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Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

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)

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Changes over time for: Regulation (EU) 2016/426 of the European Parliament and of the Council (Annexes only)

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ANNEX IU.K.ESSENTIAL REQUIREMENTS

PRELIMINARY OBSERVATIONS:U.K.

1.The essential requirements laid down in this Regulation are compulsory.U.K.

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 technical and economic considerations which are consistent with a high degree of energy efficiency and of health and safety protection.U.K.

1.GENERAL REQUIREMENTSU.K.

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.U.K.

Fittings shall be so designed and constructed as to fulfil correctly their intended purpose when incorporated into an appliance or assembled to constitute 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 risk assessment.U.K.

1.3.In selecting the most appropriate solutions, the manufacturer shall apply the principles set out below, in the following order:U.K.

(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 foreseeable uses.U.K.

1.5.All appliances shall:U.K.

(a)

be accompanied by instructions for installation 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.

1.6.1.The instructions for installation intended for the installer shall contain all the instructions for installation, adjustment and servicing required to ensure that those operations are correctly performed so that the appliance may be used safely.U.K.

The instructions for installation intended for the installer 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.U.K.

The manufacturers shall note in the instructions where additional care is needed or where it would be advisable that any of the above work be carried out by a professional. This shall be without prejudice to national requirements to that effect.

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 to be 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.U.K.

1.7.The instructions for incorporation of the fitting into an appliance or its assembly in order to constitute an appliance and for its adjustment, operation and maintenance shall be provided with the fittings concerned as part of the F1... declaration of conformity.U.K.

Textual Amendments

2.MATERIALSU.K.

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.

3.DESIGN AND CONSTRUCTIONU.K.

The obligations arising for appliances from the essential requirements set out in this point apply also to fittings, as far as relevant.

3.1.GeneralU.K.

3.1.1.Appliances shall be so designed and constructed that, when normally used, no instability, distortion, breakage or wear likely to impair their safety may occur.U.K.
3.1.2.Condensation produced at the start-up and/or during use shall not affect the safety of appliances.U.K.
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.U.K.
3.1.4.Appliances shall be so designed and constructed that water and inappropriate air penetration into the gas circuit does not occur.U.K.
3.1.5.In the event of a normal fluctuation of auxiliary energy, appliances shall continue to operate safely.U.K.
3.1.6.Abnormal fluctuation or failure of auxiliary energy or its restoration shall not lead to an unsafe situation.U.K.
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 [F2the Radio Equipment Regulations 2017] or the safety objectives of [F3the Electrical Equipment (Safety) Regulations 2016] shall be taken into account.U.K.

Textual Amendments

3.1.8.Appliances shall 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 [F4the Radio Equipment Regulations 2017] or [F5the Electromagnetic Compatibility Regulations 2016] shall be taken into account.U.K.

Textual Amendments

3.1.9.All pressurised parts of an appliance shall withstand the mechanical and thermal stresses to which they are subjected without any deformation affecting safety.U.K.
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.U.K.
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.U.K.
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.U.K.
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.U.K.

3.2.Unburned gas releaseU.K.

3.2.1.Appliances shall be so designed and constructed that the gas leakage rate is not dangerous.U.K.
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.U.K.
3.2.3.Appliances intended to be used in indoor spaces and rooms shall be so designed and constructed as 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.U.K.
3.2.4.Appliances designed and constructed to burn gas containing carbon monoxide or other toxic components shall not present a danger to the health of persons and domestic animals exposed.U.K.

3.3.IgnitionU.K.

Appliances shall be so designed and constructed that, when normally used, ignition and re-ignition is smooth and cross-lighting is assured.

3.4.CombustionU.K.

3.4.1.Appliances shall be so designed and constructed that, when normally used, the combustion process is stable and combustion products do not contain unacceptable concentrations of substances harmful to health.U.K.
3.4.2.Appliances shall be so designed and constructed that, when normally used, there will be no accidental release of combustion products.U.K.
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.U.K.
3.4.4.Appliances shall be so designed and constructed that, when normally used, they do not cause a concentration of carbon monoxide or other substances harmful to health, such as they would be likely to present a danger to the health of persons and domestic animals exposed.U.K.

3.5.Rational use of energyU.K.

Appliances shall 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.TemperatureU.K.

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.U.K.
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.U.K.
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 the health and safety of persons exposed and in particular to children and elderly people, for whom an appropriate reaction time shall be taken into account.U.K.

3.7.Contact with food and water intended for human consumptionU.K.

Without prejudice to Regulations (EC) No 1935/2004(1) and (EU) No 305/2011(2) of the European Parliament and of the Council, 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(3), shall not impair quality of the food or water.

ANNEX IIU.K.CONTENT F6... OF THE GAS SUPPLY CONDITIONS [F7TO BE PUBLISHED UNDER ARTICLE 4]

Textual Amendments

1. [F8The Secretary of State must provide the following content in the information that is published under Article 4]:U.K.

(a)
(i)gross calorific value (GCV) in MJ/m3
minimum/maximum;
(ii)Wobbe index 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 content in %
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.

Textual Amendments

2.The reference conditions for Wobbe index and gross calorific value shall be the following:U.K.

(a)combustion reference temperature:15 °C;
(b)volume measurement reference temperature:15 °C;
(c)volume measurement reference pressure:1 013,25 mbar.

ANNEX IIIU.K.CONFORMITY ASSESSMENT PROCEDURES FOR APPLIANCES AND FITTINGS

1.MODULE B: F9... TYPE-EXAMINATION — PRODUCTION TYPEU.K.

1.1.F10... type-examination is the part of a conformity assessment procedure in which [F11an approved] 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 that apply to it.U.K.

Textual Amendments

1.2.F12... type-examination shall be 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).U.K.

Textual Amendments

1.3.The manufacturer shall lodge an application for F13... type-examination with [F14a single approved] body of his choice.U.K.

Textual Amendments

1.3.1.The application shall include the following:U.K.
(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 [F15approved] 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 [F16designated] standards applied in full or in part F17... and, where those [F16designated] standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied [F16designated] 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)

instructions for installation and use of the appliance;

(8)

the F18... declaration of conformity of the fitting containing the instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance;

(d)

the specimens representative of the production envisaged. The [F19approved] body may request further specimens where needed for carrying out the test programme;

(e)

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 [F20designated] standards have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his behalf and under his responsibility.

Textual Amendments

1.3.2.Where appropriate, the manufacturer shall also submit to the [F21approved] body the following documents:U.K.

Textual Amendments

(a)

the F22... type-examination certificate and the F22... declaration of conformity 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 [F21approved] body to improve its assessment.

Textual Amendments

1.4.The [F23approved] body shall:U.K.

Textual Amendments

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 [F24designated] standards, as well as the elements which have been designed in accordance with other relevant technical specifications;

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 [F25designated] standards, 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 [F26designated] standards have not been applied, the solutions adopted by the manufacturer applying other relevant technical specifications 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.

Textual Amendments

1.5.The [F27approved] 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 vis-à-vis the [F28Secretary of State], the [F27approved] body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.U.K.

Textual Amendments

1.6.Where the appliance or the fitting type meets the requirements of this Regulation, the [F29approved] body shall issue [F30a] 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, such as the type of gas, appliance category and gas supply pressure, and, if relevant, descriptions of its functioning. The certificate may have one or more annexes attached.U.K.

Textual Amendments

The F31... type-examination 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. It shall also indicate any conditions to which its issue may be subject and be accompanied by the descriptions and drawings necessary for identification of the approved type.

Textual Amendments

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 [F29approved] body shall refuse to issue [F30a] type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

1.7.The [F32approved] 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 [F32approved] body shall inform the manufacturer accordingly.U.K.

Textual Amendments

The manufacturer shall inform the [F32approved] body that holds the technical documentation relating to the F33... 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 F33... type-examination certificate.

Textual Amendments

1.8.Each [F34approved] body shall inform [F35the Secretary of State] concerning the F36... type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to [F35the Secretary of State] the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.U.K.

Textual Amendments

Each [F34approved] body shall inform the other [F34approved] bodies concerning the F36... type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

[F37The Secretary of State] and the other [F34approved] bodies may, on request, obtain a copy of the F36... type-examination certificates and/or additions thereto. On request, the [F38Secretary of State] may obtain a copy of the technical documentation and the results of the examinations carried out by the [F34approved] body. The [F34approved] body shall keep a copy of the F36... 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 that certificate.

Textual Amendments

1.9.The manufacturer shall keep a copy of the F39... type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the [F40enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.U.K.

Textual Amendments

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.U.K.

Textual Amendments

2.MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT CHECKS AT RANDOM INTERVALSU.K.

2.1.Conformity to type based on internal production control plus supervised product checks at random intervals is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2.2, 2.3 and 2.4, and ensures and declares on his sole responsibility that the appliances or the fittings concerned are in conformity with the type described in the F41... type-examination certificate and satisfy the requirements of this Regulation that apply to them.U.K.

Textual Amendments

2.2.ManufacturingU.K.

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 F42... type-examination certificate and with the requirements of this Regulation that apply to them.

Textual Amendments

2.3.Product checksU.K.

[F43An approved] body, chosen by the manufacturer, shall carry out product 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 or the fitting, 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 [F44the approved] body before the placing on the market, shall be examined and appropriate tests as identified by the relevant parts of the [F45designated] standards, and/or equivalent tests set out in other relevant technical specifications, 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, [F44the approved] body shall take appropriate measures.

Textual Amendments

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 [F46approved] body, affix the [F46approved] body's identification number during the manufacturing process.

Textual Amendments

2.4.[F47UK] marking and F48... declaration of conformityU.K.

2.4.1.The manufacturer shall affix the [F49UK] marking to each individual appliance or fitting that is in conformity with the type described in the F50... type-examination certificate and satisfies the applicable requirements of this Regulation.U.K.

Textual Amendments

2.4.2.The manufacturer shall draw up a written F51... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F52enforcement authority] for 10 years after the appliance or fitting has been placed on the market. The F51... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.U.K.

Textual Amendments

A copy of the F51... declaration of conformity shall be made available to the [F53enforcement authority] upon request. A copy of the F51... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

Textual Amendments

2.5.Authorised representativeU.K.

The manufacturer's obligations set out in point 2.4 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 PROCESSU.K.

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 points 3.2 and 3.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the F54... type-examination certificate and satisfy the requirements of this Regulation that apply to them.U.K.

Textual Amendments

3.2.ManufacturingU.K.

The manufacturer shall operate an approved quality system for production, final product 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 systemU.K.

3.3.1.The manufacturer shall lodge an application for assessment of his quality system with the [F55approved] body of his choice, for the appliances or fittings concerned.U.K.

Textual Amendments

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 [F55approved] 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 F56... type-examination certificate.

Textual Amendments

3.3.2.The quality system shall ensure that the appliances or fittings are in conformity with the type described in the F57... type-examination certificate and comply with the requirements of this Regulation that apply to them.U.K.

Textual Amendments

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 product 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.;

(e)

the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

3.3.3.The [F58approved] body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.3.2.U.K.

Textual Amendments

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant [F59designated] standard.

Textual Amendments

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and the product 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.U.K.
3.3.5.The manufacturer shall keep the [F60approved] body that has approved the quality system informed of any intended change to the quality system.U.K.

Textual Amendments

The [F60approved] 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 [F61approved] bodyU.K.

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.U.K.
3.4.2.The manufacturer shall, for assessment purposes, allow the [F62approved] body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:U.K.

Textual Amendments

(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.

3.4.3.The [F63approved] body shall carry out periodic audits 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.U.K.

Textual Amendments

3.4.4.In addition, the [F64approved] body may pay unexpected visits to the manufacturer. During such visits the [F64approved] body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The [F64approved] body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.U.K.

Textual Amendments

Textual Amendments

3.5.[F65UK] marking and F66... declaration of conformityU.K.

3.5.1.The manufacturer shall affix the [F67UK] marking and, under the responsibility of the [F68approved] body referred to in point 3.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the F69... type-examination certificate and satisfies the applicable requirements of this Regulation.U.K.

Textual Amendments

3.5.2.The manufacturer shall draw up a written F70... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F71enforcement authority] for 10 years after the appliance or the fitting has been placed on the market. The F70... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.U.K.

Textual Amendments

A copy of the F70... declaration of conformity shall be made available to the [F72enforcement authority] upon request. A copy of the F70... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

Textual Amendments

3.6.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 [F73enforcement authority]:U.K.

Textual Amendments

(a)

the documentation referred to in point 3.3.1;

(b)

the information relating to the change referred to in point 3.3.5, as approved;

(c)

the decisions and reports of the [F74approved] body referred to in points 3.3.5, 3.4.3 and 3.4.4.

Textual Amendments

3.7.Each [F75approved] body shall inform [F76the Secretary of State] of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to [F76the Secretary of State] the list of quality systems approvals refused, suspended or otherwise restricted.U.K.

Textual Amendments

Each [F75approved] body shall inform the other [F75approved] bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

3.8.Authorised representativeU.K.

The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 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 PRODUCT QUALITY ASSURANCEU.K.

4.1.Conformity to type based on product 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, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the F77... type-examination certificate and satisfy the requirements of this Regulation that apply to them.U.K.

Textual Amendments

4.2.ManufacturingU.K.

The manufacturer shall operate an approved quality system for final product 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 systemU.K.

4.3.1.The manufacturer shall lodge an application for assessment of his quality system with the [F78approved] body of his choice, for the appliances or fittings concerned.U.K.

Textual Amendments

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 [F78approved] body;

(c)

all relevant information for the product category envisaged;

(d)

the documentation concerning the quality system; and

(e)

the technical documentation of the approved type and a copy of the F79... type-examination certificate.

Textual Amendments

4.3.2.The quality system shall ensure compliance of the appliances or the fittings with the type described in the F80... type-examination certificate and with the applicable requirements of this Regulation.U.K.

Textual Amendments

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 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 [F81approved] body shall assess the quality system to determine whether it satisfies the requirements referred to in point 4.3.2.U.K.

Textual Amendments

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant [F82designated] standard.

Textual Amendments

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product 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.U.K.
4.3.5.The manufacturer shall keep the [F83approved] body that has approved the quality system informed of any intended change to the quality system.U.K.

Textual Amendments

The [F83approved] 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 [F84approved] bodyU.K.

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.U.K.
4.4.2.The manufacturer shall, for assessment purposes, allow the [F85approved] body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:U.K.

Textual Amendments

(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 [F86approved] body shall carry out periodic audits 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.U.K.

Textual Amendments

4.4.4.In addition, the [F87approved] body may pay unexpected visits to the manufacturer. During such visits the [F87approved] body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The [F87approved] body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.U.K.

Textual Amendments

Textual Amendments

4.5.[F88UK] marking and F89... declaration of conformityU.K.

4.5.1.The manufacturer shall affix the [F90UK] marking and, under the responsibility of the [F91approved] body referred to in point 4.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the F92... type-examination certificate and satisfies the applicable requirements of this Regulation.U.K.

Textual Amendments

4.5.2.The manufacturer shall draw up a written F93... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F94enforcement authority] for 10 years after the appliance or the fitting has been placed on the market. The F93... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.U.K.

Textual Amendments

A copy of the F93... declaration of conformity shall be made available to the [F95enforcement authority] upon request. A copy of the F93... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

Textual Amendments

4.6.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 [F96enforcement authority]:U.K.

Textual Amendments

(a)

the documentation referred to in point 4.3.1;

(b)

the information relating to the change referred to in point 4.3.5, as approved;

(c)

the decisions and reports of the [F97approved] body referred to in points 4.3.5, 4.4.3 and 4.4.4.

Textual Amendments

4.7.Each [F98approved] body shall inform [F99the Secretary of State] of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to [F99the Secretary of State] the list of quality system approvals refused, suspended or otherwise restricted.U.K.

Textual Amendments

Each [F98approved] body shall inform the other [F98approved] bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

4.8.Authorised representativeU.K.

The manufacturer's obligations set out in points 4.3.1, 4.3.5, 4.5 and 4.6 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 PRODUCT VERIFICATIONU.K.

5.1.Conformity to type based on product 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 5.6, and ensures and declares on his sole responsibility that the appliances or fittings concerned, which have been subject to point 5.3, are in conformity with the type described in the F100... type-examination certificate and satisfy the requirements of this Regulation that apply to them.U.K.

Textual Amendments

5.2.ManufacturingU.K.

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 F101... type-examination certificate and with the requirements of this Regulation that apply to them.

Textual Amendments

5.3.VerificationU.K.

[F102An approved] 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 F103... type-examination certificate and with the appropriate requirements of this Regulation.

Textual Amendments

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 fittingU.K.

5.4.1.All appliances or fittings shall be individually examined and appropriate tests set out in the relevant [F104designated] standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify conformity with the approved type described in the F105... type-examination certificate and with the appropriate requirements of this Regulation.U.K.

Textual Amendments

In the absence of such a [F104designated] standard, the [F106approved] body concerned shall decide on the appropriate tests to be carried out.

Textual Amendments

5.4.2.The [F107approved] 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.U.K.

Textual Amendments

The manufacturer shall keep the certificates of conformity available for inspection by the [F108enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

5.5.Statistical verification of conformityU.K.

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.U.K.
5.5.2.A random sample shall be taken from each lot in accordance with the requirements of point 5.5.3. All appliances or fittings in a sample shall be individually examined and appropriate tests set out in the relevant [F109designated] standard(s) and/or equivalent tests set out in other relevant technical specifications, shall be carried out in order to verify 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 [F109designated] standard, the [F110approved] body concerned shall decide on the appropriate tests to be carried out.U.K.

Textual Amendments

5.5.3.The [F111approved] body shall apply a sampling system with the following characteristics:U.K.

Textual Amendments

  • a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity percentage of between 0,5 % and 1,5 %,

  • a limit quality corresponding to a probability of acceptance of 5 % with a non-conformity percentage of between 5 % and 10 %.

5.5.4.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.U.K.

The [F112approved] 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.

Textual Amendments

The manufacturer shall keep the certificates of conformity at the disposal of the [F113enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

5.5.5.If a lot is rejected, the [F114approved] body or the [F115enforcement authority] shall take appropriate measures to prevent that lot being placed on the market. In the event of the frequent rejection of lots the [F114approved] body may suspend the statistical verification and take appropriate measures.U.K.

Textual Amendments

5.6.[F116UK] marking and F117... declaration of conformityU.K.

5.6.1.The manufacturer shall affix the [F118UK] marking and, under the responsibility of the [F119approved] body referred to in point 5.3, the latter's identification number to each individual appliance or fitting that is in conformity with the approved type described in the F120... type-examination certificate and satisfies the applicable requirements of this Regulation.U.K.

Textual Amendments

5.6.2.The manufacturer shall draw up a written F121... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F122enforcement authority], for 10 years after the appliance or the fitting has been placed on the market. The F121... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up.U.K.

Textual Amendments

A copy of the F121... declaration of conformity shall be made available to the [F123enforcement authority] upon request. A copy of the F121... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

If the [F124approved] body referred to in point 5.3 agrees and under its responsibility, the manufacturer may also affix the [F124approved] body's identification number to the appliance or the fitting.

Textual Amendments

Textual Amendments

5.7.If the [F125approved] body agrees and under its responsibility, the manufacturer may affix the [F125approved] body's identification number to the appliances or the fittings during the manufacturing process.U.K.

Textual Amendments

5.8.Authorised representativeU.K.

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 VERIFICATIONU.K.

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 or the fitting concerned, which has been subject to point 6.4, is in conformity with the requirements of this Regulation that apply to it.U.K.

6.2.Technical documentationU.K.

The manufacturer shall establish the technical documentation and make it available to the [F126approved] body referred to in point 6.4. 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.

Textual Amendments

6.2.1.The technical documentation shall, wherever applicable, contain at least the following elements:U.K.
(a)

a general description of the appliance or the fitting;

(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 or the fitting;

(d)

a list of the [F127designated] standards applied in full or in part F128..., and, where those [F127designated] standards have not been applied, descriptions of the solutions adopted to meet the essential requirements of this Regulation, including a list of other relevant technical specifications applied. In the event of partly applied [F127designated] 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)

instructions for installation and use, for appliances;

(h)

instructions for incorporation into an appliance or for assembly, for fittings.

Textual Amendments

6.2.2.Where appropriate, the manufacturer shall also submit to the [F129approved] body the following documents:U.K.

Textual Amendments

(a)

the F130... type-examination certificate and the F130... declaration of conformity 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 or the fitting;

(c)

any other document making it possible for the [F131approved] body to improve its assessment.

Textual Amendments

The manufacturer shall keep the technical documentation at the disposal of the [F132enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

6.3.ManufacturingU.K.

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 applicable requirements of this Regulation.

6.4.VerificationU.K.

[F133An approved] body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant [F134designated] standards and/or equivalent tests set out in other relevant technical specifications, to check the conformity of the appliances or fittings with the applicable requirements of this Regulation, or have them carried out. In the absence of such a [F134designated] standard [F135the approved] body concerned shall decide on the appropriate tests to be carried out.

Textual Amendments

If deemed necessary by the [F136approved] body, the examinations and tests may be carried out after the incorporation of the fitting, the assembly or the installation of the appliance.

Textual Amendments

The [F136approved] 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 appliances or fittings, or have it affixed under its responsibility.

The manufacturer shall keep the certificates of conformity at the disposal of the [F137enforcement authority] for 10 years after the appliance or the fitting has been placed on the market.

Textual Amendments

6.5.[F138UK] marking and F139... declaration of conformityU.K.

6.5.1.The manufacturer shall affix the [F140UK] marking and, under the responsibility of the [F141approved] body referred to in point 6.4, the latter's identification number to each appliance or fitting that satisfies the applicable requirements of this Regulation.U.K.

Textual Amendments

6.5.2.The manufacturer shall draw up a written F142... declaration of conformity and keep it at the disposal of the [F143enforcement authority] for 10 years after the appliance or the fitting has been placed on the market. The F142... declaration of conformity shall identify the appliance or the fitting for which it has been drawn up.U.K.

Textual Amendments

A copy of the F142... declaration of conformity shall be made available to the [F144enforcement authority] upon request. A copy of the F142... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

Textual Amendments

6.6.Authorised representativeU.K.

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 IVU.K.INSCRIPTIONS

1.In addition to the [F145UK] marking referred to in Article 16, the appliance or its data plate shall bear the following information:U.K.

(a)

the manufacturer's name, registered trade name or registered trade mark;

(b)

the appliance type, batch or serial number of the appliance or other element allowing its identification;

(c)

the type of electrical supply used, where applicable;

(d)

the appliance category marking;

(e)

the nominal supply pressure for the appliance;

(f)

the necessary information to ensure correct and safe installation, according to the nature of the appliance.

Textual Amendments

2.The fitting or its data plate shall bear, as far as relevant, the information provided for in point 1.U.K.

ANNEX VU.K.F146... DECLARATION OF CONFORMITY No …(4)

Textual Amendments

1.Appliance or fitting /appliance or fitting model (product, type, batch or serial number):U.K.

2.Name and address of the manufacturer and, where applicable, his authorised representative:U.K.

3.This declaration of conformity is issued under the sole responsibility of the manufacturer.U.K.

4.Object of the declaration (identification of the appliance or fitting allowing traceability; where necessary for the identification of the appliance or the fitting, an image may be included): description of the appliance or the fitting.U.K.

5.The object of the declaration described in point 4 is in conformity with the relevant [F147statutory requirements]: … F148....U.K.

Textual Amendments

6.References to the relevant [F149designated] standards used or references to the other technical specifications in relation to which conformity is declared:U.K.

Textual Amendments

7.The [F150approved] body … (name, address, number) … performed … (description of intervention) … and issued the certificate(s): … (details, including its date, and, where appropriate, information on the duration and conditions of its validity).U.K.

Textual Amendments

8.In the case of fittings, instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance in order to assist compliance with the essential requirements applicable to finished appliances.U.K.

9.Additional information:U.K.

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

F151ANNEX VIU.K.CORRELATION TABLE

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

(1)

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/EEC (OJ L 338, 13.11.2004, p. 4).

(2)

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).

(3)

Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ L 330, 5.12.1998, p. 32).

(4)

It is optional for the manufacturer to assign a number to the declaration of conformity.

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