- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (31/12/2020)
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Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance)
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
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Point in time view as at 31/12/2020.
There are currently no known outstanding effects for the Regulation (EU) 2016/425 of the European Parliament and of the Council, ANNEX V.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
Textual Amendments
F2Word in Annex 5 para. 1 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in Annex 5 para. 1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(b); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F4Word in Annex 5 para. 2 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
The manufacturer shall lodge an application for F6... type-examination with a single [F7approved] body of his choice.
Textual Amendments
F6Word in Annex 5 para. 3 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
F7Word in Annex 5 para. 3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other [F7approved] body;
the technical documentation described in Annex III;
the specimen(s) of the PPE representative of the production envisaged. The [F7approved] body may request further specimens if needed for carrying out the test programme. For PPE produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, and for PPE produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.
Textual Amendments
F5Word in Annex 5 para. 3 heading omitted (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. 35 para. 3(48)(a); 2020 c. 1, Sch. 5 para. 1(1)
The [F9approved] body shall:
Textual Amendments
F9Word in Annex 5 para. 4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
examine the technical documentation to assess the adequacy of the technical design of the PPE. In conducting such an examination, point (j) of Annex III need not be taken into account;
for PPE produced in series where each item is adapted to fit an individual user, examine the description of the measures to assess their adequacy;
for PPE produced as a single unit to fit an individual user, examine the instructions for manufacturing such PPE on the basis of the approved basic model to assess their adequacy;
verify that the specimen(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant [F10designated] standards as well as the elements which have been designed in accordance with other technical specifications;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant [F10designated] standards, these have been applied correctly;
carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant [F10designated] standards have not been applied, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential health and safety requirements and have been applied correctly.
Textual Amendments
F10Word in Annex 5 para. 4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(g); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F8Word in Annex 5 para. 4 heading omitted (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. 35 para. 3(48)(a) (with Sch. 35 para. 3(42)); 2020 c. 1, Sch. 5 para. 1(1)
The [F11approved] body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the [F12Secretary of State], the [F11approved] body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
Textual Amendments
F11Word in Annex 5 para. 5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
F12Words in Annex 5 para. 5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(h); 2020 c. 1, Sch. 5 para. 1(1)
The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years.
Textual Amendments
F14Word in Annex 5 para. 6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
F15Word in Annex 5 para. 6.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(i); 2020 c. 1, Sch. 5 para. 1(1)
the name and identification number of the [F17approved] body;
the name and address of the manufacturer and, if the application is lodged by the authorised representative, the latter's name and address;
identification of the PPE covered by the certificate (type number);
a statement that the PPE type complies with the applicable essential health and safety requirements;
where [F18designated] standards have been fully or partially applied, the references of those standards or parts thereof;
where other technical specifications have been applied, their references;
where applicable, the performance level(s) or protection class of the PPE;
for PPE produced as a single unit to fit an individual user, the range of permissible variations of relevant parameters based on the approved basic model;
the date of issue, the date of expiry and, where appropriate, the date(s) of renewal;
any conditions attached to the issue of the certificate;
for category III PPE, a statement that the certificate shall only be used in conjunction with one of the conformity assessment procedures referred to in point (c) of Article 19.
Textual Amendments
F17Word in Annex 5 para. 6.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
F18Words in Annex 5 para. 6.2(e) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(j); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F16Word in Annex 5 para. 6.2 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F19Word in Annex 5 para. 6.3 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F20Word in Annex 5 para. 6.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
F21Word in Annex 5 para. 6.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(i); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F13Word in Annex 5 para. 6 heading omitted (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. 35 para. 3(48)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F23Word in Annex 5 para. 7.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F24Word in Annex 5 para. 7.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
F25Word in Annex 5 para. 7.2 omitted (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. 35 para. 3(48)(d); 2020 c. 1, Sch. 5 para. 1(1)
in the case of a modification to the approved type referred to in point 7.2;
in the case of a change in the state of the art referred to in point 7.3;
at the latest, before the date of expiry of the certificate.
In order to allow the [F26approved] body to fulfil its tasks, the manufacturer shall submit his application at the earliest 12 months and at the latest 6 months prior to the expiry date of the F27... type-examination certificate.
Textual Amendments
F26Word in Annex 5 para. 7.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
F27Word in Annex 5 para. 7.4 omitted (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. 35 para. 3(48)(d); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F28Word in Annex 5 para. 7.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
F29Word in Annex 5 para. 7.5 omitted (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. 35 para. 3(48)(d); 2020 c. 1, Sch. 5 para. 1(1)
his name and address and data identifying the F31... type-examination certificate concerned;
confirmation that there has been no modification to the approved type as referred to in point 7.2, including materials, sub-components or sub-assemblies, nor to the relevant [F32designated] standards or other technical specifications applied;
confirmation that there has been no change in the state of the art as referred to in point 7.3;
where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer; and
for category III products, where not already available to the [F30approved] body, information on the results of the supervised product checks at random intervals carried out in accordance with Annex VII, or on the results of audits of his quality system carried out in accordance with Annex VIII.
Textual Amendments
F31Word in Annex 5 para. 7.6 omitted (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. 35 para. 3(48)(d); 2020 c. 1, Sch. 5 para. 1(1)
F32Words in Annex 5 para. 7.6(b) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(j); 2020 c. 1, Sch. 5 para. 1(1)
Where the [F30approved] body has confirmed that no modification to the approved type referred to in point 7.2 and no change in the state of the art referred to in point 7.3 has occurred, the simplified review procedure shall be applied and the examinations and tests referred to in point 7.5 shall not be carried out. In such cases, the [F30approved] body shall renew the F31... type-examination certificate.
The costs associated with that renewal shall be proportionate to the administrative burden of the simplified procedure.
If the [F30approved] body finds that a change in the state of the art referred to in point 7.3 has occurred, the procedure set out in point 7.5 shall apply.
Textual Amendments
F30Word in Annex 5 para. 7.6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F33Word in Annex 5 para. 7.7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(e); 2020 c. 1, Sch. 5 para. 1(1)
F34Word in Annex 5 para. 7.7 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F22Word in Annex 5 para. 7 heading omitted (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. 35 para. 3(48)(a); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F35Word in Annex 5 para. 8 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(f); 2020 c. 1, Sch. 5 para. 1(1)
F36Words in Annex 5 para. 8 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(k)(i); 2020 c. 1, Sch. 5 para. 1(1)
F37Word in Annex 5 para. 8 omitted (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. 35 para. 3(48)(d) ; 2020 c. 1, Sch. 5 para. 1(1)
Each [F35approved] body shall inform the other [F35approved] bodies concerning the F37... type-examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.
[F38The Secretary of State] and the other [F35approved] bodies may, on request, obtain a copy of the F37... type-examination certificates and/or additions thereto. [F39The Secretary of State may on request] obtain a copy of the technical documentation and the results of the examinations carried out by the [F35approved] body.
Textual Amendments
F38Words in Annex 5 para. 8 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(k)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)
F39Words in Annex 5 para. 8 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(48)(k)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)
The [F35approved] body shall keep a copy of the F37... type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.
Textual Amendments
F40Word in Annex 5 para. 9 omitted (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. 35 para. 3(48)(c); 2020 c. 1, Sch. 5 para. 1(1)
Textual Amendments
F1Word in Annex 5 heading omitted (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. 35 para. 3(48)(a); 2020 c. 1, Sch. 5 para. 1(1)
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