CHAPTER I
GENERAL PROVISIONS
Article 1
Scope
Article 2
Definitions
Article 3
Making available on the market and putting into service
Article 4
Gas supply conditions
Article 5
Essential requirements
Article 6
Making available, putting into service and exhibition at trade fairs, etc
Article 6A
Designated standard
CHAPTER II
OBLIGATIONS OF ECONOMIC OPERATORS
Article 7
Obligations of manufacturers
Article 8
Authorised representatives
Article 9
Obligations of importers
Article 10
Obligations of distributors
Article 11
Cases in which obligations of manufacturers apply to importers and distributors
Article 12
Identification of economic operators
CHAPTER III
CONFORMITY OF APPLIANCES AND FITTINGS
Article 13
Presumption of conformity of appliances and fittings
Article 14
Conformity assessment procedures for appliances and fittings
Article 15
... Declaration of conformity
Article 16
General principles of the UK marking
Article 17
Rules and conditions for affixing the UK marking
Article 18
Inscriptions
CHAPTER IV
APPROVAL OF CONFORMITY ASSESSMENT BODIES
Article 19
Notification
Article 20
Approval of conformity assessment bodies
Article 21
UK national accreditation body
Article 22
Monitoring obligations
Article 23
Approved Body Requirements
Article 24
Presumption of conformity of approved bodies
Article 25
Subsidiaries of, and subcontracting by, approved bodies
Article 26
Application for notification
Article 27
Notification procedure
Article 28
Identification numbers and register of approved bodies
Article 29
Restriction, suspension or withdrawal of approval
Article 30
Challenge of the competence of notified bodies
Article 31
Operational obligations of approved bodies
Article 32
Appeal against decisions of approved bodies
Article 33
Information obligation on approved bodies
Article 34
Exchange of experience
Article 35
Coordination of notified bodies
CHAPTER V
MARKET SURVEILLANCE AND CONTROL OF APPLIANCES AND FITTINGS ENTERING THE MARKET OF GREAT BRITAIN
Article 36
Market surveillance and control of appliances and fittings entering the United Kingdom market
Article 37
Procedure ... for dealing with appliances or fittings presenting a risk
Article 38
Union safeguard procedure
Article 39
Compliant appliances or fittings which present a risk
Article 40
Formal non-compliance
CHAPTER VI
DELEGATED ACTS AND COMMITTEE PROCEDURE
Article 41
Exercise of the delegation
Article 42
Committee procedure
CHAPTER VII
TRANSITIONAL AND FINAL PROVISIONS
Article 43
Penalties
Article 44
Transitional provision in relation to EU exit
Article 45
Repeal
Article 46
Entry into force and application
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...
1.
GENERAL REQUIREMENTS
1.1.
Appliances shall be so designed and constructed as to operate...
1.2.
The manufacturer is under an obligation to analyse the risks...
1.3.
In selecting the most appropriate solutions, the manufacturer shall apply...
1.4.
When designing and constructing the appliance, and when drafting the...
1.5.
All appliances shall:
1.6.1.
The instructions for installation intended for the installer shall contain...
1.6.2.
The instructions for use and servicing intended for the user...
1.6.3.
The warning notices on the appliance and its packaging shall...
1.7.
The instructions for incorporation of the fitting into an appliance...
2.
MATERIALS
3.
DESIGN AND CONSTRUCTION
3.1.
General
3.1.1.
Appliances shall be so designed and constructed that, when normally...
3.1.2.
Condensation produced at the start-up and/or during use shall not...
3.1.3.
Appliances shall be so designed and constructed as to minimise...
3.1.4.
Appliances shall be so designed and constructed that water and...
3.1.5.
In the event of a normal fluctuation of auxiliary energy,...
3.1.6.
Abnormal fluctuation or failure of auxiliary energy or its restoration...
3.1.7.
Appliances shall be so designed and constructed as to obviate...
3.1.8.
Appliances shall be so designed and constructed as to obviate...
3.1.9.
All pressurised parts of an appliance shall withstand the mechanical...
3.1.10.
Appliances shall be so designed and constructed that failure of...
3.1.11.
If an appliance is equipped with safety and controlling devices,...
3.1.12.
All parts of appliances which are set or adjusted at...
3.1.13.
Levers and other controlling and setting devices shall be clearly...
3.2.
Unburned gas release
3.2.1.
Appliances shall be so designed and constructed that the gas...
3.2.2.
Appliances shall be so designed and constructed that gas release...
3.2.3.
Appliances intended to be used in indoor spaces and rooms...
3.2.4.
Appliances designed and constructed to burn gas containing carbon monoxide...
3.3.
Ignition
3.4.
Combustion
3.4.1.
Appliances shall be so designed and constructed that, when normally...
3.4.2.
Appliances shall be so designed and constructed that, when normally...
3.4.3.
Appliances connected to a flue for the dispersal of combustion...
3.4.4.
Appliances shall be so designed and constructed that, when normally...
3.5.
Rational use of energy
3.6.
Temperature
3.6.1.
Parts of appliances which are intended to be installed or...
3.6.2.
The surface temperature of parts of appliances intended to be...
3.6.3.
The surface temperatures of external parts of appliances, with the...
3.7.
Contact with food and water intended for human consumption
ANNEX II
CONTENT ... OF THE GAS SUPPLY CONDITIONS TO BE PUBLISHED UNDER ARTICLE 4
1.
The Secretary of State must provide the following content in...
2.
The reference conditions for Wobbe index and gross calorific value...
ANNEX III
CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS
1.
MODULE B: ... TYPE-EXAMINATION — PRODUCTION TYPE
1.1.
... Type-examination is the part of a conformity assessment procedure...
1.2.
... Type-examination shall be carried out by assessment of the...
1.3.
The manufacturer shall lodge an application for ... type-examination with...
1.3.1.
The application shall include the following:
1.3.2.
Where appropriate, the manufacturer shall also submit to the approved...
1.4.
The approved body shall:
1.5.
The approved body shall draw up an evaluation report that...
1.6.
Where the appliance or the fitting type meets the requirements...
1.7.
The approved body shall keep itself apprised of any changes...
1.8.
Each approved body shall inform the Secretary of State concerning...
1.9.
The manufacturer shall keep a copy of the ... type-examination...
1.10.
The manufacturer's authorised representative may lodge the application referred to...
2.
MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL...
2.1.
Conformity to type based on internal production control plus supervised...
2.2.
Manufacturing
2.3.
Product checks
2.4.
UK marking and ... declaration of conformity
2.4.1.
The manufacturer shall affix the UK marking to each individual...
2.4.2.
The manufacturer shall draw up a written ... declaration of...
2.5.
Authorised representative
3.
MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF...
3.1.
Conformity to type based on quality assurance of the production...
3.2.
Manufacturing
3.3.
Quality system
3.3.1.
The manufacturer shall lodge an application for assessment of his...
3.3.2.
The quality system shall ensure that the appliances or fittings...
3.3.3.
The approved body shall assess the quality system to determine...
3.3.4.
The manufacturer shall undertake to fulfil the obligations arising out...
3.3.5.
The manufacturer shall keep the approved body that has approved...
3.4.
Surveillance under the responsibility of the approved body
3.4.1.
The purpose of surveillance is to make sure that the...
3.4.2.
The manufacturer shall, for assessment purposes, allow the approved body...
3.4.3.
The approved body shall carry out periodic audits at least...
3.4.4.
In addition, the approved body may pay unexpected visits to...
3.5.
UK marking and ... declaration of conformity
3.5.1.
The manufacturer shall affix the UK marking and, under the...
3.5.2.
The manufacturer shall draw up a written ... declaration of...
3.6.
The manufacturer shall, for a period ending at least 10...
3.7.
Each approved body shall inform the Secretary of State of...
3.8.
Authorised representative
4.
MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE...
4.1.
Conformity to type based on product quality assurance is that...
4.2.
Manufacturing
4.3.
Quality system
4.3.1.
The manufacturer shall lodge an application for assessment of his...
4.3.2.
The quality system shall ensure compliance of the appliances or...
4.3.3.
The approved body shall assess the quality system to determine...
4.3.4.
The manufacturer shall undertake to fulfil the obligations arising out...
4.3.5.
The manufacturer shall keep the approved body that has approved...
4.4.
Surveillance under the responsibility of the approved body
4.4.1.
The purpose of surveillance is to make sure that the...
4.4.2.
The manufacturer shall, for assessment purposes, allow the approved body...
4.4.3.
The approved body shall carry out periodic audits at least...
4.4.4.
In addition, the approved body may pay unexpected visits to...
4.5.
UK marking and ... declaration of conformity
4.5.1.
The manufacturer shall affix the UK marking and, under the...
4.5.2.
The manufacturer shall draw up a written ... declaration of...
4.6.
The manufacturer shall, for a period ending at least 10 years...
4.7.
Each approved body shall inform the Secretary of State of...
4.8.
Authorised representative
5.
MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
5.1.
Conformity to type based on product verification is the part...
5.2.
Manufacturing
5.3.
Verification
5.4.
Verification of conformity by examination and testing of every appliance...
5.4.1.
All appliances or fittings shall be individually examined and appropriate...
5.4.2.
The approved body shall issue a certificate of conformity in...
5.5.
Statistical verification of conformity
5.5.1.
The manufacturer shall take all measures necessary so that the...
5.5.2.
A random sample shall be taken from each lot in...
5.5.3.
The approved body shall apply a sampling system with the...
5.5.4.
If a lot is accepted, all appliances or fittings of...
5.5.5.
If a lot is rejected, the approved body or the...
5.6.
UK marking and ... declaration of conformity
5.6.1.
The manufacturer shall affix the UK marking and, under the...
5.6.2.
The manufacturer shall draw up a written ... declaration of...
5.7.
If the approved body agrees and under its responsibility, the...
5.8.
Authorised representative
6.
MODULE G: CONFORMITY BASED ON UNIT VERIFICATION
6.1.
Conformity based on unit verification is the conformity assessment procedure...
6.2.
Technical documentation
6.2.1.
The technical documentation shall, wherever applicable, contain at least the...
6.2.2.
Where appropriate, the manufacturer shall also submit to the approved...
6.3.
Manufacturing
6.4.
Verification
6.5.
UK marking and ... declaration of conformity
6.5.1.
The manufacturer shall affix the UK marking and, under the...
6.5.2.
The manufacturer shall draw up a written ... declaration of...
6.6.
Authorised representative
ANNEX IV
INSCRIPTIONS
1.
In addition to the UK marking referred to in Article...
2.
The fitting or its data plate shall bear, as far...
ANNEX V
EU DECLARATION OF CONFORMITY No …
1.
Appliance or fitting /appliance or fitting model (product, type, batch...
2.
Name and address of the manufacturer and, where applicable, his...
3.
This declaration of conformity is issued under the sole responsibility...
4.
Object of the declaration (identification of the appliance or fitting...
5.
The object of the declaration described in point 4 is...
6.
References to the relevant designated standards used or references to...
7.
The approved body … (name, address, number) … performed …...
8.
In the case of fittings, instructions on how the fitting...
9.
Additional information:
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):
ANNEX VI
CORRELATION TABLE
Regulation (EU) 2016/426 of the European Parliament and of the Council
of 9 March 2016
on appliances burning gaseous fuels and repealing Directive 2009/142/EC
(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 ,
Acting in accordance with the ordinary legislative procedure ,
Whereas:
(1)
Directive 2009/142/EC of the European Parliament and of the Council lays down rules for the placing on the market and the putting into service of appliances burning gaseous fuels (‘appliances’).
(2)
Directive 2009/142/EC is based on the ‘new approach’ principles, as set out in the Council Resolution of 7 May 1985 on a new approach to technical harmonisation and standards . Thus, it sets out only the essential requirements applying to appliances, 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 . 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 that sector and should be maintained and even further promoted.
(3)
Experience acquired 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 thus ensure legal certainty as regards the definitions relating to its scope, the content of the Member States' communications of the types of gas and corresponding supply pressures used on their territory and certain essential requirements.
(4)
Since the scope, essential requirements and conformity assessment procedures have to 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 thus ensures uniform implementation throughout the Union.
(5)
Decision No 768/2008/EC of the European Parliament and of the Council lays down common principles and reference provisions intended to apply across sectoral legislation 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 lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking.
(7)
The scope of this Regulation should reflect the scope of Directive 2009/142/EC. This Regulation should apply to domestic and non-domestic appliances intended for a number of specified applications and to fittings designed to be incorporated into such appliances.
(8)
This Regulation covers appliances and fittings which are new to the Union market when they are placed on the market; that is to say, they are either new appliances and fittings made by a manufacturer established in the Union or appliances and fittings, whether new or second-hand, imported from a third country.
(9)
Appliances possessing a historic or artistic value within the meaning of Article 36 of the Treaty on the Functioning of the European Union (TFEU) and not put into service, such as antique and other appliances serving exhibition or collection purposes, should not be considered as appliances covered by this Regulation.
(10)
This Regulation should apply to all forms of supply, including distance selling.
(11)
This Regulation should aim to ensure the functioning of the internal market of appliances and of fittings as regards gas safety risks and energy efficiency.
(12)
This Regulation should not apply in respect of aspects covered more specifically by other Union harmonisation legislation. This includes the measures adopted pursuant to Directive 2009/125/EC of the European Parliament and of the Council .
(13)
This Regulation should prevent 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 should not affect the possibility for Member States, when implementing other Union acts, to impose requirements which affect the energy efficiency of products, including appliances, as long as such measures are compatible with the TFEU.
(14)
Directive 2009/28/EC of the European Parliament and of the Council 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 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 requires Member States to take sufficient measures to progressively reduce energy consumption in different areas, including in buildings.
(15)
This Regulation should not affect the obligation for Member States to adopt 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 those Directives that national measures may in certain circumstances limit the installation of appliances which comply with the rational use of energy requirement of this Regulation, provided that such measures do not constitute an unjustifiable market barrier.
(16)
Member States should take the necessary steps to ensure that appliances are made available on the market and put into service only where they do not compromise the health and safety of persons, domestic animals or property, when normally used.
(17)
This Regulation should not affect the Member States' entitlement to lay down rules concerning commissioning or periodic inspections of appliances or other measures such as installer training or certification, in order to ensure the correct installation, use and maintenance of appliances, including precautionary safety measures. Those rules and measures are essential in preventing gas poisoning, including from carbon monoxide (CO), and the leakage of any substances harmful to health and safety.
(18)
This Regulation should 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 requirements do not impose design requirements on appliances.
(19)
As this Regulation does not cover risks caused by appliances in the case of incorrect installation, maintenance or use, Member States should be encouraged to take measures to ensure that the public is made aware of the health and safety risks related to combustion products and the need for proper precautionary safety measures, inter alia in relation to emissions of carbon monoxide.
(20)
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 is put into service is very important for its safe and correct functioning, therefore that aspect should be taken into consideration 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.
(21)
In order to avoid barriers to trade with regard to appliances on grounds relating to the fact that the gas supply conditions are not yet harmonised and to ensure that economic operators are sufficiently informed, Member States should communicate to the other Member States and to the Commission the types of gas and corresponding supply pressures used on their territory and any changes thereof in good time.
(22)
The communication of the gas types and supply pressures by Member States should contain the necessary information for economic operators. In that framework, the primary source of the gaseous fuel supplied is not relevant for the characteristics, the performance and the compatibility of appliances with the communicated gas supply conditions.
(23)
When determining the gas families and gas groups used on their territory, Member States are encouraged to take into account the ongoing standardisation work concerning gas qualities and thus ensure, across the Union, a coherent and coordinated approach towards harmonisation of gaseous fuels via standardisation.
(24)
When, in accordance with Directive 2009/73/EC of the European Parliament and of the Council and the ongoing standardisation work of CEN on 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 that they update in a timely manner their communication of the types of gas in the event that the quality of the supplied gas does not remain within the already communicated quality range.
(25)
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 renewable energies and in particular biogas in the total energy consumption, they are encouraged to consider the possibilities of injecting such gases into the gas distribution network.
(26)
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 that are compatible with the local gas supply conditions.
(27)
Appliances covered by this Regulation and complying with it 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.
(28)
The appliance category marking indicated on the appliance or its data plate establishes a direct link with the gas families and/or gas groups for which an appliance 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.
(29)
The essential requirements laid down in this Regulation should be observed in order to ensure that appliances are safe when normally used at the desired performance level.
(30)
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 and safety protection and rational use of energy.
(31)
Economic operators should be responsible for the compliance of appliances 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 and safety of persons and domestic animals, protection of consumers and of property, and rational use of energy, and to guarantee fair competition on the Union market.
(32)
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 or fittings 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.
(33)
The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment should therefore remain solely the obligation of the manufacturer.
(34)
The manufacturer should provide sufficient and detailed information on the intended use of the appliance 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.
(35)
This Regulation should not apply to any natural person who manufactures an appliance on a non-professional basis and uses it exclusively for his own purposes.
(36)
In order to facilitate 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.
(37)
It is necessary to ensure that appliances 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 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 the CE marking on appliances and fittings and documentation drawn up by manufacturers are available for inspection by the competent national authorities.
(38)
The distributor makes an appliance 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.
(39)
When placing an appliance or a fitting on the market, 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 appliance or fitting.
(40)
Any economic operator that either places an appliance or a fitting on the market under his own name or trademark or modifies an appliance 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.
(41)
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 or fitting concerned.
(42)
Ensuring traceability of an appliance or a fitting throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates the market surveillance authorities' task of tracing economic operators who made non-compliant appliances or fittings available on the market. When keeping the information required under this Regulation for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with an appliance or a fitting or to whom they have supplied an appliance or a fitting.
(43)
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 and fittings which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 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.
(44)
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.
(45)
In order to enable economic operators to demonstrate and the competent authorities to ensure that appliances and 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.
(46)
Manufacturers should draw up an EU declaration of conformity to provide information required under this Regulation on the conformity of an appliance or a fitting with the requirements of this Regulation and of other relevant Union harmonisation legislation.
(47)
To ensure effective access to information for market surveillance purposes, the information required to identify all applicable Union acts for an appliance or a fitting should be available in a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, that single EU declaration of conformity may be a dossier made up of relevant individual declarations of conformity.
(48)
The CE marking, indicating the conformity of an appliance or a fitting, 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 on appliances and fittings should be laid down in this Regulation. Exceptions should be provided for in cases where the size or nature of the appliance or fitting does not allow the CE marking to be affixed to it.
(49)
Fittings are not appliances but intermediate products intended for appliance manufacturers and designed to be incorporated into an appliance. However, fittings should satisfy the essential requirements so as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute an appliance. With a view to simplification and in order to avoid any confusion and misunderstanding for manufacturers in meeting their obligations, it is considered justified that fittings should also bear the CE marking.
(50)
A check on compliance of appliances and of fittings with the essential requirements is necessary in order to provide effective protection of the health and safety of persons, of domestic animals and of property.
(51)
In order to ensure compliance of appliances and fittings 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.
(52)
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.
(53)
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 notified bodies throughout the Union. It is, however, essential that all notified 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.
(54)
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.
(55)
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.
(56)
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.
(57)
Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity, 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.
(58)
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 and the fittings 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.
(59)
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.
(60)
Since notified 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.
(61)
In the interests of competitiveness, it is crucial that notified 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 notified bodies.
(62)
Interested parties should have the right to appeal against the result of a conformity assessment carried out by a notified body. For that reason, it is important to ensure that an appeal procedure against decisions taken by notified bodies is available.
(63)
In order to ensure legal certainty, it is necessary to clarify that rules on Union market surveillance and control of products entering the Union market provided for in Regulation (EC) No 765/2008 apply to appliances and fittings covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks.
(64)
Directive 2009/142/EC already provides for a safeguard procedure which is necessary to allow for the possibility of contesting the conformity of an appliance or fitting. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with a view to making it more efficient and drawing on the expertise available in Member States.
(65)
The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to appliances and fittings presenting a risk to the health or safety of persons or to domestic animals or property. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an earlier stage in respect of such appliances and fittings.
(66)
Where the Member States and the Commission agree as to the justification of a measure taken by a Member State, no further involvement of the Commission should be required, except where non-compliance can be attributed to shortcomings of a harmonised standard.
(67)
The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of the content of the Member States' communications on the gas supply conditions on their territory. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. 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.
(68)
In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council .
(69)
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.
(70)
The examination procedure should be used for the adoption of implementing acts to define the form for the Member States' communications on the gas supply conditions on their territory.
(71)
The examination procedure should also be used for the adoption of implementing acts with respect to compliant appliances and fittings which present a risk to the health or safety of persons or to domestic animals or property.
(72)
The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to compliant appliances or fittings which present a risk to the health or safety of persons, imperative grounds of urgency so require.
(73)
In line with established practice, the committee set up by this Regulation can play a useful role in examining matters concerning the application of this Regulation raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.
(74)
When matters relating to this Regulation, other than its implementation or infringements, are being examined, i.e. in a Commission expert group, the European Parliament should, in line with existing practice, receive full information and documentation and, where appropriate, an invitation to attend such meetings.
(75)
The Commission should, by means of implementing acts and, given their special nature, acting without the application of Regulation (EU) No 182/2011, determine whether measures taken by Member States in respect of non-compliant appliances or fittings are justified or not.
(76)
It is necessary to provide for reasonable transitional arrangements that allow the making available on the market and the putting into service without the need to comply with further product requirements, of appliances and fittings that have already been placed on the market in accordance with Directive 2009/142/EC before the date of application of this Regulation. Distributors should therefore be able to supply appliances and fittings that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation.
(77)
Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.
(78)
Since the objective of this Regulation, namely to ensure that appliances and fittings on the Union market fulfil the requirements providing for a high level of protection of health and safety of persons, of domestic animals and of property and for rational use of energy, while guaranteeing the functioning of the internal market, cannot be sufficiently achieved by the Member States, but can rather, 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.
(79)
Directive 2009/142/EC should therefore be repealed,
HAVE ADOPTED THIS REGULATION:
OJ C 458, 19.12.2014, p. 25.
Position of the European Parliament of 20 January 2016 (not yet published in the Official Journal) and decision of the Council of 12 February 2016.
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).
OJ C 136, 4.6.1985, p. 1.
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).
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).
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).
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).
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).
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).
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).
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).
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 Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).