PART 2Obligations of economic operators
Chapter 1Manufacturers
Design and manufacture in accordance with essential health and safety requirementsI15
Before placing a product on the market or using a product for their own purposes, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential health and safety requirements.
Technical documentation and conformity assessmentI26
Before placing a product on the market or using it for their own purposes, a manufacturer must—
a
carry out the relevant conformity assessment procedure or have a relevant conformity assessment procedure carried out; and
F5b
draw up the technical documentation referred to—
i
for a product in respect of which the conformity assessment procedure in regulation 39(1)(a) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;
ii
for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in paragraph 3(c) of Part 1 of Schedule 3A to these Regulations;
iii
for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in paragraph 2 of Part 6 of Schedule 3A to these Regulations;
iv
for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in paragraph 2 of Part 7 of Schedule 3A to these Regulations.
F27Declaration of conformity and F28UK markingI37
1
Save for where a product is a component, where the conformity of a product with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the product on the market—
a
2
The manufacturer must keep the F31... declaration of conformity up-to-date.
3
Where the conformity of a component with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the component on the market, draw up a written attestation of conformity in accordance with regulation 39(3) (conformity assessment procedures).
4
Subject to paragraph (5), before placing a product on the market, the manufacturer must ensure that each product is accompanied by a copy of the F32... declaration of conformity or attestation of conformity as appropriate.
5
Where a large number of products are delivered to a single user, the batch or consignment may be accompanied by a single copy of the F33... declaration or attestation of conformity as appropriate.
F346
Where a product is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.
Retention of technical documentation and F6... declaration of conformityI48
A manufacturer must keep the technical documentation and the F7... declaration of conformity (or where applicable, the attestation of conformity) drawn up in respect of a product for a period of 10 years beginning on the day on which the product is placed on the market.
Compliance procedures for series productionI59
1
A manufacturer of a product which is manufactured by series production must ensure that, before placing a product on the market, procedures are in place to ensure that any product so manufactured will be in conformity with Part 2.
MonitoringI610
1
When appropriate, with regard to the risks to the health and safety of end-users presented by a product, a manufacturer must—
a
carry out sample testing of a product manufactured by the manufacturer made available on the market,
b
investigate complaints that a product manufactured by the manufacturer is not in conformity with Part 2, and
c
keep distributors informed of any actions carried out under sub-paragraphs (a) and (b).
2
A manufacturer must keep a register of—
a
complaints that a product is not in conformity with Part 2,
b
products which are found not to be in conformity with Part 2, and
c
product recalls.
3
A manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.
Labelling and packaging of productsI711
1
Before placing a product on the market, a manufacturer must ensure that it bears a type, batch or serial number or other element allowing its identification.
2
If the size or nature of the product does not provide sufficient space for the labelling requirements in paragraph (1), the manufacturer must ensure that the information is provided on the packaging or in a document accompanying the product.
Labelling and packaging of products, other than componentsI812
Save for where a product is a component, before placing a product on the market a manufacturer must ensure that it—
a
bears the specific marking of explosion protection as referred to at paragraph 5(1)(f) of Schedule 1, and
b
where applicable, bears the other markings and information referred to at paragraph 5 of Schedule 1.
Information identifying manufacturerI913
1
Before placing a product on the market, a manufacturer must indicate on the product—
a
the name, registered trade name or registered trade mark of the manufacturer, and
b
a postal address at which the manufacturer can be contacted.
2
Where it is not possible to indicate the information specified in paragraph (1) on the product, the manufacturer must indicate that information—
a
on the product packaging, or
b
in a document accompanying the product.
F103
The information specified in paragraph (1) must be in a language which can be easily understood by end users and the market surveillance authority.
F11Provision of instructions and safety information14
When placing a product on the market, a manufacturer must ensure that a product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.
Duty to take action in respect of a product placed on the market which is considered not to be in conformityI1015
1
A manufacturer who considers, or has reason to believe, that a product which the manufacturer has placed on the market is not in conformity with Part 2, must immediately take the corrective measures necessary to—
a
bring the product into conformity,
b
withdraw the product, or
c
recall the product.
2
Where the product presents a risk, the manufacturer must immediately inform the market surveillance authorityF12... of the risk, giving details of—
a
the respect in which the product is considered not to be in conformity with Part 2, and
b
any corrective measures taken.
Provision of information and cooperationI1116
1
A manufacturer must, further to a reasoned request from the market surveillance authority, and within such period as the market surveillance authority may specify, provide the authority with the information and documentation necessary to demonstrate that the product is in conformity with Part 2—
a
in paper or electronic form, and
b
in a language which can be easily understood by the market surveillance authority.
2
A manufacturer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—
a
evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);
b
eliminate the risks posed by a product which the manufacturer has placed on the market.
Authorised representativesI1217
1
A manufacturer may, by written mandate, appoint a person established in the F13United Kingdom as their authorised representative to perform specified tasks on the manufacturer’s behalf.
2
A manufacturer who has appointed an authorised representative to perform, on the manufacturer’s behalf, a task under these Regulations remains responsible for the proper performance of that task.
3
4
The mandate must allow the authorised representative to do at least the following in relation to a product covered by the mandate—
a
b
perform the manufacturer’s obligations under regulation 16 (provision of information and cooperation).
5
An authorised representative must comply with all duties imposed on the manufacturer in relation to each obligation under these Regulations that the authorised representative is appointed by the mandate to perform and, accordingly as far as those duties are concerned, as well as the penalties for failure to comply with those duties, references in these Regulations (except in this regulation) to the manufacturer are to be taken as including a reference to the authorised representative.
Chapter 2Importers
Prohibition on placing on the market products which are not in conformityI1318
An importer must not place a product on the market unless it is in conformity with the essential health and safety requirements.
Requirements which must be satisfied before an importer places a product on the marketI1419
1
Before placing a product on the market, an importer must ensure that—
a
a relevant conformity assessment procedure has been carried out by the manufacturer,
b
the manufacturer has drawn up the technical documentation,
2
In paragraph (1)(c)(iii), “required documents” means any documents that are required to be provided with a product pursuant to—
a
regulation 11(2) (labelling and packaging of products);
b
regulation 13(2)(b) (information identifying manufacturer);
c
regulation F1714 (provision of instructions and safety information).
Prohibition on placing on the market products considered not to be in conformity with the essential health and safety requirementsI1520
1
Where an importer considers, or has reason to believe, that a product is not in conformity with the essential health and safety requirements, the importer must not place the product on the market.
2
Where the product presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.
Information identifying importerI16C121
1
Before placing a product on the market, an importer must indicate on the product—
a
the name, registered trade name or registered trade mark of the importer, and
b
a postal address at which the importer can be contacted.
2
The information specified in paragraph (1) must be in a language which can be easily understood by end-users and F25the market surveillance authority.
F263
Paragraph (1) does not apply where—
a
either—
i
it is not possible to set out the information referred to in paragraph (1) on the product, or
ii
the importer has imported the product from an EEA state or Switzerland and places it on the market within the period of F36seven years beginning with IP completion day, and
b
before placing the product on the market, the importer sets out the information referred to in paragraph (1)—
i
on the packaging; or
ii
in a document accompanying the product.
F18Provision of Instructions and safety information22
When placing a product on the market, an importer must ensure that the product is accompanied by instructions and safety information that are clear, legible and in easily understandable English.
Storage and transportI1723
Each importer must ensure that, whilst a product is under that importer’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential health and safety requirements.
MonitoringI1824
1
When deemed appropriate, with regard to the risks to the health and safety of end-users presented by a product, an importer must—
a
carry out sample testing of a product made available by the importer on the market,
b
investigate complaints that a product placed on the market by the importer is not in conformity with Part 2, and
c
keep distributors informed of actions carried out under sub-paragraphs (a) and (b).
2
An importer must keep a register of—
a
complaints that a product is not in conformity with Part 2,
b
products which are found not to be in conformity with Part 2, and
c
product recalls.
3
An importer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.
Duty to take action in respect of a product placed on the market which is considered not to be in conformityI1925
1
An importer who considers, or has reason to believe, that a product which the importer has placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—
a
bring the product into conformity,
b
withdraw the product, or
c
recall the product.
2
Where the product presents a risk, the importer must immediately inform the market surveillance authorityF19... of the risk, giving details of—
a
the respect in which the product is considered not to be in conformity with Part 2, and
b
any corrective measures taken.
Provision of information and cooperationI2026
1
An importer must, further to a reasoned request from the market surveillance authority and within such period as the market surveillance authority may specify, provide the authority with the information and documentation necessary to demonstrate that the product is in conformity with Part 2—
a
in paper or electronic form, and
b
in a language which can be easily understood by the market surveillance authority.
2
An importer must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—
a
evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);
b
eliminate the risks posed by the product which the importer has placed on the market.
Retention of technical documentation and F20... declaration of conformityI2127
An importer must, for a period of ten years beginning on the day on which the product was placed on the market, keep and, upon request, make available to the market surveillance authority—
a
a copy of the F21... declaration of conformity or, where applicable, the attestation of conformity, and
b
the technical documentation.
Chapter 3Distributors
Duty to act with due careI2228
When making a product available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.
Requirements which must be satisfied before a distributor makes a product available on the marketI2329
1
Before making a product available on the market, the distributor must verify that—
a
the product—
i
bears a F22UK marking where applicable;
ii
is accompanied by the F23... declaration of conformity or the attestation of conformity;
iii
is accompanied by the required documents;
F24iv
is accompanied by instructions and safety information that are clear, legible and in easily understandable English;
b
c
the importer has complied with the requirements set out in regulation 21 (information identifying importer).
2
In paragraph (1)(a)(iii), “required documents” means the documents that the manufacturer or importer is required to provide with the product pursuant to—
a
regulation 11(2) (labelling and packaging of products);
b
regulation 13(2)(b) (information identifying manufacturer);
c
regulation 21(3)(b) (information identifying importer).
Storage and transportI2430
Each distributor must ensure that, whilst a product is under that distributor’s responsibility, its storage or transport conditions do not jeopardise its conformity with the essential health and safety requirements.
Prohibition on making available on the market where product not considered to be in conformity with safety objectivesI2531
1
Where a distributor considers, or has reason to believe, that a product is not in conformity with the essential health and safety requirements, the distributor must not make the product available on the market.
2
Where the product presents a risk, the distributor must inform the following persons of the risk—
a
the manufacturer or the importer, and
b
the market surveillance authority.
Duty to take action in respect of products made available on the market which are not in conformityI2632
1
A distributor who considers, or has reason to believe, that a product which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—
a
bring that product into conformity,
b
withdraw the product, or
c
recall the product.
2
Where the product presents a risk, the distributor must immediately inform the market surveillance authorityF1... of that risk, giving details of—
a
the respect in which the product is considered not to be in conformity with Part 2, and
b
any corrective measures taken.
Provision of information and cooperationI2733
1
A distributor must, further to a reasoned request from the market surveillance authority and within such period as the authority may specify, provide the authority with the information and documentation, in paper or electronic form, necessary to demonstrate that the product is in conformity with Part 2.
2
A distributor must, at the request of the market surveillance authority, cooperate with the authority on any action taken to—
a
evaluate a product in accordance with regulation 55 (evaluation of a product presenting a risk);
b
eliminate the risks posed by a product which the distributor has made available on the market.
Chapter 4Importers and distributors
Cases in which obligations of manufacturers apply to importers and distributorsI2834
An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of these Regulations and is subject to the obligations of the manufacturer under this Part, where A—
a
places a product on the market under A’s own name or trademark; or
b
modifies a product already placed on the market in such a way that it may affect whether the product is in conformity with Part 2.
Chapter 5All economic operators
Identification of economic operatorsI2935
1
An economic operator (“E”) who receives a request from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority—
a
any economic operator who has supplied E with a product, and
b
any economic operator to whom E has supplied a product.
2
The relevant period is—
a
for information under paragraph (1)(a), a period of 10 years beginning on the day on which E was supplied with the product;
b
for information under paragraph (1)(b), a period of 10 years beginning on the day on which E supplied the product.
Prohibition on improper use of F2UK markingI3036
1
An economic operator must not affix the F3UK marking to a product unless—
a
that economic operator is the manufacturer, and
b
the conformity of the product with the essential health and safety requirements has been demonstrated by a relevant conformity assessment procedure.
2
An economic operator must not affix to a product a marking (other than the F3UK marking) which purports to attest that the product is in conformity with the essential health and safety requirements.
3
An economic operator must not affix to a product a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the F3UK marking.
4
An economic operator must not affix to a product any other marking if the visibility, legibility and meaning of the F3UK marking would be impaired as a result.
F35Obligations which are met by complying with obligations in the ATEX Directive36A
1
In this regulation—
a
any reference to an Article or an Annex is a reference to an Article or an Annex of the ATEX Directive;
b
“CE marking” has the meaning given to it in Article 2(26); and
c
“harmonised standard” has the meaning given to in in Article 2(18).
2
Subject to paragraphs (6) and (7) paragraph (3) applies where, before placing the product on the market, the manufacturer—
a
ensures that the product has been designed and manufactured in accordance with the essential safety requirements set out in Annex II;
b
ensures that the relevant conformity assessment procedures that apply to that product in accordance with Article 13(1) and (2) have been carried out;
c
draws up the technical documentation referred to in Annexes III to IX;
d
ensures that the records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;
e
affixes a CE marking and the inscriptions in accordance with Articles 15 and 16(1) to (4);
f
draws up an EU declaration of conformity, in accordance with Article 14; and
g
ensures that the declaration of conformity is prepared in or translated into English.
3
Where this paragraph applies—
a
the requirements of regulations 5, 6, 7(1), (3) and 7(6) are to be treated as being satisfied;
b
regulations 2(a), 7(6), 8, 9(2), 17(4), 36 and 59 apply subject to the modifications in paragraph (10);
c
Part 3 does not apply; and
d
regulation 57 does not apply.
4
Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing a product on the market, the importer ensures that—
a
the relevant conformity assessment procedure referred to in Article 13 has been carried out;
b
the manufacturer has drawn up the technical documents relevant to the conformity assessment procedure followed; and
c
the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II.
5
Where this paragraph applies—
a
the requirements of regulation 19(1)(a) to (c) are to be treated as being satisfied; and
b
regulations 2(a),18, 23 and 27 apply subject to the modifications in paragraph (10).
6
This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 12.
7
Where paragraph (6) applies, paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to carry out—
a
the conformity assessment procedure set out in Article 13(1)(b); and
b
the relevant conformity assessment procedure that applies to that product in accordance with Article 13(2).
8
Paragraph (9) applies where, before making a product available on the market, a distributor ensures that the product bears the CE marking and inscriptions referred to in point 1.0.5 of Annex II.
9
Where this paragraph applies—
a
regulation 29(1)(a)(i) is to be treated as being satisfied; and
b
regulations 2(a), 30 and 31(1) apply subject to the modifications in paragraph (10).
10
The modifications referred to in subparagraphs (3)(b), (5)(b) and (9)(b) are that—
a
any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;
b
any reference to “UK marking” is to be read as reference to the CE marking;
c
any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements referred to in Annex II;
d
any reference to “designated standard” is to be read as a reference to a harmonised standard;
e
any reference to “relevant conformity assessment procedure” is to be read as a reference to the relevant conformity assessment procedures referred to in Article 13;
f
any reference to “technical documentation” is a reference to the technical documentation referred to in Annexes III to IX.
Conformity assessment procedure obligation which is met by complying with the ATEX Directive36B
1
In this regulation any reference to an Article or Annex is a reference to an Article or an Annex of the ATEX Directive;
2
Paragraph (3) applies where, prior to the manufacture of a product, the manufacturer ensures that the conformity assessment procedure that applies to that product in accordance with Annex III as referred to in Article 13(1)(a) and (b) has been carried out.
3
Where this paragraph applies—
a
any requirement to follow the Type-examination set out in Part 1 of Schedule 3A in regulation 39 is to be treated as being satisfied;
b
any reference to “relevant conformity assessment procedure” in regulations 6(a), 7(1), 19(a), 36(1)(b), 40(c) and 41(3) is to be read as including the conformity assessment procedure set out in Annex III as referred to in Article 13(1)(a) and (b); and
c
any reference to “technical documentation” in regulations 6(b), 8, 19(b) and 27(b) is to be read as including the technical documentation relating to the design of the product referred to in Annex III.
Expiry of regulations 36A and 36B36C
1
Subject to paragraph (2), regulation 36A ceases to have effect at the end of the period of F37four years beginning with IP completion day.
2
Notwithstanding the expiry of regulation 36A—
a
any product which was placed on the market pursuant to regulation 36A may continue to be made available on the market on or after the expiry of regulation 36A;
b
any obligation to which a person was subject under regulation 36A in respect of any product placed on the market pursuant to regulation 36A continues to have effect after the expiry of regulation 36A, in respect of that product.
3
Subject to paragraph (4), regulation 36B ceases to have effect at the end of the period of F38four years beginning with IP completion day.
4
Where a conformity assessment procedure has been completed pursuant to regulation 36B in relation to a product prior to the expiry of regulation 36B, regulation 36B continues to apply in respect of that pressure equipment or assembly where—
a
the manufacturer arranges for the EU-Type examination certificate and any annexes to be transferred to an approved body;
b
the approved body referred to in sub-paragraph (a) accepts responsibility for the EU-Type examination certificate; and
c
the approved body issues a Type-examination certificate relying, or relying in part, on any examinations or tests undertaken prior to the issue of the EU-Type examination certificate.
5
In paragraph (4) “EU-Type examination certificate” means a certificate issued after the conformity assessment referred to in regulation 36B(2) has been carried out.
Qualifying Northern Ireland Goods36D
1
In this regulation—
“the 2017 Regulations” means the Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017;
“CE marking” has the meaning given to it in regulation 2(1) of the 2017 Regulations;
“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;
“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1) of the 2017 Regulations;
“technical documentation” has the meaning given to it in regulation 2(1) of the 2017 Regulations.
2
Where paragraph (3) applies, a product is to be treated as being in conformity with Part 2.
3
This paragraph applies where—
a
a product—
i
is in conformity with Part 2, within the meaning of regulation 2(2) of the 2017 Regulations; and
ii
is qualifying Northern Ireland goods; and
b
an importer has complied with the obligations set out in paragraph (4).
4
The obligations referred to in paragraph (3)(b) are that, before placing the product on the market, the importer—
a
complies with regulation 21;
b
ensures that—
i
the relevant conformity assessment procedure has been carried out in relation to the product;
ii
the manufacturer has drawn up the technical documentation; and
iii
the product bears the CE marking.
Translation of declaration of conformityF437
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