Role of Machinery Importers Under Regulation (EU) 2023/1230

The role of an Importer of machinery under Regulation (EU) 2023/1230 has become a critical link in ensuring the safety and compliance of products entering the European Union market. This regulation outlines precise responsibilities, including verifying compliance assessments, ensuring proper documentation, and being ready to take immediate corrective actions if risks are identified. This article delves into the practical aspects of this role and what every importer must know to avoid penalties and ensure smooth market operations.

(This article is based on the content of Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery, which repeals Directive 2006/42/EC. References to articles, annexes, and other provisions are from this Regulation unless stated otherwise.)

Introduction and Context

The new Regulation (EU) 2023/1230 on machinery marks a significant step in unifying and updating the safety regulations for machinery within the European Union. It replaces the well-known Machinery Directive 2006/42/EC, which governed the machinery sector for many years. This Regulation introduces precise definitions, expands the responsibilities of economic operators (manufacturers, importers, and distributors), adapts rules to new technologies, and sets guidelines for digital technical documentation. For companies importing machinery from outside the EU, the new set of obligations is crucial, as it clearly defines the role and responsibilities of importers.

Key Provisions of Regulation 2023/1230

The Regulation aims to:

• Ensure a high level of health and safety protection for people, and where applicable, domestic animals, property, and the environment.
• Harmonize requirements for machinery and related products across all EU member states.
• Consider technological advancements, digitization, robotics, and autonomous systems.
• Replace Directive 2006/42/EC to ensure greater consistency with other EU harmonization legislation and uniform application across the Union.

The Regulation introduces a new structure of definitions, including terms like “machinery,” “related products,” and “incomplete machinery.” It also outlines four conformity assessment procedures (Module A, B+C, G, H) and expands the list of essential health and safety requirements. For importers, Chapter II of the Regulation details the obligations of each economic operator in the supply chain, including importers.

Scope and Key Definitions for Importers

Definition of Importer According to the Regulation

According to Article 3 point 20 of Regulation 2023/1230, an importer is:

“a natural or legal person established in the Union who places a product covered by this Regulation from a third country on the Union market.”

It is important to note that an importer can be either a company or an individual conducting business, as long as they introduce products (machinery, related products, or incomplete machinery) from outside the EU to the EU market.

Machinery, Related Products, and Incomplete Machinery

• Machinery (Article 3 point 1) refers to assemblies of parts (at least one movable part) with a drive mechanism other than human or animal power, ready for independent operation. This definition has been expanded to include software and new technologies.
• Related Products (Article 3 point 1 in conjunction with Article 2) include interchangeable equipment, safety components, lifting accessories, etc.
• Incomplete Machinery (Article 3 point 10) are partially complete assemblies that cannot be used independently for a specific application and are intended to be incorporated into machinery or other incomplete machinery.

Importers can introduce all these categories of products, so they must identify what exactly they are placing on the market, as obligations vary depending on whether they import ready-to-use machinery, incomplete machinery, or related products.

Other Important Definitions for Importers

The Regulation in Article 3 provides several definitions describing terms such as “distributor,” “economic operator,” “significant modification,” or “assembly of machines.” Importers should pay special attention to:

• “Significant modification” (Article 3 point 16) – a change to machinery or a related product, physical or digital, not foreseen by the manufacturer and affecting operational safety. This definition is crucial if the importer makes any adaptations or changes to the imported device.
• “Making available on the market” (Article 3 point 11) – any supply on the EU market for distribution or use, whether for payment or free of charge. The importer becomes a key link in this process.

Obligations of Importers – Overview of Articles

The obligations of importers are scattered across several provisions of Regulation (EU) 2023/1230, but the main basis is Articles 13 (for machinery and related products) and 14 (for incomplete machinery). Below is a detailed overview.

Article 13: Obligations of Importers of Machinery and Related Products

Basic Scope

According to Article 13(1) of the Regulation, importers may only place on the market machinery or related products that are compliant with the Regulation. They cannot place on the market devices they know or have reason to believe are non-compliant with the requirements of this act.

Key obligations under Article 13 include:

1. Checking compliance and possession of documents:
   • The importer must ensure that the manufacturer has carried out the appropriate conformity assessment procedure (Article 13(2)).
   • They must check whether the product is CE marked and accompanied by an EU declaration of conformity (or other required documents), and that the manufacturer has met the requirements regarding markings and information.
2. Placing importer contact details on the product:
   • According to Article 13(3), importers place their name, registered trade name (trademark), postal address, and electronic contact details (e.g., email address, website address) on the machinery or related product.
   • If it is not possible to place these details directly on the device (due to size or nature), they can be placed on the packaging or accompanying document.
3. Instructions and safety information:
   • Importers ensure that machinery and related products are accompanied by operating instructions and the information specified in the Regulation, including in the language required by the member state where the product is made available (Article 13(4)).
4. Storage, transport, and distribution conditions:
   • According to Article 13(5), importers should ensure that during the time they are responsible for machinery or related products, their storage or transport does not impair compliance with essential requirements.
5. Monitoring and cooperation in corrective actions:
   • If they consider or have reason to believe that machinery or related products are non-compliant, they do not place them on the market (Article 13(2) in fine) and take corrective actions (Article 13(7)).
   • In case of a threat, the importer must inform the market surveillance authorities, providing details of the non-compliance and actions taken.
6. Storing the declaration of conformity and documentation:
   • Importers store a copy of the EU declaration of conformity for at least 10 years from the moment of placing on the market.
   • On request, they provide the technical documentation specified in Annex IV Part A.
   • In certain cases, if the authorities request the source code or programming logic (Article 13(8–9)), the importer is obliged to cooperate, provided this documentation is necessary to demonstrate compliance.

Transaction Registration and Identification of Economic Operators

Article 19 (Identification of economic operators) states that importers, upon request from market surveillance authorities, provide the details of the entity that supplied them with the product and the entity to whom they supplied the product. This information must be kept for 10 years, requiring the maintenance of an appropriate transaction register.

Article 14: Obligations of Importers of Incomplete Machinery

A similar, though somewhat simplified and tailored to the specifics of incomplete machinery, set of obligations is found in Article 14. The main points are:

1. Checking documents:
   • In particular, the importer must check whether the manufacturer has provided assembly instructions (Annex XI) and an EU declaration of incorporation (Article 14(2)).
2. Placing importer details:
   • As with complete machinery, the importer places their name, address, trademarks (Article 14(3)).
3. Safe storage and transport:
   • Article 14(5) requires ensuring that compliance with essential requirements is not impaired during transport, storage, etc.
4. Monitoring non-compliance:
   • As in Article 13, the importer takes appropriate corrective actions if the incomplete machinery is non-compliant (Article 14(6)).
5. Storing documentation:
   • The importer must store a copy of the EU declaration of incorporation for 10 years and ensure that the technical documentation is available upon request by the authorities (Article 14(7)).

Documentation and Retention Period

As indicated, the importer must as a rule store declarations and – if necessary – provide access to documentation for 10 years (Article 13(8), Article 14(7)). This obligation is a novelty, strengthened in the Regulation, but transferred from Article 5(3) of Directive 2006/42/EC in a modified form. If market surveillance authorities inquire about the compliance of machinery or related products, the importer must cooperate (Article 13(9), Article 14(8)).

Due Diligence and Intervention in Case of Non-Compliance

The Regulation clearly emphasizes that the importer must act with due diligence, “before placing the machinery on the market” (Article 13(2–5)). When non-compliance or a safety risk arises, the importer cannot remain passive. They are obliged to:

• refrain from placing the product on the market,
• notify the manufacturer,
• inform the authorities,
• and – if necessary – withdraw the product from the market, recover it from distributors (Article 13(7)).

Cooperation of Importers with Manufacturers and Other Entities

Compliance Control, Documentation, and Information

To place machinery or related products on the market, the importer must verify the device’s compliance with the Regulation. They must check whether:

• the manufacturer has carried out the appropriate conformity assessment procedures (Article 25),
• the product is accompanied by operating instructions (or assembly instructions) and an EU declaration of conformity (or EU declaration of incorporation),
• the machinery is CE marked (if required),
• the manufacturer has placed the appropriate identification data (name, address, markings).

Additionally, they should obtain assurance that the manufacturer:

• has prepared the technical documentation (Annex IV),
• has carried out certification if necessary (if it is machinery from Annex I Part A or B),
• has met the requirements regarding any software relevant to safety (Art. 1.1.9 and Art. 1.2.1 of Annex III).

Special Situations (Modifications, Corrective Actions)

If the importer makes any changes to the imported machinery that can be considered a “significant modification” (Article 3 point 16), then the importer may be considered the manufacturer under the Regulation (see Articles 17 and 18). This means a full range of manufacturer obligations, including the need for reassessment of conformity, marking, and preparation of a declaration of conformity.

In practice – if the importer plans, for example, to integrate new control software, replace key components, or add elements affecting safety – they must be aware that the role of the importer may transition to the role of the manufacturer under the regulations.

Transitional Periods and Application Dates

Issue of Previous Regulations (Directive 2006/42/EC)

Regulation 2023/1230 (Article 51(2)) repeals Directive 2006/42/EC on 14 January 2027. Until then, Directive 2006/42/EC applies to matters where the Regulation has not yet been implemented. Article 52 further stipulates that member states cannot hinder the placing on the market of products that were placed on the market in accordance with Directive 2006/42/EC before 14 January 2027.

Important Dates in Regulation 2023/1230 (from 2024 and 2027)

• From 14 July 2024 – Articles 6(2–6), 8, and 11 (regarding adding categories of machinery to Annex I, definitions of these high-risk machinery categories, etc.) and Article 53(3) apply.
• From 14 January 2024 – Provisions regarding the notification of conformity assessment bodies (Articles 26–42), certain obligations of member state authorities, etc., will apply (see Article 54).
• From 14 January 2027 – The Regulation applies fully to machinery, related products, and incomplete machinery. On this day, Directive 2006/42/EC loses its effect (Article 51(2)).

From the importer’s perspective, 14 January 2027 will be crucial – from this day, as a rule, machinery placed on the market must fully comply with the requirements of Regulation 2023/1230 (noting that some provisions of the Regulation will apply earlier).

Consequences of Violating Regulations and Penalties

The Regulation does not specify penalties for importers directly but obliges member states to establish national penalties for non-compliance (Article 50). It is expected that penalties will include, among others, financial fines, orders to withdraw from the market, or confiscation of non-compliant machinery. Additionally, an importer who introduced a non-compliant product and caused damage may be held liable in civil and possibly criminal proceedings (if the violation is particularly egregious).

Technical Documentation and the Role of the Importer

Scope of Technical Documentation

As indicated by the Regulation (Annex IV), technical documentation of machinery includes:

• a full description of the machinery or related product,
• risk assessment,
• plans, diagrams, calculations,
• test results and conformity assessment reports.

The manufacturer is responsible for its creation, while the importer must have – upon request from authorities – access to such documentation (Article 13(2) and (3)).

Maintaining and Providing Documentation

The importer is not required to create documentation from scratch (except in situations where they become the manufacturer due to “significant modification”), but they must store the EU declaration of conformity and ensure the possibility of viewing the technical documentation upon request. Authorities may – in specific cases – request the source code or programming logic if it concerns key safety aspects. In such a situation, the importer should cooperate with the manufacturer to provide the required information to the authority (Article 13(9)).

CE Marking, Declaration of Conformity, and Language Obligations

Responsibility for CE Marking

CE marking (Articles 23 and 24) on machinery or related products is external proof that the essential requirements have been met. According to Regulation 2023/1230, the responsibility for placing the CE marking primarily lies with the manufacturer. However, the importer should check whether the CE marking is placed and whether it actually pertains to the device in question (Article 13(2)).

Instructions and Translations

Imported machinery or related products must have operating instructions in the language(s) required by the country where the product is made available (Article 13(4)). Regulation 2023/1230 confirms the possibility of providing instructions in digital form, but in certain situations, such as at the request of the end user, a paper form must be provided free of charge. Additionally, key safety information must be in a language easily understood by non-professional users (Article 10(7) fourth paragraph).

The importer risks penalties if they place machinery on the market with operating instructions in a language that does not meet the requirements of the member state. It is recommended to arrange with the manufacturer or ensure the appropriate translation of instructions before making machinery available in the EU.

Corrective Actions, Withdrawal from the Market, and Cooperation with Authorities

Non-Compliance Situations

If it turns out that the machinery (or related product) is non-compliant with Regulation 2023/1230 (Article 43), market surveillance authorities may order the importer to take corrective actions, such as withdrawal from the market, recovery of products from customers, or a total ban on making them available on the market (Articles 43 and 44). The importer is obliged to immediately inform the relevant authorities if they believe that the product they introduced poses a risk (Article 13(7)).

Notifying Relevant National Authorities

In the event of detecting non-compliance that may pose a risk to health and safety, the importer informs the authorities of the member states where the product was made available, providing detailed information on the non-compliance and corrective actions. Such actions must be proportionate to the nature of the threat (Article 13(9)).

Relation of Regulation 2023/1230 to Other Acts (Chapters VI and VII of the Regulation)

Regulation 2023/1230 interacts with other EU harmonization legislation, such as Regulation (EU) 2019/1020 (on market surveillance and product compliance) and Regulation (EU) No 765/2008 (on accreditation and CE marking requirements). Importers should also be aware that in certain aspects (e.g., for machinery with radio or telecommunication functions), additional regulations may apply (e.g., Directive 2014/53/EU on radio equipment).

Chapters VI (Notifying conformity assessment bodies) and VII (Market surveillance, EU safeguard procedures, etc.) specify the framework for the functioning of the conformity assessment system. Although formally these issues concern manufacturers and notified bodies to a greater extent, the importer must know the status of the conformity assessment body with which the manufacturer cooperates and how procedures proceed in case of disputes with surveillance authorities.

The obligations of importers in Regulation 2023/1230 are similar to those previously arising from Directive 2006/42/EC but have been significantly clarified. Key points include:

1. Responsibility for verifying compliance with the Regulation before placing on the market.
2. Checking whether the manufacturer has conducted a conformity assessment, ensured CE marking, prepared an EU declaration of conformity (or EU declaration of incorporation – in the case of incomplete machinery).
3. Placing importer identification details on the machinery or related product (or, in exceptional situations, on the packaging or document).
4. Ensuring operating instructions in the appropriate language, along with safety information.
5. Storing the EU declaration of conformity (or EU declaration of incorporation) for at least 10 years and cooperating in providing documentation to surveillance authorities.
6. Corrective, informational, and withdrawal actions in case of non-compliance or threats.

It is worth remembering that an importer introducing machinery and related products from outside the EU becomes the first link in the legal circulation within the Community and assumes a significant part of the responsibilities related to safety, including potential liability for the consequences of dangerous products. Therefore, it is crucial for every importer to thoroughly verify whether the delivered devices meet the requirements of Regulation 2023/1230.

The Regulation will come fully into effect on 14 January 2027, meaning there is still time to adjust procedures, sign appropriate agreements with manufacturers, and make necessary modifications to internal quality control and documentation procedures. However, it is advisable to prepare for the new regulations now, as some provisions will apply earlier, notably in 2024.

Note:

Machines listed in Annex I of the Regulation are subject to the Regulation from 20.01.2025.

For importers, it is particularly important to regulate in contracts with foreign manufacturers the issues of access to technical documentation, compliance confirmations, and liability in case of non-compliance. Organizing these matters in advance will help reduce the risk of sanctions and financial liability.

Sources:

• Regulation (EU) 2023/1230 on machinery.
• Regulation (EU) 2019/1020 (market surveillance) and Regulation (EC) No 765/2008 (accreditation and CE marking).

Disclaimer: This article is for informational purposes only and does not constitute legal advice. For binding interpretation, it is recommended to consult the full text of Regulation 2023/1230 and seek professional advice.

FAQ: Machinery Importer under Machinery Regulation 2023/1230