Statutory Instruments

2016 No. 1025

Merchant Shipping

The Merchant Shipping (Marine Equipment) Regulations 2016

Made

31st October 2016

Laid before Parliament

9th November 2016

Coming into force

5th December 2016

(a)

  

(b)

  

(c)

  

M1M2The Secretary of State is a Minister designated for the purposes of the European Communities Act 1972 in relation to measures relating to maritime transport and measures relating to the safety of ships and the health and safety of persons on them .

In accordance with section 86(4) of the Merchant Shipping Act 1995 the Secretary of State has consulted the persons referred to in that section.

Modifications etc. (not altering text)

Marginal Citations

PART 1 U.K.Preliminary

Citation and commencementU.K.

1.  The Regulations may be cited as the Merchant Shipping (Marine Equipment) Regulations 2016 and come into force on 5th December 2016.

InterpretationU.K.

2.—(1) In these Regulations—

[F1“accreditation” means an attestation by the United Kingdom national accreditation body that a conformity assessment body meets the requirements set out in Schedule 3 to carry out conformity assessment activities;]

[F1“accreditation certificate” means a certificate issued by the United Kingdom national accreditation body, attesting that a conformity assessment body meets the approved body requirements set out in Schedule 3;]

“the Act” means the Merchant Shipping Act 1995;

[F2“the Agreement” means the Agreement between the United Kingdom of Great Britain and Northern Ireland and the United States of America on the Mutual Recognition of Certificates of Conformity for Marine Equipment dated 14th February 2019;]

“applicable international standards” means the design, construction and performance requirements of the international instruments which the equipment must satisfy as set out in Annex 1 or 2 of Merchant Shipping Notice MSN 1874 [F3Amendment 3];

“applicable UK standards” means the requirements set out in Annex 3 of Merchant Shipping Notice MSN 1874 [F4Amendment 3] for equipment which is not subject to applicable international standards;

[F5“approved body” means a conformity assessment body which—

(a)

has been approved by the Secretary of State pursuant to the procedure set out in Schedule 4; or

(b)

immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action to suspend or withdraw the body's status as a notified body];

[F5“approved body requirements” means the requirements set out in Schedule 3;]

[F5authorised representative” means a person who—

(a)

immediately before IP completion day was established in an EEA state and appointed in accordance with article 13 of the Directive; or

(b)

after IP completion day is appointed in accordance with regulation 16 (authorised representatives);]

“category C waters” has the meaning given in Merchant Shipping Notice MSN 1837(M) Amendment 1;

“competent national authority” means the competent national authority in each member State responsible for ensuring compliance with the requirements of the Directive;

[F6“conformity assessment” means the process demonstrating whether marine equipment complies with the requirements set out in these Regulations];

[F6“conformity assessment activities” means any activities connected with conformity assessment, including calibration, testing, certification and inspection;]

[F6“conformity assessment body” means a body that performs conformity assessment activities;]

[F6“conformity assessment procedure” means a procedure referred to in regulations 4 (designation of approved and nominated bodies), 11 (applications for grant of United Kingdom conformity approval) and 12 (grant of United Kingdom conformity approval: obligations of an approved body) and Schedule 2 (United Kingdom conformity assessment procedures); ]

“conformity mark” means the mark affixed to equipment by the manufacturer in accordance with regulation 15;

“the Directive” means Directive 2014/90/EU of the European Parliament and of the Council of 23rd July 2014 on marine equipment and repealing Council Directive 96/98/EC M3;

[F7“distributor” means any person in the supply chain, other than the manufacturer or the importer, who makes marine equipment available on the United Kingdom market;]

“domestic passenger ship” means a passenger ship which has been issued a certificate to embark on voyages in category C waters or seaward of those waters, but not for international voyages;

“economic operator” means a manufacturer, authorised representative, importer or distributor;

[F8“EU conformity approval” means approval issued by an EU notified body in accordance with the Directive;]

[F9“EU notified body” means a body designated by the competent national authority of an EU Member State in accordance with the Directive;]

“fishing vessel” means a vessel used to catch fish or other living resources of the sea with a registered length of 24 metres or more;

[F10“importer” means a person who—

(a)

is established in the United Kingdom; and

(b)

who places marine equipment from a country outside of the United Kingdom on the United Kingdom market;]

[F10“international conventions” means the following conventions, together with their protocols and codes of mandatory application, adopted under the auspices of the International Maritime Organisation (“IMO”), which have entered into force and which lay down specific requirements for the approval by the flag State of marine equipment to be placed on board ships—

(a)

the 1972 Convention on the International Regulations for Preventing Collisions at Sea (Colreg);

(b)

the 1973 International Convention for the Prevention of Pollution from Ships (Marpol);

(c)

the 1974 International Convention for the Safety of Life at Sea (Solas);]

[F10“international instruments” means the international conventions, together with the resolutions and circulars of the IMO giving effect to those conventions as amended from time to time, and the testing standards; ]

“international voyage” means a voyage from a port in one country to a port in another country, either of the countries being a country to which the 1974 Convention for the Safety of Life at Sea M4 applies;

“length” means the greater of the following distances—

(a)

the distance between the fore side of the stem and the axis of the rudder stock, or

(b)

96 per cent of the distance between the fore side of the stem and the aft side of the stern,

the points and measurements being taken respectively at and along the waterline at 85 per cent of the least moulded depth of the ship; in the case of a ship with a rake of keel, the waterline must be parallel to the designated waterline;

[F11“making available on the market” means any supply of marine equipment on the United Kingdom market in the course of a commercial activity, whether in return for payment or free of charge;]

[F11“manufacturer” means any person who—

(a)

manufactures marine equipment or has marine equipment designed or manufactured; and

(b)

markets that equipment under that person's name or trademark;]

[F11“marine equipment” means equipment falling within the scope of these Regulations; ]

F12...

“Merchant Shipping Notice” means a notice described as such and issued by the Secretary of State and any reference to a particular Merchant Shipping Notice includes a reference to a Merchant Shipping Notice amending or replacing that Notice which is considered by the Secretary of State to be relevant from time to time;

“nominated body” means a person designated as a nominated body under regulation 4(2);

[F13“notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission and the member States of the European Union in accordance with Article 17 of the Directive;]

“passenger” means every person on a ship other than—

(a)

the master and the members of the crew or other persons employed or engaged in any capacity on board a ship on the business of that ship,

(b)

a person on board the ship in pursuance of an obligation on the master to carry shipwrecked, distressed or other persons or by reason of any circumstance that neither the master nor the owner could have prevented, and

(c)

a child under one year of age;

“passenger ship” means a ship which carries more than 12 passengers;

[F14“product” means an item of marine equipment;]

[F14“RAMS” means Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No. 339/93;]

[F14“recall” means any measure aimed at achieving the return of marine equipment that has already been placed on board a United Kingdom ship or purchased with the intention of being placed on a United Kingdom ship;]

[F14“recognised third country” means a country, that is not part of the United Kingdom or the European Union, whose marine equipment accreditation and conformity assessment procedures the Secretary of State is satisfied, taking into account relevant international instruments, is equivalent to those of the United Kingdom; ]

“relevant period” means a period of at least 10 years from the date that the [F15United Kingdom] conformity mark was affixed to the equipment and not less than the expected life of the equipment;

[F16“United Kingdom conformity mark” means the mark affixed to equipment by the manufacturer in accordance with regulation 15;]

[F16“United Kingdom declaration of conformity” means a statement issued by the manufacturer in accordance with regulation 14(2);]

[F16“United Kingdom national accreditation body” means “the body appointed by the Secretary of State in accordance with Article 4 of RAMS; ]

“United Kingdom ship” means a ship which is—

(a)

a United Kingdom ship within the meaning of section 85(2) of the Act,

(b)

a Government ship within the meaning of section 308(4) of the Act, or

(c)

a hovercraft registered under the Hovercraft Act 1968 M5.

[F17“US declaration of conformity” means the Certificate of Type Approval issued by the United States Coast Guard certifying that a product fulfils the relevant legislative, regulatory, and administrative requirements of the United States of America;]

[F18“withdrawal”, in relation to marine equipment, means any measure aimed at preventing marine equipment in the supply chain from being made available on the United Kingdom market]

F19(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) In the application of these Regulations to a hovercraft, a reference to the master of a ship includes a reference to the captain of that hovercraft.

F20(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Where a ship is managed by a person other than the owner (whether on behalf of the owner, some other person or on his own behalf), a reference in these Regulations to the owner is construed as including a reference to that person.

(6) Any direction, prohibition or restriction given under these Regulations must be given in writing and must specify the date on which it takes effect and the conditions (if any) on which it is given.

Textual Amendments

Marginal Citations

M3OJ L257, 28.8.2014, p.146.

M4Cmnd 7874.

ApplicationU.K.

3.  These Regulations apply to any United Kingdom ship wherever it may be.

Designation of [F21approved] and nominated bodiesU.K.

4.—[F22(1) The Secretary of State may designate any person as an approved body to carry out the procedures specified in Schedule 2 (which makes provision about United Kingdom Conformity Assessment Procedures), provided that the Secretary of State is satisfied that person meets the requirements specified in Schedule 3 (which makes provision about requirements to be met by conformity assessment bodies in order to become approved bodies).]

(2) The Secretary of State may designate any person as a nominated body to carry out the procedures specified in paragraphs 11 and 12 of Part II of [F23Merchant Shipping Notice MSN 1874 Amendment 3].

(3) A designation must be made in writing and set out—

(a)the functions to be performed by the [F24approved] or nominated body;

(b)the equipment to which the designation applies; and

(c)any time limit or condition which applies to the designation.

(4) The Secretary of State may withdraw a designation—

(a)on request by the [F25approved] or nominated body;

(b)where the [F26approved] body ceases to comply with the requirements in [F27Schedule 3]; or

(c)where the [F28approved body] or nominated body fails to comply with any condition imposed under paragraph (3) above.

(5) The Secretary of State may vary a designation—

(a)on request by [F29the approved] or nominated body; or

(b)where it appears necessary or expedient to do so.

(6) The Secretary of State may inspect [F30an approved] or nominated body to ensure it is performing its functions—

(a)under regulation 12 or 18; and

(b)in accordance with the conditions of its designation.

[F31(6A) The procedure for making a designation under paragraph (1) is specified in Schedule 4 (designation procedure).]

(7) Where a person applies for designation under paragraph (1) or (2), the Secretary of State must inform that person in writing of the reasons for—

(a)refusing to designate that person as [F32an approved] or nominated body;

(b)imposing any condition more onerous than proposed by the applicant; or

(c)withdrawing or varying a designation.

Textual Amendments

PART 2 U.K.Requirements for Equipment

Requirements for equipmentU.K.

5.—(1) Subject to paragraph (2), where under international instruments equipment must be approved by the flag state administration, that equipment must comply with applicable international standards when it is placed on board a ship.

(2) When equipment is placed on board a domestic passenger ship or a fishing vessel and that equipment is listed in Annex 1 or 2 of Merchant Shipping Notice MSN 1874 [F33Amendment 3] it must comply with—

(a)applicable international standards;

(b)an alternative standard; or

(c)(where there is no requirement to place that equipment on board a ship but it is placed on board voluntarily) the standard specified by the Secretary of State.

(3) When equipment listed in Annex 3 of Merchant Shipping Notice MSN 1874 [F34Amendment 3] is placed on board a ship it must comply with applicable UK standards.

[F35(4) Equipment listed in Annex 1 of Merchant Shipping Notice MSN 1874 Amendment 3 must be taken to comply with applicable international standards where it is—

(a)approved by an approved body, accompanied by—

(i)a declaration of United Kingdom conformity under regulation 14; and

(ii)affixed with a conformity mark under regulation 15;

(b)approved by an EU notified body, accompanied by an EU declaration of conformity and affixed with an EU conformity mark; or

(c)approved by a recognised third country [F36other than the United States of America] and accompanied by such declarations and marks of conformity (if any) as the Secretary of State may specify.]

[F37(4A) Equipment listed in Annex 6 of Merchant Shipping Notice MSN 1874 Amendment 3 must be taken to comply with applicable international standards where it is—

(a)approved by the United States Coast Guard;

(b)accompanied by a US declaration of conformity; and

(c)affixed with the United Kingdom conformity mark.

(4B) Paragraph (4A) does not apply to any equipment in respect of which approval has been suspended in accordance with Article 15 of the Agreement.]

(5) Equipment listed in [F38Annex 2 of Merchant Shipping Notice MSN 1874 Amendment 3] must be taken to comply with applicable international standards or an alternative standard where it is accompanied by a certificate under regulation 18.

(6) In this regulation—

“alternative standard” means a standard specified as an alternative to an applicable international standard in any instrument listed [F39Annex 4 of Merchant Shipping Notice MSN 1874 Amendment 3].

Textual Amendments

[F40ExemptionsU.K.

6.—(1) The Secretary of State may allow equipment that does not comply with applicable international standards to be placed on board a ship, provided that the Secretary of State is satisfied, by whatever means, that—

(a)compliance with applicable international standards is either impracticable or unreasonable in that case or cases; and

(b)the exemption is subject to such conditions and limitations as will provide a level of safety which is at least equivalent to that provided by applicable international standards.

(2) The Secretary of State may, on reasonable notice, alter or cancel any exemption granted under paragraph (1).

(3) An exemption granted under paragraph (1) and an alteration or cancellation under paragraph (2) must be given in writing and must specify the date on which it takes effect and the terms (if any) on which it is given.]

Textual Amendments

Exemptions for technical innovationU.K.

F417.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exemptions for testing or evaluationU.K.

F428.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Exemptions in exceptional circumstancesU.K.

F439.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

Transfer of a shipU.K.

10.—(1) Where a ship is transferred to the United Kingdom register, the Secretary of State must inspect any relevant equipment to ensure—

(a)its condition corresponds to the safety certificates for that equipment; and

(b)the equipment complies with applicable international standards or is equivalent to equipment that complies with those standards.

(2) Where, following inspection of equipment under paragraph (1), the Secretary of State is not satisfied that the equipment complies with the applicable international standards or is equivalent to equipment that complies with those standards, the Secretary of State must direct the owner in writing to replace the equipment.

(3) Where, following inspection under paragraph (1), the Secretary of State considers that the equipment does not comply with applicable international standards but is equivalent to equipment that complies with those standards, the Secretary of State must issue a certificate for that equipment, which must—

(a)confirm the Secretary of State's approval of the equipment;

(b)specify any restrictions or conditions on the use of the equipment; and

(c)be carried with the equipment.

(4) The Secretary of State may withdraw a certificate where a restriction or condition on the use of equipment is breached.

(5) In this regulation—

“relevant equipment” means any equipment—

(a)

to which regulation 5(1) would have applied at the time the equipment was placed on board the ship if that ship had been a United Kingdom ship at that time; and

(b)

that is specified in Annex 1 of Merchant Shipping Notice MSN 1874 [F44Amendment 3].

Textual Amendments

PART 3U.K.[F45United Kingdom Conformity Assessment Procedures]

Textual Amendments

Applications for grant of [F46United Kingdom] conformity approvalU.K.

11.—[F47(1) Subject to paragraph (2), for equipment listed in Annex 1 of Merchant Shipping Notice MSN 1874 Amendment 3, the manufacturer must apply to an approved body for United Kingdom conformity approval in accordance with the procedures set out in Schedule 2.]

(2) A manufacturer must not apply under paragraph (1) where an application for [F48a United Kingdom] conformity assessment has been made (whether by that manufacturer or another), in respect of that type of equipment, under these Regulations F49..., and that application has not been withdrawn.

(3) An application under paragraph (1) must be—

(a)in writing; and

(b)accompanied by the documentation required by [F50Schedule 2].

Textual Amendments

[F51Grant of United Kingdom conformity approval: obligations of an approved bodyU.K.

12.—(1) An approved body must—

(a)decide whether to grant or refuse United Kingdom conformity approval in accordance with the provisions of Schedule 2; and

(b)where an application is made under Part 1 of Schedule 2 (Module B), produce an evaluation report recording the activities undertaken in accordance with paragraph 5 of that Schedule and their outcomes.

(2) Where an approved body grants United Kingdom conformity approval, it must—

(a)for the type approval of equipment under Part 1 (Module B) of Schedule 2, issue a certificate containing the information specified in paragraph 7 of that module;

(b)for approval of a quality system under Part 2 (Module D) or Part 3 (Module E) of Schedule 2, notify the manufacturer of its decision in writing, including the conclusions of the audit of the quality system and the reasons for its decision; or

(c)where verifying a product under Part 4 (Module F) or Part 5 (Module) G of Schedule 2, issue a certificate of conformity for that product.

(3) Where an approved body refuses United Kingdom conformity approval, it must notify the manufacturer, giving detailed reasons for its decision.

(4) An approved body must—

(a)periodically audit a quality system that it has approved; and

(b)provide the manufacturer with a report containing the results of the audit.

(5) Where an approved body knows or has reason to believe that—

(a)equipment to which it has granted United Kingdom conformity approval no longer complies with applicable international standards; or

(b)a manufacturer has failed to comply with an obligation under regulation 20(1) to (6) (obligations of a manufacturer),

it must require the manufacturer to take immediate corrective measures to ensure that the equipment complies with applicable international standards, and where necessary, suspend or withdraw its approval for that equipment.

(6) Following the grant of United Kingdom conformity approval, an approved body must comply with the provision of information requirements in Schedule 2 and must, in particular, inform the Secretary of State about any refusal, restriction, suspension or withdrawal of a conformity certificate and, on request, information about the conformity assessment activities performed within the scope of that approved body's designation, and any other activity performed.]

Textual Amendments

[F52Amendments to United Kingdom conformity approvalU.K.

13.—(1) The manufacturer of equipment granted a United Kingdom type approval certificate by an approved body must notify that body of any changes that may affect the conformity of the equipment with applicable international standards or the conditions for validity of the certificate.

(2) The manufacturer must notify the approved body that approved a quality system under regulation 12(2)(b) of any intended changes to that system.

(3) Following receipt of a notification under paragraph (1) or (2), the approved body must determine whether an amendment to the United Kingdom conformity approval certificate or to the approval of the quality system is required and notify the manufacturer accordingly.

(4) Where an amendment to the United Kingdom conformity approval certificate or to the approval of the quality system is required, the manufacturer must apply in writing for the approval to be amended and provide such documents as requested by the approved body.]

Textual Amendments

Declarations of [F53United Kingdom] conformityU.K.

14.—(1) A manufacturer must provide a declaration of conformity with all equipment for which [F54United Kingdom] conformity approval has been granted.

[F55(2) The declaration of conformity must provide the information specified in Schedule 5.]

(3) The manufacturer must provide a copy of the declaration of [F56United Kingdom] conformity [F57in English] with the equipment and send a copy of that declaration to the [F58approved] body which granted the conformity approval certificate.

(4) The owner and master of a ship must each ensure that the declaration of [F59United Kingdom] conformity is kept with the equipment on board the ship.

Textual Amendments

Affixing the [F60United Kingdom] conformity markU.K.

15.—(1) The manufacturer must, at the end of the production stage, affix the [F61United Kingdom] conformity mark to—

(a)each item of equipment for which a declaration of [F62United Kingdom] conformity is required, or

(b)a data plate attached to that equipment, and

where relevant, embed the [F63United Kingdom] conformity mark in the equipment's software.

(2) Where it is not possible or warranted due to the nature of the item of equipment to affix the [F64United Kingdom] conformity mark in accordance with paragraph (1), it must be affixed to—

(a)the packaging of the item of equipment;

(b)a label on the item of equipment or its packaging; or

(c)a document distributed with the item of equipment.

(3) The [F65United Kingdom] conformity mark must be—

(a)in the form specified in [F66Annex 5 of MSN 1874 Amendment 3];

(b)affixed so that it is visible, legible and indelible; and

(c)followed by—

[F67(i)the identification number of the approved body which approved the equipment and the year in which the mark was affixed, where that body is involved in the production control phase; or

(ii)the identification number assigned to the United States Coast Guard by the Secretary of State, and the year in which the mark was affixed, where equipment listed in Annex 6 of Merchant Shipping Notice MSN 1874 Amendment 3 has been approved by the United States Coast Guard and granted a US declaration of conformity.]

(4) Where the number of the [F68approved] body is to be affixed under paragraph (3)(c)(i), it must be affixed by—

(a)the [F68approved] body itself; or

(b)the manufacturer on instruction of the [F68approved] body.

(5) No person may affix a mark or inscription which is likely to mislead any person with regard to the meaning or the graphics of the mark.

(6) In this regulation—

“production control phase” means the phase of production during which the manufacturer ensures that each item of equipment complies with its [F69United Kingdom] conformity approval in accordance with modules D, E, F or G of [F70Schedule 2].

Textual Amendments

Authorised RepresentativesU.K.

[F7116.—(1) Where a manufacturer is not located in the United Kingdom, that manufacturer may, by a written mandate, appoint an authorised representative with the mandate to include the name and contact address of the authorised representative.

(2) Where a manufacturer appoints an authorised representative, that representative must carry out the manufacturer's obligations under regulation 20(1)(c) and 22(2).]

Textual Amendments

PART 4 U.K.Other Conformity Assessment Procedures

Application for grant of conformity approvalU.K.

[F7217.—(1) For equipment listed in Annex 2 of Merchant Shipping Notice MSN 1874 Amendment 3, the manufacturer must apply to a nominated body for conformity approval in accordance with the procedures set out in paragraph 10 of Merchant Shipping Notice MSN 1874 Amendment 3.

(2) An application under paragraph (1) must be—

(a)in writing; and

(b)accompanied by the documentation required by paragraph 10 of Merchant Shipping Notice MSN 1874 Amendment 3.]

Textual Amendments

Grant of conformity approval: obligations of nominated bodiesU.K.

18.—(1) A nominated body must decide whether to grant or refuse conformity approval for equipment in accordance with the requirements of [F73paragraph 11 of Merchant Shipping Notice MSN 1874 Amendment 3].

(2) Where a nominated body grants conformity approval for equipment, it must issue a certificate containing the information specified in [F74paragraph 12 of Merchant Shipping Notice MSN 1874 Amendment 3].

(3) Where a nominated body refuses conformity approval, it must notify the manufacturer, giving detailed reasons for its decision in writing.

Textual Amendments

PART 5 U.K.Obligations of Economic Operators

Application of Part 5U.K.

19.  This Part applies only to equipment to which regulation 5(1) applies that is listed in [F75Annex 1 of Merchant Shipping Notice MSN 1874 Amendment 3].

Textual Amendments

Obligations of a ManufacturerU.K.

20.—[F76(1) A manufacturer must ensure that—

(a)a United Kingdom conformity assessment is carried out in respect of all marine equipment using one of the procedures referred to in paragraph (1A);

(b)marine equipment is marked in accordance with regulation 15 (affixing the United Kingdom conformity mark); and

(c)keep the technical documentation specified in Schedule 2 and the United Kingdom declaration of conformity for the relevant period.

(1A) The procedures mentioned in paragraph (1)(a) are—

(a)where the United Kingdom type-examination as outlined in Part 1 of Schedule 2 (module B) is to be used, before being placed on the market, all marine equipment must be subject to—

(i)production-quality assurance as outlined in Part 2 of Schedule 2 (module D);

(ii)product-quality assurance as outlined in Part 3 of Schedule 2 (module E); or

(iii)product verification as outlined in Part 4 of Schedule 2 (module F);

(b)where sets of marine equipment are produced individually or in small quantities and not in series or in mass, the conformity assessment procedure may be the unit verification as set out in Part 5 of Schedule 2 (module G).]

(2) A manufacturer must undertake to fulfil any obligation arising from a quality system approved under regulation 12(2)(b) and must ensure that quality system is maintained.

(3) A manufacturer must ensure—

(a)its name,

(b)a type, batch or serial number or other element allowing identification of its product,

(c)its registered trade name or trade mark, and

(d)the address at which it can be contacted,

is on any equipment or, where that is not possible, on the packaging of that equipment or in a document accompanying that equipment or both, as appropriate.

(4) A manufacturer must provide with any equipment—

(a)clear instructions and all necessary information for that equipment to be installed and operated safely; and

(b)any other documentation required by international instruments.

(5) Where a manufacturer knows or has reason to believe that its equipment does not comply with applicable international standards, that manufacturer must—

(a)take immediate corrective measures to ensure that the equipment complies with applicable international standards;

(b)withdraw the equipment from the [F77United Kingdom] market; or

(c)issue a recall of the equipment.

(6) Where a manufacturer considers that equipment presents a risk, that manufacturer must immediately inform the [F78Secretary of State] of the risk and provide details of any non-compliance with applicable international standards and any action taken in accordance with paragraph (5).

(7) On request by [F79the Secretary of State], a manufacturer must provide to [F80to the Secretary of State]—

(a)samples of equipment approved by [F81an approved] body at the manufacturer's own cost; or

(b)access to such samples.

(8) This regulation applies to an importer or a distributor as if that person were a manufacturer where the importer or distributor—

(a)places equipment on the [F82United Kingdom] market or on board a ship under the importer or distributor's own name or trademark; or

(b)modifies equipment already placed on the [F83United Kingdom] market or on board a ship in such a way that compliance with applicable international standards may be affected.

(9) In this regulation—

“clear instructions” means instructions in a form and language which the user easily understands.

Textual Amendments

Obligations of an importerU.K.

21.  An importer which places on the [F84United Kingdom] market or on board a ship any equipment accompanied by a [F85United Kingdom] declaration of conformity under regulation 14 must ensure that—

(a)its name,

(b)registered trade name or trade mark, and

(c)the address at which it can be contacted,

is on the equipment or, where that is not possible, on the packaging of the equipment or in a document accompanying the equipment or both, as appropriate.

Textual Amendments

Obligations of an economic operatorU.K.

22.—(1) On receipt of a request from [F86the Secretary of State], an economic operator must identify any other economic operator—

(a)who has supplied it with equipment, or

(b)to whom it has supplied equipment,

during the relevant period.

(2) On receipt of a written request from [F87the Secretary of State], which includes the reasons for making the request, an economic operator must—

(a)provide [F88the Secretary of State] with all information and documents necessary to show that the equipment meets applicable international standards; and

(b)cooperate with [F89the Secretary of State] in any action it takes to eliminate risks posed by that equipment.

(3) Information and documents provided to [F90the Secretary of State] must be in a language easily understood by, or acceptable to, [F91the Secretary of State].

Textual Amendments

PART 6 U.K.Enforcement

Restricting, suspending or withdrawing [F92United Kingdom] conformity approvalU.K.

23.—(1) [F93An approved] body may by giving notice to the manufacturer restrict, suspend or withdraw EU conformity approval of equipment or a quality system where a manufacturer fails—

(a)to take corrective measures required under regulation 12(5); or

(b)to comply with regulation 16 or 20(1) to (6).

(2) Before issuing a notice under paragraph (1), [F94an approved] body must give the manufacturer an opportunity to make written representations.

(3) A notice under paragraph (1) must—

(a)be in writing;

(b)specify the date on which it is to take effect; and

(c)specify the grounds for the decision.

(4) [F95The approved] body must send a copy of any notice given under paragraph (1) to the Secretary of State.

Textual Amendments

Sample checksU.K.

24.  Where equipment approved by [F96an approved] body under regulation 12 is placed on the [F97United Kingdom] market or supplied for use in the United Kingdom but not yet placed on board a ship, the Secretary of State may carry out sample checks of that equipment to ensure it complies with the applicable international standards.

Textual Amendments

Defective EquipmentU.K.

25.—(1) The Secretary of State may—

(a)direct an economic operator to withdraw or recall defective equipment from the [F98United Kingdom] market;

(b)prohibit or restrict the extent to which an economic operator may place defective equipment on the [F99United Kingdom] market; or

(c)prohibit or restrict the use of defective equipment on ships.

(2) Before issuing a direction, prohibition or restriction, the Secretary of State must notify any economic operator in writing and give the economic operator, not less than 10 days, to make written representations.

(3) The Secretary of State may withdraw or vary a direction, prohibition or restriction.

(4) In this regulation—

“defective equipment” means equipment to which regulation 5(1) applies that is specified in Annex 1 of Merchant Shipping Notice MSN 1874 [F100Amendment 3] [F101or Annex 6 of Merchant Shipping Notice MSN 1874 Amendment 3] and complies with applicable international standards, but which, in the opinion of the Secretary of State—

(a)

may compromise the health and safety of the ship's crew, passengers or other persons; or

(b)

adversely affect the marine environment.

Textual Amendments

Offences and penaltiesU.K.

26.—(1) The owner and master of a ship are each guilty of an offence, where—

(a)equipment is placed on a ship otherwise than in compliance with regulation 5; or

(b)any of the restrictions or conditions imposed by a certificate issued under [F102regulation 10 are not complied with].

(2) It is an offence for a person—

(a)to affix a conformity mark to equipment which has not been granted EU conformity approval;

(b)to fail to comply with regulation 14, 15, 20, 21 or 22;

(c)to forge, counterfeit or otherwise alter, deface or remove any conformity mark or identification number affixed to equipment under these Regulations; or

(d)to fail to comply with a direction, prohibition or restriction given under regulation 25.

(3) A person guilty of an offence under this regulation is liable—

(a)on summary conviction—

(i)in England and Wales to a fine, and

(ii)in Scotland and Northern Ireland to a fine not exceeding the statutory maximum, or

(b)on conviction on indictment, to imprisonment for a term not exceeding two years or a fine, or both.

(4) Where a body corporate is guilty of an offence under this regulation and that offence is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, any director, manager, secretary or other similar officer of the body corporate or a person who was purporting to act in any such capacity, that person as well as the body corporate is guilty of an offence.

(5) Where the affairs of the body corporate are managed by its members, paragraph (4) applies in relation to the acts and defaults of a member in connection with that member's functions of management as if that member were a director of the body corporate.

(6) Where an offence under this regulation is committed by a Scottish partnership is proved to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner, that partner as well as the partnership is guilty of that offence.

(7) In any proceedings for an offence under these Regulations, it is a defence for the person charged to show that all reasonable steps had been taken by that person to ensure compliance with the provision concerned.

Textual Amendments

Powers to detainU.K.

27.—(1) A ship is liable to be detained where a surveyor of ships is satisfied that there is or has been a failure—

(a)to comply with regulation 5(1); or

(b)by the owner of a ship to comply with a direction issued under regulation 10(2).

(2) Section 284(1) to (6) and (8) of the Act (enforcing detention of ship) M6 applies to a ship which is liable to be detained under this regulation as if references to detention of a ship under the Act were references to detention of the ship in question under this regulation.

(3) Where a ship is liable to be detained under this regulation the person detaining the ship must serve on the master of the ship a detention notice which—

(a)states that a surveyor of ships is of the opinion that, in relation to that ship, there is a failure to comply with the requirements of regulation 5(1) or a direction issued under regulation 10(2);

(b)details the reasons that the surveyor is of the opinion those requirements of regulation 5(1) or a direction issued under regulation 10(2) are not met; and

(c)requires the terms of the notice to be complied with until the ship is released.

(4) Sections 96 and 97 of the Act (which relate to arbitration and compensation in connection with detention of a ship) apply in relation to a detention notice under this regulation as those sections apply to a detention notice under section 95 of the Act with the following modifications—

(a)the arbitrator must have regard in coming to a decision to any other matters not specified in the detention notice which appear to be relevant to whether or not the ship was liable to be detained under paragraph (1); and

(b)the arbitrator must state in the decision whether or not there was a valid basis for detention of the ship.

Marginal Citations

Application of powers of inspectors in relation to Government shipsU.K.

28.  Sections 258 to 266 of the Act M7 apply to these Regulations as if they were for all purposes made under section 85 of the Act and accordingly those sections apply in relation to Government ships.

Marginal Citations

M7These sections provide powers to inspect ships and their equipment, powers of inspectors in relation to premises and ships, for the service of improvement and prohibition notices and their reference to arbitration, compensation for invalid prohibition notices and offences for failing to comply with improvement and prohibition notices.

PART 7 U.K.Miscellaneous

Market SurveillanceU.K.

29.—(1) The Secretary of State must carry out market surveillance of equipment listed in [F103Annex 1 of Merchant Shipping Notice MSN 1874 Amendment 3].

(2) In this regulation—

“market surveillance” means the measures required under the EU market surveillance framework set out in Chapter III of Regulation (EC) No 765/2008 to ensure equipment placed on the market in the United Kingdom complies with applicable international standards.

Textual Amendments

ReviewU.K.

30.—(1) The Secretary of State must from time to time—

(a)carry out a review of these Regulations;

(b)set out the conclusions of the review in a report; and

(c)publish the report.

(2) In carrying out the review the Secretary of State must, so far as is reasonably practicable, have regard to how the Directive is implemented in other member States.

(3) The report must in particular—

(a)set out the objectives intended to be achieved by F104... these Regulations;

(b)assess the extent to which those objectives are achieved; and

(c)assess whether those objectives remain appropriate and, if so, the extent to which they could be achieved with a system that imposes less regulation.

(4) The first report under this regulation must be published before the end of the period of five years beginning with the day on which these Regulations come into force.

(5) Reports under this regulation must afterwards be published at intervals not exceeding five years.

Textual Amendments

Amendment of RegulationsU.K.

31.  The Regulations specified in the Schedule are amended in accordance with the Schedule.

RevocationsU.K.

32.—(1) The following instruments are revoked—

(a)The Merchant Shipping (Delegation of Type Approval) Regulations 1996 M8;

(b)The Merchant Shipping (Marine Equipment) Regulations 1999 M9; and

(c)The Merchant Shipping (Marine Equipment) (Amendment) Regulations 2009 M10.

(2) Any certificate or declaration of conformity issued or mark of conformity affixed under Part III of the Merchant Shipping (Marine Equipment) Regulations 1999 which is valid immediately before the day on which these Regulations come into force has effect on and after that date as if that certificate or declaration were issued or that mark were affixed under these Regulations.

Marginal Citations

M9S.I. 1999/1957 as amended by S.I. 2001/1638, 2004/302, 2004/1266, 2009/2021 and 2011/1043.

Signed by authority of the Secretary of State for Transport

John Hayes

Minister of State

Department for Transport

We consent

Guto Bebb

Stephen Barclay

Two of the Lords Commissioners of Her Majesty's Treasury

Regulation 31

[F105SCHEDULE 1] U.K.Amendment of Regulations

Textual Amendments

The Merchant Shipping (Prevention of Oil Pollution) Regulations 1996U.K.

F1061.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

The Merchant Shipping (Crew Accommodation) Regulations 1997U.K.

2.  In regulation 36 of the Merchant Shipping (Crew Accommodation) Regulations 1997 (equipment to be of an approved type) M11, for paragraph (2), substitute—

“(2) In this regulation—

“approved” means, in relation to an item of equipment, approved under the Merchant Shipping (Marine Equipment) Regulations 2016.”.

Marginal Citations

The Merchant Shipping (Fire Protection: Small Ships) Regulations 1998U.K.

3.  In regulation 1 of the Merchant Shipping (Fire Protection: Small Ships) Regulations 1998 (Interpretation) M12, for the definition of “approved”, substitute—

““approved” means, in relation to any equipment or arrangement, approved under the Merchant Shipping (Marine Equipment) Regulations 2016;”.

Marginal Citations

M12S.I. 1998/1011. The definition of “approved” was substituted by S.I. 1999/1957, regulation 3, Schedule 1, paragraph 3.

The Merchant Shipping (Fire Protection: Large Ships) Regulations 1998U.K.

F1074.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

The Merchant Shipping (Radio Installations) Regulations 1998U.K.

5.  In regulation 6(4) of the Merchant Shipping (Radio Installations) Regulation 1998 (performance standards) M13, for “the Merchant Shipping (Marine Equipment) Regulations 1999” substitute “ the Merchant Shipping (Marine Equipment) Regulations 2016 ”.

Marginal Citations

The Merchant Shipping (Life-Saving Appliances for Passenger Ships other than Ships of Classes III to VI(A)) Regulations 1999U.K.

F1086.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

The Merchant Shipping (Life-Saving Appliances for Passenger Ships of Classes III to VI(A)) Regulations 1999U.K.

7.  In regulation 10 of the Merchant Shipping (Life-Saving Appliances for Passenger Ships of Classes III to VI(A)) Regulations 1999 (approval and replacement of appliances and arrangements) M14, for paragraph (1), substitute—

“(1) Life-saving appliances and arrangements required by these Regulations shall be of a type which has been approved under the Merchant Shipping (Marine Equipment) Regulations 2016.”.

Marginal Citations

The Fishing Vessels (EC Directive on Harmonised Safety Regime) Regulations 1999U.K.

8.  In Schedule 4 to the Fishing Vessels (EC Directive on Harmonised Safety Regime) Regulations 1999 M15—

(a)in paragraph 39, for “the Merchant Shipping (Marine Equipment) Regulations 1999” substitute “ the Merchant Shipping (Marine Equipment) Regulations 2016 ”; and

(b)in paragraph 59, for “Council Directive 96/98/EC on marine equipment, as amended by Commission Directives 98/35/EC, 2001/53/EC and 2002/75/EC”, substitute “ Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC M16 ”.

Marginal Citations

M16O.J. L 257, 28.8.2014, p.146.

The Merchant Shipping (Radio) (Fishing Vessels) Regulations 1999U.K.

9.  In regulation 7(1) of the Merchant Shipping (Radio) (Fishing Vessels) Regulations 1999 (performance standards) M17, for paragraph (c), substitute—

“(c)in either case, be of a type approved under the Merchant Shipping (Marine Equipment) Regulations 2016;”.

Marginal Citations

The Merchant Shipping (Fire Protection) Regulations 2003U.K.

F10910.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

The Merchant Shipping (High Speed Craft) Regulations 2004U.K.

F11011.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

The Merchant Shipping (Fees) Regulations 2006U.K.

12.  In the Table in Schedule 1 to the Merchant Shipping (Fees) Regulations 2006 (fees under the Merchant Shipping Act 1995) M18, for the entry relating to the Merchant Shipping (Marine Equipment) Regulations 1999, substitute—

(a)in column 1, “the Merchant Shipping (Marine Equipment) Regulations 2016”; and

(b)in column 2, “S.I. 2016/1025”.

Marginal Citations

M18S.I. 2006/2055. There are amendments to these Regulations, but none is relevant.

The Merchant Shipping and Fishing Vessels (Provision and Use of Work Equipment) Regulations 2006U.K.

13.  In the Table in Schedule 1 of the Merchant Shipping and Fishing Vessels (Provision and Use of Work Equipment) Regulations 2006 (instruments which give effect to Community Directives concerning the safety of products) M19, omit the entry for the Merchant Shipping (Marine Equipment) Regulations 1999 and, in the appropriate place, add—

(a)in column 1, “The Merchant Shipping (Marine Equipment) Regulations 2016”, and

(b)in column 2, “S.I. 2016/1025”.

Marginal Citations

The Legislation and Regulatory Reform (Regulatory Functions) Order 2007U.K.

14.  In Part 2 of the Schedule to the Legislation and Regulatory Reform (Regulatory Functions) Order 2007 (regulatory functions) M20, under the heading “Marine Transport”, omit “Merchant Shipping (Marine Equipment) Regulations 1999 and, in the appropriate place, add “ Merchant Shipping (Marine Equipment) Regulations 2016 ”.

Marginal Citations

M20S.I. 2007/3544. There are amendments to his Order, but none is relevant.

The Merchant Shipping (Prevention of Pollution by Sewage and Garbage from Ships) Regulations 2008U.K.

15.  In regulation 21(1)(a) of the Merchant Shipping (Prevention of Pollution by Sewage and Garbage from Ships) Regulations 2008 (sewage systems) M21, for “the Merchant Shipping (Marine Equipment) Regulations 1999” substitute “ the Merchant Shipping (Marine Equipment) Regulations 2016 ”.

Marginal Citations

The Merchant Shipping (Prevention of Air Pollution from Ships) Regulations 2008U.K.

16.—(1) The Merchant Shipping (Prevention of Air Pollution from Ships) Regulations 2008 M22 are amended as follows.

(2) In regulation 21(7) (nitrogen oxides), for “Merchant Shipping Notice 1734(M + F) or Merchant Shipping Notice 1735 (M + F) as appropriate”, substitute “ the Merchant Shipping (Marine Equipment) Regulations 2016 ”.

(3) In regulation 24 (shipboard incineration), for “Merchant Shipping Notice 1734 (M + F)”, wherever occurring, substitute “ the Merchant Shipping (Marine Equipment) Regulations 2016 ”.

Marginal Citations

Regulation 4

[F111SCHEDULE 2U.K.United Kingdom Conformity Assessment Procedures

Textual Amendments

PART 1U.K.

United Kingdom Type-Examination (Module B)U.K.

1.  United Kingdom type-examination is the part of a conformity assessment procedure in which an approved body examines the technical design of marine equipment and verifies and attests that the technical design of the marine equipment meets the applicable requirements of these Regulations.

2.  United Kingdom type-examination may be carried out in either of the following ways—U.K.

(a)examination of a specimen, representative of the production envisaged, of the complete product (production type);

(b)assessment of the adequacy of the technical design of the marine equipment through examination of the technical documentation and supporting evidence referred to in paragraph 3, plus examination of specimens, representative of the production envisaged, of one or more critical parts of the product (combination of production type and design type).

3.—(1) The manufacturer must lodge an application for United Kingdom-type examination with a single approved body of its choice.U.K.

(2) The application must include—

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)the technical documentation;

(e)the specimens representative of the production envisaged. The approved body may request further specimens if needed for carrying out the test programme;

(f)the supporting evidence for the adequacy of the technical solution; this supporting evidence must—

(i)mention any documents that have been used;

(ii)include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility.

4.  The technical documentation referred to in paragraph 3(2)(c) must—U.K.

(a)make it possible to assess the conformity of the marine equipment with the applicable international standards and must include an adequate analysis and assessment of the risks;

(b)specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the marine equipment;

(c)contain, wherever applicable, at least the following elements—

(i)a general description of the marine equipment;

(ii)conceptual design and manufacturing drawings and schemes of components , sub-assemblies and circuits;

(iii)descriptions and explanations necessary for the understanding of those drawings and schemes and of the operation of the marine equipment;

(iv)a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with these Regulations, together with a description of the solutions adopted to meet those requirements;

(v)results of design calculations made and examinations carried out;

(vi)test reports.

5.—(1) The approved body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the marine equipment.U.K.

(2) When examining a specimen, the approved body must—

(a)verify that the specimen has been manufactured in conformity with the technical documentation;

(b)identify the elements which have been designed in accordance with the relevant applicable requirements of these Regulations and testing standards, as well as the elements which have been designed without applying the relevant provisions of those standards;

(c)carry out appropriate examinations and tests, or have them carried out in accordance with these Regulations;

(d)agree with the manufacturer on a location where the examinations and tests will be carried out.

6.  The approved body must draw up an evaluation report that records the activities taken in accordance with paragraph 5 and their outcomes and, without prejudice to its obligations in relation to the Secretary of State, the approved body may disclose the content of that report, in full or in part, only with the agreement of the manufacturer.U.K.

7.—(1) Where the type meets the requirements of the applicable international standards that apply to the marine equipment concerned, the approved body must issue a United Kingdom type-examination certificate to the manufacturer, which must contain—U.K.

(a)the name and address of the manufacturer;

(b)the conclusions of the examination;

(c)the conditions (if any) for its validity;

(d)all relevant information to allow the conformity of manufactured products with the examined type to be evaluated and to allow for in-service control; and

(e)the necessary data for identification of the approved type.

(2) The United Kingdom-type examination certificate referred to in sub-paragraph (1) may have one or more annexes attached.

(3) Where the type does not satisfy the applicable requirements of the applicable international standards, the approved body must refuse to issue a United Kingdom-type certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

8.—(1) Where the approved type no longer complies with the applicable requirements, the approved body must determine whether further testing or a new conformity assessment procedure is necessary.U.K.

(2) A manufacturer must inform the approved body that holds the technical documentation relating to the United Kingdom-type examination certificate of all modifications to the approved type that may affect the conformity of the marine equipment with the requirements of the applicable international standards or the conditions for validity of the certificate; such modifications require additional approval in the form of an addition to the original United Kingdom-type examination certificate.

9.—(1) Each approved body must inform the Secretary of State about all the United Kingdom type-examination certificates and any additions to those certificates which it has issued or withdrawn, and must, periodically or on request, make available to the Secretary of State the list of such certificates and any additions to those certificates which it has refused, suspended or otherwise restricted.U.K.

(2) Each approved body must inform the other approved bodies about all the United Kingdom-type examination certificates and any additions to those certificates which it has refused, withdrawn, suspended or otherwise restricted.

(3) An approved body must, on request, provide the other approved bodies with a copy of the United Kingdom type-examination certificates and any additions to those certificates which it has issued.

(4) An approved body must keep a copy of United Kingdom-type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of that certificate.

(5) The Secretary of State may, on request, obtain—

(a)a copy of a United Kingdom-type examination certificate from an approved body that it has issued, refused, suspended or restricted;

(b)a copy of the technical documentation and the results of the examinations carried out by approved bodies.

10.  A manufacturer must keep a copy of the United Kingdom type-examination certificate, its annexes and additions together with the technical documentation at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and, in no case for a period shorter than the expected life of the marine equipment concerned.U.K.

11.  The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 8(2) and 10, provided that they are specified in the mandate.U.K.

PART 2U.K.

Conformity to type based on quality assurance of the production process (Module D)U.K.

12.  Conformity to type based on quality assurance of the production process is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 13 and 16 and it is the manufacturer's sole responsibility to ensure and declare that the marine equipment concerned is in conformity with the type described in the United Kingdom type-examination certificate and that it satisfies the requirements of the applicable international standards that apply to it.

ManufacturingU.K.

13.  A manufacturer must operate an approved quality system for production, final product inspection and testing of the products concerned as specified in paragraph 14, and be subject to surveillance as specified in paragraph 15.

Quality systemU.K.

14.—(1) A manufacturer that seeks to obtain approval for its quality system for manufacture must lodge an application for assessment with an approved body of its choice.

(2) The application must include—

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, its name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the marine equipment category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the United Kingdom type-examination certificate.

(3) The quality system must ensure that the products are in conformity with the type described in the United Kingdom type-examination certificate and that they comply with the applicable international standards that apply to them.

(4) The manufacturer must document in the form of written policies, procedures and instructions all the elements, requirements and provisions that it has adopted.

(5) The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records and must include an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(c)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(d)the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned; and

(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.

(6) The approved body must assess the quality system to determine whether it satisfies the requirements set out in sub-paragraphs (3), (4) and (5).

(7) The auditing team of the approved body must include members with experience in quality management and must include at least one member with —

(a)experience of evaluation in the relevant marine equipment field;

(b)experience of the marine technology concerned;

(c)knowledge of the applicable requirements of the applicable international standards.

(8) The audit carried out by the approved body must include —

(a)an assessment visit to the manufacturer's premises, and

(b)a review of the technical documentation of the approved type in order to verify the manufacturer's ability to identify the applicable international standards and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(9) The approved body must notify the manufacturer of its decision and that notification must contain the conclusions of the audit and the reasoned assessment decision.

(10) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and maintain the quality system so that it remains adequate and efficient.

(11) The manufacturer must keep the approved body that has approved the quality system informed of any intended changes to the quality system.

(12) Where the manufacturer proposes changes to the quality system, the approved body must—

(a)evaluate any proposed changes;

(b)decide whether the modified quality system will continue to satisfy the requirements set out in sub-paragraphs (3), (4) and (5) or whether a re-assessment is necessary;

(c)notify the manufacturer of its decision and that notification must contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved bodyU.K.

15.—(1) The manufacturer must allow the approved body access to the manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned.

(2) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and must provide the manufacturer with an audit report.

(3) The approved body may make unannounced visits to the manufacturer and, during such visits may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly.

(4) Where the approved body has made an unannounced visit to the manufacturer, the approved body must provide the manufacturer with a visit report and, if tests have been carried out during such a visit, with a test report.

United Kingdom conformity marking and declaration of conformityU.K.

16.—(1) The manufacturer must affix the United Kingdom conformity mark and the identification number of the approved body that has approved the quality system to each individual product that is in conformity with the type described in the United Kingdom-type examination certificate and that satisfies the applicable international standards.

(2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity marking has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

(3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request.

(4) The manufacturer must keep at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned—

(a)the documentation referred to in paragraph 14(2);

(b)any change referred to in paragraph 14(11), which has been approved;

(c)the decisions and reports of the approved body referred to in paragraph 14(12)(c), 15(2) and 15(4).

(5) Each approved body must inform the Secretary of State of quality system approvals that it has issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals that it has refused, suspended or otherwise restricted.

(6) Each approved body must inform the other United Kingdom approved bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted and, on request, of quality system approvals which it has issued.

Authorised representativeU.K.

17.  The manufacturer's obligations set out in paragraphs 14(1), (2), (11) and (12) and 16(1), (2), (3) and (4) may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.

PART 3U.K.

Conformity to type based on product quality assurance (Module E)U.K.

18.  Conformity to type based on product quality assurance is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 19 and 22 and it is the manufacturer's sole responsibility to ensure and declare that the marine equipment concerned is in conformity with the type described in the United Kingdom type-examination certificate and that it satisfies the applicable international standards that apply to it.

ManufacturingU.K.

19.  A manufacturer must operate an approved quality system for final product inspection and testing of the products concerned as specified in paragraph 20, and must be subject to surveillance as specified in paragraph 21.

Quality systemU.K.

20.—(1) A manufacturer must lodge an application for assessment of its quality system for the marine equipment concerned with an approved body of its choice.

(2) The application must include —

(a)the name and address of the manufacturer and if the application is lodged by the authorised representative, its name and address as well;

(b)a written declaration that the same application has not been lodged with any other approved body;

(c)all relevant information for the marine equipment category envisaged;

(d)the documentation concerning the quality system;

(e)the technical documentation of the approved type and a copy of the United Kingdom type-examination certificate.

(3) The quality system must ensure compliance of the products with the type described in the United Kingdom type-examination certificate and with the applicable international standards.

(4) The manufacturer must document in the form of written policies, procedures and instructions all the elements, requirements and provisions that it has adopted.

(5) The quality system documentation must enable a consistent interpretation of the programmes, plans, manuals and records and must include an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality;

(b)the examinations and tests that will be carried out after manufacture;

(c)the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned;

(d)the means of monitoring the effective operation of the quality system.

(6) The approved body must assess the quality system to determine whether it satisfies the requirements set out in sub-paragraphs (3), (4) and (5).

(7) The auditing team of the approved body must include members with experience in quality management systems and must include at least one member with—

(a)experience of evaluation in the relevant marine equipment field;

(b)experience of the marine equipment technology concerned;

(c)knowledge of the applicable international standards.

(8) The audit carried out by the approved body must include—

(a)an assessment visit to the manufacturer's premises, and

(b)a review of the technical documentation of the approved type in order to verify the manufacturer's ability to identify the applicable international standards and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(9) The approved body must notify the manufacturer of its decision and that notification must contain the conclusions of the audit and the reasoned assessment decision.

(10) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(11) The manufacturer must keep the approved body that has approved the quality system informed of any intended change to the quality system.

(12) Where the manufacturer proposes changes to the quality system, the approved body must—

(a)evaluate any proposed changes;

(b)decide whether the modified quality system will continue to satisfy the requirements set out in sub-paragraphs (3), (4) and (5) or whether a re-assessment is necessary;

(c)notify the manufacturer of its decision and that notification must contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved bodyU.K.

21.—(1) The manufacturer must allow the approved body access to the manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned.

(2) The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system, and must provide the manufacturer with an audit report.

(3) The approved body may make unannounced visits to the manufacturer and, during such visits may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly.

(4) Where the approved body has made an unannounced visit to the manufacturer, the approved body must provide the manufacturer with a visit report and, if tests have been carried out during such a visit, with a test report.

United Kingdom conformity marking and declaration of conformityU.K.

22.—(1) The manufacturer must affix the United Kingdom conformity mark and the identification number of the approved body that has approved the quality system to each individual product that is in conformity with the type described in the United Kingdom type-examination certificate and that satisfies the applicable international standards.

(2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

(3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request.

(4) The manufacturer must keep at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned—

(a)the documentation referred to in paragraph 20(2);

(b)the change referred to in paragraph 20(12), as approved;

(c)the decisions and reports of the approved body referred to in paragraphs 20(12), 21(2) and 21(4).

(5) Each approved body must inform the Secretary of State of quality system approvals that it has issued or withdrawn and must, periodically or on request, make available to the Secretary of State the list of quality system approvals that it has refused, suspended or otherwise restricted.

(6) Each approved body must inform the other United Kingdom approved bodies of quality system approvals which it has refused, suspended or withdrawn, and, on request, of quality system approvals which it has issued.

Authorised representativeU.K.

23.  The manufacturer's obligations set out in paragraphs 20(1), (2), (10) and (11) and 22(1), (2), (3) and (4) may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.

PART 4U.K.

Conformity to type based on product verification (Module F)U.K.

24.  Conformity to type based on product verification is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 25, 28(1) and 29 and it is the manufacturer's sole responsibility to ensure and declare that the products concerned, which have been subject to the verification provisions set out in paragraph 26, are in conformity with the type described in the United Kingdom-type examination certificate and that they satisfy the applicable international standards.

ManufacturingU.K.

25.  A manufacturer must take all measures necessary so that the manufacturing procedure and its monitoring ensure conformity of the manufactured products with the type described in the United Kingdom type-examination certificate and with applicable international standards.

VerificationU.K.

26.—(1) An approved body of the manufacturer's choice must carry out appropriate examinations and tests in order to check the conformity of the products with the approved type described in the United Kingdom-type examination certificate and with applicable international standards.

(2) The examinations and tests to check conformity of the products with the applicable international standards must be carried out, at the manufacturer's choice, either by examination and testing of every product as specified in paragraph 27 or by examination and testing of the products on a statistical basis as specified in paragraph 28.

Verification of conformity by examination and testing of every productU.K.

27.—(1) Where verification is to be by examination and testing of every product, all products must be individually examined and tested in accordance with these Regulations, in order to verify conformity with the approved type described in the United Kingdom-type examination certificate and with applicable international standards.

(2) An approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to each approved product or have it affixed under its responsibility.

(3) The manufacturer must keep the certificates of conformity available for inspection by the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

Statistical verification of conformityU.K.

28.—(1) Where verification is to be by examination and testing of the products on a statistical basis, the manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure the homogeneity of each lot produced, and must present its products for verification in the form of homogeneous lots.

(2) A random sample must be taken from each lot and all products in a sample must be individually examined and tested in accordance with these Regulations, in order to ensure their conformity with applicable international standards and to determine whether the lot is accepted or rejected.

(3) If a lot is accepted—

(a)all products of the lot must be considered approved, except for those products from the sample that have been found not to satisfy the tests;

(b)the approved body must issue a certificate of conformity in respect of the examinations and tests carried out, and must affix its identification number to each approved product or have it affixed under its responsibility;

(c)the manufacturer must keep the certificate of conformity at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

(4) If a lot is rejected, the approved body or the Secretary of State must take appropriate measures to prevent that lot being placed on the United Kingdom market and, in the event of the frequent rejection of lots, the approved body may suspend the statistical verification and take appropriate measures.

United Kingdom conformity marking and declaration of conformityU.K.

29.—(1) The manufacturer must affix the United Kingdom conformity mark and, under the responsibility of the approved body referred to in paragraph 26, the latter's identification number to each individual product that is in conformity with the approved type described in the United Kingdom type-examination certificate and that satisfies applicable international standards.

(2) The manufacturer must draw up a written United Kingdom declaration of conformity for each product model and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

(3) The United Kingdom declaration of conformity must identify the marine equipment model for which it has been drawn up and a copy of the United Kingdom declaration of conformity must be made available to the Secretary of State upon request.

(4) If the approved body agrees, under its responsibility, the manufacturer may affix the approved body's identification number to the products during the manufacturing process.

Authorised representativeU.K.

30.  The manufacturer's obligations under this Part may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate but an authorised representative may not fulfil the manufacturer's obligations set out in paragraphs 25 and 28(1).

PART 5U.K.

Conformity based on unit verification (Module G)U.K.

31.  Conformity based on unit verification is a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 32, 33 and 35 and it is the manufacturer's sole responsibility to ensure and declare that the product concerned, which has been subject to the verification provisions set out in paragraph 34, is in conformity with the applicable international standards.

Technical documentationU.K.

32.—(1) A manufacturer must draw up the technical documentation and make it available to the approved body referred to in paragraph 34.

(2) The technical documentation referred to in sub-paragraph (1) must—

(a)make it possible to assess the product's conformity with the relevant requirements of these Regulations and must include an analysis and assessment of the risks;

(b)specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product;

(c)contain, wherever applicable, at least the following elements—

(i)a general description of the product;

(ii)conceptual design and manufacturing drawings and schemes of component, sub-assemblies and circuits;

(iii)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the product;

(iv)a list of the requirements and testing standards which are applicable to the marine equipment concerned in accordance with these Regulations and descriptions of the solutions adopted to meet those requirements;

(v)results of design calculations made and examinations carried out;

(vi)test reports.

(3) A manufacturer must keep the technical documentation at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

ManufacturingU.K.

33.  A manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured product with applicable international standards.

VerificationU.K.

34.—(1) An approved body of the manufacturer's choice must carry out appropriate examinations and tests in accordance with these Regulations in order to check the conformity of the product with applicable international standards.

(2) The approved body must issue a certificate of conformity in respect of the examinations and tests carried out and must affix its identification number to the approved product or have it affixed under its responsibility.

(3) The manufacturer must keep the certificates of conformity at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned.

United Kingdom conformity marking and declaration of conformityU.K.

35.—(1) The manufacturer must affix the United Kingdom conformity mark, under the responsibility of the approved body referred to in paragraph 34, the latter's identification number, to each product that satisfies the applicable international standards.

(2) The manufacturer must draw up a written declaration of United Kingdom declaration of conformity and keep it at the disposal of the Secretary of State for a period of at least 10 years after the United Kingdom conformity mark has been affixed on the last product manufactured and in no case for a period shorter than the expected life of the marine equipment concerned. The United Kingdom declaration of conformity must identify the product for which it has been drawn up.

(3) A copy of the United Kingdom declaration of conformity must be made available to the Secretary of State on request.

Authorised representativeU.K.

36.  The manufacturer's obligations set out in paragraphs 32 and 35 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.]

Regulation 4

[F111SCHEDULE 3U.K.Requirements to be met by Conformity Assessment Bodies in order to become Approved Bodies

1.  In order to be designated as an approved body, a conformity assessment body must meet the requirements set out in paragraphs 2 to 19.U.K.

2.  A conformity assessment body must be established in the United Kingdom and have legal personality.U.K.

3.  A conformity assessment body must be a third party body independent of the organisation or the marine equipment which it assesses. A body belonging to a business association or professional federation representing businesses involved in the design, manufacturing, provision, assembly, use or maintenance of marine equipment which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered a conformity assessment body.U.K.

4.—(1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, or an authorised representative of a manufacturer, supplier, installer, purchaser, owner, user or maintainer of the marine equipment which is assessed.U.K.

(2) Sub-paragraph (1) does not preclude the use of products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that marine equipment, or represent the parties engaged in those activities. They must not engage in any activity (including consultancy services) that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated.U.K.

6.  A conformity assessment body must ensure that the activities of its subsidiaries or sub-contractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.U.K.

7.  A conformity assessment body and its personnel must carry out conformity assessment activities with the highest degree of professional integrity and the requisite competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, particularly with regard to persons or groups of persons who have an interest in the results of those activities.U.K.

8.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been designated, whether that assessment is carried out by the body itself or on its behalf and under its responsibility.U.K.

9.  A conformity assessment body must have at its disposal—U.K.

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of and the ability to reproduce those procedures, and have appropriate policies and procedures in place that distinguish between tasks it carries out as an approved body and other activities;

(c)procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the marine equipment technology in question and the mass or serial nature of the production process.

10.  A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to the necessary equipment and facilities.U.K.

11.  The personnel responsible for carrying out conformity assessment must have—U.K.

(a)sound technical and vocational training, covering all conformity assessment activities in relation to which the conformity assessment body has been designated;

(b)satisfactory knowledge of the requirements of the assessments which the conformity assessment body carries out, and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the applicable requirements and testing standards and of the applicable provisions of these Regulations; and

(d)the ability to draw up certificates, records and reports demonstrating that the assessments have been carried out.

12.  A conformity assessment body must be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities.U.K.

13.  The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities must not depend on the number of assessments carried out or on the results of those assessments.U.K.

14.  A conformity assessment body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities.U.K.

15.  A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations, and that proprietary rights are protected.U.K.

16.  Paragraph 15 does not prevent the personnel from providing the information to the Secretary of State.U.K.

17.  A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities, are informed of the relevant standardisation activities and the activities of any approved body co-ordination group that may be established and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.U.K.

18.  A conformity assessment body must meet the requirements of standard EN ISO/IEC 17065:2012.U.K.

19.  A conformity assessment body must ensure that testing laboratories used for conformity assessment purposes meet the requirements of standard EN ISO/IEC 17025:2017.]U.K.

Regulation 4

[F111SCHEDULE 4U.K.Designation Procedure

Application for designationU.K.

1.—(1) An application by a conformity assessment body to become an approved body must be made to the Secretary of State and be accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment module or modules in respect of which the conformity assessment body claims to be competent;

(iii)the marine equipment for which that body claims to be competent; and

(iv)either—

(aa)an accreditation certificate; or

(bb)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(2) The Secretary of State must be satisfied that that the conformity assessment body meets the approved body requirements and may accept an accreditation certificate, provided in accordance with paragraph 1(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

Designation procedureU.K.

2.  The Secretary of State may designate as approved bodies only those conformity assessment bodies which have satisfied the requirements set out in Schedule 3.

Identification numbers and lists of approved bodiesU.K.

3.  The Secretary of State must—

(a)assign an identification number to each approved body;

(b)make and maintain an up-to-date public list of approved bodies, which will include the identification numbers that have been allocated to them and the conformity assessment activities that they carry out.]

Regulation 14

[F111SCHEDULE 5U.K.United Kingdom Declaration of Conformity

1.  A United Kingdom declaration of conformity must provide—U.K.

(a)the unique identification number of the marine equipment in respect of which the declaration of conformity is issued;

(b)the name and address of the manufacturer;

(c)a statement that the declaration of conformity is issued under the sole responsibility of the manufacturer;

(d)the object of the declaration (identification of marine equipment allowing traceability; it may, where necessary for the identification of the marine equipment, include an image);

(e)that the object of the declaration described in sub-paragraph (d) is in conformity with the applicable international standards;

(f)references to the applicable international standards used or references to the specifications in relation to which conformity is declared;

(g)details of the approved body (name, number) which performed the intervention (details of the intervention) and issued the certificate

(h)any additional information;

(i)a statement that the declaration of conformity has been signed for, and on behalf of the approved body in question, together with the name of the place it was signed and the date of its issue, and the name, function and signature of the person making the statement.]

Explanatory Note

(This note is not part of the Regulations)

These Regulations implement Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L257, 28.8.2014, p. 146) (“the Directive”).

Part 1 (regulations 1 to 4) contains introductory provisions and a power to designate notified and nominated bodies. Regulation 2 contains interpretation provisions. Regulation 3 applies the Regulations to all United Kingdom ships wherever they may be. Regulation 4 gives the Secretary of State a power to designate notified and nominated bodies to carry out conformity assessment procedures. These procedures assess and confirm that equipment complies with the relevant design, construction and performance standards, ensuring uniform levels of safety and environmental protection are achieved.

Part 2 (regulations 5 to 10) provides for requirements to apply to equipment placed on board a ship and for exemptions from those requirements.

Regulation 5 requires equipment placed on board a ship to meet the design, construction and performance standards specified in Annexes 1 to 3 of Merchant Shipping Notice MSN 1874 and to be approved in accordance with the conformity assessment procedures in Parts 3 and 4 of the Regulations. Regulation 6 sets out the manner in which regulations 7 to 9 apply. Regulations 7 to 9 enable the Secretary of State to allow equipment that does not meet applicable international standards to be placed on board a ship in certain specified circumstances, subject to any restrictions or conditions imposed. Regulation 10 requires the Secretary of State to inspect equipment on a ship that transfers to the UK Register to ensure the equipment complies with its safety certificates and with applicable international standards or is equivalent to equipment that complies with those standards.

Part 3 (regulations 11 to 17) makes provision for EU conformity procedures and related matters.

Regulation 11 provides for applications to notified bodies for EU conformity approval of equipment following the conformity procedures set out in Annex II of the Directive. Regulation 12 sets out the approval procedure for notified bodies and prescribes (also by reference to Annex II of the Directive) the requirements that must be fulfilled for granting EU conformity approval. Regulation 13 provides for the amendment of conformity approvals. Regulations 14 and 15 require manufacturers of equipment to issue declarations of conformity and affix conformity marks as prescribed. Regulation 16 requires a manufacturer located outside the EU to appoint an authorised representative situated in the EU.

Part 4 (regulations 17 and 18) makes provision for conformity approval of equipment on UK ships to which EU conformity approval procedures do not apply and for related matters.

Regulation 17 requires a manufacturer to apply to a nominated body for conformity approval of equipment to be placed on board a domestic passenger ship or fishing vessel in accordance with the procedures set out in Part II of Merchant Shipping Notice 1874. Regulation 18 sets out the approval procedures for a nominated body and the requirements that must be fulfilled for conformity approval to be granted by reference to Merchant Shipping Notice 1874.

Part 5 (regulations 19 to 22) sets out obligations on economic operators.

Regulation 19 sets out the manner in which regulations 20 to 22 apply. Regulation 20 imposes obligations on manufacturers during and after the EU conformity approval process and applies these obligations to distributors and importers in specified circumstances. Regulation 21 imposes an obligation on importers which place equipment on the market. Regulation 22 imposes obligations on economic operators generally to comply with certain requests from market surveillance authorities and competent national authorities.

Part 6 (regulations 23 to 28) makes provision for enforcement.

Regulation 23 enables notified bodies to suspend or withdraw their EU conformity approvals in certain circumstances. Regulations 24 allows the Secretary of State to carry out sample checks of equipment for market surveillance purposes. Regulation 25 enables the Secretary of State to take action where equipment complies with applicable international standards, but is nonetheless considered a threat to the safety of persons on board a ship or to the marine environment. Regulation 26 creates offences and provides penalties for breach of these Regulations, and provides a “reasonable steps” defence for those offences. Regulation 27 provides for the detention of ships in certain circumstances. Regulation 28 enables the enforcement powers in sections 258 to 266 of the Merchant Shipping Act 1995 to be used in relation to Government ships.

Part 7 (regulations 29 to 32) contains miscellaneous provisions.

Regulation 29 requires the Secretary of State to carry out market surveillance in accordance with the EU market surveillance framework. Regulation 30 requires the Secretary of State to review the operation and effect of the Regulations and publish a report within 5 years after they come into force and every five years after that. Following a review, it will fall to the Secretary of State to consider whether the Regulations should continue in force with or without amendment. A further instrument would be needed to revoke the Regulations. Regulation 31 introduces the Schedule which makes consequential amendments to other legislation. Regulation 32 revokes the Merchant Shipping (Delegation of Type Approval) Regulations 1996, the Merchant Shipping (Marine Equipment) Regulations 1999 and the Merchant Shipping (Marine Equipment) (Amendment) Regulations 2009; and makes a savings provision in respect of the revoked Regulations for equipment placed on board a ship before these Regulations come into force.

An impact assessment of the effect of these Regulations on the cost to business is published with the Explanatory Memorandum and Transposition Note alongside this instrument on www.legislation.gov.uk.

Merchant Shipping Notices are published by the Maritime and Coastguard Agency. Copies may be downloaded from the MCA's website https://www.gov.uk/government/organisations/maritime-and-coastguard-agency or by e-subscription from mnotices@ecgroup.co.uk with ‘Subscribe’ in the subject heading, or from M-Notices Subscriptions, P.O. Box 362, Europa Park, Grays Essex RM17 9AY, tel 01375 484548, fax 01375 484556.

A copy of the Directive is available on the website, http://eur-lex.europa.eu, and copies of the international instruments can be obtained from the International Maritime Organisation (IMO) at www.imo.org/Publications, by e-mail from sales@imo.org or by post from the IMO, 4 Albert Embankment, London, SE1 7SR, tel +44 (0)20 7735 7611, fax +44 (0)20 7587 3241 as a priced publication.