- Latest available (Revised)
- Point in Time (20/11/2003)
- Original (As adopted by EU)
Directive 97/23/EC of the European Parliament and of the Council of 29 May 1997 on the approximation of the laws of the Member States concerning pressure equipment (repealed)
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Version Superseded: 18/07/2016
EU Directives are being published on this site to aid cross referencing from UK legislation. After IP completion day (31 December 2020 11pm) no further amendments will be applied to this version.
The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.
Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.
a general description of the 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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports.
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:
establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,
take samples of 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 pressure equipment samples.
Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.
On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.
The application must include:
the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation described in section 3.
The applicant must place at the disposal of the notified body a representative example of the production envisaged, hereinafter called ‘type’. The notified body may request further examples should the test programme so require.
A type may cover several versions of pressure equipment provided that the differences between the versions do not affect the level of safety.
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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports,
information concerning the tests provided for in manufacture,
information concerning the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.
In particular, the notified body must:
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 harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,
approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,
verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 or 3.1.3 of Annex I.
A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.
If the notified body refuses to issue an EC type-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.
Each notified body must also communicate to the other notified bodies the relevant information concerning the EC type-examination certificates it has withdrawn or refused.
Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.
The experimental design method provided for in section 2.2.4 of Annex I may not be used in the context of this module.
The application must include:
the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,
a written declaration that the same application has not been lodged with any other notified body,
the technical documentation described in section 3.
The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.
a general description of the 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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
the necessary supporting evidence for the adequacy of the design solution, in particular where the standards referred to in Article 5 have not been applied in full; this supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf,
results of design calculations made, examinations carried out, etc.,
information regarding the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.
In particular, the notified body must:
assess the materials where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials,
approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,
verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I.
A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.
If the notified body refuses to issue an EC design-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.
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.
the EC design-examination certificates and additions granted,
the EC design-examination certificates and additions withdrawn.
Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.
Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.
During such visits, the notified body must:
establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,
take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body must assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.
Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.
On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.
The application must include:
all relevant information on the pressure equipment concerned,
the documentation concerning the quality system,
the technical documentation for the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.
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.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,
the means of monitoring the achievement of the required quality and the effective operation of the quality system.
The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.
The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
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.
the category of the equipment,
the results of previous surveillance visits,
the need to follow up corrective action,
special conditions linked to the approval of the system, where applicable,
significant changes in manufacturing organization, policy or techniques.
During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.
the documentation referred to in the second indent of 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, the last paragraph of 3.4, and in 4.3 and 4.4.
Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.
The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:
a general description of the 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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports.
The application must include:
all relevant information on the pressure equipment concerned,
the documentation concerning the quality system.
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.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I,
the means of monitoring the achievement of the required quality and the effective operation of the quality system.
The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.
The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.
If must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
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.
the category of the equipment,
the results of previous surveillance visits,
the need to follow up corrective action,
special conditions linked to the approval of the system, where applicable,
significant changes in manufacturing organization, policy or techniques.
During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.
the technical documentation referred to in section 2,
the documention referred to in the second indent of 4.1,
the adjustments referred to in the second paragraph of 4.4,
the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4, and in 5.3 and 5.4.
Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.
The application must include:
all relevant information on the pressure equipment concerned,
the documentation concerning the quality system,
the technical documentation for the approved type and a copy of the EC type-examination certificate.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
the examinations and tests to be carried out after manufacture,
the means of monitoring the effective operation of the quality system,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I.
The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
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.
the category of the equipment,
the results of previous surveillance visits,
the need to follow up corrective action,
special conditions linked to the approval of the system, where applicable,
significant changes in manufacturing organization, policy or techniques.
During such visits, the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.
the documentation referred to in the second indent of 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, the last paragraph of 3.4, and in 4.3 and 4.4.
Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.
The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:
a general description of the 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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports.
The application must include:
all relevant information on the pressure equipment concerned,
the documentation concerning the quality system.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,
the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,
the examinations and tests to be carried out after manufacture,
the means of monitoring the effective operation of the quality system,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I.
The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.
The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
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.
the category of the equipment,
the results of previous surveillance visits,
the need to follow up corrective action,
special conditions linked to the approval of the system, where applicable,
significant changes in manufacturing organization, policy or techniques.
During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.
the technical documentation referred to in section 2,
the documentation referred to in the second indent of 4.1,
the adjustments referred to in the second paragraph of 4.4,
the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4 and in 5.3 and 5.4.
Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.
in the EC type-examination certificate, or
in the EC design-examination certificate
and satisfies the requirements of the Directive which apply to it.
in the EC type-examination certificate, or
in the EC design-examination certificate
and with the requirements of the Directive which apply to it.
The manufacturer, or his authorized representative established within the Community, must affix the CE marking to all pressure equipment and draw up a declaration of conformity.
The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured.
In particular, the notified body must:
verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I,
verify the certificate issued by the materials manufacturer in accordance with section 4.3 of Annex I,
carry out or have carried out the final inspection and proof test referred to in section 3.2 of Annex I and examine the safety devices, if applicable.
The application must contain:
the name and address of the manufacturer and the location of the pressure equipment,
a written declaration to the effect that a similar application has not been lodged with another notified body,
technical documentation.
The technical documentation must contain:
a general description of the 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 pressure equipment,
a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,
results of design calculations made, examinations carried out, etc.,
test reports,
appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with sections 3.1.2 and 3.1.3 of Annex I.
In particular the notified body must:
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 harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,
approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with section 3.1.2 of Annex I,
verify the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I,
carry out the final inspection referred to in section 3.2.1 of Annex I, perform or have performed the proof test referred to in section 3.2.2 of Annex I, and examine the safety devices, if applicable.
The application must include:
all relevant information concerning the pressure equipment in question,
the documentation concerning the quality system.
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 procedural and quality measures such as programmes, plans, manuals and records.
It must contain in particular an adequate description of:
the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the design and to product quality,
the technical design specifications, including standards, that will be applied and, where the standards referred to in Article 5 are not applied in full, the means that will be used to ensure that the essential requirements of the Directive which apply to the pressure equipment will be met,
the design control and design verification techniques, processes and systematic measures that will be used when designing the pressure equipment, particularly with regard to materials in accordance with section 4 of Annex I,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,
the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,
the means of monitoring the achievement of the required pressure equipment design and quality and the effective operation of the quality system.
The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.
The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.
The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.
The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.
It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.
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 personnel concerned, etc.
the category of the equipment,
the results of previous surveillance visits,
the need to follow up corrective action,
special conditions linked to the approval of the system, where applicable,
significant changes in manufacturing organization, policy or techniques.
During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.
the documentation referred to in the second indent of the second subparagraph of 3.1;
the adjustments referred to in the second subparagraph of 3.4;
the decisions and reports from the notified body which are referred to in the last subparagraph of 3.3, the last subparagraph of 3.4, and in 4.3 and 4.4.
Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.
the manufacturer must lodge an application for examination of the design with the notified body;
the application must enable the design, manufacture and operation of the pressure equipment to be understood, and enable conformity with the relevant requirements of the Directive to be assessed.
It must include:
the technical design specifications, including standards, which have been applied,
the necessary supporting evidence for their adequacy, in particular where the standards referred to in Article 5 have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;
the notified body must examine the application and where the design meets the provisions of the Directive which apply to it 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 pressure equipment or accessories;
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 essential requirements of the Directive or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate;
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.
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