EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 27.1.2016  
COM(2016) 31 final 
2016/0014 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the approval and market surveillance of motor vehicles and their trailers, and of 
systems, components and separate technical units intended for such vehicles 
(Text with EEA relevance) 
{SWD(2016) 9 final} 
{SWD(2016) 10 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
1.1. Grounds for and objectives of the proposal 
The legal framework for the type-approva l of automotive products covers three 
categories of vehicles: motor vehicles and their trailers, motorcycles, and tractors. 
The objective of this proposal is to revise the legal framework for the type-approval of motor vehicles and their trailers. The legal framework for the two other vehicle 
categories has already been the su bject of a major revision in 2013. 
Type-approval requirements for motor vehicles and their trai lers are currently set out 
in Directive 2007/46/EC of the European  Parliament and of the Council (the 
‘Framework Directive’)
1. This framework aims at facilitating the free movement of 
motor vehicles and trailers in the in ternal market by laying down harmonised 
requirements designed to achieve common environmental and safety objectives. 
Directive 2007/46/EC covers motor vehi cles for the carriage of passengers 
(category M) and of goods (category N), a nd their trailers (category O), as well as 
their systems and components. It provi des a framework under which separate 
regulatory acts with specific safety and environmental requirements are operating. 
These regulatory acts deal with a multitude  of detailed technical requirements for 
different types of vehicles, systems and components. 
As part of the commitments the Commission made in its CARS2020 Action Plan for 
a strong, competitive and sustainable European car industry2, the EU type-approval 
framework for motor vehicles has been the subject of a comprehensive fitness check 
in 2013. It confirmed that the EU type-appr oval legal framework is appropriate for 
achieving the main goals of harmonisation, e ffective operation of the internal market 
and fair competition. However, it was also recognised that differences in interpretation and strictness in applicati on of the requirements across Member States 
are reducing the effectiveness of th e framework. The Commission Staff Working 
document on this Fitness Check therefor e acknowledged room for improvement and 
singled out the review of Di rective 2007/46/EC as a matter of priority, with the need 
to focus on the following aspects: 
– introduction of market surveillance provisions to complement the type-
approval requirements; 
– clarification of the recall  and safeguard procedures, as well as the conditions 
for granting extensions to approvals  for existing types of vehicle; 
– improving the enforcement of the type-approval framework by harmonising 
and enhancing the type-approval and c onformity of production procedures 
applied by Member State author ities and technical services; 
– clarification of the role s and responsibilities of economic operators in the 
supply chain, and of the authorities and parties involved in the enforcement of 
the framework; and 
– improving the suitability of alternative type-approval scheme s (national small 
series and individual approvals) and of the multi-stage type-approval process to provide appropriate flexibility for ni che markets and SMEs, without however 
distorting the leve l playing field. 
                                                
 
1 OJ L 263, 9.10.2007, p. 1 
2 COM/2012/0636 final EN 3   EN Although the fitness check confirmed that the existing regulatory framework has its 
merits in meeting policy obj ectives, it has come under harsh criticis m after the 
discovery that a German manufacturer (VW)  had for several years used software to 
manipulate the emission performance of its cars. Within a week of the outbreak of 
the scandal, the Commission announced th at it would reinforc e the type-approval 
system, in particular by ensuring adequa te supervisory mechanisms to ensure a 
correct and harmonised applic ation of the type-approval pr ocedures. In an internal 
market with 28 Member States and in a sect or subject to consta nt technological and 
scientific progress, substantia l divergences in the interpre tation and application of the 
rules entail the risk of undermining the effectiveness of  the system and therefore the 
main policy objectives of ensuring the safety  and health of citizens and the protection 
of the environment. Many stakeholders openly called for such a revision in the 
aftermath of the VW scandal. 
This revision aims to overcome these flaws and gaps and to restor e the citizen's trust 
in the capability of the regulatory system to ensure an adequate level of protection of 
health and the environment. 
1.2. Existing provisions in the area of the proposal 
– Directive 2007/46/EC of the Europ ean Parliament and of the Council 
establishing a framework for the approval of motor vehicles and their trailers, 
and of systems, components and techni cal units intended for such vehicles. 
– Regulation 765/2008/EC on accreditation and market surveillance, containing 
rules for the European policy on accreditation3 (control of the competence of 
laboratories and certification/inspection bodies delivering certificates in the EU) and for the policy in the field of market surveillance and controls of 
products from third countries (for sa fe products whatever their origin). 
– Decision 768/2008/EC establishing a comm on framework for the marketing of 
products
4, containing standard provisions to be used in EU internal market 
legislation for products (e.g. definitions , obligations of economic operators, 
safeguard clause, etc.). 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
The European Commission launched a public consultation in 20105, seeking to 
gather the views of interested parties on its intention to revise the framework 
directive. The aim of this  public consultation was to verify whether the areas 
identified by the Commission services  as having a potential for improving the 
enforcement of EU type-approval legislati on for motor vehicles would provide the 
right scope and focus for the envisaged re view of Framework Directive 2007/46/EC. 
Forty relevant responses were  received which, overall, i ndicated a strong support for 
the aims of the initiative. Whilst 74% of the respondents concurred that the current 
type-approval framework was already of  fairly high quality, 57.6% of them 
considered that nonetheless more could be  done to emphasise and properly focus the 
legal application of market surveillance pr inciples, with 47% of respondents saying 
                                                 
3 OJ L 218, 13.8.2008, p. 30 
4 OJ L 218, 13.8.2008, p. 82 
5 http://ec.europa.eu/enterprise/sectors/automotive/documents/consultations/2010-internal-
market/index_en.htm   EN 4   EN that existing market surveillance provisions ar e ineffective, while just 2.9% agreed it 
was effective. This outcome clearly demonstrated that stakeholders share the view that more can and should be done to comple ment the ex-ante controls offered by the 
type-approval framework with ex-p ost market surveillance provisions. 
The Commission services also commissione d a number of external studies to 
accompany and feed in to the Impact Assessment process. An ex-post evaluation study
6 on the framework directiv e was carried out in the first half of 2011, followed 
by an impact assessment (IA) study7 in the second half of 2011. This study assessed 
the impact of the possible options develope d for each of the needs identified by the 
Commission services and which were conf irmed to be relevant by the public 
consultation. Based on the results of th e public consultation and the IA study, a 
preferred combination of policy options for addressing these needs has been 
identified. 
Further work on the preparation of the im pact assessment and the review of the 
Framework Directive was undertaken in 2012 /2013 by means of a fitness check pilot 
project. A study contract has been awarded for that purpose whic h was finalised in 
March 2013. A Commission Staff working doc ument reporting on the outcome of the 
fitness check pilot project was published in November 20138, highlighting the 
priorities for the envisage d revision of Directive 2007/46/ EC (See point 1.1 above). 
High level involvement of stakeholders has taken place in the c ontext of the CARS 
21 High Level Group, resulting in a number of recommendations in relation to the 
type-approval framework that have been  taken up by the Commission in its CARS 
2020 Action Plan adopted in November 2012. 
Finally, and in line with the commitments  the European Commission made in its 
CARS 2020 Action Plan, a competitiveness pr oofing study has been carried out in 
the second half of 2013 to complement th e above mentioned actions. The need for 
mitigating measures for SMEs has been considered in the context of this study, 
which demonstrated that for the combinati on of policy options re tained there would 
not be any significant impacts for the SMEs in the sector to the extent that they would require mitigating measures. 
In addition, specific exchanges with Memb er States' authoritie s have taken place 
during the entire impact assessment process at meetings of the Technical Committee Motor Vehicles (TCMV) and the Type -Approval Authoritie s Experts Group 
(TAAEG). Exchange of views with industry an d user associations about the initiative 
have taken place in the framework for th e Motor Vehicles Working Group (MVWG). 
All interested stakeholders have also been consulted by the external study contractors 
for the collection of data and views. 
Triggered by the outburst of the VW emissi ons scandal, the European Parliament 
adopted on 5 October 2015 a Resolution on emission measurements in the automotive sector, calling on the Commi ssion for significantly strengthening the 
current EU type approval regime including more EU oversight, in particular with 
regard to market surveillance, coordination and follow up regime for vehicles sold in 
the Union. 
                                                
 
6 http://ec.europa.eu/enterprise/sectors/automotive/files/projects/report-internal-market-legislation_en.pdf   
7 http://ec.europa.eu/enterprise/sectors/automotive/ files/projects/impact-assessment-internal-market-
legislation_en.pdf   
8 SWD(2013) 466 final EN 5   EN 3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
3.1. Legal basis 
The legal basis of the proposal is Article 114 of the Treaty on the Functioning of the 
European Union (TFEU). 
3.2. Subsidiarity principle 
The framework legislation for the type-approv al of motor vehicles contributes to the 
implementation of the internal market  for goods. This proposal envisages at 
rendering the implementation and enforcement of this legislation more effective as 
part of the overall policy objective to deepen the internal market strategy. 
Although Member States are responsible for the implementation of the legislation in 
their territory, ensuri ng a harmonised and co-ordinated  approach based on commonly 
applicable criteria and uniformly applie d by Member States is essential for 
maintaining a level playing field acr oss the EU by mean s of a harmonised 
interpretation, implementation and enfor cement of the type-approval requirements, 
and backed-up by harmonised provisions on market surveillance to provide Member 
States with adequate means for post-mar ket controls and for taking effective and 
common remedial action against the presen ce of non-compliant and unsafe products 
on the market. 
The differences in the national organisation of type-approval and market surveillance 
in the Member States may give rise to  a non-harmonised enforcement when viewed 
in the framework of the Union's Internal Market which no longer has internal borders 
and where controls at national borders have  practically disappeared. To avoid that 
non-compliant products are placed on their te rritory, Member States also depend to a 
large extent on the effectiveness of th e enforcement policy of their neighbours. 
Consequently, weaknesses in enforcement by one single Member State can seriously 
undermine the efforts taken by other Memb er States to prevent non-compliant 
products from entering their market. This in terdependence is reinforced by the fact 
that the competence of enforcement authorities is limited to the national territory. Where remedial action is n eeded beyond the border , these authorities must rely on 
their colleagues in other Member States. 
This is due to fact that the type-approval framework is based on the principle that all 
new vehicles produced in conformity w ith a type of vehicle approved by one 
Member State benefit from the right of bei ng freely marketed and registered in the 
other Member States. This right applies to all such vehicles, ir respective of their 
origin of production. This means that also vehicles produced outside the EU can be 
freely imported within the EU provided they the manufacturer has certified that they 
have been produced in compliance with a t ype of vehicle approved in one of the EU 
Member States. In view of the global natu re of automotive sector, with substantial 
imports of automotive products from outside  the EU, this important cross-border 
dimension calls for co-ordinated action at EU level to ensure a level playing field. 
If actions were to be taken individually by Member States at national level to address 
market problems, this may entail the risk of creating obstacles to the free movement 
of motor vehicles ensured by the framework le gislation. Hence it is justified to take 
action at EU level. EN 6   EN 3.3. Proportionality principle 
The proposal complies with the proportiona lity principle because it does not go 
beyond what is necessary in order to achie ve the objectives of  ensuring the proper 
functioning of the inte rnal market while at the same  time providing for a high level 
of public safety and environmental protection. 
The measures proposed to reinforce and fu rther harmonise the implementation of the 
type-approval procedures are based on the agreed principles laid down in the 
common framework for the marketing of products, and on the reference provisions 
for Union harmonisation legislation for products  as laid down in Annex I of Decision 
No 768/2008/EC. Where necessary and justifie d, these provisions have been adapted 
to the specificities of the automotive sector, in particular with the view to recognise 
the existence of an already well-establishe d type-approval framework and to ensure 
full coherence with this framework. This ha s in particular the case for the provisions 
on the information exchange and co- operation between market surveillance 
authorities on the one hand and the type-approva l authorities and their designated 
technical services on the other. 
3.4. Choice of instruments 
The use of a Regulation is considered to  be appropriate in that it provides the 
required assurance for direct and harmonised application and enforcement while not requiring transposition into Member States’ legislation. 
The proposal continues to build on the ‘spl it-level approach’ already introduced in 
the EU type-approval framework for moto r vehicles. This approach provides for 
legislation in three steps:  
– the fundamental provisions and scope  are laid down by the European 
Parliament and the Council in a Regul ation based on Article 114 TFEU in 
accordance with the ordinary  legislative procedure. 
– the detailed technical specifi cations associated with the fundamental provisions 
will be laid down in delegated acts adopted by the Commission in accordance 
with Article 290 of the Treaty on the Functioning of the European Union. 
– implementing acts setting out the admi nistrative provisions, such as the 
template for the information document and the type-approval certificates, the certificate of conformity, etc. will  be adopted by the Commission in 
accordance with Article 291 of the Treaty on the Functioning of the European 
Union. 
4. BUDGETARY
 IMPLICATION 
The budgetary implications of this proposal are as follows: 
• Commission staff to organise  and participate in 'joint  assessments' of technical 
services; 
• Costs for national assessors participating in 'joint assessments' of technical 
services in accordance with the Commi ssion's rules on the reimbursement of 
expenses incurred by experts; 
• Commission staff to provide scientific, technical and logistic support to the 
peer review system (joint audits of te chnical services)and to  the coordination of EN 7   EN Member States' market surveillance ac tivities in the field of automotive 
products; 
• Commission staff to manage and further develop the EU regu latory framework 
for the type-approval and market-surve illance of motor vehicles and their 
trailers, and of systems, components and separate technical units intended for 
such vehicles (functioning of this  Regulation and preparation of 
delegated/implementing acts) and to s upport and monitor Member States in 
ensuring its effective and efficient implementation; 
• Costs for organising meetings of th e Enforcement Forum laid down in 
Article 10, including reimbursement of th e travel expenses of the Member 
States; 
• Costs for the establishment and manageme nt of the supervisory mechanism in 
respect of conformity assessments carried out by technical services; 
• Costs for running compliance and conform ity testing of motor vehicles by the 
Commission and 
• Costs for participation in international regulatory cooperation, in particular in 
UNECE; 
Details of the costs are set out in the legislative financial statement. 
In view of the constraints of the Multiannual Financial Framework 2014-2020 the 
implementation of the legislative proposal will have to be built on existing resources and to be designed in such a manner that a dditional financial resources under the EU 
budget are not needed. Actions foreseen in this draft proposal for a Regulation will 
have no budgetary impact on EU budget ove r and beyond the appropriations already 
foreseen in the official financial programming of the Commission as any 
requirements for financial resources would have to be met through assigned revenues 
and internal redeployment. 
For the period following 31 December 2020, the amount shall be  subject to the 
multiannual financial framework in force for the period commencing in 2021, in accordance with Article 312 of the Treaty on the Functioning of the European Union. 
5. OPTIONAL
 ELEMENTS 
5.1. European Economic Area 
The proposed act concerns matters relati ng to the European Economic Area (EEA) 
and should therefore be extended to the EEA. 
5.2. Repeal of existing legislation 
The adoption of the proposal will lead to the repeal of existing legislation. EN 8   EN 2016/0014 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the approval and market surveillance of motor vehicles and their trailers, and of 
systems, components and separate tec hnical units intended for such vehicles 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
9, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) The internal market comprises an area w ithout internal frontiers in which the free 
movement of goods, persons, services and cap ital must be ensured. Internal market 
rules should be transparent, simple and c onsistent, thus providi ng legal certainty and 
clarity for the benefit of businesses and consumers. 
(2) To that end, a comprehensive EU type -approval framework for motor vehicles and 
their trailers, and of systems, components and separate technical  units intended for 
such vehicles, was established by Directiv e 2007/46/EC of the European Parliament 
and of the Council
10. 
(3) An assessment of the Union legal framew ork for the type-approval of motor vehicles 
and their trailers, and of systems, component s and separate techni cal units intended for 
such vehicles, carried out in 201311, showed that the framework established by 
Directive 2007/46/EC is appr opriate for achieving the ma in goals of harmonisation, 
effective operation of the internal market and fair competition, and therefore should 
continue to apply. 
(4) In that assessment it was concluded, however , that there is a need to introduce market 
surveillance provisions to complement the type-approval requirements, a need to 
clarify the recall and safeguard procedures , as well as the conditions for granting 
extensions to approvals for existing types of vehicle, a need to improve the enforcement of the type-approval framewor k by harmonising and enhancing the type-
                                                
 
9 OJ C , , p. . 
10 Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing 
a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles  (Framework Directive)(OJ L 263, 9.10.2007, p. 1). 
11 Commission Staff Working Document 'Fitness Check of the EU legal framework for the type-approval 
of motor vehicles' (SWD(2013) 466 final). EN 9   EN approval and conformity of production procedures applied by Member States' 
authorities and technical services, a need to  clarify the roles and responsibilities of 
economic operators in the supply chain, and of  the authorities and parties involved in 
the enforcement of the framework, and a need to improve the suitability of alternative 
type-approval schemes (national small series  and individual vehicle approvals) and of 
the multi-stage type-approval process to provide appropriate flexibility for niche markets and SMEs, without however distorting the leve l playing field. 
(5) In addition, recent problems encountered w ith the implementation of the type-approval 
framework have revealed particular wea knesses and demonstrate the need for a 
fundamental revision to ensure a robust, transparent, predicta ble and sustainable 
regulatory framework that provides a hi gh level of safety and of health and 
environmental protection. 
(6) This Regulation sets out the harmonised ru les and principles for the type-approval of 
motor vehicles and their trailers, and of systems, components and separate technical 
units intended for such vehi cles, and the individual vehicl e approval, with a view to 
ensuring the proper functioning of the internal  market for the benefit of businesses and 
consumers and to offer a high level of sa fety and protection of health and the 
environment. 
(7) This Regulation lays down the substantiv e technical and administrative type-approval 
requirements for motor vehicles of categorie s M and N and their tr ailers (category O), 
and for the systems, components and separa te technical units intended for such 
vehicles with a view to ensuring an ade quate level of safety and environmental 
performance. These categories cover motor vehicles for the car riage of passengers, 
motor vehicles for the carriage of goods, and their trailers, respectively. 
(8) This Regulation should strengthen the curre nt type-approval framework, in particular 
through the introduction of provisions on mark et surveillance. Market surveillance in 
the automotive sector should be introduced  by specifying the obligations of the 
economic operators in the supply chain, th e responsibilities of the enforcement 
authorities in the Member States, and the measures to be taken when automotive products are encountered on the market that represent serious safety or environmental 
risks or that do not comply with  the type-approval requirements. 
(9) An effective implementation of the type-a pproval requirements should be ensured by 
enhancing the provisions on conformity of  production by, inter alia, providing for 
mandatory periodic audits of the conformity control methods and the continued 
conformity of the products concerned and by reinforcing the requirements relating to 
the competence, obligations and performance of  the technical services that carry out 
tests for whole-vehicle t ype-approval under the respons ibility of type-approval 
authorities . The proper functioning of technica l services is crucial for ensuring a high 
level of safety and environmental protection and citizens' confidence in the system. The criteria for designation of technical  services provided by Directive 2007/46/EC 
should be laid down in greater detail in orde r to assure their cons istent application. 
The assessment methods of technical services  in the Member States have a tendency to 
progressively differ due to th e increased complexity of th eir work. Therefore, it is 
necessary to provide for pro cedural obligations that ensure an information exchange 
and monitoring of Member States' prac tices for the assessment, designation, 
notification and monitoring of their technical services. T hose procedural obligations 
should remove any existing discrepancies in the methods used and in the interpretation 
of the criteria for the designation of technical services. EN 10   EN (10) The need for control and monitoring of technical servi ces by the designating 
authorities has increased since technical pr ogress has raised the risk that technical 
services do not possess the necessary compet ence to test new technologies or devices 
emerging within their scope of designati on. As technical progress shortens product 
cycles and as the intervals of surveillan ce on-site assessments and of the monitoring 
vary between designating authorities, mi nimum requirements with regard to the 
intervals of the surveillan ce and monitoring of the tec hnical services should be 
established. 
(11) Designation and monitoring of technical se rvices by the Member States, in accordance 
with detailed and strict criteria, should ther efore be subject to su pervisory controls at 
Union level, including independent audits as a condition for the renewal of their 
notification after five years. The position of technical services vis-à-vis manufacturers 
should be strengthened, including their right and duty to ca rry out unannounced 
factory inspections and to c onduct physical or laboratory tests on products covered by 
this Regulation, in order to ensure conti nuous compliance by manufacturers after they 
have obtained a type-approval for their products. 
(12) In order to increase transparency and mutu al trust and to furthe r align and develop the 
criteria for the assessment, designation, and no tification of technical services, as well 
as extension and renewal procedures, Member  States should cooperate with each other 
and with the Commission. They should c onsult each other and the Commission on 
questions with general relevance for the im plementation of this Regulation and inform 
each other and the Commission on their model assessment checklist. 
(13) Where designation of a technical service is based on accreditation in the meaning of 
Regulation (EC) No 765/2008 of the Euro pean Parliament and of the Council12, 
accreditation bodies and designating authoritie s should exchange information relevant 
for the assessment of the competence of technical services. 
(14) The Member States should levy fees for the designation and monitoring of technical 
services to ensure sustainability of the monitoring of those technical services by 
Member States and to establish a level playi ng field for technical services. In order to 
ensure transparency, the Member States should inform the Commission and the other 
Member States before they adopt th e level and struct ure of the fees. 
(15) When, in spite of the measures taken to ensure a coherent app lication and follow up of 
the requirements by the Member States, the competence of a techni cal service is in 
doubt, the Commission should have the possibi lity to investigate individual cases. 
(16) In order to ensure that tests and re ports provided by techni cal services are not 
influenced by non-legitimate circumstan ces, the organisation and operation of 
technical services should ensure full impartiali ty. To be able to carry out their tasks in 
a coherent and systematic manner the techni cal services should possess a satisfactory 
management system including provisions on professional secrecy. In order to allow 
technical services to perform their wo rk properly, the level of knowledge and 
competence and independence of their personne l should be guarant eed at all times. 
(17) The independence of tec hnical services vis-à-vis manuf acturers should be ensured, 
including by avoiding direct  or indirect payments by th e manufacturers for the type-
approval inspections and tests they have carried out. Therefore the Member States 
                                                 
12 Regulation (EC) No 765/2008 of the European Par liament and of the Council of 9 July 2008 setting out 
the requirements for accreditation and market surve illance relating to the marketing of products and 
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30). EN 11   EN should establish a type-approval fee structur e that should cover the costs for carrying 
out all type-approval tests and inspections  carried out by the technical services 
designated by the type-approval authority, as  well as the administrative costs for 
issuing the type-approval and the cost s for carrying out ex-post compliance 
verification tests and inspections. 
(18) A robust compliance enforcement mechanism is necessary in order to ensure that the 
requirements under this Regulation are me t. Ensuring compliance with the type-
approval and conformity of production requi rements of the legislation governing the 
automotive sector should remain the key re sponsibility of the a pproval authorities, as 
it is an obligation closely linked to the issuing of the type-a pproval and requires 
detailed knowledge of its content. It is therefore important that the performance of 
approval authorities is regular ly verified by means of pee r-reviews, to ensure that a 
uniform level of quality and stringency is applied by all appr oval authorities in 
enforcing the type-approval requirements. More over, it is important  to provide for the 
verification of the correctness of the type approval itself. 
(19) Closer coordination between national au thorities through information exchange and 
coordinated assessments under the direction of  a coordinating author ity is fundamental 
for ensuring a consistently high level of  safety and health  and environmental 
protection within the internal market. This should also lead to more efficient use of 
scarce resources at national level. For th is purpose a Forum should be established for 
Member States and the Commission to exch ange information on and to coordinate 
their activities related to the enforcement of type-approval legislation. The currently 
informal cooperation between Member States  in this respect would benefit from a 
more formal framework. 
(20) The rules on Union market surveillance and control of produc ts entering the Union 
market provided for in Regulation (EC) No 765/2008 apply to motor vehicles and their 
trailers, and to systems, components and se parate technical units intended for such 
vehicles without preventing Member States from choosing the competent authorities to 
carry out those tasks. Market surveillan ce may be a competence shared between 
different national authorities to take acc ount of the national market surveillance 
systems in the Member States esta blished under Regulation (EC) No 765/2008. 
Effective coordination and monitoring at Un ion and national levels should guarantee 
that approval and market surveillance au thorities enforce the new type-approval and 
market surveillance framework. 
(21) It is necessary to include rules on market  surveillance in this Regulation in order to 
reinforce the rights and obligations of th e national competent authorities, to ensure 
effective coordination of th eir market surveillance activ ities and to clarify the 
applicable procedures. 
(22) In order to increase transparency in the approval process and facilitate the exchange of 
information and the independent verificatio n by market surveillance authorities, 
approval authorities and the Commission, type approval documentation should be 
provided in electronic format and be made publicly available, subject to exemptions 
due to protection of commercial intere sts and the protection of personal data. 
(23) The obligations of national authorities c oncerning market surveillance provided in this 
Regulation are more specific than those laid down in Article 19 of Regulation 
(EC) No 765/2008 to take account of the speci ficities of the type-approval framework 
and the need to complement that framework with an effective market surveillance EN 12   EN mechanism ensuring a robust ex-post veri fication of compliance of the products 
covered by this Regulation. 
(24) Those more specific obligations for nati onal authorities provided in this Regulation 
should include ex-post compliance verification testing and inspections of a sufficient 
number of vehicles placed on th e market. The selection of the vehicles to be subject to 
this ex-post compliance verification should be  based on an appropria te risk assessment 
which takes account of the seriousness of the possible non-compliance and the 
likelihood of its occurrence. 
(25) In addition, the Commission should organise and carry out or require to carry out ex-
post compliance verification tests and inspec tions, independent from those carried out 
by Member States under their national mark et surveillance obligations. When non-
compliance is established by those tests and inspections, or where it is found that a type approval has been granted on the ba sis of incorrect data the Commission should 
be entitled to initiate Uni on-wide remedial actions to re store the conformity of the 
vehicles concerned and to investigate the reasons for the incorrectness of the type 
approval. Appropriate funding should be ensu red in the general budg et of the Union to 
enable the execution of such compliance veri fication testing and in spections. In view 
of the budgetary constraints of the Mu ltiannual Financial Framework 2014-2020 the 
implementation of the legislative proposal will have to be built on existing resources and to be designed in such a manner that they do not generate additional financial 
resources. The Commission should be entit led to impose administrative fines where 
non-compliance is established. 
(26) In order to ensure a high level of vehi cle functional safety, the protection of vehicle's 
occupants and other road users, and environmental protection, the technical 
requirements and environmental standard s applicable to vehicles, systems, 
components and separate technical units should continue to be harmonised and 
adapted to technical a nd scientific progress. 
(27) The objectives of this Regulation should not be affected by the fact that certain 
systems, components, separate technical units  or parts and equipment can be fitted to 
or in a vehicle after that vehicle has been placed on the market, registered or entered 
into service. Appropriate measures should therefore be taken to ensure that the 
systems, components, separate technical units or parts and equipment that can be fitted 
to or in vehicles and that can significantly impair the functioning of systems that are 
essential for environmental protection or functional safety are controlled by an 
approval authority before they are placed on the market, registered or entered into 
service. 
(28) The EU type-approval system has to enab le each Member State to  confirm that every 
type of vehicle and every type of syst em, component and separate technical unit 
intended for such type of ve hicle has undergone the tests and inspections provided for 
in this Regulation to verify its compliance with the type-approval requirements of this Regulation and that its manuf acturer has obtained a type -approval certificate for it. 
The EU type-approval system obliges a manuf acturer to produce his vehicles, systems, 
components and separate tec hnical units in conformity with the approved type. A 
vehicle manufacturer has to certify this by i ssuing a certificate of conformity for every 
vehicle. Every vehicle accompanied by a vali d certificate of conformity should be 
permitted to be made available on the market and registered for use throughout the Union. EN 13   EN (29) Conformity of production is  one of the cornerstones of the EU type-approval system, 
and therefore the arrangements set up by the manufacturer to ensure such conformity 
should be approved by the competent aut hority or by an appropriately qualified 
technical service designated for that purpose, and be subject to regular verification by 
means of independent periodic audits. In addition, approval author ities should ensure 
the verification of the continued c onformity of the products concerned. 
(30) The continued validity of the type-approva ls requires that the manufacturer informs 
the authority that has approved his type  of vehicle about any changes to the 
characteristics of the type or the safety  and environmental performance requirements 
applicable to that type. It is therefore important that the validity of issued type-
approval certificates is limited in time and that those certificates can only be renewed when the approval authority ha s verified and is satisfied that the type of vehicle 
continues to comply with all the applicable requirements. Furthermore, the conditions for extending type-approvals s hould be clarified to ensure a uniform application of the 
procedures and enforcement of the type -approval requirements throughout the Union. 
(31) The assessment of reported serious risks to safety and of harm to public health and the 
environment should be conducte d at national level, but co ordination at Union level 
should be ensured where the reported risk or harm may exist beyond the territory of 
one Member State with the objective of sh aring resources and ensuring consistency 
regarding the corrective action to be taken to mitigate the identified risk and harm. 
(32) In order to ensure that all vehicles, systems, component s and separate technical units 
placed on the market offer a high level of safety and environmental protection, the 
manufacturer or any other economic operator in the supply chain should take effective 
corrective measures, including the recall of  vehicles, where a vehicle, system, 
component or separate tec hnical unit presents a serious  risk for users or the 
environment as referred to in Article 20 of Regulation (EC) No 765/2008. Approval 
authorities should be empowered to assess and verify whether those measures are 
sufficient. The authorities of other Member  States' should have the right to take 
safeguard measures in case they would c onsider that the manufacturer's corrective 
measures are not sufficient. 
(33) Appropriate flexibility should be provi ded by means of alte rnative type-approval 
schemes for manufacturers who produce vehicles  in small series. They should be able 
to benefit from the advantages of the Un ion internal market provided that their 
vehicles comply with the specific EU type-approval requirements for vehicles 
produced in small series. In certain limited cases, it is appropriate to allow for national small series type-approval. In order to prevent misuse, any simplified procedure for 
vehicles produced in small series should be  restricted to cases of very limited 
production. It is therefore necessary to de fine precisely the concept of vehicles 
produced in small series in terms of the nu mber of vehicles produced, the requirements 
to be complied with and the conditions for pl acing those vehicles on the market. It is 
equally important to specify an alternative ap proval scheme for indi vidual vehicles, in 
particular to provide sufficient flexibility fo r the approval of vehicles built in multiple 
stages. 
(34) The Union is a contracting party to the Agreement of the United Nations Economic 
Commission for Europe (UNECE) concerni ng the adoption of uniform technical 
prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or 
be used on wheeled vehicles and the conditio ns for reciprocal recognition of approvals EN 14   EN granted on the basis of these prescriptions (‘Revised 1958 Agreement’)13. The Union 
has accepted a significant number of regu lations annexed to the Revised 1958 
Agreement and has therefore the obligatio n to accept type-approvals issued in 
accordance with those regulations, as complying with the equivalent Union 
requirements. For the purpose of simplifyi ng its type-approval framework and aligning 
it with the international framework of  the UNECE, the Union in Regulation 
(EC) No 661/2009 of the European Parliament and of the Council14 repealed its 
specific type-approval Directives  and replaced them with th e obligatory application of 
the relevant UNECE regulations. To reduce the administrative burden of the type-
approval process, manufacturers of vehi cles, systems, components and separate 
technical units should be allowed to seek type-approval in accordance with this Regulation, where appropria te, directly by means of obtaining approval under the 
relevant UNECE regulations referred to  in the Annexes to  this Regulation. 
(35) Consequently, UNECE regulations and th e amendments thereto which the Union has 
voted in favour of or that the Union a pplies, in accordance with Council Decision 
97/836/EC
15, should be incorporated within the EU type-approval legislation. 
Accordingly, the power should be delegate d to the Commission to amend the Annexes 
to this Regulation and to adopt delegated acts to ensure that the references to the UNECE regulations and their respective am endments in the list of the relevant 
regulatory acts are kept up-to-date. 
(36) Unrestricted access to vehicle repair a nd maintenance information, via a standardised 
format that can be used to retrieve the technical inform ation, and effective competition 
on the market for services providing such information is necessary to improve the functioning of the inte rnal market, particularly as re gards the free movement of goods, 
the freedom of establishment and the free dom to provide servi ces. The requirements 
for the provision of repair and maintenance in formation have so far been laid down in 
Regulation (EC) No 715/2007 of the Eur opean Parliament and of the Council
16, 
Regulation (EC) No 595/2009 of the Eur opean Parliament and of the Council17, 
Commission Regulation (EU) No 692/200818 and Commission Regulation 
                                                 
13 Council Decision 97/836/EC of 27 November 19 97 with a view to acce ssion by the European 
Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be 
fitted to and/or be used on wheeled vehicles and the conditions for reciprocal  recognition of approvals 
granted on the basis of these prescriptions ('Revised 1958 Agreement') (OJ L 346, 17.12.1997, p. 81). 
14 Regulation (EC) No 661/2009 of the European Parliament and of the Council of 13 July 2009 
concerning type-approval requirements for the genera l safety of motor vehicles, their trailers and 
systems, components and separate technical units intended therefor (OJ L 200, 31.7.2009, p. 1). 
15 Council Decision 97/836/EC of 27 November 1997 (OJ L 346, 17.12.1997, p. 78). 
16 Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type 
approval of motor vehicles with respect to emissions from light passenger and commercial vehicles 
(Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, 
p. 1). 
17 Regulation (EC) No 595/2009 of the European Parliament and of the Council of 18 June 2009 on type-
approval of motor vehicles and engines with respect to emissions from heavy duty vehicles (Euro VI) 
and on access to vehicle repair and maintenance information and amending Regulation (EC) No 715/2007 and Directive 2007/46/EC and repealing Directives 80/1269/EEC, 2005/55/EC and 
2005/78/EC (OJ L 188, 18.7.2009, p. 1). 
18 Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation 
(EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles 
with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on 
access to vehicle repair and maintenance in formation (OJ L 199, 28.7.2008, p. 1). EN 15   EN (EU) No 582/201119. Those requirements should be c onsolidated in this Regulation 
and Regulations (EC) No 715/2007, (E C) No 595/2009, (EU) No 692/2008 and 
(EU) No 582/2011 should be amended accordingly. 
(37) Whereas technical progress introduci ng new methods or t echniques for vehicle 
diagnostics and repair, such as remote access to vehicle information and software, 
should not weaken the objectives  of this Regulation with re spect to access to repair 
and maintenance information for independent operators. 
(38) In order to ensure uniform conditions for the implementation of this Regulation, 
implementing powers should be conferred on the Commission. Those powers should 
be exercised in accordance with Regul ation (EU) No 182/2011 of the European 
Parliament and of the Council20. 
(39) In order to supplement this Regulation w ith further technical details, the power to 
adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to th e Commission in respec t of type-approval 
requirements concerning the environmental an d safety performance of motor vehicles 
and their trailers, and of systems, compone nts and separate technical units for such 
vehicles. It is of partic ular importance that the Co mmission carry out appropriate 
consultations during its prepar atory work, including at e xpert level. The Commission, 
when preparing and drawing up delegated acts, should ensure simultaneous, timely 
and appropriate transmission of relevant docum ents to the European Parliament and to 
the Council. 
(40) Member States should lay down rules on penalties for the infringements of this 
Regulation and ensure that those rules are implemented. Those penalties should be 
effective, proportionate and dissuasive. Me mber States shall report the imposed 
penalties to the Commission annually, to m onitor the coherence of the implementation 
of these provisions. 
(41) In the interests of clarity, rationality  and simplification, Di rective 2007/46/EC should 
be repealed and replaced by this Regulation. The adoption of a Regulation ensures that 
provisions are directly appli cable and that they can be updated in a timely and more 
efficient manner to take better account  of technical progr ess and regulatory 
developments in the context of the Revised 1958 Agreement. 
(42) In order to properly implement the comp liance verification by the Commission and to 
ensure a level playing field for economic operators and national authorities, the 
Commission should be compet ent to impose harmonized ad ministrative fines upon the 
economic operators found to have infringe d upon this regulation regardless of where 
the vehicle, system, component or separa te technical unit wa s originally type-
approved. 
(43) Whenever the measures provided for in  this Regulation entail the processing of 
personal data, they should be carried out in  accordance with Directive 95/46/EC of the 
                                                
 
19 Commission Regulation (EU) No 582/2011 of 25 May 2011 implementing and amending Regulation 
(EC) No 595/2009 of the European Parliament and of the Council with respect to emissions from heavy 
duty vehicles (Euro VI) and amending Annexes I and III to Directive 2007/46/EC of the European 
Parliament and of the Council (OJ L 167, 25.6.2011, p. 1). 
20 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 
laying down the rules and general principles concerni ng mechanisms for contro l by Member States of 
the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). EN 16   EN European Parliament and of the Council21 and Regulation (EC)  No 45/2001 of the 
European Parliament and of the Council22, as well as the national implementing 
measures thereto. 
(44) In order to enable Me mber States and national aut horities as well as economic 
operators to prepare for the application of the new rule s introduced by the act, an 
application date following the entr y into force should be set.  
(45) Since the objectives of this Regulation, namely to lay down harmonised rules on the 
administrative and technical requirements  for the type-approval of vehicles of 
categories M, N and O, and of systems, co mponents and separate technical units, and 
on market surveillance of such vehicles, sy stems, components and separate technical 
units, cannot be sufficiently achieved by the Member States, but can rather, by reason 
of their scale and effects, be better achie ved at Union level, the Union may adopt 
measures in accordance with the principle of su bsidiarity as set out in Article 5 of the 
Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not  go beyond what is necessary in order to 
achieve those objectives, 
HAVE ADOPTED THIS REGULATION: 
CHAPTER  I 
SUBJECT  MATTER,  SCOPE  AND  DEFINITIONS 
Article 1 
Subject matter 
1. This Regulation establishes the administ rative provisions and technical requirements 
for the type-approval and placing on the market of all new vehicles, systems, 
components and separate techni cal units intended for such vehicles referred to in 
Article 2(1). It also applies to  individual vehicle approvals. 
2. This Regulation establishes the requirements for the market surveillance of vehicles, 
systems, components and separate technica l units that are subject to approval in 
accordance with this Regulation, as well as of parts and equipment for such vehicles. 
Article 2 
Scope 
1. This Regulation shall apply to  motor vehicles of categorie s M and N and their trailers 
of category O, that are intended to be us ed on public roads, in cluding those designed 
and constructed in one or more stages, and to systems, components and separate 
technical units, as well as to parts and equipment, designed and constructed for such 
vehicles and trailers. 
2. This Regulation does not appl y to the following vehicles: 
                                                 
21 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the 
protection of individuals with regard to the processing of personal data and on the free movement of 
such data (OJ L 281, 23.11.1995, p. 31).  
22 Regulation (EC) No 45/2001 of the European Parliament and of the Council of 18 December 2000 on 
the protection of individuals with regard to the processing of personal data by the Community 
institutions and bodies and on the free movement  of such data (OJ L 8, 12.1.2001, p. 1). EN 17   EN (a) agricultural or forestry vehicles, as defined in Regulation (EU) No 167/2013 of 
the European Parliament and of the Council23; 
(b) two- or three-wheel vehicles and quadr icycles, as defined in Regulation 
(EU) No 168/2013 of the European Parliament and of the Council24; 
(c) vehicles that are used on tracks. 
3. For the following vehicles and machiner y, the manufacturer may apply for type-
approval or individual vehicle approval unde r this Regulation, provided that those 
vehicles fulfil the substantive re quirements of this Regulation: 
(a)  vehicles designed and constructed for us e principally on construction sites or 
in quarries, port or airport facilities; 
(b) vehicles designed and constructed for us e by the armed servi ces, civil defence, 
fire services and forces responsib le for maintaining public order; 
(c) any self-propelled vehicle designed and constructed specifically to perform 
work and that, because of its constructi on characteristics, is not suitable for 
carrying passengers or for transporting goods. 
4. For the following vehicles, the manufactur er may apply for individual vehicle 
approval under this Regulation: 
(a) vehicles intended exclusiv ely for racing on roads; 
(b) prototypes of vehicles used on the road under the responsibility of a 
manufacturer to perform a specific test  programme provided they have been 
specifically designed and cons tructed for that purpose. 
Article 3 
Definitions 
For the purposes of this Regulation, th e following definitions shall apply: 
(1) ‘type-approval’ means the procedure whereby a type-approval authority certifies that 
a type of vehicle, system, component or se parate technical unit sa tisfies the relevant 
administrative provisions a nd technical requirements; 
(2) ‘market surveillance’ means the activities carried out and meas ures taken by the 
market surveillance authorit ies to ensure that vehicl es, systems, components or 
separate technical units as well as parts and equipment made available on the market comply with the requirements set out in the relevant Union legislation and do not endanger health, safety or any other as pect of public in terest protection; 
(3) ‘vehicle’ means any motor vehicle or its tra iler as defined in points (10) and (11); 
(4) ‘system’ means an assembly of devices co mbined to perform one or more specific 
functions in a vehicle and that  is subject to the requirement s of this Regulation or any 
of the regulatory acts listed in Annex IV; 
                                                
 
23 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the 
approval and market surveillance of agricultural or forestry vehicles (OJ L 60, 2.03.2013, p. 1). 
24 Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the 
approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.03.2013, 
p. 52). EN 18   EN (5) ‘component’ means a device that is intended to  be part of a vehicle and that may be 
type-approved independently of that vehicle and that is subj ect to the requirements of 
this Regulation or any of the re gulatory acts listed in Annex IV; 
(6) ‘separate technical unit’ mean s a device intended to be part of a vehicle that may be 
type-approved separately, but only in rela tion to one or more specified types of 
vehicle and that is subject to the require ments of this Regulation or any of the 
regulatory acts listed in Annex IV; 
(7) ‘parts’ means goods used for the assembly, repair and maintenance of a vehicle as 
well as spare parts; 
(8) ‘equipment’ means goods other than parts that can be added to or installed on a 
vehicle; 
(9) ‘manufacturer’ means a natural or legal person who is resp onsible for all aspects of 
the type-approval of a vehicl e, system, component or sepa rate technical unit, or the 
individual vehicle approval, or the authoris ation process for parts and equipment, for 
ensuring conformity of produc tion and for market surveillance matters regarding that 
vehicle, system, component, separate t echnical unit, part and equipment produced, 
irrespective of whether that person is or is not directly involved in  all stages of the 
design and construction of that vehicle, sy stem, component or separate technical unit 
concerned; 
(10) ‘motor vehicle’ means any power-driven vehicle designed and constructed to be 
moved by its own means, having at least f our wheels, being complete, completed or 
incomplete, with a maximum design speed exceeding 25 km/h; 
(11) ‘trailer’ means any non-self-p ropelled vehicle on wheels de signed and constructed to 
be towed by a motor vehicle; 
(12) ‘approval authority’ means the authority or authorities of a Member State, notified to 
the Commission by that Member State, with competence for all aspects of the type-
approval of a vehicle, system, component or separate technica l unit, or of the 
individual vehicle approval, for the authoris ation process for parts and equipment, for 
issuing and, if appropriate, withdrawing or  refusing approval certificates, for acting 
as the contact point for the approval authorities of the other Member States, for designating the technical services, and for en suring that the obligations regarding the 
conformity of production of the manufacturer are met; 
(13) ‘market surveillance authority’ means th e national authority or authorities 
responsible for carrying out ma rket surveillance on the territory of the Member State; 
(14) ‘national authority’ means an approval aut hority or any other authority involved in 
and responsible for market surveillance, bor der control or registration in a Member 
State in respect of vehicles , systems, components, separa te technical units and parts 
or equipment; 
(15) ‘placing on the market’ means making av ailable a vehicle, system, component, 
separate technical unit, pa rt or equipment for the first time in the Union; 
(16) 
‘registration’ means the permanent or tem porary administrative authorisation for the 
entry into service in road traffic of a vehicle, including the identification of the vehicle and the issuing of a serial number; 
(17) ‘entry into service’ means the first use, for its intende d purpose, in the Union, of a 
vehicle, system, component, separate  technical unit, pa rt or equipment; EN 19   EN (18) ‘economic operator’ means the manufacturer , the manufacturer’s representative, the 
importer or the distributor; 
(19) ‘whole-vehicle type-approval’ means the procedure whereby an approval authority 
certifies that an incomplete, complete or completed type of vehicle satisfies the relevant administrative provision s and technical requirements; 
(20) ‘multi-stage type-approval’ means the procedure whereby one or more approval 
authorities certify that depending on the state of completion, an incomplete or 
completed type of vehicle satisfies the relevant administrative provisions and 
technical requirements; 
(21) ‘incomplete vehicle’ means any vehicle that  requires at least one  further stage of 
completion in order to meet the relevant technical requirements of this Regulation 
and of the regulatory acts listed in Annex IV; 
(22) ‘EU type-approval’ means the procedure wher eby an approval authority certifies that 
a type of vehicle, system, component or se parate technical unit sa tisfies the relevant 
administrative provisions and technical re quirements of this Re gulation and of the 
regulatory acts listed in Annex IV; 
(23) ‘type-approval certificate’ means the doc ument whereby the approval authority 
officially certifies th at a type of vehicle, system, component or separate technical 
unit is type-approved; 
(24) ‘manufacturer’s representative’ means any natural or legal person established in the 
Union who is duly appointed  by the manufacturer to re present the manufacturer 
before the approval authority or the market  surveillance authority and to act on the 
manufacturer’s behalf in matte rs covered by this Regulation; 
(25) ‘importer’ means a natural or legal person established in the Union who places on the 
market a vehicle, system, component, separate  technical unit, part or equipment that 
has been manufactured in a third country; 
(26) ‘national type-approval’ means the procedur e whereby an approval authority certifies 
that a type of vehicle, sy stem, component or separate technical unit satisfies the 
relevant administrative pr ovisions and technical requi rements laid down by the 
national law of a Member State, the validity of such approval bei ng restricted to the 
territory of that Member State; 
(27) ‘certificate of conformity’ means the docum ent set out in Anne x IX, issued by the 
manufacturer, which certifies that a produced  vehicle conforms to the approved type 
of vehicle; 
(28) ‘distributor’ means a dealer or any other natural or legal pers on in the supply chain, 
other than the manufacturer or the importer, who makes available on the market a 
vehicle, system, component, separate  technical unit, pa rt or equipment; 
(29) ‘making available on the market’ means any supply of a vehicle, system, component, 
separate technical unit, part or equipment for distribution or use on the market in the 
course of a commercial activity, whether in  return for payment or free of charge; 
(30) ‘step-by-step type-approval’ means the pr ocedure consisting of  the step-by-step 
collection of the whole set of EU type -approval certificates for the systems, 
components and separate technical units form ing part of a vehicle, and which leads, 
at the final stage, to th e whole-vehicle type-approval; EN 20   EN (31) ‘single-step type-approval’ means the procedure whereby an approval authority 
certifies that a type of ve hicle, system, component or separate technical unit as a 
whole satisfies the relevant administrati ve provisions and technical requirements by 
means of a single operation; 
(32) ‘mixed type-approval’ means a step-by-step  type-approval for which one or more 
system type-approvals have been obtained during the final stage of the approval of 
the whole vehicle, without the need to is sue the EU type-approval certificates for 
those systems; 
(33) ‘completed vehicle’ means a vehicle resu lting from the multi-s tage type-approval 
that meets the relevant technical requi rements of this Regulation and of the 
regulatory acts listed in Annex IV; 
(34) ‘complete vehicle’ means a vehicle that does  not need to be completed in order to 
meet the relevant technical requirements of this Regulation and of  the regulatory acts 
listed in Annex IV; 
(35) ‘type of vehicle’ means a particular categor y of vehicles that shares at least the 
essential criteria specified in Part B of A nnex II, and that may contain variants and 
versions as referred thereto; 
(36) ‘technical service’ means an organisa tion or body designated by the approval 
authority as a testing laboratory to carry out tests, or as a conformity assessment 
body to carry out the initial assessmen t and other tests or inspections; 
(37) ‘base vehicle’ means any vehicle that is used  at the initial stage of a multi-stage type-
approval; 
(38) ‘system type-approval’ means the procedure whereby an approval authority certifies 
that a type of system satisfies the rele vant administrative pr ovisions and technical 
requirements; 
(39) ‘separate technical unit type-approval’ m eans the procedure whereby an approval 
authority certifies that a type of separate technical unit satisfies the relevant 
administrative provisions and technical re quirements in relation to one or more 
specified types of vehicles; 
(40) ‘component type-approval’ means the pro cedure whereby an approval authority 
certifies that a type of co mponent independently of a vehicle satisfies the relevant 
administrative provisions a nd technical requirements; 
(41) ‘virtual testing method’ means computer  simulations, including calculations, to 
demonstrate that a vehicle, a system, a com ponent or a separate technical unit fulfils 
the technical requirements of a regulatory act listed in Annex IV without requiring 
the use of a physical vehicle, system, component or separate technical unit; 
(42) ‘individual vehicle approval’ means the pr ocedure whereby an approval authority 
certifies that a particular vehicle, whether unique or not, satisfies the relevant 
administrative provisions and technical requirements for EU individual vehicle 
approval and national indi vidual vehicle approval; 
(43) ‘end-of-series vehicle’ means a vehicle that is part of a stock and that, due to the 
entry into force of new technical require ments against which it has not been type-
approved, cannot or can no longer be made available on the market, registered or 
entered into service; EN 21   EN (44) ‘alternative requirements’ means admi nistrative provisions  and technical 
requirements that aim to ensure a level of  functional safety, environmental protection 
and occupational safety that to the greatest extent practicable is equivalent to the level provided for by one or more of th e regulatory acts li sted in Annex IV; 
(45) ‘spare parts’ means goods that are to be installed in or on a vehicle to replace original 
parts of that vehicle, including goods that ar e necessary for the use of a vehicle, with 
the exception of fuel; 
(46) ‘vehicle repair and maintenance information’ means all information required for 
diagnosing, servicing, insp ecting, periodic monitoring, re pairing, re-programming or 
re-initialising of a vehicle as well as for the fitting on vehicles of parts and equipment, and that is provided by the ma nufacturer to his authorised dealers and 
repairers, including all subse quent amendments and supplements to that information; 
(47) ‘independent operator’ means a natural or legal person, other than an authorised 
dealer or repairer, who is directly or indirectly involved in the repair and 
maintenance of vehicles, including repairer s, manufacturers or di stributors of repair 
equipment, tools or spare parts, publishe rs of technical information, automobile 
clubs, roadside assistance operators, ope rators offering inspection and testing 
services, operators offering training for installers, ma nufacturers and repairers of 
equipment for alternative fuel vehicles; it al so means authorised repairers, dealers or 
distributors within the distribution system  of a given vehicle manufacturer to the 
extent that they provide repair and mainte nance services for vehi cles in respect of 
which they are not members of the vehi cle manufacturer’s distribution system; 
(48) ‘authorised repaire r’ means a natural or legal pe rson providing  repair and 
maintenance services for vehicles operat ing within the manufacturer’s distribution 
system; 
(49) ‘independent repaire r’ means a natural or legal pe rson providing repair and 
maintenance services for vehicles not  operating within the manufacturer’s 
distribution system; 
(50) ‘vehicle  on-board diagnostic (OBD) information’  means the information relating to a 
system on board of a vehicle or that is connected to an engine and that has the 
capability of detecting a malfunction, a nd, where applicable, of indicating its 
occurrence by means of an alert system, of  identifying the likely area of malfunction 
by means of information stored in a com puter memory, and of communicating that 
information off-board; 
(51) ‘vehicle produced in small series’ means a type of vehicle of which the number of 
units that is made available on the market, registered or entered into service does not 
exceed the quantitative annual li mits laid down in Annex XII; 
(52) ‘special purpose vehicle’ (SPV) means a vehicle of category M, N or O having 
specific technical features to perform a func tion that requires special arrangements or 
equipment; 
(53) ‘Semi–trailer’ means a towed vehicle, in wh ich the axle(s) is (are) positioned behind 
the centre of gravity of the vehicle (when uniformly loaded), and which is equipped 
with a connecting device permitting horizontal and vertical forces to be transmitted to the towing vehicle. EN 22   EN (54) ‘national accreditation body’ means the sole body in a Me mber State that performs 
accreditation with authority derived from the State, as laid down in Article 2(11) of 
Regulation (EC) No 765/2008; 
(55) ‘on-site assessment’ means a verificatio n by the type-approva l authority in the 
premises of the technical se rvice or of one of its subc ontractors or subsidiaries; 
(56) ‘surveillance on-site assessment’ means a periodic routine on-site assessment which 
is neither the on-site assessment undertaken for the initial designation, nor the on-site 
assessment undertaken for the renewal of the designation; 
Article 4 
Vehicle categories 
1. For the purposes of this Regulation, the following vehicle categories shall apply: 
(a) Category M comprises motor vehicles designed and constructed primarily for 
the carriage of persons a nd their luggage, namely: 
(i) Category M 1: motor vehicles comprising not more than eight seating 
positions in addition to the driver’s seating position and without space for standing passengers. The number of sea ting positions may be restricted to 
the driver’s seating position; 
(ii) Category M
2: motor vehicles comprising more than eight seating 
positions in addition to the driver’s seating position and having a maximum mass not exceeding 5 tonnes. These motor vehicles may have 
space for standing passengers; 
(iii) Category M
3: motor vehicles comprising more than eight seating 
positions in addition to the driver’s seating position and having a maximum mass exceeding 5 tonnes. These motor vehicles may have space for standing passengers. 
(b) Category N comprises motor vehicles designed and constructed primarily for 
the carriage of goods, namely: 
(i) Category N
1: motor vehicles having a maximum mass not exceeding 
3,5 tonnes; 
(ii) Category N 2: motor vehicles having a maximum mass exceeding 3,5 
tonnes but not exceeding 12 tonnes; 
(iii) Category N 3: motor vehicles having a maximum mass exceeding 12 
tonnes. 
(c) Category O comprises trailers designe d and constructed for the carriage of 
goods or of persons, as well as for the accommodation of persons, namely: 
(i) Category O 1: trailers having a maxi mum mass not exceeding 0,75 
tonnes; 
(ii) Category O 2: trailers having a maximu m mass exceeding 0,75 tonnes 
but not exceeding 3,5 tonnes; 
(iii) Category O 3: trailers having a maximu m mass exceeding 3,5 tonnes 
but not exceeding 10 tonnes; 
(iv) Category O 4: trailers having a maximu m mass exceeding 10 tonnes. EN 23   EN 2. The criteria for the categorisation of vehicl es, types of vehicle, variants and versions 
are specified in Annex II. 
The Commission shall be empowered to adopt  delegated acts in accordance with 
Article 88 to amend Annex II concerni ng the categorisation of vehicle sub-
categories, types of vehicle and types of bodywork in order to adapt it to technical 
progress. 
CHAPTER  II 
GENERAL  OBLIGATIONS 
Article 5 
General substantive requirements 
1. Vehicles, systems, component s and separate technical un its shall comply with the 
requirements of the regulatory  acts listed in Annex IV. 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex IV to take account of technological and regulatory 
developments by introducing and updating re ferences to regulator y acts containing 
the requirements with which vehicles, syst ems, components and separate technical 
units have to comply. 
Article 6 
Obligations of Member States 
1. Member States shall establish or appoint  the approval authorities and the market 
surveillance authorities. Member States shall notify the Commission of the establishment and appointment  of such authorities. 
That notification shall include the name of those authorities, their address, including 
their electronic address, and their comp etences. The Commission shall publish on its 
website a list and details of the approval authorities and the market surveillance 
authorities. 
2. Member States shall permit the placing on the market, registra tion or entry into 
service of only those vehicles, systems, co mponents and separate technical units that 
comply with the requirements set out in this Regulation. 
3. Member States shall not prohibit, restri ct or impede the placing on the market, 
registration or entry into service of ve hicles, systems, components or separate 
technical units that comply with the require ments set out in this Regulation, except in 
the cases provided in Article 52. 
By way of derogation from that rule, Memb er States are not obliged to allow the 
placing on the market, registration or entry in to service of vehicles that are type-
approved in accordance with this Regulati on, but exceed the harmonised dimensions 
laid down in Annex I to Council Directive 96/53/EC
25. 
                                                 
25 Council Directive 96/53/EC of 25 July 1996 laying down for certain road vehicles circulating within the 
Community the maximum authorized dimensions in national and international traffic and the maximum 
authorized weights in international traffic (OJ L 235 17.9.1996, p. 59). EN 24   EN 4. Member States shall organise and carry out market surveillance and controls of 
vehicles, systems, component s or separate technical un its entering the market, in 
accordance with Chapter III of  Regulation (EC) No 765/2008. 
5. Member States shall take the necessary m easures to ensure that market surveillance 
authorities may, where they consider it nece ssary and justified, be entitled to enter 
the premises of economic operators and seize the necessary samples of vehicles, systems, components and separate techni cal units for the purposes of compliance 
testing. 
6. The Member States shall periodically review  and assess the func tioning of their type-
approval activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be  communicated to the other Member States 
and the Commission. The Member State conc erned shall make a summary of the 
results accessible to the public, in particular  the number of type-approval granted and 
the identity of the co rresponding manufacturers. 
7. The Member States shall pe riodically review and asse ss the functioning of their 
surveillance activities. Such reviews and a ssessments shall be carried out at least 
every four years and the results thereof sh all be communicated to the other Member 
States and the Commission. The Member St ate concerned shall make a summary of 
the results accessi ble to the public. 
Article 7 
Obligations of approval authorities 
1. Approval authorities shall only approve such vehicles, systems, components or 
separate technical units that comply w ith the requirements of this Regulation. 
2. Approval authorities shall car ry out their duties independently and impartially. They 
shall observe confidentiality where necessary in order to protect commercial secrets, 
subject to the obligation of information laid down in Article 9(3) in order to protect 
the interests of users in the Union. 
3. A Member State where more than one appr oval authority is responsible for vehicle 
approval including individual vehicle appr oval, shall designate a unique type 
approval authority responsible  for the exchange of information with the approval 
authorities of the other Member States an d for the obligations laid down in Chapter 
XV of this Regulation. 
Approval authorities within a Member State shall coopera te with each other by 
sharing information relevant to their role and functions. 
4. Where an approval authority is informed  in accordance with Articles 8(5), 9(5), 
52(4) or 54, it shall take all necessary m easures to review the approval granted and, 
where appropriate, correct or withdraw the approval depending on the reasons and 
the seriousness of the deviations demonstrated. 
5. The Commission may adopt implementing acts to lay down the common criteria to 
appoint, review and assess the approval authorities at national level. Those 
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). EN 25   EN Article 8 
Obligations of market surveillance authorities 
1. Market surveillance authorit ies shall perform regular checks to verify compliance of 
vehicles, systems, components and separate technical units with the requirements set 
out in this Regulation as well as with th e correctness of the type approvals. Those 
checks shall be performed on an adequate  scale, by means of documentary checks 
and real-drive and laboratory tests on the basis of statistically relevant samples. 
When doing so, market surveillance author ities shall take account of established 
principles of risk assessment, complaints and other information. 
2. Market surveillance authorities shall require economic operators to make the 
documentation and information available as they consider necessary for the purpose 
of carrying out their activities. 
3. For type-approved vehicles, systems, co mponents and separate technical units, 
market surveillance authorities shall take due account of certificates of conformity 
presented by economic operators. 
4. Market surveillance authorities shall take appropriate measures to alert users within 
their territories within an adequate timefram e of hazards they have identified relating 
to any vehicle, system, component and sepa rate technical unit so as to prevent or 
reduce the risk of injury or other damage. 
Market surveillance authorit ies shall cooperate with ec onomic operators regarding 
actions which could prevent or reduce risk s caused by vehicles, systems, components 
and separate technical units made available by those operators. 
5. Where the market surveillance authorities of one Member State decide to withdraw a 
vehicle, system, component and separate  technical unit from the market in 
accordance with Article 49(5), they shall inform the economic operator concerned 
and where applicable the re levant approval authority. 
6. Market surveillance authorities shall carry out their dutie s independently and 
impartially. They shall observe confidentia lity where necessary in order to protect 
commercial secrets, subject to the obligation of information laid down in Article 9(3) to the fullest extent necessary in order to protect the interests of users in the European Union. 
7. The Member States shall pe riodically review and asse ss the functioning of their 
surveillance activities. Such reviews and a ssessments shall be carried out at least 
every four years and the results thereof sh all be communicated to the other Member 
States and the Commission. The Member St ate concerned shall make a summary of 
the results accessi ble to the public. 
8. The market surveillance authorities of diffe rent Member States shall coordinate their 
market surveillance activities, cooperate w ith each other and share with each other 
and with the Commission the results th ereof. Where appropriate, the market 
surveillance authorities shall agree on work-sharing and specialisation. 
9. Where more than one authority in a Me mber State is responsible for market 
surveillance and external border controls, t hose authorities shall cooperate with each 
other, by sharing information releva nt to their role  and functions. 
10. The Commission may adopt implementing acts to lay down the cr iteria for setting 
out the scale, scope and frequency with which the compliance verification checks of 
samples taken referred to in paragraph 1 have to be performed. Those implementing EN 26   EN acts shall be adopted in accordance with the examination procedure referred to in 
Article 87(2). 
Article 9 
Compliance verification by the Commission and  
enforcement co-ordination with Member States 
1. The Commission shall organise and carry out, or require to be carried out, on an 
adequate scale, tests and inspections of vehicles, systems, components and separate 
technical units already made available on the market, with a view to verifying that 
those vehicles, systems, components and sepa rate technical units conform to the type 
approvals and to applicable legislation as we ll as to ensure the correctness of the type 
approvals.  
Those tests and inspections may take place on new vehicles supp lied by manufacturers 
or the economic operator as provided in paragraph 2 below. 
Those tests and inspections may also take place on registered vehicles in agreement 
with the vehicle registration holder. 
2. Manufacturers holding type-approvals or th e economic operators shall, upon request, 
supply to the Commission a statistically relevant number of production vehicles, 
systems, components and separate technical  units selected by the Commission that 
are representative for the ve hicles, systems, components an d separate technical units 
available for placing on the market unde r that type-approval. Those vehicles, 
systems, components and separate technical units shall be supplied for testing at the 
time and place and for the peri od the Commission may require. 
3. For the purpose of enabling the Commission to carry out the testing referred to in 
paragraphs 1 and 2, Member States shall make availabl e to the Commission all data 
related to the type-approval of the vehi cle, systems, components and separate 
technical units subject to compliance verifi cation testing. Those da ta shall include at 
least the information included in the type-approval certificate and its attachments 
referred to Article 26(1). 
For vehicles approved in accordance with the step-by-step or multistage type-
approval procedure, Member St ates shall also provide th e Commission with the type-
approval certificate and its attachments referr ed to in Article 26(1) for the underlying 
type-approvals of systems, compon ents and separate technical units. 
4. Vehicle manufacturers shall make public da ta which are needed for the purpose of 
compliance verification testing by third parties. The Commission shall adopt implementing acts in order to define the da ta to be made public and the conditions 
for such publication, subject to the pr otection of commercial secrets and the 
preservation of personal da ta pursuant to Union and national legislation. Those 
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). 
5. Where the Commission establishes that th e vehicles tested or inspected do not 
comply with the type-approval requirements laid down in this Regulation or any of the regulatory acts listed in Annex IV or th at the type approval has been granted on 
the basis of incorrect data, it shall require  in accordance with Article 54(8) without 
delay the economic operator concerned to take  all appropriate corrective measures to 
bring the vehicles in compliance with those requirements, or it shall take restrictive 
measures, either by requiring the economic  operator to withdr aw the vehicles EN 27   EN concerned from the market, or to recall them within a reasonable period of time, 
depending on the seriousness of the established non-compliance. 
 Where those tests and inspections put in to question the correctness of the type 
approval itself, the Commission shall inform the approval authority or authorities concerned as well as the Forum for Exch ange of Information on Enforcement.  
 The Commission shall publish a report of its findings following any compliance 
verification testing it has carried out. 
Article 10  
Forum for Exchange of Information on Enforcement 
1. The Commission shall establish and chair a Forum for Exchange of Information on 
Enforcement (‘the Forum’). 
This Forum shall be composed of memb ers appointed by the Member States.  
2. The Forum shall coordinate a network of the national authorities responsible for the 
type-approval and market surveillance. 
Its advisory tasks shall comprise inter alia the promotion of good practices, the 
exchange of information on enforcement problems, cooperation, development of working methods and tools, development of an electronic information exchange 
procedure, evaluation of harmonised enfo rcement projects, penalties and joint 
inspections. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to lay down the composition, appoint ment process, detailed tasks, working 
methods and rules of procedure of the Forum. 
Article 11 
General obligations of manufacturers 
1. The manufacturer shall ensure that the ve hicles, systems, components or separate 
technical units that he has manufactured a nd that have been placed on the market, or 
entered into service have been manufactur ed and approved in accordance with the 
requirements set out in this Regulation. 
2. In the case of multi-stage type-approval, the manufacturer shall also be responsible 
for the approval and conformity of pr oduction of the systems, components or 
separate technical units that he has adde d at the stage of vehicle completion. Any 
manufacturer who modifies components, syst ems or separate technical units already 
approved at earlier stages shall be respons ible for the approval and conformity of 
production of the modified components, sy stems or separate technical units. The 
manufacturer of the previous stage shall provide information to  the manufacturer of 
the subsequent stage regarding any change that may affect com ponent type-approval, 
system type-approval or separate technica l unit type-approval or  the whole-vehicle 
type-approval. Such information shall be provided as soon as the new extension to the whole-vehicle type-approval has been issu ed and at the latest  on the starting date 
of production of the in complete vehicle. 
3. The manufacturer who modifies an incomp lete vehicle in such a manner that it 
qualifies as a different category of vehi cle, with the consequence that the 
requirements already assessed in a previ ous stage of type-approval have changed, EN 28   EN shall also be responsible for compliance with the requirements applicable to the 
category of vehicles for which the modified vehicle qualifies. 
4. For the purposes of EU t ype-approval, a manufacturer established outside the Union 
shall appoint a single  representative esta blished within the Un ion to represent the 
manufacturer before the a pproval authority. That manufact urer shall also appoint a 
single representative established within the Union for the purposes of market 
surveillance, who may be the same representative appointed for the purposes of EU 
type-approval. 
5. The manufacturer shall be responsible to the approval authority fo r all aspects of the 
approval procedure and for ensuring confor mity of production, whether or not he is 
directly involved in all stag es of the construction of a ve hicle, system, component or 
separate technical unit. 
6. The manufacturer shall establish procedur es to ensure that series production of 
vehicles, systems, components and separate  technical units remains in conformity 
with the approved type. 
7. In addition to the statutory plate fixed to their vehicles and type -approval marks fixed 
to their components or separate technica l units in accordance with Article 36, the 
manufacturer shall indicate his name, regist ered trade name or registered trade mark 
and his contact address in the Union on his vehicles, components or separate 
technical units made available on the market  or, where that is not possible, on the 
packaging or in a document accompanying th e component or separa te technical unit. 
Article 12 
Obligations of manufacturers concerning thei r vehicles, systems, components, separate 
technical units or parts and equipm ent that are not in conformity or that present a serious risk 
1. A manufacturer who consider s that a vehicle, system, co mponent, separate technical 
unit, or part or equipment that has been pl aced on the market or entered into service 
is not in conformity with this Regulation or that the type appr oval has been granted 
on the basis incorrect data, shall immedi ately take the appropriate measures 
necessary to bring that vehicle, system, co mponent, separate technical unit, part or 
equipment into conformity, to withdraw it from the market or to recall it, as 
appropriate. 
The manufacturer shall imme diately inform the approval authority that has granted 
the approval in detail of the non-conf ormity and of any measures taken. 
2. Where the vehicle, system, component, se parate technical unit, part or equipment 
presents a serious risk, the manufacturer  shall immediately provide detailed 
information on the non-conformity and on a ny measures taken to the approval and 
market surveillance authorities of the Memb er States in which the vehicle, system, 
component, separate technical unit, part or equipment has been made available on the 
market or has entered into service to that effect. 
3. The manufacturer shall keep the informati on package referred to in Article 24(4) for 
a period of ten years after the placing on th e market of a vehicle and for a period of 
five years after the placing on the mark et for a system, component or separate 
technical unit. 
The vehicle manufacturer shall keep at the disposal of the appr oval authorities a copy 
of the certificates of conform ity referred to in Article 34. EN 29   EN 4. The manufacturer shall, upon a reasoned request from a national authority, provide 
that authority, through the approval authorit y, with a copy of the EU type-approval 
certificate or the authorisation referred to in Article 55(1) dem onstrating conformity 
of the vehicle, system, component or separa te technical unit, in  a language that can 
be easily understood by the national authority. 
The manufacturer shall, following a reas oned request from a national authority, 
cooperate with that authority on any acti on taken in accordance with Article 20 of 
Regulation (EC) No 765/2008 to eliminate th e risks posed by the vehicle, system, 
component, separate technical unit, part or equipment that he has made available on 
the market. 
Article 13 
Obligations of manufacturer’s represen tatives concerning market surveillance 
1. The manufacturer’s representative for mark et surveillance shall perform the tasks 
specified in the mandate received from th e manufacturer. That mandate shall provide 
for that representative to do at least the following: 
(a) have access to the information folder referred to in Article 22 and the 
certificate of conformity referred to in Article 34 in one of the official Union 
languages. Such documentation shall be made available to the approval authorities for a period of ten years after the placing on the market of a 
vehicle and for a period of five year s after the placing on the market for a 
system, component or separate technical unit; 
(b) following a reasoned request from an approval authority, provide that 
authority with all the information and documentation necessary to demonstrate the conformity of produc tion of a vehicle, system, component 
or separate technical unit; 
(c) cooperate with the approval or market  surveillance authorities, at their 
request, on any action taken to eliminat e the serious risk posed by vehicles, 
systems, components, separate techni cal units, parts or equipment covered 
by that mandate; 
(d) immediately inform the manufacturer about complaints and reports relating 
to risks, suspected incidents, non-comp liance issues with vehicles, systems, 
components, separate technical units, parts or equipment covered by that 
mandate; 
(e) terminate that mandate if the manufacturer acts contrary to his obligations 
under this Regulation. 
2. A manufacturer's representative who term inates the mandate on the grounds referred 
to in point (e) of paragraph 1 shall immediat ely inform the type a pproval authority that 
granted the approval and the Commission. 
3. The details of a change shall addr ess at least the following aspects: 
(a) the date of termination of the mandate with the outgoing authorised 
representative and date of beginning of the manda te with the incoming 
manufacturer's representative; EN 30   EN (b) the date until which the outgoing ma nufacturer's representative may be 
indicated in the information supplied  by the manufacturer, including any 
promotional material; 
(c) the transfer of documents, including confidentiality aspects and property 
rights; 
(d) the obligation of the ou tgoing manufacturer's repres entative after the end of 
the mandate to forward to the manuf acturer or incoming manufacturer's 
representative any complain ts or reports about risk s and suspected incidents 
related to a vehicle, system, component , separate technica l unit, part or 
equipment for which he had been designated as manufacturer's representative. 
Article 14 
Obligations of importers 
1. The importer shall place on the market only vehicles, systems, components or 
separate technical units that have either received EU type-approval or national type-
approval, or parts or equipment that comp ly with the requirements of Regulation 
(EC) No 765/2008. 
2. Before placing on the market a type-a pproved vehicle, system, component or 
separate technical unit, the importer shall ve rify that an information package referred 
to in Article 24(4) has been put togeth er by the approval aut hority, and that the 
system, component or separate technical unit bears the required type-approval mark 
and complies with Article 11(7). 
In the case of a vehicle, the importer shal l ensure that the vehicle is accompanied by 
the required certificate of conformity. 
3. Where the importer considers that a vehicle,  system, component or separate technical 
unit is not in conformity with the requireme nts of this Regulati on, and in particular 
that it does not correspond to its type-approval, he sh all not place on the market, 
allow to enter into service or register the vehicle, sy stem, component or separate 
technical unit, until it has been  brought into conformity. Wh ere he considers that the 
vehicle, system, component, separate tec hnical unit, part or equipment presents a 
serious risk, he shall inform the manufacturer  and the market surv eillance authorities 
thereof. For type-approved vehicles, syst ems, components and separate technical 
units, he shall also inform the approval au thority that has granted the type-approval. 
4. The importer shall indicate his name, registered trade name or registered trade mark 
and his contact address on the vehicle, sy stem, component, separate technical unit, 
part or equipment, or, where this is not possible, on its packaging or in a document accompanying the system, component, separate  technical unit, part or equipment. 
5. The importer shall ensure that the vehicle,  system, component or separate technical 
unit is accompanied by the inst ructions and information requ ired by Article 63 in the 
official language or languages of the Member States concerned. 
6. The importer shall, to protect the health and safety of consumers, investigate and 
keep a register of complaints and recalls of vehicles, systems, components, separate 
technical units, parts or equipment that he has placed on the market and keep his 
distributors informed of such monitoring. EN 31   EN Article 15 
Obligations of importers concerning their veh icles, systems, components or separate 
technical units that are not in conformity or concerning their vehicles,  systems, components, 
separate technical units, parts or equi pment that present a serious risk 
1. Where a vehicle, system, component or sepa rate technical unit th at has been placed 
on the market by the importer is not in conf ormity with this Regulation, the importer 
shall immediately take the appropriate meas ures necessary to bring that vehicle, 
system, component or separate technical uni t into conformity, to withdraw it from 
the market or to recall it, as appropriate. 
2. Where a vehicle, system, component, sepa rate technical unit, part or equipment 
presents a serious risk, the importer shall immediately provide detailed information 
on the serious risk to the manufacturer and the approval and market surveillance 
authorities of the Member States in whic h the vehicle, system, component, separate 
technical unit, part or  equipment has been placed on the market. 
The importer shall also inform the approva l and market surveilla nce authorities of 
any action taken and give details, in particul ar of the serious risk and of corrective 
measures taken by the manufacturer. 
3. The importer shall, for a period of ten ye ars after the placing on the market of the 
vehicle and for a period of five years as from the placing on the market for a system, 
component or separate technical unit, keep a copy of the certificat e of conformity at 
the disposal of the approval and market su rveillance authorities and ensure that the 
information package referred to in Article 24(4) can be made available to those authorities, upon request. 
4. The importer shall, upon a reasoned request from a national authority, provide that 
authority with all the information and documentation necessary to demonstrate the conformity of a vehicle, system, component  or separate techni cal unit in a language 
that can be easily understood by that aut hority. The importer shall, following a 
reasoned request from a national authorit y, cooperate with that authority on any 
action taken in accordance with Article 20 of Regulation (EC) No 765/2008 to 
eliminate the risks posed by the vehicle, sy stem, component, separate technical unit, 
part or equipment that he ha s made available on the market. 
Article 16 
Obligations of distributors 
A distributor shall verify, befo re making available on the market , registering or entering into 
service of a vehicle, system, component or separa te technical unit, that that vehicle, system, 
component or separate technical unit bears the required statutor y plate or type-approval mark, 
that it is accompanied by the required documen ts and by instructions a nd safety information, 
required by Article 63, in the official language or  languages of the relevant Member State, and 
that the manufacturer and the importer have complied with the requirements set out in Article 11(7) and Article 14(4) respectively. EN 32   EN Article 17 
Obligations of distributors concerning thei r vehicles, systems, components or separate 
technical units that are not in  conformity or concerning their vehicles, systems, components, 
separate technical units, parts or equi pment that present a serious risk 
1. Where the distributor considers that a vehicle, system, component or separate 
technical unit is not in confor mity with the requirements of this Regulation, he shall 
not make available on the market, register or  enter into service the vehicle, system, 
component or separate technical unit until  it has been brought into conformity. 
2. The distributor who considers that a vehicl e, system, component or  separate technical 
unit that he has made available on the ma rket is not in conformity with this 
Regulation, shall inform the manufacturer or the importer to ensure that the appropriate measures necessary to bring that  vehicle, system, co mponent or separate 
technical unit into conformity, to withdraw it from the market or to recall it, as 
appropriate, are taken in accordance w ith Article 12(1) or Article 15(1). 
3. Where the vehicle, system, component, se parate technical unit, part or equipment 
presents a serious risk, the distributor shall immediately provide detailed information 
on that serious risk to the manufacturer, the importer and the approval and market 
surveillance authorities of the Member St ates in which that vehicle, system, 
component, separate technical unit, part or equipment has been made available on the 
market. The distributor shall also inform them  of any action taken and give details, in 
particular of the serious risk and of co rrective measures taken by the manufacturer. 
4. The distributor shall, following a reas oned request from a national authority, 
cooperate with that authority on any acti on taken in accordance with Article 20 of 
Regulation (EC) No 765/2008 to eliminate th e risks posed by the vehicle, system, 
component, separate technical unit, part or equipment that he has made available on 
the market. 
Article 18 
Cases in which obligations of manufac turers apply to impor ters and distributors 
An importer or distributor shall be consider ed a manufacturer for the purposes of this 
Regulation and shall be subject to the obligations  of the manufacturer under Articles 8, 11 and 
12, where the importer or distributor makes availa ble on the market, registers or is responsible 
for the entry into service of a vehicle, system , component or separate technical unit under its 
name or trademark or modifies a vehicle, sy stem, component or sepa rate technical unit in 
such a way that it may no longer comp ly with the applicable requirements. 
Article 19 
Identification of economic operators 
Upon a request of an approval au thority or a market surveillance authority, for a period of ten 
years after the placing on the ma rket of a vehicle and for a pe riod of five years after the 
placing on the market of a system, component, se parate technical unit, part or equipment, 
economic operators shall provide information on the following: 
(a) the identity of any economic operator who ha s supplied them with a vehicle, system, 
component, separate technical  unit, part or equipment; 
(b) the identity of any economic operator to wh om they have supplied a vehicle, system, 
component, separate technical unit, part or equipment. EN 33   EN CHAPTER  III 
PROCEDURES  FOR  EU TYPE-APPROVAL 
Article 20 
Procedures for EU type-approval 
1. Where applying for a whole-vehicle type-a pproval, the manufacturer may choose one 
of the following procedures: 
(a) step-by-step type-approval; 
(b) single-step type-approval; 
(c) mixed type-approval. 
In addition, the manufacturer may c hoose multi-stage type-approval for an 
incomplete or completed vehicle. 
2. For system type-approval, component type-a pproval and separate technical unit type-
approval only the single-step type-approval is applicable. 
3. Multi-stage type-approval shall be granted in respect of an incomplete or completed 
type of vehicle that, having regard to the st ate of completion of the vehicle, conforms 
to the particulars in the information folder  provided for in Article 22 and meets the 
technical requirements laid dow n in the relevant regulatory acts listed in Annex IV. 
The multi-stage type-approval shall also a pply to complete vehicles converted or 
modified by another manufacturer after their completion. 
4. The EU type-approval for the final stage of completion shall be granted only after the 
approval authority has verified that the ty pe of vehicle approve d at the final stage 
meets at the time of the approval all appli cable technical requirements. Verification 
shall include a documentary check of a ll requirements covered by an EU type-
approval for an incomplete type of vehicl e granted in the course of a multi-stage 
procedure, even where granted for a different category of vehicle. 
5. The choice of type-approval re ferred to in paragraph 1 shal l not affect the applicable 
substantive requirements with which the appr oved type of vehicle has to comply with 
at the time of issuing of th e whole-vehicle type-approval. 
6. Multi-stage type-approval may also be us ed by a single manufacturer, provided it is 
not used to circumvent the requirements applic able to vehicles built in a single stage. 
Vehicles built by a single manufacturer are not considered to be built in multiple stages for the purposes of Article s 39, 40 and 47 of this Regulation. 
Article 21 
Application for EU type-approval 
1. The manufacturer shall submit to the appr oval authority an application for EU type-
approval and the information fold er referred to in Article 22. 
2. Only one application may be submitted in respect of a particular type of vehicle, 
system, component or separate techni cal unit and in one Member State only. 
3. A separate application shall be submitted for each type of vehicle, system, 
component or separate technical unit to be approved. EN 34   EN Article 22 
Information folder 
1. The information folder referred to in Article 21(1) shall include the following: 
(a) an information document, as set out in Annex I for single-step or mixed type-
approval or in Annex III for step-by-step type-approval; 
(b) all data, drawings, photographs a nd other relevant information; 
(c) for vehicles, an indication of the pro cedure(s) chosen in accordance with 
Article 20(1); 
(d) any additional information requested by th e approval authority in the context of 
the application procedure. 
2. The information folder shall be supplied in an electronic format to be provided by the 
Commission but may also be supplied on paper. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annexes I and III to take account of technical and regulatory developments by updating the template for the information document, including a 
harmonised electronic format as referred to in paragraph 2. 
Article 23 
Additional information to be provided with an application 
for certain EU type-approvals 
1. An application for a step-by-step type-appr oval shall, in addition to the information 
folder referred to in Article 22, be acco mpanied by the complete set of EU type-
approval certificates, including the test re ports, required pursuant to the applicable 
acts listed in Annex IV. 
In case of an application for a system type-approval, component type-approval or 
separate technical unit type-approval, pursuant to the applicable acts listed in Annex IV, the approval authority shall have access to the information folder until the 
whole-vehicle type-approval is either issued or refused. 
2. An application for a mixed type-approval sh all, in addition to the information folder 
referred to in Article 22, be accompanie d by the EU type-approval certificates, 
including the test reports, required pursuant to the applicable acts listed in Annex IV. 
For systems for which no EU type-approv al certificate has been presented, the 
application shall, in addition to the information folder referred to in Article 22, be 
accompanied by the information specified in Annex I, required for the approval of 
those systems during the vehicle approval pha se, and by a test report instead of the 
EU type-approval certificate. 
3. An application for a multi-stage type-approval shall be accompanied by the 
following information: 
(a) in the first stage, those parts of the information folder and the EU type-
approval certificates that are relevant to the state of completion of the base 
vehicle; 
(b) in the second and subsequent stages, t hose parts of the information folder and 
the EU type-approval certificates that are relevant to the current stage of 
completion, together with a copy of th e EU type-approval certificate for the EN 35   EN vehicle issued at the preceding stage of  construction and full details of any 
changes or additions that the manuf acturer has made to the vehicle. 
The information specified in points (a) and (b) may be supplied in accordance with 
Article 22(2). 
4. The approval authority and technical servi ces shall have access to the software and 
algorithms of the vehicle. 
The approval authority may, by reasoned requ est, also require the manufacturer to 
supply any additional information needed to take a decision on which tests are 
required, or to facilitate th e execution of those tests. 
CHAPTER  IV 
CONDUCT  OF PROCEDURES  FOR  EU TYPE-APPROVAL 
Article 24 
General provisions on conduct of pr ocedures for EU type-approval 
1. For each type of vehicle, system, component  or separate technical unit, only one EU 
type-approval may be issued. 
2. An approval authority having received an application in accorda nce with Article 21 
shall grant an EU type-appr oval only after having veri fied all of the following: 
(a) the conformity of production arrang ements referred to in Article 29; 
(b) that no type-approval has been issued yet for the type of vehicle, system, 
component or separate t echnical unit concerned; 
(c) the compliance of the type of vehicle, system, compone nt or separate technical 
unit with the applicable requirements; 
(d) in the case of whole-vehicle type-appr ovals according to the step-by-step, 
mixed and multi-stage procedures, the approval authority shall verify, in accordance with Article 20(4), that the systems, components and separate 
technical units are covered by separa te type-approvals pursuant to the 
requirements applicable at the time of granting the whole-vehicle type-
approval. 
3. The procedures with respect to EU type -approval as set out in Annex V and with 
respect to multi-stage ty pe-approval as set out in  Annex XVII shall apply. 
The Commission shall be empowered to adopt  delegated acts in accordance with 
Article 88 to amend Annex V to take account of regulatory and technological 
developments by updating the procedures with respect to EU type-approval and 
Annex XVII with respect to multi-stage type-approval. 
4. The approval authority shall put together an information package consisting of the 
information folder referred to in Article  22, accompanied by the test reports and all 
other documents that were adde d to the information folder by the technical service or 
by the approval authority while carrying out their tasks. 
The information package shall contain an index indicating clearly all the pages and 
the format of each document and recordi ng chronologically the management of the 
EU type-approval. EN 36   EN The approval authority shall keep the information package available for a period of 
ten years after the end of validity of the EU type-approval concerned. 
5. The approval authority shal l refuse to grant EU type-a pproval where it finds that a 
type of vehicle, system, component or sepa rate technical unit, albeit in compliance 
with the applicable requirements, presents a serious risk to safety or may seriously harm the environment or public  health. In that case, it shall immediately send to the 
approval authorities of the other Member States and to  the Commission a detailed 
file explaining the reasons for its deci sion and setting out the evidence for its 
findings. 
6. In accordance with Article 20(4) and (5),  in the case of step-by-step, mixed and 
multi-stage type-approval procedures, the appr oval authority shall refuse to grant EU 
type-approval, where it finds that systems,  components or separate technical units do 
not comply with the requirements set out in this Regulation or in the acts listed in Annex IV. 
The approval authority shall ask the a pproval authorities which approved the 
systems, components or separate techni cal units to act in  accordance with 
Article 54(2). 
Article 25 
Notification of EU type-approvals issued, amended, refused and withdrawn 
1. The approval authority shall,  within one month of issui ng or amending the EU type-
approval certificate, send to the approval au thorities of the other Member States and 
the Commission a copy of the EU type-approval certificate, together with the attachments, including the test reports re ferred to in Article 23, for each type of 
vehicle, system, component and technical unit th at it has approved. That copy shall 
be sent by means of a common secure electron ic exchange system or in the form of a 
secure electronic file. 
2. The approval authority shall send, at three-monthly interval s, to the approval 
authorities of the other Member States and the Commission a lis t of the EU type-
approvals for systems, components or separate  technical units it has issued, amended, 
refused to grant or withdrawn during the pr eceding period. That li st shall contain the 
information specified in Annex XIV. 
3. Where requested by an approval author ity of another Memb er State or the 
Commission, the approval author ity that has issued an EU type-approval shall, within 
one month of receiving that request, send to the requesting approval authority a copy 
of the EU type-approval certif icate, together with the attachments, by means of a 
common secure electronic exchange system or in the form of a secure electronic file. 
4. The approval authority shal l without delay inform the approval authorities of the 
other Member States and the Commission of  its refusal or withdrawal of any EU 
type-approval, stating the reasons for its decision. 
5. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex XIV by updating th e template for the notification of the 
EU type-approvals for systems, components or separate technical units that have 
been issued, amended, refused, or withdrawn. EN 37   EN Article 26 
EU type-approval certificate 
1. The EU type-approval certif icate shall contain, as attachments, the following: 
(a) the information package referred to in Article 24(4); 
(b) the test reports required by th e regulatory acts referred to in Article 28(1) in the 
case of a system, component or separate  technical unit type-approval, or the 
test results sheet in the case of whole-vehicle type-approval; 
(c) the name(s) and the specimen(s) of the si gnature(s) of the pe rson(s) authorised 
to sign the certificates of conformity a nd a statement of their position in the 
company; 
(d) in the case of a whole-vehicle type-appr oval, a filled-out specimen of the 
certificate of conformity. 
2. The EU type-approval certificate shall be issued in accordance with the template laid 
down in Annex VI and numbered in accord ance with the harmonised system laid 
down in Annex VII. The test result sheet sh all be provided using the template set out 
in Annex VIII. Those documents shall be available in electronic format. 
The Commission shall be empowered to adopt  delegated acts in accordance with 
Article 88 to amend Annexes VI, VII and VIII to take account of technical and 
regulatory developments by updating the temp lates for the type-approval certificate, 
its numbering system, and the test result sheet, respectively, in cluding providing the 
relevant electronic formats. 
3. In respect of each type of vehicle, system , component or separate technical unit, the 
approval authority shall: 
(a) complete all the relevant sections of the EU type-approval ce rtificate, including 
its attachments; 
(b) compile the index to the information package; 
(c) issue the completed EU type-approval certificate, together with its attachments, 
to the manufacturer without delay. 
4. In case of an EU type-approval the va lidity of which has been restricted in 
accordance with Articles 37 and 41 and Part III of Annex IV, or in relation to which 
certain provisions of this Re gulation or of the regulatory acts referred to in Annex IV 
do not apply, the EU type-approv al certificate shall specify those restrictions or the 
non-application of the relevant provisions. 
5. Where the vehicle manufacturer chooses  the mixed type-approval procedure, the 
approval authority shall complete the inform ation package with the references to the 
test reports required by the regulatory acts referred to in Article 28(1) for the 
systems, components or separate techni cal units for which no EU type-approval 
certificate has been issued. 
6. Where the vehicle manufacturer chooses the single-step type-approv al procedure, the 
approval authority shall appe nd to the EU type-approval cer tificate a list of relevant 
regulatory acts in accordance with the template provided in the Appendix to 
Annex VI. EN 38   EN Article 27 
Specific provisions concerni ng EU type-approvals for systems, components or separate 
technical units 
1. An EU type-approval shall be  granted in respect of a sy stem, component or separate 
technical unit that conforms to the particul ars in the information folder provided for 
in Article 22 and that meets the technical re quirements laid down in the relevant acts 
listed in Annex IV. 
2. Where components or separate  technical units, whether or  not intended for repair, 
servicing or maintenance, are also covere d by a system type-approval with respect to 
a vehicle, no additional com ponent or separate technical unit type-approval shall be 
required, unless provided for under the re levant acts listed in Annex IV. 
3. Where a component or separate technical un it fulfils its function or offers a specific 
feature only in conjunction with other parts of the vehicle, thereby making it possible 
to verify compliance only where the comp onent or separate technical unit is 
operating in conjunction with those other ve hicle parts, the scope of the component 
or the separate technical unit EU type-approval shall be  restricted accordingly. 
In those cases, the EU type-approval certi ficate shall specify any restriction on the 
use of the component or th e separate technical unit a nd shall indicate the special 
conditions for its fitting in a vehicle. 
Where that component or separate technica l unit is fitted in a vehicle, the approval 
authority shall verify, at the time of the ap proval of the vehicle, compliance with any 
applicable restrictions on th e use or conditions for fitting. 
Article 28 
Tests required for EU type-approval 
1. Compliance with the technical requirements of this Regulation and of the regulatory 
acts listed in Annex IV shall be demons trated by means of appropriate tests in 
accordance with the relevant regulatory acts listed in Annex IV, performed by 
designated technical services. 
2. The manufacturer shall provi de the approval authority w ith the vehicles, systems, 
components or separate techni cal units that are required under the relevant acts listed 
in Annex IV for the performance of the required tests. 
3. The required tests shall be performed on those vehicles, systems , components and 
separate technical units th at are representative of th e type to be approved. 
4. At the request of the manu facturer and subject to the agreement of the approval 
authority, virtual testing methods may be used  as alternatives to the test procedures 
referred to in paragraph 1 in accordance with Annex XVI. 
5. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex XVI to take  account of technical and regulatory 
developments by updating the list of regulat ory acts in respect of which virtual 
testing methods may be used by a manuf acturer or a technical service and the 
specific conditions under which virtua l testing methods are to be used. EN 39   EN Article 29 
Conformity of production arrangements 
1. An approval authority that has granted an EU type-approval shall take the necessary 
measures in accordance with Annex X to veri fy, where necessary in cooperation with 
the approval authoriti es of the other Member States, that the manufacturer produces 
the vehicles, systems, components or separate  technical units in conformity with the 
approved type. 
2. An approval authority that has granted a whole-vehicle type-approval shall verify a 
statistically relevant number of samples of  vehicles and certificates of conformity on 
their compliance with Articles 34 and 35 an d shall verify that the data in the 
certificates of conformity are correct. 
3. An approval authority that has granted an EU type-approval shall take the necessary 
measures to verify, where necessary in c ooperation with the appr oval authorities of 
the other Member States, that the arrange ments referred to in paragraphs 1 and 2 
continue to be adequate so that vehicles , systems, components or separate technical 
units in production continue to conform to the approved type and certificates of 
conformity continue to co mply with Articles 34 and 35. 
4. In order to verify that a vehicle, sy stem, component or separate technical unit 
conforms to the approved type, the approval authority that has gr anted the EU type-
approval shall carry out checks or tests re quired for EU type-approval, on samples 
taken at the premises of the manufac turer, including pr oduction facilities. 
5. An approval authority that has granted an EU type-approv al and establishes that the 
manufacturer no longer produces the vehicl es, systems, components or separate 
technical units in conformity with the approved type, or establishes that the 
certificates of conformity no longer comp ly with Articles 34 and 35, even though 
production is continued, shall take the necessary measures to ensure that the 
procedure for conformity of production is followed correctly or withdraw the type-
approval. 
6. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex X to take account of technological and regulatory 
developments by updating the conformity of production procedures. 
Article 30 
National fee structure for type-appro vals and market surveillance costs 
1. Member States shall establish a national fee structure to cover the costs for their 
type-approvals and market surveillance activities as well as for the type-approval testing and conformity of production tes ting and inspections carried out by the 
technical services th ey have designated. 
2. Those national fees shall be levied on the manufacturers who have applied for type-
approval in the Member State concerned. Fees shall not be levied directly by 
technical services. 
3. The national fee structure shall also cove r the costs for the compliance verification 
inspections and tests carried  out by the Commission in accordance with Article 9. EN 40   EN These contributions shall constitute external  assigned revenues for the general budget 
of the European Union, according to Ar t. 21(4) of the Financial Regulation26. 
4. Member States shall notify the details of their national fee structure to the other 
Member States and the Commission. The fi rst notification shall be effected on [ date 
of entry into force of this Regulation + 1 year] . Subsequent update s of the national 
fee structures shall be notified to the other Member States and to the Commission on a yearly basis. 
5. The Commission may adopt implementing acts in order to define the top-up referred 
to in paragraph 3 to be app lied to the national fees referred to in paragraph 1. Those 
implementing acts shall be adopted in accordance with the examination procedure referred to in Article 87(2). 
CHAPTER  V 
AMENDMENTS  TO AND  VALIDITY  OF EU TYPE-APPROVALS 
Article 31 
General provisions on amendments and validity of EU type-approvals 
1. The manufacturer shall inform  without delay the approval authority that has granted 
the EU type-approval of any ch ange in the particulars recorded in the information 
package. 
The approval authority shall decide whethe r that change is to be covered by an 
amendment, in the form of either a revisi on or an extension of the EU type-approval 
in accordance with the procedures laid dow n in Article 32, or whether this change 
requires a new type-approval. 
2. An application for that amendment shall be submitted exclusively to the approval 
authority that has granted the original EU type-approval. 
3. Where the approval authorit y finds that that amendment needs the repetition of 
inspections or tests, it shall in form the manufacturer accordingly. 
4. Where the approval authority on the basis of the inspection s or tests referred to in 
paragraph 3 finds that the requirements for EU type-approval continue to be fulfilled, the procedures referred to  in Article 32 shall apply. 
5. Where the approval authority finds that the changes in the particulars recorded in the 
information package are substantial, to the extent that they cannot be covered by an 
extension of the existing type-approval, it shall refuse to amend the EU type-
approval and shall request th e manufacturer to apply for a new EU type-approval. 
Article 32 
Revisions and extensions of EU type-approvals 
1. The amendment shall be designated a ‘revision’ where the approval authority finds 
that despite the change in the particular s recorded in the information package the 
concerned type of vehicle, system, component  or separate technical unit continues to 
                                                
 
26 Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council of 25 October 
2015 on the financial rules applicable to the general budget of the Union and repealing Council Regulation (EC, 
Euratom) No 1605/2002 (OJ L 298, 26.10.2012, p. 1–96). EN 41   EN comply with the applicable requirements for this type and th at, therefore, no 
inspections or tests n eed to be repeated. 
In that case, the approval authority shall i ssue without delay the revised pages of the 
information package as necessary, marking each revised page to show clearly the nature of the change and the date of reissu e, or issue a consolid ated, updated version 
of the information package, accompanied by a detailed description of the changes. 
2. The amendment shall be designated an ‘extension’ where the approval authority 
finds that the particulars recorded in the information packag e have changed and 
where any of the following occurs: 
(a) further inspections or tests are required to verify continued compliance with the 
requirements upon which the existing type-approval has been based; 
(b) any information on the EU type-approval certificate, ex cept for its attachments, 
has changed; 
(c) new requirements under any act listed in Annex IV become applicable to the 
approved type of vehicle, system, co mponent or separate technical unit. 
In the event of an extension, the approva l authority shall issu e without delay an 
updated EU type-approval certif icate denoted by an extension number, incremented 
in accordance with the number of successi ve extensions already granted. That 
approval certificate shall clearly state the reason for the extension and the date of reissue and validity. 
3. Whenever amended pages or a consolidate d, updated version are issued, the index to 
the information package shall be amended acco rdingly to show the date of the most 
recent extension or revision, or the date of  the most recent consolidation of the 
updated version. 
4. No extension to the type-approval of a type  of vehicle shall be required if the new 
requirements referred to in point (c) of pa ragraph 2 are, from a technical point of 
view, irrelevant to that type of vehicle or  concern categories of vehicle other than the 
category to which it belongs. 
Article 33 
Termination of validity 
1. Type-approvals for vehicles, systems, com ponents and separate technical units shall 
be issued for a limited period of 5 years wi thout the possibility of prolongation. The 
expiry date shall be indicated in the type-approval certificate. After the expiry of the type-approval certificate, it may be rene wed upon application by the manufacturer 
and only where the approval authority has veri fied that the type of vehicle, system, 
component and separate technical unit comp lies with all the requirements of the 
relevant regulatory acts for new vehicl es, systems, components and separate 
technical units of that type. 
2. An EU type-approval of a vehicle shall beco me invalid before its expiry date in any 
of the following cases: 
(a) where new requirements applicable to the approved type of vehicle become 
mandatory for the making available on th e market, registrati on or entry into 
service of vehicles, and the type-appr oval cannot be extended in accordance 
with point (c) of Article 32(2); EN 42   EN (b) where the production of vehicles in c onformity with the approved type of 
vehicle is permanently discontinued on a voluntary basis; 
(c) where the validity of the type-approval certificate expires due to a restriction 
referred to in Article 37(6); 
(d) where the type-approval has been withdr awn in accordance w ith Article 29(5) 
or Article 53(1); 
(e) where the type-approval was found to be based on false declarations, falsified 
test results or where data were withheld  which would have le d to the refusal to 
grant the type approval. 
3. Where the type-approval of only one variant within a type of ve hicle or one version 
within a variant becomes invalid, the EU type-approval of the type of vehicle in 
question shall become invalid only in so far as the particular variant or version is concerned. 
4. Where production of a partic ular type of vehicle, syst em, component or separate 
technical unit is permanently discontinued, the manufacturer shall notify without 
delay the approval authority that granted the EU type-a pproval for that type of 
vehicle, system, component or se parate technical unit thereof. 
Within one month of receiving the notification referred to in the first subparagraph, 
the approval authority that granted the EU type-approval for the type of vehicle, 
system, component or separate technical uni t shall inform the approval authorities of 
the other Member States accordingly. 
5. Where an EU type-approval certificate for a type of vehicle, system, component or 
separate technical unit is due to beco me invalid, the manufacturer shall notify 
without delay the approval authority that  granted the EU type-approval thereof. 
6. Upon reception of the notification made by the manufacturer, the approval authority 
that granted the EU type-approval shall communicate without delay to the approval 
authorities of the other Member States a nd the Commission all relevant information 
for the making available on the market, re gistering or enteri ng into service of 
vehicles, where appropriate. 
That communication shall specify the date of production and the vehicle 
identification number ('VIN'), as define d in Article 2 of Commission Regulation 
(EU) 19/2011
27, of the last vehicle produced. 
                                                 
27 Commission Regulation (EU) 19/2011 concerning type-approval requirements for the manufacturer’s 
statutory plate and for the vehicl e identification number of motor vehicles and their trailers 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 therefor (OJ L 8, 12.1.2011, p. 1). EN 43   EN CHAPTER  VI 
CERTIFICATE  OF CONFORMITY  AND  MARKINGS 
Article 34 
General provisions on the cer tificate of conformity 
1. The manufacturer shall issue a certificate of conformity as a paper document to 
accompany each vehicle, whether complete , incomplete or completed, that is 
manufactured in conformity with  the approved type of vehicle. 
The certificate of conformity shall be delivered free of ch arge to the buyer together 
with the vehicle. Its delivery may not be made dependent on an explicit request or 
the submission of additional information to the manufacturer. 
For a period of ten years after the producti on date of the vehicle, the manufacturer 
shall, at the request of the vehicle owner, issue a duplicate of the certificate of conformity against a payment not exceeding the cost of issuing it. The word ‘duplicate’ shall be clearly visible on  the face of any dup licate certificate. 
2. The manufacturer shall use the template for the certificate of conformity set out in 
Annex IX. 
The Commission shall be empowered to adopt  delegated acts in accordance with 
Article 88 to amend Annex IX to take account of technological and regulatory 
developments by updating the template for the certificate of conformity. 
3. The certificate of conformity shall be dr awn up in at least one  of the official 
languages of the Union. 
4. The person(s) authorised to sign certific ates of conformity shall be employed by the 
manufacturer and shall be dul y authorised to fully engage the legal responsibility of 
the manufacturer with respect to the design and the construction of the vehicle or to 
the conformity of its production. 
5. The certificate of conformity shall be comp leted in its entirety and shall not contain 
restrictions as regards the us e of the vehicle other than those provided for in this 
Regulation or any of the regulat ory acts listed in Annex IV. 
6. Without prejudice to paragraph 1, the manu facturer may also transmit the certificate 
of conformity by electronic means to th e national authoritie s responsible for 
registration. 
Article 35 
Specific provisions on the cer tificate of conformity 
1. In case of an incomplete or completed vehicle, the manufacturer shall fill in only 
those fields of the certificate of conform ity that concern the additions or changes 
carried out at the current stage of approva l and, where applicable, shall attach all 
certificates of conformity deliv ered at the previous stages. 
2. The certificate of conformity shall, for vehicles type-approved in accordance with 
Article 37, display in its titl e: ‘For complete/completed  vehicles, type-approved in 
application of Article 37 of  Regulation (EU) No …/201X of the European Parliament 
and of the Council of ... on th e approval and market survei llance of motor vehicles 
(provisional approval)’ [ PO: please insert the reference ]. EN 44   EN 3. The certificate of conformity shall, for vehicles type-approved in accordance with 
Article 39, display in its ti tle ‘For complete/completed vehicles type-approved in 
small series’, and in close proximity th ereto the year of production followed by a 
sequential number, between 1 and the limit indicated in the table in Annex XII, 
denoting, in respect of each year of producti on, the position of that vehicle within the 
production allocated for that year. 
Article 36 
Statutory plate  
and type-approval mark of compone nts or separate technical units 
1. The manufacturer of a vehicle shall a ffix to every vehicle manufactured in 
conformity with the approved type a statut ory plate with the marking required by the 
relevant regulatory acts listed in Annex IV. 
2. The manufacturer of a component or sepa rate technical unit sh all affix to every 
component or separate technical unit manuf actured in conformity with the approved 
type, whether or not it is part of a sy stem, the type-approval mark required by the 
relevant regulatory acts listed in Annex IV. 
Where no such type-approval mark is require d, the manufacturer shall affix to the 
component or separate technical unit at l east the trade name or trade mark of the 
manufacturer, and the type numbe r or an identification number. 
3. The EU type-approval mark shall be  in accordance with Annex VII. 
CHAPTER  VII 
NEW  TECHNOLOGIES  OR  NEW  CONCEPTS 
Article 37 
Exemptions for new technol ogies or new concepts 
1. The manufacturer may apply for an EU type-a pproval in respect of a type of vehicle, 
system, component or separate technical uni t that incorporates new technologies or 
new concepts that are incompatible with one or more regulator y acts listed in 
Annex IV. 
2. The approval authority shall grant the EU  type-approval referred to in paragraph 1 
where all of the following conditions are met: 
(a) the application for the EU type-appr oval states the reasons why the new 
technologies or new concepts make the ve hicle, system, com ponent or separate 
technical unit incompatible with one or more regulatory acts listed in Annex IV; 
(b) the application for the EU type-a pproval describes the safety and 
environmental implications of the new technology or new concept and the 
measures taken in order to ensure at least an equiva lent level of safety and 
environmental protection as  that provided by the requirements from which 
exemption is sought; 
(c) test descriptions and re sults are presented provi ng that the condition in 
point (b) is met. EN 45   EN 3. The granting of EU type-a pprovals exempting new technologies or new concepts 
shall be subject to authorisation by th e Commission. That authorisation shall be 
given by means of an implementing act. That  implementing act shall be adopted in 
accordance with the examination proce dure referred to in Article 87(2). 
4. Pending the decision on authorisation by the Commission, the ap proval authority 
may issue a provisional EU type-approval, valid only in the territory of the Member 
State of that approval aut hority, in respect of a type  of vehicle covered by the 
exemption sought. The approval authorit y shall inform without delay the 
Commission and the other Member States th ereof by means of a file containing the 
information referred to in paragraph 2. 
The provisional nature and the limited terr itorial validity of the EU type-approval 
shall be apparent from the heading of the type-approval certificat e and the heading of 
the certificate of conformity. 
5. Approval authorities of other Member States may de cide to accept the provisional 
EU type-approval referred to in paragra ph 4 within their territory, provided they 
inform in writing the approval authority that granted the provisional EU type-approval of their acceptance. 
6. Where appropriate, the aut horisation of the Commission re ferred to in paragraph 3 
shall specify whether it is subject to any rest rictions, in particular with regard to the 
maximum number of vehicles covered. In a ll cases, the EU type-approval shall be 
valid for at least 36 months. 
7. Where the Commission refuses authorisati on referred to in paragraph 3, the approval 
authority shall immediately inform the holder of the provisional type-approval 
referred to in paragraph 4 that the provisi onal EU type-approval approval shall be 
revoked six months after the date  of the Commission’s refusal. 
However, vehicles that have been manufact ured in conformity with the provisional 
EU type-approval before it ceased to be valid may be placed on the market, 
registered or entered into service in any Member State that has accepted the provisional EU type-approval in  accordance with paragraph 5. 
Article 38 
Subsequent adaptation of  regulatory acts 
1. Where the Commission has authorised th e granting of an EU type-approval in 
accordance with Article 37, it shall immediately take the necessary steps to adapt the 
regulatory acts concerned to the la test technological developments. 
Where the exemption under Article 37 relates to a UNECE regulation, the 
Commission shall make proposals to ame nd the relevant UNECE regulation in 
accordance with the provisions of A nnex III of Council Decision 97/836/EC. 
2. Once the relevant regulatory acts have  been amended, any restriction in the 
Commission decision authorisi ng the granting of an EU t ype-approval shall be lifted. 
3. Where the necessary steps to adapt the regul atory acts referred to in paragraph 1 have 
not been taken, the Commission may author ise the extension of  the provisional EU 
type-approval by means of a decision and at  the request of the Member State that 
granted the provisional EU t ype-approval. Those implementing acts shall be adopted 
in accordance with the examination pr ocedure referred to in Article 87(2). EN 46   EN CHAPTER  VIII 
VEHICLES  PRODUCED  IN SMALL  SERIES 
Article 39 
EU type-approval of vehicles produced in small series 
1. At the request of the manuf acturer and within the quantit ative annual limits  set out in 
Section 1 of Annex XII, Member States shal l grant an EU type-approval for a type of 
vehicle produced in small series that satis fies at least the re quirements set out in 
Appendix 1 to Part I of Annex IV. 
2. Paragraph 1 shall not apply to special purpose vehicles. 
3. EU type-approval certificates for vehicles produced in small series shall be numbered 
in accordance with Annex VII. 
Article 40 
National type-approval of vehic les produced in small series 
1. The manufacturer may apply for a national type-approval of vehicles produced in 
small series within the quantitative annual limits set out in Section 2 of Annex XII. 
Those limits shall apply to the making ava ilable on the market, re gistration or entry 
into service of vehicles of the approved type on the market of each Member State in 
a given year. 
2. Member States may decide to exempt any type of vehicle referre d to in paragraph 1 
from one or more of the substantive re quirements laid down in the regulatory acts 
listed in Annex IV, provided that those Memb er States lay down relevant alternative 
requirements. 
3. For the national type-approval of vehicles produced in small series, the approval 
authority shall accept systems, components or  separate technical units that are type-
approved in accordance with the acts listed in Annex IV. 
4. The national type-approval ce rtificate of vehicles produced in small series shall be 
drafted in accordance with the template set out in Annex VI, but shall bear the 
heading ‘National small series vehicle type -approval certificate’ and shall specify the 
content and the nature of the exemptions  granted pursuant to paragraph 2. Type-
approval certificates shall be numbered in accordance with the harmonised system 
referred to in Annex VII. 
Article 41 
Validity of a national type -approval of vehicles produced in small series 
1. The validity of a national type -approval of vehicles produced  in small series shall be 
restricted to the territory of the Member  State of the approval authority that has 
granted that type-approval. 
2. At the request of the manufacturer, the a pproval authority shall send to the approval 
authorities of the Member States designate d by the manufacturer a copy of the type-
approval certificate and its attachments, ei ther by registered or electronic mail. 
3. The approval authorities of the Member St ates designated by th e manufacturer shall, 
within three months of rece ipt of the documents referred  to in paragraph 2, decide 
whether they accept the type-approval or not. EN 47   EN The approval authorities of the Member  States shall accept the national type-
approval, unless they have reasonable grounds  to believe that the national technical 
requirements in accordance with which the t ype of vehicle has been approved are not 
equivalent to their own. 
4. The approval authorities of Member St ates shall communicate within two months 
their decision to the approval authority th at has granted the na tional type-approval. 
5. At the request of an applicant who wishes to place on the market, register or enter in 
to service in another Member State a vehicl e with national type-a pproval of vehicles 
produced in small series, the approval au thority that granted the national type-
approval of vehicles produced  in small series shall provi de the national authority of 
the other Member State with a copy of th e type-approval certif icate, including the 
information package. 
The national authority of the other Memb er State shall permit the placing on the 
market, registration or entry into service of such vehicle, unless it has reasonable 
grounds to believe that the national techni cal requirements in accordance with which 
the type of vehicle has been appr oved are not equiva lent to its own. 
CHAPTER  IX 
INDIVIDUAL  VEHICLE  APPROVALS 
Article 42 
EU individual vehicle approvals 
1. Member States shall grant an EU indivi dual vehicle approval for a vehicle that 
complies with the requirements set out in A ppendix 2 to Part I of Annex IV or, for 
special purpose vehicles, in Part III of Annex IV. 
2. An application for an EU individual vehicle approval shall be submitted by the 
manufacturer, or by the owner of the vehicl e, or by the representative of the latter, 
provided that that representative is established within the Union. 
3. Member States shall not carry out destruc tive tests to establish whether the vehicle 
complies with the requirements set out in paragraph 1 and shall use any relevant information provided by the a pplicant for that purpose. 
4. An EU individual vehicle approval certificate shall comply with the template set out 
in Annex VI. EU individual vehicle appr oval certificates shall be numbered in 
accordance with Annex VII. 
5. Member States shall permit the placing on the market, registra tion or entry into 
service of vehicles with a valid EU individual vehicle a pproval certificate. 
Article 43 
National individual vehicle approvals 
1. Member States may decide to exempt a pa rticular vehicle, wh ether unique or not, 
from compliance with one or more of the pr ovisions of this Re gulation or with the 
substantive requirements laid down in th e regulatory acts li sted in Annex IV, 
provided that those Member  States impose relevant alternative requirements. EN 48   EN 2. An application for national individual  vehicle approval shall be submitted by the 
manufacturer, or by the owner of the vehicl e, or by the representative of the latter, 
provided that that representative  is established within Union. 
3. Member States shall not carry out destruc tive tests to establish whether the vehicle 
complies with the alternative requirements set out in paragraph 1 and shall use any relevant information provided by the applicant for that purpose. 
4. For the purpose of a national individual ve hicle approval, the a pproval authority shall 
accept systems, components or separate t echnical units that are type-approved in 
accordance with the acts listed in Annex IV. 
5. A Member State shall issue without de lay a national indivi dual vehicle approval 
certificate where the vehicle conforms to th e description appended to the application 
and satisfies the relevant alternative requirements. 
6. The format of the national individual vehicle approval certifi cate shall follow the 
template of the EU type-approval certificate set out in Annex VI and shall contain at 
least the information necessary to apply fo r the registration provided for in Council 
Directive 1999/37/EC
28. 
A national individual vehicle approval certificate shall bear the VIN of the vehicle 
concerned and shall bear the heading ‘National individual vehicle approval 
certificate’. 
Article 44 
Validity of national indi vidual vehicle approvals 
1. The validity of a national individual ve hicle approval shall be restricted to the 
territory of the Member State that granted the approval. 
2. At the request of an appli cant who wishes to make ava ilable on the market, register 
or enter into service in another Member State a vehicle with a national individual 
vehicle approval, the Member State that  granted the approval shall provide the 
applicant with a statement of the technical  provisions against which the vehicle has 
been approved. 
3. A Member State shall permit a vehicle for which another Member State has granted a 
national individual vehicle approval in accordance with  Article 43 to be made 
available on the market, registered or ente red into service, unless that Member State 
has reasonable grounds to believe that the re levant alternative requirements against 
which the vehicle has been approve d are not equivale nt to its own. 
4. The provisions of this Article may apply to  vehicles that have been type-approved in 
accordance with this Regulation and that ha ve been modified before their first 
registration or entr y into service. 
Article 45 
Specific provisions 
1. The procedures set out in Articles 43 and 44 may apply to a particular vehicle during 
the successive stages of its completion in accordance with a multi-stage type-
approval. 
                                                 
28 Council Directive 1999/37/EC of 29 April 1999 on the registration documents for vehicles (OJ L 138, 
1.6.1999, p. 57). EN 49   EN 2. The procedures set out in Articles 43 a nd 44 may not replace an intermediate stage 
within the normal sequence of a multi-stag e type- approval and may not apply for the 
purposes of obtaining the first- stage approval of a vehicle. 
CHAPTER  X 
MAKING  AVAILABLE  ON  THE  MARKET,   
REGISTRATION  OR  ENTRY  INTO  SERVICE 
Article 46 
Making available on the market, re gistration or entry into service of vehicles other than end-
of-series vehicles 
1. Without prejudice to Arti cles 49 to 51, vehicles fo r which whole-vehicle type-
approval is mandatory, or for which th e manufacturer has obtained that type-
approval, shall only be made available on the market, registered or enter into service 
if they are accompanied by a valid certifi cate of conformity issued in accordance 
with Articles 34 and 35. 
Incomplete vehicles may be made available on  the market or entered into service, but 
the national authorities responsible fo r vehicle registration may refuse the 
registration and the use on th e road of such vehicles. 
2. Vehicles exempted from the requirement concerning a certificate of conformity may 
also be made available on the market, registered or entered into service if they comply with the relevant technical  requirements of this Regulation. 
3. The number of vehicles produced in sma ll series made available on the market, 
registered or entered into se rvice in the course of a sing le year shall not exceed the 
quantitative annual limits laid down in Annex XII. 
Article 47 
Making available on the market, re gistration or entry into servi ce of end-of-series vehicles 
1. End-of-series vehicles for which the EU  type-approval has become invalid pursuant 
to Article 33(2)(a) may only be made availa ble on the market, registered or entered 
into service, provided that the requirement set out in pa ragraph 4 and the time limits 
laid down in paragraphs 2 and 4 are complied with. 
The first subparagraph shall onl y apply to vehicles that we re already on the territory 
of the Union and had not yet been made av ailable on the market nor registered or 
entered into service before their EU type-approval lost its validity. 
2. Paragraph 1 shall apply to complete vehicl es for a period of 12 months from the date 
on which the EU type-approval became inva lid, and to completed vehicles for a 
period of 18 months from that date. 
3. A manufacturer wishing to make available on the market , register or enter into 
service end-of-series vehicles in accordan ce with paragraph 1 shall submit a request 
for that purpose to the nati onal authority of the Member State that granted the EU 
type-approval. That request shall speci fy any technical or economic reasons 
preventing those vehicles from complying with the new type-approval requirements 
and shall include the VIN of the vehicles concerned. EN 50   EN The national authority concerned shall decide, within three months of receipt of that 
request, whether to permit the placing on th e market, registration and entry into 
service of those vehicles within the terr itory of the Member State concerned and 
determine the number of vehicles in resp ect of which permission may be granted. 
4. Only end-of-series vehicles with a valid ce rtificate of conformity that has remained 
valid for at least three months after its date  of issue, but for which the type-approval 
has become invalid pursuant to point (a) of  Article 33(2), may be  made available on 
the market, registered or ente red into service in the Union. 
5. The certificate of conformity of the vehicl es made available on the market, registered 
or entered into service in accordance with this Article shall include a special entry indicating that those vehicles are end-of-s eries vehicles, as well as the date until 
which those vehicles may be made available on the market, registered or entered into 
service in the Union. 
6. Member States shall keep records of the VIN of the vehicles that they permitted to be 
made available on the market, registered or entered into service in accordance with 
this Article. 
Article 48 
Making available on the market  or entry into service 
of components and separate technical units 
1. Components or separate technical units, in cluding those intended for the aftermarket, 
may only be made available on the market or  entered into service where they comply 
with the requirements of the relevant regu latory acts listed in Annex IV and are 
marked in accordance with Article 36. 
2. Paragraph 1 shall not apply to components or separate technical  units specifically 
constructed or designed for new vehicles that are not covered by this Regulation. 
3. Member States may permit the making available on the market or entry into service 
of components or separate technical units th at are exempted under Article 37 or to be 
used on vehicles covered by approvals granted under Article 39, 40, 42 and 43 concerning the component or separate technical unit in question. 
4. Member States may also permit the making available on the market or entry into 
service of components or separa te technical units to  be used on vehicles that were not 
required to be type-approved under this Re gulation or under Directive 2007/46/EC at 
the time those vehicles were made availabl e on the market, registered or entered into 
service. 
CHAPTER  XI 
SAFEGUARD  CLAUSES 
Article 49 
Procedure for dealing with veh icles, systems, components 
or separate technical uni ts presenting a serious risk at national level 
1. Market surveillance authorities of one Me mber State that have taken action pursuant 
to Article 20 of Regulation (EC) No 765/ 2008 and Article 8 of this Regulation, or 
that have sufficient reason to believe that a vehicle, system, component or separate 
technical unit covered by this Regulation presents a serious risk to the health or EN 51   EN safety of persons or to othe r aspects of the protection of public interests covered by 
this Regulation, shall inform without dela y the approval authority that granted the 
approval about its findings. 
2. The approval authority referred to in para graph 1 shall carry out an evaluation in 
relation to the vehicle, sy stem, component or separate  technical un it concerned 
covering all the requirements laid down in  this Regulation. The relevant economic 
operators shall cooperate fully with the a pproval and market su rveillance authorities. 
Where, in the course of that evaluati on, the approval authority  that granted the 
approval finds that the vehicle, system, co mponent or separate technical unit does not 
comply with the requirements laid down in this Regulation, it shall require without 
delay the relevant economic ope rator to take all appropriate corrective measures to 
bring the vehicle, system, component or se parate technical unit into compliance with 
those requirements, or take restrictive m easures, either to withdraw the vehicle, 
system, component or separate technical unit from the market, or to recall it within a 
reasonable period, depending on the nature of the risk. 
Article 21 of Regulation (EC) No 765/2008 sh all apply to the restrictive measures 
referred to in the second subparagraph. 
3. The relevant approval authority shall in form the Commission and the other Member 
States of the results of the evaluation referred to in paragraph 1 and the action 
required of the economic operator. 
4. The economic operator shall, in accordan ce with the obligations referred to in 
Articles 11 to 19, ensure that all appropriate  corrective measures are taken in respect 
of all non-compliant vehicles, systems, components or sepa rate technical units that it 
has placed on the market, registered or  has entered into service in the Union. 
5. Where the economic operator does not take adequate corrective measures within the 
period referred to in the second subparagraph of paragraph 2, the national authorities 
shall take all appropriate provisional restri ctive measures to prohi bit or restrict the 
making available on the market, registration or entry into service of non-compliant 
vehicles, systems, components or separate te chnical units on their national market, or 
to withdraw them from that  market or to recall them. 
Article 50 
Notification and objection procedures  
related to restrictive measur es taken at national level 
1. The national authorities shall inform th e Commission and the other Member States 
without delay of the restrictive measures  taken in accordance with Article 49(1) 
and (5). 
The information provided shall include all av ailable details, in particular the data 
necessary for the identification of the non- compliant vehicle, system, component or 
separate technical unit, its origin, the nature of the non-conformity alleged and the 
risk involved, the nature and duration of the national restrictive measures taken, and 
the arguments put forward by th e relevant economic operator. 
2. The approval authority referred to in Ar ticle 49(1) shall indicate whether the non-
conformity is due to e ither of the following: 
(a) failure of the vehicle, system, component  or separate tech nical unit to meet 
requirements relating to the health or sa fety of persons, the protection of the EN 52   EN environment or to other as pects of the protection of public interests covered by 
this Regulation; 
(b) shortcomings in the relevant regu latory acts listed in Annex IV. 
3. Member States other than the Member St ate initiating the proc edure shall inform 
within one month of the receipt of the in formation referred to in paragraph 1 the 
Commission and the other Member States of any restrictive measures adopted and of 
any additional information at their dispos al relating to the non- conformity of the 
vehicle, system, component or separate t echnical unit concerned, and, in the event of 
disagreement with the notified natio nal measure, of their objections. 
4. Where, within one month of the receipt of the information referred to in paragraph 1, 
an objection has been raised by either a nother Member State or the Commission in 
respect of a restrictive measure taken by a Member State, that measure shall be 
evaluated by the Commission in  accordance with Article 51. 
5. Where, within one month of the receipt of the information referred to in paragraph 1, 
no objection has been raised by either a nother Member State or the Commission in 
respect of a restrictive measure taken by a Member State, that measure shall be 
deemed justified. The other Member States  shall ensure that similar restrictive 
measures are taken in respect of the vehicle, system, com ponent or separate technical 
unit concerned. 
Article 51 
Union safeguard procedure 
1. Where, during the procedure set out in Ar ticle 50(3) and (4), objections have been 
raised against a restrictive measure ta ken by a Member State, or where the 
Commission has considered that a national m easure is contrary to Union legislation, 
the Commission shall evaluate without de lay the national measure after having 
consulted the Member States and the releva nt economic operator or operators. On the 
basis of the results of that evaluation, the Commission shall adopt a decision on 
whether the national measure is considered  justified or not. Those implementing acts 
shall be adopted in accordance with th e examination procedure referred to in 
Article 87(2). 
The Commission shall addre ss its decision to all Me mber States and shall 
immediately communicate it to the relevant  economic operators. The Member States 
shall implement the Commission decision without delay and inform the Commission accordingly. 
2. Where the Commission considers the nationa l measure to be justified, all Member 
States shall take the necessary measures to ensure that the non-compliant vehicle, 
system, component or separa te technical unit is withdr awn from their market, and 
shall inform the Commission accordi ngly. Where the Commission considers the 
national measure to be unjustified, the Memb er State concerned shall withdraw or 
adapt the measure, in accordance with the Commission decision referred to in paragraph 1. 
3. Where the national measure is considered ju stified and is attributed to shortcomings 
in regulatory acts referred to in Annex IV , the Commission shall propose appropriate 
measures as follows: EN 53   EN (a) where regulatory acts are concerne d, the Commission shall propose the 
necessary amendments to the act concerned; 
(b) where UNECE regulations are concerne d, the Commission shall propose the 
necessary draft amendments to the relevant UNECE regulations in accordance 
with the provisions of Annex III of Council Decision 97/836/EC. 
Article 52 
Compliant vehicles, systems, components or separate technical units 
that present a serious risk to safety or serious harm to health and the environment 
1. Where, having performed an evaluation unde r Article 49(1), a Member State finds 
that vehicles, systems, components or sepa rate technical units, although they comply 
with the applicable requirements or are properly marked, present a serious risk to 
safety or may seriously harm the environm ent or public health, it shall require the 
relevant economic operator to take all appropriate corrective measures to ensure that the vehicle, system, component or separate  technical unit concerned, when placed on 
the market, registered or ente red into service, no longer presents that risk, or it shall 
take restrictive measures to  withdraw the vehicle, system, component or separate 
technical unit from the market or to recal l it within a reasonable period, depending on 
the nature of the risk. 
The Member State may refuse to register  such vehicles until the economic operator 
has taken all appropriate  corrective measures. 
2. The economic operator shall ensure that appr opriate corrective measures are taken in 
respect of all vehicles, systems, components or separate technical units referred to in 
paragraph 1. 
3. The Member State shall within one month of the request referre d to in paragraph 1 
provide the Commission and the other Member States with all available information, 
in particular the data necessary for th e identification of th e vehicle, system, 
component or separate techni cal unit concerned, the orig in and the supply chain of 
the vehicle, system, component or separate  technical unit, the nature of the risk 
involved and the nature and duration of the national restrictive measures taken. 
4. The Commission shall consult without delay the Member States and the relevant 
economic operator or operators and, in par ticular, the approval authority that granted 
the type-approval, and shall evaluate the na tional measure taken. On the basis of that 
evaluation, the Commission shall decide whet her the national measure referred to in 
paragraph 1 is considered justified or not, and where necessar y, propose appropriate 
measures. Those implementing acts shall be adopted in accordance with the 
examination procedure referred to in Article 87(2). 
5. The Commission shall addre ss its decision to all Me mber States and shall 
immediately communicate it to the rele vant economic operator or operators. 
Article 53 
General provisions related to non-compliant vehicles, systems, components or separate 
technical units  
1. Where vehicles, systems, components or se parate technical units  accompanied by a 
certificate of conformity or bearing an a pproval mark do not conform to the approved 
type, or are not in conformity with this regulation or were approved on the basis of EN 54   EN incorrect data, the approval authorities, market surveillance authorities or the 
Commission may take the necessary rest rictive measures in accordance with 
Article 21 of Regulation (EC) No 765/2008, to prohibit or restrict the making 
available on the market, registration or entry into service on the market of non-
compliant vehicles, systems, components or separate technical units, or to withdraw 
them from that market or  to recall them, including th e withdrawal of the type-
approval by the approval authority that granted the EU type-approval, until the 
relevant economic operator has taken all appr opriate corrective measures to ensure 
that vehicles, systems, components or se parate technical un its are brought into 
conformity. 
2. For the purposes of paragraph 1, deviati ons from the particular s in the EU type-
approval certificate or the information package shall be deemed to constitute a failure 
to conform to the approved type. 
Article 54 
Notification and objection procedures related to non-compliant vehicles, systems, components 
or separate technical units  
1. Where an approval authority or market su rveillance authority finds that vehicles, 
systems, components or separate technical units are not in conformity with this 
Regulation or that the type-a pproval has been granted on th e basis of incorrect data 
or that vehicles, systems, components or separate technical units accompanied by a certificate of conformity or bearing an a pproval mark do not conform to the approved 
type, it may take all appropriate restri ctive measures in accordance with 
Article 53(1). 
2. The approval authority or market surveillan ce authority or the Commission shall also 
request the approval authority that grante d the EU type-approva l to verify that 
vehicles, systems, components or separate technical units in pr oduction continue to 
conform to the approved type or, wher e applicable, that vehicles, systems, 
components or separate technical units already placed on the market are brought 
back into conformity.  
3. In the case of a whole-vehicle type-approva l, where the non-conformity of a vehicle 
is due to a system, component or separate technical unit, the re quest referred to in 
paragraph 2 shall also be addressed to th e approval authority that granted the EU 
type-approval for that system, component or separate technical unit. 
4.  In the case of a multi-stage type-approva l, where the non-conformity of a completed 
vehicle is due to a system, component or sepa rate technical unit that forms part of the 
incomplete vehicle or to the incomplete vehicle itself, the re quest referred to in 
paragraph 2 shall also be addressed to th e approval authority that granted the EU 
type-approval for that system, component, separate technical unit or incomplete 
vehicle. 
5. On receipt of the request referred to in pa ragraphs 1 to 4 the approval authority that 
granted the EU type-approval shall carry out an evaluation in relation to the vehicles, 
systems, components or separate tec hnical units concerned covering all the 
requirements laid down in this Regulation. The approval authority shall also verify 
the data on the basis of which the approval was granted. The relevant economic operators shall fully cooperate with the approval authority.  EN 55   EN 6. Where non-conformity is established by th e approval authority that granted the EU 
type-approval for a vehicle, system, com ponent or separate technical unit, that 
approval authority shall require  without delay the relevant economic operator to take 
all appropriate corrective measures to br ing the vehicle, system, component or 
separate technical unit into compliance a nd where necessary the approval authority 
that granted the EU type-approval shall take the measures referred to in Article 53(1) 
as soon as possible and at the latest with in one month of the date of the request. 
7. The national authorities taking restrictive measures in accordance with Article 53(1) 
shall immediately inform the Commi ssion and the other Member States. 
8. Where, within one month after the notification of the restrictive measures taken by 
an approval authority or a market surv eillance authority in accordance with 
Article 53(1), an objection ha s been raised by an other Member State in respect of the 
notified restrictive measure or where the Commission establishes a non-compliance 
in accordance with Article 9(5), the Commission shall consult without delay the Member States and the relevant economic ope rator or operators a nd, in particular, the 
approval authority that granted the type-a pproval, and shall evaluate the national 
measure taken. On the basis of that evalua tion, the Commission may decide to take 
the necessary restrictive measures foreseen in Article 53(1) by means of implementing acts. Those implementing acts shall be adopted in accordance with the 
examination procedure referred to in Article 87(2). 
The Commission shall addre ss its decision to all Me mber States and shall 
immediately communicate it to the relevant  economic operators. The Member States 
shall implement the Commission decision without delay and inform the Commission accordingly. 
9. Where, within one month after the notification of the restrictive measures taken in 
accordance with Article 53(1), no objection has been raised by either another 
Member State or by the Commission in respect of a restrictive measure taken by a 
Member State, that measure shall be deemed  justified. The other Member States shall 
ensure that similar restrictive measures ar e taken in respect of the vehicle, system, 
component or separate t echnical unit concerned. 
Article 55 
Placing on the market and entry into  service of parts or equipment  
that may pose a serious risk to the co rrect functioning of essential systems 
1. Parts or equipment that may pose a serious risk to the correct functioning of systems 
that are essential for the safety of the ve hicle or for its environmental performance 
shall not be placed on the market or entere d into service and shall be prohibited, 
unless they have been aut horised by an approval auth ority in accordance with 
Article 56(1) and (4). 
2. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to lay down the requirements that  the parts and equipment referred to in 
paragraph 1 have to comply with. 
Those requirements may be based on the regula tory acts listed in Annex IV or may 
consist of a comparison of the parts or e quipment with the environmental or safety 
performance of the original parts or equipm ent, as appropriate. In either case, the 
requirements shall ensure that the parts or  equipment do not impair the functioning of EN 56   EN those systems that are essential for the sa fety of the vehicle or its environmental 
performance. 
3. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex XIII to take  account of techni cal and regulatory 
developments by updating the list of parts or equipment on the basis of information 
regarding: 
(a) the seriousness of the risk to the safe ty or environmental performance of 
vehicles fitted with the part s or equipment in question; 
(b) the potential effect on consumers and aftermarket manufacturers of a possible 
authorisation for the parts or  equipment under Article 56(1). 
4. Paragraph 1 shall not apply to  original parts or equipment and to parts or equipment 
belonging to a system that has been type-a pproved in accordance with the regulatory 
acts listed in Annex IV, except where the t ype-approval relates to aspects other than 
the serious risk referred to in paragraph 1. 
For the purposes of this paragraph, origin al parts or equipment means parts or 
equipment that are manufactured according to the specifications and production standards provided by the vehi cle manufacturer for the as sembly of the vehicle in 
question. 
5. Paragraph 1 shall not apply to parts or equipment that are exclusively produced for 
racing vehicles. Parts or equipment listed in Annex XIII that are used both in racing and on the road shall not be made available for vehicles intended for use on public roads, unless they comply with the requirements laid down in the delegated acts referred to in paragraph 2 and have been  authorised by the Commission by means of 
implementing acts. Those implementing acts shall be adopted in accordance with the 
examination procedure referred to in Article 87(2). 
Article 56 
Related requirements for parts or eq uipment that may pose a serious risk 
 to the correct functioning of essential systems 
1. A manufacturer of parts or equipment may apply for the authorisation referred to in 
Article 55(1) by submitting to the approval authority an application accompanied by a test report that is drafted by a designated te chnical service and that certifies that the 
parts or equipment for which authorisati on is sought comply with the requirements 
referred to in Article 55(2). The manufact urer may submit only one application for 
each type of part or equipment and to one approval authority only. 
2. The application for the authorisation shall include details of the manufacturer of parts 
or equipment, the type, the identification a nd part numbers of the parts or equipment, 
the vehicle manufacturer’s name, the type of  vehicle and, where appropriate, the year 
of construction or any other information permitting the identification of the vehicle to which the parts or equipment are to be fitted. 
The approval authority shall authorise the placement on the market and the entering 
into service of the parts or equipment where it finds, taking into account the test report referred to in paragra ph 1 and other evidence, that the parts or equipment in 
question comply with th e requirements referred to in Article 55(2). EN 57   EN The approval authority shall issue to the ma nufacturer without de lay an authorisation 
certificate in accordance with the template set out in Appendix 1 of Annex XI, numbered in accordance with point 2 of Annex XI. 
The Commission shall be empowered to adopt  delegated acts in accordance with 
Article 88 to amend Annex XI to take  account of technical and regulatory 
developments by updating the template and the numbering system for the 
authorisation certificate. 
3. The manufacturer shall inform  without delay the approval authority  that gave the 
authorisation of any change  affecting the conditions unde r which the authorisation 
has been issued. That approval authority sha ll decide whether the authorisation has to 
be reviewed or reissued and wh ether further tests are necessary. 
The manufacturer shall ensure that the part s or equipment are produced and continue 
to be produced under the conditions under wh ich the authorisation has been issued. 
4. Before issuing any authoris ation, the approval authority sh all verify the existence of 
arrangements and procedures for ensuring effective control of the conformity of 
production. 
Where the approval authority finds that the conditions for issuing the authorisation 
are no longer fulfilled, it  shall request the manufactur er to take the necessary 
measures to ensure that the parts or e quipment are brought into conformity. Where 
necessary, it shall withdraw the authorisation. 
5. Upon request of a national authority of anot her Member State, the approval authority 
that has issued the authorisa tion shall, within one month of  the receipt of that request, 
send to the former a copy of the issued au thorisation certificat e together with its 
attachments by means of a common secure electronic exchange system. The copy 
may also take the form of a secure electronic file. 
6. An approval authority that  disagrees with the author isation issued by another 
Member State shall bring the reasons for its disagreement to the attention of the 
Commission. The Commission shall take th e appropriate measures in order to 
resolve the disagreement, which may in clude, where nece ssary, requiring the 
withdrawal of the authorisation, afte r having consulted the relevant approval 
authorities. Those implementing acts sha ll be adopted in accordance with the 
examination procedure referred to in Article 87(2). 
7. Until the list referred to in Article 55(3) has been established, Member States may 
maintain national provisions dealing with parts or equipment that may affect the 
correct functioning of systems essential for the safety of the vehicle or its 
environmental performance. 
Article 57 
General provisions on recall of vehicles, syst ems, components or se parate technical units 
1. A manufacturer who has been granted a whole-vehicle type-appr oval and is obliged 
to recall vehicles in accordance with Ar ticle 12(1), Article 15(1), Article 17(2), 
Article 49(1), Article 49(6), Article 51(4), Article 52(1), and Article 53(1) of this 
Regulation or Article 20 of Regulation (EC) No 765/2008, shall immediately inform 
the approval authority that  granted the whole-vehicl e type-approval thereof. 
2. A manufacturer of systems, components or  separate technical units, who has been 
granted an EU type-approval and is oblig ed to recall systems, components or EN 58   EN separate technical units in accordance with Article 12(1), Article 15(1), Article 17(2), 
Article 49(1), Article 49(6), Article 51(4), Article 52(1), and Article 53(1) of this 
Regulation or Article 20 of Regulation (EC) No 765/2008, shall immediately inform 
the approval authority that granted the EU type-approval. 
3. The manufacturer shall propose to the ap proval authority that  granted the type-
approval a set of appropriate remedies to bring the vehicles, systems, components or 
separate technical uni ts in conformity and, where appropriate, to neutralise the 
serious risk referred to in Artic le 20 of Regulation (EC) No 765/2008. 
The approval authority shall carry out an evaluation to verify whether the proposed 
remedies are sufficient and timely enough, and it shall communicate the remedies 
that it has approved to the a pproval authorities of the othe r Member States and to the 
Commission without delay. 
Article 58 
Specific provisions on recall of vehicles, syst ems, components or se parate technical units 
1. Where an approval authority or the Commission considers that the remedies referred 
to in Article 57(3) are insu fficient or are not implemented quickly enough, they shall 
notify their concern to the approval author ity that granted the EU type-approval and 
the Commission without delay. 
The approval authority that granted th e EU type-approval shall request the 
manufacturer to take corrective measures to  address the concerns  notified. Where the 
manufacturer does not propose and implem ent effective corrective measures, the 
approval authority that granted the EU type-approval shall ta ke all restrictive 
measures required, including the withdrawal  of the EU type-approval and mandatory 
recall, and inform the approval authoritie s of the other Member States and the 
Commission about the restrictive measures ta ken. In the case of withdrawal of the 
EU type-approval, the approval author ity shall inform without delay the 
manufacturer by registered le tter or equivalent electroni c means of that withdrawal. 
2. Where an approval authority  considers that the restrictive measures taken by the 
approval authority that granted the EU type -approval pursuant to article 58(1) are not 
sufficient or timely enough, .it shall inform the Commission thereof and it may take appropriate restrictive measur es to prohibit or restrict the making available on the 
market, registration or entry into service of the concerned non- compliant vehicles, 
systems, components or separate technica l units on their national market, or to 
withdraw them from that market or to recall them. 
3. The Commission shall hold a ppropriate consultations with  the parties involved and 
shall decide whether the restrictive meas ures taken by the appr oval authority that 
granted the EU type-approval are sufficien t and timely enough, and where necessary, 
propose appropriate measures to  ensure that the conformity is restored and/or the 
serious risk referred to in Article 57(3) is  effectively neutralised. That decision shall 
also address the suitability of the restri ctive measures taken by approval authorities 
who considered the action taken by the appr oval authority that gr anted the EU type-
approval as not sufficient or timely enough. Those implementing acts shall be adopted in accordance with the examination procedure refe rred to in Article 87(2). 
The Commission shall address its decision to  the Member States concerned and shall 
immediately communicate it to th e relevant economic operators. EN 59   EN 4. The Member States shall implement without delay the Commission decision and 
inform the Commission accordingly. 
5. Where, within one month of receipt of  the notification regarding the approved 
remedies referred to in Ar ticle 57(3), no objection has b een raised against those 
remedies by either another Member State or  the Commission, those remedies shall be 
deemed justified. The other Member States shall ensure that those remedies are applied in respect of the ve hicles, systems, components or  separate te chnical units 
concerned that have been made available on the market, registered, or entered into 
service in their territory. 
Article 59 
Right to be heard of economic  operators, notification of d ecisions and remedies available 
1. Except in cases where immediate action is necessary for reasons of serious risk to 
human health, safety and the environment, the economic operator concerned shall be 
given the opportunity to make submissions  to the national au thority within an 
appropriate period of time before any m easure pursuant to Articles 49 to 58 is 
adopted by the national authorities of the Member States. 
If action has been taken without the econom ic operator’s being heard, the economic 
operator shall have the opport unity to make submissions as soon as possible and the 
national authority shall review th e measure promptly thereafter. 
2. Any measure adopted by the national au thorities shall state the exact grounds on 
which it is based. 
Where the measure is addressed to a specif ic economic operator, it shall be notified 
without delay to the economi c operator concerned, who sh all at the same time be 
informed of the remedies available under the law of the Member State concerned and 
of the time limits to which such remedies are subject. 
Where the measure is of general scope, it shall be appropriatel y published in the 
national official journal or in  an equivalent instrument. 
3. Any measure adopted by the national author ities shall be immediately withdrawn or 
amended upon the economic operator’s demonstr ating that effectiv e corrective action 
has been taken. 
CHAPTER  XII 
INTERNATIONAL  REGULATIONS 
Article 60 
UNECE regulations required  for EU type-approval 
1. UNECE regulations or amendments theret o which the Union has voted in favour of 
or that the Union applies and that are lis ted in Annex IV shall be part of the 
requirements for the EU type-approval of a vehicle. 
2. The approval authorities of the Member States shall accept approvals granted in 
accordance with the UNECE regulations re ferred to in paragraph 1 and, where 
applicable, the relevant approval marks, in place of the corresponding approvals and approval marks granted in accordance with this Regulation and the regulatory acts 
adopted pursuant to this Regulation. EN 60   EN 3. Where the Union has voted in favour of a UNECE regulation or amendments thereto 
for the purpose of whole-vehicle type-a pproval, the Commission shall adopt a 
delegated act in accordance with Article  88 to make the UNECE regulation or 
amendments thereto compulsory or to amend this Regulation, as appropriate. 
That delegated act shall specify the date s of mandatory application of the UNECE 
regulation or amendments thereto and include transitional provisions, where 
appropriate. 
Article 61 
Equivalence of UNECE regulations fo r the purpose of EU type-approval 
1. The UNECE regulations liste d in Part II of Annex IV  are recognised as being 
equivalent to the corresponding regulatory acts to the extent that they share the same 
scope and subject matter. 
2. The approval authorities of the Member St ates shall accept type -approvals granted in 
accordance with the UNECE regulations re ferred to in paragraph 1 and, where 
applicable, the relevant approval marks, in place of the corresponding type-approvals 
and approval marks that have been granted in accordance with this Regulation and 
the regulatory acts adopted pursuant to this Regulation. 
Article 62 
Equivalence with other regulations 
The Council may, acting by qualified majority on a proposal from the Commission, recognise 
the equivalence between the conditions or pr ovisions for EU type-approval of systems, 
components and separate technical units laid down by this Regulation and the conditions or 
provisions laid down by internat ional regulations or regulations  of third countries in the 
framework of multilateral or bilateral agreements between the Union and third countries. 
CHAPTER  XIII 
PROVISION  OF TECHNICAL  INFORMATION 
Article 63 
Information intended for users 
1. The manufacturer shall not s upply any technical information related to the particulars 
of the type of vehicle, syst em, component or separate t echnical unit provided for in 
this Regulation, or in the de legated or implementing acts  adopted pursuant to this 
Regulation, that diverges from the partic ulars of the type-approved by the approval 
authority. 
2. The manufacturer shall make available to users all relevant information and 
necessary instructions describing any special  conditions or restrictions linked to the 
use of a vehicle, a system, a component or a separate technical unit. 
3. The information referred to in paragraph 2 shall be supplied in the official language 
or languages of the Member State where the vehicle, system, component or separate 
technical unit is to be placed on the market, regi stered or is to be entered into service. 
It shall be provided in the owner’s manual af ter acceptance by the approval authority. EN 61   EN Article 64 
Information intended for manufacturers 
1. The vehicle manufacturer shall make avai lable to the manufacturers of systems, 
components or separate techni cal units all particulars that  are necessary for EU type-
approval of systems, components or sepa rate technical units or to obtain the 
authorisation referred to in Article 55(1). 
The vehicle manufacturer ma y impose a binding agreemen t on the manufacturers of 
systems, components or separa te technical units to protect the conf identiality of any 
information that is not in the public domain, including information related to intellectual property rights. 
2. The manufacturer of systems, components or  separate technical units shall provide 
the vehicle manufacturer with all detailed information on the restrictions that apply 
to his type-approvals and that are either re ferred to in Article 27(3) or imposed by a 
regulatory act listed in Annex IV. 
 
CHAPTER  XIV 
ACCESS  TO REPAIR  AND  MAINTENANCE  INFORMATION 
Article 65 
Manufacturers’ obligations to provide vehicle repair and main tenance information 
1. Manufacturers shall provide to independent  operators unrestricted and standardised 
access to vehicle OBD information, diagnosti c and other equipment, tools including 
any relevant software and vehicle repair and maintenance information. 
Manufacturers shall provide a standardised, secure and remote facility to enable 
independent repairers to complete opera tions that involve access to the vehicle 
security system. 
2. Until the Commission has adopted the rele vant standard through the work of the 
European Committee for Standardization (CEN) or comparable standardisation 
bodies, the vehicle OBD and vehicle repair  and maintenance information shall be 
presented in an easily accessible manner that can be processed by independent operators with reasonable effort. 
The vehicle OBD and the vehicle repair a nd maintenance information shall be made 
available on the websites of manufacturers us ing a standardised format or, if this is 
not feasible, due to the nature of the info rmation, in another appropriate format. In 
particular, this access shall be granted in a manner which is non-discriminatory 
compared to the provision given or acce ss granted to authorised dealers and 
repairers. 
3. The Commission shall establish and update the appropriate tec hnical specifications 
on how vehicle OBD and vehi cle repair and maintenance information shall be 
provided. The Commission shall take into account current information technology, 
foreseeable vehicle technology developm ents, existing ISO standards and the 
possibility of a worldwide ISO standard. EN 62   EN 4. The details of the requirements with re gard to access to vehicle repair and 
maintenance information, in particular t echnical specifications on how vehicle repair 
and maintenance information shall be provided, are laid down in Annex XVIII. 
5. Manufacturers shall also make  training material availabl e to independent operators 
and authorised dealers and repairers. 
6. The manufacturer shall ensure that the ve hicle repair and maintenance information 
shall always be accessible, except as required for maintenance purposes of the information system. 
The manufacturer shall make subsequent amendments and supplements to vehicle 
repair and maintenance information available on its websites at the same time they are made available to authorised repairers. 
7. For the purposes of manufacturing and serv icing of OBD-compatible replacement or 
service parts and diagnostic tools and test equipment, ma nufacturers shall provide the 
relevant vehicle OBD and vehicle repair and mainte nance information on a non-
discriminatory basis to any interested manufacturer or repairer of component, 
diagnostic tool or test equipment. 
8. For the purposes of the design, manufacturing and the repair of automotive 
equipment for alternative-fuel vehicles, manufacturers shall provide the relevant 
vehicle OBD and vehicle repair a nd maintenance information on a non-
discriminatory basis to any interested manuf acturer, installer or repairer of equipment 
for alternative-fuel vehicles. 
9. Independent repairers shall have access fr ee of charge to repair and maintenance 
records of a vehicle that are kept in a centr al database of the vehicle manufacturer or 
in a database on its behalf. 
Those independent repairers shall be able  to enter into the relevant database 
information on the repair and maintenance they have carried out. 
10. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend and supplement Annex XVIII to take account of technical and 
regulatory developments or prevent misu se by updating the requirements concerning 
the access to vehicle OBD and vehicle re pair and maintenance information and by 
adopting and integrating the standards referred to in paragraphs 2 and 3. 
Article 66 
Obligations with regard to several type-approval holders 
1. The manufacturer responsible for th e respective type-approval of a system, 
component or separate technical unit or for a particular stage of a vehicle shall be 
responsible, in the ev ent of a mixed type-approval, a st ep-by-step type-approval or a 
multi-stage type-approval, for communicating to both the final manufacturer and the 
independent operators the repair and ma intenance information relating to the 
particular system, component or separate t echnical unit or to th e particular stage. 
2. The final manufacturer shall be responsib le for providing to independent operators 
information about the whole vehicle. EN 63   EN Article 67 
Fees for access to vehicle re pair and maintenance information 
1. The manufacturer may charge reasonable a nd proportionate fees for access to vehicle 
repair and maintenance information other than the records referred to in Article 65(8). Those fees shall not discourag e access to that information by failing to 
take into account the extent to which the independent operator uses it. 
2. The manufacturer shall make available vehi cle repair and maintenance information, 
including transactional servic es, such as reprogramming, or technical assistance, on 
an hourly, daily, monthly, and yearly basis, with fees for access to such information varying in accordance with the respective periods of time for which access is 
granted. 
In addition to time-based access, manufacturers may offer transaction-based access, 
for which fees are charged per transacti on and not based on the duration for which 
access is granted. 
Where both access systems are offered by th e manufacturer, independent repairers 
shall choose an access system, either  time-based or transaction-based. 
Article 68 
Proof of compliance with repair and maintenance informat ion obligations 
1. The manufacturer that has applied for EU type-approval or na tional type-approval 
shall provide the approval authority with proof of compliance with Articles 65 to 70 within six months from the date of the respective type-approval. 
2. Where that proof of compliance is not provided within the period referred to in 
paragraph 1, the approval authority shall take appropriate measures in accordance 
with Article 69. 
Article 69 
Compliance with the obligations  regarding access to vehicle OBD and vehicle repair and 
maintenance information 
1. An approval authority may at any time, wh ether on its own initiative, on the basis of 
a complaint, or on the basis of an assessment by a technical service, check the compliance of a manufacturer with Articles 65 to 70, an d with the terms of the 
Certificate on Access to Vehicle OBD and Vehicle Repair and Maintenance 
Information laid down in Appendix 1 of Annex XVIII. 
2. Where an approval authority finds that the manufacturer has failed to comply with 
his obligations regarding access to vehicle OBD and vehicle repair and maintenance 
information, the approval authority that gran ted the relevant type-approval shall take 
appropriate measures to remedy the situation. 
Those measures may include withdrawal or su spension of the type-a pproval, fines, or 
other measures adopted pursuant to Article 89. 
3. Where an independent operator or a tr ade association representing independent 
operators files a complaint to the approval authority on the failure of the manufacturer to comply with  Articles 65 to 70, the approva l authority sh all carry out 
an audit in order to verify compliance by the manufacturer. EN 64   EN 4. When carrying out the audit, the approval authority may ask a technical service or 
any other independent expert to carry out  an assessment to verify whether the 
obligations concerning access to vehicle OB D and vehicle repair and maintenance 
information have been met. 
Article 70 
Forum on Access to Vehicle Information 
1. The Forum on Access to Vehicle Information established in accordance with 
Article 13(9) of Regulation (EC) No 692/2008 shall carry out its activities in 
accordance with the provisions  laid down in Annex XVIII. 
2. The Forum referred to in paragraph 1 sh all advise the Commission on measures to 
prevent misuse of vehicle OBD and vehi cle repair and maintenance information. 
CHAPTER  XV 
ASSESSMENT,  DESIGNATION,  NOTIFICATION   
AND  MONITORING  OF TECHNICAL  SERVICES 
Article 71 
Type approval authority responsib le for technical services 
1. The type approval authority  designated by the Member State in accordance with 
Article 7(3), hereinafter referred to as the ‘type-approval authority', shall be responsible for the assessm ent, designation, notificatio n and the monitoring of 
technical services, including, where appropriate, the subcontra ctors or subsidiaries of 
those technical services. 
2. The type-approval authority shall be established, organi sed and operated so as to 
safeguard its objectivity and impartiality and to avoid any conflicts  of interests with 
the technical services. 
3. The type-approval authority shall be organi sed so that the notification of a technical 
service is done by personnel different from  those who carried out the assessment of 
the technical service. 
4. The type-approval authority shall not perform any activities that technical services 
perform and shall not provide consultancy services on a commercial or competitive basis. 
5. The type-approval authority shall safeguard the confidentiality of the information it 
obtains. 
6. The type-approval authority shall have a sufficient number of competent personnel at 
its disposal for the proper performance of the tasks foreseen by this Regulation 
7. Member States shall provide the Commi ssion and the other Member States with 
information on their procedures for the as sessment, designation and notification of 
technical services and for the monitoring of  technical services, and of any changes 
thereto. 
8. The type-approval authority shall be pee r-reviewed by two type-approval authorities 
of other Member States every two years.  EN 65   EN The Member States shall draw up the annual plan for the peer-review, ensuring an 
appropriate rotation in respect  of reviewing and reviewed  type-approval authorities, 
and submit it to the Commission.  
The peer-review shall include an on-site  visit to a technical service under the 
responsibility of th e reviewed authority. The Comm ission may participate in the 
review and decide on its part icipation on the basis of a risk assessment analysis.  
9. The outcome of the peer-review shall be communicated to all Member States and to 
the Commission and a summary of the outcome  shall be made publicly available. It 
shall be discussed by the Forum estab lished in Article 10 on the basis of an 
assessment of this outcome carried out by the Commission and issue recommendations. 
10. The Member States shall provide info rmation to the Commission and the other 
Member States on how it has addresse d the recommendations in the peer-review 
report. 
Article 72 
Designation of technical services 
1. The type-approval authorities shall designat e technical services for one or more of 
the following categories of activities, depending on their field of competence: 
(a) category A: tests referred to in this Regulation and in the acts listed in 
Annex IV that those tech nical services carry out in their own facilities; 
(b) category B: supervision of the tests referre d to in this Regulation and in the acts 
listed in Annex IV, where those tests are performed in the manufacturer’s 
facilities or in the facilities of a third party; 
(c) category C: assessment and monitoring on a regular basis of the procedures of 
the manufacturer for controlling conformity of production; 
(d) category D: supervision or performan ce of tests or inspections for the 
surveillance of conf ormity of production. 
2. A Member State may designate  an approval authority as a technical service for one 
or more of the categories of  activities referred to in pa ragraph 1. Where an approval 
authority is designated as a technical service and is financed by a Member State, or is 
subject to managerial and financial contro l by that Member State, Articles 72 to 85 
and Appendices 1 and 2 to Annex V shall apply. 
3. A technical service shall be  established under the national law of a Member State and 
have legal personality, except for an accr edited in-house technical service of a 
manufacturer, as referr ed to in Article 76. 
4. A technical service shall take out liability insurance for its activities unless that 
liability is assumed by the Member State in accordance with national law, or the Member State itself is directly resp onsible for the conformity assessment. 
5. Technical services of a thir d country, other than those designated in accordance with 
Article 76, may be notified for the purposes  of Article 78 only where a bilateral 
agreement between the Union and the th ird country concerned provides for the 
possibility of designating t hose technical services. This shall not prevent a technical 
service established under the national law of a Member State in accordance with EN 66   EN paragraph 3 from establishing subsidiaries  in third countries, provided that the 
subsidiaries are directly ma naged and controlled by the desi gnated technical service. 
Article 73 
Independence of the technical services 
1. A technical service, including its personnel,  shall be independent and shall carry out 
the activities for which it has been designa ted with the highest degree of professional 
integrity and the requisite technical competence in the specific field in which it operates and shall be free from all pressure s and inducements, particularly financial, 
that might influence its judgment or the result s of its assessment activities, especially 
such pressures or inducements emanating fr om persons or groups of persons with an 
interest in the results of those activities. 
2. A technical service shall be a third-party organisation or body that is not  involved in 
the process of design, manufacturing, supply or maintenance of the vehicle, system, 
component or separate technical uni t it assesses, tests or inspects. 
An organisation or body belonging to a business association or professional 
federation representing undertakings that are involved in the design, manufacturing, 
supply or maintenance of the vehicles, sy stems, components or separate technical 
units that it assesses, tests or inspect s, may be considered as fulfilling the 
requirements of the first subparagraph, provided that its independence and the 
absence of any conflict of interest are demonstrated to the designating approval 
authority of the relevant Member State. 
3. A technical service, its top-level mana gement and the personnel responsible for 
carrying out the activities for which they are designated in accordance with Article 72(1) shall not de sign, manufacture, supply, or  maintain the vehicles, 
systems, components or separate technical un its that they assess, nor represent parties 
engaged in those activities. This shall not preclude the use of those vehicles, systems, 
components or separate technical units th at are necessary for the operation of the 
technical service or the us e of such vehicles, system s, components or separate 
technical units for personal purposes. 
4. A technical service shall ensu re that the activities of its subsidiaries or subcontractors 
do not affect the confidentiality, objectivit y or impartiality of the categories of 
activities for which it has been designated. 
5. The personnel of a technical service shall obs erve professional secrecy with regard to 
all information obtained in carrying out th eir tasks under this Regulation, except in 
relation to the approval aut hority or where required by Union or national law. 
Article 74 
Competence of the technical services 
1. A technical service shall be capable of ca rrying out all the activ ities for which it is 
applying to be designated in accordance with  Article 72(1). It shall demonstrate to 
the type approval authority that  it has all of the following: 
(a) its personnel has the appropr iate skills, the specific technical knowledge, the 
vocational training and sufficient and a ppropriate experien ce to perform the 
activities for which it is seeking to be designated; EN 67   EN (b) it possesses the descriptions of the proce dures relevant for the performance of 
the activities for which it is seeking to be designated, taking due account of the 
degree of complexity of the technology of the relevant vehicle, system, 
component or separate technical unit in que stion, as well as the mass or serial 
nature of the production process. The t echnical service shall demonstrate the 
transparency and reproducibility of those procedures; 
(c) it has the necessary means to perform the tasks connected with the categories 
of activities for which it is seeking to be  designated and that it has access to all 
necessary equipment or facilities. 
2. A technical service shall also demonstrat e that it has the appropriate skills, the 
specific technical knowledge and proven experi ence to carry out tests and inspections 
for assessing the conformity of the vehi cles, systems, components and separate 
technical units with this Regul ation, with the regulatory ac ts listed in Annex IV and 
its compliance with the standards li sted in Appendix 1 to Annex V. 
Article 75 
Subsidiaries of and subcontracting by technical services 
1. Technical services may subcontract, with the agreement of their designating type-
approval authority, some of the categories of activities for which they have been 
designated in accordance with Article 72(1), or have those activities carried out by a 
subsidiary. 
2. Where a technical service subcontracts speci fic tasks from the categories of activities 
for which it has been designated or has r ecourse to a subsidiary to perform those 
tasks, it shall ensure that the subcontractor or the subsidiary complies with the requirements set out in Articles 73 and 74 and it shall inform  the type-approval 
authority thereof. 
3. Technical services shall take full res ponsibility for the tasks performed by their 
subcontractors or subsidiaries, regard less of their place of establishment. 
4. Technical services shall k eep at the disposal of the type-approval authority the 
relevant documents concerning the asse ssment of the qualifications of the 
subcontractor or the subsidiary and the tasks performed by them. 
Article 76 
In-house technical services of the manufacturer 
1. An in-house technical service of a manu facturer may be designated for category A 
activities as referred to in Article 72(1)(a ) only with regard to  the regulatory acts 
listed in Annex XV. An in-house technical service shall constitute a separate and 
distinct part of the manuf acturer's company and shall no t be involved in the design, 
manufacturing, supply or maintenance of the vehicles, systems, components or 
separate technical un its that it assesses. 
2. An in-house technical service shall co mply with the following requirements: 
(a) it has been accredited by a national accreditation body as  defined in point 11 of 
Article 2 of Regulation (EC) No 765/2008 and in accordance with Appendices 1 and 2 to Anne x V to this Regulation; 
(b) the in-house technical se rvice, including its personne l, is organisationally 
identifiable and has reporting methods within the manufacturer’s company of EN 68   EN which they form part that ensures its impartiality and demonstrates that 
impartiality to the releva nt national accreditation body; 
(c) neither the in-house technical service nor its personnel is engaged in any 
activity that might conflict with its inde pendence or its integr ity to perform the 
activities for which it has been designated; 
(d) it supplies its services exclusively to the manufacturer’s company of which it 
forms part. 
3. An in-house technical service does not need  to be notified to the Commission for the 
purposes of Article 78, but information con cerning its accreditati on shall be given by 
the manufacturer of which it forms part or by the national a ccreditation body to the 
type-approval authority at th e request of that authority. 
4. The Commission shall be empowered to a dopt delegated acts in accordance with 
Article 88 to amend Annex XV to take account of technica l and regulatory 
developments by updating the list of regul atory acts and restrictions contained 
therein. 
Article 77 
Assessment and designation of  technical services 
1. Before designating a technica l service, the type-approval authority shall assess it in 
accordance with an assessment check-list that  covers at least the requirements listed 
in Appendix 2 of Annex V. The assessment sh all include an on-site assessment of the 
premises of the applying tec hnical service, and, where rele vant, of any subsidiary or 
sub-contractor, located insi de or outside the Union. 
Representatives of the type-a pproval authorities of at l east two other Member States 
shall, in coordination with the type-approva l authority of the Member State in which 
the applicant technical service is established, and together with a representative of the Commission, form a joint assessment t eam and participate in  the assessment of 
the applicant technical serv ice, including the on-site assessment. The designating 
type-approval authority of the Member Stat e where the applicant technical service is 
established shall give those representatives timely access to the documents necessary to assess the applicant technical service. 
2. The joint assessment team shall raise findings regarding non-compliance of the 
applicant technical se rvice with the require ments set out in Articles 72 to 76, in 
Articles 84 and 85 and in Appendix 2 to Annex V during the assessment process. 
These findings shall be discussed between the designating approval authority and the 
joint assessment team with a view to fi nding common agreement with respect to the 
assessment of the application. 
3. The joint assessment team shall produce with in 45 days after the on-site assessment a 
report setting out the extent to which th e applicant complies with the requirements 
set out in in Articles 72 to 76, in Articles 84 and 85 and in  Appendix 2 to Annex V of 
this Regulation. 
4. This report shall contain a summary of identified non-compliances. Divergent 
opinions between members of the joint asse ssment team shall be reflected in the 
report, together with a re commendation whether the appli cant could be designated as 
technical service. EN 69   EN 5. The Member States shall notify to the Commission the names of the representatives 
of the type-approval auth ority to call upon for each joint assessment.  
6. The competence of a technical service sh all be assessed in accordance with the 
provisions of Appendix 2 to Annex V. 
7. The type-approval authority shall notify the assessment report to the Commission 
and to designating authorities of the othe r Member States with documentary evidence 
regarding the competence of the technical se rvice and the arrangements in place to 
regularly monitor the technica l service and ensure that it continues to comply with 
the requirements of this Regulation.  
The notifying type-approval authority sha ll furthermore submit evidence of the 
availability of competent personnel fo r monitoring the technical service in 
accordance with Article 71(6). 
8. The type-approval authorities of the ot her Member States and the Commission may 
review the assessment report and the docum entary evidence, raise questions or 
concerns and request further documentary  evidence within one month after the 
notification of the asse ssment report and the documentary evidence.. 
9. The type-approval authority of the Member State where the applicant technical 
service is established shall respond to the questions, concerns and requests for further 
documentary evidence within four  weeks following their receipt. 
10. The type-approval authorities of the ot her Member States or the Commission may 
individually or jointly addr ess recommendations to the t ype-approval auth ority of the 
Member State where the applicant technical service is established within four weeks 
following the receipt of the response referred to in para graph 9. That type-approval 
authority shall take account of the recommendations when it takes the decision on the designation of the technical service. Where that type-approval authority decides not 
to follow the recommendations addressed by the other Member States or the 
Commission, it shall give the reasons ther efor within two w eeks after taking its 
decision. 
11. The validity of the designation of technical  services shall be limited to a maximum of 
five years. 
12. The approval authority that  intends to be designated as a technical service in 
accordance with Article 72(2) shall document compliance w ith the requirements of 
this Regulation through an assessment conducted by independent auditors. Those auditors shall not belong to the same a pproval authority and shall comply with the 
requirements laid down in Appendix 2 of Annex V.  
Article 78 
Notification to the Commission concerning technical services 
1. Member States shall notify to the Comm ission the name, the address, including the 
electronic address, the res ponsible persons and the cate gory of activities of every 
technical service that they have designate d. The notification shall clearly specify the 
scope of the designation, the conformity assessment activities and procedures, the 
type of products and the subjects listed in Annex IV for which the technical services 
have been designated, and subsequent m odifications to any of those details. 
That notification shall be ma de prior to the conduct of any activity referred to in 
Article 72(1) by the designa ted technical services. EN 70   EN 2. Within 28 days of a notification, a Me mber State or the Commission may raise 
written objections, setting out  its arguments, with regard either to the technical 
service or to its monitoring by the type-appr oval authority. When a Member State or 
the Commission raises objections, the effect of the notification sh all be suspended. In 
this case, the Commission shall consult th e parties involved and shall decide by 
means of an implementing act whether the su spension of the notification can be lifted 
or not. That implementing act shall be a dopted in accordance with the examination 
procedure referred to in Article 87(2). 
Where no objection is raised or where the Commission is of the opinion that the 
notification may be accepted fully or partially, the Commission shall publish the 
notification in accordance with paragraph 5. 
3. The same technical service may be desi gnated by several type-a pproval authorities 
and notified to the Commission by the Memb er States of those type-approval 
authorities, irrespective of th e category or categories of ac tivities that that technical 
service shall carry out in accordance with Article 72(1). 
4. Where a regulatory act listed in Annex IV  requires a type-approval authority to 
designate a specific organisation or comp etent body to carry out an activity not 
included in the categories of activities referre d to in Article 72(1), the Member State 
shall make the notification referred to in paragraph 1. 
5. The Commission shall publish on its webs ite an updated list and details of the 
technical services and the specific organisa tions and competent bodies that have been 
notified to it in accord ance with this Article. 
Article 79 
Changes to and renewal of designa tions of technical services 
1. Where the type-approval authority has as certained or has been informed that a 
technical service no longer complies with  the requirements laid down in this 
Regulation, that authority shall restrict, susp end or withdraw the designation, as 
appropriate, depending on the seriousness of  the failure to comply with those 
requirements. 
The type-approval authority shall immedi ately inform the Commission and the other 
Member States of any suspension, restri ction or withdrawal  of a notification. 
The Commission shall update the informati on published referred to in Article 78(4) 
accordingly. 
2. In the event of a restriction, suspension or  withdrawal of the designation, or where 
the technical service has ceased its activit y, the designating approval authority shall 
transfer the files of that technical service to another technical service for further 
processing or keep them available for the approval authorities or for the market surveillance authorities. 
3. The type-approval authority shall inform the other type-approval authorities and the 
Commission when non-compliance of the technical service has an impact on type-approval certificates issued on the basis of  the inspection and test reports issued by 
the technical service subject of  the change in notification. 
Within two months after ha ving notified the changes to the notification, the type-
approval authority shall submit a report on its findings regarding the non-compliance 
to the Commission and the other type-appr oval authorities. Where necessary to EN 71   EN ensure the safety of vehicles, systems, co mponents or separate technical units already 
placed on the market, the designating type-approval authority shall instruct the concerned approval authorities to suspend or  withdraw within a reasonable period of 
time, any certificates which were unduly issued. 
4. The other certificates which were issued on the basis of inspec tion and test reports 
issued by the technical service for which the notification has been suspended, restricted or withdrawn shall remain  valid in the following circumstances: 
(a) in the case of suspension of a notif ication, on condition that, within three 
months after the suspension, the type-a pproval authority that issued the 
type-approval certificate confirms in writing to the type-approval authorities of the other Member States and the Commission that it is assuming the 
functions of the technical service during the period of suspension; 
(b) in the case of restriction or withdraw al of a notification, for a period of three 
months after the restriction or withdr awal. The type-approval authority that 
issued the certificates may extend the va lidity of the certificates for further 
periods of three months, for a maxi mum period altogether, of twelve 
months, provided it is assuming during that period the functions of the technical service whose notification has been restricted or withdrawn. 
The type-approval authority assuming the functions of th e technical service shall 
immediately inform the other type-approval au thorities, the other technical services 
and the Commission thereof. 
5. An extension of the scope of the technica l service's designation may be granted in 
accordance with the procedure set out in Ar ticle 77 and subject to the notification 
referred to in Article 78. 
6. A designation as technical service can only be renewed after the type-approval 
authority has verified whether the technica l service continues to comply with the 
requirements of this Regulation. That asse ssment shall be carried out in accordance 
with the procedure set out in Article 77. 
Article 80 
Monitoring of technical services 
1. The type-approval authority  shall continuously monitor the technical services to 
ensure compliance with the requirements set out in Articles 72 to 76, in Articles 84 
and 85 and in Appendix 2 to Annex V.  
Technical services sh all, on request,  supply all relevant in formation and documents, 
required to enable that type-approval auth ority to verify compliance with those 
requirements. 
Technical services shall, without delay, in form the type-approval authority of any 
changes, in particular regarding their personnel, facilities, subsidiaries or 
subcontractors, which may affect complia nce with the require ments set out in 
Articles 72 to 76, in Articles 84 and 85 a nd in Appendix 2 to Annex V, or their 
ability to perform the conformity assessment tasks relating to the vehicles, systems, components and separate technical units for which they have been designated. 
2. Technical services shall respond without  delay to requests by a type-approval 
authority or by the Commission in relation to the conformity assessments they have carried out. EN 72   EN 3. The type-approval authority of the Member State in whic h the technical service is 
established shall ensure that the technical service carries out its obligation laid down 
in paragraph 2, unless there is a le gitimate reason for not doing so. 
When the type-approval author ity of the Member State in which the technical service 
is established invokes a legitimate reason, it shall inform the Commission thereof. 
The Commission shall consult without delay th e Member States. On the basis of that 
evaluation, the Commission shall decide by means of an implementing act whether 
the legitimate reason is considered justified or not. Those implementing acts shall be adopted in accordance with the examination procedure refe rred to in Article 87(2). 
The technical service or the type-approval authority may request that any information 
transmitted to the authorities of another Me mber State or to the Commission shall be 
treated confidentially. 
3. At least every 30 months, the type-appr oval authority shall assess whether each 
technical service under its responsibility cont inues to satisfy the requirements set out 
in Articles 72 to 76, in Articles 84 and 85 and in Appendix 2 to Annex V. This 
assessment shall include an on-site vi sit to each technical  service under its 
responsibility. 
Within two months after finalising this assessment of the technical service, the 
Member States shall report to the Comm ission and to the other Member States on 
those monitoring activities. The reports shall contain a summary of the assessment which shall be made publicly available. 
4. Five years after the notif ication of a technical service, and every fifth years 
thereafter, the assessment to determine wh ether the technical service still complies 
with the requirements set out in Article s 72 to 76, in Articles 84 and 85 and in 
Appendix 2 to Annex V shall be carried ou t by the type-approval authority of the 
Member State in which the technical service is established and a joint assessment 
team designated in accordance with the proced ure described in Article 77(1) to (4). 
Article 81 
Challenge to the competence of technical services 
1. The Commission shall investig ate all cases where concerns  have been brought to its 
attention regarding the competence of a technical service or the continued 
compliance by a technical service with the re quirements and respons ibilities to which 
it is subject under this Regulation. It may also commence such investigations on its 
own initiative. 
The Commission shall investigate the respons ibility of the technical service in the 
case where it is demonstrated or where ther e are justified grounds to consider that a 
type approval has been grante d on the basis of false data or  that the test results have 
been falsified or that data or technical sp ecifications have been withheld that would 
have led to the refusal to  grant the type approval,. 
2. The Commission shall consul t the type-approval author ity of the Member State 
where the technical service is established as part of the investigation referred to in paragraph 1. The type-approval authority of  that Member State shall provide the 
Commission, upon request, with all relevant information relating to the performance 
and the compliance with the requirement s concerning independence and competence 
of the technical service concerned. EN 73   EN 3. The Commission shall ensure that all sensi tive information obtained in the course of 
its investigations is treated confidentially. 
4. Where the Commission ascertains that a technical service does not or no longer 
comply with the requirements for its designa tion or that it is responsible for any of 
the wrong-doings referred to in paragraph 1, it shall inform the Member State of the 
type-approval authority thereof. 
The Commission shall request that Member  State to take restrictive measures, 
including the suspension, restriction or  withdrawal of the designation, where 
necessary. 
Where the Member State fails to take the necessary restrictive measures, the 
Commission may, by means of implementing acts,  suspend, restrict  or withdraw the 
designation of the technical service concer ned. Those implementing acts shall be 
adopted in accordance with the examination procedure referred to in Article 87(2). 
The Commission shall notify th e Member State concerned of its decision and shall 
update the information published referre d to in Article 78(4) accordingly. 
Article 82 
Exchange of information on assessment, desi gnation and monitoring of technical services 
1. Type-approval authorities shall consult each other and the Commission on questions 
with general relevance with regard to th e implementation of the requirements set out 
in this Regulation in relation with the assessment, designati on and monitoring of 
technical services. 
2. Type-approval authorities shall communi cate to each other and the Commission not 
later than two years after the entry into  force of this Regulation the model for 
assessment check-list used in accordance with Article 77(1) and thereafter the 
adaptations made to this check-list un til the Commission has adopted a harmonised 
assessment check-list. The Commission shal l be empowered to adopt implementing 
acts to establish the template of the a ssessment check-list. Those implementing acts 
shall be adopted in accordance with th e examination procedure referred to in 
Article 87(2). 
3. When the assessment reports referred to in Article 77(3) indicate discrepancies in the 
general practice of type-appr oval authorities, Member St ates or the Commission may 
request an exchange of information. 
4. The exchange of information shall be co-ordinated by the Forum referred to in 
Article 10. 
Article 83 
Cooperation with national accreditation bodies 
1. Where designation of a technical serv ice is based on accreditation within the 
meaning of Regulation (EC) No 765/2008, Me mber States shall ensure that the 
national accreditation body that has accredite d a particular techni cal service is kept 
informed by the type-approval authority on incident reports and other information 
that relate to matters under the control of the technical service when that information 
is relevant for the assessment of the performance of the technical service. 
2. Member States shall ensu re that the national accred itation body in charge of the 
accreditation of a partic ular technical service is kept  informed by the type-approval EN 74   EN authority of the Member State where the t echnical service is es tablished on findings 
relevant for the accreditation. The national accreditation body sha ll inform the type-
approval authority of the Member State wher e the technical service is established on 
its findings. 
Article 84 
Operational obligations of technical services 
1. Technical services shall ca rry out the activities for whic h they have been designated 
in accordance with Article 72(1). 
2. Technical services shall comply at all times with all of the following: 
(a) allow their approval authority to witn ess the performance of the technical 
service during the conf ormity assessment; 
(b) provide their approval authority, upon request, with information on the 
categories of activities for which they have been designated. 
3. Where a technical service finds that a manufacturer does not comply with the 
requirements laid down in this Regulation, it shall report this to the approval 
authority in order for the approval author ity to require the manufacturer to take 
appropriate corrective measures. The approval authority shall refuse to issue a type-
approval certificate where those appropria te corrective measures have not been 
taken. 
Article 85 
Information obligations of technical services 
1. Technical services shall inform thei r approval authority of the following: 
(a) any non-conformity encountered which ma y require a refusal, restriction, 
suspension or withdrawal of  a type-approval certificate; 
(b) any circumstances affecting the scope of  and conditions for their designation; 
(c) any request for information which they ha ve received from market surveillance 
authorities regarding their activities. 
2. Upon request from their a pproval authority, technica l services shall provide 
information on the activities within the sc ope of their designation and on any other 
activity performed, including cross-bo rder activities and subcontracting. 
Article 86 
National fees for costs relating to the activiti es exercised by the ty pe-approval authorities  
1. The Member States shall levy fees on tec hnical services applying to be designated 
established in their territory to cover w holly or partly, the costs relating to the 
activities exercised by the na tional authorities responsible for technical services in 
accordance with this Regulation. 
2. The Commission may adopt implementing acts in order to set out the structure and 
the level of the fees referred to in paragraph 1, taking into account the objectives of 
safety and the protection of human health  and the environment, support of innovation 
and cost-effectiveness. When fixing the a ppropriate level of the fees, particular 
attention shall be paid to technical services that submitted a valid certificate EN 75   EN delivered by the national accreditation body as referred to in Article 83 and to  
technical services that are small and me dium-sized enterprises as defined in 
Commission Recommendation 2003/361/EC29.. Those implementing acts shall be 
adopted in accordance with the examination procedure refe rred to in Article 87(2). 
CHAPTER  XVI 
IMPLEMENTING  AND  DELEGATED  POWERS 
Article 87 
Committee procedure 
1. The Commission shall be assisted by th e Technical Committee — Motor Vehicles. 
That committee shall be a committee within the meaning of Regulation 
(EU) No 182/2011. 
2. Where reference is made to this  paragraph, Article 5 of Regulation 
(EU) No 182/2011 shall apply. 
Article 88 
Exercise of the delegation 
1. The power to adopt delegated acts is conferred on the Commission subject to the 
conditions laid down in this Article. 
2. The power to adopt delegated acts referr ed to in Article 4(2), Article 5(2), 
Article 10(3), Article 22(3), Article 24(3), Article 25(5), Article 26(2), Article 28(5), 
Article 29(6), Article 34(2), Article 55(2)  and (3), Article 56(2), Article 60(3), 
Article 65(10), Article 76(4) and Article 90(2) shall be conferred on the Commission 
for an indeterminate period of time from the date of entry into force of this Regulation. 
3. The delegation of power referred to in Article 4(2), Article 5(2), Article 10(3), 
Article 22(3), Article 24(3), Article 25(5), Article 26(2), Article 28(5), Article 29(6), 
Article 34(2), Article 55(2) and (3), Artic le 56(2), Article 60(3), Article 65(10), 
Article 76(4) and Article 90(2) may be  revoked at any time by the European 
Parliament or by the Council. A decision to  revoke shall put an end to the delegation 
of the power specified in that decision. It  shall take effect the day following the 
publication of the decision in the Official Journal of the European Union  or at a later 
date specified therein. It shal l not affect the validity of any delegated acts already in 
force. 
4. As soon as it adopts a delegated act, th e Commission shall notify it simultaneously to 
the European Parliament and to the Council. 
5. A delegated act adopted pu rsuant to Article 4(2), Ar ticle 5(2), Article 10(3), 
Article 22(3), Article 24(3), Article 25(5), Article 26(2), Article 28(5), Article 29(6), 
Article 34(2), Article 55(2) and (3), Artic le 56(2), Article 60(3), Article 65(10), 
Article 76(4) and Article 90(2) shall ente r into force only if no objection has been 
expressed either by the European Parliame nt or the Council within a period of two 
months of notification of th at act to the European Parl iament and the Council or if, 
before the expiry of that period, the European Parliament  and the Council have both 
                                                
 
29 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-
sized enterprises (OJ L 124, 20.5.2003, p. 36). EN 76   EN informed the Commission that they will not  object. That period shall be extended by 
two months at the initiati ve of the European Parliament or of the Council. 
CHAPTER  XVII 
FINAL  PROVISIONS 
Article 89 
Penalties 
1. Member States shall lay down the rules on penalties for infringement by economic 
operators and technical services  of their obligations laid down in the Articles of this 
Regulation, in particular Ar ticles 11 to 19 and 72 to 76, 84 and 85 and shall take all 
measures necessary to ensure that they are implemented. The penalties provided for 
shall be effective, proportionate and dissuasive. 
2. The types of infringements by economic opera tors and technical services subject to 
penalties shall be at least the following: 
(a) making false declarations dur ing approval procedures or  procedures leading to 
a recall; 
(b) falsifying test results for type-approval; 
(c) withholding data or techni cal specifications that coul d lead to the recall of 
vehicles, systems, components and separate  technical units, or to the refusal or 
withdrawal of type-a pproval certificate; 
3. In addition to the types of infringeme nts set out in paragraph 2, the types of 
infringements by economic operators that are also subject to penalties shall be at 
least the following: 
(a) refusing to provide access to information; 
(b) making available on the market vehicles , systems, components or separate 
technical units subject to approval without such approval or falsifying 
documents or markings with that intention. 
4. Member States shall notify the provisions  implementing paragraphs 1 to 3 to the 
Commission by dd/mm/yyyy [ PO: please insert the date 12 months after entry into 
force of this Regulation. ] and shall notify the Commission without delay of any 
subsequent amendment affecting those provisions. 
5. Member States shall report to the Commi ssion every year on the penalties they have 
imposed. 
Article 90 
Administrative fines  
 
1. Where the compliance verification by the Commission referred to in 
Article 9(1) and (4), or Article 54(1) reve als non-compliance of the vehicle, system, 
component, separate techni cal unit with the requireme nts laid down in this 
Regulation, the Commission may impose ad ministrative fines upon the concerned 
economic operator for the infringement of this Regulation. The administrative fines 
provided for shall be effective, proportionate  and dissuasive. In particular the fines EN 77   EN shall be proportionate to the number of non-compliant vehicles registered in the 
Union market, or the number of non-comp liant systems, components or separate 
technical unit made availa ble on the Union market. 
The administrative fines imposed by the Comm ission shall not be in addition to the 
penalties imposed by the Member States in  accordance with Article 89 for the same 
infringement and shall not exceed EUR 30  000 per non-compliant vehicle, system, 
component or separate technical unit. 
2. The Commission may adopt delegated acts in  accordance with Article 88 to lay down 
the methods for the calculation and collection of the administrative fines referred to 
in paragraph 1. 
3 The amounts of administrative fines shall be  considered as revenue for the general 
budget of the European Union. 
Article 91 
Amendments to Regulation (EC) No 715/2007 
1. Regulation (EC) No 715/2007 is amended as follows: 
(1) The title of the Regulation is replaced by the following: 
‘Regulation (EC) No 715/2007of the Eur opean Parliament and of the Council 
of 20 June 2007 on type approval of motor vehicles with respect to emissions 
from light passenger and commercial vehicles (Euro 5 and Euro 6)’; 
(2) in Article 1, paragraph 2 is replaced by the following: 
‘2. In addition, this Regulation lays down rules for in-service conformity, 
durability of pollution control devices,  vehicle OBD systems and measurement 
of fuel consumption.’; 
(3) in Article 3, points 14 and 15 are deleted; (4) Articles 6 to 9 are deleted; (5) in Article 13(2), point (e) is deleted. 
(6) The following Article 11a shall be inserted: 
‘Article 11a 
1. On the basis of appropriate and representative samples, approval 
authorities shall verify that 
(a) vehicles that have entered into service conform to the CO
2 emission 
and fuel consumption values recorded  in the type appr oval certificates 
and certificates of conformity; 
(b) CO 2 emissions and fuel consumption values determined through the 
applicable test procedure are representative of emissions measured under real driving conditions. 
2. The Commission may adopt implementing acts in order to determine 
the verification procedures referred to  in points (a) and (b) and any action 
necessary to take into account the re sult of those verifications. Those 
implementing acts shall be adopted in accordance with the examination procedure referred to in Article […].’ EN 78   EN 2. References to the deleted provisions of Regulation (EC) No 715/2007 shall be 
construed as references to this Regulation and shall be read in accordance with the correlation table set out in point 1 of Annex XVIII to this Regulation. 
Article 92 
Amendments to Regulation (EC) No 595/2009 
1. Regulation (EC) No 595/2009 is amended as follows: 
(1) in Article 1, paragraph 2 is replaced by the following: 
‘2. This Regulation also lays down ru les for in-service conformity of 
vehicles and engines, durability of pollution control devices, vehicle OBD 
systems, measurement of fuel c onsumption and CO2 emissions and 
accessibility of vehicle OBD.’ 
(2) in Article 3, points 11 and 13 are deleted; (3) Article 6 is deleted; (4) in Article 11(2), point (e) is deleted. 
2. References to the deleted provisions of Regulation (EC) No 595/2009 shall be 
construed as references to this Regulation and shall be read in accordance with the correlation table set out in point 2 of Annex XVIII to this Regulation. 
Article 93 
Amendment to Regulation (EC) No 692/2008 
1. Annex XIV to Regulation (EC) No 692/2008 is deleted. 
2. References to the deleted provisions of Regulation (EC) No 692/2008 shall be 
construed as references to this Regulation and shall be read in accordance with the correlation table set out in point 3 of Annex XVIII to this Regulation. 
Article 94 
Amendments to Regulation (EU) No 582/2011 
1.  Regulation (EU) No 582/ 2011 is amended as follows: 
(1) Articles 2a to 2h are deleted; 
(2) Annex XVII is deleted. 
2. References to the deleted provisions of Regulation (EU) No 582/2011 shall be 
construed as references to this Regulation and shall be read in accordance with the correlation table set out in point 4 of Annex XVIII to this Regulation. 
Article 95 
Repeal of Directive 2007/46/EC 
Directive 2007/46/EC is repealed with effect from 1 January 201X. 
References to Directive 2007/46/EC shall be cons trued as references to  this Regulation and 
shall be read in accordance with the correlation ta ble set out in point 5 of Annex XVIII to this 
Regulation. EN 79   EN Article 96 
Transitional provisions 
1. This Regulation shall not invalidate any whole-vehicle type-appr oval or EU type-
approval granted to vehicles or to system s, components or separate technical units 
before [ PO: please insert the date of applic ation as mentioned in Article 98 ]. 
2. Approval authorities shall grant extensi ons and revisions of whole-vehicle type-
approvals and EU type-approvals to the ve hicles, systems, components or separate 
technical units referred to in paragraph 1 in accordance with Articles 31 and 32 of 
this Regulation. 
3. The validity of whole-vehicle type-appr ovals referred to in  paragraph 1 shall 
terminate at the latest on [PO: please insert the date,  which should be the date of 
application as mentioned in Article 98 + 5 years]  and approval authorities may only 
renew those whole-vehicle type-approvals  in accordance with the provisions of 
Article 33 of this Regulation. 
4. Technical services already designated before  the entry into force of this Regulation 
shall be subject to the assessm ent referred to in Article 77. 
The designation of t echnical services already designate d before the entry into force 
of this Regulation shall be renewed within two years of the entry into force of this Regulation where those technical services comply with the relevant requirements set out in this Regulation. 
The validity of the designation of technical services made before the entry into force 
of this Regulation shall terminate at the late st two years after the date of entry into 
force of this Regulation. 
Article 97 
Reporting 
1. By 31 December 20xx [PO: please insert the year,  which should be the year of 
application as mentioned in Article 98 + 5 years] Member States shall inform the 
Commission of the application of the type-approval and ma rket surveillance 
procedures laid down in this Regulation. 
2. On the basis of the information supplied under paragraph 1, the Commission shall 
present an evaluation report to the Eur opean Parliament and the Council on the 
application of this Regulation, including on the functioning of the  compliance 
verification in accordance with  Article 9 by 31 December 20yy. [PO: please insert 
the year, which should be the year 20xx as mentioned in paragraph 1 + 1 year]  
Article 98 
Entry into force and application 
This Regulation shall enter into  force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from 1 January 201X. However, from [...] [ PO: please insert the date 12 months after entry into force of this 
Regulation. ], national authorities shall not refuse to  grant EU type-approv al or national type-
approval for a new type of vehicl e, or prohibit registration, placi ng on the market or entry into 
service of a new vehicle where the vehicle concerned complies with this Regulation and the EN 80   EN delegated and implementing acts adopted pursuan t to this Regulation, if a manufacturer so 
requests. 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
For the European Parliament For the Council 
The President The President EN 81   EN LEGISLATIVE FINANCIAL STATEMENT  
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE 
 1.1. Title of the proposal/initiative 
 1.2. Policy area(s) concerned in the ABM/ABB structure  1.3. Nature of the proposal/initiative 
 1.4. Objective(s)  1.5. Grounds for the proposal/initiative  1.6. Duration and financial impact  1.7. Management mode(s) planned 
2. MANAGEMENT
 MEASURES 
 2.1. Monitoring and reporting rules 
 2.2. Management and control system  2.3. Measures to prevent fraud and irregularities 
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE 
 3.1. Heading(s) of the multiannual fina ncial framework and expenditure budget 
line(s) affected 
 3.2. Estimated impact on expenditure  
 3.2.1. Summary of estimated impact on expenditure 
 3.2.2. Estimated impact on ope rational appropriations 
 3.2.3. Estimated impact on appropriati ons of an administrative nature 
 3.2.4. Compatibility with the current  multiannual financial framework 
 3.2.5. Third-party contributions 
 3.3. Estimated impact on revenuEN 82   EN LEGISLATIVE FINANCIAL STATEMENT 
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE 
 1.1. Title of the proposal/initiative 
 1.2. Policy area(s) concerned in the ABM/ABB structure  1.3. Nature of the proposal/initiative 
 1.4. Objective(s)  1.5. Grounds for the proposal/initiative  1.6. Duration and financial impact  1.7. Management mode(s) planned 
2. MANAGEMENT
 MEASURES 
 2.1. Monitoring and reporting rules 
 2.2. Management and control system  2.3. Measures to prevent fraud and irregularities 
3. ESTIMATED
 FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE 
 3.1. Heading(s) of the multiannual fina ncial framework and expenditure budget 
line(s) affected 
 3.2. Estimated impact on expenditure  
 3.2.1. Summary of estimated impact on expenditure 
 3.2.2. Estimated impact on ope rational appropriations 
 3.2.3. Estimated impact on appropriati ons of an administrative nature 
 3.2.4. Compatibility with the current  multiannual financial framework 
 3.2.5. Third-party contributions 
 3.3. Estimated impact on revenuEN 83   EN LEGISLATIVE FINANCIAL STATEMENT 
1. FRAMEWORK  OF THE  PROPOSAL/INITIATIVE 
1.1. Title of the proposal/initiative 
Proposal for a Regulation of the European  Parliament and of the Council on the 
approval and market surveillance of motor vehi cles and their traile rs, and of systems, 
components and separate technical units intended for such vehicles 
1.2. Policy area(s) concerned in the ABM/ABB structure30 
Internal market, Industry, Entrepreneursh ip and SMEs - Internal market for goods 
and services 
1.3. Nature of the proposal/initiative 
⌧ The proposal/initiative relates to a new action  
 The proposal/initiative relates to a new action following a pilot 
project/preparatory action31 
 The proposal/initiative relates to the extension of an existing action  
 The proposal/initiative relates to an action redirected towards a new action  
1.4. Objective(s) 
1.4.1. The Commission's multiannual strategi c objective(s) targeted by the 
proposal/initiative 
The proposal aims at contributing to the Gene ral Objective to ensure  an open internal 
market for goods and services conducive to growth and jobs 
1.4.2. Specific objective(s) and ABM/ABB activity(ies) concerned 
Specific objective No 1: To regularly review existing inte rnal market rules in specific 
sectors and propose new initia tives whenever appropriate 
Specific objective No 2: To ensure the correct application of EU law 
Specific objective No 3: EU businesses bene fit from a regulatory level playing field 
and consistent market access at international level 
ABM/ABB activity(ies) concerned  
Internal market for goods 
                                                 
30 ABM: activity-based management; ABB: activity-based budgeting. 
31 As referred to in Article 54(2)(a) or (b) of the Financial Regulation. EN 84   EN 1.4.3. Expected result(s) and impact 
Specify the effects which the proposal/initiative should have on the beneficiaries/groups targeted. 
– European citizens (vehicle users as we ll as other road users) should benefit 
from the measures aimed at avoiding poor safety and environmental performance of 
motor vehicles in those instances wh ere unsafe and non-compliant automotive 
products are involved, which ar e contributing to road accid ents and poor air quality, 
both resulting in harm to personal health. 
– Economic operators in the automotive supply chain should benefit from the 
measures aimed at doing away with an  unlevelled playing field and unfair 
competition from those ignoring or not comp lying with the rules of the game. SMEs 
in the automotive sector are the most vulnerable to suffer from the market failures 
and regulatory shortcomings and particular attention is given to the potential impact 
the envisaged measures may have on them. 
– National enforcement aut horities should benefit from the measures aimed at 
addressing the regulatory shortcomings and avoiding additional burden upon them to 
remedy these shortcomings by taking correc tive actions against non-compliant and 
unsafe products on their markets. 
1.4.4. Indicators of results and impact 
Specify the indicators for monitoring implementation of the proposal/initiative. 
– changes in the views of/complaints fr om consumers received by enforcement 
authorities relating to motor vehicles and vehicle components; 
– changes in the number/percentage of non-compliant and unsafe automotive 
products present on the EU market (e .g. compared with existing surveys); 
– changes in the number/percentage of safeguard measures taken by EU 
authorities against non-complia nt and unsafe produc ts both from intra-EU and extra-
EU manufacturers/importers (i.e. taki ng into account increased traceability 
requirements for automotive products); 
– changes in trends in RAPEX notifications for vehicles; and 
– changes in trends in voluntary recalls of  motor vehicles (as an indicator for the 
effectiveness of the policy options retain ed in reducing the number of automotive 
products on the market representing a safety or environmental risk). 
1.5. Grounds for the proposal/initiative 
1.5.1. Requirement(s) to be met in the short or long term 
The existing regulatory framework is being criticised for not sufficiently ensuring 
reliable ex-ante conformity assessments and effective post-market controls. The 
criticism has arisen in the aftermath of the findings in September 2015 that VW over 
several years manipulated the controls of the exhaust gas treatment devices. 
In reponse to this criticism and weaknesses identified in the evaluation of the type-
approval framework this proposal contains a wide range of measures related to: 
- Traceability of products and role and re sponsibilities of economic operators in 
the supply chain; EN 85   EN - Responsibilities of and co-operation be tween the different national authorities 
involved in the enforcement of the technical harmonisa tion legislation for motor 
vehicles; 
- quality of the type-appr oval and conformity assessm ent tasks carried out by 
technical services; 
- post-market safeguard procedures and th e provisions for the recall of vehicles, 
and 
- procedures for ensuring conformity of production. 
 
1.5.2. Added value of EU involvement 
Member States are responsible for the im plementation of the legislation in their 
territory, but ensuri ng a harmonised and co-ordinated  approach based on commonly 
applicable criteria and uniformly applied by Member States is essential for 
maintaining a level playing field acro ss the EU by means of a harmonised 
interpretation, implementation and enfor cement of the type-a pproval requirements, 
and backed-up by harmonised provisions on ma rket surveillance to provide Member 
States with adequate means for post-marke t controls and for ta king effective and 
common remedial action against the presen ce of non-compliant and unsafe products 
on the market. 
1.5.3. Lessons learned from sim ilar experiences in the past 
The existing directive relating to the type-a pproval of motor vehicles, has been the 
subject of a revision in 2007.  However, experience with the implementation has 
demonstrated that the mechanisms for ensuring a harmonised implementation and 
enforcement are not sufficiently robust. Impor tant divergences in the interpretation 
and application of the rules have emerge d, thus undermining the directive's main 
objectives, i.e. achieving an adequate leve l of safety and environmental performance 
of motor vehicles. 
1.5.4. Compatibility and possible synergy w ith other appropriate instruments 
Enhanced coherence is expect ed with other legislation in  the field of type-approval 
(e.g. concerning agricultural tractors and mo torcycles), which has been reviewed in 
2013. 
Synergies are expected in the field of  market surveillan ce by building on the 
principles and standard reference pr ovisions of the NLF regulation 765/2008 and 
Decision 768/2008. EN 86   EN 1.6. Duration and financial impact 
 Proposal/initiative of limited duration 
–  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY 
–  Financial impact from YYYY to YYYY 
⌧ Proposal/initiative of unlimited duration  
– Implementation with a start-up period from 2017 to 2020, 
– followed by full-scale operation. 
1.7. Management mode(s) planned32 
⌧ Direct management  by the Commission 
– ⌧ by its departments, including by its  staff in the Union delegations; 
–  by the executive agencies 
 Shared management  with the Member States 
 Indirect management  by entrusting budget implementation tasks to: 
–  third countries or the bodi es they have designated; 
–  international organisations and th eir agencies (to be specified); 
– the EIB and the European Investment Fund; 
–  bodies referred to in Articles 208 and 209 of the Financial Regulation; 
–  public law bodies; 
–  bodies governed by private law with a public  service mission to the extent that 
they provide adequate financial guarantees; 
–  bodies governed by the private law of a Member State that are entrusted with 
the implementation of a public-private pa rtnership and that provide adequate 
financial guarantees; 
–  persons entrusted with the implementation of specific actions in the CFSP 
pursuant to Title V of the TEU, and id entified in the relevant basic act. 
– If more than one management mode is indicated, pl ease provide details in the ‘Comments’ section. 
Comments 
The Commission intends to ensure the impl ementation of the measures concerned via 
centralised direct management through its own services, in particular via the JRC for the 
technical and scien tific support, this will be regulated through th e administrative arrangement 
instrument. 
                                                 
32 Details of management modes and references to the Financial Regulation may be found on the 
BudgWeb site: http://www.cc.cec/budg/man/b udgmanag/budgmanag_en.html  EN 87   EN 2. MANAGEMENT  MEASURES 
2.1. Monitoring and reporting rules 
Specify frequency and conditions. 
The Technical Committee Motor Vehicles (TCMV), set up by this Regulation, and 
the Forum laid down in Article 10 will provid e a platform to regularly discuss issues 
related to the implementation of the stre nghtened regulatory framework for the type-
approval and market survei llance of motor vehicles. 
Member states will have to report to th e Commission on a yearly basis the penalties 
they have implemented. 
Five years after its entry into force, Member States shall inform the Commission of 
the application of the type-a pproval and market surveillan ce procedures laid down in 
this Regulation. Based on this informati on, the Commission shall report to the 
European Parliament and to the Counc il about the implemen tation of the new 
Regulation. 
2.2. Management and control system 
2.2.1. Risk(s) identified 
The measures proposed to limit the dura tion of validity of the designation of 
technical sevrices could resu lt in a temporary shortage of technical services and 
could result in delays for the manufacturers  to have their products  type-approved. 
2.2.2. Information concerning the in ternal control system set up 
The introduction of a coordinated superv ision of technical services will be 
accompanied by suitable transitional provisions to enable technical services 
designated under Directive 2007/46/EC to have their designa tion renewed in 
accordnace with the provisions of the new Regulation, within a two years time span 
from the date of entry into force of the Regulation. The Commission shall create 
guidance to ensure a proportionate and wo rkable operation of the new supervisory 
mechanism. 
2.2.3. Estimate of the costs and bene fits of the contro ls and assessment of the expected level 
of risk of error 
The costs for the supervisory control mechan ism will consist of the participation of 
EU Member states' experts and Commissi on representative in joint audits of 
technical services. The benefit will consist of ensuring a high level of reliability in 
the performance of conformity assessment activities carried out by technical services. 
2.3. Measures to prevent fraud and irregularities 
Specify existing or envisaged prevention and protection measures. 
In addition to the applicati on of all regulatory control mechanisms, the Commission 
services will devise an anti-fraud strate gy in line with the Commission's anti-fraud 
strategy (CAFS) adopted on 24 Ju ne 2011 in order to ensure inter alia that its internal 
anti-fraud related controls are fully aligne d with the CASF and that its fraud risk 
management approach is geared to identify fraud risk areas, in particular in relation 
to the financing of implementing activities of this Regulation. In particular a series of 
measures will be put in place such as: EN 88   EN - decisions, agreements and contracts resu lting from the financing of implementing 
activities of the Regulation will expressl y entitle the Commission, including OLAF, 
and the Court of Auditors to conduct a udits, on-the-spot ch ecks and inspections; 
- during the evaluation phase of a call for proposals/tender, the proposers and 
tenderers will be checked against th e published exclusion criteria based on 
declarations and the Earl y Warning System (EWS); 
Moreover,the Commission will control a strict application of the rules on conflict of 
interests for the implementing actions under this Regulation. EN 89   EN 3. ESTIMATED  FINANCIAL  IMPACT  OF THE  PROPOSAL/INITIATIVE 
3.1. Heading(s) of the multiannual financ ial framework and expenditure budget 
line(s) affected 
• Existing budget lines 
In order  of multiannual financial framewor k headings and budget lines. 
Budget line  Type of  
expenditureContribution  
Heading of 
multiannual 
financial 
framework  Chapter  02.03 
Internal market of goods and services  Diff./Non-
diff.33 from 
EFTA 
countries
34 
 from 
candidate 
countries35 
 from third 
countries within the 
meaning of 
Article 21(2)(b) of 
the Financial 
Regulation  
1a 02.03 .01 Operation and development of 
the internal market of goods and services  
 Diff YES NO NO NO 
                                                 
33 Diff. = Differentiated appropriations / Non-diff. = Non-differentiated appropriations. 
34 EFTA: European Free Trade Association.  
35 Candidate countries and, where applicable, poten tial candidate countries from the Western Balkans.  
EN 90   EN 3.2. Estimated impact on expenditure 
3.2.1. Actions foreseen in this draft proposal for a Regulation will have no budgetary impact on EU budget over and beyond the 
appropriations already foreseen in the official financial progra mming of the Commission as any requirements for financial resou rces 
would have to be met through assigned revenues and redeployment.  
3.2.2. Summary of estimated impact on expenditure 
EUR million (to three decimal places) 
Heading of multiannual financial  
framework  1a Competitiveness for Growth and Jobs  
 
DG: GROW    Year  
2017  Year 
2018  Year 
2019  Year 
2020  TOTAL of years 
2017-2020 Following Years36 
 
y Operational appropriations        
Commitments (1) 9,450 9,285 9,020 6,557 34,312 6,594 
Payments (2) 5,600 9,835 9,170 9,707 34,312  Number of budget line: 02.03.01  
 
Appropriations of an administrative nature financed from the 
envelope of specific programmes37       
Number of budget line   (3)       
Commitments =1+1a 
+3 9,450 9,285 9,020 6,557 34,312 6,594 
TOTAL appropriations  
for DG GROW  
Payments =2+2a 
+3 5,600 9,835 9,170 9,707 34,312  
                                                 
36 For the period following 31 December 2020, the amount shall be subject to the multiannual financial framework in force for the  period commencing in 2021, in 
accordance with Article 312 of the Treaty on the Functi oning of the European Union 
37 Technical and/or administrative assistance and expenditure in su pport of the implementation of EU programmes and/or actions (f ormer ‘BA’ lines), indirect research, 
direct research.  
EN 91   EN  
Commitments (4) 9,450 9,285 9,020 6,557 34,312 6,594 y TOTAL operational appropriations  
Payments (5) 5,600 9,835 9,170 9,707 34,312  
y TOTAL appropriations of an administrative nature 
financed from the envelope for specific programmes  (6)       
Commitments =4+ 6 9,450 9,285 9,020 6,557 34,312 6,594 TOTAL appropriations  
under HEADING 1a  
of the multiannual financial framework  Payments =5+ 6 5,600 9,835 9,170 9,707 34,312  
  
EN 92   EN  
Heading of multiannual financial  
framework  5 ‘Administrative expenditure’  
EUR million (to three decimal places) 
   Year  
2017  Year 
2018  Year 
2019  Year 
2020  TOTAL of years 
2017-2020 Following Years38 
DG: GROW   
y Human resources  1,206 1,206 1,206 1,206 4,824 1,206 
y Other administrative expenditure  0,235 0,240 0,244 0,249 0,968 0,254 
TOTAL DG GROW  Appropriations  1,441 1,446 1,450 1,455 5,792 1,460  
 
TOTAL appropriations  
under HEADING 5  
of the multiannual financial framework   (Total commitments = 
Total payments)  1,441 1,446 1,450 1,455 5,792  
 
1,460  
EUR million (to three decimal places) 
   Year  
2017  Year 
2018  Year 
2019  Year 
2020  TOTAL of years 
2017-2020 Following Years 
Commitments  10,891 10,731 10,470 8,012 40,104 8,054  TOTAL appropriations  
under HEADINGS 1 to 5  
of the multiannual financial framework   Payments  7,041 11,281 10,620 11,262 40,104 1,460 
                                                 
38 For the period following 31 December 2020, the amount shall be subject to the multiannual financial framework in force for the  period commencing in 2021, in 
accordance with Article 312 of the Treaty on the Functi oning of the European Union.  
EN 93   EN 3.2.3. Estimated impact on ope rational appropriations 
–  The proposal/initiative does not requir e the use of operational appropriations 
– ⌧ The proposal/initiative requires the use of ope rational appropriations, as explained below: 
Commitment appropriations in EUR million (to three decimal places) 
  Year 
2017  Year 
2018  Year 
2019  Year 
2020  TOTAL of years 
2017-2020  FollowingYears 
 
 OUTPUTS  Indicate 
objectives 
and 
outputs 
 
Ø Type39 
 Average 
cost 
No Cost 
No Cost 
No Cost 
No Cost Total No Total 
cost Cost 
SPECIFIC OBJECTIVE No 140…  Establish mechanisms to ensure harmonised implementa tion and enforcement of the type-approval and market 
surveillance rules by all Member States with a sustainabl e, effective and credible mùanagement at EU level, with 
access to internal and external techni cal and scientific expert ise, enabling improved coordination, cooperation and 
resource sharing between enforcement authorities in the Member States 
- Output TCMV and  
Enforcement 
Forum 
meetings   20 
meeting 
days 0,500 20 
meeting 
days 0,510 20 
meeting 
days 0,520 20 
meeting 
days 0,530 2.06 20 meetin g
days 0,541 
- Output Technical and 
scientific 
support (JRC)   7,700  7,500  7,200  4,700 27,100  4,700 
- Output Audits/ joint 
assessments 
of technical 
services    1,250  1,275  1,300  1,327 5,152  1,353 
Subtotal for specific objective No 1  9,450  9,285  9,020  6,557 34,312  6,594 
TOTAL COST   9,450  9,285  9,020  6,557 34,312  6,594 
                                                 
39 Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc .). 
40 As described in point 1.4.2. ‘Specific objective(s)…’   
EN 94   EN 3.2.4. Estimated impact on appropriations  of an administrative nature 
3.2.4.1. Summary 
–  The proposal/initiative does not require  the use of appr opriations of an 
administrative nature 
– ⌧ The proposal/initiative requires the use of appropriations of an administrative 
nature, as explained below: 
EUR million (to three decimal places) 
 
 Year 2017 Year 2018 Year 2019 Year 2020 Total of years 2017-
2020 Following Years 
HEADING 5  
of the multiannual 
financial framework       
Human resources  (DG-
GROW) 1,206 1,206 1,206 1,206 4,824 1,206 
Other administrative 
expenditure  (DG-
GROW) 0,235 0,240 0,244 0,249 0,968 0,254 
Subtotal HEADING 5  
of the multiannual 
financial framework  1,441 1,446 1,450 1,455 5,792 1,460 
 
Outside HEADING 541 
of the multiannual 
financial framework 
       
Human resources        
Other expenditure  
of an administrative 
nature       
Subtotal  
outside HEADING 5  
of the multiannual 
financial framework        
 
TOTAL  1,441  1,446  1,450  1,455  5,792 1,460  
The appropriations required for human res ources and other expenditure of an admi nistrative nature will be met by 
appropriations from  DG-GROW that are already assigned to mana gement of the action and/or have been redeployed within 
the DG, together if necessary with an y additional allocation whic h may be granted to the managing DG under the annual 
allocation procedure and in the light of budgetary constraints.
                                                 
41 Technical and/or administrative assistance and expenditure in support of the implementation of 
EU programmes and/or actions (former ‘BA’ lines), indirect research, direct research  
EN 95   EN 3.2.4.2. Estimated requirements of human resources 
–  The proposal/initiative does not require the use of human resources. 
– ⌧ The proposal/initiative re quires the use of human re sources, as explained 
below: 
Estimate to be expressed in full time equivalent units 
 Year 
2017  Year 
2018  Year  
2019  Year  
2020  Following 
years42 
y Establishment plan posts (officials and temporary staff)   
02 01 01 01 (Headquarters and Commission’s 
Representation Offices)  9 (GROW) 9 (GROW) 9 (GROW)  9 (GROW)  9 (GROW) 
XX 01 01 02 (Delegations)      
XX 01 05 01 (Indirect research)      
10 01 05 01 (Direct research)      
y External staff (in Full Time Equivalent unit: FTE)43 
 
XX 01 02 01 (AC, END, INT from the ‘global envelope’)       
XX 01 02 02 (AC, AL, END, INT and JED in the 
delegations)      
- at Headquarters  
      XX 01 04 yy 44 
 
- in Delegations       
XX 01 05 02 (AC, END, INT - Indirect research)      
10 01 05 02 (AC, END, INT - Direct research)      
Other budget lines (specify)      
TOTAL  9 9 9 9 9 
XX is the policy area or  budget title concerned. 
The human resources required will be met by staff fro m DG GROW who are already assigned to management of 
the current type-approval framework and/ or have been redeployed within or from outside the DG (estimated 
needs: 6 AD/FTE and 3 AST/FTE). 
 
Description of tasks to be carried out: 
Officials and temporary staff Contro l of appropriate imlementation and enforcement of this Regulation; 
development of delegated/implementing acts and guidance; organisation and 
supervision of 'joint assessments' of technical services and control of designation and monitoring process by Member States; coordination of 
market surveillance activities at EU level 
External staff  
                                                 
42 See Footnote 38. 
43 AC= Contract Staff; AL = Lo cal Staff; END= Seco nded National Expert; INT = agency staff; 
JED= Junior Experts in Delegations.  
44 Sub-ceiling for external staff covered by op erational appropriations (former ‘BA’ lines).  
EN 96   EN 3.2.5. Compatibility with the current  multiannual financial framework 
– ⌧ The proposal/initiative is compatible the current multiannual financial 
framework. 
–  The proposal/initiative will entail reprogr amming of the releva nt heading in the 
multiannual financial framework. 
Explain what reprogramming is required, specifying the budget lines concerned and the corresponding 
amounts. 
 
–  The proposal/initiative requires applica tion of the flexibility instrument or 
revision of the multiannual financial framework. 
Explain what is required, specifying the headings and budget lines concerned and the corresponding 
amounts. 
 
3.2.6. Third-party contributions 
– The proposal/initiative does not provide for co-financing by third parties. 
– ⌧The proposal/initiative provides for th e co-financing es timated below: 
Appropriations in EUR mill ion (to three decimal places) 
 Year 
2017  Year 
2018  Year 
2019  Year 
2020  Total Following 
Years 
Specify the co-financing body : Member States 
through their national fee 
structure to finance their type-approval and market 
surveillance activities and to 
contribute to the costs for the independent compliance 
verification testing by the 
Commission 
      
 
TOTAL appropriations co-
financed 7,700 7,500 7,200 4,700 27,100  xx  
EN 97   EN 3.3. Estimated impact on revenue 
–  The proposal/initiative has no financial impact on revenue. 
– ⌧ The proposal/initiative has the following financial impact: 
–  on own resources 
– ⌧ on miscellaneous revenue (contri butions from Member States as 
indicated in section 3.2.5) 
EUR million (to three decimal places)  
Impact of the proposal/initiative45 
Budget revenue line: Appropriation
s available for 
the current 
financial year Year 
2017  Year 
2018  Year 
2019  Year 
2020   
Article 6600  7,700  7,500  7,200  4,700     
For miscellaneous ‘assigned’ revenue, speci fy the budget expenditure line(s) affected. 
02.0301 Operation and development of the inte rnal market of goods and services  
Specify the method for calcula ting the impact on revenue. 
 
 
 
                                                 
45 As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net 
amounts, i.e. gross amounts after deduction of 25 % for collection costs.