The Noise Emission in the Environment by Equipment for use Outdoors Regulations 2001

Internal control of production with assessment of technical documentation and periodical checking U.K.

1.  This [F1 Schedule] describes the procedure whereby the manufacturer, or his authorised representative F2 ... who carries out the obligations laid down in points 2, 5 and 6 ensures and declares that the equipment concerned satisfies the requirements of [F3 these Regulations]. The manufacturer, or his authorised representative F2 ..., must affix the [F4 UK] marking of conformity and the indication of the guaranteed sound power level as required in [F5 regulation 7(2)(c), regulation 11 and Schedule 7] to each piece of equipment and draw up a written EC declaration of conformity as required in [F6 regulation 7(2)(d) and Schedule 5]. E+W+S

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Word in Sch. 9 para. 1 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(i) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Sch. 9 para. 1 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(ii) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(iii) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Sch. 9 para. 1 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(iii) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Sch. 9 para. 1 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(iv) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Sch. 9 para. 1 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(v) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Sch. 9 para. 1 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(a)(vi) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

1.  This Annex describes the procedure whereby the manufacturer, or his authorised representative established in the [F28 European Union] who carries out the obligations laid down in points 2, 5 and 6 ensures and declares that the equipment concerned satisfies the requirements of this Directive. The manufacturer, or his authorised representative established in the [F28 European Union], must affix the CE marking of conformity and the indication of the guaranteed sound power level as required in Article 11 to each piece of equipment and draw up a written EC declaration of conformity as required in Article 8. N.I.

Extent Information

E6 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F28 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2-68-10

2.  The manufacturer, or his authorised representative [F7 established in the [F8 European Union]], must draw up the technical documentation described in point 3 and he must keep it for a period ending at least 10 years after the last product has been manufactured at the disposal of the relevant national authorities for inspection purposes. The manufacturer, or his authorised representative [F7 established in the [F8 European Union]], may entrust another person to keep the technical documentation. In this case he has to include the name and address of this person in the [F9 EC] declaration of conformity. U.K.

Textual Amendments

F7 Words in Sch. 9 para. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(b)(i) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(iii) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2-6

F9 Word in Sch. 9 para. 2 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(b)(ii) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.  The technical documentation must enable the conformity of the equipment with the requirements of [F10 these Regulations] to be assessed. It must contain at least the following information: E+W+S

• — name and address of the manufacturer or his authorised representative F11 ...

• — a description of the equipment

• — make

• — trade name

• — type, series and numbers

• — the technical data relevant for the identification of the equipment and the assessment of its noise emission, including, if appropriate, schematic drawings and any description and explanation necessary for their understanding

• — the reference to [F10 these Regulations]

• — the technical report of noise measurements carried out in accordance with the provisions of [F10 these Regulations]

• — the technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F10 Words in Sch. 9 para. 3 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(c)(i) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Sch. 9 para. 3 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(c)(ii) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(iii) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.  The technical documentation must enable the conformity of the equipment with the requirements of this Directive to be assessed. It must contain at least the following information: N.I.

• — name and address of the manufacturer or his authorised representative established in the [F29 European Union]

• — a description of the equipment

• — make

• — trade name

• — type, series and numbers

• — the technical data relevant for the identification of the equipment and the assessment of its noise emission, including, if appropriate, schematic drawings and any description and explanation necessary for their understanding

• — the reference to this Directive

• — the technical report of noise measurements carried out in accordance with the provisions of this Directive

• — the technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.

Extent Information

E7 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F29 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2-68-10

4.  The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured equipment with the technical documentation referred to in points 2 and 3 and with the requirements of [F12 these Regulations]. E+W+S

Extent Information

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F12 Words in Sch. 9 para. 4 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(d) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

4.  The manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the manufactured equipment with the technical documentation referred to in points 2 and 3 and with the requirements of this Directive. N.I.

Extent Information

E8 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

5.  Evaluation by [F13 the approved] body prior to placing on the market E+W+S

• The manufacturer, or his authorised representative F14 ..., shall present a copy of his technical documentation to [F15 an approved] body of his choice before the first item of equipment is placed on the market or put into service.

• If there are doubts about the plausibility of the technical documentation, [F13 the approved] body shall inform accordingly the manufacturer or his authorised representative F14 ..., and, if need be, carry out, or have carried out modifications to the technical documentation, or possibly, tests deemed necessary.

• After [F13 the approved] body has issued a report confirming that the technical documentation satisfies the provisions of this Directive, the manufacturer or his authorised representative F16 ... may affix the [F17 UK] marking to the equipment and issue [F18 a] declaration of conformity in accordance with [F19 regulation 7(2)(c) and (d), regulation 11 and Schedules 5 and 7], for which he will bear complete responsibility.

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F13 Words in Sch. 9 para. 5 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(i) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F14 Words in Sch. 9 para. 5 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(iii) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(iii) and S.I. 2020/676, regs. 1(1)(2)); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Sch. 9 para. 5 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(ii) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Sch. 9 para. 5 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(iiia) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(h) and S.I. 2020/676, regs. 1(1)(2)); 2020 c. 1, Sch. 5 para. 1(1)

F17 Word in Sch. 9 para. 5 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(iv) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Sch. 9 para. 5 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(v) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Sch. 9 para. 5 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(e)(vi) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

5.  Evaluation by the notified body prior to placing on the market N.I.

• The manufacturer, or his authorised representative established in the [F30 European Union], shall present a copy of his technical documentation to a notified body of his choice before the first item of equipment is placed on the market or put into service.

• If there are doubts about the plausibility of the technical documentation, the notified body shall inform accordingly the manufacturer or his authorised representative established in the [F30 European Union], and, if need be, carry out, or have carried out modifications to the technical documentation, or possibly, tests deemed necessary.

• After the notified body has issued a report confirming that the technical documentation satisfies the provisions of this Directive, the manufacturer or his authorised representative established within the [F30 European Union] may affix the CE marking to the equipment and issue an EC declaration of conformity in accordance with Articles 11 and 8, for which he will bear complete responsibility.

Extent Information

E9 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F30 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2-68-10

6.  Evaluation by the [F20 approved] body during production E+W+S

• The manufacturer, or his authorised representative F21 ..., shall further involve the [F20 approved] body in the production phase according to one of the following procedures to be chosen by the manufacturer or his authorised representative F22 ...:

  • — the [F20 approved] body shall carry out periodical checks in order to verify continuing compliance of the manufactured equipment with the technical documentation and with the requirements of [F23 these Regulations]; in particular the [F20 approved] body shall concentrate on:

  • — the correct and complete marking of the equipment according to [F24 regulation 7(2)(c), regulation 11 and Schedule 7],

  • — issuing of the EC declaration of conformity according to [F25 regulation 7(2)(d) and Schedule 5],

  • — the technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.

• The manufacturer, or his authorised representative F21 ..., shall give the [F20 approved] body free access to all the internal documentation supporting these procedures, the actual results of the internal audits and the corrective actions which have been taken, if any.

• Only if the above checks give unsatisfactory results shall the [F20 approved] body carry out noise tests, which, on its own judgement and experience, may be simplified or completely carried out according to the provisions laid down in [F26 Schedule 6] for the relevant type of equipment,

  • — the [F20 approved] body shall carry out or have carried out product checks at random intervals. An adequate sample of the final equipment, chosen by the [F20 approved] body, must be examined and appropriate noise tests as set out in [F26 Schedule 6], or equivalent tests, must be carried out to check the conformity of the product with the relevant requirements of the Directive. The product checking must include the following aspects:

    • — the correct and complete marking of the equipment according to [F24 regulation 7(2)(c), regulation 11 and Schedule 7],

    • — issuing of the EC declaration of conformity according to [F25 regulation 7(2)(d) and Schedule 5].

• In both procedures, the frequency of the checks shall be defined by the [F20 approved] body according to the results of previous evaluations, the need to monitor corrective actions and further guidance for the frequency of the checks that may be given by the yearly production and the general reliability of the manufacturer to maintain the guaranteed values; however a check shall be carried out at least once every three years.

• If there are doubts about the plausibility of the technical documentation or the adherence during production, the [F20 approved] body shall inform accordingly the manufacturer, or his authorised representative F21 ....

• In those cases where equipment checked does not conform to the provisions of [F23 these Regulations], the [F20 approved] body must inform the [F27 Secretary of State].

Extent Information

E5 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F20 Word in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(i) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F21 Words in Sch. 9 para. 6 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(ii) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(iii) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Sch. 9 para. 6 omitted (E.W.S.) (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(iia) (with Sch. 8 para. 14) (as amended by S.I. 2019/1246, regs. 1(3), 10(c)(i) and S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(iii) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F24 Words in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(iv) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(v) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F26 Words in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(vi) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F27 Words in Sch. 9 para. 6 substituted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 8 para. 22(f)(vii) (with Sch. 8 para. 14) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

6.  Evaluation by the notified body during production N.I.

• The manufacturer, or his authorised representative established in the [F31 European Union], shall further involve the notified body in the production phase according to one of the following procedures to be chosen by the manufacturer or his authorised representative established within the [F31 European Union]:

  • — the notified body shall carry out periodical checks in order to verify continuing compliance of the manufactured equipment with the technical documentation and with the requirements of this Directive; in particular the notified body shall concentrate on:

  • — the correct and complete marking of the equipment according to Article 11,

  • — issuing of the EC declaration of conformity according to Article 8,

  • — the technical instruments applied and the results of the evaluation of the uncertainties due to production variation and their relation to the guaranteed sound power level.

• The manufacturer, or his authorised representative established in the [F31 European Union], shall give the notified body free access to all the internal documentation supporting these procedures, the actual results of the internal audits and the corrective actions which have been taken, if any.

• Only if the above checks give unsatisfactory results shall the notified body carry out noise tests, which, on its own judgement and experience, may be simplified or completely carried out according to the provisions laid down in Annex III for the relevant type of equipment,

  • — the notified body shall carry out or have carried out product checks at random intervals. An adequate sample of the final equipment, chosen by the notified body, must be examined and appropriate noise tests as set out in Annex III, or equivalent tests, must be carried out to check the conformity of the product with the relevant requirements of the Directive. The product checking must include the following aspects:

    • — the correct and complete marking of the equipment according to Article 11,

    • — issuing of the EC declaration of conformity according to Article 8.

• In both procedures, the frequency of the checks shall be defined by the notified body according to the results of previous evaluations, the need to monitor corrective actions and further guidance for the frequency of the checks that may be given by the yearly production and the general reliability of the manufacturer to maintain the guaranteed values; however a check shall be carried out at least once every three years.

• If there are doubts about the plausibility of the technical documentation or the adherence during production, the notified body shall inform accordingly the manufacturer, or his authorised representative established in the [F31 European Union].

• In those cases where equipment checked does not conform to the provisions of this Directive, the notified body must inform the notifying Member State.

Extent Information

E10 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F31 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2-68-10