The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004

Made: 1st April 2004

Laid before Parliament: 16th April 2004

Coming into force: 10th May 2004

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PART 1 — INTRODUCTORY PROVISIONS

Citation and commencement

1

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Interpretation

2

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Application

3

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Application to international carriage

4

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Application to tanks, pressure receptacles, battery-vehicles, battery-wagons, MEGCs, UN MEGCs and transportable pressure equipment

5

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Application to armed forces

6

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Exemptions

7

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Competent authority

8

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PART 2 — REQUIREMENTS OF ADR AND RID

Training

9

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Safety obligations

10

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Class 7 goods for carriage by rail

11

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Safety advisers

12

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Reports on accidents or incidents

13

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Emergency plans for marshalling yards

14

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Classification of goods

15

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Prohibition from carriage

16

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Dangerous goods list and special provisions

17

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Use of packagings

18

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Use of tanks, battery-vehicles, battery-wagons, MEGCs and UN-certified MEGCs

19

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Consignment

20

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Construction and testing of packagings and packages

21

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Construction and testing of tanks, battery-vehicles, battery-wagons, MEGCs and UN-certified MEGCs

22

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Carriage, loading, unloading and handling

23

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Vehicle crews, equipment, operation and documentation

24

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Construction and approval of vehicles

25

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PART 3 — COMPETENT AUTHORITY FUNCTIONS

Interpretation of Part 3 and Schedule 3

26

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Grant of approvals by the GB competent authority

27

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Grant of unilateral and multilateral approvals by the GB competent authority in relation to class 7 goods for carriage by rail

28

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Appointment of persons by the GB competent authority

29

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Recognition of approvals, tests, methods, standards and procedures etc. by the GB competent authority

30

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Imposing of requirements by the GB competent authority

31

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Issuing of safety adviser vocational training certificates by the GB competent authority

32

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Issuing of driver training certificates by the GB competent authority

33

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Notification under sub-section 1.8.2.2 of ADR or of RID

34

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Miscellaneous functions of the GB competent authority

35

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Exemption certificates, temporary and ad hoc exemptions

36

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PART 4 — TRANSPORTABLE PRESSURE EQUIPMENT

Interpretation of Part 4

37

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Placing on the market and use at work of transportable pressure equipment

38

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Transportable pressure equipment placed on the market and used at work exclusively in Great Britain

39

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Reassessment of conformity

40

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Periodic inspection and repeated use

41

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Notified bodies

42

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Approved bodies

43

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Appointment of notified bodies and approved bodies by the competent authority

44

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Conformity marking

45

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PART 5 — ADDITIONAL REQUIREMENTS TO ADR AND RID

Attendant for carriage of class 1 goods by road

46

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Duration of carriage and delivery of class 1 goods by road

47

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Miscellaneous security requirements for carriage of class 1 goods by road

48

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Miscellaneous security requirements for carriage of class 1 goods by rail

49

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Security requirement for carriage of class 1 goods by road or rail and class 7 goods by rail

50

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Carriage of class 1 goods in vehicles used to carry passengers for hire or reward

51

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Carriage of class 1 goods by road in motor vehicles

52

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Marshalling and formation of trains

53

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Keeping of information by carriers

54

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Placards, marks and plate markings for carriage within Great Britain

55

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PART 6 — MISCELLANEOUS

Fees for applications relating to pressure receptacles and tanks

56

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Transitional defence

57

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Defence and enforcement

58

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Amendments to the Health and Safety (Fees) Regulations 2004

59

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Amendments to Chemicals (Hazard Information and Packaging for Supply) Regulations 2002

60

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Amendments to the Classification and Labelling of Explosives Regulations 1983

61

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Consequential amendments

62

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Revocations and savings

63

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SCHEDULE 1 — OLD TANKS

Interpretation

1

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Construction of tanks of old tank-vehicles, tank containers and old tank wagons for carriage by road or rail

2

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Testing, examination and maintenance for carriage by road or rail

3

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Testing, examination and maintenance for carriage by road

4

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Testing, examination and maintenance for carriage by rail

5

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Use of old tank-vehicles, old tank wagons or tank-containers for carriage by road or rail

6

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Keeping of documents

7

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Appointment of inspection bodies by the competent authority

8

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Exceptions

9

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SCHEDULE 2 — OLD PRESSURE RECEPTACLES

Interpretation

1

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Duties on those designing, manufacturing, importing, supplying, modifying or repairing old pressure receptacles

2

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Conformity to approved design standard or specification

3

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Examination of old pressure receptacles by competent or approved persons

4

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Filling of old pressure receptacles

5

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Approved design specification

6

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Modification, repair and re-rating of old pressure receptacles

7

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Additional requirements for old pressure receptacles containing certain dangerous goods not classified as class 2

8

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Approvals by the competent authority

9

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Exceptions

10

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SCHEDULE 3 — COMPETENT AUTHORITY FUNCTIONS

PART 1 — APPROVALS BY THE GB COMPETENT AUTHORITY

1

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2

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PART 2 — MULTILATERAL AND UNILATERAL APPROVALS BY THE GB COMPETENT AUTHORITY

3

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4

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5

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PART 3 — APPOINTMENT OF PERSONS BY THE GB COMPETENT AUTHORITY

6

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PART 4 — RECOGNITION OF APPROVALS, TESTS, METHODS, STANDARDS, PROCEDURES ETC. BY THE GB COMPETENT AUTHORITY

7

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8

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PART 5 — IMPOSING OF REQUIREMENTS BY THE GB COMPETENT AUTHORITY

9

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10

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SCHEDULE 4 — CONFORMITY ASSESSMENT PROCEDURES

(This Schedule substantially reproduces the provisions of Part 1 of Annex IV of the Transportable Pressure Equipment Directive)

Module A—internal production control

1

This module describes the procedure whereby the manufacturer, or his authorised representative established within the Community who carries out the obligations laid down in paragraph 2, ensures and declares that transportable pressure equipment satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to all transportable pressure equipment and draw up a written declaration of conformity.

2

The manufacturer must draw up the technical documentation described in paragraph 3 and either the manufacturer or his authorised representative established within the Community must keep it at the disposal of the competent authority for inspection purposes for a period of 10 years after the last of the transportable pressure equipment has been manufactured. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available is the responsiblity of the person who places the transportable pressure equipment on the market.

3

The technical documentation must enable an assessment to be made of the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the transportable pressure equipment and contain—

• a general description of the transportable pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the transportable pressure equipment,

• a description of the solutions adopted to meet the requirements of Part 4 of these Regulations,

• results of the design calculations, examinations carried out, etc.,

• test reports.

4

The manufacturer, or his authorised representative established within the Community, must keep a copy of the declaration of conformity with the technical documentation.

5

The manufacturer must take all measures necessary to ensure that the manufacturing process requires the manufactured transportable pressure equipment to comply with the technical documentation referred to in paragraph 2 and with the relevant requirements of Part 4 of these Regulations.

Module A1—internal manufacturing checks with monitoring of the final assessment

In addition to the requirements of module A, the following applies.

Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

• ensure that the manufacturer actually performs final assessment,

• take samples of transportable pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the equipment samples.

Should one or more of the items of transportable pressure equipment not conform, the notified body must take appropriate measures.

On the responsiblity of the notified body, the manufacturer must affix that body’s identification number to each item of transportable pressure equipment.

Module B—EC type-examination

1

This module describes the part of the procedure by which a notified body ascertains and attests that a representative example of the production envisaged meets the relevant requirements of Part 4 of these Regulations.

2

The application of EC type-examination must be lodged by the manufacturer or by his authorised representative established within the Community with a single notified body of his choice.

3

The technical documentation must enable an assessment to be made of the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the transportable pressure equipment and contain:

• a general description of the type,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the transportable pressure equipment,

• a description of the solutions adopted to meet the essential requirements of Part 4 of these Regulations,

• results of the design calculations made, examinations carried out, etc.,

• test reports,

• information concerning the tests provided for in manufacture,

• information concerning the qualifications or approvals.

4

The notified body must:

4.1

examine the technical documentation, verify that the type has been manufactured in conformity with it and identify the components designed in accordance with the relevant provisions of Part 4 of these Regulations and in particular:

• examine the technical documentation with respect to the design and the manufacturing procedures,

• assess the materials used where these are not in conformity with the relevant provisions of the Directive and check the certificate issued by the materials manufacturer,

• approve the procedures for the permanent joining of pressure equipment parts or check that they have been previously approved,

• verify that the staff undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved;

4.2

perform or have performed the appropriate examinations and necessary tests to establish whether the solutions adopted by the manufacturer meet the relevant requirements of Part 4 of these Regulations;

4.3

perform or have performed the appropriate examinations and necessary tests to establish whether the relevant provisions of Part 4 of these Regulations have been applied;

4.4

agree with the applicant the location where the examinations and necessary tests are to be carried out.

5

Where the type satisfies the relevant provisions of Part 4 of these Regulations, the notified body must issue an EC type-examination certificate to the applicant. The certificate, which should be valid for 10 years and be renewable, must contain the name and address of the manufacturer, the conclusions of the examination and the necessary data for identification of the approved type.

6

The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved transportable pressure equipment; these are subject to additional approval where they may affect conformity with the relevant requirements of Part 4 of these Regulations or the prescribed conditions for use of the equipment. This additional approval must be given in the form of an addition to the original EC type-examination certificate.

7

Each notified body must communicate to the member States, the relevant information concerning EC type-examination certificates which it has withdrawn, and, on request, those it has issued.

8

The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The annexes to the certificates must be held at the disposal of the other notified bodies.

9

The manufacturer, or his authorised representative established within the Community, must keep with the technical documentation copies of the EC type-examination certificates and their additions for a period of 10 years after the last of the transportable pressure equipment has been manufactured.

Module B1—EC design examination

1

This module describes the part of the procedure whereby a notified body ascertains and attests that the design of an item of transportable pressure equipment meets the relevant provisions of Part 4 of these Regulations.

2

The manufacturer, or his authorised representative established within the Community, must lodge an application for EC design examination with a single notified body.

3

The technical documentation must enable an assessment to be made of the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the transportable pressure equipment and contain:

• a general description of the equipment in question,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the equipment,

• a description of the solutions adopted to meet the relevant requirements of Part 4 of these Regulations,

• the necessary supporting evidence for the adequacy of the design solution; this supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf,

• results of the design calculations made, examinations carried out, etc.,

• information regarding qualifications or approvals.

4

The notified body must:

4.1

examine the technical documentation and identify components which have been designed in accordance with the relevant provisions of Part 4 of these Regulations and in particular must:

• assess the materials used where these are not in conformity with the relevant provisions of Part 4 of these Regulations,

• approve the procedures for the permanent joining of pressure equipment parts or check that they have been previously approved,

• verify that the staff undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved;

4.2

perform the necessary examinations to establish whether the solutions adopted by the manufacturer meet the relevant requirements of Part 4 of these Regulations;

4.3

perform the necessary examinations to establish whether the relevant provisions of these Regulations have actually been applied.

5

Where the design meets the relevant provisions of Part 4 of these Regulations, the notified body must issue an EC design-examination certificate to the applicant. The certificate must contain the name and address of the applicant, the conclusions of the examination, conditions for its validity and the necessary data for identification of the approved design.

6

The applicant must inform the notified body that holds the technical documentation concerning the EC design-examination certificate of all modifications to the approved design; these are subject to additional approval where they may affect conformity with the relevant requirements of Part 4 of these Regulations or the prescribed conditions for use of the equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate.

7

Each notified body must communicate to the member States the relevant information concerning the EC design-examination certificates which it has withdrawn, and, on request, those it has issued.

8

The other notified bodies may on request obtain the relevant information concerning:

• the EC design-examination certificates and additions granted,

• the EC design-examination certificates and additions withdrawn.

9

The manufacturer, or his authorised representative established within the Community, must keep with the technical documentation referred to in paragraph 3 copies of EC design-examination certificates and their additions for a period of 10 years after the last of the transportable pressure equipment has been manufactured.

Module C1—conformity to type

1

This module describes that part of the procedure whereby the manufacturer, or his authorised representative established within the Community, ensures and declares that transportable pressure equipment is in conformity with the type described in the EC type-examination certificate and satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to all transportable pressure equipment and draw up a written declaration of conformity.

2

The manufacturer must take all measures necessary to ensure that the manufacturing process requires the manufactured transportable pressure equipment to comply with the type as described in the EC type-examination certificate and with the relevant requirements of Part 4 of these Regulations.

3

The manufacturer, or his authorised representative established within the Community, must keep a copy of the declaration of conformity for a period of 10 years after the last of the transportable pressure equipment has been manufactured.

4

Final assessment must be subject to monitoring in the form of unexpected visits by a notified body chosen by the manufacturer.

5

During such visits, the notified body must:

• ensure that the manufacturer actually performs final assessment,

• take samples of transportable pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the equipment samples.

Module D—production quality assurance

1

This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that the transportable pressure equipment concerned is in conformity with the type described in the EC type-examination certificate or EC design-examination certificate and satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to all transportable pressure equipment and draw up a written declaration of conformity. The conformity marking must be accompanied by the identification number of the notified body responsible for Community surveillance as specified in paragraph 4.

2

The manufacturer must operate an approved quality system for production, final inspection and testing as specified in paragraph 3 and be subject to surveillance as specified in paragraph 4.

3

Quality system

3.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice and the application must include:

• all relevant information on the transportable pressure equipment concerned,

• the documentation concerning the quality system,

• the technical documentation of the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.

3

2 The quality system must ensure compliance of the transportable pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the relevant requirements of Part 4 of these Regulations.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3.4

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

4

Surveillance under the responsibility of the notified body

4.1

The purpose of the surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report. The frequency of periodic audits must be such that full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• where applicable, special conditions linked to the approval of the system,

• significant changes in manufacturing organisations, policy or techniques.

5

The manufacturer must, for a period of 10 years after the last of the transportable pressure equipment has been manufactured, hold at the disposal of the competent authority:

• the documentation referred to in the second indent of paragraph 3.1,

• the adjustments referred to in the second paragraph of 3.4,

• the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, in the last paragraph of 3.4, and in paragraphs 4.3 and 4.4.

6

Each notified body must communicate to the member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Module D1—production quality assurance

1

This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 3 ensures and declares that the items of transportable pressure equipment concerned satisfy the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to all transportable pressure equipment and draw up a written declaration of conformity. The conformity marking must be accompanied by the identification number of the notified body responsible for Community surveillance as specified in paragraph 5.

2

The manufacturer must draw up the technical documentation described below. The technical documentation must enable an assessment to be made of the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the transportable pressure equipment and contain:

• a general description of the equipment in question,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the equipment,

• a description of the solutions adopted to meet the relevant requirements of Part 4 of these Regulations,

• results of the design calculations made, examinations carried out, etc.,

• test reports.

3

The manufacturer must operate an approved quality system for production, final inspection and testing as specified in paragraph 4 and be subject to surveillance as specified in paragraph 5.

4

Quality system

4.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

4.2

The quality system must ensure compliance of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations.

4.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 4.2.

4.4

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

5

Surveillance under the responsibility of the notified body

5.1

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• where applicable, special conditions linked to the approval of the system,

• significant changes in manufacturing organisation, policy or techniques.

6

The manufacturer must, for a period of 10 years after the last of the transportable pressure equipment has been manufactured, hold at the disposal of the competent authority:

• the documentation referred to in paragraph 2,

• the documentation referred to in the second indent of paragraph 4.1,

• the adjustments referred to in the second sub-paragraph of paragraph 4.4,

• the decisions and reports from the notified body which are referred to in the last sub-paragraph of paragraph 4.3, in the last sub-paragraph of paragraph 4.4 and in paragraphs 5.3 and 5.4.

7

Each notified body must communicate to the member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Module E—product quality assurance

1

This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that the item of transportable pressure equipment is in conformity with the type as described in the EC type-examination certificate and satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to each product and draw up a written declaration of conformity. The conformity marking must be accompanied by the identification number of the notified body responsible for Community surveillance as specified in paragraph 4.

2

The manufacturer must operate an approved quality system for production, final inspection and testing as specified in paragraph 3 and be subject to surveillance as specified in paragraph 4.

3

Quality system

3.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

3.2

Under the quality system, each item of transportable pressure equipment must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements of Part 4 of these Regulations. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3.4

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

4

Surveillance under the responsibility of the notified body

4.1

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the technical documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• where applicable, special conditions linked to the approval of the system,

• significant changes in manufacturing organisation, policy or techniques.

5

The manufacturer must, for a period of 10 years after the last of the transportable pressure equipment has been manufactured, hold at the disposal of the competent authority:

• the documentation referred to in the second indent of the second sub-paragraph of paragraph 3.1,

• the adjustments referred to in the second sub-paragraph of paragraph 3.4,

• the decisions and reports from the notified body which are referred to in the last sub-paragraph of paragraph 3.3, in the last sub-paragraph of paragraph 3.4, and in paragraphs 4.3 and 4.4.

6

Each notified body must communicate to the member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Module E1—production quality assurance

1

This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 3 ensures and declares that the transportable pressure equipment satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to each item of transportable pressure equipment and draw up a written declaration of conformity. The conformity marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in paragraph 5.

2

The manufacturer must draw up the technical documentation described below.

3

The manufacturer must operate an approved quality system for the final transportable pressure equipment inspection and testing as specified in paragraph 4 and be subject to surveillance as specified in paragraph 5.

4

Quality system

4.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

4.2

Under the quality system, each item of transportable pressure equipment must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements of Part 4 of these Regulations. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

4.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 4.2.

4.4

The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

5

Surveillance under the responsibility of the notified body

5.1

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

5.2

The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the technical documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

5.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• where applicable, special conditions linked to the approval of the system,

• significant changes in manufacturing organisation, policy or techniques.

6

The manufacturer must, for a period of 10 years after the last of the transportable pressure equipment has been manufactured, hold at the disposal of the competent authority:

• the documentation referred to in paragraph 2,

• the documentation referred to in the second indent of paragraph 4.1,

• the adjustments referred to in the second sub-paragraph of paragraph 4.4,

• the decisions and reports from the notified body which are referred to in the last sub-paragraph of paragraph 4.3, in the last sub-paragraph of paragraph 4.4, and in paragraphs 5.3 and 5.4.

7

Each notified body must communicate to the member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Module F—product verification

1

This module describes the procedure whereby a manufacturer, or his authorised representative established within the Community, ensures and declares that the transportable pressure equipment subject to the provisions of paragraph 3 is in conformity with the type described:

• in the EC type-examination certificate, or

• in the EC design-examination certificate,

and satisfies the relevant requirements of Part 4 of these Regulations.

2

The manufacturer must take all measures necessary to ensure that the manufacturing process requires the transportable pressure equipment to comply with the type described:

• in the EC type-examination certificate, or

• in the EC design-examination certificate,

and with the relevant requirements of Part 4 of these Regulations.

3

The notified body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations by examining and testing every product in accordance with paragraph 4.

4

Verification by examination and testing of each item of transportable pressure equipment

4.1

Each item of transportable pressure equipment must be individually examined and must undergo appropriate examinations and tests in order to verify that it conforms to the type and the relevant requirements of Part 4 of these Regulations.

4.2

The notified body must affix its identification number or have it affixed to each item of transportable pressure equipment and draw up a written certificate of conformity relating to the tests carried out.

4.3

The manufacturer, or his authorised representative established within the Community, must ensure that the certificates of conformity issued by the notified body can be made available on request.

Module G—EC unit verification

1

This module describes the procedure whereby the manufacturer ensures and declares that transportable pressure equipment which has been issued with the certificate referred to in paragraph 4.1 satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to the equipment and draw up a declaration of conformity.

2

The manufacturer must apply to a notified body of his choice for unit verification. The application must contain:

• the name and address of the manufacturer and the location of the transportable pressure equipment,

• a written declaration to the effect that a similar application has not been lodged with another notified body,

• technical documentation.

3

The technical documentation must enable the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations to be assessed and the design, manufacture and operation of the transportable pressure equipment to be understood.

4

The notified body must examine the design and construction of each item of transportable pressure equipment and during manufacture perform appropriate tests to ensure its conformity with the relevant requirements of Part 4 of these Regulations.

4.1

The notified body must affix its identification number or have it affixed to the transportable pressure equipment and draw up a certificate of conformity for the tests carried out. This certificate must be kept for a period of 10 years.

4.2

The manufacturer, or his authorised representative established within the Community, must ensure that the declaration of conformity and certificate of conformity issued by the notified body can be made available on request.

Module H—full quality assurance

1

This module describes the procedure whereby the manufacturer who satisfies the obligations of paragraph 2 ensures and declares that the transportable pressure equipment in question satisfies the relevant requirements of Part 4 of these Regulations. The manufacturer, or his authorised representative established within the Community, must affix the conformity marking to each item of transportable pressure equipment and draw up a written declaration of conformity. The conformity marking must be accompanied by the identification number of the notified body responsible for the surveillance referred to in paragraph 4.

2

The manufacturer must implement an approved quality system for design, manufacture, final inspection and testing as specified in paragraph 3 and be subject to surveillance as specified in paragraph 4.

3

Quality system

3.1

The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice.

3.2

The quality system must ensure compliance of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3.4

The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient.

4

Surveillance under the responsibility of the notified body

4.1

The purpose of this surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

4.2

The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• the quality records provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the staff concerned, etc.

4.3

The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provides the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years.

4.4

In addition, the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system:

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• where applicable, special conditions linked to the approval of the system,

• significant changes in manufacturing organisation, policy or techniques.

5

The manufacturer must, for a period of 10 years after the last of the transportable pressure equipment has been manufactured, keep at the disposal of the competent authority:

• the documentation referred to in the second sub-paragraph of paragraph 3.1,

• the adjustments referred to in the second sub-paragraph of paragraph 3.4,

• the decisions and reports from the notified body which are referred to in the last sub-paragraph of paragraph 3.3, in the last sub-paragraph of paragraph 3.4, and in paragraphs 4.3 and 4.4.

6

Each notified body must communicate to the other member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued.

Module H1—full quality assurance with design examination and special surveillance of the final test

1

In addition to the requirements of module H, the following apply:

• (a) the manufacturer must lodge an application for examination of the design with the notified body;

• (b) the application must enable the design, manufacture and operation of the transportable pressure equipment to be understood, and enable conformity with the relevant requirements of Part 4 of these Regulations to be assessed.

It must include:

• the technical design specifications, including standards, which have been applied,

• the necessary supporting evidence for their adequacy. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;

• (c) the notified body must examine the application and where the design meets the relevant requirements of Part 4 of these Regulations issue an EC design-examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the transportable pressure equipment;

• (d) the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the relevant requirements of Part 4 of these Regulations or the prescribed conditions for use of the transportable pressure equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate;

• (e) each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

2

Final assessment is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body must conduct examinations on the transportable pressure equipment.

SCHEDULE 5 — MODULES TO BE FOLLOWED FOR CONFORMITY ASSESSMENT

(This Schedule substantially reproduces the provisions of Annex V to the Transportable Pressure Equipment Directive)

The following table indicates which modules are to be followed when undertaking conformity assessment procedures.

Category of transportable pressure equipment	Modules
Pressure receptacles for which the product of the test pressure and the capacity is no more than 30 MPa x litre (300 bar x litre)	A1, D1 or E1
Pressure receptacles for which the product of the test pressure and the capacity is more than 30 and no more than 150 MPa x litre (300 and 1,500 bar x litre respectively)	H, B in combination with E, B in combination with C1, B1 in combination with F, or B1 in combination with D
Pressure receptacles and tanks for which the product of the test pressure and the capacity exceeds 150 MPa x litre (1,500 bar x litre)	G, H1, B in combination with D, or B in combination with F

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SCHEDULE 6 — CONFORMITY REASSESSMENT PROCEDURE

(This Schedule substantially reproduces the provisions of Part II of Annex IV to the Transportable Pressure Equipment Directive)

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SCHEDULE 7 — PERIODIC INSPECTION PROCEDURES

(This Schedule substantially reproduces the provisions of Part III of Annex IV to the Transportable Pressure Equipment Directive)

Module 1—periodic inspection of products

1

This module describes the procedure whereby the owner, or his authorised representative established within the Community, ensures that the transportable pressure equipment subject to paragraph 3 continues to meet the relevant requirements of Part 4 of these Regulations.

2

To meet the requirements referred to in paragraph 1 the owner, or his authorised representative established in the Community, must take all measures necessary to ensure that the conditions of use and of maintenance ensure the continued conformity of the transportable pressure equipment to the relevant requirements of Part 4 of these Regulations, in particular so that:

• the transportable pressure equipment is used as intended,

• it is filled in appropriate filling centres,

• any maintenance work or repairs are carried out,

• the periodic inspections necessary are carried out.

3

The notified body or approved body must perform the appropriate examinations and tests in order to check the conformity of the transportable pressure equipment with the relevant requirements of Part 4 of these Regulations by examining and testing every product.

3.1

All transportable pressure equipment must be examined individually and appropriate tests as required pursuant to Part 4 of these Regulations, must be carried out in order to check that it meets the relevant requirements of that Part of these Regulations.

3.2

The notified body or approved body must affix, or have affixed, its identification number to each product being periodically inspected immediately after the date of the periodic inspection and draw up a written periodic inspection certificate. That certificate may cover a number of items of equipment.

3.3

The owner or his authorised representative established in the Community must keep the periodic inspection certificate required under paragraph 3.2, and the documents required under paragraph 2 at least until the next periodic inspection.

Module 2—periodic inspection through quality assurance

1

This module describes the following procedures:

• the procedure whereby the owner or his authorised representative established in the Community, who satisfies the obligations of paragraph 2, ensures and declares that the transportable pressure equipment continues to meet the relevant requirements of Part 4 of these Regulations. The owner or his authorised representative established in the Community must affix the date of the periodic inspection to all transportable pressure equipment and draw up a written declaration of conformity. The date of the periodic inspection must be accompanied by the identification number of the notified body responsible for surveillance as specified in paragraph 4.

• the procedure whereby, in the case of the periodic inspection of tanks performed by the approved body in accordance with regulation 43(1)(iii), the approved body which satisfies the obligations of the last sub-paragraph of paragraph 2, certifies that the transportable pressure equipment continues to meet the relevant requirements of Part 4 of these Regulations. The approved body must affix the date of the periodic inspection to all transportable pressure equipment and draw up a periodic inspection certificate.

2

The owner or his authorised representative established within the Community must take all steps necessary to ensure that the conditions of use and of maintenance are such as to enable the transportable pressure equipment to comply permanently with the relevant requirements of Part 4 of these Regulations and in particular that:

• the transportable pressure equipment is used as intended,

• it is filled in appropriate filling centres,

• any maintenance work or repairs are carried out,

• the periodic inspections necessary are carried out.

3

Quality system

3.1

The owner or his authorised representative established in the Community or the approved body must lodge an application for assessment of his quality system for the transportable pressure equipment with a notified body of his choice.

3.2

Under the quality system, each item of transportable pressure equipment must be examined and appropriate tests must be carried out in order to ensure its conformity with the relevant requirements referred to in Part 4 of these Regulations. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

3.3

The notified body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3.2.

3.4

The owner or his authorised representative established in the Community or the approved body must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient.

4

Surveillance under the responsibility of the notified body

4.1

The purpose of surveillance is to make sure that the owner or his authorised representative established in the Community or the approved body duly fulfils the obligations arising out of the approved quality system.

4.2

The owner or his authorised representative established in the Community or the approved body must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular:

• the quality system documentation,

• the technical documentation,

• the quality records, such as inspection reports and test data, reports concerning the qualifications of the personnel concerned etc.

4.3

The notified body must carry out periodic audits to make sure that the owner or his authorised representative established in the Community or the approved body maintains and applies the quality system and provides the owner or his authorised representative established in the Community or the approved body with an audit report.

4.4

In addition, the notified body may pay unannounced visits to the owner or his authorised representative established in the Community or the approved body. During such visits, the notified body may if necessary perform tests or have tests performed to verify if necessary that the quality system is functioning correctly. The notified body must provide the owner or his authorised representative established in the Community or the approved body with a visit report and, if a test has taken place, with a test report.

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SCHEDULE 8 — CONFORMITY MARKING

The conformity mark shall take the following form—

If the mark is reduced or enlarged, the proportions of the above drawing must be respected.

The various components of the mark must have substantially the same vertical dimensions, which may not be less than 5mm.

This minimum dimension may be waived for small devices.

SCHEDULE 9 — PLACARDS, MARKS AND PLATE MARKINGS FOR CARRIAGE WITHIN GREAT BRITAIN

PART 1 — CARRIAGE OF GOODS BY ROAD

1

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2

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3

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4

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5

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6

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Hazard warning panel

PART 2 — CARRIAGE OF GOODS BY RAIL

7

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8

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9

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SCHEDULE 10 — AMENDMENTS TO THE HEALTH AND SAFETY (FEES) REGULATIONS 2004

1

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2

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3

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4

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5

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SCHEDULE 11 — AMENDMENTS TO THE CHEMICALS (HAZARD INFORMATION AND PACKAGING FOR SUPPLY) REGULATIONS 2002

1

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2

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SCHEDULE 12 — AMENDMENTS TO THE CLASSIFICATION AND LABELLING OF EXPLOSIVES REGULATIONS 1983

1

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2

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3

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4

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5

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6

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7

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8

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9

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SCHEDULE 13 — CONSEQUENTIAL AMENDMENTS

Amendment to the Petroleum (Consolidation) Act 1928

1

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Amendment to the Compressed Acetylene (Importation) Regulations 1978

2

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Amendments to the Dangerous Substances in Harbour Areas Regulations 1987

3

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Amendment to the Dangerous Substances (Notification and Marking of Sites) Regulations 1990

4

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Amendment to the Control of Explosives Regulations 1991

5

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Amendment to the Coal and Other Safety-Lamp Mines (Explosives) Regulations 1993

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Amendment to the Notification of New Substances Regulations 1993

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Amendments to the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995

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Amendment to the Health and Safety (Safety Signs and Signals) Regulations 1996

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Amendments to the Pressure Systems Safety Regulations 2000

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Amendments to the Radiation (Emergency Preparedness and Public Information) Regulations 2001

11

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Amendments to the Control of Asbestos at Work Regulations 2002

12

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Amendment to the Control of Lead at Work Regulations 2002

13

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

Amendment to the Control of Substances Hazardous to Health Regulations 2002

14

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

Amendment to the Dangerous Substances and Explosive Atmospheres Regulations 2002

15

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

SCHEDULE 14 — REVOCATIONS

Regulations revoked	References	Extent of revocation
The Gas Cylinders (Pattern Approval) Regulations 1987	S.I. 1987/116	The whole Regulations
The Pressure Vessels (Verification) Regulations 1988	S.I. 1988/896	The whole Regulations
The Packaging of Explosives for Carriage Regulations 1991	S.I. 1991/2097	The whole Regulations
The Carriage of Dangerous Goods by Rail Regulations 1996	S.I. 1996/2089	Regulations 1, 2 and 5 to 34 and the Schedules
The Carriage of Dangerous Goods (Classification, Packaging and Labelling) and Use of Transportable Pressure Receptacles Regulations 1996	S.I. 1996/2092	The whole Regulations
The Carriage of Explosives by Road Regulations 1996	S.I. 1996/2093	The whole Regulations
The Carriage of Dangerous Goods by Road (Driver Training) Regulations 1996	S.I. 1996/2094	The whole Regulations
The Carriage of Dangerous Goods by Road Regulations 1996	S.I. 1996/2095	Regulations 1 to 4, 7 to 19 and 21 to 29 and the Schedules
The Carriage of Dangerous Goods (Amendment) Regulations 1998	S.I. 1998/2885	The whole Regulations
The Carriage of Dangerous Goods (Amendment) Regulations 1999	S.I. 1999/303	The whole Regulations
The Transport of Dangerous Goods (Safety Advisers) Regulations 1999	S.I. 1999/257	The whole Regulations
The Transportable Pressure Vessels Regulations 2001	S.I. 2001/1426	The whole Regulations
The Packaging, Labelling and Carriage of Radioactive Material by Rail Regulations 2002	S.I. 2002/2099	The whole Regulations
The Carriage of Dangerous Goods and Transportable Pressure Vessels (Amendment) Regulations 2003	S.I. 2003/1431	The whole Regulations

Signed

Signed by authority of the Secretary of State

David Jamieson — Parliamentary Under Secretary of State — Department for Transport — 2004-04-01

Explanatory note

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Footnotes