KANBrief 2/21
The state of the art plays a key role in product safety. The term “state of the art” is however often defined or formulated somewhat differently by different parties, including at European level. One question raised during standardization work is what technical level should serve as the basis for requirements in standards.1
Since the “Kalkar decision” taken by Germany’s Federal Constitutional Court (BVerfG) on 8 August 1978 with respect to nuclear legislation, the state of the art has been defined within a widely accepted three-stage model:
In accordance with the provisions governing international (ISO/IEC Directives, Part 2), European (CEN/CENELEC Regulations, Part 3, Clause 4) and German (DIN 820-2) standardization activity, the purpose of standardization documents is to provide clear and unambiguous specifications for the promotion of international trade and communication. For this purpose, documents are required among other things to:
The particular importance of the state of the art is evident from the need for a standard to be revised when new technology is sufficiently stable and has become established on the market, and can therefore be considered as the state of the art (ISO Guide 78, Clause 5.2; CEN Guide 414, 5.2). This is expressed even more clearly in the provisions of German standardization, such as in DIN 820-4, Chapter 7, which explicitly requires the content of a standard to be revised should it no longer correspond to the state of the art.
DIN standards reflect current accepted good practice in the affected circles and are thus particularly suitable for determining what, according to prevailing opinion, is deemed necessary in the interests of safety (German Federal Supreme Court (BGH), 1 March 1988). At the same time however, the German courts clearly emphasize the inherently dynamic nature of standardization. Standards do not by their mere existence have the quality of accepted good practice and do not warrant any claim of exclusivity (BVerwG, 30 September 1996): DIN standards may reflect accepted good practice, or may lag behind it (BGH, judgement of 14 May 1998, case VII ZR 184/97).
In its judgement of 10 March 1987, the Federal Supreme Court draws attention to a further important point, namely that standards do not constitute legislation. Critical analysis of their application with consideration for the current state of the art is expressly permitted. This is particularly the case where the standard in question is a new standard or has only recently been introduced, and has yet to prove itself as “accepted good practice”.2
In product safety law, the state of the art is an abstract legal concept. Under the EU Product Safety Directive, a product is deemed safe for consumers when it complies with the legislation of a Member State, harmonized European standards, other standards, the state of the art and technology or the safety which may reasonably be expected. The German Product Safety Act also states in Section 34(1) that systems requiring regular inspection must be designed in compliance with the state of the art.
Although the “state of the art” is not defined in the relevant EU legislation, the concept is of significance, for example in EU New Approach directives4, which among other things govern CE marking. Annex IX, paragraph 9.2 of the EU Machinery Directive for example stipulates for machinery subject to type examination that the manufacturer is responsible for ensuring that the machinery meets the corresponding state of the art. Recitals 6 and 14 of the directive also emphasize that standardization must take account of the state of the art.
The European Commission’s “Blue Guide” on the implementation of EU product rules states that in the absence of standards, a manufacturer must “develop solutions in accordance with general engineering or scientific knowledge [...] in order to meet the essential requirements of the legislation in question” (Blue Guide 2016, 4.1.2.2). A special role is accorded to harmonized European standards, which can be assumed to reflect the “generally acknowledgeable state of the art” and whose presumption of conformity would otherwise have to be withdrawn (Blue Guide 2016, 4.1.2.5).
With regard to the actual expected implementation, Section 161 of the Guide to application of the Machinery Directive 2006/42/EC states clearly that the technical solutions used to meet the essential health and safety requirements correspond to the state of the art if:
Manufacturers must therefore take account of technical progress and implement the most effective technical solutions suitable for the machinery concerned as soon as they become available at reasonable cost.
Standardization is an essential element for supporting the – initially abstract – legal concept of the state of the art. In the context of this statement, the inherent objective of standardization, the view of the legislator and the view of the courts are consistent.
Inconsistencies in the interpretation of this concept arise from the fact that standardization bodies and legislators formulate an objective which is to be implemented through work carried out in standardization bodies. Conversely, case law primarily considers the legal impact of a completed standard upon third parties. By its nature, this impact changes dynamically from the day of the standard’s publication as the state of the art progresses, independently of the standard and departing from its content.
Consequently, if standardization activity is to meet the demands made of it in full, a standard must reflect the state of the art, at least at the time of its publication. Those involved within standards bodies must be conscious of their great responsibility and actively seek technical solutions that satisfy the demanding requirements imposed by the legislation and legislators. Where decisions are contentious, those involved are not at liberty to resort to the lowest common denominator, which is often much easier to determine. The maxim that “less is more” does not hold true in this context.
Michael Robert
robert@kan.de
1 This article is not intended to constitute a legal opinion. The references to court decisions are taken from a 2016 KAN expert report by Dr Thomas Wilrich on case law concerning technical standards. www.kan.de/en/publications/kan-studies.
2 It is however not universally the case that standards do not have binding force. Exceptions exist, for example in European construction legislation or where binding force arises through direct references to standards in legislation.
3 Under the New Approach, EU regulations and directives set out essential requirements in the sphere of product safety. These requirements are supported by European standards.