The Rail Safety (Amendment etc.) (EU Exit) Regulations 2019

PART 4 E+W+S Amendments to retained direct EU legislation in respect of Great Britain

CHAPTER 1 E+W+S Safety certificates and authorisations

Amendments to Commission Regulation (EU) No 1158/2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety certificates E+W+S

12.—(1) Commission Regulation (EU) No 1158/2010 on a common safety method for assessing conformity with the requirements for obtaining railway safety certificates is amended as follows.

(2) Omit Article 1 (subject matter).

(3) In Article 2 (definitions)—

(a) for “definition” substitute “ definitions ”;

(b) at the end of the definition of “supervision”, insert—

“;

“Intergovernmental Commission” has the meaning provided in section 49(1) of the Channel Tunnel Act 1987;

“national safety authority” means one or both of—

(a) a safety authority; and

(b) the safety authority for the tunnel system as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

“Part A safety certificate” and “Part B safety certificate” have the meanings provided by the Railways and Other Guided Transport Systems (Safety) Regulations 2006 for “Part A of a safety certificate” and “Part B of a safety certificate” respectively.”.

(4) In Article 3 (procedures for assessing applications)—

(a) for paragraph 1, substitute—

“1.   When examining applications for both Part A safety certificates and Part B safety certificates, national safety authorities shall apply the procedure set out in Annex I to this Regulation for assessing their conformity with requirements for safety certificates issued in accordance with regulations 7, 8 and 9 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006. National safety authorities shall use the assessment criteria set out in Annex II to this Regulation for Part A safety certificates and those contained in Annex III to this Regulation for Part B safety certificates. These criteria shall also be used in case of renewal of safety certificates in accordance with regulation 9 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or where the national safety authority is the Intergovernmental Commission.”;

(b) in paragraph 3—

(i) for “Union legislation”, substitute “ legislation in Great Britain ”;

(ii) after the final sentence, insert “ Products or services provided by contractors or suppliers to railway undertakings shall be presumed to conform to safety requirements if the contractors, suppliers or products are certified in accordance with relevant certification schemes established under European Union legislation for the provision of such products and services, unless there are reasonable grounds for believing that they do not so conform. ”.

(5) In Article 4 (supervision), after “Part A”, insert “ safety certificates ”.

(6) Omit the words following Article 5 (entry into force), up to but not including “Annex I”.

(7) In Annex I (procedure for assessing conformity with requirements for obtaining safety certificates to be issued in accordance with Article 10(2)(a) and (b) of Directive 2004/49/EC)—

(a) in the heading, for “Article 10(2)(a) and (b) of Directive 2004/49/EC”, substitute “ regulations 7, 8 and 9 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or by the Intergovernmental Commission ”;

(b) in paragraph 2, for “complies with Commission Regulation (EC) No 653/2007”, substitute “ is in the format specified in Part 4 of Schedule 8 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”;

(c) in paragraph 6—

(i) after “Part A” in the first place it occurs, insert “ safety certificates ”;

(ii) after “Part A”, in the second place it occurs, insert “ safety ”;

(iii) omit “as provided for in Regulation (EC) No 653/2007”;

(d) in paragraph 7, for “Article 10(2)(b) of Directive 2004/49/EC”, substitute “ regulation 7(4)(b)(ii) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 and to applications to the Intergovernmental Commission for Part B safety certificates ”;

(e) in paragraph 8—

(i) omit “as referred to in Article 10(2)(b) of Directive 2004/49/EC”;

(ii) after “Part A”, insert “ safety ”;

(f) for paragraph 10, substitute—

“10.   National safety authorities shall cooperate to address issues of non-compliance with the Part B safety certificate assessment criteria or to deal with queries on the application for a Part B safety certificate. A national safety authority assessing an application for a Part B safety certificate shall liaise with the national safety authority that issued the Part A safety certificate to discuss and agree what action, if any, each one will take to ensure compliance with the Part B safety certificate assessment criteria.”.

(8) In Annex II (criteria for assessing conformity with the requirements for obtaining safety certificates to be issued in accordance with Article 10(2)(b) of Directive 2004/49/EC)—

(a) for the heading, substitute “ Criteria for assessing conformity with the requirements for obtaining Part A safety certificates ”;

(b) in point A.4, for “in accordance with Article 4(3) of Directive 2004/49/EC”, substitute “ for the safe operation of the railway ”;

(c) in point E.3, for “Article 9 and Annex III of Directive 2004/49/EC”, substitute “ regulations 5 and 6 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 22 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 M1 ”;

(d) in point K.3, for “member state level”, substitute “ a national level ”;

(e) in point M.2, for “Commission Regulation (EC) No 352/2009”, substitute “ Commission Implementing Regulation (EU) No 402/2013 as it has effect in Great Britain ”;

(f) in point Q.2, for “national investigating body” substitute “ Rail Accident Investigation Branch M2 ”.

(9) In Annex III (criteria for assessing conformity with the requirements for obtaining safety certificates to be issued in accordance with Article 10(2)(b) of Directive 2004/49/EC)—

(a) for the heading, substitute “ Criteria for assessing conformity with the requirements for obtaining Part B safety certificates ”;

(b) in the paragraph headed “GENERAL”—

(i) after “Part B”, insert “ safety ”;

(ii) for “Article 10(2)(a) of Directive 2004/49/EC”, substitute “ Regulation 7(4)(b)(ii) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 39 to 55 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”.

(10) In Annex IV (principles for supervision after the award of a Part A or Part B certificate)—

(a) in the heading, for “Part A or Part B”, substitute “ Part A safety certificate or Part B safety certificate ”;

(b) in paragraph 1, omit “as referred to in Article 4(1) and 16(2)(e) of Directive 2004/49/EC”;

(c) in paragraph 7, for “National safety authorities shall be accountable for their decisions in accordance with Article 17(3) of Directive 2004/49/EC”, substitute “ The decisions of national safety authorities shall be subject to judicial review. ”.

Commencement Information

I1 Reg. 12 in force on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

I2 Reg. 12 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M1 S.I. 2013/407.

M2 The Rail Accident Investigation Branch was established by section 3 of the Railways and Transport Safety Act 2003 (c. 20).

Amendments to Commission Regulation (EU) No 1169/2010 on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation E+W+S

13.—(1) Commission Regulation (EU) No 1169/2010 on a common safety method for assessing conformity with the requirements for obtaining a railway safety authorisation is amended as follows.

(2) Omit Article 1 (subject matter).

(3) In Article 2 (definition)—

(a) in the heading and in the first paragraph, for “definition” substitute “ definitions ”;

(b) after the definition of “supervision”, insert—

“‘national safety authority’ means one or both of—

(a) a safety authority; and

(b) the safety authority for the tunnel system, as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006.”.

(4) In Article 3 (procedures for assessing applications)—

(a) in paragraph 1, omit “for assessing their conformity with requirements in Directive 2004/49/EC”;

(b) in paragraph 3—

(i) for “Union” substitute “ domestic ”;

(ii) after the final sentence, insert “ Products or services provided by contractors or suppliers to railway undertakings shall be presumed to conform to safety requirements if the contractors, suppliers or products are certified in accordance with relevant certification schemes established under European Union legislation for the provision of such products and services, unless there are reasonable grounds for believing that they do not so conform. ”.

(5) Omit the words following Article 5 (entry into force), up to but not including “Annex I”.

(6) In Annex I (procedure for assessing conformity with requirements for obtaining safety authorisations), in the heading, for “Article 11(1)(a) and (b) of Directive 2004/49/EC”, substitute “ regulations 10, 11 and 12 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 27 to 38 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”.

(7) In Annex II (criteria for assessing conformity with the requirements for obtaining safety authorisations)—

(a) in the heading, for “Article 11(1)(a) and (b) of Directive 2004/49/EC”, substitute “ regulations 10, 11 and 12 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 27 to 38 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(b) in point A.4, for “in accordance with Article 4(3) of Directive 2004/49/EC”, substitute “ for the safe operation of the railway ”;

(c) in point E.3, for “Article 9 and Annex III of Directive 2004/49/EC”, substitute “ regulations 5 and 6 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 22 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(d) in point K.3 for “member state level”, substitute “ a national level ”;

(e) in point M.2, for “Commission Regulation (EC) No 352/2009”, substitute “ Commission Implementing Regulation (EU) No 402/2013 as it has effect in Great Britain ”;

(f) in point Q.1, for “national bodies”, substitute “ the Rail Accident Investigation Branch ”.

(8) In Annex III (principles for supervision after the award of an authorisation)—

(a) in paragraph 1, omit “as referred to in Article 4(1) and 16(2)(e) of Directive 2004/49/EC”;

(b) in paragraph 7, for “National safety authorities shall be accountable for their decisions in accordance with Article 17(3) of Directive 2004/49/EC”, substitute “ The decisions of national safety authorities shall be subject to judicial review. ”.

Commencement Information

I3 Reg. 13 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

CHAPTER 2 E+W+S Supervision and monitoring

Prospective

Amendments to Commission Regulation (EU) No 1077/2012 on a common safety method for supervision by national safety authorities after issuing a safety certificate or safety authorisation E+W+S

F1 14.  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Reg. 14 omitted (31.12.2020 immediately before IP completion day) by virtue of The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(3); 2020 c. 1, Sch. 5 para. 1(1)

Amendments to Commission Regulation (EU) No 1078/2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance E+W+S

15.—(1) Commission Regulation (EU) No 1078/2012 on a common safety method for monitoring to be applied by railway undertakings, infrastructure managers after receiving a safety certificate or safety authorisation and by entities in charge of maintenance is amended as follows.

(2) In Article 1 (subject matter and scope), in paragraph 2(a), for “Article 10(2)(a) and 11(1)(a) and the provisions adopted to obtain the certification/authorisation specified in Article 10(2)(b) and 11(1)(b) of Directive 2004/49/EC”, substitute “ regulations 7(4) and 10(3) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or Chapter 3 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”.

(3) For Article 2 (definitions) substitute—

“Article 2 E+W+S Definitions

For the purposes of this Regulation the following definitions apply.

‘accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences; accidents are divided into the following categories: collisions, derailments, level-crossing accidents, accidents to persons caused by rolling stock in motion, fires and others;

‘entity in charge of maintenance’ means an entity in charge of maintenance of a vehicle, and registered as such in the National Vehicle Register;

‘incident’ means any occurrence, other than an accident, associated with the operation of trains and affecting the safety of operation;

‘infrastructure manager’ means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC M3 , which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings.

‘interfaces’ means all points of interaction during a system or subsystem life-cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

‘management system’ means either a safety management system as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or the system of maintenance of entities in charge of maintenance complying with requirements laid down in paragraph 3 of Regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55B of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013;

‘monitoring’ means the arrangements put in place by railway undertakings, infrastructure managers or entities in charge of maintenance to check their management system is correctly applied and effective;

‘national safety authority’ means one or both of—

(a)

a safety authority; and

(b)

the safety authority for the tunnel system

as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

‘railway system’ means the totality of the subsystems in Great Britain for structural and operational areas, as defined in paragraph 2(1) to 2(7) of Annex II to Directive 2008/57/EC, as well as the management and operation of the system as a whole;

‘railway undertaking’ means a public or private undertaking, licensed according to applicable legislation, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only.”.

(4) In Article 5 (reporting)—

(a) in paragraph 1, omit “in accordance with Article 9(4) of Directive 2004/49/EC”;

(b) omit paragraph 2;

(c) in paragraph 3—

(i) for “point I.7.4(k) of Annex III to Regulation (EU) No 445/2011”, substitute “ paragraph 27(4)(k) of Schedule 10 to the Railways and Other Guided Systems (Safety) Regulations 2006 ”;

(ii) omit the final sentence;

(d) omit paragraphs 4 to 7.

(5) Omit the words following Article 6 (entry into force), up to but not including “Annex”.

Commencement Information

I4 Reg. 15 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M3 OJ No. L 237, 24.08.1991, p. 25-28.

CHAPTER 3 E+W+S Risk evaluation and assessment

Amendments to Commission Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 E+W+S

16.—(1) Commission Implementing Regulation (EU) No 402/2013 on the common safety method for risk evaluation and assessment and repealing Regulation (EC) No 352/2009 is amended as follows.

(2) Omit Article 1 (subject matter).

(3) In Article 2 (scope)—

(a) in paragraph 1, for “a Member State”, substitute “ Great Britain ”;

(b) in paragraph 3—

(i) in the first place that it occurs, for “Directive 2008/58/EC applies” substitute “ the Railways (Interoperability) Regulations 2011 M4 apply ”;

(ii) omit paragraph (a);

(iii) in paragraph (b), omit “, by virtue of Article 15(1) of Directive 2008/57/EC”;

[F2 (c) in paragraph 4—

(i) for “TSIs” substitute “ NTSNs ”;

(ii) for the second sentence substitute “ If such contradictions occur, the proposer shall inform the Secretary of State who may then decide to publish a variation of the NTSN in accordance with paragraphs (3) and (4) of regulation 3B of the Railways (Interoperability) Regulations 2011 or issue an exemption in accordance with regulation 14 of those Regulations. ”]

(d) omit paragraphs 5 and 6.

(4) For Article 3 (definitions) substitute—

“Article 3 E+W+S Definitions

For the purposes of this Regulation the following definitions shall apply.

‘accident’ means an unwanted or unintended sudden event or a specific chain of such events which have harmful consequences; accidents are divided into the following categories: collisions, derailments, level-crossing accidents, accidents to persons caused by rolling stock in motion, fires and others;

‘accreditation’ means an attestation by a national accreditation body that a conformity assessment body meets the requirements set by designated standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity;

‘actors’ means all parties which are, directly or through contractual arrangements, involved in the application of this Regulation;

[F3 ‘approved body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;]

‘assessment body’ means the independent and competent external or internal individual, organisation or entity which undertakes investigation to provide a judgement, based on evidence, of the suitability of a system to fulfil its safety requirements;

‘barrier’ means a technical, operational or organisational risk control measure outside the system under assessment that either reduces the frequency of occurrence of a hazard or mitigates the severity of the potential consequence of that hazard;

‘catastrophic accident’ means an accident typically affecting a large number of people and resulting in multiple fatalities;

‘certification body’ has the meaning provided in regulation 2 of the Railways and Other Guided Transport (Safety) Regulations 2006;

‘code of practice’ means a written set of rules that, when correctly applied, can be used to control one or more specific hazards;

‘conformity assessment body’ means a body that performs conformity assessment activities including calibration, testing, certification and inspection;

‘critical accident’ means an accident typically affecting a very small number of people and resulting in at least one fatality;

[F4 ‘designated body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;]

‘designated standard’ has the meaning provided in Article 3A;

‘entity in charge of maintenance’ means an entity in charge of maintenance of a vehicle, and registered as such in the National Vehicle Register;

[F5 ‘EU notified body’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;]

‘hazard’ means a condition that could lead to an accident;

‘hazard identification’ means the process of finding, listing and characterising hazards;

‘hazard record’ means the document in which identified hazards, their related measures, their origin and the reference to the organisation which has to manage them are recorded and referenced;

‘highly improbable’ means an occurrence of failure at a frequency less than or equal to 10^-9 per operating hour;

‘improbable’ means an occurrence of failure at a frequency less than or equal to 10^-7 per operating hour.

‘incident’ means any occurrence, other than an accident, associated with the operation of trains and affecting the safety of operation;

‘infrastructure manager’ means any body or undertaking that is responsible in particular for establishing and maintaining railway infrastructure, or a part thereof, as defined in Article 3 of Directive 91/440/EEC, which may also include the management of infrastructure control and safety systems. The functions of the infrastructure manager on a network or part of a network may be allocated to different bodies or undertakings;

‘interfaces’ means all points of interaction during a system or subsystem life cycle, including operation and maintenance where different actors of the rail sector will work together in order to manage the risks;

‘investigation’ means a process conducted for the purpose of accident and incident prevention which includes the gathering and analysis of information, the drawing of conclusions, including the determination of causes and, when appropriate, the making of safety recommendations;

‘national accreditation body’ means the sole body in the United Kingdom that performs accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9th July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93;

[F6 ‘national rule’ means NTRs as defined in regulation 2 of the Railways (Interoperability) Regulations 2011 and national safety rules as defined in regulation 2 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

‘NTSN’ has the meaning provided in regulation 2 of the Railways (Interoperability) Regulations 2011;]

‘national safety authority’ means one or both of—

(a)

a safety authority; and

(b)

the safety authority for the tunnel system; as defined in the Railways and Other Guided Transport Systems (Safety) Regulations 2006;

F7 ...

F8 ...

‘proposer’ means one of the following—

(a)

a railway undertaking or an infrastructure manager;

(b)

an entity in charge of maintenance;

(c)

[F9 a contracting entity or manufacturer which invites—

(i)

an approved body or a designated body to apply the UK verification assessment procedure in accordance with regulation 17 of and Schedule 4 to the Railways (Interoperability) Regulations 2011; or

(ii)

an EU notified body to apply the EC verification procedure in accordance with Directive 2008/57/EC or a designated body according to Article 17(3) of that Directive;]

‘railway system’ means the totality of the subsystems in Great Britain for structural and operational areas, as defined in paragraph 2(1) to 2(7) of Annex II to Directive 2008/57/EC, as well as the management and operation of the system as a whole;

‘railway undertaking’ means a public or private undertaking, licensed according to applicable legislation, the activity of which is to provide transport of goods and/or passengers by rail on the basis that the undertaking must ensure traction; this also includes undertakings which provide traction only;

‘recognition’ means an attestation by a national body other than the national accreditation body that the assessment body meets the requirements set out in Annex II to this Regulation to carry out the independent assessment activity specified in Article 6(1) and (2);

‘reference system’ means a system proven in use to have an acceptable safety level and against which the acceptability of the risks from a system under assessment can be evaluated by comparison;

‘risk’ means the frequency of occurrence of accidents and incidents resulting in harm caused by a hazard and the degree of severity of that harm;

‘risk acceptance criteria’ means the terms of reference by which the acceptability of a specific risk is assessed; these criteria are used to determine that the level of a risk is sufficiently low that it is not necessary to take any immediate action to reduce it further;

‘risk acceptance principle’ means the rules used in order to arrive at the conclusion whether or not the risk related to one or more specific hazards is acceptable;

‘risk analysis’ means systematic use of all available information to identify hazards and to estimate the risk;

‘risk assessment’ means the overall process comprising a risk analysis and a risk evaluation;

‘risk estimation’ means the process used to produce a measure of the level of risks being analysed, consisting of the following steps: estimation of frequency, consequence analysis and their integration;

‘risk evaluation’ means a procedure based on the risk analysis to determine whether an acceptable level of risk has been achieved;

‘risk management’ means the systematic application of management policies, procedures and practices to the tasks of analysing, evaluating and controlling risks;

‘safety’ means freedom from unacceptable risk of harm;

‘safety acceptance’ means the status given to the change by the proposer based on the safety assessment report provided by the assessment body;

‘safety assessment report’ means the document containing the conclusions of the assessment performed by an assessment body on the system under assessment;

‘safety management system’ means the organisation and arrangements established by an infrastructure manager or a railway undertaking to ensure the safe management of its operations;

‘safety measures’ means a set of actions either reducing the frequency of occurrence of a hazard or mitigating its consequences in order to achieve and/or maintain an acceptable level of risk;

‘safety requirements’ means the safety characteristics (qualitative or quantitative, or when needed both qualitative and quantitative) necessary for the design, operation (including operational rules) and maintenance of a system in order to meet legal or company safety targets;

‘system’ means any part of the railway system which is subjected to a change whereby the change may be of a technical, operational or organisational nature;

‘systematic failure’ means a failure that occurs repeatedly under some particular combination of inputs or under some particular environmental or application conditions;

‘systematic fault’ means an inherent fault in the specification, design, manufacturing, installation, operation or maintenance of the system under assessment;

F10 ...

‘technical system’ means a product or an assembly of products including the design, implementation and support documentation; the development of a technical system starts with its requirements specification and ends with its acceptance; although the design of relevant interfaces with human behaviour is considered, human operators and their actions are not included in a technical system; the maintenance process is described in the maintenance manuals but is not itself part of the technical system;

‘vehicle’ means a railway vehicle suitable for circulation on its own wheels on railway lines, with or without traction. A vehicle is composed of one or more structural and functional subsystems or parts of such subsystems.”.

(5) After Article 3 (definitions), insert—

“Article 3A E+W+S Designated standards

1.   Subject to paragraphs 6 and 7, in this Regulation a “designated standard” means a technical specification which is—

(a) adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and

(b) designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

2.   For the purposes of paragraph 1, a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a) the characteristics required of a product, including—

(i) levels of quality, performance, interoperability, environmental protection, health, safety or dimensions; and

(ii) the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b) production methods and processes relating to the product, where these have an effect on the characteristics of the product.

3.   For the purposes of this article, a “recognised standardisation body” means any one of the following organisations—

(a) the European Committee for Standardisation (CEN);

(b) the European Committee for Electrotechnical Standardisation (Cenelec);

(c) the European Telecommunications Standards Institute (ETSI);

(d) the British Standards Institution (BSI).

4.   When considering whether the manner of publication of a reference is appropriate in accordance with paragraph 1(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

5.   Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies.

6.   The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph 1(b).

7.   Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.”.

(6) In Article 4 (significant changes), for the first sentence of paragraph 1, substitute “ The proposer shall consider the potential impact of a change on the safety of the railway system. ”.

(7) In Article 6 (independent assessment)—

(a) in paragraph 1, omit “Union or”;

(b) in paragraph 3(a), for “Directive 2004/49/EC”, substitute “ regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 55A of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

[F11 (c) in paragraph 3(b), for “a notified body as defined by Article 2(j) of Directive 2008/57/EC or a body designated in accordance with Article 17 of that Directive” substitute “ an EU notified body or an approved body ”;]

(d) in paragraph 4, for “Without prejudice to Union legislation, the” substitute “ The ”;

(e) in paragraph 4(a) and (b), omit the words following “service”;

(f) in paragraph 4(c), omit the words following “operation”;

(g) in paragraph 4(d), omit the words following “framework”;

(h) in paragraph 4(e), omit the words following “maintenance”;

(i) in paragraph 4(f), omit the words following “framework”;

[F12 (j) in the final paragraph—

(i) omit “as referred to in Article 15(1) or Article 20 of Directive 2008/57/EC”;

(ii) for “a notified body in accordance with Article 18(2) of that Directive”, substitute “ an approved body ”.]

(8) In Article 7 (accreditation/recognition of the assessment body)—

(a) omit “referred to in Article 13(1)” in both places where it occurs;

(b) for “under the requirement of Article 9(2)” substitute “ where it fulfils the requirements set out in Annex II and the accreditation functions of the national safety authority are demonstrably independent of its other functions ”.

(9) In Article 8 (acceptance of accreditation/recognition)—

[F13 (a) in paragraph 1—

(i) for “Commission Regulation (EU) No 1158/2010 or Commission Regulation (EU) No 1169” substitute “ regulation 7 or 10 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006, or Chapter 3 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(ii) for “by a Member State in accordance with Article 7” substitute “ in Northern Ireland ”;]

(b) in paragraph 2—

(i) for “Regulation (EU) No 445/2011”, substitute “ Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”;

[F14 (ii) for “by a Member State”, substitute “ in Northern Ireland ”;]

(10) In Article 9 (types of recognition of the assessment body)—

(a) in paragraph 1(a), after “Member State” insert “ of the European Union ”;

(b) in paragraph 1(c), omit “in conformity with Article 10 of Regulation (EU) No 445/2011”;

(c) in paragraph 1(d), for “by the Member State” substitute “ in the United Kingdom ”;

(d) omit paragraph 2.

(11) In Article 10 (validity of recognition)—

(a) in paragraph 1, for “Article 9(2)”, substitute “ where the national safety authority is recognised as an assessment body ”;

(b) in paragraph 2(a), for “harmonised format of safety certificates provided in Annex I to Commission Regulation (EC) No 653/2007”, substitute “ safety certificates in the form provided in Part 2 of Schedule 8 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”;

(c) in paragraph 3(a), for “harmonised format of certificates for entities in charge of maintenance provided in Annex V, or Annex VI where relevant, of Regulation (EU) No 445/2011”, substitute “ certificates in the forms provided in Part 1 or Part 4 of Schedule 9 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006, as appropriate ”.

(12) Omit Article 12 (relaxed criteria where a significant change is not to be mutually recognised), Article 13 (provision of information to the Agency) and Article 14 (support from the Agency to accreditation or recognition of the assessment body).

[F15 (13) In Article 15 (safety assessment reports)—

(a) in paragraph 3, for “Without prejudice to Article 16 of Directive 2008/57/EC, the” substitute “ The ”;

(b) in paragraph 4—

(i) for “In the case referred to in point (a) of Article 2(3)” substitute “ Where the application of this Regulation or part of this Regulation is required by a relevant NTSN ”;

(ii) for “notified body” substitute “ approved body ”;]

(14) In Article 17 (risk control management and audits)—

(a) in paragraph 1, for “Article 9 of Directive 2004/49/EC”, substitute “ regulations 5 and 6 of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 22 to 26 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(b) in paragraph 2, for “Article 14a(3) of Directive 2004/49/EC”, substitute “ regulation 18A of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 55A and 55B of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(c) in paragraph 3—

(i) for “As part of the tasks defined in Article 16(2)(e) of Directive 2004/49/EC, the” substitute “ The ”;

(ii) for “Regulation (EU) No 445/2011”, substitute “ Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”;

(d) in paragraph 4, for “Article 7(1) of Regulation (EU) No 445/2011”, substitute “ paragraph 7(1) of Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”.

(15) In Article 18 (feedback and technical progress)—

(a) in paragraph 1, for “referred to in Article 9(4) of Directive 2004/49/EC”, substitute “ pursuant to regulation 20(1) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraph 16 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

(b) omit paragraph 2;

(c) in paragraph 3—

(i) for “point I(7)(4)(k) of Annex III to Regulation (EU) No 445/2011”, substitute “ paragraph 7(4)(k) of Part 4 of Schedule 10 to the Railways and Other Guided Transport Systems (Safety) Regulations 2006 ”;

(ii) omit the final sentence;

(d) omit paragraphs 4, 5 and 6.

(16) Omit Article 19 (repeal).

(17) In Article 20 (entry into force and application), omit the [F16 last sentence] .

(18) In Annex I (general principles applicable to the risk management process)—

(a) in point 1.1.4(a), for “Article 10(2)(a) or Article 11(1)(a) of Directive 2004/49/EC”, substitute “ regulation 7(4)(b)(i) or regulation 10(1)(b)(ii) of the Railways and Other Guided Transport Systems (Safety) Regulations 2006 or paragraphs 22 to 26 of the Schedule to the Channel Tunnel (Safety) (Amendment) Order 2013 ”;

[F17 (aa) in point 1.1.4(b)—

(i) for “a TSI” substitute “ an NTSN ”;

(ii) for “notified national rules” substitute “ national rules ”;]

(b) in point 1.1.5, for “Member States”, substitute “ United Kingdom ”;

[F18 (bb) in point 1.2.1, for “TSIs” substitute “ NTSNs ”;

(bc) in point 1.2.6, for “notified national rule” substitute “ national rule ”;]

[F19 (c) in point 2.3.3—

(i) for “TSIs”, in both places it occurs, substitute “ NTSNs ”;

(ii) omit “by Directive 2008/57/EC”;

(iii) for “TSI” substitute “ NTSN ”;]

[F20 (cc) in point 2.3.4, omit “notified in accordance with Article 8 of Directive 2004/49/EC and Article 17(3) of Directive 2008/57/EC”;]

(d) in point 2.4.2(a), for “and would therefore still qualify for approval in the Member State where the change is to be introduced”, substitute “ in the United Kingdom ”;

[F21 (e) in point 2.5.2, for—

(i) for “Union legislation” substitute “ legislation applying in Great Britain ”;

(ii) “notified national rules”, substitute “national rules”;]

(f) in points 2.5.5 to 2.5.8, omit “harmonised” in each place it occurs;

[F22 (ff) in point 2.5.5, for “definition (23) and definition (35)” substitute “ catastrophic accident or critical accident ”.]

(g) in point 2.5.6—

(i) omit “They shall be the most demanding design targets that can be required for mutual recognition.”;

(ii) omit “of a Member State”;

(h) omit point 2.5.10;

(i) in point 2.5.11—

(i) for “Member State where the system is being used” substitute “ United Kingdom ”;

(ii) for “harmonised design target”, substitute “ design target ”;

(iii) omit “of the harmonised one”.

(19) In Annex II (criteria for accreditation or recognition of the assessment body), in paragraph 2, for “By analogy to Article 28 of Directive 2008/57/EC concerning the notification of notified bodies, the”, substitute “ The ”.

Textual Amendments

F2 Reg. 16(3)(c) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in reg. 16(4) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in reg. 16(4) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in reg. 16(4) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in reg. 16(4) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 16(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(v); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in reg. 16(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(vi); 2020 c. 1, Sch. 5 para. 1(1)

F9 Words in reg. 16(4) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(vii); 2020 c. 1, Sch. 5 para. 1(1)

F10 Words in reg. 16(4) omitted (31.12.2020 immediately before IP completion day) by virtue of The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(b)(viii); 2020 c. 1, Sch. 5 para. 1(1)

F11 Reg. 16(7)(c) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

F12 Reg. 16(7)(j) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F13 Reg. 16(9)(a) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

F14 Reg. 16(9)(b)(ii) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F15 Reg. 16(13) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(e); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in reg. 16(17) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(f); 2020 c. 1, Sch. 5 para. 1(1)

F17 Reg. 16(18)(aa) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(i); 2020 c. 1, Sch. 5 para. 1(1)

F18 Reg. 16(18)(bb)(bc) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F19 Reg. 16(18)(c) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F20 Reg. 16(18)(cc) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F21 Reg. 16(18)(e) substituted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(v); 2020 c. 1, Sch. 5 para. 1(1)

F22 Reg. 16(18)(ff) inserted (31.12.2020 immediately before IP completion day) by The Railways (Safety, Access, Management and Interoperability) (Miscellaneous Amendments and Transitional Provision) (EU Exit) Regulations 2019 (S.I. 2019/1310), regs. 1(2)(c), 7(4)(g)(vi); 2020 c. 1, Sch. 5 para. 1(1)

Commencement Information

I5 Reg. 16 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1

Marginal Citations

M4 S.I. 2011/3066; relevant amending instruments are S.I. 2011/3066 and 2015/2022.