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Product Safety Act (Cap. 427) Ec Type Approval Of Motor Vehicles And Their Trailers (Amendment) Regulations, 2011 (L.N. 7 Of 2011 )

PRODUCT SAFETY ACT (CAP. 427)EC TYPE APPROVAL OF MOTOR VEHICLES AND THEIR TRAILERS (AMENDMENT) REGULATIONS, 2011

IN exercise of the powers conferred by articles 38 to 40 of the Product Safety Act, the office of the Prime Minister on the advice of the Malta Standards Authority, has made the following regulations:-

(1) Regulation (EC) No. 661/2009 of the European Parliament and of the Council of 13 July 2009 concerning type- approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefore. Regulation (EC) No. 661/2009 amends Schedule IV, VI, XI, XXI, XXII of L.N. 148 of 2009

.

( i ) R e g u l a t i o n ( E C ) N o . 6 6 1 / 2 0 0 9 R e p e a l s t h e following Directives;

70/221/EEC, 70/222/EEC, 70/311/EEC, 70/387/EEC,

70/388/EEC, 71/320/EEC, 72/245/EEC, 74/60/EEC, 74/61/ EEC, 74/297/EEC, 74/408/EEC, 74/483/EEC, 75/443/EEC,

76/114/EEC, 76/115/EEC, 76/756/EEC, 76/757/EEC, 76/758/ EEC, 76/759/EEC, 76/760/EEC, 76/761/EEC, 76/762/EEC,

77/389/EEC, 77/538/EEC, 77/539/EEC, 77/540/EEC, 77/541/ EEC, 77/649/EEC, 78/316/EEC, 78/317/EEC, 78/318/EEC,

78/549/EEC, 78/932/EEC, 89/297/EEC, 91/226/EEC, 92/21/

Citation.

L.N. 148 of 2009

.

Scope and

Commencement.

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EC, 92/22/EEC, 92/24/EEC, 92/114/EEC, 94/20/EC, 95/28/ EC, 96/27/EC, 96/79/EC, 97/27/EC, 98/91/EC, 2000/40/EC,

2001/56/EC, 2001/85/EC, 2003/97/EC shall be repealed with effect from 1 November 2014.

(ii) Directive 92/23/EEC shall be repealed with effect from 1 November 2017.

(iii) Regulation (EC) No.661/2009 shall apply from 1

November 2011, However;

Article 13(15), Article 14 and points 1(a)(iii), 1(b)(iii) and (iv), 2(c), 3(a)(iii), 3(b)(iii), 3(e)(iii) and 3(f)(i) of Annex III shall be deemed to have entered into force on 20 August

2009.

Points 1(a)(i), 1(b)(i), 2(a), 3(a)(i), 3(b)(i), 3(c)(i),

3(d)(i), 3(e)(i) and 3(f)(ii) of Annex III shall apply from 1

November 2014.

Points 1(a)(ii), 1(b)(ii), 2(b), 3(a)(ii), 3(b)(ii), 3(c)(ii),

3(d)(ii), 3(e)(ii) and point 4 of Annex III shall apply from 1

November 2017;

(2) Commission Directive 2010/19/EU of 9 March

2010 amending, for the purpose of adaptation to technical progress in the field of spray-suppression systems of certain categories of motor vehicles and their trailers, Council Directive 91/226/EEC and Directive 2007/46/EC of the European Parliament and of the Council. This Directive amends Schedule IV, XI, XXI, XXII of L.N. 148 of 2009

;

(3) Commission Regulation (EU) No. 371/2010 of

16 April 2010 replacing Annexes V, X, XV, and XVI to Directive

2007/46/EC of the European Parliament and of the Council establishing a framework for the approval of motor vehicles and their trailers, and of systems, components an separate technical units intended for such vehicles. This Regulation amends Schedule V, X, XV, XVI, XXII of L.N. 148 of 2009

. Commission Regulation (EU) No. 371/2010 shall be deemed to have entered into force on

29 April 2010;

( 4 ) C o m m i s s i o n R e g u l a t i o n ( E U ) N o . 4 0 6 / 2 0 1 0 of 26 April 2010 implementing Regulation (EC) No. 79/2009 of the European Parliament and of the Council on type-approval

of hydrogen-powered motor vehicles. This Regulation amends Schedule XXI of L.N. 148 of 2009

. Commission Regulation (EU) No. 406/2010 has be deemed to have entered into force 7 June

2010;

(5) Commission Regulation (EU) No 672/2010 of 27

July 2010 concerning type-approval requirements for windscreen defrosting systems of certain motor vehicles and implementing Regulation (EC) No 661/2009 of the European Parliament and of the Council concerning type-approval requirements for the general safety of motor vehicles, their trailers and systems, components and separate technical units intended therefore. This Regulation amends Schedule XXI of L.N. 148 of 2009

. Commission Regulation (EU) No.672/2010 shall be deemed to have entered into force on 17

August 2010.

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Substitutes Schedule IV to the principal regulations.

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“SCHEDULE IV

LIST OF REGULATORY ACTS SETTING THE REQUIREMENTS FOR THE PURPOSE OF EC TYPE- APPROVAL OF VEHICLES

PART I

List of regulatory acts for EC type-approval of vehicles produced in unlimited series

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X Regulatory act applicable (see act for details).

(1) Vehicles of this category shall be fitted with an adequate windscreen defrosting and demisting device. (2) Vehicles of this category shall be fitted with adequate windscreen washing and wiping devices.

(3) The requirements of Directive 94/20/EC shall apply only to vehicles equipped with couplings.

(4) The requirements of Directive 98/91/EC shall apply only when the manufacturer applies for the type-approval of a vehicle intended for the transport of dangerous goods.

(5) In case of LPG or CNG vehicles, pending the adoption of the relevant amendments to Directive 70/221/EEC in order to include LPG and CNG tanks, a vehicle approval in

accordance with UNECE Regulation No 67, as amended by the 01 series of amendments or UNECE Regulation No 110 is required. (6) Not exceeding 2,5 tonnes technically permissible maximum laden mass.

(8) Only for vehicles of category N1, class I as described in the first table in point 5.3.1.4 of Annex I to Directive 70/220/EEC.

(9) For vehicles with a reference mass not exceeding 2610kg.At the manufacturer’s request may apply to vehicles with a reference mass not exceeding 2840kg. (10) For vehicles with a reference mass exceeding 2610kg and which did not benefit from the opportunity offered in footnote (9).

(11) Only applicable to vehicles where the “seating reference point (‘R’ point)” of the lowest seat is not more than 700mm high above the ground level. The “R” point is defined in Directive 77/649/EEC.

(12) For vehicles with reference mass exceeding 26100kg which are not type-approved (at the manufacturer’s request and provided their reference mass does not exceed 2840kg) under Regulation (EC) No 715/2007.

(13) Applicable to those categories with effect from 9 April 2010. Directive 91/226/EEC is Not mandatory to off-road vehicles.

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Appendix I

List of regulatory acts for type-approval of vehicles belonging to the category M1, produced in small series pursuant to Article 22

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( ) Electronic sub-assembly. ( ) Component.

( ) Vehicle.

( ) Installation prescriptions.

( ) However, Article 7 of Directive

2005/64/EC applies.

Key

X: EC type-approval certificate shall be issued; conformity of production shall be ensured.

A: No exemptions permitted except those specified in the regulatory act. Type-approval certificate and type-approval mark are not required. Test reports shall be established by a notified technical service.

B: The technical prescriptions of the regulatory act shall be fulfilled. The tests provided for in the regulatory act shall be performed in their entirety; subject to the agreement of the approval authority, they may be performed by the manufacturer himself; the manufacturer may be allowed to issue the technical report; a type-approval certificate does not have to be issued and type-approval is not required.

C: The manufacturer shall demonstrate to the satisfaction of the approval authority that the essential requirements of the regulatory act are fulfilled. N/A This regulatory act is not applicable (no requirements).

N/A This regulatory act is not applicable (no requirements).

x Any frontal protection system supplied with the vehicle shall comply with the requirements of Regulation (EC) No 78/2009. Shall be provided with a type approval number and shall be marked accordingly.

P/A This Regulation is partially applicable. The precise scope of application is established in the implementing measures to this Regulation

PART II

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List of UNECE regulations recognised as an alternative to directives or regulations mentioned in Part I

Where reference is made to a separate Directive or Regulation in the table of Part I, an approval issued under the following UNECE Regulations to which the Community has acceded as a Contracting Party to the United Nations Economic Commission for Europe “Revised 1958 Agreement” by virtue of Council Decision 97/836/EC ( ), or subsequent Council decisions as referred to in Article 3(3) of that Decision, shall be considered as equivalent to an EC type-approval granted under the relevant separate Directive or Regulation.

Any further amendment of the UNECE Regulations listed below ( ) shall also be deemed to be equivalent, subject to the Community Decision as referred to in Article 4(2) of Decision 97/836/EC.

( ) OJ L 346, 17.12.1997, p. 78.

( ) For subsequent amendments, see UNECE TRANS/WP.29/343 in its latest revision.

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Where the separate directive or regulation contains installation requirements, these apply also to components and separate technical units approved in accordance with the UNECE Regulations.

(*) The numbering of the entries in this table refers to the numbering used in the table of Part I.”.

Substitutes Schedule V to the principal regulations.

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“SCHEDULE V

0. Objectives and scope
0.1. This Schedule establishes the procedures for the proper operation of the vehicle type-approval in accordance with the provisions of Article 9.
0.2. It also includes:
(a) the list of international standards which are of relevance for the designation of the technical services in accordance with Article 41;
(b) the description of the procedure to be followed for the assessment of the skills of technical services in accordance with Article 42;
(c) the general requirements for the drafting of test reports by technical services.
1. Type-approval process
When receiving an application for vehicle type-approval, the approval authority shall:
(a) verify that all EC type-approval certificates issued pursuant to the regulatory acts which are applicable for vehicle type-approval cover the vehicle type and correspond to the prescribed requirements;
(b) by reference to the documentation make sure that the vehicle specifications and data contained in Part I of the vehicle information document are included in the data in the information packages and in the EC type-approval certificates in respect of the relevant regulatory acts;
(c) when an item number in Part I of the information document is not included in the information package of any of the regulatory acts, confirm that the relevant part or characteristic conforms to the particulars in the information folder;
(d) on a selected sample of vehicles from the type to be approved carry out or arrange to be carried out inspections of vehicle parts and systems to verify that the vehicle(s) is/are built in accordance with the relevant data contained in the authenticated information package in respect of the relevant EC type-approval certificates;
(e) carry out or arrange to be carried out relevant installation checks in respect of separate technical units where applicable;
(f) carry out or arrange to be carried out necessary checks in respect of the presence of the devices provided for in footnotes (1) and (2) of Part I of Schedule IV where applicable;
(g) carry out or arrange to be carried out necessary checks in order to ensure that the requirements provided for in footnote (5) of Part I of Schedule IV are fulfilled.

2. Combination of technical specifications

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The number of vehicles to be submitted shall be sufficient to permit the proper check of the various combinations to be type-approved according to the following criteria:

3. Specific Provisions
Where no approval certificates for any of the relevant regulatory acts are available, the approval authority shall: (a) arrange for the necessary tests and checks as required by each of the relevant regulatory acts;
(b) verify that the vehicle conforms to the particulars in the vehicle information folder and that it meets the technical requirements of each of the relevant regulatory acts;
(c) carry out or arrange to be carried out relevant installation checks in respect of separate technical units where applicable;
(d) carry out or arrange to be carried out necessary checks in respect of the presence of the devices provided for in footnotes (1) and (2) of Part I of Schedule IV where applicable;
(e) carry out or arrange to be carried out necessary checks in order to ensure that the requirements provided for in footnote (5) of Part I of Schedule IV are fulfilled.

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Appendix 1

1. Activities related to testing for type-approval, to be carried out in accordance with the regulatory acts listed in
Schedule IV:
1.1. Category A (tests performed in own facilities):
EN ISO/IEC 17025:2005 on the general requirements for the competence of testing and calibration laboratories. A technical service designated for category A activities may carry out or supervise the tests provided for in the
regulatory acts for which it has been designated, in the facilities of a manufacturer or of a third party.
1.2. Category B (supervising of tests performed in the manufacturer’s facilities or in the facilities of a third party): EN ISO/IEC 17020:2004 on the general criteria for the operation of various types of bodies performing
inspection.
Before performing or supervising any test in the facilities of a manufacturer or of a third party, the technical service shall check that the tests facilities and measurement devices comply with the appropriate requirements of the standard referred to in point 1.1.
2. Activities related to Conformity of Production
2.1. Category C (procedure for the Initial Assessment and surveillance audits of the manufacturer’s quality management system):
EN ISO/IEC 17021:2006 on the requirements for bodies providing audit and certification of management systems.
2.2. Category D (inspection or testing of production samples or supervision thereof):
EN ISO/IEC 17020:2004 on the general criteria for the operation of various types of bodies performing inspection.

Appendix 2

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1. Purpose of this Appendix
1.1. This Appendix establishes the conditions according to which the assessment procedure of the technical services shall be conducted by the competent authority referred to in Article 42.
1.2. These requirements shall apply mutatis mutandis to all technical services, irrespective of their legal status (inde- pendent organisation, manufacturer or approval authority acting as technical service).
2. Principles of assessing
Assessing shall be characterised by reliance on a number of principles:
— independence which is the basis for the impartiality and objectivity of the conclusions,
— an evidence-based approach which guarantees reliable and reproducible conclusions. Auditors shall show trust and integrity. They shall respect confidentiality and discretion. They shall report truthfully and accurately findings and conclusions.
3. Skills required of the auditors
3.1. The assessments may only be conducted by auditors having the technical and administrative knowledge necessary for such purposes.
3.2. The auditors shall have been trained specifically for assessment activities. In addition, they shall have the specific knowledge of the technical area in which the technical service will exercise its activities.
3.3. Without prejudice to points 3.1 and 3.2 of this Appendix, the assessment referred to in Article 42 shall be conducted by auditors independent of the activities for which the assessment is conducted.
4. Application for designation
4.1. A duly authorised representative of the applicant technical service shall make a formal application to the competent authority that includes the following:
(a) general features of the technical service, including corporate entity, name, addresses, legal status and technical resources;
(b) a detailed description including curriculum vitae of the personnel in charge of testing and of the managerial staff as evidenced by the skills both educational and professional;
(c) in addition to the above, technical services which use virtual testing methods shall provide evidence of their ability to work in a Computer-Aided-x environment;
(d) general information concerning the technical service such as its activities, its relationship in a larger corporate entity if any, and addresses of all its physical location(s) to be covered by the scope of designation;
(e) an agreement to fulfil the requirements for designation and the other obligations of the technical service as applicable in the relevant Directives;
(f) a description of the conformity assessment services that the technical service undertakes in the framework of the applicable regulatory acts and a list of the regulatory acts for which the technical service applies for designation, including limits of capability where applicable;
(g) a copy of the quality manual of the technical service.

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4.2. The competent authority shall review for adequacy the information supplied by the technical service.
5. Resource review
The competent authority shall review its ability to carry out the assessment of the technical service, in terms of its own policy, its competence and the availability of suitable auditors and experts.
6. Subcontracting the assessment
6.1. The competent authority may subcontract parts of the assessment to another designation authority or ask for support from technical experts provided by other competent authorities. The subcontractors and experts have to be accepted by the applicant technical service.
6.2. The competent authority shall take into account accreditation certificates with adequate scope in order to complete its global assessment of the technical service.
7. Preparation for assessment
7.1. The competent authority shall formally appoint an assessment team. The former shall ensure that the expertise brought to each assignment is appropriate. In particular, the team as a whole:
(a) shall have appropriate knowledge of the specific scope for which designation is sought; and
(b) shall have understanding sufficient to make a reliable assessment of the competence of the technical service to operate within its scope of designation.
7.2. The competent authority shall clearly define the assignment given to the assessment team. The task of the assessment team is to review the documents collected from the applicant technical service and to conduct the on- site assessment.
7.3. The competent authority shall agree, together with the technical service and the assigned assessment team, to the date and schedule for the assessment. However, it remains the responsibility of the competent authority to pursue a date that is in accordance with the surveillance and reassessment plan.
7.4. The competent authority shall ensure that the assessment team is provided with the appropriate criteria documents, previous assessment records, and the relevant documents and records of the technical service.
8. On-site assessment
The assessment team shall conduct the assessment of the technical service at the premises of the technical service from which one or more key activities are performed and, where relevant, shall perform witnessing at other selected locations where the technical service operates.
9. Analysis of findings and assessment report
9.1. The assessment team shall analyse all relevant information and evidence gathered during the document and record review and the on-site assessment. This analysis shall be sufficient to allow the team to determine the extent of competence and conformity of the technical service with the requirements for designation.
9.2. The competent authority’s reporting procedures shall ensure that the following requirements are fulfilled.
9.2.1. A meeting shall take place between the assessment team and the technical service prior to leaving the site. At this meeting, the assessment team shall provide a written and/or oral report on its findings obtained from the analysis. An opportunity shall be provided for the technical service to ask questions about the findings, including non- conformities, if any, and their basis.
9.2.2. A written report on the outcome of the assessment shall be promptly brought to the attention of the technical service. This assessment report shall contain comments on competence and conformity, and shall identify non- conformities, if any, to be resolved in order to conform to all of the requirements for designation.
9.2.3. The technical service shall be invited to respond to the assessment report and to describe the specific actions taken or planned to be taken, within a defined time, to resolve any identified non-conformities.

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9.3. The competent authority shall ensure that the responses of the technical service to resolve non-conformities are reviewed to see if the actions appear to be sufficient and effective. If the technical service responses are found not to be sufficient, further information shall be requested. Additionally, evidence of effective implementation of actions taken may be requested, or a follow-up assessment may be carried out to verify effective implementation of corrective actions.
9.4. The assessment report shall include, as a minimum the following: (a) unique identification of the technical service;
(b) date(s) of the on-site assessment;
(c) name(s) of the auditors(s) and/or experts involved in the assessment; (d) unique identification of all premises assessed;
(e) proposed scope of designation that was assessed;
(f) a statement on the adequacy of the internal organisation and procedures adopted by the technical service to give confidence in its competence, as determined through its fulfilment of the requirements for designation;
(g) information on the resolution of all non-conformities;
(h) a recommendation of whether the applicant should be designated or confirmed as technical service and, if so, the scope of designation.
10. Granting/confirming a designation
10.1. The approval authority shall, without undue delay, make the decision on whether to grant, confirm or extend designation on the basis of the report(s) and any other relevant information.
10.2. The approval authority shall provide a certificate to the technical service. This certificate shall identify the following:
(a) the identity and logo of the approval authority;
(b) the unique identity of the designated technical service;
(c) the effective date of granting of designation and the expiry date;
(d) a brief indication of or a reference to the scope of designation (applicable directives, regulations or part of them);
(e) a statement of conformity and a reference to the present Directive.
11. Reassessment and surveillance
11.1. Reassessment is similar to an initial assessment except that experience gained during previous assessments shall be taken into account. Surveillance on-site assessments are less comprehensive than reassessments.
11.2. The competent authority shall design its plan for reassessment and surveillance of each designated technical service so that representative samples of the scope of designation are assessed on a regular basis.
The interval between on-site assessments, whether reassessment or surveillance, depends on the proven stability that the technical service has reached.
11.3. When, during surveillance or reassessments, non-conformities are identified, the competent authority shall define strict time limits for corrective actions to be implemented.

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11.4. When the corrective or improvement actions have not been taken within the agreed timeframe or are not deemed to be sufficient, the competent authority shall adopt appropriate measures, such as conducting a further assessment or suspending/withdrawing the designation for one or more of the activities for which the technical service has been designated.
11.5. When the competent authority decides to suspend or withdraw the designation of a technical service, it shall inform the latter by registered mail. In any case, the competent authority shall adopt all the necessary measures to ensure the continuity of the activities already undertaken by the technical service.
12. Records on designated technical services
12.1. The competent authority shall maintain records on technical services to demonstrate that requirements for designation, including competence, have been effectively fulfilled.
12.2. The competent authority shall keep the records on technical services secure to ensure confidentiality.
12.3. Records on technical services shall include at least the following: (a) relevant correspondence;
(b) assessment records and reports; (c) copies of designation certificates.

Appendix 3

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1. For each of the regulatory acts listed in Part I of Schedule IV, the test report shall comply with the provisions of Standard EN ISO/IEC 17025:2005. In particular it shall include the information mentioned in point 5.10.2, including footnote (1) of that Standard.
2. The template of the test reports shall be laid down by the approval authority in accordance with its rules of good practice.
3. The test report shall be drafted in the official language of the Community determined by the approval authority.
4. Moreover it shall include at least the following information:
(a) the identification of the vehicle, component or separate technical unit tested;
(b) a detailed description of the vehicle, component or separate technical unit characteristics in connection with the regulatory act;
(c) the results of the measurements specified in the relevant regulatory acts and, when required, the limits or thresholds which are to be met;
(d) in regard to each measurement mentioned in point 4(c) the relevant decision: passed or failed;
(e) a detailed statement of compliance with the various provisions which are to be met, i.e. such provisions for which it is not required to make measurements.
Example from Section 3.2.2 of Annex I to Council Directive 76/114/EEC ( 1 ):
“Check that the vehicle identification number is placed in such a way that it cannot be obliterated or deteriorate”;
the report shall include a statement such as: “the place of stamping the vehicle identification number fulfils the requirements of Section 3.2.2 of Schedule I”;
(f) when test methods other than those prescribed in the regulatory acts are permitted the report shall include a description of the test method used for performing the test.
The same applies when alternative provisions in the regulatory acts may be used;
(g) pictures taken during testing, the number of which shall be decided by the approval authority.
In the case of virtual testing, screen prints or other suitable evidence may replace pictures; (h) conclusions drawn up;
(i) when opinions and interpretations have been made, they shall be documented properly and marked as such in the test report.
5. When the tests are conducted on a vehicle, component or technical unit that combines a number of most unfavourable features with regard to the required level of performance to be achieved (i.e. the worst-case), the test report shall include a reference stating how the selection has been made by the manufacturer in agreement with the approval authority. ”.

Substitutes Schedule VI to the principal regulations.

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“SCHEDULE VI

MODELS OF THE TYPE-APPROVAL CERTIFICATE

MODEL A

(to be used for type-approval of a vehicle)

Maximum format: A4 (210 × 297 mm)

EC VEHICLE TYPE-APPROVAL CERTIFICATE

Stamp of type-approval authority

Communication concerning: Of a type of:

1 1

EC type-approval ( ) — complete vehicle ( )

1 1

extension of EC type-approval ( ) — completed vehicle ( )

1 1

refusal of EC type-approval ( ) — incomplete vehicle ( )

1 1

withdrawal of EC type-approval ( ) — vehicle with complete and incomplete variants ( )

1

— vehicle with completed and incomplete variants ( )

with regard to Directive 2007/46/EC as last amended by Directive …./…/EC / Regulation (EC) No. …/… ( ) EC type-approval number:

Reason for extension:

SECTION I

0.1. Make (trade name of manufacturer):

0.2. Type:

0.2.1. Commercial name(s) ( ):

0.3. Means of identification of type, if marked on the vehicle:

0.3.1. Location of that marking:

0.4. Category of vehicle ( ):

0.5. Name and address of manufacturer of the complete vehicle ( ):

( ) Delete where not applicable.

( ) If not available at the time of granting the type-approval, this item shall be completed at the latest when the vehicle is introduced on the market.

( ) As defined in Annex II.A.

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1 4

Name and address of manufacturer of the base vehicle ( ) ( ):

1 4

Name and address of manufacturer of the latest built stage of the incomplete vehicle ( ) ( ):

1 4

Name and address of manufacturer of the completed vehicle ( ) ( ):

0.8. Name(s) and address(es) of assembly plant(s):

0.9. Name and address of the manufacturer's representative (if any):

SECTION II

The undersigned hereby certifies the accuracy of the manufacturer's description in the attached information document of the vehicle(s) described above ((a) sample(s) having been selected by the EC type-approval authority and submitted by the manufacturer as prototype(s) of the vehicle type) and that the attached test results are applicable to the vehicle type.

1. For complete and completed vehicles/variants ( ):

The vehicle type meets/does not meet ( ) the technical requirements of all the relevant regulatory acts as

1 4

prescribed in Annex IV and Annex XI ( ) ( ) to Directive 2007/46/EC.

2. For incomplete vehicles/variants ( ):

The vehicle type meets/does not meet ( ) the technical requirements of the regulatory acts listed in the table on side 2.

3. The approval is granted/refused/withdrawn ( ).

4. The approval is granted in accordance with Article 20 and the validity of the approval is thus limited to dd/mm/yy.

(Place) (Signature) (Date)

Attachments: Information package. Test results (see Annex VIII).

Name(s) and specimen(s) of the signature(s) of the person(s) authorised to sign certificates of conformity and a statement of their position in the company.

NB: If this model is used for type-approval pursuant to Articles 20, 22 or 23, it may not bear the heading “EC Vehicle

Type-Approval Certificate”, except:

- in the case mentioned in Article 20 where the Commission has decided to allow a Member State to grant a type- approval in accordance with this Directive,

- in the case of vehicles of the category M1, type-approved according to the procedure prescribed in Article 22.

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Side 2

This EC type-approval is, where incomplete and completed vehicles, variants or versions are concerned, based on the approval(s) for incomplete vehicles listed below:

Stage 1: Manufacturer of the base vehicle: EC type-approval number:

Dated:

Applicable to variants or versions (as appropriate): Stage 2: Manufacturer:

EC type-approval number: Dated:

Applicable to variants or versions (as appropriate): Stage 3: Manufacturer:

EC type-approval number: Dated:

Applicable to variants or versions (as appropriate):

In the case where the approval includes one or more incomplete variants or versions (as appropriate), list those variants or versions (as appropriate) which are complete or completed. Complete/completed variant(s): List of requirements

applicable to the approved incomplete vehicle type, variant or version (as appropriate, taking account of the scope and latest amendment to each of the regulatory acts listed below).

(List only subjects for which an EC type-approval exists.)

In the case of special purpose vehicles, exemptions granted or special provisions applied pursuant to Annex XI and exemptions granted pursuant to Article 20:

Appendix I

List of regulatory acts to which the type of vehicle complies

(to be filled in only in the case of type-approval in accordance with Article 6(3))

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Model B

(to be used for type-approval of a system or type-approval of a vehicle with regard to a system)

Maximum format: A4 (210 × 297 mm)

EC TYPE-APPROVAL CERTIFICATE

Stamp of type-approval authority

Communication concerning:

- EC type-approval ( )

1 1

- extension of EC type-approval ( )

- refusal of EC type-approval ( ) ;

- withdrawal of EC type-approval ( )

= of a type of system/type of a vehicle with regard to a system ( )

with regard to Directive …/…/EC / Regulation (EC) No …/… ( ), as last amended by Directive …/…/EC / Regulation

(EC) No …/… ( )

EC type-approval number:

Reason for extension:

SECTION I

0.1. Make (trade name of manufacturer):

0.2. Type:

0.2.1. Commercial name(s) (if available):

0.3. Means of identification of type, if marked on the vehicle ( ):

0.3.1. Location of that marking:

0.4. Category of vehicle ( ):

0.5. Name and address of manufacturer:

0.8. Name(s) and address(es) of assembly plant(s):

0.9. Name and address of the manufacturer's representative (if any):

SECTION II

1. Additional information (where applicable): see Addendum.

2. Technical service responsible for carrying out the tests:

3. Date of test report:

( ) Delete where not applicable.

( ) If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this information document, such characters shall be represented in the documentation by the symbol “?” (e.g. ABC??123??).

( ) As defined in Annex II, Section A.

4 Number of test report:

5 Remarks (if any): see Addendum.

6 Place:

7 Date:

8 Signature:

Attachments: Information package

Test report

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Addendum

to EC type-approval certificate No …

1. Additional information

1.1. […]:

1.1.1. […]: […]

2. Type-approval number of each component or separate technical unit installed on the vehicle type to comply with this Directive or Regulation

2.1. […]:

3. Remarks

3.1. […]:

MODEL C

(to be used for component/separate technical unit type-approval)

Maximum format: A4 (210 × 297 mm)

EC TYPE-APPROVAL CERTIFICATE

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Stamp of type-approval authority

Communication concerning:

— EC type-approval ( ) 9

— extension of EC type-approval ( )

— refusal of EC type-approval ( )

— withdrawal of EC type-approval ( )

of a type of component/separate technical unit ( )

with regard to Directive …/…/EC / Regulation (EC) No …/… ( ), as last amended by Directive …/…/EC / Regulation

(EC) No …/… ( )

EC type-approval number: Reason for extension:

SECTION I

0.1. Make (trade name of manufacturer):

0.2. Type:

1 2

0.3. Means of identification of type, if marked on the component/separate technical unit ( ) ( ):

0.3.1. Location of that marking:

0.5. Name and address of manufacturer:

0.7. In the case of components and separate technical units, location and method of affixing of the EC approval mark:

0.8. Name(s) and address(es) of assembly plant(s):

0.9. Name and address of the manufacturer's representative (if any):

SECTION II

1. Additional information (where applicable): see Addendum

2. Technical service responsible for carrying out the tests:

3. Date of test report:

4. Number of test report:

5. Remarks (if any): see Addendum

( ) Delete where not applicable.

( ) If the means of identification of type contains characters not relevant to describe the vehicle, component or separate technical unit types covered by this information document, such characters shall be represented in the documentation by the symbol “?” (e.g.. ABC??123??).

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6. Place:

7. Date:

8. Signature:

Attachments: Information package.

Test report.

Addendum

to EC type-approval certificate No …

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1. Additional information

1.1. […]:

1.1.1. […]: […]

2. Restriction of use of the device (if any)

2.1. […]:

3. Remarks

3.1. […]: ”.

Substitutes Schedule X to the principal regulations.

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“ SCHEDULE X

0. Objectives
0.1. The conformity of production procedure aims to ensure that each produced vehicle, system, component and technical separate unit is in conformity with the approved type.
0.2. Procedures include inseparably the assessment of quality management systems, referred to below as “initial assessment” and verification of the approval subject and product-related controls, referred to as “product conformity arrangements”.
1. Initial assessment
1.1. The approval authority of a Member State shall verify the existence of satisfactory arrangements and procedures for ensuring effective control so that components, systems, separate technical units or vehicles when in production conform to the approved type.
1.2. Guidance for conducting assessments may be found in Standard EN ISO 19011:2002 — Guidelines for quality and/or environmental management systems auditing.
1.3. The requirements referred to in point 1.1 shall be verified to the satisfaction of the authority granting type- approval.
That authority shall be satisfied with the initial assessment and the product conformity arrangements at section 2 below, taking account as necessary of one of the arrangements described in points 1.3.1 to 1.3.3, or a
combination of those arrangements in full or in part as appropriate.
1.3.1. The actual initial assessment and/or verification of product conformity arrangements shall be carried out by the approval authority granting the approval or an appointed body acting on behalf of the approval authority.
1.3.1.1. When considering the extent of the initial assessment to be carried out, the approval authority may take account of available information relating to:
(a) the manufacturer’s certification described in point 1.3.3 below, which has not been qualified or recognised under that point;
(b) in the case of component or separate technical unit type-approval, quality system assessments performed in the component or separate technical unit manufacturer’s premises by vehicle manufacturer(s), according to one or more of the industry sector specifications satisfying the requirements in harmonised standard EN ISO
9001:2008.
1.3.2. The actual initial assessment and/or verification of product conformity arrangements may also be carried out by the approval authority of another Member State or the appointed body designated for this purpose by the approval authority.
1.3.2.1. In such a case, the approval authority of the other Member State shall prepare a statement of compliance outlining the areas and production facilities it has covered as relevant to the product(s) to be type-approved and to the regulatory acts according to which these products are to be type-approved.
1.3.2.2. On receiving an application for a compliance statement from the approval authority of a Member State granting type-approval, the approval authority of another Member State shall send forthwith the statement of compliance or advise that it is not in a position to provide such a statement.

1.3.2.3. The statement of compliance shall include at least the following: (a) Group or company (e.g. XYZ Automotive)
(b) Particular organisation (e.g. European Division)
(c) Plants/Sites (e.g. Engine Plant 1 (United Kingdom) — Vehicle Plant 2 (Germany)) (d) Vehicle/Component range (e.g. All Category M 1 models)
(e) Areas assessed (e.g. Engine assembly, body pressing and assembly, vehicle assembly) (f) Documents examined (e.g. Company and site quality manual and procedures)
(g) Date of the assessment (e.g. Audit conducted from 18 to 30.5.2009)
(h) Planned monitoring visit (e.g. October 2010)

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1.3.3. The approval authority shall also accept the manufacturer’s suitable certification to harmonised standard EN ISO
9001:2008 or an equivalent harmonised standard as satisfying the initial assessment requirements of point 1.3. The manufacturer shall provide details of the certification and undertake to inform the approval authority of any revisions to its validity or scope.
1.4. For the purpose of vehicle type-approval, the initial assessments carried out for granting approvals for systems, components and technical units of the vehicle need not be repeated but shall be completed by an assessment covering the locations and activities relating to the assembly of the whole vehicle not covered by the former assessments.
2. Product conformity arrangements
2.1. Every vehicle, system, component or separate technical unit approved pursuant to this Directive or a separate Directive or Regulation shall be so manufactured as to conform to the type approved by meeting the requirements of this Directive or the applicable regulatory acts listed in Schedule IV.
2.2. The approval authority of a Member State shall verify the existence of adequate arrangements and documented control plans, to be agreed with the manufacturer for each approval, to carry out at specified intervals those tests or associated checks necessary to verify continued conformity with the approved type including specifically physical tests specified in the regulatory acts.
2.3. The holder of the type-approval shall, in particular:
2.3.1. ensure the existence and application of procedures for effective control of the conformity of products (vehicles, systems, components or separate technical units) to the approved type;
2.3.2. have access to the testing or other appropriate equipment necessary for checking the conformity to each approved type;
2.3.3. ensure that test or check results data are recorded and that annexed documents remain available for a period to be determined in agreement with the approval authority. This period shall not exceed 10 years;
2.3.4. analyse the results of each type of test or check, in order to verify and ensure the stability of the product characteristics, making allowance for variation of an industrial production;
2.3.5. ensure that for each type of product, at least the checks prescribed in this Directive and the tests prescribed in the applicable regulatory acts listed in Schedule IV are carried out;
2.3.6. ensure that any set of samples or test pieces, giving evidence of non-conformity in the type of test or check in question gives rise to a further sampling and test or check. All the necessary steps shall be taken to restore conformity of the corresponding production;
2.3.7. in the case of vehicle type-approval, the checks referred to in point 2.3.5 shall at least consist in verifying the correct built specifications in relation to the approval and the information required for certificates of conformity given in Schedule IX.

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3. Continued verification arrangements
3.1. The authority which has granted type-approval may at any time verify the conformity control methods applied in each production facility.
3.1.1. The normal arrangements shall be to monitor the continued effectiveness of the procedures laid down in
Sections 1 and 2 (initial assessment and product conformity arrangements) of this Schedule.
3.1.1.1. Surveillance activities carried out by the technical services (qualified or recognised as required in point 1.3.3) shall be accepted as satisfying the requirements of point 3.1.1 with regard to the procedures established at initial assessment.
3.1.1.2. The normal frequency of verifications by the approval authority (other than those referred to in point 3.1.1.1) shall be such as to ensure that the relevant controls applied in accordance with Sections 1 and 2 are reviewed over a period consistent with the climate of trust established by the approval authority.
3.2. At every review, records of tests or checks and records of production shall be made available to the inspector;
in particular, records of those tests or checks documented as required in point 2.2.
3.3. The inspector may select samples at random to be tested in the manufacturer’s laboratory or in the facilities of the technical service. In such a case only physical test shall be carried out. The minimum number of samples may be determined according to the results of the manufacturer’s own verification.
3.4. Where the level of control appears unsatisfactory, or when it seems necessary to verify the validity of the tests carried out in accordance with point 3.2, the inspector shall select samples to be sent to a technical service to perform physical tests.
3.5. Where unsatisfactory results are found during an inspection or a monitoring review, the approval authority shall ensure that all necessary steps are taken to restore conformity of production as rapidly as possible.”.

Substitutes Schedule XI to the principal regulations.

“SCHEDULE XI

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LIST OF REGULATORY ACTS SETTING THE REQUIREMENTS FOR THE PURPOSE OF EC TYPE- APPROVAL OF SPECIAL PURPOSE VEHICLES

Appendix 1

Motor-caravans, ambulances and hearses

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( ) Technically permissible maximum laden mass.

( ) Not exceeding 3,5 tonnes maximum laden mass.

(*) Any frontal protection system supplied with the vehicle shall comply with the requirements of Regulation (EC) No 78/2009, shall be provided with a type approval and shall be marked accordingly.

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Appendix 2

Armoured vehicles

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( ) The requirements of Directive 98/91/EC are only applicable when the manufacturer applies for the EC type-approval of a vehicle intended for the transport of dangerous goods.

Appendix 3

Wheelchair accessible vehicles

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Appendix 4

Other special purpose vehicles (including trailer caravans)

Application of the exemptions is only permitted if the manufacturer demonstrates to the satisfaction of the approval authority that the vehicle, due to the special function, cannot meet all the requirements.