As of September 1, 2020, new regulations for approving vehicles and vehicle components will apply in the EU in the shape of Regulation 2018/858 . This will harmonize approval requirements throughout the EU and also have an impact on the legal requirements pertaining to “Conformity of Production” (CoP).
In this connection, reuschlaw’s Daniel Wuhrmann, Equity Partner, and Thorsten Deeg, Senior Associate, have written a guest commentary particularly aimed at answering the question of for whom it is compulsory to demonstrate CoP and which requirements need to be met by those facing such a commitment.
As of September 1, 2020, new regulations in the shape of Regulation 2018/858 will apply within the European Union (EU) to the approval of motor vehicles of categories M and N (and their trailers of category O), as well as to components for these vehicles. This Regulation thus replaces Directive 2007/46/EC, which remains in force until August 31, 2020, and harmonizes the legal requirements concerning approval throughout the EU. From a quality perspective, the regulations on Conformity of Production (CoP) are also part of these newly harmonized regulations. In this connection, we regularly answer questions on what CoP actually means in terms of content, for whom it is compulsory and which requirements have to be met within the context of CoP from a legal viewpoint.
NEED FOR CoP AND WHAT IT ENTAILS
What we mean by CoP is ensuring conformity of production. In effect, the aim is to ensure that all the products manufactured remain consistent and are identical to the product that was originally developed by way of special quality assurance measures.
From a product liability perspective and when considering the legal requirements pertaining to product safety, this is an important factor in being able to avoid production-related failures and safety risks resulting from the products. Ultimately, however, from a liability point of view and when looking at the legal safety requirements, it is, in principle, also possible to have deviating production parameters, provided that these do not result in the products representing or causing a safety risk.
BACKGROUND
In order for vehicles and certain vehicle components to be licensed in the EU Member States, these must have been approved beforehand. The most important form of approval for series production is the ‘EU type-approval’. For this type of approval, manufacturers have samples of a vehicle or vehicle component tested by a “Technical Service” (TS) to check that these comply with the technical requirements. If the results are positive, they are granted a type-approval by the approval authority in the country concerned. The result of this is that every vehicle or vehicle component produced by this particular manufacturer which matches the approved sample is also considered to be approved.
However, the requirement for obtaining EU type-approval is that the manufacturer makes quality-related arrangements to ensure conformity of production and that he/she also demonstrates this accordingly vis-à-vis the approval authority (Article 13 (6) of Regulation 2018/858).
CoP-Q AS PART OF THE INITIAL ASSESSMENT PROCESS
Before type-approval is granted, the manufacturer must, therefore, undergo a so-called “initial assessment” in which the manufacturer’s quality assurance management system is examined (Annex IV to Regulation 2018/858). This is aimed, in particular, at determining whether the manufacturer has established respective arrangements and procedures (processes) to ensure that the conformity of the products manufactured with the approved type during series production is effectively controlled (so-called “CoP-Q”).
The manufacturer has the following options for providing respective proof:
- Inspection by the approval authority
- Presentation of an EN ISO 9001 or ISO/TS16949 certification or comparable (e.g. IATF 16949), including a “CoP report”
- Acceptance of the initial assessment of an approval authority in another EU Member State
However, providing proof through the presentation of an existing certification is only possible, if such certification was carried out by a TS and the certificate also incorporates a so-called “CoP report”, i.e. it additionally certifies that the “approval relevant requirements” (ARR) have been fulfilled at the company. If this CoP report is missing, either an additional inspection has to be carried out by the approval authority or the manufacturer assures the authority that the approval relevant requirements will be checked during the next regular surveillance audit or re-certification process and attested in a CoP report issued by the respective TS. Until such point in time, type-approval will only be granted by the authority subject to the presentation of valid certification. Failure to present such certification may lead to the withdrawal of the type-approval by the authority concerned.
APPROVAL RELEVANT REQUIREMENTS (ARR)
Regulation 2018/858 determines the scope of the respective ARR, meaning essentially that the following processes and procedures must be in place:
- Planning and effective implementation of preventive, monitoring and corrective action
- Sufficient product testing and test recording
- Traceability and the recalling of non-compliant products
- Exertion of influence on any third-party manufacturers used
- Timely notification of the approval authority of any (planned) changes with regard to the data on which the type-approval is based
The details of the individual requirements are defined by the respective approval authority of the EU Member State concerned. To this purpose, the KBA [Federal Motor Transport Authority] has published a CoP report containing examples and explanations which can be downloaded from the KBA homepage.
CONTINUOUS CoP AUDITING
Even after type-approval has been granted, the approval authority may verify conformity of production at the manufacturer’s premises at regular intervals or when circumstances require.
In addition to the examination of the existing processes (CoP-Q), the manufactured products are also tested with regard to their de facto conformity with the approved sample (so-called “CoP-P”).
Should the approval authority discover that conformity of production is no longer given, this approval authority shall take all the necessary measures to ensure that the manufacturer restores conformity of production as quickly as possible (e.g. obligation to take corrective action) or withdraw the respective type-approval (Article 31 (7) of Regulation 2018/858).
CONCLUSIONS REGARDING WHETHER CoP IS COMPULSORY OR NOT
As the obligation to ensure CoP originates form the approval legislation, it is basically only compulsory for those companies that submit type-approval applications for vehicles or vehicle components. In the case of vehicle components, this also concerns, in particular, manufacturers of such vehicle components that are destined for the spare parts or retrofitting markets.
On the other hand, some companies that do not actually submit applications for type-approval may be indirectly under obligation to ensure conformity of production through contractual arrangements with their own customers. If one is unable to demonstrate to one’s customers that such precautions have been taken, this can have serious consequences for the relationship with these customers (e.g. classification as a critically regarded supplier). For this reason, such contractual arrangements should be closely examined. If such arrangements have already been agreed upon, those companies affected should look into the details of the newly harmonized CoP provisions in order to avoid adverse consequences.
Daniel Wuhrmann
Daniel Wuhrmann is Equity Partner and Teamleader Automotive at reuschlaw Legal Consultants, a commercial law firm specializing in the field of product liability. As an expert who can pull on extensive industrial know-how, he primarily provides support and advice to clients from the automotive/automotive supplier industry. His main areas of expertise are drafting and negotiating international contracts, providing legal advice in connection with product recalls, litigation and product liability.
Thorsten Deeg
Thorsten Deeg is Senior Associate in the Automotive Team at reuschlaw Legal Consultants, a commercial law firm specializing in the field of product liability.
He primarily provides advice to clients from the automotive/automotive supplier industry. His main areas of expertise are drafting and negotiating international contracts, product liability and product safety, as well as the homologation of vehicles and vehicle components. Thorsten Deeg completed his Master of Laws (LL.M.) at Trier University of Applied Science and is a VDA-certified Product Safety & Conformity Representative (PSCR).
