Do I necessarily have to enclose an operating manual in paper form for my product? Is this still a current practice?

Do I necessarily have to enclose an operating manual in paper form for my product? Is this still a current practice?

This is a question that concerns many manufacturing companies and is becoming increasingly important, especially regarding their orientation on sustainability. If one wanted to push it to the extreme, a conflict of interests between sustainability and safety could be mentioned; in the following, however, we will focus purely on the well-founded legal framework and practical experience.

Legal basis

The example of the Machinery Directive 2006/42/EC clearly shows how the requirement for operating instructions is anchored at European level.

Article 5 para. 1 c.) of the Machinery Directive requires the provision of operating instructions.

“(1) Before placing machinery on the market and/or putting it into service, the manufacturer or his authorised representative shall: c) provide, in particular, the necessary information, such as instructions;”

This requirement is further specified by Annex I 1.7.4:

“All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service.

The instructions accompanying the machinery must be either ‘Original instructions’ or a ‘Translation of the original instructions’, in which case the translation must be accompanied by the original instructions.”

It is undisputed that the operating instructions must be available in the respective official language of the EU country in which the product is placed on the market. Likewise, concrete requirements for the contents of the operating instructions are defined. What is not clearly regulated, however, is the form in which the operating instructions must be enclosed.

It is, therefore, questionable how the form can be specified.

Guide to the Machinery Directive

§ 255 of the guide states the following: “It is generally agreed that all health and safety related instructions must be supplied in paper form, since it cannot be assumed that the user has access to the means of reading instructions supplied in electronic form or made available on an Internet site.

At first glance, a concrete statement on form is made here. However, the Guide contains recommendations for action by the Commission with the purpose of assisting the interpretation of the Directive. The Guide itself already clarifies its lack of legal effect when it stresses “that only the Machinery Directive and the texts implementing its provisions into national law are legally binding”.

Nevertheless, the position of the guide in the industry should not be underestimated, as it provides a corresponding orientation aid on the basis of which the directive is interpreted in day-to-day practice.

National law:

§ 6 of the ProdSG (Product Safety Act) states that “The manufacturer, his authorized representative and the importer shall (…) when making a consumer product available on the market (…) provide the consumer with the information that the consumer requires in order to be able to assess the risks associated with the consumer product during its normal or reasonably foreseeable period of use and which are not immediately apparent without appropriate information, and to protect himself against them, (…)”.

In the Official Explanatory Memorandum to this legal standard (BT-Drs. 19/28406 of 13.04.2021), it is stated in this regard, concretizing § 6, paragraph 1, number 1:

“Number 1 is adapted in content to the first sentence of the first subparagraph of Article 5(1) of Directive 2001/95/EC. Directive 2001/95/EC requires that information relevant to the consumer be provided. Where the previous version referred to “ensure”, this wording is not to be retained. “Ensure” is defined in the literature as meaning that the party obliged to provide information chooses a form of information in which it can be reasonably assumed that the consumer will receive the information (Klindt in Klindt, ProdSG, 2nd ed., § 3 marginal no. 33). Due to strongly changing information and communication technology, the making available of the relevant information can also take place in another way than by physically providing the information (for example in paper form) at the product (for example OLG Frankfurt, judgment of 28.2.2020 - 6 U 181/17, marginal no. 51 - juris).”

The reference to the judgment 6 U 181/17 of 28.2.2020 aims at the following execution:

“3. The plaintiff also has a claim for injunctive relief against the defendant from §§ 3, 3a, 8 I UWG in conjunction with. § 3 IV ProdSG, to put the product on the market without enclosing a German-language instruction manual. (…)

b) It is undisputed that the defendant did not initially enclose German instructions for use in paper form with the product. This is also not required. The form in which operating instructions are to be supplied is not regulated in § 3 para. 4 sentence 1, 1st half-sentence ProdSG. An obligation to enclose the operating instructions in printed form on paper cannot be derived from the ProdSG (LG Potsdam, Urt. v. 26.6.2014 - 2 O 188/13, marginal no. 31 - juris; Czernik, MMR 2015, 338). A different interpretation also does not result from Directive 95/2001/EC, which was implemented by the Product Safety Act. According to Art. 5(1), the consumer is only to be provided with relevant information to enable him to assess and protect himself against the risks arising from the product during its normal or reasonably foreseeable period of use and which are not immediately apparent without appropriate warnings. Nothing else can be derived from the recitals either. Section 7 II No. 2 of the Second Ordinance to the Product Safety Act (Ordinance on the Safety of Toys) also only states that the instructions for use and safety information in German must be “attached” to the toy.

c) It is therefore sufficient if the defendant provides the buyer with a German-language instruction manual by email as a PDF file before delivery. (…)”

Admittedly, it is costly to send each customer an email with operating instructions in the national language for a specific product, even if the personal data is relatively easy to access when ordering online. Whether an economic saving can be made here must be examined in each individual case but seems questionable. From the essence of the judgment, however, it can be inferred that there is no legal obligation to include operating instructions in paper form at the national legal level.

9th Product Safety Ordinance (national implementation of the Machinery Directive).

§ 3 Para. 2 No. 3 9th ProdSV (German Product Safety Ordinance) “in particular provide the necessary information, such as the operating instructions in the sense of Annex I of Directive 2006/42/EC,”

Analogous to the Machinery Directive, no specific form is prescribed in the German implementation of the Directive.

Result

Neither European nor national legislation specifically regulates the form in which the operating instructions must be enclosed. It must therefore be examined in detail how the legally prescribed “enclosure” affects the form of the operating instructions.

For this purpose, the “Verkörperungsdoktrin” resulting from German case law can be used for interpretation (LG Potsdam, judgment of June 26, 2014 - 2 O 188/13 = MMR 2015, 335, OLG Frankfurt, February 28, 2019 - 6 U 181/17 = GRUR-RR 2019, 381), since the term “Beifügen” permits both electronic and paper form. However, according to the “Verkörperungsdoktrin”, only those electronic forms are covered by the electronic form which do not lack embodiment as is the case, for example, with purely digital solutions.

A USB stick containing an instruction manual in the national language would therefore also be a suitable medium for meeting the “enclose” requirement.

The respective requirements for a paper form result from the guidelines to the Directive. However, the guidelines themselves indicate that they are not directly legally binding, but only the underlying legal acts.

As a result, the requirement to include a paper version of the operating instructions is more a result of recognized practice than of specific legal norms.

Suggested action

According to settled case law, when interpreting a Union provision, not only its wording but also its context and the objectives pursued by the regulation of which it forms part must be taken into account. Taking the Machinery Directive as an example, reference can be made here to the harmonized standard DIN EN ISO 12100, since one of the guiding objectives of the Machinery Directive is to specify and ensure compliance with health and safety requirements. In addition to an inherently safe design, risks can also be minimized by safety or warning instructions. However, this presupposes that this information is also communicated to the user.

As already noted, there is no binding legal basis for the mandatory inclusion of operating instructions in paper form. The guidelines of the European Union present general interpretation rules for the manufacturers and distributors and illustrate the lived practice of the users. The extent to which the strictly legal assessment is followed, or its loopholes exploited is therefore also a matter to be decided by the manufacturer, after weighing the risks. In particular, an assessment must be made of the risk posed by the distributed product and the extent to which user-friendliness and the obligation to provide information are fulfilled if the product is not accompanied by written instructions.

Also questionable is the knowledge and possibility of the user to open and read an electronically embodied medium (for example a pdf document on a supplied USB stick). The argumentation in the Machinery Directive guide is mainly based on the assumption that not every customer or user has the possibility to retrieve and read an electronically embodied document, as this requires either a smartphone or a PC, as well as access to the Internet.

Thus, a decision to save paper form can also always lead to an increase in risk for the user and must be considered individually depending on the characteristics and risk potential of the product.

One ray of hope on the horizon is the draft of the new Machinery Ordinance. This currently provides for the possibility of digital operating instructions, but requires that the customer can also be provided with corresponding instructions in paper form on request. Even if there will certainly be individual interpretations of this, it is clear that the issue has been addressed and that a clear potential for digitization may open up in the future.

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