Search Legislation

The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations (Northern Ireland) 2017

What Version

 Help about what version
  • Latest available (Revised)
  • Original (As made)

Status:

This is the original version (as it was originally made). This item of legislation is currently only available in its original format.

CHAPTER 1MANUFACTURERS

Design and manufacture in accordance with essential health and safety requirements

5.  Before placing a product on the market or using a product for their own purposes, a manufacturer shall ensure that it has been designed and manufactured in accordance with the essential health and safety requirements.

Technical documentation and conformity assessment

6.  Before placing a product on the market or using it for their own purposes, a manufacturer shall—

(a)carry out the relevant conformity assessment procedure or have a relevant conformity assessment procedure carried out; and

(b)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 point 3(c) of Module B of Annex III to the ATEX Directive (as amended from time to time);

(ii)for a product in respect of which the conformity assessment procedure in regulation 39(1)(b) is being carried out, in point 3(c) of Module B of Annex III to the ATEX Directive (as amended from time to time);

(iii)for a product in respect of which the conformity assessment procedure in regulation 39(1)(c) is being carried out, in point 2 of Module A of Annex VIII to the ATEX Directive (as amended from time to time);

(iv)for a product in respect of which the conformity assessment procedure in regulation 39(1)(d) is being carried out, in point 2 of Module G of Annex IX to the ATEX Directive (as amended from time to time);

EU declaration of conformity and CE marking

7.—(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 shall, before placing the product on the market—

(a)draw up a declaration of conformity in accordance with regulation 40 (EU declaration of conformity); and

(b)affix the CE marking in accordance with regulation 41 (CE marking).

(2) The manufacturer shall keep the EU 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 shall, 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 shall ensure that each product is accompanied by a copy of the EU 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 EU declaration or attestation of conformity as appropriate.

(6) Where a product is subject to more than one EU instrument requiring a declaration of conformity to be drawn up, the manufacturer shall draw up a single declaration of conformity, which—

(a)identifies the EU instruments; and

(b)includes references to the publication of those EU instruments in the Official Journal.

Retention of technical documentation and EU declaration of conformity

8.  A manufacturer shall keep the technical documentation and the EU 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 production

9.—(1) A manufacturer of a product which is manufactured by series production shall 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.

(2) In doing so, the manufacturer shall take adequate account of—

(a)any change in the product design or characteristics; and

(b)any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity or attestation of conformity was drawn up.

Monitoring

10.—(1) When appropriate, with regard to the risks to the health and safety of end-users presented by a product, a manufacturer shall—

(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 shall 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 shall 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 products

11.—(1) Before placing a product on the market, a manufacturer shall ensure that it bears a type, batch, 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 shall ensure that the information is provided on the packaging or in a document accompanying the product.

Labelling and packaging of products, other than components

12.  Save for where a product is a component, before placing a product on the market a manufacturer shall 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 manufacturer

13.—(1) Before placing a product on the market, a manufacturer shall 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 shall indicate that information—

(a)on the product packaging; or

(b)in a document accompanying the product.

(3) The information specified in paragraph (1) shall be in a language which can be easily understood by end-users and the competent national authority in the Member State in which it is to be made available to such end-users.

Instructions and safety information

14.—(1) When placing a product on the market, a manufacturer shall ensure that it is accompanied by instructions and safety information in a language which can be easily understood by end-users in the Member State in which it is to be made available on the market.

(2) The instructions and safety information referred to in paragraph (1) and any labelling shall be clear and understandable.

(3) Where the Member State referred to in paragraph (1) is the United Kingdom, the language referred to in that paragraph shall be English.

Duty to take action in respect of a product placed on the market which is considered not to be in conformity

15.—(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, shall 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 shall immediately inform the market surveillance authority, and the competent national authorities of any other Member State in which the manufacturer made the product available on the market, 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 cooperation

16.—(1) A manufacturer shall, 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 shall, 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 products presenting a risk);

(b)eliminate the risks posed by a product which the manufacturer has placed on the market.

Authorised representatives

17.—(1) A manufacturer may, by written mandate, appoint a person established in the EU 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) The obligations laid down in regulation 5 (Design and manufacture in accordance with essential health and safety requirements) and regulation 6(b) (Technical documentation and conformity assessment) shall not form part of an authorised representative’s mandate.

(4) The mandate shall allow the authorised representative to do at least the following in relation to a product covered by the mandate—

(a)perform the manufacturer’s obligations under regulation 8 (Retention of technical documentation and EU declaration of conformity); and

(b)perform the manufacturer’s obligations under regulation 16 (Provision of information and cooperation);

(5) An authorised representative shall 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 is to be taken as including a reference to the authorised representative.

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As Enacted or Made):The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

Explanatory Memorandum

Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Rule and provides information about its policy objective and policy implications. They aim to make the Statutory Rule accessible to readers who are not legally qualified and accompany any Northern Ireland Statutory Rule or Draft Northern Ireland Statutory Rule laid before the UK Parliament during the suspension of the Northern Ireland Assembly.

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as enacted version that was used for the print copy
  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as made version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources