FITING VERIFICATION
5.1. Conformity
to type based on appliance or fitting verification is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down
in points 5.2, 5.5.1 and point 5.6 or 5.7, and ensures and declares on his sole
responsibility that the appliances or fittings concerned, which have been
subject to the provisions of point 5.3, are in conformity with the type described
in the EU-type examination certificate and satisfy the requirements of this
Regulation that apply to them.
5.2.
Manufacturing
The
manufacturer shall take all measures necessary so that the manufacturing
process and its monitoring ensure conformity of the manufactured appliances or
fittings with the approved type described in the EU-type examination
certificate and with the requirements of this Regulation that apply to them.
5.3.
Verification
A notified body
chosen by the manufacturer shall carry out appropriate examinations and tests, or have them carried out, in order to check the
conformity of the appliances or fittings with the approved type described in
the EU-type examination certificate and with the appropriate requirements of
this Regulation.
The
examinations and tests to check the conformity of the appliances or fittings
with the appropriate requirements shall be carried out, at the choice of the
manufacturer either by examination and testing of every appliance or fitting as
specified in point 5.4 or by examination and testing of the appliances or
fittings on a statistical basis as specified in point 5.5.
5.4.
Verification of conformity by examination and testing of every appliance or
fitting
5.4.1. All
appliances or fittings shall be individually examined and appropriate tests set
out in the relevant harmonised standard(s) and/or technical specifications, or
equivalent tests, shall be carried out in order to verify conformity with the
approved type described in the EU-type examination certificate and with the
appropriate requirements of this Regulation.
In the absence
of such a harmonised standard, the notified body concerned shall decide on the
appropriate tests to be carried out.
5.4.2. The
notified body shall issue a certificate of conformity in respect of the
examinations and tests carried out, and shall affix its identification number
to each approved appliance or fitting, or have it affixed under its
responsibility.
The
manufacturer shall keep the certificates of conformity available for inspection
by the national authorities for 10 years after the appliance or the fitting has
been placed on the market.
5.5.
Statistical verification of conformity 
5.5.1. The
manufacturer shall take all measures necessary so that the manufacturing
process and its monitoring ensure the homogeneity of each lot produced, and
shall present his appliances or fittings for verification in the form of
homogeneous lots.
5.5.2. A random
sample shall be taken from each lot according to the requirements of this Regulation. All appliances or fittings in
a sample shall be individually examined and appropriate tests set out in the
relevant harmonised standard(s) and/or technical specifications, or equivalent
tests, shall be carried out in order to ensure their conformity with the
applicable requirements of this Regulation and to determine whether the lot is
accepted or rejected. In the absence of such a harmonised standard, the
notified body concerned shall decide on the appropriate tests to be carried
out.
5.5.3. If a lot
is accepted, all appliances or fittings of the lot shall be considered
approved, except for those appliances or fittings from the sample that have
been found not to satisfy the tests.
The notified
body shall issue a certificate of conformity in respect to the examinations and
tests carried out, and shall affix its identification number to each approved appliance
or fitting, or have it affixed under its responsibility.
The
manufacturer shall keep the certificates of conformity at the disposal of the
national authorities for 10 years after the appliance or the fitting has been
placed on the market.
5.5.4. If a lot
is rejected, the notified body or the competent authority shall take
appropriate measures to prevent that lot's being placed on the market. In the
event of the frequent rejection of lots the notified body may suspend the
statistical verification and take appropriate measures.
5.6. CE marking
and EU declaration of conformity
5.6.1. The manufacturer
shall affix the CE marking and the inscriptions
provided for in Annex IV and, under
the responsibility of the notified body referred to in point 5.3, the latter's
identification number to each individual appliance that is in conformity with
the approved type described in the EU-type examination certificate and satisfies
the applicable requirements of this Regulation.
5.6.2. The
manufacturer shall draw up a written EU declaration of conformity for each
appliance model and keep it at the disposal of the national authorities, for 10
years after the appliance has been placed on the market. The EU declaration of
conformity shall identify the appliance model for which it has been drawn up.
A copy of the
EU declaration of conformity shall be made available to the relevant
authorities upon request.
If the notified
body referred to in point 5.3 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
appliances.
5.7. Fitting conformity
certificate
5.7.1. The
manufacturer shall affix the inscriptions provided for in point 3 of Annex IV
and, under the responsibility of the notified body referred to in point 5.3,
the latter's identification number to each individual fitting that is in
conformity with the approved type described in the EU-type examination
certificate and satisfies the applicable requirements of this Regulation.
5.7.2. The
manufacturer shall draw up a written Fitting conformity certificate for each
fitting model and keep it at the disposal of the national authorities for 10
years after the fitting has been placed on the market. The Fitting conformity
certificate shall identify the fitting model for which it has been drawn up and
shall accompany the fitting.
If the notified
body referred to in point 5.3 agrees and under its responsibility, the
manufacturer may also affix the notified body's identification number to the
fittings.
5.8. If the
notified body agrees and under its responsibility, the manufacturer may affix
the notified body's identification number to the appliances or the fittings
during the manufacturing process.
5.9. Authorised
representative
The
manufacturer's obligations may be fulfilled by his authorised representative,
on his behalf and under his responsibility, provided that they are specified in
the mandate. An authorised representative may not fulfil the manufacturer's
obligations set out in points 5.2 and 5.5.1.
6. MODULE G: CONFORMITY
BASED ON UNIT VERIFICATION
6.1. Conformity based on unit verification
is the conformity assessment procedure whereby the manufacturer fulfils the
obligations laid down in points 6.2, 6.3 and 6.5, and ensures and declares on
his sole responsibility that the appliance concerned, which has been subject to
the provisions of point 6.4, is in conformity with the requirements of this
Regulation that apply to it.
6.2. Technical documentation
The manufacturer shall establish the
technical documentation and make it available to the notified body referred to
in point 6.4. The documentation shall make it possible to assess the
appliance’s conformity with the relevant requirements, and shall include an
adequate analysis and assessment of the risk(s). The technical documentation
shall specify the applicable requirements and cover, as far as relevant for the
assessment, the design, manufacture and operation of the appliance.
6.2.1. The technical documentation shall,
wherever applicable, contain at least the following elements:
(a)                   
a general description of the appliance;
(b)                   
conceptual design and manufacturing drawings and
schemes of components, sub-assemblies, circuits, etc.;
(c)                   
descriptions and explanations necessary for the
understanding of those drawings and schemes and the operation of the appliance;
(d)                  
a list of the harmonised standards and/or other
relevant technical specifications the references of which have been published
in the Official Journal of the European Union, applied in full or in
part, and descriptions of the solutions adopted to meet the essential
requirements of this Regulation where those harmonised standards have not been
applied. In the event of partly applied harmonised standards, the technical
documentation shall specify the parts which have been applied;
(e)                   
results of design calculations made,
examinations carried out, etc.;
(f)                    
test reports;
(g)                   
manuals for installation and use.
6.2.2. Where appropriate, the design
documentation shall contain the following elements:
(a)                   
the conformity certificate relating to the
fittings incorporated into the appliance;
(b)                   
attestations and certificates relating to the
methods of manufacture and inspection and monitoring of the appliance;
(c)                   
any other document making it possible for the
notified body to improve its assessment.
The manufacturer shall keep the technical
documentation at the disposal of the relevant national authorities for 10 years
after the appliance has been placed on the market.
6.3. Manufacturing
The manufacturer shall take all measures
necessary so that the manufacturing process and its monitoring ensure
conformity of the manufactured appliances with the applicable requirements of
this Regulation.
6.4. Verification
A notified body chosen by the manufacturer
shall carry out appropriate examinations and tests, set out in the relevant
harmonised standards and/or technical specifications, or equivalent tests, to
check the conformity of the appliance with the applicable requirements of this Regulation,
or have them carried out. In the absence of such a harmonised standard and/or
technical specification the notified body concerned shall decide on the
appropriate tests to be carried out.
If deemed necessary by the notified body,
the examinations and tests may be carried out after installation of the
appliance.
The notified body shall issue a certificate
of conformity in respect of the examinations and tests carried out and shall
affix its identification number to the approved appliance, or have it affixed
under its responsibility.
The manufacturer shall keep the
certificates of conformity at the disposal of the national authorities for 10
years after the appliance has been placed on the market.
6.5. CE marking and EU declaration of
conformity
6.5.1. The manufacturer shall affix the CE
marking and the inscriptions provided for in Annex IV and, under the responsibility of the notified body referred to in
point 6.4, the latter's identification number to each appliance that satisfies
the applicable requirements of this Regulation.
6.5.2. The manufacturer shall draw up a
written EU declaration of conformity and keep it at the disposal of the
national authorities for 10 years after the appliance has been placed on the
market. The EU declaration of conformity shall identify the appliance for which
it has been drawn up.
A copy of the EU declaration of conformity
shall be made available to the relevant authorities upon request.
6.6. Authorised representative
The manufacturer's obligations set out in
points 6.2 and 6.5 may be fulfilled by his authorised representative, on his
behalf and under his responsibility, provided that they are specified in the
mandate.
ANNEX IV
            CE MARKING AND INSCRIPTIONS
(1)                   
The appliance or its data plate shall bear the
CE marking provided for in Annex II to Regulation (EC) No 765/2008 followed by
the identification number of the notified body involved in the production
control phase and the last two digits of the year in which the CE marking was
affixed. 
(2)                   
The appliance or its data plate shall bear the
following information:
(a)         
The manufacturer's name, registered trade name,
registered trade mark or identification symbol.
(b)         
The appliance type, batch or serial number or
other element allowing its identification.
(c)         
The type of electrical supply used, where
applicable.
(d)        
The appliance category marking.
(e)         
The gas supply pressure.
(f)          
The necessary information to ensure correct and
safe installation, according to the nature of the appliance.
(3)                   
The fitting or its data plate shall bear, as far
as relevant, the information provided for in paragraph (2).
ANNEX V
EU
DECLARATION OF CONFORMITY
The EU declaration of conformity shall
contain the following elements:
(a)                   
Appliance/appliance model (product, batch, type
or serial number).
(b)                   
Name and address of the manufacturer and, where
applicable, his authorised representative.
(c)                   
This declaration of conformity is issued under
the sole responsibility of the manufacturer.
(d)                  
Object of the declaration (identification of the
appliance allowing traceability. It may, where necessary for the identification
of the appliance, include an image):
(1)         
description of the appliance;
(2)         
conformity assessment procedure followed;
(3)         
name and address of the notified body which
carried out the conformity assessment;
(4)         
reference to the EU-type examination
certificate.
(e)                   
The object of the declaration described above is
in conformity with the relevant Union harmonisation legislation: …………….
(reference to the other Union acts applied):
(f)                    
References to the relevant harmonised standards
used or references to the specifications in relation to which conformity is
declared:
(g)                   
The notified body or bodies … (name, address,
number) … performed … (description of intervention) … and issued the
certificate(s): …
(h)                   
Additional information:
Signed for and on behalf of: …………………….
(place and date of issue):
(name, function) (signature):
ANNEX VI
FITTING
CONFORMITY CERTIFICATE
The Fitting
conformity certificate shall contain the following elements:
(a)                   
Fitting/fitting model (product, batch, type or
serial number).
(b)                   
Name and address of the manufacturer and, where
applicable, his authorised representative.
(c)                   
This Fitting conformity certificate is issued
under the sole responsibility of the fitting manufacturer.
(d)                  
Object of the declaration (identification of the
fitting allowing traceability. It may, where necessary for the identification
of the fitting, include an image):
(1)         
description and characteristics of the fitting;
(2)         
conformity assessment procedure followed;
(3)         
name and address of the notified body which
carried out the conformity assessment;
(4)         
reference to the EU-type examination
certificate.
(e)                   
The object of the Fitting conformity certificate
described above is in conformity with Regulation ……………. On appliances burning
gaseous fuels (reference to this Regulation):
(f)                    
References to the relevant harmonised standards
used or references to the specifications in relation to which conformity is
declared.
(g)                   
The notified body or bodies … (name, address,
number) … performed … (description of intervention) … and issued the
certificate(s): …
(h)                   
Instructions on how the fitting should be incorporated
into an appliance or assembled to constitute such an appliance in order to
assist compliance with the essential requirements applicable to finished
appliances.
(i)                     
Additional information:
Signed for and on behalf of: …………;
(place and date of issue);
(name, function) and signature.
ANNEX VII
 CORRELATION TABLE 
 Directive 2009/142/EC || This Regulation 
   ||   
 Article 1(1) first subparagraph || Article 1(1) 
 Article 1(1) second subparagraph || Article 1(3)(a) 
 Article 1(2) || Article 2(1), (2) and (5) 
 Article 1(3) || Article 1(2) 
 ___ || Article 2(3), (4), (6) to (31) 
 Article 2(1) || Article 3(1) 
 ___ || Article 3(2) 
 Article 2(2) || Article 4(1) 
 ___ || Article 4(2) 
 Article 3 || Article 5 
 Article 4 || Article 6 
 ___ || Article 7 
 ___ || Article 8 
 ___ || Article 9 
 ___ || Article 10 
 ___ || Article 11 
 ___ || Article 12 
 ___ || Article 13 
 Article 5(1)(a) || ___ 
 Article 5(1)(b) || ___ 
 Article 5(2) || ___ 
 Article 6 || ___ 
 Article 7 || ___ 
 Article 8(1) to (4) || Article 14(1) to (5) 
 Article 8(5) || ___ 
 ___ || Article 14(6) 
 Article 8(6) || Article 14(7) 
 ___ || Article 15 
 ___ || Article 16 
 ___ || Article 17 
 Article 9 || ___ 
 Article 10(1) || Article 18(1) 
 Article 10(2) || ___ 
 Article 11 || ___ 
 Article 12 || ___ 
 ___ || Article 18(2) to (5) 
 ___ || Article 19 
 ___ || Article 20 
 ___ || Article 21 
 ___ || Article 22 
 ___ || Article 23 
 ___ || Article 24 
 ___ || Article 25 
 ___ || Article 26 
 ___ || Article 27 
 ___ || Article 28 
 ___ || Article 29 
 ___ || Article 30 
 ___ || Article 31 
 ___ || Article 32 
 ___ || Article 33 
 ___ || Article 34 
 ___ || Article 35 
 ___ || Article 36 
 ___ || Article 37 
 ___ || Article 38 
 ___ || Article 39 
 ___ || Article 40 
 Article 13 || __ 
 Article 14 || __ 
 Article 15 || __ 
 Article 16 || __ 
 ___ || Article 41 
 Annex I || Annex I 
 ___ || Annex II 
 Annex II || Annex III 
 Annex III || Annex IV 
 Annex IV || __ 
 Annex V || __ 
 Annex VI || __ 
 ___ || Annex V 
 ___ || Annex VI 
 ___ || Annex VII 
[1]               Directive 1999/5/EC of the European Parliament and of
the Council of 9 March 1999 on radio equipment and telecommunications terminal
equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999,
p.10).
[2]               Directive 2006/95/EC of the European Parliament and
of the Council of 12 December 2006 on the approximation of the laws of the
Member States relating to electrical equipment designed for use within certain
voltage limits (OJ L 374, 27.12.2006, p.10).
[3]               Directive 2004/108/EC of the European Parliament and
of the Council of 15 December 2004 on the approximation of the laws of the
Member States relating to electromagnetic compatibility and repealing Directive
89/336/EEC (OJ L 390, 31.12.2004, p.24).
[4]               Regulation (EC) No 1935/2004 of the European
Parliament and of the Council of 27 October 2004 on materials and articles
intended to come into contact with food and repealing Directives 80/590/EEC and
89/109/EC (OJ L 338, 13.11.2004, p.4).
[5]               Regulation (EU) No 305/2011 of the European
Parliament and of the Council of 9 march 2011 laying down harmonised conditions
for the marketing of construction products and repealing Council Directive
89/106/EEC (OJ L 88, 4.4.2011, p.5).
[6]               Council Directive
98/83/EC of 3 November 1998 on the quality of water intended for human
consumption (OJ L 330, 5.12.98, p.32).