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Directive 2014/68/EU of the European Parliament and of the CouncilDangos y teitl llawn

Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance)

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  1. Introductory Text

  2. CHAPTER 1 GENERAL PROVISIONS

    1. Article 1.Scope

    2. Article 2.Definitions

    3. Article 3.Making available on the market and putting into service

    4. Article 4.Technical requirements

    5. Article 5.Free movement

  3. CHAPTER 2 OBLIGATIONS OF ECONOMIC OPERATORS

    1. Article 6.Obligations of manufacturers

    2. Article 7.Authorised representatives

    3. Article 8.Obligations of importers

    4. Article 9.Obligations of distributors

    5. Article 10.Cases in which obligations of manufacturers apply to importers and distributors

    6. Article 11.Identification of economic operators

  4. CHAPTER 3 CONFORMITY AND CLASSIFICATION OF PRESSURE EQUIPMENT AND ASSEMBLIES

    1. Article 12.Presumption of conformity

    2. Article 13.Classification of pressure equipment

    3. Article 14.Conformity assessment procedures

    4. Article 15.European approval for materials

    5. Article 16.User inspectorates

    6. Article 17.EU declaration of conformity

    7. Article 18.General principles of the CE marking

    8. Article 19.Rules and conditions for affixing the CE marking

  5. CHAPTER 4 NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

    1. Article 20.Notification

    2. Article 21.Notifying authorities

    3. Article 22.Requirements relating to notifying authorities

    4. Article 23.Information obligation on notifying authorities

    5. Article 24.Requirements relating to notified bodies and recognised third-party organisations

    6. Article 25.Requirements relating to user inspectorates

    7. Article 26.Presumption of conformity of conformity assessment bodies

    8. Article 27.Subsidiaries of and subcontracting by conformity assessment bodies

    9. Article 28.Application for notification

    10. Article 29.Notification procedure

    11. Article 30.Identification numbers and lists of notified bodies

    12. Article 31.Lists of recognised third-party organisations and user inspectorates

    13. Article 32.Changes to notifications

    14. Article 33.Challenge of the competence of notified bodies, recognised third party organisations and user inspectorates

    15. Article 34.Operational obligations of notified bodies, user inspectorates and recognised third party organisations

    16. Article 35.Appeal against decisions of notified bodies, recognised third party organisations and user inspectorates

    17. Article 36.Information obligation on notified bodies, recognised third party organisations and user inspectorates

    18. Article 37.Exchange of experience

    19. Article 38.Coordination of notified bodies, recognised third-party organisations and user inspectorates

  6. CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF PRESSURE EQUIPMENT AND ASSEMBLIES ENTERING THE UNION MARKET, AND UNION SAFEGUARD PROCEDURE

    1. Article 39.Union market surveillance and control of pressure equipment and assemblies entering the Union market

    2. Article 40.Procedure for dealing with pressure equipment or assemblies presenting a risk at national level

    3. Article 41.Union safeguard procedure

    4. Article 42.Compliant pressure equipment or assemblies which present a risk

    5. Article 43.Formal non-compliance

  7. CHAPTER 6 COMMITTEE PROCEDURE AND DELEGATED ACTS

    1. Article 44.Committee procedure

    2. Article 45.Delegated power

    3. Article 46.Exercise of the delegation

  8. CHAPTER 7 TRANSITIONAL AND FINAL PROVISIONS

    1. Article 47.Penalties

    2. Article 48.Transitional provisions

    3. Article 49.Transposition

    4. Article 50.Repeal

    5. Article 51.Entry into force and application

    6. Article 52.Addressees

  9. Signature

    1. ANNEX I

      ESSENTIAL SAFETY REQUIREMENTS

      1. PRELIMINARY OBSERVATIONS

        1. 1. The obligations arising from the essential safety requirements listed in...

        2. 2. The essential safety requirements laid down in this Directive are...

        3. 3. The manufacturer is under an obligation to analyse the hazards...

        4. 4. The essential safety requirements are to be interpreted and applied...

        5. 1. GENERAL

          1. 1.1. Pressure equipment shall be designed, manufactured and checked, and if...

          2. 1.2. In choosing the most appropriate solutions, the manufacturer shall apply...

          3. 1.3. Where the potential for misuse is known or can be...

        6. 2. DESIGN

          1. 2.1. General

          2. 2.2. Design for adequate strength

            1. 2.2.1. The pressure equipment shall be designed for loadings appropriate to...

            2. 2.2.2. Design for adequate strength shall be based on either of...

            3. 2.2.3. Calculation method

              1. (a) Pressure containment and other loading aspects

              2. (b) Resistance

              3. (c) Stability aspects

            4. 2.2.4. Experimental design method

          3. 2.3. Provisions to ensure safe handling and operation

          4. 2.4. Means of examination

            1. (a) Pressure equipment shall be designed and constructed so that all...

            2. (b) Means of determining the internal condition of the equipment shall...

            3. (c) Other means of ensuring the safe condition of the pressure...

          5. 2.5. Means of draining and venting

          6. 2.6. Corrosion or other chemical attack

          7. 2.7. Wear

          8. 2.8. Assemblies

          9. 2.9. Provisions for filling and discharge

          10. 2.10. Protection against exceeding the allowable limits of pressure equipment

          11. 2.11. Safety accessories

            1. 2.11.1. Safety accessories shall:

            2. 2.11.2. Pressure limiting devices

            3. 2.11.3. Temperature monitoring devices

          12. 2.12. External fire

        7. 3. MANUFACTURING

          1. 3.1. Manufacturing procedures

            1. 3.1.1. Preparation of the component parts

            2. 3.1.2. Permanent joining

            3. 3.1.3. Non-destructive tests

            4. 3.1.4. Heat treatment

            5. 3.1.5. Traceability

          2. 3.2. Final assessment

            1. 3.2.1. Final inspection

            2. 3.2.2. Proof test

            3. 3.2.3. Inspection of safety devices

          3. 3.3. Marking and labelling

          4. 3.4. Operating instructions

            1. (a) When pressure equipment is made available on the market, it...

            2. (b) Instructions shall cover information affixed to the pressure equipment in...

            3. (c) If appropriate, these instructions shall also refer to risks arising...

        8. 4. MATERIALS

          1. 4.1. Materials for pressurised parts shall:

          2. 4.2. The pressure equipment manufacturer shall:

          3. 4.3. The equipment manufacturer shall take appropriate measures to ensure that...

      2. SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS

        1. 5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF...

        2. 6. PIPING AS REFERRED TO IN ARTICLE 4(1)(c)

        3. 7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT

          1. 7.1. Allowable stresses

            1. 7.1.1. Symbols

            2. 7.1.2. The permissible general membrane stress for predominantly static loads and...

          2. 7.2. Joint coefficients

          3. 7.3. Pressure limiting devices, particularly for pressure vessels

          4. 7.4. Hydrostatic test pressure

          5. 7.5. Material characteristics

    2. ANNEX II

      CONFORMITY ASSESSMENT TABLES

      1. 1. The references in the tables to categories of modules are...

      2. 2. The safety accessories defined in point 4 of Article 2,...

      3. 3. The pressure accessories defined in point 5 of Article 2,...

      4. 4. The demarcation lines in the following conformity assessment tables indicate...

    3. ANNEX III

      CONFORMITY ASSESSMENT PROCEDURES

      1. The obligations arising from the provisions on pressure equipment in...

      2. 1. MODULE A: (INTERNAL PRODUCTION CONTROL)

        1. 1. Internal production control is the conformity assessment procedure whereby the...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. CE marking and EU declaration of conformity

          1. 4.1. The manufacturer shall affix the CE marking to each individual...

          2. 4.2. The manufacturer shall draw up a written EU declaration of...

        5. 5. Authorised representative

      3. 2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS...

        1. 1. Internal production control plus supervised pressure equipment checks at random...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Final assessment and pressure equipment checks

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking to each individual...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. Authorised representative

      4. 3. MODULE B: EU-TYPE EXAMINATION

        1. 3.1. EU-Type examination – production type

          1. 1. EU-type examination — production type is the part of a...

          2. 2. EU-type examination — production type shall consist of an assessment...

          3. 3. The manufacturer shall lodge an application for EU-type examination with...

          4. 4. The notified body shall:

          5. 5. The notified body shall draw up an evaluation report that...

          6. 6. Where the type meets the requirements of this Directive, the...

          7. 7. The notified body shall keep itself apprised of any changes...

          8. 8. Each notified body shall inform its notifying authority concerning the...

          9. 9. The manufacturer shall keep a copy of the EU-type examination...

          10. 10. The manufacturer’s authorised representative may lodge the application referred to...

        2. 3.2. EU-Type examination – design type

          1. 1. EU-type examination – design type is the part of a...

          2. 2. The EU-type examination – design type shall consist of an...

          3. 3. The manufacturer shall lodge an application for EU-type examination —...

          4. 4. The notified body shall:

          5. 5. The notified body shall draw up an evaluation report that...

          6. 6. Where the design meets the requirements of this Directive, the...

          7. 7. The notified body shall keep itself apprised of any changes...

          8. 8. Each notified body shall inform its notifying authorities concerning the...

          9. 9. The manufacturer shall keep a copy of the EU-type examination...

          10. 10. The manufacturer’s authorised representative may lodge the application referred to...

      5. 4. MODULE C2: CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL...

        1. 1. Conformity to type based on internal production control plus supervised...

        2. 2. Manufacturing

        3. 3. Final assessment and pressure equipment checks

        4. 4. CE marking and EU declaration of conformity

          1. 4.1. The manufacturer shall affix the CE marking to each individual...

          2. 4.2. The manufacturer shall draw up a written EU declaration of...

        5. 5. Authorised representative

      6. 5. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF...

        1. 1. Conformity to type based on quality assurance of the production...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of his...

          2. 3.2. The quality system shall ensure that the pressure equipment is...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

        4. 4. Surveillance under the responsibility of the notified body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 4.3. The notified body shall carry out periodic audits to make...

          4. 4.4. In addition the notified body may pay unexpected visits to...

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking and, under the...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. The manufacturer shall, for a period ending 10 years after...

        7. 7. Each notified body shall inform its notifying authorities of the...

        8. 8. Authorised representative

      7. 6. MODULE D1: QUALITY ASSURANCE OF THE PRODUCTION PROCESS

        1. 1. Quality assurance of the production process is the conformity assessment...

        2. 2. Technical documentation

        3. 3. The manufacturer shall keep the technical documentation at the disposal...

        4. 4. Manufacturing

        5. 5. Quality system

          1. 5.1. The manufacturer shall lodge an application for assessment of his...

          2. 5.2. The quality system shall ensure compliance of the pressure equipment...

          3. 5.3. The notified body shall assess the quality system to determine...

          4. 5.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 5.5. The manufacturer shall keep the notified body that has approved...

        6. 6. Surveillance under the responsibility of the notified body

          1. 6.1. The purpose of surveillance is to make sure that the...

          2. 6.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 6.3. The notified body shall carry out periodic audits to make...

          4. 6.4. In addition the notified body may pay unexpected visits to...

        7. 7. CE marking and EU declaration of conformity

          1. 7.1. The manufacturer shall affix the CE marking and, under the...

          2. 7.2. The manufacturer shall draw up a written EU declaration of...

        8. 8. The manufacturer shall, for a period ending 10 years after...

        9. 9. Each notified body shall inform its notifying authorities of the...

        10. 10. Authorised representative

      8. 7. MODULE E: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT QUALITY...

        1. 1. Conformity to type based on pressure equipment quality assurance is...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of his...

          2. 3.2. The quality system shall ensure compliance of the products with...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

        4. 4. Surveillance under the responsibility of the notified body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 4.3. The notified body shall carry out periodic audits to make...

          4. 4.4. In addition the notified body may pay unexpected visits to...

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking and, under the...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. The manufacturer shall, for a period ending 10 years after...

        7. 7. Each notified body shall inform its notifying authorities of quality...

        8. 8. Authorised representative

      9. 8. MODULE E1: QUALITY ASSURANCE OF FINAL PRESSURE EQUIPMENT INSPECTION AND...

        1. 1. Quality assurance of final pressure equipment inspection and testing is...

        2. 2. Technical documentation

        3. 3. The manufacturer shall keep the technical documentation at the disposal...

        4. 4. Manufacturing

        5. 5. Quality system

          1. 5.1. The manufacturer shall lodge an application for assessment of his...

          2. 5.2. The quality system shall ensure compliance of the pressure equipment...

          3. 5.3. The notified body shall assess the quality system to determine...

          4. 5.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 5.5. The manufacturer shall keep the notified body that has approved...

        6. 6. Surveillance under the responsibility of the notified body

          1. 6.1. The purpose of surveillance is to make sure that the...

          2. 6.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 6.3. The notified body shall carry out periodic audits to make...

          4. 6.4. In addition the notified body may pay unexpected visits to...

        7. 7. CE marking and EU declaration of conformity

          1. 7.1. The manufacturer shall affix the CE marking and, under the...

          2. 7.2. The manufacturer shall draw up a written EU declaration of...

        8. 8. The manufacturer shall, for a period ending 10 years after...

        9. 9. Each notified body shall inform its notifying authorities of quality...

        10. 10. Authorised representative

      10. 9. MODULE F: CONFORMITY TO TYPE BASED ON PRESSURE EQUIPMENT VERIFICATION...

        1. 1. Conformity to type based on pressure equipment verification is the...

        2. 2. Manufacturing

        3. 3. Verification

        4. 4. Verification of conformity by examination and testing of every item...

          1. 4.1. All pressure equipment shall be individually examined and appropriate tests...

          2. 4.2. The notified body shall issue a certificate of conformity in...

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking and, under the...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. If the notified body agrees and under its responsibility, the...

        7. 7. Authorised representative

      11. 10. MODULE G: CONFORMITY BASED ON UNIT VERIFICATION

        1. 1. Conformity based on unit verification is the conformity assessment procedure...

        2. 2. Technical documentation

        3. 3. Manufacturing

        4. 4. Verification

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking and, under the...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. Authorised representative

      12. 11. MODULE H: CONFORMITY BASED ON FULL QUALITY ASSURANCE

        1. 1. Conformity based on full quality assurance is the conformity assessment...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of his...

          2. 3.2. The quality system shall ensure compliance of the pressure equipment...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

        4. 4. Surveillance under the responsibility of the notified body

          1. 4.1. The purpose of surveillance is to make sure that the...

          2. 4.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 4.3. The notified body shall carry out periodic audits to make...

          4. 4.4. In addition, the notified body may pay unexpected visits to...

        5. 5. CE marking and EU declaration of conformity

          1. 5.1. The manufacturer shall affix the CE marking and, under the...

          2. 5.2. The manufacturer shall draw up a written EU declaration of...

        6. 6. The manufacturer shall, for a period ending 10 years after...

        7. 7. Each notified body shall inform its notifying authorities of quality...

        8. 8. Authorised representative

      13. 12. MODULE H1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN...

        1. 1. Conformity based on full quality assurance plus design examination and...

        2. 2. Manufacturing

        3. 3. Quality system

          1. 3.1. The manufacturer shall lodge an application for assessment of his...

          2. 3.2. The quality system shall ensure compliance of the pressure equipment...

          3. 3.3. The notified body shall assess the quality system to determine...

          4. 3.4. The manufacturer shall undertake to fulfil the obligations arising out...

          5. 3.5. The manufacturer shall keep the notified body that has approved...

          6. 3.6. Each notified body shall inform its notifying authorities of quality...

        4. 4. Design examination

          1. 4.1. The manufacturer shall lodge an application for examination of the...

          2. 4.2. The application shall make it possible to understand the design,...

          3. 4.3. The notified body shall examine the application, and where the...

          4. 4.4. The notified body shall keep itself apprised of any changes...

          5. 4.5. Each notified body shall inform its notifying authorities of the...

          6. 4.6. The manufacturer shall keep a copy of the EU design...

        5. 5. Surveillance under the responsibility of the notified body

          1. 5.1. The purpose of surveillance is to make sure that the...

          2. 5.2. The manufacturer shall, for assessment purposes, allow the notified body...

          3. 5.3. The notified body shall carry out periodic audits to make...

          4. 5.4. In addition, the notified body may pay unexpected visits to...

          5. 5.5. Special surveillance of the final assessment

        6. 6. CE marking and EU declaration of conformity

          1. 6.1. The manufacturer shall affix the CE marking and, under the...

          2. 6.2. The manufacturer shall draw up a written EU declaration of...

        7. 7. The manufacturer shall, for a period ending 10 years after...

        8. 8. Authorised representative

    4. ANNEX IV

      EU DECLARATION OF CONFORMITY (No XXXX)

      1. 1. Pressure equipment or assembly (product, type, batch or serial number):...

      2. 2. Name and address of the manufacturer and, where applicable, his...

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

      4. 4. Object of the declaration (identification of pressure equipment or assembly...

      5. 5. The object of the declaration described above is in conformity...

      6. 6. References to the relevant harmonised standards used or references to...

      7. 7. Where appropriate, the name, address and number of the notified...

      8. 8. Additional information:

    5. ANNEX V

    6. ANNEX VI

  10. ATTACHMENTS

    1. STATEMENT OF THE EUROPEAN PARLIAMENT

Yn ôl i’r brig

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