SAFETY OF MACHINERY AND EQUIPMENT: MODERN APPROACHES TO MANDATORY REQUIREMENTS, CERTIFICATION, LABELING AND LEGAL RESPONSIBILITY OF THE PRODUCERS

ABSTRACT

This article examines current approaches to ensuring the safety of machinery and equipment as a combination of technical and legal regulation. The authors argue that product safety depends not only on engineering solutions, but also on mandatory requirements, conformity assessment procedures, labeling, state supervision, and manufacturer liability. Using the examples of the EAEU, the European Union, and the United States, the article highlights the differences between national and supranational regulatory models. In the EAEU, special attention is given to technical regulations and supporting documentation; in the EU, the focus is placed on risk-based regulation, conformity assessment, and market surveillance; in the US, the emphasis is on occupational safety requirements and product liability mechanisms. The article also considers the growing importance of technical documentation, digital instructions, cybersecurity, and risks associated with software and artificial intelligence. It concludes that the global trend is shifting from formal conformity assessment toward continuous risk management throughout the entire product life cycle.

Keywords: safety of machinery and equipment, legal regulation, mandatory safety requirements, conformity assessment procedures.

Traditionally, machine safety is viewed as an engineering task, but it is actually a complex legal regime. The law sets a framework for acceptable risk and transforms technical solutions into legally significant actions: risk-oriented design is linked to product marketing, subsequent state oversight, and a system of liability for harm.

Approaches to regulating the safety of machinery and equipment differ from country to country, so a single rule cannot be created. The EU has a pre-release system with mandatory requirements, conformity assessment and labelling, and market surveillance. In the US, safety of operation (especially in workplaces) is prioritized and supported by private standards and producer responsibility. In the Russian Federation and EAEU countries, regulation is based on technical regulations, conformity verification procedures (declaration and certification), marking and administrative and civil liability mechanisms.

In the EAEU, machinery safety is primarily governed by Technical Regulation "On the safety of machines and equipment" [9], which sets minimum mandatory requirements for mechanical hazards, operational safety, safeguards, labeling, and documentation. Comprehensive compliance usually requires applying related regulations, particularly those for low-voltage equipment and electromagnetic compatibility.

The conformity assessment system offers two routes: declaration or certificate of conformity, depending on product risks and production type (serial, batch, or single item). Both require a substantiated "package of evidence" including technical descriptions, operating documentation, test reports, and safety justifications. Weak documentation increases regulatory scrutiny and limits legal protection.

The content of the "package of evidence" is practically significant: technical description and identification of the product, operating instructions and/or passport, test and inspection reports, justification of the protective measures applied, as well as other documents, allowing security logic to be replicated. Weak or fragmented evidence increases the likelihood of supervisory claims and complicates a producer’s legal protection in an incident.

Market access requires the EAEU label, but marking is only permitted after full compliance verification and documentation are complete. Proper product identification and documentation are therefore essential for legal market entry.

The regulatory framework operates through Federal Law 184-FZ on technical regulation (Federal Law 184-FZ "On Technical Regulation" [5]), with administrative liability under the Code of Administrative Offenses (Article 14.43) [3]. Serious violations may trigger criminal liability under Article 238 of the Criminal Code [4] when safety breaches create threats or cause harm.

Private law provides additional enforcement through product liability under Civil Code Article 1095 [2] and consumer protection mechanisms (Law of the Russian Federation № 2300-1 [6]), enabling compensation claims. Together, public supervision and private remedies create an integrated system incentivizing compliance with mandatory safety requirements.

The European machinery safety framework is based on Regulation (EU) 2023/1230 [8], which establishes directly applicable requirements across all member states for uniform enforcement without national transposition.

The regulation adopts a risk-based approach focused on essential safety requirements rather than prescribed designs. Manufacturers retain technical freedom but bear full responsibility for compliance. Harmonized standards offer a voluntary presumption of conformity-manufacturers deviating from them must prove compliance independently. The scope now explicitly includes cybersecurity and AI threats.

Conformity assessment follows a structured process from risk identification through testing and technical documentation to EU declaration and CE marking. Assessment depth varies by risk:

- Low-risk products: self-certification (Module A)

- Higher-risk machinery: mandatory notified body involvement (Modules B+C, H, or new Module G for unit verification)

CE marking constitutes the manufacturer's public declaration of compliance with all applicable requirements. Technical documentation must be prepared pre-launch and maintained for 10 years, now incorporating cybersecurity and AI safety considerations. Digital instructions are permitted if accessible throughout the product's lifetime, though member states may require translations.

Market surveillance under Regulation (EU) 2019/1020 [7] enables border and domestic controls through production suspensions, inspections, and corrective actions. Manufacturers face liability through EU declaration commitments, administrative penalties, and criminal sanctions (in Germany: fines up to €100,000 and imprisonment). A key innovation: parties making substantial modifications-including software changes-may assume full manufacturer responsibilities.

The US machine safety framework combines workplace safety requirements with powerful post-market liability mechanisms that incentivize safety "ex post."

Unlike the EU, the US has no single market entry regulation. Mandatory equipment requirements are found in 29 CFR 1910 [10] Subpart O, administered by Occupational Safety and Health Administration (OSHA)-but these govern safe workplace use, not product market admission. The foundational standard, 29 CFR 1910.212, requires point-of-operation guarding and equipment fixation, placing responsibility on employers rather than prescribing specific product designs.

Third-party certification is mandatory only for categories explicitly listed in OSHA standards, requiring Nationally Recognized Testing Laboratory (NRTL) approval (e.g., UL, CSA). However, certification to UL or ANSI standards has become a de facto market requirement through insurer demands and corporate purchasing practices, even where OSHA doesn't mandate "approval."

The primary compliance driver is tort liability rather than administrative oversight. The Restatement (Third) of Torts: Products Liability [1] codifies three product defect categories: manufacturing defect (deviation from specifications), design defect (hazardous design with reasonable alternative), warning defect (inadequate risk warnings). These defect definitions shape litigation and make product safety a legal risk management issue. Judicial practice effectively functions as market surveillance, with standards serving as evidentiary tools for parties asserting claims.

By analyzing all of the above, a few global trends can be identified regarding the regulation of machine safety.

Firstly, the shift to a risk-based approach is changing the way security is assessed: it is not the "right" document that matters, but the ability to manage risks effectively. This increases the legal value of three elements:

• complete identification of all potential hazards;
• reasoned choice of safeguards;
• an opportunity to trace the logic of decision-making - why a particular level of protection is chosen and what tests have proven its effectiveness.

As a result, in dispute resolution, quality risk assessment becomes key evidence of the manufacturer’s integrity.

Secondly, instructions, technical documentation, change notifications and software updates are increasingly presented in a digital dynamic format. This raises legal questions: who is responsible for the configuration changes after product release, how to record versions of documentation and confirm user information. Manufacturers need to set up a managed product lifecycle and document changes to maintain compliance.

Thirdly, the growing share of software management and hardware connectivity means that cyber vulnerabilities can have physically dangerous consequences. As a result, security begins to include elements of protection: prevention of unauthorized impact on critical functions, management of updates and access, accounting for digital threats in design and instructions. This also changes the private law block: defects can be assessed as design flaws or insufficient warnings on cyber risks if they lead to harm.

Finally, another trend is the growing importance of market surveillance and coercive measures (restraining, withholding, withdrawing, informing). For producers, this becomes a separate "pain point": in addition to initial compliance, prompt corrective action, supply traceability, and response procedures are required. In legal terms, the emphasis is shifting from single market access to continuous risk management of already-traded products.

In conclusion, machine and equipment safety requires a consistent combination of engineering solutions and legal regulations at all stages - from design and risk assessment to continuing certification and labeling (CE or EAC) procedures and post-sales supervision. Different approaches are used in different regions: the EAEU relies on technical regulations and a "package of evidence", the EU has Regulation 2023/1230 with focus on cybersecurity and AI, while the US has OSHA standards and tort liability mechanisms play a key role. It is worth noting that global trends are also aimed at implementing continuous risk management throughout the product life cycle.

References:

1. 29 C.F.R. § 1910. Occupational Safety and Health Standards.// URL: https://www.ecfr.gov/current/title-29/part-1910 (04.03.2026)
2. Civil Code of the Russian Federation : Federal law of 30 November 1994 51-FZ // ConsultantPlus : reference and legal system- URL: https://www.consultant.ru/document/cons_doc_LAW_9027/ (04.03.2026)
3. Code of the Russian Federation on Administrative Offenses : Federal law dated 30 December 2001 195-FZ // ConsultantPlus : reference and legal system- URL: https://www.consultant.ru/document/cons_doc_LAW_34661/ (04.03.2026)
4. Criminal Code of the Russian Federation : Federal law dated 13 June 1996 63-FZ // ConsultantPlus : reference and legal system. - URL: https://www.consultant.ru/document/cons_doc_LAW_10699/ (04.03.2026)
5. Federal Law of 27 December 2002 184-FZ "On technical regulation".
6. Law of the Russian Federation "On protection of consumer rights" dated 7 February 1992 № 2300-1// ConsultantPlus : reference and legal system. - URL: https://www.consultant.ru/document/cons_doc_LAW_305/ (04.03.2026)
7. Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011// ELI: http://data.europa.eu/eli/reg/2019/1020/oj (04/03/2026)
8. Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC // ELI:  http://data.europa.eu/eli/reg/2023/1230/oj (04.03.2026).
9. Stapleton, Jane. (2000). Restatement (Third) of Torts: Products Liability, an Anglo-Australian Perspective. Washburn Law J. 39
10. Technical Regulation of the Customs Union TC 010/2011 "On the safety of machinery and equipment" (Resolution of the Commission of the Customs Union dated 18 October 2011, № 823).