LegalizeThe Supply of Machinery (Safety) Regulations 2008
PART 2 — Annex II: Declarations
| 1. | CONTENT | CONTENT |
|---|---|---|
| A. | EC DECLARATION OF CONFORMITY OF THE MACHINERY | EC DECLARATION OF CONFORMITY OF THE MACHINERY |
| This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters. | This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters. | |
| This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user. | This declaration relates exclusively to the machinery in the state in which it was placed on the market, and excludes components which are added and/or operations carried out subsequently by the final user. | |
| The EC declaration of conformity must contain the following particulars: | The EC declaration of conformity must contain the following particulars: | |
| 1. | business name and full address of the manufacturer and, where appropriate, the manufacturer's authorised representative; | |
| 2. | name and address of the person authorised to compile the technical file , who must be established in a relevant state; | |
| 3. | description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name; | |
| 4. | a sentence expressly declaring that the machinery fulfils all the relevant provisions of the Directive these Regulations and where appropriate, a similar sentence declaring the conformity with other Directives and/or enactments or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union; | |
| 5. | where appropriate, the name, address and identification number of the notified approved body which carried out the EC type- Type- examination referred to in Annex IX (Part 9 of this Schedule) and the number of the EC type- Type- examination certificate; | |
| 6. | where appropriate, the name, address and identification number of the notified approved body which approved the full quality assurance system referred to in Annex X (Part 10 of this Schedule); | |
| 7. | where appropriate, a reference to the published harmonised designated standards used; | |
| 8. | where appropriate, the reference to other technical standards and specifications used; | |
| 9. | the place and date of the declaration; | |
| 10. | the identity and signature of the person empowered to draw up the declaration on behalf of the responsible person. | |
| B. | DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY | DECLARATION OF INCORPORATION OF PARTLY COMPLETED MACHINERY |
| This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters. | This declaration and translations thereof must be drawn up under the same conditions as the instructions (see Annex I (Part 1 of this Schedule), section 1.7.4.1(a) and (b)), and must be typewritten or else handwritten in capital letters. | |
| The declaration of incorporation must contain the following particulars: | The declaration of incorporation must contain the following particulars: | |
| 1. | business name and full address of the manufacturer of the partly completed machinery and, where appropriate, the manufacturer's authorised representative; | |
| 2. | name and address of the person authorised to compile the relevant technical documentation , who must be established in a relevant state; | |
| 3. | description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name; | |
| 4. | a sentence declaring which essential health and safety requirements are applied and fulfilled and that the relevant technical documentation is compiled in accordance with Annex VII (Part 7 of this Schedule), part B, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives enactments. These references must be those of the texts published in the Official Journal of the European Union; | |
| 5. | an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery; | |
| 6. | a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of the Directive these Regulations, where appropriate; | |
| 7. | the place and date of the declaration; | |
| 8. | the identity and signature of the person empowered to draw up the declaration on behalf of the responsible person. | |
| 2. | CUSTODY | CUSTODY |
| The manufacturer of machinery or the manufacturer's authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery. | The manufacturer of machinery or the manufacturer's authorised representative shall keep the original EC declaration of conformity for a period of at least 10 years from the last date of manufacture of the machinery. | |
| The manufacturer of partly completed machinery or the manufacturer's authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery. | The manufacturer of partly completed machinery or the manufacturer's authorised representative shall keep the original declaration of incorporation for a period of at least 10 years from the last date of manufacture of the partly completed machinery. |
PART 3 — Annex III: CE marking Annex III UK marking
The CE conformity marking shall consist of the initials “CE” taking the following form:
If the CE marking is reduced or enlarged the proportions shown in the above drawing must be respected.
The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm. The minimum dimension may be waived for small-scale machinery.
The CE marking must be affixed in the immediate vicinity of the name of the responsible person, using the same technique.
Where the full quality assurance procedure prescribed in Annex X (Part 10 of this Schedule) has been applied, the CE marking must be followed by the identification number of the notified body.
PART 4 — Annex IV: Categories of machinery to which one of the procedures referred to in regulation 11 or 12 must be applied
| 1. | Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types: |
|---|---|
| 1.1. | sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed; |
| 1.2. | sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage; |
| 1.3. | sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading; |
| 1.4. | sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading. |
| 2. | Hand-fed surface planing machinery for woodworking. |
| 3. | Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking. |
| 4. | Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types: |
| 4.1. | sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece; |
| 4.2. | sawing machinery with blade(s) assembled on a carriage with reciprocating motion. |
| 5. | Combined machinery of the types referred to in points 1 to 4 and point 7 of this Annex, for working with wood and material with similar physical characteristics. |
| 6. | Hand-fed tenoning machinery with several tool holders for woodworking. |
| 7. | Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics. |
| 8. | Portable chainsaws for woodworking. |
| 9. | Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s. |
| 10. | Injection or compression plastics-moulding machinery with manual loading or unloading. |
| 11. | Injection or compression rubber-moulding machinery with manual loading or unloading. |
| 12. | Machinery for underground working of the following types: |
| 12.1. | locomotives and brake-vans; |
| 12.2. | hydraulic-powered roof supports. |
| 13. | Manually loaded trucks for the collection of household refuse incorporating a compression mechanism. |
| 14. | Removable mechanical transmission devices including their guards. |
| 15. | Guards for removable mechanical transmission devices. |
| 16. | Vehicle servicing lifts. |
| 17. | Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres. |
| 18. | Portable cartridge-operated fixing and other impact machinery. |
| 19. | Protective devices designed to detect the presence of persons. |
| 20. | Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this Annex. |
| 21. | Logic units to ensure safety functions. |
| 22. | Roll-over protective structures (ROPS). |
| 23. | Falling-object protective structures (FOPS). |
PART 5 — Annex V: Indicative list of safety components
| 1. | Guards for removable mechanical transmission devices. | Guards for removable mechanical transmission devices. | Guards for removable mechanical transmission devices. |
|---|---|---|---|
| 2. | Protective devices designed to detect the presence of persons. | Protective devices designed to detect the presence of persons. | Protective devices designed to detect the presence of persons. |
| 3. | Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in Annex IV (Part 4 of this Schedule), points 9, 10 and 11. | Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in Annex IV (Part 4 of this Schedule), points 9, 10 and 11. | Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in Annex IV (Part 4 of this Schedule), points 9, 10 and 11. |
| 4. | Logic units to ensure safety functions. | Logic units to ensure safety functions. | Logic units to ensure safety functions. |
| 5. | Valves with additional means for failure detection intended for the control of dangerous movements on machinery. | Valves with additional means for failure detection intended for the control of dangerous movements on machinery. | Valves with additional means for failure detection intended for the control of dangerous movements on machinery. |
| 6. | Extraction systems for machinery emissions. | Extraction systems for machinery emissions. | Extraction systems for machinery emissions. |
| 7. | Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery. | Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery. | Guards and protective devices designed to protect persons against moving parts involved in the process on the machinery. |
| 8. | Monitoring devices for loading and movement control in lifting machinery. | Monitoring devices for loading and movement control in lifting machinery. | Monitoring devices for loading and movement control in lifting machinery. |
| 9. | Restraint systems to keep persons on their seats. | Restraint systems to keep persons on their seats. | Restraint systems to keep persons on their seats. |
| 10. | Emergency stop devices. | Emergency stop devices. | Emergency stop devices. |
| 11. | Discharging systems to prevent the build-up of potentially dangerous electrostatic charges. | Discharging systems to prevent the build-up of potentially dangerous electrostatic charges. | Discharging systems to prevent the build-up of potentially dangerous electrostatic charges. |
| 12. | Energy limiters and relief devices referred to in Annex I (Part 1 of this Schedule), sections 1.5.7, 3.4.7 and 4.1.2.6. | Energy limiters and relief devices referred to in Annex I (Part 1 of this Schedule), sections 1.5.7, 3.4.7 and 4.1.2.6. | Energy limiters and relief devices referred to in Annex I (Part 1 of this Schedule), sections 1.5.7, 3.4.7 and 4.1.2.6. |
| 13. | Systems and devices to reduce the emission of noise and vibrations. | Systems and devices to reduce the emission of noise and vibrations. | Systems and devices to reduce the emission of noise and vibrations. |
| 14. | Roll-over protective structures (ROPS). | Roll-over protective structures (ROPS). | Roll-over protective structures (ROPS). |
| 15. | Falling-object protective structures (FOPS). | Falling-object protective structures (FOPS). | Falling-object protective structures (FOPS). |
| 16. | Two-hand control devices. | Two-hand control devices. | Two-hand control devices. |
| 17. | Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list: | Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list: | Components for machinery designed for lifting and/or lowering persons between different landings and included in the following list: |
| (a) | (a) | devices for locking landing doors; | devices for locking landing doors; |
| (b) | (b) | devices to prevent the load-carrying unit from falling or unchecked upwards movement; | devices to prevent the load-carrying unit from falling or unchecked upwards movement; |
| (c) | (c) | overspeed limitation devices; | overspeed limitation devices; |
| (d) | (d) | energy-accumulating shock absorbers, | energy-accumulating shock absorbers, |
| non-linear, or | |||
| with damping of the return movement; | |||
| (e) | (e) | energy-dissipating shock absorbers; | energy-dissipating shock absorbers; |
| (f) | (f) | safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls; | safety devices fitted to jacks of hydraulic power circuits where these are used as devices to prevent falls; |
| (g) | (g) | electric safety devices in the form of safety switches containing electronic components. | electric safety devices in the form of safety switches containing electronic components. |
PART 6 — Annex VI: Assembly instructions for partly completed machinery
The assembly instructions for partly completed machinery must contain a description of the conditions which must be met with a view to correct incorporation in the final machinery, so as not to compromise safety and health.
The assembly instructions must be written in an official Community language acceptable to the manufacturer of the machinery in which the partly completed machinery will be assembled, or to the manufacturer’s authorised representative.
PART 7 — Annex VII: Technical files
| A. | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery | Technical file for machinery |
|---|---|---|---|---|---|---|---|---|---|---|
| This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | This part describes the procedure for compiling a technical file. The technical file must demonstrate that the machinery complies with the provisions of the Directive these Regulations. It must cover the design, manufacture and operation of the machinery to the extent necessary for this assessment. The technical file must be compiled in one or more official Community languages English, except for the instructions for the machinery, for which the special provisions of Annex I (Part 1 of this Schedule), section 1.7.4.1 apply. | |
| 1. | 1. | 1. | The technical file shall comprise the following: | The technical file shall comprise the following: | The technical file shall comprise the following: | The technical file shall comprise the following: | The technical file shall comprise the following: | The technical file shall comprise the following: | The technical file shall comprise the following: | |
| (a) | (a) | (a) | (a) | (a) | (a) | (a) | a construction file including: | a construction file including: | a construction file including: | a construction file including: |
| a general description of the machinery, | a general description of the machinery, | a general description of the machinery, | ||||||||
| the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery, | the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery, | the overall drawing of the machinery and drawings of the control circuits, as well as the pertinent descriptions and explanations necessary for understanding the operation of the machinery, | ||||||||
| full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the machinery with the essential health and safety requirements, | ||||||||
| the documentation on risk assessment demonstrating the procedure followed, including: | the documentation on risk assessment demonstrating the procedure followed, including: | the documentation on risk assessment demonstrating the procedure followed, including: | ||||||||
| (i) | (i) | (i) | (i) | (i) | (i) | (i) | (i) | (i) | (i) | a list of the essential health and safety requirements which apply to the machinery, |
| (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, when appropriate, the indication of the residual risks associated with the machinery, |
| the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, | the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, | the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, | ||||||||
| any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person, | any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person, | any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person, | ||||||||
| a copy of the instructions for the machinery, | a copy of the instructions for the machinery, | a copy of the instructions for the machinery, | ||||||||
| where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery, | where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery, | where appropriate, the declaration of incorporation for included partly completed machinery and the relevant assembly instructions for such machinery, | ||||||||
| where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery, | where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery, | where appropriate, copies of the EC declaration of conformity of machinery or other products incorporated into the machinery, | ||||||||
| a copy of the EC declaration of conformity; | a copy of the EC declaration of conformity; | a copy of the EC declaration of conformity; | ||||||||
| (b) | (b) | (b) | (b) | (b) | (b) | (b) | for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive these Regulations. | for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive these Regulations. | for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive these Regulations. | for series manufacture, the internal measures that will be implemented to ensure that the machinery remains in conformity with the provisions of the Directive these Regulations. |
| The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the completed machinery to determine whether by its design or construction it is capable of being assembled and put into service safely. The relevant reports and results shall be included in the technical file. | ||||
| 2. | 2. | 2. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | The technical file referred to in point 1 of this Annex must be made available to the enforcement authorities and the competent authorities of any other relevant state for at least 10 years following the date of manufacture of the machinery or, in the case of series manufacture, of the last unit produced. | |
| The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | The technical file does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. However, it must be capable of being assembled and made available within a period of time commensurate with its complexity by the person designated in the EC declaration of conformity. | ||||
| The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | The technical file does not have to include detailed plans or any other specific information as regards the sub-assemblies used for the manufacture of the machinery unless a knowledge of them is essential for verification of conformity with the essential health and safety requirements. | ||||
| 3. | 3. | 3. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | Failure to present the technical file in response to a duly reasoned request by the competent national authorities enforcement authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements. | |
| B. | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery | Relevant technical documentation for partly completed machinery |
| This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | This part describes the procedure for compiling relevant technical documentation. The documentation must show which provisions of the Directive these Regulations are applied and fulfilled. It must cover the design, manufacture and operation of the partly completed machinery to the extent necessary for the assessment of conformity with the essential health and safety requirements applied. The documentation must be compiled in one or more official Community languages English. | |
| Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | Relevant technical documentation shall comprise the following: | |
| (a) | (a) | (a) | a construction file including: | a construction file including: | a construction file including: | a construction file including: | a construction file including: | a construction file including: | a construction file including: | a construction file including: |
| the overall drawing of the partly completed machinery and drawings of the control circuits, | the overall drawing of the partly completed machinery and drawings of the control circuits, | the overall drawing of the partly completed machinery and drawings of the control circuits, | the overall drawing of the partly completed machinery and drawings of the control circuits, | the overall drawing of the partly completed machinery and drawings of the control circuits, | ||||||
| full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | full detailed drawings, accompanied by any calculation notes, test results, certificates, etc., required to check the conformity of the partly completed machinery with the applied essential health and safety requirements, | |||||
| the risk assessment documentation showing the procedure followed, including: | the risk assessment documentation showing the procedure followed, including: | the risk assessment documentation showing the procedure followed, including: | the risk assessment documentation showing the procedure followed, including: | the risk assessment documentation showing the procedure followed, including: | ||||||
| (i) | (i) | (i) | (i) | (i) | (i) | (i) | (i) | (i) | a list of the essential health and safety requirements applied and fulfilled, | a list of the essential health and safety requirements applied and fulfilled, |
| (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | (ii) | the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks, | the description of the protective measures implemented to eliminate identified hazards or to reduce risks and, where appropriate, the indication of the residual risks, |
| (iii) | (iii) | (iii) | (iii) | (iii) | (iii) | (iii) | (iii) | (iii) | the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, | the standards and other technical specifications used, indicating the essential health and safety requirements covered by these standards, |
| (iv) | (iv) | (iv) | (iv) | (iv) | (iv) | (iv) | (iv) | (iv) | any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person, | any technical report giving the results of the tests carried out either by the manufacturer or by a body chosen by the responsible person, |
| (v) | (v) | (v) | (v) | (v) | (v) | (v) | (v) | (v) | a copy of the assembly instructions for the partly completed machinery; | a copy of the assembly instructions for the partly completed machinery; |
| (b) | (b) | (b) | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. | for series manufacture, the internal measures that will be implemented to ensure that the partly completed machinery remains in conformity with the essential health and safety requirements applied. |
| The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | The manufacturer must carry out necessary research and tests on components, fittings or the partly completed machinery to determine whether by its design or construction it is capable of being assembled and used safely. The relevant reports and results shall be included in the technical file. | ||
| The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | The relevant technical documentation must be available for at least 10 years following the date of manufacture of the partly completed machinery or, in the case of series manufacture, of the last unit produced, and on request presented to an enforcement authority or a competent authority of any other relevant state. It does not have to be located in the territory of a relevant state United Kingdom, nor does it have to be permanently available in material form. It must be capable of being assembled and presented to the relevant authority by the person designated in the declaration for incorporation. | ||
| Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. | Failure to present the relevant technical documentation in response to a duly reasoned request by an enforcement authority or a competent authority of any other relevant state may constitute sufficient grounds for doubting the conformity of the partly completed machinery with the essential health and safety requirements applied and attested. |
PART 8 — Annex VIII: Assessment of conformity with internal checks on the manufacture of machinery
| 1. | This Annex describes the procedure by which the responsible person, who carries out the obligations laid down in points 2 and 3 of this Annex, ensures and declares that the machinery concerned satisfies the relevant provisions of the Directive these Regulations. |
|---|---|
| 2. | For each representative type of the series in question, the responsible person shall draw up the technical file referred to in Annex VII (Part 7 of this Schedule), part A. |
| 3. | The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured machinery with the technical file referred to in Annex VII, part A, and with the provisions of the Directive these Regulations. |
PART 9 — Annex IX: EC type- Type- examination
EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative model of machinery referred to in Annex IV (Part 4 of this Schedule) (hereafter named the type) satisfies the provisions of the Directive.
| 1. | The responsible person must, for each type, draw up the technical file referred to in Annex VII (Part 7 of this Schedule), part A. |
|---|---|
| 2. | For each type, the application for an EC type-examination shall be submitted by the responsible person to a notified body chosen by the responsible person. The application shall include: the name and address of the manufacturer and, where appropriate, the manufacturer’s authorised representative, a written declaration that the application has not been submitted to another notified body, the technical file. Moreover, the applicant shall place at the disposal of the notified body a sample of the type. The notified body may ask for further samples if the test programme so requires. |
| 3. | The notified body shall: |
| 3.1. | examine the technical file, check that the type was manufactured in accordance with it and establish which elements have been designed in accordance with the relevant provisions of published harmonised standards, and those elements whose design is not based on the relevant provisions of those standards; |
| 3.2. | carry out or have carried out appropriate inspections, measurements and tests to ascertain whether the solutions adopted satisfy the essential health and safety requirements, where published harmonised standards were not applied; |
| 3.3. | where published harmonised standards were used, carry out or have carried out appropriate inspections, measurements and tests to verify that those standards were actually applied; |
| 3.4. | agree with the applicant as to the place where the check that the type was manufactured in accordance with the examined technical file and the necessary inspections, measurements and tests will be carried out. |
| 4. | If the type satisfies the provisions of the Directive, the notified body shall issue the applicant with an EC type-examination certificate. The certificate shall include the name and address of the manufacturer and the manufacturer’s authorised representative, the data necessary for identifying the approved type, the conclusions of the examination and the conditions to which its issue may be subject. The manufacturer and the notified body shall retain a copy of this certificate, the technical file and all relevant documents for a period of 15 years from the date of issue of the certificate. |
| 5. | If the type does not satisfy the provisions of the Directive, the notified body shall refuse to issue the applicant with an EC type-examination certificate, giving detailed reasons for its refusal. It shall inform the applicant, the other notified bodies and the Member State which notified it. An appeal procedure must be available. |
| 6. | The applicant shall inform the notified body which retains the technical file relating to the EC type-examination certificate of all modifications to the approved type. The notified body shall examine these modifications and shall then either confirm the validity of the existing EC type-examination certificate or issue a new one if the modifications are liable to compromise conformity with the essential health and safety requirements or the intended working conditions of the type. |
| 7. | The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EC type-examination certificates. On reasoned request, the Commission and the Member States may obtain a copy of the technical file and the results of the examinations carried out by the notified body. |
| 8. | Files and correspondence referring to the EC type-examination procedures shall be written in the official language(s) of the EEA state where the notified body is established or in any other official Community language acceptable to the notified body. |
| 9. | Validity of the EC type-examination certificate |
| 9.1. | The notified body has the ongoing responsibility of ensuring that the EC type-examination certificate remains valid. It shall inform the manufacturer of any major changes which would have an implication on the validity of the certificate. The notified body shall withdraw certificates which are no longer valid. |
| 9.2. | The manufacturer of the machinery concerned has the ongoing responsibility of ensuring that the said machinery meets the corresponding state of the art. |
| 9.3. | The manufacturer shall request from the notified body the review of the validity of the EC type-examination certificate every five years. If the notified body finds that the certificate remains valid, taking into account the state of the art, it shall renew the certificate for a further five years. The manufacturer and the notified body shall retain a copy of this certificate, of the technical file and of all the relevant documents for a period of 15 years from the date of issue of the certificate. |
| 9.4. | In the event that the validity of the EC-type examination certificate is not renewed, the manufacturer shall cease the placing on the market of the machinery concerned. |
PART 10 — Annex X: Full quality assurance
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