What’s changing in 2026: Product Safety Law and Ecodesign Law

Tag: Machinery

What’s changing in 2026: Product Safety Law and Ecodesign Law

Product safety in 2026 will primarily be shaped by national legislative developments concerning the new Product Safety Act (Produktsicherheitsgesetz – ProdSG). This reform responds to the EU General Product Safety Regulation (Regulation (EU) 2023/988 – GPSR), applicable throughout the EU since 13.12.2024 and recently supplemented by the long-awaited GPSR Guidelines of the European Commission. Sector-specific product safety law will be marked by developments in EU toy law and EU machinery law. Finally, important changes are expected in the field of Ecodesign law.

A. Amendment to the Construction Products Act (BauPG)

Just today, on 14 January 2026, the law amending the Construction Products Act and other legal provisions to comply with Regulation (EU) 2024/3110 laying down harmonized rules for the marketing of construction products was published in the German Federal Law Gazette. At the heart of the article law is Art. 1, which amends the German Construction Products Act (BauPG). The reformed BauPG also serves to implement the new EU Construction Products Regulation (Regulation (EU) 2024/3110), which will apply in parallel with the old Construction Products Regulation (Regulation (EU) No 305/2011) for the next few years. Sec. 10 para. 3 BauPG contains numerous new administrative offenses for violations of Regulation (EU) 2024/3110, which will come into force tomorrow, on 15 January 2026. In fact, the new EU Construction Products Regulation is largely applicable throughout the EU since 8 January 2026.

B. The New Product Safety Act (ProdSG)

After an unsuccessful attempt by the previous governing coalition to reform the Product Safety Act (Produktsicherheitsgesetz – hereinafter ProdSG), the project was taken up again by the new Federal Government. On 9 October 2025, the Federal Government published its draft act amending the Product Safety Act and other product-safety‑related provisions (BR‑Drs. 548/25). The new Government has largely based its proposal on the earlier draft of the previous coalition, which had been controversial only in certain details. New emphasis has been placed, for example, on the administrative offences set out in Sec. 28 ProdSG‑E. The legislative process is now coming to an end.

The new Product Safety Act will, alongside Regulation (EU) 2023/988 (the General Product Safety Regulation – hereninafter GPSR), naturally no longer have the central role that the national ProdSG has held from 2011. In the future, the ProdSG will primarily serve to implement various EU directives (Sec. 1 para. 1 ProdSG‑E), supplement the GPSR with additional national provisions (Sec. 1 para. 2 ProdSG‑E), and continue to operate as residual legislation for the non‑harmonised B2B sector, meaning products for professional users without CE marking (Sec. 1 para. 3 ProdSG‑E).

Of practical importance is the new Sec. 6 ProdSG‑E, which will regulate the language requirements for information, safety information, instructions and warnings. In the Federal Republic of Germany, this will — unsurprisingly — require the use of the German language. The national legislator thereby continues the existing approach under Sec. 3 para. 4 ProdSG, which likewise prescribes the German language for user instructions.

The legislator is also using the ProdSG reform to introduce several adjustments to the rules governing the GS mark in Sec. 20 ff. ProdSG‑E. Unlike the CE marking, the GS mark is, as is well known, a genuine quality mark awarded exclusively by a third‑party body (a so‑called GS body) following, in particular, a stringent safety assessment of a specimen. Under the key testing programme in Sec. 20 para.3 No 1 ProdSG‑E, future assessments will no longer refer solely to compliance with Sec. 3 ProdSG/ProdSG‑E. For harmonised products subject to directly applicable EU regulations, corresponding references to Union law will be incorporated. For instance, with respect to personal protective equipment (PPE), it is clarified that such products must comply with Art. 5 Regulation (EU) 2016/425 (the so-called PPE Regulation) in conjunction with Annex II to Regulation (EU) 2016/425. The relevant benchmark is therefore the essential health and safety requirements. Furthermore, the decision to award the GS mark must in future be taken solely by the GS body’s own personnel, pursuant to Sec. 21 para. 1 third sentence ProdSG‑E. Conversely, the technical assessment of the test results under Sec. 20 para. 3 ProdSG/ProdSG‑E may be performed by a specialist certifier from an external body. This is intended to facilitate the involvement of external bodies, particularly in Asia, where many GS‑marked products are actually manufactured. The prohibitions on use and advertising relating to the GS mark are also expanded in Sec. 24 para. 2, second sentence ProdSG/ProdSG‑E. A manufacturer may no longer use the GS mark or advertise with it if the GS body has not awarded the mark (No. 1). The same applies where the period of validity under Sec. 20 para. 5, second sentence ProdSG/ProdSG‑E has expired. According to the legislator, both adjustments merely clarify the existing legal situation (BR‑Drs. 548/25, p. 28).

The amended provision in Sec. 28 para. 2 ProdSG‑E, which sets out administrative offences for culpable infringements of the GPSR, is of substantial practical relevance. No fewer than 32 administrative offences are planned. Most may be punished with fines of up to EUR 10,000, while two infringements of the GPSR may — under Sec. 28 para. 3 ProdSG‑E — lead to fines of up to EUR 100,000. These relate to the respective duties of manufacturers and importers to take corrective action in the field in relation to dangerous products (Sec. 28 para. 2, No 7, 19, para. 3 ProdSG‑E). The administrative offence originally proposed by the previous government coalition in No. 21 — which would have penalised distributors’ violations of the prohibition on making products available under Art. 12 para. 3 GPSR with fines of up to EUR 100,000 (BR‑Drs. 231/24) — has now been softened. Distributors now face only a fine of up to EUR 10,000.

C. GPSR-Guidelines

The year 2026 will also be shaped by the new GPSR Guidelines (Commission Notice C/2025/6233). After all, the publication of these guidelines at the end of 2025 had been eagerly awaited for quite some time. The GPSR Guidelines will provide small and medium-sized enterprises in particular with a helpful introduction to the requirements under the GPSR. The checklists and templates the guidelines contain are likely to prove useful in practice. However, as they largely reiterate the statutory requirements set out in the GPSR, they offer only limited added value for larger companies with established compliance structures.

In detail, we would like to draw attention to the following aspects of the guidelines:

The GPSR Guidelines are intended to bring clarity with regard to both the personal and material scope of application. For example, they state that the GPSR applies to companies of all sizes (Guideline 1.1, p. 2). In addition, the specific design of a service may determine whether a company is to be classified as a distributor or a manufacturer, or as a manufacturer or a provider of an online marketplace (Guideline 1.1, p. 3). Furthermore, the Regulation is intended to apply not only to tangible products, but also to intangible products such as software, apps and chatbots (Guideline 2.1, p. 6). This classification should, however, be viewed with caution, as the concept of an “item” generally presupposes a tangible nature. From a manufacturer’s perspective, the explanations on risk analysis and technical documentation (including a model template that also addresses risk analysis) are of particular interest (Guideline 3.1.1, p. 10 ff.). With regard to the electronic address — incorrectly referred to there as an email address — the Commission maintains its position that a static website should not be sufficient (Guideline 3.1.1, p. 13), although this does not explicitly follow from the GPSR itself. Existing uncertainties as to the concrete duties of the responsible person under Art. 16 GPSR are reduced by the guidelines, as the tasks of the responsible person are set out in detail (Guideline 3.2, p. 29 f.). Furthermore, operators of online marketplaces are urged by the guidelines to review dangerous products listed in the Safety Gate portal before offering a consumer product online (Guideline 3.3, p. 33).

D. Reform of EU Toy Laws

On 26.11.2025, toy legislation was reformed. In the future, this area of product safety law will be governed by Regulation (EU) 2025/2509 (the so-called EU Toy Regulation). Even though the new EU Toy Regulation will only apply from 1 August 2030 pursuant to Art. 59 para. 2 Regulation (EU) 2025/2509, and thus provides for a lengthy transitional period, this time should be used to review the new regulatory framework. As this is a fundamental reform, internal corporate adjustments will often be on the agenda. Until then, Directive 2009/48/EC (the so-called EC Toy Safety Directive) will remain relevant. Given the more than 15 years separating the two legal acts, it comes as no surprise that European toy law is being significantly modified and digitalised. The core pillars of the sector-specific provisions, however, will remain intact.

The scope of application of European toy law is intended to remain largely unchanged. Nevertheless, there are certain detailed amendments. For example, paintball equipment will in the future be expressly excluded from the material scope of application pursuant to point 20 of Part II of Annex I to Regulation (EU) 2025/2509. With regard to the practically important decorative items for festive occasions and celebrations listed in point 1 of Part II of Annex I to Regulation (EU) 2025/2509, the legislator has now incorporated what the Commission had previously already postulated in its guidelines. According to this, only those decorative articles are excluded “which have no play value”. This means that the vexed debate over the play value of these products—often situated in a toy-law “grey area”—will continue. For the legal certainty of all parties involved, a different interpretation, which would equally be possible, would be far more helpful: namely, that the decorative articles in question should not be assessed under toy safety law regardless of their play value.

The essential safety requirements are set out in Art. 5 Regulation (EU) 2025/2509. In this respect, the distinction remains between the general safety requirement pursuant to Art. 5 para. 2 Regulation (EU) 2025/2509 on the one hand, and the specific safety requirements pursuant to Art. 5 para. 1 Regulation (EU) 2025/2509 in conjunction with Annex II to Regulation (EU) 2025/2509 on the other. The specific safety requirements are laid down in Annex II to Regulation (EU) 2025/2509, with particular attention to be paid to the chemical properties set out in Part III. The rules on warnings follow from Annex III to Regulation (EU) 2025/2509.

The obligations of economic operators in Artt. 9 ff. Regulation (EU) 2025/2509 are being brought into line with the current state of legislation. New provisions include the obligations of fulfilment service providers in Art. 11 Regulation (EU) 2025/2509 and the obligations of providers of online marketplaces in Art. 14 Regulation (EU) 2025/2509. The specific obligations of fulfilment service providers deserve particular emphasis, as they have so far only appeared sporadically in product safety law, whereas online sales platforms have already been required, since 13.12.2024, to comply with the extensive catalogue of obligations set out in Art. 22 Regulation (EU) 2023/988.

Finally, a Digital Product Passport (DPP) will be introduced. The provisions in Artt. 19-25 Regulation (EU) 2025/2509 make up the entirety of Chapter V of the EU Toy Regulation. Pursuant to Art. 19 para. 1 first sentence Regulation (EU) 2025/2509, manufacturers must issue a digital product passport before placing a toy on the market. The individual elements of the DPP are specified in Part I of Annex VI to Regulation (EU) 2025/2509. Security information and warnings on the one hand, and instructions for use on the other, are therefore not mandatory elements (Part II of Annex VI to Regulation (EU) 2025/2509). The DPP is intended to play a role in any customs controls in connection with the digital product passport pursuant to Art.23 Regulation (EU) 2025/2509. In addition, a dedicated register for the passports will be established (see in detail Art. 22 Regulation (EU) 2025/2509).

E. Preparing for the New EU Machinery Laws

As well known, the new EU Machinery Regulation (Regulation (EU) 2023/1230) will become applicable across the EU on 20.012027. With the Act Implementing Regulation (EU) 2023/1230 (Maschinenverordnung-Durchführungsgesetz – MaschinenDG), the Federal Republic of Germany has recently created the nationally required legal framework for the application of European machinery law on the German market. The MaschinenDG allocates responsibilities, regulates market surveillance mechanisms and provides for sanctions in the form of administrative fines and criminal penalties in the event of relevant infringements of machinery law. At the same time, it repeals the former Ninth Ordinance to the Product Safety Act (9. ProdSV). The Act entered into force on 06.12.2025.

As usual, the German legislator requires the German language to be used for the instructions for use pursuant to Art. 10 para. 7 Regulation (EU) 2023/1230, for any information pursuant to Art. 10 para. 7, first sentence Regulation (EU) 2023/1230 in conjunction with Annex III to Regulation (EU) 2023/1230, and for the EU declaration of conformity pursuant to Art. 10 para. 8 Regulation (EU) 2023/1230 in conjunction with Part A of Annex V to Regulation (EU) 2023/1230; see Sec. 2 para. 1 first sentence MaschinenDG. The extensive catalogue of administrative offences is set out in Sec. 9 para. 1 MaschinenDG, while the criminal offences in Sec. 10 MaschinenDG should, based on experience, play no practical role.

In view of the approaching date of application of the new European machinery law, every manufacturer of machinery and industrial plants would be well advised to familiarise itself with the substantive changes in good time. The key developments lie in European law, whereas the MaschinenDG merely serves its national implementation.

F. Ecodesign Laws

Regulation (EU) 2024/1781 (the so-called EU Ecodesign Regulation; hereinafter “ESPR”) entered into force on 18 July 2024. As a framework regulation, the ESPR establishes the regulatory basis for uniform rules and sets out how ecodesign requirements for different product groups are to be specified in the future through the adoption of delegated acts pursuant to Art. 4 ESPR. The ESPR does not specify which products will be subject to which concrete requirements in the future. On the basis of Art. 18 para. 3 ESPR, the Commission presented its first Working Plan for 2025-2030 on 16.04.2025 (COM(2025) 187 final), thereby outlining for the first time when it intends to adopt delegated acts for which prioritised product groups. The focus is on those product groups that have particularly high potential for resource conservation and emission reduction, namely textiles, furniture and tyres, as well as the key basic materials iron, steel and aluminium. The Commission already intends to adopt delegated acts for iron and steel this year.

The transitional period for a total of 19 product groups that were already regulated under Directive 2009/125/EC (the so-called Ecodesign Directive) will expire on 31 December 2026. Until then, the existing rules will continue to apply unchanged. Sixteen of these products were included in the Working Plan 2025-2030, as the Commission considers that there is potential for improvement. These product groups will remain fully within the existing directive-based system until the end of 2026, while the Commission simultaneously makes preparations to gradually adopt new or revised legal acts under the ESPR. The product groups for which a revision or the initial establishment of requirements is planned in 2026 include the following:

  • Low-temperature radiant heaters
  • Household dishwashers
  • Household washing machines and wash-dryers
  • Commercial washing machines
  • Commercial dishwashers
  • Local space heaters (however, only with regard to energy labelling requirements)

Once ecodesign requirements are established for a product group, the relevant product will be assigned a digital product passport (Art. 9 para. 1 ESPR). The adoption of an implementing act establishing a digital product passport register pursuant to Art. 13 para. 5 subpara. 3 ESPR is expected in the first quarter of 2026.

In Chapter VI, the ESPR introduces transparency obligations and prohibitions relating to the destruction of unsold consumer products. Large companies are (partly) already required to disclose information on the destruction of unsold consumer products for the first financial year following the entry into force of the ESPR (Art. 24 para. 1 ESPR). A draft implementing act specifying the format and presentation requirements for such disclosures has already been published. From 19 July 2026, large companies will also be subject, pursuant to Art. 25 para. 1 ESPR in conjunction with Annex VII ESPR, to a ban on the destruction of the following unsold consumer products:

  • Clothing and clothing accessories
  • Footwear

Medium-sized enterprises will follow in 2030, while small and micro-enterprises are, for the time being, exempted from the prohibition on destruction. The Commission must define exceptions to the prohibition by means of a delegated act (Art. 25 para. 5 ESPR). In this respect, a draft has been available since summer 2025, which specifies the grounds for exemption listed in Art. 25 para. 5 ESPR, such as health, hygiene and safety reasons, damage to products, or the refusal of products for use as donations. The adoption of both drafts was originally planned for the third quarter of 2025. Even though it is currently not yet clear when the drafts will be adopted, adoption can be expected this year.

For further reading: Schucht, Aktuelle Rechtsfragen zur neuen EU-Produktsicherheitsverordnung (GPSR), CCZ 2025, 44; Schucht/Wiebe, EU-Produktsicherheitsverordnung. General Product Safety Regulation, 2025; Schucht/Wiebe, Die neue EU-Produktsicherheitsverordnung. General Product Safety Regulation (GPSR), 2024; Wiebe/Daelen, Die neue EU-Ökodesignverordnung im Überblick, ESG 2024, 359.

Do you have any questions about this news item or would you like to discuss it with the author? Please feel free to contact: Dr Carsten Schucht and Marie Carnap, LL.M.

14. January 2026 Dr. Carsten Schucht & Marie Carnap, LL.M.
Bild Dr. Carsten Schucht
Dr. Carsten Schucht
Lawyer / Partner
Bild Marie Carnap, LL.M.
Marie Carnap, LL.M.
Lawyer

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The New Machinery Regulation Implementation Act – National Specifications Supplementing the EU Machinery Regulation

With Regulation (EU) 2023/1230 the European regulatory framework for machinery has been comprehensively updated. The new regime was adopted on 14.06.2023 and will apply in full and directly in all Member States from 20.01.2027.

The Regulation (EU) 2023/1230 (the so-called EU Machinery Regulation, hereinafter MR) modernises the existing machinery law in a fundamental way, strengthens the digital provision of documentation, and clarifies and expands responsibilities along the supply chain. At the same time, it marks the departure from the previous Machinery Directive, aiming to more effectively reflect technological developments such as AI, connectivity, and software.

Although the MR does not generally require national transposition, a national implementation act is still necessary because the regulation leaves room for Member State provisions in key areas—such as language requirements, procedures, and sanctions.

Germany provides the necessary legal framework through the Act Implementing Regulation (EU) 2023/1230 (Maschinenverordnung-Durchführungsgesetz, hereinafter: MaschinenDG). The MaschinenDG defines competences, sets out administrative and criminal offences, regulates market surveillance mechanisms, and simultaneously repeals the previous 9th Ordinance to the Product Safety Act (Neunte Verordnung zum Produktsicherheitsgesetz, hereinafter 9. ProdSV). The Act entered into force on 06.12.2025.

The following provides an overview of key provisions of the MaschinenDG.

A. Language Requirements

The MR allows Member States to determine the mandatory language for instructions and safety information under Annex III MR (Art. 10(7), subpara. 5 MR).

Under Sec. 2(1) No. 1–3 MaschinenDG, German will be mandatory for the following documents:

  • instructions for use,
  • safety information, and
  • the EU declaration of conformity.

The same applies to assembly instructions and EU declarations of incorporation for partly completed machinery (Sec. 2(2) MaschinenDG). Distributors must ensure that all documentation is available in German.

The MR permits digital provision of instructions, provided that they can be downloaded, stored and printed, and remain available online for at least ten years (Art. 10(7) MR). The MaschinenDG further specifies these requirements: all access information to the digital instructions must likewise be provided in German (Sec. 2(1) subpara. 2; Sec. 2(2) subpara. 2 MaschinenDG).

Manufacturers, importers and distributors must therefore verify already prior to placing machinery on the market that all documents are complete and available in the German language.

B. Notification of Conformity Assessment Bodies

Chapter V MR (Art. 26 et seq.) governs the notification procedure for conformity assessment bodies (Notified Bodies).

The Central Office of the Federal States for Safety (Zentralstelle der Länder für Sicherheitstechnik, hereinafter ZLS) will continue to act as the national notifying authority under the MR. Sec. 3 MaschinenDG refers to the existing provision in Sec. 10(1) sentence 1 of the Act on Making Products Available on the Market (Produktsicherheitsgesetz, hereinafter ProdSG), according to which the competent authority holds the power to designate conformity assessment bodies.

Testing bodies must therefore submit their designation applications to the ZLS and notify any changes directly to the ZLS.

C. Market Surveillance – Sampling Benchmark and Notification Channels

Pursuant to Sec. 4(2) MaschinenDG, the nationwide sampling benchmark of 0.5 samples per 1,000 inhabitants per year applies (Sec. 25(2) ProdSG).

Market surveillance will be subject to stronger central coordination. Market surveillance authorities must notify the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, hereinafter BAuA) of any non-compliance of machinery, related products or partly completed machinery within the meaning of Art. 43(2) and (4), subpara. 2 MR (Secs. 5–7 MaschinenDG). Risks existing despite the conformity of machinery within the meaning of Art. 45 MR must likewise be reported to BAuA (Sec. 7 MaschinenDG).

If a market surveillance authority authorises the placing on the market of certain machinery under the emergency procedure provided for in Art. 25c MR (as introduced by Amending Regulation (EU) 2024/2748), it must immediately notify the European Commission and the other EU Member States via BAuA (Sec. 8 MaschinenDG).

D. Administrative Fines and Criminal Provisions

Sec. 9 MaschinenDG sets out 26 administrative offences subject to fines of up to EUR 10,000 or EUR 100,000, for instance in cases of missing CE marking or failure to carry out corrective actions. In particular, violations of labelling obligations—e.g., absence of CE marking (Sec. 9(1) No. 21 MaschinenDG)—are covered. Notably, compliance with the safety and health requirements under Annex III MR is not included among the fine provisions.

In cases of intentional, persistent violations or endangerment of life or health, imprisonment of up to one year or a fine may be imposed (Sec. 10 MaschinenDG).

The level of the fine depends on the severity of the violation.

E. Transitional and Applicability Provisions

In principle, the MaschinenDG, including the language requirements and sanction provisions, will apply from 20.01.2027 (Secs. 12–13 MaschinenDG).

Under Sec. 11 MaschinenDG, machinery placed on the market under the 9. ProdSV before 20.01.2027 may continue to be operated and marketed. However, new machinery may only be placed on the market under the new law from that date onwards. The transitional regime thus enables an orderly shift to the new framework.

Conclusion and Outlook

With the MaschinenDG, Germany establishes the necessary foundation for harmonised and digital machinery regulation under the MR.

For companies, the new provisions mean:

  • All instructions for use, safety information and EU declarations of conformity must be available in German; this also includes access information for digital instructions.
  • ZLS will continue to serve as the notifying authority for conformity assessment bodies.
  • Economic operators may face fines of up to EUR 10,000 or EUR 100,000 for violations of various obligations under the MR.
  • The key provisions relevant for companies will apply from 20.01.2027.

The time until entry into effect in 2027 should be used to adapt internal processes—manufacturers and distributors, in particular, should ensure at an early stage that their instructions, compliance processes and IT infrastructure meet the new requirements.

The MaschinenDG thus marks the next important step towards a modern and digital machinery safety framework.

Do you have any questions about this news or would you like to discuss it with the author? Please contact: Marie Carnap

9. December 2025 Marie Carnap, LL.M.
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Marie Carnap, LL.M.
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Reform of the European Machinery Laws

The publication of the new EU Machinery Regulation in the Official Journal of the EU at the end of June 2023 marks a turning point for the machinery and plant construction industry. It is now clear that the EC Machinery Directive from 2006, which is now outdated in several respects, will have an expiry date.

Even though the relevant deadline still lies in the distant future at the beginning of 2027, all those affected would do well to deal with the forthcoming changes in good time. This article summarizes the most important changes for economic operators.

A. Background

Much has happened since the adoption of the EC Machinery Directive in 2006: The ability of machines to learn, become more autonomous or process information in real time on the one hand, and new forms of mobility and developments in sensor systems on the other, are new challenges for machine safety. By contrast, when the EC Machinery Directive was published in 2006, artificial intelligence (AI), the Internet of Things and robotics were still in their infancy. For this reason, it was time for the adoption of Regulation (EU) 2023/1230 and thus for the new EU Machinery Regulation (“MR“), especially as European product safety law has also developed significantly in the meantime. Against this background, the new EU Machinery Regulation is nothing less than the legislator’s answer to the digitalisation of the product world, which will dominate in 2023 and which will not stop at machinery in particular. In principle, it will apply throughout the EU from 20.01.2027.

B. Scope of application

The scope of the EU Machinery Regulation remains fundamentally unchanged: The focus is therefore still on complete and partly completed machinery. Interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices are now referred to as related products, but (continue to) be subject to the same set of rules as complete machines.

The core elements of the concept of machinery remain unchanged, i.e. there is still no de minimis limit, which is occasionally discussed with regard to ballpoint pens or animal beating traps for smaller animals. However, modifications in detail are to be noted. For example, the absence of the installation of software intended for a specific application does not mean that no machine is present, Art. 3 para. 1 (f) MR.

In accordance with Art. 3 No. 10 MR a partly completed machinery “means an assembly which is not yet machinery as it cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming machinery”. The indeed complicated conceptual element from the EC Machinery Directive, according to which partly completed machinery “is almost machinery”, Art. 2 2nd sentence (g) Directive 2006/42/EC, has thus been dropped.

C. Substantial change

The practically relevant substantial modification of a (complete!) machine or an related product is defined for the first time (Art. 3 No. 16 MR). Up to now, there has been no comparable definition in European Machinery Laws. The practice (at least in Germany) therefore regularly consults the non-legally binding interpretation paper of the Federal Ministry of Labour and Social Affairs (BMAS) on the topic of “substantial modification of machinery”, which is dated 09.04.2015. In the future, a significant change can also be a digital change. In any case, it must affect the safety of the machine, which in turn means that either guards or protective devices must be added or additional protective measures must be taken, e.g. to stabilise the machine. A substantial modification is also “a modification by physical or digital means (…) which is not foreseen or planned by the manufacturer” that takes place after the machinery has been placed on the market or put into service. Anyone who substantially modifies a machine or an related product becomes a manufacturer according to Art. 18 (1) MR and must fulfil the manufacturer’s obligations from Art. 10 MR.

The European legislator thus takes up much of what is currently the subject of the BMAS paper in question. Namely, neither a constant level of security nor an increase in security leads to a significant change.

D. Obligations of economic operators

For the first time, separate obligations of economic operators are created with regard to machinery, whereby the fulfilment service provider is explicitly not an economic operator. Except in the case of the authorised representative, there are two standards each, which refer – admittedly without too many differences – on the one hand to complete machinery and related products and on the other hand to partly completed machinery. This results in the following structure:

  • Obligations of manufacturers of machinery and related products: Art. 10 MR
  • Obligations of manufacturers of partly completed machinery: Art. 11 MR
  • Obligations of the authorised representative: Art. 12 MR
  • Obligations of importers of machinery and related products: Art. 13 MR
  • Obligations of importers of partly completed machinery: Art. 14 MR
  • Obligations of distributors of machinery and related products: Art. 15 MR
  • Obligations of distributors of partly completed machinery: Art. 16 MR

The differences between the respective obligations with regard to machinery or related products on the one hand and partly completed machinery on the other are comparatively small. In addition, the catalogue of obligations is based on the model provisions from Annex I to Decision No. 768/2008/EC. Those who are familiar with Low Voltage or EMC Laws will quickly get used to the new regulatory concept. As a result, there will be both pre-market and post-market obligations in Machinery Laws in the future. While the pre-market obligations (e.g. with regard to labelling provisions) can be relevant for the marketability (of a machine or a related product), the after-market is about product monitoring and corrective measures in the field.

It should be particularly emphasised that in future there will also be notification obligations in Machinery Laws, namely for manufacturers, importers and distributors. This means informing the competent market surveillance authorities if machinery or related products give rise to risks, in particular for the safety or health of persons in the field. For manufacturers, this will follow in future from Art. 10 para. 9 2nd sentence, 11 para. 9 2nd sentence MR. It should be noted that notification obligations for dangerous machinery since 16.07.2021 also already follow from Art. 4 para. 3 (c) Regulation (EU) 2019/1020 for the respective EU economic operator.

E. Recognition of digital solutions

Digital operating instructions will be permitted in the future, but there has not yet been a complete breakthrough. The linchpin will be Art. 10 para. 7 MR as of 20.01.2027. A distinction will be made between consumer products (B2C products) and non-consumer products (B2B products) as follows:

  • For B2B products, the digital form is permissible. However, a paper operating manual must be provided to the user free of charge upon request within one month.
  • B2C products still require the paper form.

In the event that the digital form is chosen, further requirements must be fulfilled, e.g. it must be indicated how the digital instruction handbook can be accessed; in addition, it must be printable and downloadable. Accordingly, the digital assembly instructions are also permitted for partly completed machinery, Art. 11 para. 7 MR.

Digitisation then also applies to the EU declaration of conformity (Art. 10 para. 8 subpara. 2 MR) and to the documents and information required to prove the conformity of the machinery or the related product (Art. 10 para. 10 1st sentence MR).

F. Essential health and safety requirements

The essential health and safety requirements have moved from Annex I to Directive 2006/42/EC to Annex III to MR, but have been developed only cautiously, especially with regard to artificial intelligence (AI) and cybersecurity.

In the future, AI will play a role in particular where “self-evolving behaviour” or “self-evolving logic” is mentioned. In future, any hazards arising from this very behaviour will be an explicit subject of the risk assessment. As far as cybersecurity is concerned, “protection against corruption” must be ensured with regard to certain hardware components, software and data. Against this background, cybersecurity is addressed as a genuine manufacturer’s obligation, which must also be fulfilled in the event of intentional (hacker) attacks by third parties (No. 1.1.9 of Annex III to MR). It should be noted that machines or related products must “collect evidence of a legitimate or illegitimate intervention in that hardware component”. The same applies to the “safety and reliability of control systems” (No. 1.2.1 of Annex III to MR), when it refers to “reasonably foreseeable malicious attempts from third parties leading to a hazardous situation”. Even if this allocation of responsibility is not legally self-evident, it is undoubtedly in the process of becoming established in legislation at the European level. At present, it can be assumed that the Machinery Laws requirements for cybersecurity will be considered fulfilled in the future if the EU Cybersecurity Regulation, which is currently in the legislative process, is complied with.

G. Conformity assessment procedure

The linchpin for the future law on conformity assessment is Art. 25 MR. Currently, a distinction is made between so-called Annex IV machines on the one hand and the remaining machines on the other. In all cases, internal checks come into consideration. This applies even to the potentially more critical Annex IV machines, if and insofar as harmonised standards are used as a basis (Art. 12 para. 3 (a) Directive 2006/42/EC).

In future, this (industry-friendly) approach will no longer be permitted in all cases, i.e. there will be scenarios in which it will be mandatory to involve a notified body. The following four case groups are to be distinguished:

  • The machine is listed in Part A of Annex I to MR (Art. 25 para. 2 MR).
  • Machine is listed in Part B of Annex I to MR and has not been manufactured in accordance with standards or common specifications harmonised for this category of machinery or associated products.
  • Machine is listed in Part B of Annex I to MR and has been manufactured in accordance with standards or common specifications harmonised for that category of machinery or associated products.
  • all other machines

In the relevant Part A, which consists of six numbers, for example, removable mechanical transmission devices including their guards (No. 1) or vehicle servicing lifts (No. 3) are mentioned. Part B, with a total of 19 numbers, covers e.g. certain types of single- and multi-blade circular saws, e.g. for working with wood (No. 1), portable chain saws for woodworking (No. 8) or logic units to ensure safety functions (No. 17). As a result, the previous Annex IV machines (with their 23 entries) were transferred wholesale to the new Annex I to MR, whereby two different risk groups are now formed (Part A and Part B). The machines listed in Annex I to MR can be described as high-risk machines, even though this term has not found its way into the EU Machinery Regulation.

For the categories of machinery listed in part A, only the following modules or combinations of modules can be considered: module B+C, module G or module H. These three modules or combinations of modules are also applicable when machinery is listed in part B and no harmonised standards or common specifications are applied. Conversely, internal production control (module A) is applicable to these machines when harmonised standards or common specifications are applied. Finally, module A also applies to all machines other than those listed in Annex I to MR. Module A therefore remains the legal normal case.

H. Conclusion

The adaptation of the Machinery Laws (from 2006!) both to technical developments in the meantime, such as AI and cybersecurity, and to the status quo of legislation in European product safety law was overdue. For the economic actors, however, this also entails new obligations that must be carefully considered: Manufacturers, authorised representatives, importers and distributors must check whether they are already prepared to fulfil these obligations or whether and, if so, what adjustments need to be made. The advantage is that there will be time for any adjustments until 20.01.2027.

The entry of digitalisation into Machinery Laws is to be welcomed, even if, as expected, this paradigm shift is still being tackled very cautiously. Whether the only slightly changed definition of partly completed machinery will lead to fewer interpretation problems in the future remains to be seen. Viewed in the light of day, it is not particularly likely. Within the essential health and safety requirements, particular attention must be paid to the new requirements for AI and cybersecurity.

Finally, it is important firstly to observe the (slight) tightening in the law on conformity assessment: in future, a notified body will have to be involved without exception for six categories of (high-risk) machinery. Secondly, it should not be overlooked that the substantial modification of machinery in particular will be defined by law in the future, whereby the legislator has fortunately closely followed the BMAS paper.

Do you have any questions about this news or would you like to discuss it with the author? Please contact: Dr. Carsten Schucht

2. November 2023 Dr. Carsten Schucht
Bild Dr. Carsten Schucht
Dr. Carsten Schucht
Lawyer / Partner

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