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Introduction
This RDW Guideline sets out the documentation and justification requirements applicable where, within the framework of a type-approval application under UNECE Regulation No. 16 (Safety belts and restraint systems – components) and UNECE Regulation No. 129 (Child Restraint Systems), no physical tests or only a limited number of tests are performed. Such omission or limitation of testing is only permissible where the applicable UNECE Regulation allows the approval authority to assess compliance based on technical documentation and supporting evidence, without requiring additional physical testing.
This Guideline is issued by the RDW in its capacity as Type Approval Authority pursuant to Regulation (EU) 2018/858.
This Guideline provides further clarification of the manner in which the RDW applies its assessment criteria within the applicable legal framework.
It forms part of the RDW policy framework governing the assessment of technical documentation submitted in support of a type-approval decision and is published to ensure transparency and consistent application towards manufacturers and Technical Services.
This Guideline is made publicly available, including via the RDW website (typeapproval.rdw.nl), in order to ensure its accessibility and to support equal treatment in the assessment of type-approval applications.
The objective of this Guideline is to ensure transparency, technical substantiation and legal verifiability, including in the context of administrative review, judicial proceedings and EU peer reviews, when reliance is placed on worst-case configurations or on previously obtained test results.
For the purpose of this Guideline, references to UNECE Regulation No. 16 are limited to its application to components, such as safety belts and restraint systems.
Legal framework
This Guideline is based on the following legal and regulatory framework:
Regulation (EU) 2018/858, in particular:
- Article 30(1) and (2), concerning compliance verification by means of appropriate tests and the recording of the fundamental elements of such tests in a test report;
- Article 33 and Article 34, concerning amendments to EU type-approvals (including extensions and revisions);
- Article 72, concerning the designation of Technical Services;
- Articles 80 and 81, concerning the operational obligations and information obligations of Technical Services;
- Article. 67(1),(2),(7)–(10), concerning the assessment and monitoring of Technical Services, internal audits by type-approval authorities, and peer evaluations.
UNECE Regulations, in particular: - UN Regulation No. 16, paragraph 6.3.3 (possibility for the Technical Service to dispense with one or more strap conditioning tests where the test(s) are rendered superfluous by material composition or information already available) and paragraph 6.4.1.2.2 (no repetition of a corrosion test where already performed);
- UN Regulation No. 129, paragraph 6.7.1.8.3 (possibility for the Type Approval Authority to dispense with the buckle strength test where information already available renders the test superfluous) and paragraph 11.1.1 (assessment of modifications and whether additional testing is needed).
Dutch administrative law, in particular: - Article 3:2 of the General Administrative Law Act (Algemene wet bestuursrecht, Awb), requiring administrative bodies to prepare decisions with due care;
- Article 3:46 Awb, requiring administrative decisions to be properly reasoned and substantiated.
ISO/IEC 17025, in particular: - Clause 7.8.2 (Common requirements for reports) and clause 7.8.3 (Specific requirements for test reports).
Scope
This Guideline applies to all manufacturers submitting applications for type approval or extension of approval under UNECE Regulation No. 16 (components) and UNECE Regulation No. 129 to the RDW.
This Guideline sets out documentation and justification requirements that shall be met as part of such applications, including where the supporting test reports and technical assessments are prepared by a Technical Service designated in accordance with Regulation (EU) 2018/858.
This Guideline applies in particular where, in the context of such applications, no physical tests or only a limited number of prescribed tests are carried out.
The RDW may extend the application of this Guideline to additional UNECE Regulations in the future where comparable assessment principles apply.
Situations in which testing may be omitted or limited
The omission or limitation of testing is only acceptable where this is in line with the provisions of the applicable UNECE Regulation and where sufficient technical justification demonstrates that compliance with the relevant requirements is not adversely affected.
Within the context of a type-approval application or an extension of approval, situations may arise in which no new tests are performed or only part of the prescribed test program is carried out, in particular where:
- a worst-case configuration has been selected to represent a defined range of variants or versions in accordance with UNECE Regulation No. 16 or No. 129; or
- test results obtained for a previously approved reference type or earlier version remain technically valid and applicable to the variant under assessment.
Such situations do not remove the obligation to demonstrate compliance with the applicable regulatory requirements. In particular, where modifications are limited and do not affect the performance characteristics relevant to the regulatory requirements, the RDW may determine that no additional testing is required, provided that this conclusion is duly justified and traceable in the approval file.
Documentation and justification requirements
In all cases where testing is omitted or limited, the Technical Service shall draw up a dedicated justification document.
This justification document shall form an integral part of the relevant test report and shall be submitted as part of the approval file to the RDW.
The justification document constitutes an essential element of the evidentiary basis for the RDW’s administrative decision and shall therefore be sufficiently detailed to allow an independent assessment of compliance.
The justification document shall contain at least the following elements:
a. A clear and precise description of the constructional, material or functional differences between the tested and non-tested parts, variants or versions, insofar as these differences are relevant for the applicable test requirements under UNECE Regulation No. 16 and/or No. 129.
b. A description of the worst-case or acceptance criteria applied in determining that specific tests could be omitted or limited, including a reasoned technical explanation demonstrating that these criteria are appropriate in light of the safety objectives and performance requirements of the applicable UNECE Regulation.
c. Technical supporting evidence demonstrating that the non-tested part or variant can be expected to behave equivalently under the prescribed test conditions when compared to the tested reference configuration. Such evidence may include previous test results, engineering calculations, simulations or analytical assessments.
d. Explicit references to the applicable approval number, type designation and test report number of the reference type or model on which the justification is based, ensuring full traceability within the approval file.
Responsibilities of the Technical Service
The Technical Service remains fully responsible, within the meaning of Articles 80 and 81 of Regulation (EU) 2018/858, for the technical accuracy, completeness and reliability of the justification provided and for making available, upon request, the relevant information supporting its technical assessments and test reporting.
The application of worst-case principles or reliance on previous test results does not relieve the Technical Service of its obligation to ensure that the technical assessment demonstrates compliance with the substantive requirements of UNECE Regulation No. 16 and/or No. 129.
Where the justification is considered insufficient, incomplete or ambiguous, the RDW may, in accordance with Article 30 of Regulation (EU) 2018/858 and, where applicable, Articles 33 and 34 thereof, request additional information and/or require supplementary testing before granting a type approval or an extension thereof.
Traceability, auditability and legal certainty
The documentation requirements laid down in this Guideline are intended to ensure traceability, consistency and legal certainty in cases where testing is omitted or limited.
They ensure that the RDW’s decisions can be effectively reviewed in the context of national administrative objection and appeal procedures, internal audits and peer evaluations pursuant to Article 67 of Regulation (EU) 2018/858, reporting obligations pursuant to Article 90 of that Regulation, and international cooperation within the UNECE type-approval framework.
Questions
Questions regarding this RDW Guideline can be sent to: [email protected] (please mention: ‘Guideline No. 028).