The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016

Chapter 2 Importers

Prohibition on placing on the market products which are not in conformity

18.  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 market

19.—(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,

(c) the product—

(i) bears the CE marking where applicable,

(ii) is accompanied by the EU declaration of conformity or the attestation of conformity as appropriate, and

(iii) is accompanied by the required documents, and

(d) the manufacturer has complied with the requirements set out in regulation 11 (labelling and packaging of products), regulation 12 (labelling and packaging of products, other than components) and regulation 13 (information identifying manufacturer).

(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 14(1) (instructions and safety information).

Prohibition on placing on the market products considered not to be in conformity with the essential health and safety requirements

20.—(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 importer

21.—(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 by the competent national authority in the Member State in which it is to be made available to end-users.

(3) Where it is not possible to indicate the information specified in paragraph (1) on the product, the importer must indicate that information—

(a) on the packaging, or

(b) in a document accompanying the product.

Instructions and safety information

22.—(1) When placing a product on the market, an importer must 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 the product is to be made available.

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

Storage and transport

23.  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.

Monitoring

24.—(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 conformity

25.—(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 authority, and the competent national authorities of any other Member State in which the importer 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

26.—(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 EU declaration of conformity

27.  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 EU declaration of conformity or, where applicable, the attestation of conformity, and

(b) the technical documentation.