Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2021/0105(COD)**

**COVER NOTE**

**Brussels, 22 April 2021**
**(OR. en)**

**8095/21**

**MI 270**
**ENT 75**
**CODEC 571**

From: Secretary-General of the European Commission, signed by Ms Martine
DEPREZ, Director

date of receipt: 22 April 2021

To: Mr Jeppe TRANHOLM-MIKKELSEN, Secretary-General of the Council
of the European Union

No. Cion doc.: COM(2021) 202 final

Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on machinery products

Delegations will find attached document COM(2021) 202 final.

Encl.: COM(2021) 202 final

8095/21 AW/nm

## ECOMP.3.A EN

EUROPEAN

COMMISSION

Brussels, 21.4.2021
COM(2021) 202 final

2021/0105 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on machinery products**

(Text with EEA relevance)

{SEC(2021) 165 final} - {SWD(2021) 82 final} - {SWD(2021) 83 final}

# **EN EN**

**EXPLANATORY MEMORANDUM**

**1.** **CONTEXT** **OF** **THE** **PROPOSAL**

**1.1.** **Reasons for and objectives of the proposal**

The Machinery Directive (hereafter ‘MD’) [1 ] establishes a regulatory framework for placing
machinery on the Single Market, based on Article 114 of the TFEU (the approximation of
laws. The general objectives of the MD are to: i) ensure free movement of machinery within
the internal market; and ii) ensure a high level of protection for users and other exposed
persons. The MD follows the ‘new approach’ principles of EU legislation. It is intentionally
written to be technology neutral, which means that it lays down the essential health and safety
requirements (hereafter ‘safety requirements’) to be complied with, without prescribing any
specific technical solution to comply with those requirements. The choice of the technical
solution is a prerogative of manufacturers, which leaves space for innovation and new design
development.

During the REFIT evaluation [2] of the directive, all interested parties confirmed it is an
essential piece of legislation although it identified a necessity to improve, simplify and adapt
the MD to the needs of the market. Some Members of the European Parliament’s expressed
their support to the revision of the Machinery Directive. In particular, by ‘taking the
legislation’ to the XXI century and promoting innovation for the EU economy.

As part of the Commission Work Programme 2020 under the priority ‘A Europe fit for the
Digital Age’, the revision of the product safety Directive 2006/42/EC on Machinery (MD) [3]
contributes to the digital transition and to the strengthening of the Single Market. Indeed,
regarding new technologies and their impact on safety legislation, the Commission has
published in February 2020 a White Paper on Artificial Intelligence accompanied by a
‘Report on the safety and liability implications of Artificial Intelligence, the Internet of
Things and robotics’ [4] . The Report, which has conducted an analysis of the impact of new
technologies and the challenges they pose to Union safety legislation, concluded that the
current product safety legislation contains a number of gaps that need to be addressed, in
particular, among other, in the Machinery Directive. This is even more relevant for a
sustainable recovery from the COVID pandemic, since the machinery sector is an essential
part of the engineering industry and one of the industrial mainstays of the EU economy.

In view of dealing with the elements highlighted in the evaluation and developed in the
impact assessment report of the machinery directive [5], as well as responding to the
Commission policy objectives on digitalization, this proposal expects to tackle the following
problems:

**Problem 1** : The MD does not sufficiently cover new risks originating from emerging
technologies.

1 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.
2 SWD (2018) 160 final, Evaluation of the Machinery Directive.
3 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery.
4 [Available at: https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-](https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en)
[ai-internet-things-and-robotics-0_en](https://ec.europa.eu/info/publications/commission-report-safety-and-liability-implications-ai-internet-things-and-robotics-0_en)
5 SWD (2021) […] final, Impact assessment of the Machinery Directive.

# EN 1 EN

In order to boost the trust in digital technologies, the MD needs to provide legal certainty as
regards those technologies, existing gaps could hinder a level playing field for manufacturers,
which would impact the efficiency of the MD.

There are several aspects that need to be addressed within this problem. The first one relates
to the potential risks that originate from a direct human-robot collaboration as the
collaborative robots (co-bots) that are designed to work alongside human and employees are
exponentially increasing. A second source of potential risk originates from connected
machinery. A third area of concern lies with the way software updates affects the ‘behaviour’
of the machinery after its placing on the market. A fourth concern relates to the ability of
manufacturers to conduct a full risk assessment on machine learning applications before the
product is placed on the market. Finally, as far as the autonomous machines and remote
supervisory stations, the current MD foresees a driver or an operator responsible for the
movement of a machine. The driver may be transported by the machinery or may be
accompanying the machinery, or may guide the machinery by remote control, but does not
consider the possibility of no driver, and sets up no requirements for autonomous machines.

**Problem 2** : (i) Legal uncertainty due to a lack of clarity on the scope and definitions; and (ii)
possible safety gaps in traditional technologies.

The MD needs greater legal certainty in its scope and definitions, which generated some
difficulties for manufacturers to understand the correct legal framework they should apply.
Some overlaps or inconsistencies with other EU specific legislation were identified. With
respect to the definitions set by the Directive, the definition of 'partly completed machinery'
raised a number of concerns particularly centred at the borderline with the definition of
'machinery' and the definition of ‘machinery’ has been clarified. Besides, there is a need to
clarify the exclusion of means of transport and to reinforce the coherence of the exclusion of
some products covered by the **Low Voltage Directive** 2014/35/EU [6] when those products
integrate a Wi-Fi function.

Furthermore, it is a common practice that machines placed on the market are modified in
order for example to add a function or improve the performance. The problem is that if the
machine suffers a **substantial modification,** without the manufacturer’s agreement, may be
not in conformity any longer with the essential health and safety requirements. The current
MD does not address this situation.

There are a number of requirements on **traditional technologies** not related to new
technologies that were identified either as not clear or safe enough, or as too prescriptive and
potentially hindering innovation. These requirements are related to installation of lifting
appliances, slow speed lifts, seating, protection against hazardous substances, overhead power
lines and vibration from portable handheld and hand guided machinery.

**Problem 3** : Insufficient provisions for high risk machines.

The third party conformity assessment is considered by some Member States and stakeholders
more adapted to address the high risks stemming from certain groups of machines.

6 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
electrical equipment designed for use within certain voltage limits, available at:
[http://data.europa.eu/eli/dir/2014/35/oj.](http://data.europa.eu/eli/dir/2014/35/oj)

# EN 2 EN

Another problem is that **the current list of high-risk machines in Annex I was elaborated**
**15 years ago**, and the market has much evolved since then. It is necessary to remove
machines no longer considered high risk and/or introducing new ones (such as machinery
embedding AI systems, which fulfil a safety function).

**Problem 4** : Monetary and environmental costs due to extensive paper-based documentation.

The MD requires manufacturers to provide the necessary machinery information, such as
instructions. To ensure that every machine user has access to the instructions, providing a
printed version was considered as the most viable option. Since then, however, the use of the
internet and digital technologies has increased. The requirement to provide printed versions
increases the costs and administrative burdens for economic operators and has a negative
impact on the environment. However, it must be also considered that some users are less
digitally savvy, there is a lack of internet access in certain environments and the digital
manual might not match the version of the product.

**Problem 5** : Inconsistencies with other pieces of Union product safety legislation.

The New Legislative Framework is a package of measures aimed at brought together all the
elements required for a comprehensive regulatory framework to operate effectively for the
safety and compliance of industrial products with the requirements adopted to protect the
various public interests and for the proper functioning of the single market. A main objective
of the Commission is to bring product harmonisation legislation in line with the reference
provisions of Decision 768/2008/EC. While the Machinery Directive is already a New
Approach directive, it is not yet aligned to the NLF.

The lack of MD’s alignment to the NLF creates inconsistencies with other EU product
legislation.

**Problem 6** : Divergences in interpretation due to transposition.

The fact that the current machinery legislation is a Directive leaving Member States to choose
the means to comply with the legislative objectives, has led to different interpretations of the
MD provisions creating legal uncertainty and lack of coherence throughout the single market.
Furthermore, there have been delays in the transposition of the Directive in some Member
States.

**1.2.** **Consistency with existing policy provisions in the policy area**

This initiative is in line with the Single Market Act [7], which stressed the need to restore
consumer confidence in the quality of products on the market and the importance of
reinforcing market surveillance. With this purpose, the regulation on machinery products is
aligned to the provisions of Decision No 768/2008/EC [8] .

Furthemore it reinforces the coherence with the low voltage directive 2014/35/EU [9] by
considering the fact that electrical and electronic products excluded from this Regulation will

7 Communication from the Commission to the European Parliament, the Council, the Economic and
Social Committee and the Committee of the Regions (COM(2011) 206 final).
8 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.08.2008, p. 82).
9 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35).

# EN 3 EN

be also excluded from the radio equipment directive 2014/53/EU [10] when they incorporate wifi.

**1.3.** **Consistency with other Union policies**

This proposal is coherent with the Union policy on artificial intelligence (AI) and the
upcoming Regulation on artificial intelligence, which will address the risks having an impact
on safety for high-risk AI systems embedded in a machinery or that are safety components
under the future regulation on machinery products.

In addition, this proposal is coherent with the Union policy on cybersecurity, making the link
with the future cybersecurity schemes pursuant to Regulation (EU) 2019/881 for the purpose
of demonstrating compliance with the future regulation on machinery products.

Furthermore it contributes to simplification of the regulatory environment.

**2.** **LEGAL** **BASIS,** **SUBSIDIARITY** **AND** **PROPORTIONALITY**

**2.1.** **Legal basis**

The proposal is based on Article 114 of the Treaty on the Functioning of the European Union
because the purpose of the Regulation is to harmonise health and safety requirements for
machinery in all Member States and to remove obstacles to trade in machinery between
Member States.

**2.2.** **Subsidiarity (for non-exclusive competence)**

The subsidiarity principle arises in particular with regard to the newly added provisions
aiming at the improvement of effective enforcement of Directive 2006/42/EC and the
coherence with the AI Union policy. Without a Union wide regulation, Member States could
impose diverging safety requirements, which would lead to differences in the safety of the
products for the users for manufacturers when trading machinery across different countries.
For instance, some market surveillance authorities consulted found necessary to ensure that
software updates not foreseen in the initial manufacturer’s risks assessment and having an
impact on safety would require the machine to go through a conformity assessment procedure
leading to a new CE marking. Furthermore, the future regulation on machinery products sets
up Union wide requirements underpinned by the solutions provided in European standards.
Given the Union broad level of the standardisations activities, any changes to the scope or
requirements of the future regulation on machinery products must be made at Union level to
avoid distorting the market, creating barriers to the free movement of products and
undermining the protection of human health and well-being. In addition, the newly added
provisions will align the economic operators’ obligations, the traceability provisions, the
provisions on the assessment and notification of conformity assessment bodies and on market
surveillance.

As for the added value of action at Union level, regulatory action at the Union level,
contributes to the development of the Internal (and Digital) Single Market, provides legal
certainty and a level playing field for the industry, and establishes a high level of trust among
machinery users.

10 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of radio
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).

# EN 4 EN

**2.3.** **Proportionality**

The preferred policy option is option 3 - Burden minimisation and enhanced safety.

This policy option addresses all identified problems in the most effective and efficient way,
proposing a revised MD that is not only fit for purpose now, but also in the years to come, and
ensures coherence with existing product safety legislation and with the future AI framework.

Policy option 3 adds new requirements and clarifies existing ones, in a targeted and
proportional way, only when necessary and often applicable to certain types of machinery.
Legal clarity is added to the current act in its scope, definitions and requirements, including
those covering risk stemming from new technologies and drive the standardisation activities
in this area, which enhances safety and ensures a higher level of trust and industry
competitiveness in the (digital) market. It also adapts the machines presenting high risks to the
state of the art, removes the internal check option for the conformity assessment of the highrisk machines, and ensures full coherence with the AI Regulation proposal. It proposes a
burden reduction measure highly requested by the industry which is allowing digital
documentation, while at the same time ensuring that end users and consumers can have a
printed version free of charge if they so request. Finally, the revised MD will gain in
coherence and legal certainty by aligning to the NLF and becoming a Regulation. To ensure
proportionality, this policy option includes the standardisation process with a new
Standardisation Request issued by the Commission for detailed technical solutions to be
developed by the standardisation bodies, and the Machinery Guide for detailed clarification
and examples.

As explained in the Impact Assessment, the preferred policy option adheres to the principle of
proportionality. The proposed changes to the safety requirements are targeted, limited to
certain machinery types: machinery including new technologies, specific machinery, and
high-risk machinery. The burden reduction measures are on the contrary aimed at all
machinery types (such as clarification of substantial modification, digital documentation,
alignment to the NLF, conversion to a regulation). Proportionality is also ensured by the MD
being technologically neutral. The proposed clarifications or additions to the safety
requirements are kept to the strict minimum in the proposal, to be complemented by a new
Standardisation Request issued by the Commission to empower the standardisation bodies to
develop voluntary technical solutions.

**2.4.** **Choice of the instrument**

The proposal takes the form of a Regulation. The proposed change from a Directive to a
Regulation takes into account the Commission’s general objective to simplify the regulatory
environment and the need to ensure a uniform implementation throughout the Union of the
proposed legislation.

In addition, the machinery directive is a total harmonisation directive, which means that it
establishes a high level of safety, and does not allow the Member States to impose more
restrictive obligations. In this respect, a Regulation by its legal nature, would better ensure
that Member States do not impose national technical requirements that go beyond the safety
requirements laid down in Annex I of the current Directive and/or contradict those safety
requirements.

The change from a Directive to a Regulation will not lead to any change in the regulatory
approach. The characteristics of the New Approach will be fully preserved, in particular the
flexibility given to manufacturers in the choice of the means employed to comply with the

# EN 5 EN

essential requirements (harmonised standards or other technical specifications) and in the
choice of the procedure used to demonstrate compliance from among the available conformity
assessment procedures. The existing mechanisms supporting the implementation of the
legislation (standardisation process, working groups, market surveillance, Member States
administrative cooperation (AdCo), and the development of guidance documents…) will not
be affected by the nature of the legal instrument and will continue to operate in the same
manner under the Regulation as they currently do under the Directive.

Finally, the use of Regulations in the area of internal market legislation, in accordance also
with the preference expressed by stakeholders, avoids the risk of ‘gold plating’. It also allows
manufacturers to work directly with the Regulation text instead of needing to identify and
examine 27 transposition laws. On this basis, it is considered that the choice of a Regulation is
the most appropriate solution for all involved parties as it will allow a more rapid and
coherent application of the proposed legislation and will establish a clearer regulatory
environment for economic operators.

**3.** **RESULTS** **OF** **EX-POST** **EVALUATIONS,** **STAKEHOLDER**
**CONSULTATIONS** **AND** **IMPACT** **ASSESSMENTS**

**3.1.** **Ex-post evaluations/fitness checks of existing legislation**

The evaluation of the directive concluded that a revision should aim to: i) address the risks
stemming from new technologies while allowing for technical progress; ii) improve the legal
clarity of some major concepts and definitions in the current text of the MD; iii) simplify the
requirements for documentation by allowing digital formats, hence reducing administrative
burden for economic operators, with an additional positive impact on environmental costs; iv)
ensure coherence with other Directives and Regulations for products and improve
enforcement of the legislation through the alignment to the New Legislative Framework, v)
reduce costs of transposition by converting the Directive into a Regulation.

The results of the evaluation have been taken on board in the proposal.

**3.2.** **Stakeholder consultations**

Stakeholders have been consulted throughout the preparation of the revision of the MD,
including Member States, manufacturers' federations, consumers and workers associations,
notified bodies and representatives from standardisation organisations.

The consultation included meetings for a selected group of experts as well as consultation of
the machinery Working Group and the machinery AdCo Group of market surveillance
authorities.

Some stakeholder’s views have evolved following discussions in the machinery Working
Group and bilateral meetings, in particular on the need to address explicitly the new risks
stemming from digital emerging technologies.

        - **Specific objective 1: Cover new risks related to digital emerging technologies**

While most stakeholders consider that the MD takes innovations sufficiently into account,
some expressed concerns over the potential impacts of emerging digital technologies on
safety.

        - **Specific objective 2: Ensure coherent interpretation of the scope and**

**definitions and improve safety for traditional technologies**

# EN 6 EN

On the scope and definitions most stakeholders agreed on adapting the current exclusion of
low voltage products covered by the Low-Voltage Directive (LVD) in Art. 1.2(k) of the MD
to the products integrating Wi-Fi and clarifying the definition of partly completed machinery.
As for introducing conformity assessment obligations linked to the substantial modification of
a machinery placed on the market or put into service, the stakeholders’ views diverge.
Regarding the adaptation of the essential health and safety requirements for traditional
machinery, most of stakeholders agree to a greater or lesser extent, except for some specific
cases in which they consider that an adaptation is not necessary because other Union
legislation already covers the risks.

        - **Specific objective 3: Reassess machines considered as high risk and reassess**

**related conformity procedures**

The question to whether the manufacturer internal checks option in Annex I of the MD leads
to safety concerns received mixed responses in the public consultation. The interview
responses, on the other hand often referred to an adaptation and regular updates of the Annex
I as potential to bring benefits.

        - **Specific objective 4: Reduce paper-based requirements for documentation**

On allowing digital formats for documentation, almost all the stakeholder groups representing
the industry indicated that are in favour. Most Member States and consumers organisations
are in favour of ensuring also paper format.

        - **Specific objective 5: Ensure coherence with other product safety legislation**

Alignment to the New Legislative Framework received nearly universal support.

        - **Specific objective 6: Avoid divergences in interpretation derived from**

**transposition**

Most stakeholders wish to reduce the possible divergences in the interpretation of the
machinery directive derived from transposition and mention potential benefits of converting
the Directive into a Regulation. For manufacturers, a conversion could lead to a decrease of
additional costs related to differences in interpretation across Member States.

**3.3.** **Collection and use of expertise - Impact assessment**

The Commission carried out an impact assessment on the revision of the machinery Directive.
The Regulatory Scrutiny Board (RSB) issued an opinion on the draft impact assessment on 5
February 2021. The opinion of the Board as well as the final Impact Assessment and its
executive summary are published together with this proposal.

Based on the information collected, the impact assessment examined and compared four
options to address problems and issues relating to the Machinery Directive.

**Option 0 Baseline - ‘no change’**

This option would leave the standardisation process evolve as usual, without particular focus
risks stemming from new technologies, and with no particular focus on areas for improvement
related to traditional technologies. It would also revise the ‘Guide to application of the MD’
following the normal process, with limited ambition and no particular push for consensus.

**Option 1 Self-regulation by industry and changes to the Guide**

This option would make no changes to the current act. Clarifications would be introduced in
the ‘Guide to application of the MD’ with a push for consensus to clarify where possible the

# EN 7 EN

main problems as described in section 1.1. New risks stemming from new technologies (as
well certain risks from traditional technologies) would be addressed through the issuance of a
new commission standardisation request to drive the normal standardisation process.

**Option 2 Burden minimisation**

The rationale behind this option is to reduce economic operators’ burden. In view of
achieving this objective this option aims to increase the legal clarity of some provisions and
simplify some administrative obligations.

However, to minimise the economic operators’ burden there would be no adaptations in the
safety requirements for products, thus with no changes in the manufacturers’ obligations for
designing and manufacturing the machinery. The new risks stemming from new technologies
(as well certain risks from traditional technologies) would be addressed through the issuance
of a dedicated commission standardisation request to drive the normal standardisation process
as much as possible.

**Option 3 Burden minimisation and enhanced safety**

This option aims also to increase the legal clarity of some provisions and simplify some
administrative obligations. In addition, it seeks enhancing safety by adapting the safety
requirements and tailoring the conformity assessment to the risk related to the machinery
product, including new technologies.

Option 3 was found to be the preferred option because:

Option 0 means no action and would not address the problems and issues identified, with the
risk of not addressing the problems and objectives.

Option 1 achieves limited results. It does not ensure an effective response to the problems.

Option 2 boosts competitiveness by minimising burden for manufacturers, without
diminishing the number of unsafe products in the market.

On the contrary, option 3 boosts competitiveness by minimising burden for manufacturers,
and additionally enhances safety by clarifying or adding requirements. This comes with
additional costs for compliance, but also benefits related to less unsafe products in the market.
This is also the most future-proof option because addresses the risks from new technologies.

**3.4.** **Regulatory fitness and simplification**

The alignment to the NLF means a better functioning of the directive and its enforcement, but
also a burden simplification for manufacturers dealing with several product safety acts
applying to their products (e.g. machinery to which both the machinery directive and the radio
equipment directive apply). It streamlines the process of safeguard procedures, by involving
manufacturers and Member States before the Commission is notified and triggers a
Commission decision only in cases where there is disagreement between Member States.

Another simplification aspect is the complementarity between the AI and machinery legal
proposals, where the AI regulation delegates the conformity assessment to the machinery, so
that the risk assessment for the whole machinery with AI systems is done only through the
future regulation on machinery products.

Finally, the change from a directive to a regulation, will avoid Member States transpositions
and will ensure coherence in the interpretation of the legal act and in its implementation.

# EN 8 EN

**4.** **BUDGETARY** **IMPLICATIONS**

This proposal does not have any implications for the Union budget.

**5.** **OTHER** **ELEMENTS**

**5.1.** **Implementation plans and monitoring, evaluation and reporting arrangements**

The Commission will monitor the implementation, the application and the compliance to
these new provisions with a view to assessing their effectiveness. The regulation will request
a regular Commission’s evaluation and review and the submission of a public report in this
respect to the European Parliament and to the Council.

**5.2.** **Detailed explanation of the specific provisions of the proposal**

**Scope and definitions**

The scope of the proposed Regulation remains the same but is clarified by adding the subject
matter in Article 1, adapting the wording of the scope and adding a new indent in the
definition of machinery that includes assembly missing only the upload of a software intended
for its specific application to prevent manufacturers classifying them as partially completed
machinery. Furthermore, the definition of safety component has been also clarified to include
non-physical components such as software.

There is a new definition of substantial modification to ensure that machinery, placed on the
market and/or put into service, that suffers substantial modifications is in conformity with the
essential health and safety requirements in Annex III.

Additionally, the general definitions of the NLF Decision 768/2008/EC have been inserted.

The Regulation clarifies also the application of other specific Union harmonisation legislation
when the risks to be addressed in the machinery are not contemplated in Annex III.

**Exclusions**

The exemption of the means of transport on road is extended beyond the Union type approval
legislation to increase the legal certainty. The reason is to prevent that vehicles not covered by
that legislation are covered by default by the machinery legislation, as this legislation is not
meant to regulate risks other than those stemming from the machinery function (such as
sawing, excavating, etc.), and not the risks exclusively related to its transport function of
persons or goods. Furthermore, as for the exemption on the list of electrical and electronic
products regulated by the Low Voltage Directive as some of those products are progressively
incorporating Wi-Fi functions, e.g. washing machines, and are therefore covered by Directive
2014/53/EU of the European Parliament and of the Council [11] as radio equipment, those
products should also be excluded from the scope of this Regulation.

**High-risk machinery**

The proposal sets up classification rules for high-risk machinery empowering the Commission
to adopt delegated acts to adapt the list of high-risk machinery in Annex I. This list is obsolete

11 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of radio
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).

# EN 9 EN

and needs to be adapted to the technical progress and new type of machinery presenting high
risks such as machinery with AI ensuring safety functions.

**Obligations of economic operators**

The proposal incorporates obligations for manufacturers, importers and distributors to be
aligned with the NLF Decision 768/2008/EC. This will clarify the respective obligations,
which are proportionate to the economic operators’ responsibilities. Furthermore, when a
machinery is substantially modified according to the definition, the one that modifies the
machinery becomes manufacturer and must comply with the relevant obligations. As the
complexity of the machinery supply chain is increasing, there is a general obligation of
cooperation of third parties involved in the machinery supply chain, other than the economic
operators.

**Presumption of conformity of machinery**

The presumption of conformity of machinery when manufacturers apply the relevant
harmonised standards or parts thereof published in the Official Journal of the European Union
remains. However, in order to ensure the presumption of conformity when there are not
harmonised standards the Commission will be empowered to adopt technical specifications.
This will be a fall-back option to be used only in cases the standardisation bodies are not able
to provide standards or provide standards that do not respond to the Commission
standardisation request and the essential health and safety requirements of Annex III.

**Conformity assessment**

The proposal keeps the manufacturer internal check option for machinery that is not classified
as high risk. However, for high-risk machinery, considering that Annex I will be adapted to
the technological progress when needed and the NLF alignment, only third party certification
will be accepted, even when manufacturers apply the relevant harmonised standards.

The proposal updates the corresponding modules in line with the NLF Decision 768/2008/EC.

**Notified bodies**

Proper functioning of notified bodies is crucial for ensuring a high level of health and safety
protection and for the confidence of all interested parties in the New Approach system.
Therefore, in line with the NLF Decision, the proposal sets out requirements for national
authorities responsible for conformity assessment bodies (notified bodies). It leaves the
ultimate responsibility for designating and monitoring notified bodies with the individual
Member State.

**Union market surveillance, control of machinery entering the union market and union**
**safeguard procedure**

The proposal integrates the NLF Decision 768/2008/EC provisions. This will reinforce the
market surveillance and will clarify the safeguard close procedure. Commission decisions on
measures taken by Member States on products placed on the EU market will be required only
if other Member States disagree with such a measure, which will simplify Commission’s
work.

**Essential health and safety requirements (EHSRs) traditional machinery:**

The proposed Regulation adapts or adds following EHSRs to address specific machinery
risks:

**1.1.2. Principles of safety integration** has been adapted to allow the machinery users to test
the safety functions of the machinery **.**

# EN 10 EN

**1.6.1 on maintenance** has been adapted to facilitate a timely and safe rescue when operators
are trapped in the machine.

**Digital documentation: EHSRs 1.7.4 on instructions and Annex V on the manufacturer’s**
**declaration of conformity** allow that manufacturers provide digital instructions and the
declaration of conformity. Nevertheless, a paper format is mandatory upon request.

**EHSR 1.7.4 on instructions** has been further adapted to request information on emissions of
hazardous substances from the machinery and **EHSRs 2.2.1.1 and 3.6.3.1** **on vibrations**
**from portable handheld and hand-guided machinery** to adapt the instructions on
vibrations in order to reduce the exposure occupational injury.

**EHSR 2.2** **on portable hand-held and/or hand-guided machinery** is adapted to capture or
reduce emissions of hazardous substances.

**Section 3 on offset risks due to the mobility of machinery** has been adapted to address the
risks on **autonomous machines and remote supervisory stations.**

**EHSR 3.2.2 seating for mobile machinery** has been adapted to reinforce the drivers’ safety.

**EHSR 3.5.4 on risks of contact with live overhead power lines** has been added to avoid the
accidents when machinery makes contact with overhead lines.

**EHSR 6.2 on control devices** has been adapted allowing when possible on slow-speed lifts
control devices other than hold-to-run to allow innovation.

**Installation of lifting appliances:** in view of facilitating market surveillance activities the
manufacturer’s **declaration of conformity** will add the address where the machine is
permanently installed only for lifting machinery installed in a building or a structure.

**Essential health and safety requirements machinery with new digital technologies:**

**The risk assessment** that manufacturers must carry out before the machinery is placed on the
market/ put into service will need to include also the risks appearing after the machinery is
placed on the market due to its evolving and autonomous behaviour.

**Cybersecurity with an impact on safety**

In view of addressing, the risks stemming from malicious third party actions and that have an
impact on the machinery safety the proposal adds a new **EHSR 1.1.9** and clarifies E **HSR**
**1.2.1** on safety and reliability of control systems.

**Human-machinery interaction**

Machines are becoming more powerful, autonomous and some look almost like humans,
which requires adapting the EHSRs related to the contact between the human and the
machinery i.e. **EHSRs 1.1.6** on ergonomics and **1.3.7** on risks related to moving parts and
psychological stress.

**Machinery with evolving capacity**

Although AI system risks will be regulated by the Union legislation on AI, the proposal must
ensure that the entire machinery is safe, considering the interactions between the machinery
components including the AI systems. In this respect following EHSRs have been adapted:
general principles, **1.1.6** on ergonomics, **1.2.1** on safety and reliability of control systems and
**1.3.7** on risks related to moving parts and psychological stress.

**Traceability of machinery safety**

The safety of machinery increasingly relies on the software behaviour once the machinery has
been placed on the market. In view of supporting the conformity assessment process and the

# EN 11 EN

market surveillance, a few new requirements have been added in **EHSR 1.2.1** on safety and
reliability of control systems and in the information required in the technical file in **Annex**
**IV.**

**Implementing acts**

The proposal empowers the Commission to adopt, where appropriate, implementing acts to
ensure the uniform application of this Regulation. Those implementing acts will be adopted in
accordance with the provisions on implementing acts laid down in Regulation (EU) No
182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the
rules and general principles concerning mechanisms for control by the Member States of the
Commission's exercise of implementing powers.

**Delegated acts**

The proposal empowers the Commission to adopt delegated acts in order to adapt the list of
high risk machinery in Annex I to take into account the progress of technical knowledge or
new scientific evidence and the indicative list of safety components in Annex II.

**Evaluation and review**

The Commission will monitor the implementation, the application and the compliance to
these new provisions with a view to assessing their effectiveness. The regulation requests a
regular Commission’s evaluation and review and the submission of a public report in this
respect to the European Parliament and to the Council.

**Final provisions**

The proposed Regulation will become applicable 30 months after its entry into force to allow
manufacturers, notified bodies and Member States time to adapt to the new requirements.
However, the safeguard clause procedure needs to be applied shortly after the entry into force
of this Regulation to simplify the mechanism. Transitional provisions are foreseen for
products manufactured and the certificates issued by notified bodies under Directive
2006/42/EC so as to allow stocks to be absorbed and ensure a smooth transition to the new
requirements. Directive 2006/42/EC will be repealed and replaced by the proposed
Regulation.

# EN 12 EN

2021/0105 (COD)

Proposal for a

**REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL**

**on machinery products**

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular
Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee [1],

Acting in accordance with the ordinary legislative procedure,

Whereas:

(1) Directive 2006/42/EC [2] of the European Parliament and of the Council was adopted in
the context of establishing the internal market, in order to harmonise health and safety
requirements for machinery in all Member States and to remove obstacles to trade in
machinery between Member States.

(2) The machinery sector is an important part of the engineering industry and is one of the
industrial mainstays of the Union economy. The social cost of the large number of
accidents caused directly by the use of machinery can be reduced by inherently safe
design and construction of machinery and by proper installation and maintenance.

(3) Experience with the application of Directive 2006/42/EC has shown inadequacies and
inconsistencies in the product coverage and conformity assessment procedures. It is
therefore necessary to improve, simplify and adapt the provisions set out in that
Directive to the needs of the market and provide clear rules in relation to the
framework within which machinery products may be made available on the market.

(4) Since the rules setting out the requirements for machinery products, in particular the
essential health and safety requirements and the conformity assessment procedures,
need to be of uniform application for all operators across the Union, and not give room
for divergent implementation by Member States, Directive 2006/42/EC should be
replaced by a regulation.

1 OJ C […], […], p. […].
2 Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery,
and amending Directive 95/16/EC (OJ L 157, 9.6.2006, p. 24).

# EN 13 EN

(5) Member States are responsible for protecting, on their territory, the health and safety
of persons, in particular workers and consumers and, where appropriate, domestic
animals and property, notably in relation to the risks arising out of the use of
machinery. For the avoidance of doubt, domestic animals should be considered to
include farm animals.

(6) Regulation (EC) No 765/2008 of the European Parliament [3] lays down rules on the
accreditation of conformity assessment bodies, provides a framework for the market
surveillance of products and for controls on products from third countries, and lays
down the general principles of the CE marking. That Regulation should be applicable
to machinery products covered by this Regulation in order to ensure that those
products, which are benefiting from the free movement of goods within the Union,
fulfil requirements providing a high level of protection of public interests such as the
health and safety of persons and, where appropriate, domestic animals and property
and, where applicable, the environment.

(7) Regulation (EC) No 2019/1020 of the European Parliament and of the Council [4] sets
out rules on market surveillance and control of products entering the Union market.
That Regulation already applies to machinery, since Directive 2006/42/EC is listed in
its Annex I.

(8) Decision No 768/2008/EC of the European Parliament and of the Council [5] lays down
common principles and reference provisions intended to apply across sectoral
legislation. In order to ensure consistency with other sectoral product legislation, it is
appropriate to align certain provisions of this Regulation to that Decision, in so far as
sectoral specificities do not require a different solution. Therefore, certain definitions,
the general obligations of economic operators, the rules on presumption of conformity,
the rules on EU declaration of conformity, the rules on CE marking, the requirements
for conformity assessment bodies, the rules on notification procedures and conformity
assessment procedures and the rules on procedures to deal with machinery products
presenting a risk should be adapted to the reference provisions laid down in that
Decision.

(9) This Regulation should cover machinery products which are new to the Union market
when placed on the market, i.e. either new machinery products made by a
manufacturer established in the Union or machinery products, whether new or secondhand, imported from a third country.

(10) Where there is a possibility that the machinery products will be used by a consumer,
that is to say, a non-professional operator, the manufacturer should take account of the
fact that the consumer does not have the same knowledge and experience with
handling machinery products in the design and construction of the products. The same

3 Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out
the requirements for accreditation and market surveillance relating to the marketing of products and
repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
4 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 (OJ L169, 25.6.2019, p. 1.)
5 Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common
framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218,
13.08.2008, p. 82).

# EN 14 EN

applies where a machinery product is normally used to provide a service to a

consumer.

(11) Recently, more advanced machines, which are less dependent on human operators,
have been introduced on the market. These machines, known as collaborative robots or
cobots, are working on defined tasks and in structured environments, yet they can
learn to perform new actions in this context and become more autonomous. Further
refinements to machines, already in place or to be expected, include real-time
processing of information, problem solving, mobility, sensor systems, learning,
adaptability, and capability of operating in unstructured environments (e.g.
construction sites). The Commission Report on the safety and liability implications of
Artificial Intelligence, the Internet of Things and robotics [6], states that the emergence
of new digital technologies, like artificial intelligence, the Internet of things and
robotics, raises new challenges in terms of product safety. The report concludes that
the current product safety legislation, including Directive 2006/42/EC, contains a
number of gaps in this respect that need to be addressed. Thus, this Regulation should
cover the safety risks stemming from new digital technologies.

(12) In order to ensure protection of the health and safety of persons, domestic animals,
property and, where applicable, the environment, this Regulation should apply to all
forms of supply of machinery products, including distance selling as referred to in
Article 6 of Regulation (EU) 2019/1020.

(13) In order to ensure legal certainty for all users, the scope of this Regulation should be
set out in a clear manner and the concepts relating to its application should be defined
as precisely as possible.

(14) In order to avoid legislating twice the same product, is appropriate to exclude from the
scope of this Regulation weapons, including firearms that are subject to Directive
[(EU) 2017/853 of the European Parliament and of the Council](http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1496858696625&uri=CELEX:32017L0853) [7] .

(15) Since the purpose of this Regulation is to address the risks stemming from the
machinery function and not the transport of goods or persons, it should not apply to
vehicles which only objective is the mere transport of goods or persons on road, by air,
on water or on rail networks, regardless of the speed limits. However, machinery
mounted on such vehicles or mobile machinery intended for facilitating works such as
in construction sites or warehouses e.g. dumpers and forklifts, have a machinery
function and should therefore be covered by this Regulation. Since agricultural and
forestry vehicles and two- or three-wheel vehicles and quadricycles, as well as
systems, components, separate technical units, parts and equipment designed and
constructed for such vehicles, fall within the scope of Regulation (EU) No 167/2013 of
the European Parliament and of the Council [8] and Regulation (EU) No 168/2013 of the

6 Report from the Commission to the European parliament, the Council and the European economic and
social committee on the safety and liability implications of Artificial Intelligence, the Internet of Things
and robotics (COM/2020/64 final)..
7 Directive (EU) 2017/853 of the European Parliament and of the Council of 17 May 2017 amending
Council Directive 91/477/EEC on control of the acquisition and possession of weapons (OJ L 137,
24.5.2017, p.22).
8 Regulation (EU) No 167/2013 of the European Parliament and of the Council of 5 February 2013 on the
approval and market surveillance of agricultural and forestry vehicles (OJ L 60, 2.3.2013, p. 1).

# EN 15 EN

European Parliament and of the Council [9] respectively, they should be excluded from
the scope of this Regulation.

(16) Household appliances intended for domestic use which are not electrically operated
furniture, audio and video equipment, information technology equipment, office
machinery, low-voltage switchgear and control gear and electronic motors fall within
the scope of Directive 2014/35/EU of the European Parliament and of the Council [10]
and should therefore be excluded from the scope of this Regulation. Some of those
products are progressively incorporating Wi-Fi functions, e.g. washing machines, and
are therefore covered by Directive 2014/53/EU of the European Parliament and of the
Council [11] as radio equipment. Those products should also be excluded from the scope
of this Regulation.

(17) The evolution of the machinery sector has resulted in the growing use of digital means
and software plays a more and more important role in the machinery design.
Consequently, the definition of machinery should be adapted. In this respect,
machinery missing only the upload of a software intended for the specific application
of the machinery should fall under the definition of machinery and not under the
definition of partly completed machinery. Furthermore, the definition of safety
components should cover not only physical devices but also digital devices. In order to
take into account the increasing use of software as a safety component, software that
performs a safety function and is placed independently on the market should be
considered a safety component.

(18) Partly completed machinery is a machinery product which must undergo further
construction in order to be able to perform its specific application, i.e. the well-defined
operations for which the machinery product is designed. It is not necessary that all
requirements of this Regulation apply to partly completed machinery but in order to
ensure the safety of the machinery product as a whole, it is nevertheless important that
the free movement of such partly completed machinery be guaranteed by means of a
specific procedure.

(19) Where machinery products pose risks that are addressed by the essential health and
safety requirements set out in this Regulation but are also wholly or partly covered by
other more specific Union legislation, this Regulation should not apply to the extent
that those risks are covered by that other Union legislation. In other cases, machinery
products may pose risks that are not covered by the essential health and safety
requirements set out in this Regulation. For example, machinery products
incorporating a Wi-Fi function or an artificial intelligence system may pose risks not
addressed by the essential health and safety requirements set out in this Regulation, as
this Regulation does not deal with risks specific to such systems. For artificial

9 Regulation (EU) No 168/2013 of the European Parliament and of the Council of 15 January 2013 on the
approval and market surveillance of two- or three-wheel vehicles and quadricycles (OJ L 60, 2.3.2013,
p. 52).
10 Directive 2014/35/EU of the European Parliament and of the Council of 26 February 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of
electrical equipment designed for use within certain voltage limits (OJ L 96, 29.3.2014, p. 35).
11 Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the
harmonisation of the laws of the Member States relating to the making available on the market of radio
equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p. 62).

# EN 16 EN

intelligence systems, the specific Union legislation on artificial intelligence should
apply, since it contains specific safety requirements for high-risk artificial intelligence
systems. In order to avoid incoherence with regard to the type of conformity
assessment and to avoid introducing requirements to perform two conformity
assessments, those specific safety requirements should however be checked as part of
the conformity assessment procedure set out in this Regulation. The essential health
and safety requirements set out in this Regulation should in any case be applied in
order to ensure, where applicable, the safe integration of the artificial intelligence
system into the overall machinery, so as not to compromise the safety of the
machinery product as a whole.

(20) For trade fairs, exhibitions and similar events, it should be possible to exhibit
machinery products which do not meet the requirements of this Regulation, since this
would not pose any safety risk. However, for the sake of transparency, interested
parties should be properly informed that the machinery products are not compliant and
cannot be purchased.

(21) The evolution of the state of the art in the machinery sector has an impact on the
classification of high-risk machinery products. In view of properly reflecting all highrisk machinery products, criteria should be established for the assessment by the
Commission of which machinery products should be included in the list of high risk
machinery products.

(22) Other risks related to new digital technologies are those provoked by malicious third
parties that have an impact on the safety of machinery products. In this respect,
manufacturers should be required to adopt proportionate measures which are limited to
the protection of the safety of the machinery product. This does not preclude the
application to machinery products of other Union legislation specifically addressing
cybersecurity aspects.

(23) In order to ensure that machinery products, when placed on the market or put into
service, do not entail health and safety risks for persons or domestic animals and do
not cause harm to property and, where applicable, the environment, essential health
and safety requirements should be set out which have to be met in order for the
machinery products to be allowed on the market. Machinery products should comply
with the essential health and safety requirements when placed on the market or put
into service. Where such machinery products are subsequently modified, by physical
or digital means, in a way that is not foreseen by the manufacturer and that may imply
that it no longer meets the relevant essential health and safety requirements, the
modification should be considered as substantial. For example, users may upload
software in a machinery product that is not foreseen by the manufacturer and that may
generate new risks. In order to ensure the compliance of such a machinery product
with the relevant essential health and safety requirements, the person that carries out
the substantial modification should be required to perform a new conformity
assessment before placing the modified machinery product on the market or putting it
into service. That requirement should only apply with respect to the modified part of
the machinery product, provided that the modification does not affect the machinery
product as a whole. In order to avoid an unnecessary and disproportionate burden, the
person carrying out the substantial modification should not be required to repeat tests
and produce new documentation in relation to aspects of the machinery product that
are not impacted by the modification. It should be up to the person who carries out the
substantial modification to demonstrate that the modification does not have an impact
on the machinery product as a whole.

# EN 17 EN

(24) In the machinery sector, around 98 % of the companies are small or medium sized
enterprises (SMEs). In order to reduce the regulatory burden on SMEs, notified bodies
should adapt the fees for conformity assessments and reduce them proportionately to
the specific interests and needs of SMEs.

(25) Economic operators should be responsible for the compliance of machinery products
with the requirements of this Regulation, in relation to their respective roles in the
supply chain, so as to ensure a high level of protection of public interests, such as the
health and safety of persons, where appropriate, domestic animals and property and,
where applicable, the environment, as well as the fair competition on the Union
market.

(26) All economic operators intervening in the supply and distribution chain should take
appropriate measures to ensure that they make available on the market only machinery
products, which are in conformity with this Regulation. This Regulation should
provide a clear and proportionate distribution of obligations, which correspond to the
role of each economic operator in the supply and distribution chain.

(27) In order to facilitate communication between economic operators, market surveillance
authorities and users, Member States should encourage economic operators to include
a website address in addition to the postal address.

(28) The manufacturer, having detailed knowledge of the design and production process, is
best placed to carry out the conformity assessment procedure. Conformity assessment
should therefore remain solely the obligation of the manufacturer.

(29) The manufacturer or the manufacturer’s authorised representative should also ensure
that a risk assessment is carried out for the machinery product, which the manufacturer
wishes to place on the market. For this purpose, the manufacturer should determine
which of the essential health and safety requirements that are applicable to the
machinery product and in respect of which measures must be taken to address the risks
that the machinery product may present. Where the machinery product integrates an
artificial intelligence system, the risks identified during the risk assessment should
include those risks that may appear during the machinery product’s lifecycle due to an
intended evolution of its behaviour to operate with varying levels of autonomy. In this
respect, where the machinery product integrates an artificial intelligence system, the
risk assessment for the machinery product should consider the risk assessment for that
artificial intelligence system that has been carried out pursuant to Regulation (EU)
.../... of the European Parliament and of the Council **+** .

(30) The safety of the integral machinery product relies on the dependencies and
interactions between its components and partly completed machinery and individual
machinery that participate in a coordinated assembly of a machinery system _._
Therefore, manufacturers should be required to assess all those interactions in the risk
assessment. The risk assessment should also address future updates or developments
of a software installed in the machinery product, which are foreseen when the
machinery product is placed on the market.

(31) It is essential that, before drawing up the EU declaration of conformity, the
manufacturer or the manufacturer’s authorised representative established in the Union

+ OJ: Please insert in the text the number of the Regulation contained in document … .

# EN 18 EN

prepares a technical construction file, which they should be required to make available
to national authorities or notified bodies on request. Detailed plans of subassemblies
used for the manufacture of the machinery product should only be required as part of
the technical construction file where knowledge of such plans is essential for
assessing conformity with the essential health and safety requirements set out in this
Regulation.

(32) It is necessary to ensure that machinery products from third countries entering the
Union market comply with the requirements of this Regulation and do not pose a risk
to the health and safety of persons, where appropriate, domestic animals and property
and, where applicable, the environment, and in particular, that appropriate conformity
assessment procedures have been carried out by manufacturers with regard to such
machinery products. Provision should therefore be made for importers to ensure that
machinery products that they place on the market comply with the requirements of this
Regulation and do not pose a risk to the health and safety of persons, where
appropriate, domestic animals and property and, where applicable, the environment.
For the same reason, provision should also be made for importers to ensure that the
conformity assessment procedures have been carried out and that the CE marking and
technical documentation drawn up by manufacturers are available for inspection by the
competent national authorities.

(33) As the distributor makes machinery products available on the market after they have
been placed on the market by the manufacturer or the importer, the distributor should
act with due care to ensure that his or her handling of the machinery product does not
adversely affect its compliance with the requirements set out in this Regulation.

(34) When placing machinery products on the market, the importer should indicate on the
machinery product his or her name, registered trade name or registered trade mark and
the postal address at which he or she can be contacted. Exceptions should be provided
for in cases where the size or nature of the machinery product does not allow it. This
includes cases where the importer would have to open the packaging to put his or her
name and address on the machinery product.

(35) In view of ensuring the health and safety of the users of the machinery product,
economic operators should ensure that all relevant documentation, such as the user's
instructions, whilst containing precise and comprehensible information, is easily
understandable, takes into account technological developments and changes to enduser behaviour, and is as up to date as possible. When machinery products are made
available on the market in packages containing multiple units, the instructions and
information should accompany the smallest commercially available unit.

(36) Any economic operator who either places a machinery product on the market under his
or her own name or trademark or modifies a machinery product in such a way that
compliance with the requirements of this Regulation may be affected should be
considered to be the manufacturer and should assume the obligations of the
manufacturer.

(37) Distributors and importers, being close to the market place, should be involved in
market surveillance tasks carried out by the competent national authorities, and should
be prepared to participate actively, providing those authorities with all necessary
information relating to the machinery product concerned.

(38) Ensuring traceability of machinery products throughout the whole supply chain
enables a simpler and more efficient market surveillance. The economic operators

# EN 19 EN

should therefore be required to keep the information on their transactions of machinery
products for a certain period of time. However, that obligation should be proportionate
to the role of each economic operator in the supply chain and the economic operators
should not be required to update information that they have not produced.

(39) This Regulation should be limited to setting out the essential health and safety
requirements, supplemented by a number of more specific requirements for certain
categories of machinery products. In order to facilitate the assessment of conformity
with those health and safety requirements it is necessary to provide for a presumption
of conformity for machinery which is in conformity with harmonised standards that
are developed and which references are published in the _Official Journal of the_
_European Union_ in accordance with Regulation (EU) No 1025/2012 of the European
Parliament and of the Council [12] for the purpose of expressing detailed technical
specifications of those requirements.

(40) In the absence of relevant harmonised standards, the Commission should be able to
establish technical specifications for the essential health and safety requirements.
Recourse to technical specifications should be used as a fall back solution to facilitate
the manufacturer’s obligation to comply with the health and safety requirements, for
instance when the standardisation process is blocked due to a lack of consensus
between stakeholders or there are undue delays in the establishment of a harmonised
standard. Such delays could for example occur when the required quality is not
reached.

(41) Compliance with harmonised standards and with technical specifications established
by the Commission should be voluntary. Alternative technical solutions should
therefore be acceptable where compliance of the machinery with the relevant essential
health and safety requirements is demonstrated in the technical file.

(42) The essential health and safety requirements should be satisfied in order to ensure that
the machinery product is safe. Those requirements should be applied with discernment
to take account of the state of the art at the time of construction and of technical and
economic requirements.

(43) In view of addressing the risks stemming from malicious third party actions that have
an impact on the safety of machinery products, this Regulation should include
essential health and safety requirements for which a presumption of conformity may
be given to the appropriate extent by a certificate or statement of conformity issued
under a relevant cybersecurity scheme adopted pursuant to and in accordance with
Article 54(3) of Regulation (EU) 2019/881 of the European Parliament and of the
Council [13] .

12 Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives
94/9/EC, 94/25/EC(52), 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and
2009/105/EC of the European Parliament and of the Council and repealing Council Decision
87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316,
14.11.2012, p. 12).
13 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA
(the European Union Agency for Cybersecurity) and on information and communications technology
cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151,
7.6.2019, p. 15).

# EN 20 EN

(44) Regulation (EU) No 1025/2012 provides for a procedure for objections to harmonised
standards where those standards do not satisfy or entirely satisfy the requirements of
this Regulation.

(45) The list of high-risk machinery in Annex I to Directive 2006/42/EC is so far based on
the risk emanating from the intended use or any reasonably foreseeable misuse of that
machinery. Nevertheless, the machinery sector embraces new ways of designing and
constructing machinery products that may imply high risks, regardless of such
intended use or any reasonably foreseeable misuse. For example, software ensuring
safety functions of machinery based on artificial intelligence, embedded or not in the
machinery product, should be classified as a high-risk machinery product due to the
characteristics of artificial intelligence such as data dependency, opacity, autonomy
and connectivity, which might increase very much the probability and severity of harm
and seriously affect the safety of the machinery product. Furthermore, the market for
software ensuring safety functions of machinery products based on artificial
intelligence is so far very small, which results in a lack of experience and data.
Therefore, the conformity assessment of software ensuring safety functions based on
artificial intelligence should be carried out by a third party.

(46) Manufacturers should draw up an EU declaration of conformity to provide information
on the conformity of machinery products with this Regulation. Manufacturers may
also be required to draw up an EU declaration of conformity by other Union
legislation. To ensure effective access to information for market surveillance purposes,
a single EU declaration of conformity should be drawn up in respect of all Union acts.
In order to reduce the administrative burden on economic operators, it should be
possible for that single EU declaration of conformity to be a dossier made up of
relevant individual declarations of conformity.

(47) The CE marking, indicating the conformity of a product, is the visible consequence of
a whole process comprising conformity assessment in a broad sense. The general
principles governing the CE marking are set out in Regulation (EC) No 765/2008.
Rules governing the affixing of the CE marking on machinery products should be laid
down in this Regulation.

(48) The CE marking should be the only marking, which guarantees that machinery
products comply with the requirements of this Regulation. Member States should
therefore take appropriate action as regards other markings which are likely to mislead
third parties as to the meaning or the form of the CE marking.

(49) In order to enable economic operators to demonstrate and the competent authorities to
ensure that machinery made available on the market is in conformity with the essential
health and safety requirements, it is necessary to provide for conformity assessment
procedures. Decision No 768/2008/EC establishes modules for conformity assessment
procedures, which include procedures from the least to the most stringent, in
proportion to the level of risk involved and the level of safety required. In order to
ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment
procedures should be chosen from among those modules.

(50) Manufacturers should be responsible for certifying the conformity of their machinery
products with this Regulation. Nevertheless, for certain types of machinery products
that have a higher risk factor, a stricter certification procedure requiring participation
of a notified body should be required.

# EN 21 EN

(51) It is essential that all notified bodies perform their functions to the same level and
under conditions of fair competition. That requires the setting of obligatory
requirements for conformity assessment bodies wishing to be notified in order to
provide conformity assessment services.

(52) If a conformity assessment body demonstrates conformity with the criteria laid down
in harmonised standards, it should be presumed to comply with the corresponding
requirements set out in this Regulation.

(53) In order to ensure a consistent level of quality in the performance of conformity
assessment of machinery products, it is also necessary to set requirements for
notifying authorities and other bodies involved in the assessment, notification and
monitoring of notified bodies.

(54) The system set out in this Regulation should be complemented by the accreditation
system provided for in Regulation (EC) No 765/2008. Since accreditation is an
essential means of verifying the competence of conformity assessment bodies, it
should also be used for the purposes of notification.

(55) Transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring
the necessary level of confidence in certificates of conformity, should be considered
by the national public authorities throughout the Union as the preferred means of
demonstrating the technical competence of conformity assessment bodies. However,
national authorities may consider that they possess the appropriate means of carrying
out that evaluation themselves. In such cases, in order to ensure the appropriate level
of credibility of evaluations carried out by other national authorities, they should
provide the Commission and the other Member States with the necessary documentary
evidence demonstrating the compliance of the conformity assessment bodies evaluated
with the relevant regulatory requirements.

(56) Conformity assessment bodies frequently subcontract parts of their activities linked to
the assessment of conformity or have recourse to a subsidiary. In order to safeguard
the level of protection required for the machinery to be placed on the market, it is
essential that conformity assessment subcontractors and subsidiaries fulfil the same
requirements as notified bodies in relation to the performance of conformity
assessment tasks. Therefore, it is important that the assessment of the competence and
the performance of bodies to be notified, and the monitoring of bodies already
notified, cover also activities carried out by subcontractors and subsidiaries.

(57) Since notified bodies may offer their services throughout the Union, it is appropriate to
give the other Member States and the Commission the opportunity to raise objections
concerning a notified body. It is therefore important to provide for a period during
which any doubts or concerns as to the competence of conformity assessment bodies
can be clarified before they start operating as notified bodies.

(58) In the interests of competitiveness, it is crucial that notified bodies apply the
conformity assessment procedures without creating unnecessary burdens for economic
operators. For the same reason, and to ensure equal treatment of economic operators,
consistency in the technical application of the conformity assessment procedures needs
to be ensured. That can best be achieved through appropriate coordination and
cooperation between notified bodies.

(59) Market surveillance is an essential instrument inasmuch as it ensures the proper and
uniform application of Union legislation. It is therefore appropriate to put in place a

# EN 22 EN

legal framework within which market surveillance can be carried out in an appropriate

manner.

(60) Member States should take all appropriate measures to ensure that machinery products
covered by this Regulation may be placed on the market only if, when properly
installed and used for its intended purpose, or under conditions of use which can be
reasonably foreseen, it does not endanger the health or safety of persons, and, where
appropriate, domestic animals and property and, where applicable, the environment.
Machinery products covered by this Regulation should be considered as noncompliant with the essential health and safety requirements laid down in this
Regulation only under conditions of use, which could result from lawful and readily
predictable human behaviour.

(61) In the context of market surveillance, a clear distinction should be established between
the disputing of a harmonised standard conferring a presumption of conformity on
machinery products and the safeguard clause relating to machinery products.

(62) Directive 2006/42/EC already provides for a safeguard procedure, which is necessary
to allow for the possibility of contesting the conformity of machinery products. In
order to increase transparency and to reduce processing time, it is necessary to
improve the existing safeguard procedure, with a view to making it more efficient and
drawing on the expertise available in Member States.

(63) The existing safeguard procedure should be supplemented by a procedure under which
interested parties are informed of measures intended to be taken with regard to
machinery products posing a risk to the health or safety of persons and, where
appropriate, domestic animals and property and, where applicable, the environment. It
should allow market surveillance authorities, in cooperation with the relevant
economic operators, to act at an earlier stage in respect of such machinery products.

(64) Where the Member States and the Commission agree as to the justification of a
measure taken by a Member State, no further involvement of the Commission should
be required, except where non-compliance can be attributed to shortcomings of a
harmonised standard.

(65) In order to take into account technical progress and knowledge or new scientific
evidence, the power to adopt acts in accordance with Article 290 of the Treaty on the
Functioning of the European Union should be delegated to the Commission in respect
of amending the list of high-risk machinery products and the indicative list of safety
components. It is of particular importance that the Commission carries out appropriate
consultations during its preparatory work, including at expert level. The Commission,
when preparing and drawing up delegated acts, should ensure a simultaneous, timely
and appropriate transmission of relevant documents to the European Parliament and to
the Council.

(66) In order to ensure uniform conditions for the implementation of this Regulation,
implementing powers should be conferred on the Commission establishing technical
specifications for the essential health and safety requirements, requesting the notifying
Member State to take the necessary corrective measures in respect of a notified body
that does not meet the requirements for its notification and establishing whether a
national measure in respect of compliant machinery which a Member State finds to

# EN 23 EN

pose a risk to health and safety of persons is justified. Those powers should be
exercised in accordance with Regulation (EU) No 182/2011 of the European
Parliament and of the Council [14] .

(67) The Commission should adopt immediately applicable implementing acts determining
whether a national measure taken in respect of compliant machinery products that
poses a risk is justified or not where, in duly justified cases relating to the protection of
the health or safety of persons, imperative grounds of urgency so require.

(68) In line with established practice, the committee set up by this Regulation can play a
useful role in examining matters concerning the application of this Regulation raised
either by its chair or by a representative of a Member State in accordance with its rules
of procedure.

(69) When matters relating to this Regulation, other than its implementation or
infringements, are being examined in a Commission expert group, the European
Parliament should in line with existing practice receive full information and
documentation and, where appropriate, an invitation to attend such meetings.

(70) The Commission should, by means of implementing acts and, given their special
nature, acting without the application of Regulation (EU) No 182/2011, determine
whether measures taken by Member States in respect of non-compliant machinery
products are justified or not.

(71) The traceability of machinery data required for the technical file and for market
surveillance purposes, must comply with confidentiality rules to protect
manufacturers.

(72) Member States should lay down rules on penalties applicable to infringements of this
Regulation and ensure that those rules are enforced. The penalties provided for should
be effective, proportionate and dissuasive.

(73) Since the objective of this Regulation, namely to ensure that machinery products
placed on the market fulfils the requirements providing for a high level of protection
of health and safety of persons, and, where appropriate, domestic animals and property
and, where applicable, the environment, while guaranteeing the functioning of the
internal market, cannot be sufficiently achieved by the Member States, but can rather,
by reason of the need for harmonisation, be better achieved at Union level, the Union
may adopt measures, in accordance with the principle of subsidiarity set out in Article
5 of the Treaty on European Union. In accordance with the principle of
proportionality, as set out in that Article, this Regulation does not go beyond what is
necessary in order to achieve that objective.

(74) Council Directive 73/361/EEC [15] on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the certification and

14 Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011
laying down the rules and general principles concerning mechanisms for control by Member States of
the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
15 Council Directive 73/361/EEC of 19 November 1973 on the approximation of the laws, regulations and
administrative provisions of the Member States relating to the certification and marking of wire-ropes,

–
chains and hooks (OJ L 335, 5.12.1973, p. 51 55).

# EN 24 EN

marking of wire-ropes, chains and hooks should be repealed as Directive 2006/42/EC
took over its scope by including lifting accessories and chains and ropes.

(75) Directive 2006/42/EC has been amended several times. Since further substantial
amendments are needed, and in order to ensure a uniform implementation of the rules
on machinery products throughout the Union, Directive 2006/42/EC should be
repealed.

(76) It is necessary to provide for sufficient time for economic operators to comply with
their obligations under this Regulation, and for Member States to set up the
administrative infrastructure necessary for its application. The application of this
Regulation should therefore be deferred,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

**GENERAL PROVISIONS**

_Article 1_

_**Subject matter**_

This Regulation lays down requirements for the design and construction of machinery
products to allow the making available on the market or putting into service of machinery
products, and establishes rules on the free movement of machinery products in the Union.

_Article 2_

_**Scope**_

(1) This Regulation applies to the following machinery products

(a) machinery;

(b) interchangeable equipment;

(c) safety components;

(d) lifting accessories;

(e) chains, ropes, slings and webbing;

(f) removable mechanical transmission devices;

(g) partly completed machinery.

(2) This Regulation does not apply to:

(a) safety components that are intended to be used as spare parts to replace
identical components and are supplied by the manufacturer of the original
machinery product;

(b) specific equipment for use in fairgrounds or amusement parks;

(c) machinery specially designed or put into service for nuclear purposes which, in
the event of failure, may result in an emission of radioactivity;

(d) weapons, including firearms;

# EN 25 EN

(e) vehicles which have as their only objective the transport of goods or persons by
road, air, water or rail except for machinery mounted on those vehicles;

(f) two- or three-wheel vehicles and quadricycles, as well as systems, components,
separate technical units, parts and equipment designed and constructed for such
vehicles, that fall within the scope of application of Regulation (EU) No
168/2013;

(g) agricultural and forestry vehicles, as well as systems, components, separate
technical units, parts and equipment designed and constructed for such
vehicles, that fall within the scope of application of Regulation (EU) No
167/2013;

(h) seagoing vessels and mobile offshore units and machinery installed on board
such vessels or units;

(i) machinery specially designed and constructed for military or police purposes;

(j) machinery specially designed and constructed for research purposes for
temporary use in laboratories;

(k) mine winding gear;

(l) machinery intended to move performers during artistic performances;

(m) the following electrical and electronic products, insofar as they fall within the

scope of application of Directive 2014/35/EU or Directive 2014/53/EU :

(i) household appliances intended for domestic use which are not
electrically operated furniture;

(ii) audio and video equipment;

(iii) information technology equipment;

(iv) office machinery;

(v) low-voltage switchgear and control gear;

(vi) electric motors;

(n) the following high-voltage electrical products:

(i) switch gear and control gear;

(ii) transformers.

_Article 3_

_**Definitions**_

For the purposes of this Regulation, the following definitions shall apply:

(1) ‘machinery’ means:

(a) an assembly, fitted with or intended to be fitted with a drive system other than
directly applied human or animal effort, consisting of linked parts or
components, at least one of which moves, and which are joined together for a
specific application;

(b) an assembly referred to in point (a), missing only the components to connect it
on site or to sources of energy and motion;

# EN 26 EN

(c) an assembly referred to points (a) and (b), ready to be installed and able to
function as it stands only if mounted on a means of transport, or installed in a
building or a structure;

(d) assemblies of machinery referred to in points (a), (b), (c) or partly completed
machinery referred to in point (7) which, in order to achieve the same end, are
arranged and controlled so that they function as an integral whole;

(e) an assembly of linked parts or components, at least one of which moves and
which are joined together, intended for lifting loads and whose only power
source is directly applied human effort;

(f) an assembly as referred to in points (a), (b), (c), (d) and (e) missing only the
upload of a software intended for its specific application.

(2) ‘interchangeable equipment’ means a device which, after the putting into service of a
machinery product, is assembled with that machinery product by the operator himself
in order to change its function or attribute to it a new function, in so far as that
equipment is not a tool;

(3) ‘safety component’ means a physical or digital component, including software, of
machinery which serves to fulfil a safety function and which is independently placed
on the market, the failure or malfunction of which endangers the safety of persons
but which is not necessary in order for the machinery to function or may be
substituted by normal components in order for the machinery to function;

(4) ‘lifting accessory’ means a component or equipment not attached to the lifting
machinery, allowing the load to be held, which is placed between the machinery and
the load or on the load itself, or which is intended to constitute an integral part of the
load and which is independently placed on the market, including slings and their
components;

(5) ‘chains’ means chains designed and constructed for lifting purposes as part of lifting
machinery or lifting accessories;

(6) ‘ropes’ means ropes designed and constructed for lifting purposes as part of lifting
machinery or lifting accessories;

(7) ‘slings’ means slings designed and constructed for lifting purposes as part of lifting
machinery or lifting accessories;

(8) ‘webbing’ means webbing designed and constructed for lifting purposes as part of
lifting machinery or lifting accessories;

(9) ‘removable mechanical transmission device’ means a removable component for
transmitting power between self-propelled machinery or a tractor and another
machine by joining them at the first fixed bearing;

(10) ‘partly completed machinery’ means an assembly which is machinery but for the fact
that it cannot in itself function so as to 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 a machinery product;

(11) ‘making available on the market’ means any supply of a machinery product for
distribution or use on the Union market in the course of a commercial activity,
whether in return for payment or free of charge;

# EN 27 EN

(12) ‘placing on the market’ means the first making available of a machinery product on
the Union market;

(13) ‘putting into service’ means the first use, for its intended purpose, in the Union, of a
machinery product;

(14) ‘Union harmonisation legislation’ means any Union legislation harmonising the
conditions for the marketing of products;

(15) ‘artificial intelligence system’ means an artificial intelligence system as defined in
Article 3(1) of Regulation (EU) _.../..._ of the European Parliament and of the Council _[+]_

(16) ‘substantial modification’ means a modification of a machinery product, by physical
or digital means after that machinery product has been placed on the market or put
into service, which is not foreseen by the manufacturer and as a result of which the
compliance of the machinery product with the relevant essential health and safety
requirements may be affected;

(17) ‘manufacturer’ means any natural or legal person who manufactures machinery
products or who has machinery products designed or manufactured, and markets
those machinery products under his or her name or trademark or who designs and
constructs machinery products for his or her own use;

(18) ‘instructions for use’ means the information provided by the manufacturer when the
machinery product is placed on the market or put into service to inform the user of
the machinery product of the intended purpose and the proper use of that machinery
product as well as information on any precautions to be taken when using or
installing the machinery product, including information on the safety aspects;

(19) ‘authorised representative’ means any natural or legal person established within the
Union who has received a written mandate from a manufacturer to act on his or her
behalf in relation to specified tasks;

(20) ‘importer’ means any natural or legal person established within the Union who
places machinery products from a third country on the Union market;

(21) ‘distributor’ means any natural or legal person in the supply chain, other than the
manufacturer or the importer, who makes machinery products available on the
market;

(22) ‘economic operators’ means the manufacturer, the authorised representative, the
importer and the distributor;

(23) ‘technical specification’ means a document that prescribes technical requirements to
be fulfilled by machinery products;

(24) ‘harmonised standard’ means a harmonised standard as defined in Article 2(1), point
(c) of Regulation (EU) No 1025/2012;

(25) ‘CE marking’ means a marking by which the manufacturer indicates that a
machinery product is in conformity with the applicable requirements set out in Union
harmonisation legislation providing for its affixing;

+ OJ: Please insert in the text the number of the Regulation contained in document … and insert the
number, date, title and OJ reference of that Regulation in the footnote."

# EN 28 EN

(26) ‘accreditation’ means accreditation as defined in Article 2, point (10) of Regulation
(EC) No 765/2008;

(27) ‘national accreditation body’ means a national accreditation body as defined in
Article 2(11) of Regulation (EC) No 765/2008;

(28) ‘conformity assessment’ means the process demonstrating whether the essential
health and safety requirements of this Regulation relating to machinery products
have been fulfilled;

(29) ‘conformity assessment body’ means a body that performs conformity assessment
activities, including calibration, testing, certification and inspection;

(30) ‘notified body’ means a conformity assessment body notified in accordance with
Article 26 of this Regulation;

(31) ‘market surveillance authority’ means a market surveillance authority as defined in
Article 3, point (4) of Regulation (EU) 2019/1020;

(32) ‘recall’ means any measure aimed at achieving the return of a machinery product that
has already been made available to the end-user;

(33) ‘withdrawal’ means any measure aimed at preventing a machinery product in the
supply chain from being made available on the market.

_Article 4_

_**Free movement**_

1. Member States shall not impede, for reasons relating to the aspects covered by this
Regulation, the making available on the market or the putting into service of
machinery products which comply with this Regulation.

2. At trade fairs, exhibitions and demonstrations or similar events, Member States shall
not prevent the display of a machinery product which does not comply with this
Regulation, provided that a visible sign clearly indicates that it does not comply with
this Regulation and will not be available on the market until it has been brought into
conformity.

During demonstrations, adequate measures shall be taken to ensure the protection of

persons.

_Article 5_

_**High-risk machinery products**_

1. High-risk machinery products listed in Annex I shall be subject to a specific
conformity assessment procedure, as referred to in Article 21(2).

2. The Commission is empowered to adopt delegated acts in accordance with Article 45
to amend Annex I in view of technical progress and knowledge or new scientific
evidence by including in the list of high-risk machinery products a new machinery
product or withdrawing an existing machinery product from that list, pursuant to the
criteria laid down in paragraphs 3 and 4.

3. A machinery product shall be included in the list of high-risk machinery products in
Annex I if it poses a risk to human health taking into account its design and intended

# EN 29 EN

purpose. A machinery product shall be withdrawn from the list of high-risk
machinery products in Annex I if it no longer poses such risk. The risk posed by a
certain machinery product shall be established based on the combination of the
probability of occurrence of harm and the severity of that harm.

In determining the probability and severity of harm, the following shall be taken into

account:

(a) the degree to which each affected person would be impacted by the harm;

(b) the number of persons potentially affected;

(c) the degree to which potentially affected parties are dependent on the
outcome produced by the machinery product;

(d) the degree to which potentially affected parties are in a vulnerable
position vis-à-vis the user of the machinery product;

(e) the degree of reversibility of the harm produced by the machinery
product;

(f) the degree to which the machinery product has been used for a specific

purpose;

(g) indications of harm that have been caused in the past by machinery
products which have been used for a specific purpose.

4. The Commission shall thoroughly assess the criteria laid down in paragraph 3 on the
basis of available information. In particular the following information shall be
communicated to the Commission by the Member States when it becomes available
to them in connection with market surveillance or as a result of the concerns referred
to in the fifth paragraph:

(a) an assessment of the risks as referred to in paragraph 3;

(b) a cost-effectiveness analysis;

(c) a machinery accident analysis;

(d) statistics on accidents caused by the machinery product for the preceding
four years based, in particular information obtained from the Information
and Communication System for Market Surveillance (ICSMS)
information, safeguard clauses, Rapid Alert System (RAPEX) and the
Machinery Administrative Cooperation Group reporting.

5. A Member State which has concerns about a machinery product being listed or not
listed in Annex I shall immediately inform the Commission of its concerns and
provide reasons in support thereof.

_Article 6_

_**Safety components**_

1. An indicative list of safety components is set out in Annex II.

2. The Commission is empowered to adopt delegated acts in accordance with Article 45
to amend Annex II in view of technical progress and knowledge or new scientific
evidence by including a new safety component in the indicative list of safety
components or withdrawing an existing safety component from that list.

# EN 30 EN

3. The Commission shall thoroughly assess the risks that require the inclusion of a new
safety component in the list of safety components in Annex II or a withdrawal of a
safety component from that list.

4. A Member State which has concerns about a safety component being listed or not
listed in Annex II shall immediately inform the Commission of its concerns and
provide reasons in support thereof.

_Article 7_

_**Requirements for machinery products**_

Machinery products shall only be made available on the market or put into service if, where
properly installed and maintained and used for their intended purpose or under conditions
which can reasonably be foreseen, they meet the essential health and safety requirements set
out in Annex III.

_Article 8_

_**Specific Union harmonisation legislation**_

Where, for a certain machinery product, the risks addressed by the essential health and safety
requirements set out in Annex III are wholly or partly covered by other more specific Union
harmonisation legislation, this Regulation shall not apply to that machinery product to the
extent that that specific Union legislation covers such risks.

_Article 9_

_**Regulation (EU) .../... of the European Parliament and of the Council+**_

Where machinery products contain an artificial intelligence system, to which the essential
health and safety requirements of Regulation (EU) …/… apply, this Regulation shall, in
relation to that artificial intelligence system, only apply with regard to its safe integration into
the overall machinery, so as not to compromise the safety of the machinery product as a

whole.

+ OJ: Please insert in the text the number of the Regulation contained in document … .

# EN 31 EN

CHAPTER II

**OBLIGATIONS OF ECONOMIC OPERATORS**

_Article 10_

_**Obligations of manufacturers**_

1. When placing a machinery product on the market, manufacturers shall ensure that it
has been designed and constructed in accordance with the essential health and safety
requirements set out in Annex III.

2. Before placing a machinery product on the market, manufacturers shall draw up the
technical documentation referred to in Annex IV (‘technical documentation’) and
carry out the relevant conformity assessment procedures referred to in Article 21 or
Article 22 or have them carried out.

Where compliance of the machinery product with the essential health and safety
requirements laid down in Annex III has been demonstrated by that conformity
assessment procedure, manufacturers shall draw up the EU declaration of conformity
in accordance with Article 18 and affix the CE marking in accordance with
Article 20, except for partially completed machinery.

3. Manufacturers shall keep the technical documentation and the EU declaration of
conformity, where relevant, at the disposal of the market surveillance authorities for
ten years after the machinery product has been placed on the market. Where relevant,
the source code or programmed logic included in the technical documentation shall
be made available upon a reasoned request from the competent national authorities
provided that it is necessary in order for those authorities to be able to check
compliance with the essential health and safety requirements set out in Annex III.

4. Manufacturers shall ensure that procedures are in place for machinery products that
are part of a series production to remain in conformity with this Regulation. Changes
in the production process or in the design or characteristics of the machinery product
and changes in the harmonised standards or the technical specifications referred to in
Article 17 by reference to which the conformity of the machinery product is declared
or by application of which its conformity is verified shall be adequately taken into

account.

When deemed appropriate with regard to the risks presented by machinery products,
manufacturers shall, to protect the health and safety of end-users _,_ carry out sample
testing of machinery products made available on the market or put into service,
investigate, and, if necessary, keep a register of complaints, of non-conforming
machinery products and machinery product recalls, and shall keep distributors
informed of any such monitoring.

5. Manufacturers shall ensure that the machinery products which they place on the
market bears a type, batch or serial number or other element allowing its
identification, or, where the size or nature of the machinery product does not allow it,
that the required information is provided on the packaging or in a document
accompanying the machinery product.

6. Manufacturers shall indicate their name, registered trade name or registered trade
mark, the postal address and the email address at which they can be contacted on the

# EN 32 EN

machinery product or, where that is not possible, on its packaging or in a document
accompanying the machinery product. The address shall indicate a single point at
which the manufacturer can be contacted. The contact details shall be in a language
easily understood by end-users and market surveillance authorities.

7. Manufacturers shall ensure that the machinery products are accompanied by the
instructions and information set out in section 1.7 of Annex III in a language which
can be easily understood by end-users, as determined by the Member State
concerned. Such instructions and information shall be clear, understandable,
intelligible and legible.

8. Manufacturers shall either provide the EU declaration of conformity with the
machinery product or include in the instructions and information set out in section
1.7 of Annex III the internet address at which the EU declaration of conformity can
be accessed.

9. Manufacturers who consider or have reason to believe that a machinery product,
which they have placed on the market or put into service is not in conformity with
the essential health and safety requirements set out in Annex III shall immediately
take the corrective measures necessary to bring that machinery product into
conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the
machinery product presents a risk, manufacturers shall immediately inform the
competent national authorities of the Member States in which they made the
machinery product available on the market to that effect, giving details, in particular,
of the non-conformity and of any corrective measures taken.

10. Manufacturers shall, further to a reasoned request from a competent national
authority, provide it with all the information and documentation, in paper or
electronic form, necessary to demonstrate the conformity of the machinery product
with the essential health and safety requirements set out in Annex III, in a language
which can be easily understood by that authority. They shall cooperate with that
authority, at its request, on any measures taken to eliminate the risks posed by the
machinery product, which they have placed on the market or put into service.

_Article 11_

**Authorised representatives**

1. A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 10(1) and the obligation to draw up the
technical documentation shall not form part of the authorised representative's
mandate.

2. An authorised representative shall perform the tasks specified in the mandate
received from the manufacturer. The mandate shall allow the authorised
representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the
disposal of the national market surveillance authorities for ten years after the
machinery product has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that
authority with all the information and documentation necessary to demonstrate
the conformity of the machinery product;

# EN 33 EN

(c) cooperate with the competent national authorities, at their request, on any
measures taken to eliminate the risks posed by a machinery product covered by
the authorised representative's mandate.

_Article 12_

_**Obligations of importers**_

1. Importers shall only place on the market machinery products that comply with the
essential health and safety requirements set out in Annex III.

2. Before placing a machinery product on the market, importers shall ensure that the
appropriate conformity assessment procedures referred to in Article 21 or Article 22
have been carried out by the manufacturer. They shall ensure that the manufacturer
has drawn up the technical documentation, that the machinery product bears the CE
marking referred to in Article 19 and is accompanied by the required documents, and
that the manufacturer has complied with the requirements set out in Article 10(5)
and (6).

Where an importer considers or has reason to believe that a machinery product is not
in conformity with the essential health and safety requirements set out in Annex III,
the importer shall not place it on the market until it has been brought into conformity.
Furthermore, where the machinery product poses a risk to the health and safety of
persons and, where appropriate, domestic animals and property and, where
applicable, the environment, the importer shall inform the manufacturer and the
market surveillance authorities to that effect.

3. Importers shall indicate their name, registered trade name or registered trade mark,
the postal address and the email address at which they can be contacted on the
machinery product or, where that is not possible, on its packaging or in a document
accompanying the machinery product. The contact details shall be in a language
easily understood by end-users and market surveillance authorities.

4. Importers shall ensure that the machinery product is accompanied by the instructions
and information set out in section 1.7 of Annex III in a language which can be easily
understood by end-users, as determined by the Member State concerned.

5. Importers shall ensure that, while the machinery product is under their responsibility,
storage or transport conditions do not jeopardise its conformity with the essential
health and safety requirements set out in Annex III.

6. When deemed appropriate with regard to the risks to the health and safety of persons
and, where appropriate, domestic animals and property and, where applicable, the
environment, presented by a machinery product, importers shall carry out sample
testing of machinery products made available on the market, investigate, and, if
necessary, keep a register of complaints, of non-conforming machinery products and
machinery products recalls, and shall keep distributors informed of any such
monitoring.

7. Importers who consider or have reason to believe that a machinery product, which
they have placed on the market, is not in conformity with the essential health and
safety requirements set out in Annex III shall immediately take the corrective
measures necessary to bring that machinery product into conformity, to withdraw it
or recall it, as appropriate. Furthermore, where the machinery product poses a risk to

# EN 34 EN

the health and safety of persons and, where appropriate, domestic animals and
property and, where applicable, the environment, importers shall immediately inform
the competent national authorities of the Member States in which they made the
machinery product available on the market to that effect, giving details, in particular,
of the non-conformity and of any corrective measures taken.

8. Importers shall, for ten years after the machinery product has been placed on the
market, keep a copy of the EU declaration of conformity at the disposal of the market
surveillance authorities and ensure that the technical documentation can be made
available to those authorities. Where relevant, the source code or programmed logic
included in the technical documentation shall be made available upon a reasoned
request from competent national authorities provided that it is necessary in order for
those authorities to be able to check compliance with the essential health and safety
requirements set out in Annex III.

9. Importers shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation, in paper or electronic form,
necessary to demonstrate the conformity of the machinery product with the essential
health and safety requirements set out in Annex III in a language that can be easily
understood by that authority. They shall cooperate with that authority, at its request,
on any measures taken to eliminate the risks to the health and safety of persons and,
where appropriate, domestic animals and property and, where applicable, the
environment posed by a machinery product, which they have placed on the market.

_Article 13_

_**Obligations of distributors**_

1. When making a machinery product available on the market, distributors shall act
with due care in relation to the requirements of this Regulation.

2. Before making a machinery product available on the market, distributors shall verify
that:

(a) the machinery product bears the CE marking;

(b) the machinery product is accompanied by the required documents and by the
instructions and information set out in section 1.7 of Annex III in a language
which can be easily understood by end-users in the Member State in which the
machinery product is to be made available on the market;

(c) the manufacturer and the importer have complied with the requirements set out
in Article 10(5) and (6) and Article 12(3) respectively.

3. Where a distributor considers or has reason to believe that a machinery product is not
in conformity with the essential health and safety requirements set out in Annex III,
the distributor shall not make the machinery product available on the market until it
has been brought into conformity. Furthermore, where the machinery product poses a
risk to the health and safety of persons and, where appropriate, domestic animals and
property and, where applicable, the environment, the distributor shall inform the
manufacturer and the market surveillance authorities to that effect.

4. Distributors shall ensure that, while a machinery product is under their responsibility,
storage or transport conditions do not jeopardise its conformity with the essential
health and safety requirements set out in Annex III.

# EN 35 EN

5. Distributors who consider or have reason to believe that a machinery product, which
they have made available on the market, is not in conformity with the essential health
and safety requirements set out in Annex III shall make sure that the corrective
measures necessary to bring that machinery product into conformity, to withdraw it
or recall it, as appropriate, are taken. Furthermore, where the machinery product
poses a risk to the health and safety of persons and, where appropriate, domestic
animals and property and, where applicable, the environment, distributors shall
immediately inform the competent national authorities of the Member States in
which they have made the machinery product available on the market to that effect,
giving details, in particular, of the non-conformity and of any corrective measures
taken.

6. Distributors shall, further to a reasoned request from a competent national authority,
provide it with all the information and documentation, in paper or electronic form,
necessary to demonstrate the conformity of the machinery product with the essential
health and safety requirements set out in Annex III in a language that can be easily
understood by that authority. They shall cooperate with that authority, at its request,
on any measures taken to eliminate the risks to the health and safety of persons and,
where appropriate, domestic animals and property and, where applicable, the
environment, posed by a machinery product, which they have made available on the
market.

_Article 14_

_**Cases in which obligations of manufacturers apply to importers and distributors**_

An importer or distributor shall be considered a manufacturer for the purposes of this
Regulation and shall be subject to the obligations of the manufacturer set out in Article 10
where that importer or distributor places a machinery product on the market under his or her
name or trademark or carries out a substantial modification of a machinery product that has
already been placed on the market or put into service.

_Article 15_

_**Other cases in which obligations of manufacturers apply**_

A natural or legal person, other than the manufacturer, the importer or the distributor, that
carries out a substantial modification of the machinery product shall be considered a
manufacturer for the purposes of this Regulation and shall be subject to the obligations of the
manufacturer set out in Article 10 for the part of the machinery product that is affected by the
modification or, if the substantial modification has an impact on the safety of the machinery
product as a whole, for the entire machinery product _._

_Article 16_

_**Identification of economic operators**_

1. Economic operators shall, on request, identify the following to the market
surveillance authorities:

# EN 36 EN

(a) any economic operator who has supplied them with a machinery product;

(b) any economic operator to whom they have supplied a machinery product.

2. Economic operators shall be able to present the information referred to in paragraph
1 for ten years after they have been supplied with the machinery product and for ten
years after they have supplied the machinery product.

CHAPTER III

**CONFORMITY OF THE MACHINERY**

_Article 17_

_**Presumption of conformity of machinery products**_

1. A machinery product which is in conformity with harmonised standards or parts
thereof the references of which have been published in the _Official Journal of the_
_European Union_ shall be presumed to be in conformity with the essential health and
safety requirements set out in Annex III covered by those standards or parts thereof.

2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No
1025/2012, request one or more European standardisation organisations to draft
harmonised standards for the essential health and safety requirements set out in
Annex III.

3. The Commission is empowered to adopt implementing acts establishing technical
specifications for the essential health and safety requirements set out in Annex III
where the following conditions have been fulfilled:

(a) no reference to harmonised standards covering the relevant essential health and
safety requirements is published in the _Official Journal of the European Union_
in accordance with Regulation (EU) No 1025/2012;

(b) the Commission has requested one or more European standardisation
organisations to draft a harmonised standard for the essential health and safety
requirements and there are undue delays in the standardisation procedure or the
request has not been accepted by any of the European standardisation
organisations.

Those implementing acts shall be adopted in accordance with the examination
procedure referred to in Article 46(3).

4. A machinery product which is in conformity with the technical specifications or parts
thereof shall be presumed to be in conformity with the essential health and safety
requirements set out in Annex III covered by those technical specifications or parts
thereof.

5. Machinery products that have been certified or for which a statement of conformity
has been issued under a cybersecurity scheme adopted in accordance with Regulation
(EU) 2019/881 and the references of which have been published in the _Official_
_Journal of the European Union_ shall be presumed to be in conformity with the
essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1,
as regards protection against corruption and safety and reliability of control systems
in so far as those requirements are covered by the cybersecurity certificate or
statement of conformity or parts thereof.

# EN 37 EN

_Article 18_

_**EU declaration of conformity**_

1. The EU declaration of conformity shall state that the fulfilment of the applicable
essential health and safety requirements set out in Annex III has been demonstrated.

2. The EU declaration of conformity shall have the model structure set out in Annex V,
shall contain the elements specified in the relevant modules set out in Annexes VI,
VII, VIII and IX and shall be continuously updated. It shall be translated into the
language or languages required by the Member State in which the machinery product
is placed on the market or is made available on the market.

3. Where a machinery product is subject to more than one Union act requiring an EU
declaration of conformity, a single EU declaration of conformity shall be drawn up in
respect of all such Union acts. That declaration shall contain the identification of the
Union acts concerned, including their publication references.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for the compliance of the machinery product with the requirements laid
down in this Regulation.

_Article 19_

_**General principles of the CE marking**_

The CE marking shall be subject to the general principles set out in Article 30 of Regulation
(EC) No 765/2008.

_Article 20_

_**Rules for affixing the CE marking**_

1. The CE marking shall be affixed visibly, legibly and indelibly to the machinery
product. Where that is not possible or not warranted on account of the nature of the
machinery product, it shall be affixed to the packaging and to the documents
accompanying the machinery product.

2. The CE marking shall be affixed before the machinery product is placed on the
market.

3. For a machinery product in the conformity assessment of which a notified body
participates in accordance with Annex IX, the CE marking shall be followed by the
identification number of that notified body.

The identification number of the notified body shall be affixed by the body itself or,
under its instructions, by the manufacturer or the manufacturer’s authorised
representative.

4. The CE marking and, where applicable, the identification number of the notified
body may be followed by a pictogram or other marking indicating a special risk or

use.

# EN 38 EN

5. Member States shall build upon existing mechanisms to ensure correct application of
the regime governing the CE marking and shall take appropriate action in the event
of improper use of that marking.

CHAPTER IV

**CONFORMITY ASSESSMENT**

_Article 21_

_**Conformity assessment procedures for machinery products except partly completed**_

_**machinery**_

1. In order to certify the conformity of a machinery product with this Regulation, the
manufacturer or its authorised representative and the person who has carried out a
substantial modification to the machinery product, shall apply one of the procedures
for assessment of conformity referred to in paragraphs 2 and 3.

2. Where the machinery product is a high-risk machinery product listed in Annex I, the
manufacturer or the manufacturer’s authorised representative and the person who has
carried out a substantial modification to the machinery product shall apply one of the
following procedures:

(a) EU type-examination procedure (module B) provided for in Annex VII,
followed by conformity to type based on internal production control (module
C) set out in Annex VIII;

(b) Conformity based on full quality assurance (module H) set out in Annex IX.

3. Where the machinery product is not a high-risk machinery product listed in Annex I,
the manufacturer or the manufacturer’s authorised representative and the person who
has made a substantial modification to the machinery product shall apply the internal
production control procedure (module A) set out in Annex VI.

4. Notified bodies shall take into account the specific interests and needs of small and
medium sized enterprises when setting the fees for conformity assessment and reduce
those fees proportionately to their specific interests and needs.

_Article 22_

_**Conformity assessment procedures for partly completed machinery**_

1. The manufacturer of partly completed machinery or the manufacturer’s authorised
representative shall, before placing partly completed machinery on the market,
ensure that the following documents are drawn up:

(a) the relevant technical documentation that satisfies the requirements laid down
in Annex IV, part B;

(b) assembly instructions that satisfy the requirements laid down in Annex X;

(c) the EU declaration of incorporation that has the model structure set out in
Annex V.

# EN 39 EN

2. Where relevant, the manufacturer of partly completed machinery or the
manufacturer’s authorised representative shall make available to the competent
national authority upon its request the source code or programmed logic included in
the technical documentation referred to in paragraph 1, point (a),, provided that it is
needed in order for that authority to be able to check compliance with the essential
health and safety requirements set out in Annex III. The assembly instructions
referred to in paragraphs 1, point (b), and the declaration of incorporation referred to
in paragraph 1, point (c), shall accompany the partly completed machinery until it is
incorporated into the final machinery product and shall afterwards form part of the
technical file for that machinery product.

_Article 23_

_**Protection of persons during installation and use of machinery products**_

Member States may lay down requirements to ensure that persons, including workers, are
protected when installing and using machinery products, provided that such rules do not allow
for modification of a machinery product in a way that is not compatible with this Regulation.

CHAPTER V

**NOTIFICATION OF CONFORMITY ASSESSMENT BODIES**

_Article 24_

_**Notification**_

Member States shall notify the Commission and the other Member States of conformity
assessment bodies authorised to carry out conformity assessments in accordance with this
Regulation.

_Article 25_

_**Notifying authorities**_

1. Member States shall designate a notifying authority that shall be responsible for
setting up and carrying out the necessary procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified bodies,
including compliance with Article 32.

2. Member States may decide that the assessment and monitoring referred to in
paragraph 1 shall be carried out by a national accreditation body within the meaning
of and in accordance with Regulation (EC) No 765/2008.

3. Where the notifying authority delegates or otherwise entrusts the assessment,
notification or monitoring referred to in paragraph 1 of this Article to a body, which
is not a governmental entity that body shall be a legal entity and shall comply _mutatis_
_mutandis_ with the requirements laid down in Article 26. In addition, that body shall
have arrangements to cover liabilities arising out of its activities.

# EN 40 EN

4. The notifying authority shall take full responsibility for the tasks performed by the
body referred to in paragraph 3.

_Article 26_

_**Requirements relating to notifying authorities**_

1. A notifying authority shall be established in such a way that no conflict of interest
with conformity assessment bodies occurs.

2. A notifying authority shall be organised and operated so as to safeguard the
objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each decision relating to
notification of a conformity assessment body is taken by competent persons different
from those who carried out the assessment of the machinery product.

4. A notifying authority shall not offer or provide any activities that conformity
assessment bodies perform, or consultancy services on a commercial or competitive
basis.

5. A notifying authority shall safeguard the confidentiality of the information it obtains.

6. A notifying authority shall have a sufficient number of competent personnel at its
disposal for the proper performance of its tasks.

_Article 27_

_**Information obligation on notifying authorities**_

Member States shall inform the Commission of their procedures for the assessment and
notification of conformity assessment bodies and the monitoring of notified bodies, and of
any changes thereto.

The Commission shall make that information publicly available.

_Article 28_

_**Requirements relating to notified bodies**_

1. For the purposes of notification, a conformity assessment body shall meet the
requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under the national law of a
Member State and have legal personality.

3. A conformity assessment body shall be a third-party body independent of the
organisation or the machinery product it assesses.

A body belonging to a business association or professional federation representing
undertakings involved in the design, manufacture, provision, assembly, use or
maintenance of machinery products which it assesses, may, on the condition that its
independence and the absence of any conflict of interest are demonstrated, be
considered such a conformity assessment body.

# EN 41 EN

4. A conformity assessment body, its top-level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be the
designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of a
machinery product, that they assess, nor the representative of any of those parties.
This shall not preclude the use of a machinery product that is necessary for the
operations of the conformity assessment body or the use of a machinery product for
personal purposes.

A conformity assessment body, its top-level management and the personnel
responsible for carrying out the conformity assessment tasks shall not be directly
involved in the design, manufacture, marketing, installation, use or maintenance of
machinery products, or represent the parties engaged in those activities. They shall
not engage in any activity that may conflict with their independence of judgement or
integrity in relation to conformity assessment activities for which they are notified.
This shall in particular apply to consultancy services.

A conformity assessment body shall ensure that the activities of its subsidiaries or
subcontractors do not affect the confidentiality, objectivity or impartiality of its
conformity assessment activities.

5. A conformity assessment body and its personnel shall carry out the conformity
assessment activities with the highest degree of professional integrity and the
requisite technical competence in the specific field and shall be free from all
pressures and inducements, particularly financial, which might influence its
judgement or the results of its conformity assessment activities, especially as regards
persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity
assessment activities mentioned in Annexes VII, VIII and IX and in relation to which
it has been notified, whether those tasks are carried out by the conformity assessment
body itself or on its behalf and under its responsibility.

At all times, and for each conformity assessment procedure and each kind of a
machinery product for which it has been notified, a conformity assessment body shall
have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience
to perform the conformity assessment activities;

(b) descriptions of procedures in accordance with which conformity assessment is
carried out, ensuring the transparency and the ability of reproduction of those
procedures;

(c) appropriate policies and procedures to distinguish between activities that it
carries out as a notified body and other activities;

(d) procedures for the performance of conformity assessment activities which take
due account of the size of an undertaking, the sector in which it operates, its
structure, the degree of complexity of the machinery technology in question
and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the
technical and administrative tasks connected with the conformity assessment
activities in an appropriate manner and shall have access to all necessary equipment
or facilities.

# EN 42 EN

7. The personnel responsible for carrying out conformity assessment tasks shall have
the following:

(a) sound technical and vocational training covering all the conformity assessment
activities in relation to which the conformity assessment body has been
notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out
and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential health and safety
requirements set out in Annex III, of the applicable harmonised standards
referred to in Article 17, and of the relevant provisions of Union harmonisation
legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that
conformity assessments have been carried out.

8. The impartiality of a conformity assessment body, its top-level management and the
personnel responsible for carrying out the conformity assessment activities shall be
guaranteed.

The remuneration of the top-level management and the personnel responsible for
carrying out the conformity assessment activities shall not depend on the number of
conformity assessments carried out or on the results of those assessments.

9. A conformity assessment body shall take out liability insurance unless liability is
assumed by the Member State in accordance with national law, or the Member State
itself is directly responsible for the conformity assessment.

10. The personnel of a conformity assessment body shall observe professional secrecy
with regard to all information obtained in carrying out the conformity assessment
activities in accordance with Annexes VII, VIII and IX, except in relation to the
competent authorities of the Member State in which its activities are carried out.
Proprietary rights, intellectual property rights and trade secrets shall be protected.

11. A conformity assessment body shall participate in, or ensure that its personnel
responsible for carrying out the conformity assessment activities are informed of, the
relevant standardisation activities and the activities of the notified body coordination
group established under Article 40 and shall apply as general guidance the
administrative decisions and documents produced as a result of the work of that

group.

_Article 29_

_**Presumption of conformity of notified bodies**_

Where a conformity assessment body demonstrates its conformity with the criteria laid down
in the relevant harmonised standards or parts thereof the references of which have been
published in the _Official Journal of the European Union_, it shall be presumed to comply with
the requirements set out in Article 28 in so far as the applicable harmonised standards cover
those requirements.

# EN 43 EN

_Article 30_

_**Subsidiaries of and subcontracting by notified bodies**_

1. Where a notified body subcontracts specific tasks connected with conformity
assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or
the subsidiary meets the requirements set out in Article 28 and shall inform the
notifying authority accordingly.

2. A notified body shall take full responsibility for the tasks performed by
subcontractors or subsidiaries wherever those are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the
agreement of the client.

4. A notified body shall keep at the disposal of the notifying authority the relevant
documents concerning the assessment of the qualifications of the subcontractor or the
subsidiary and the work carried out by them under Annexes VII, VIII and IX.

_Article 31_

_**Application for notification**_

1. A conformity assessment body shall submit an application for notification to the
notifying authority of the Member State in which it is established.

2. The application for notification shall be accompanied by a description of the
conformity assessment activities, of the conformity assessment procedures set out in
Annexes VII, VIII and IX and of the kind of machinery product for which the
conformity assessment body claims to be competent, as well as by an accreditation
certificate, where one exists, issued by a national accreditation body attesting that the
conformity assessment body fulfils the requirements laid down in Article 28.

3. Where the conformity assessment body concerned cannot provide an accreditation
certificate as referred to in paragraph 2, it shall provide the notifying authority with
all the documentary evidence necessary for the verification, recognition and regular
monitoring of its compliance with the requirements laid down in Article 28.

_Article 32_

_**Notification procedure**_

1. A notifying authority shall notify only conformity assessment bodies which have
satisfied the requirements laid down in Article 28.

2. The notifying authority shall send a notification to the Commission and the other
Member States of each conformity assessment body referred to in paragraph 1, using
the electronic notification tool developed and managed by the Commission.

3. The notification referred to in paragraph 2 shall include the following:

(a) full details of the conformity assessment activities to be performed;

(b) an indication of the conformity assessment module or modules and the kinds of
machinery products concerned;

# EN 44 EN

(c) the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate referred to in Article
31(2), the notifying authority shall provide the Commission and the other Member
States with documentary evidence which attests to the conformity assessment body's
competence and the arrangements in place to ensure that that body will be monitored
regularly and will continue to satisfy the requirements laid down in Article 28.

5. The conformity assessment body concerned may perform the activities of a notified
body only where no objections are raised by the Commission or the other Member
States within two weeks of the validation of the notification where it includes an
accreditation certificate referred to in Article 31(2), or within two months of the
notification where it includes documentary evidence referred to in Article 31(3).

Only such a body shall be considered a notified body for the purposes of this
Regulation.

6. The notifying authority shall notify the Commission and the other Member States of
any subsequent relevant changes to the notification referred to in paragraph 2.

_Article 33_

_**Identification numbers and lists of notified bodies**_

1. The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several
Union acts.

2. The Commission shall make publicly available the list of notified bodies including
the identification numbers that have been assigned to them and the conformity
assessment activities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

_Article 34_

_**Changes to notifications**_

1. Where a notifying authority has ascertained or has been informed that a notified body
no longer meets the requirements laid down in Article 28, or that it is failing to fulfil
its obligations as set out in Article 35 the notifying authority shall restrict, suspend or
withdraw the notification, as appropriate, depending on the seriousness of the failure
to meet those requirements or fulfil those obligations. It shall immediately inform the
Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the
notified body has ceased its activity, the notifying authority shall take appropriate
steps to ensure that the files of that body are either processed by another notified
body or kept available for the responsible notifying and market surveillance
authorities at their request.

# EN 45 EN

_Article 35_

_**Challenge of the competence of notified bodies**_

1. The Commission shall investigate all cases where it doubts, or doubt is brought to its
attention regarding, the competence of a notified body or the continued fulfilment by
a notified body of the requirements and responsibilities to which it is subject.

2. The notifying authority shall provide the Commission, on request, with all
information relating to the basis for the notification or the maintenance of the
competence of the notified body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of
its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer
meets the requirements for its notification, it shall adopt an implementing act
requesting the notifying authority to take the necessary corrective measures,
including the withdrawal of the notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure
referred to in Article 46(2).

_Article 36_

_**Operational obligations of notified bodies**_

1. A notified body shall carry out conformity assessments in accordance with the
conformity assessment procedures set out in Annexes VII, VIII and IX.

2. A notified body shall perform its activities in a proportionate manner, avoiding
unnecessary burdens for economic operators, and taking due account of the size of an
undertaking, the sector in which the undertaking operates, the structure of the
undertaking, the degree of complexity of the machinery technology in question and
the mass or serial nature of the production process.

In so doing, the notified body shall nevertheless respect the degree of rigour and the
level of protection required for the compliance of the machinery product with the
requirements of this Regulation.

3. Where a notified body finds that the essential health and safety requirements set out
in Annex III, or the harmonised standards referred to in Article 17, or other technical
specifications have not been met by a manufacturer, it shall require the manufacturer
to take appropriate corrective measures and shall not issue a certificate of conformity
or adopt an approval decision

4. Where, in the course of the monitoring of conformity following the issuance of a
certificate of conformity or the adoption of an approval decision, a notified body
finds that a machinery product no longer complies, it shall require the manufacturer
to take appropriate corrective measures and shall suspend or withdraw the certificate
of conformity or the approval decision, if necessary.

5. Where corrective measures are not taken or do not have the required effect, the
notified body shall restrict, suspend or withdraw any certificates of conformity or
approval decisions, as appropriate.

# EN 46 EN

_Article 37_

_**Appeals against decisions of notified bodies**_

A notified body shall ensure that a transparent and accessible appeals procedure against its
decisions is available.

_Article 38_

_**Information obligation on notified bodies**_

1. A notified body shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate of conformity
or approval decision;

(b) any circumstances affecting the scope of, or the conditions for, its notification;

(c) any request for information which it has received from market surveillance
authorities regarding its conformity assessment activities;

(d) on request, any conformity assessment activities performed within the scope of
its notification and any other activity performed, including cross-border
activities and subcontracting.

2. A notified body shall provide other notified bodies carrying out similar conformity
assessment activities covering the same kinds of machinery product with relevant
information on issues relating to negative and, on request, positive conformity
assessment results.

_Article 39_

_**Exchange of experience**_

The Commission shall provide for the organisation of exchange of experience between the
Member States' national authorities responsible for notification policy.

_Article 40_

_**Coordination of notified bodies**_

The Commission shall ensure that appropriate coordination and cooperation between notified
bodies are put in place and properly operated in the form of a sectoral group of notified
bodies.

A notified body shall participate in the work of that group, directly or by means of designated
representatives.

CHAPTER VI

**UNION MARKET SURVEILLANCE, CONTROL OF MACHINERY PRODUCTS**

**ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE**

# EN 47 EN

_Article 41_

_**Procedure at national level for dealing with machinery products presenting a risk**_

1. Where the market surveillance authorities of one Member State have sufficient
reason to believe that a machinery product covered by this Regulation presents a risk
to the health or safety of persons, and, where appropriate, domestic animals or to
property and, where applicable, the environment, they shall carry out an evaluation in
relation to the machinery product concerned covering all relevant requirements laid
down in this Regulation. The relevant economic operators shall cooperate as
necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the
market surveillance authorities find that the machinery product does not comply with
the requirements laid down in this Regulation, they shall without delay require the
relevant economic operator to take all appropriate corrective action to bring the
machinery product into compliance with those requirements, to withdraw the
machinery product from the market, or to recall it within a reasonable period which is
commensurate with the nature of the risk referred to in the first subparagraph.

The market surveillance authorities shall inform the relevant notified body
accordingly.

2. Where the market surveillance authorities consider that non-compliance is not
restricted to their national territory, they shall inform the Commission and the other
Member States of the results of the evaluation and of the actions which they have
required the economic operator to take.

3. The economic operator shall ensure that all appropriate corrective action is taken in
respect of all the machinery products concerned that the economic operator has made
available on the market throughout the Union.

4. Where the relevant economic operator does not take adequate corrective action
within the period referred to in paragraph 1, second subparagraph, the market
surveillance authorities shall take all appropriate provisional measures to prohibit or
restrict the machinery product being made available on their national market, to
withdraw the machinery product from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other
Member States, without delay, of those measures.

5. The information referred to in paragraph 4, second subparagraph, shall include all
available details, in particular the data necessary for the identification of the noncompliant machinery product, the origin of that machinery product, the nature of the
non-compliance alleged and the risk involved, the nature and duration of the national
measures taken and the arguments put forward by the relevant economic operator. In
particular, the market surveillance authorities shall indicate whether the noncompliance is due to any of the following:

(a) failure of the machinery product to meet the requirements relating to the
essential health and safety requirements set out in Annex III;

(b) shortcomings in the harmonised standards referred to in Article 17(1);

(c) shortcomings in the technical specifications referred to in Article 17(4).

# EN 48 EN

6. Member States other than the Member State initiating the procedure under this
Article shall without delay inform the Commission and the other Member States of
any measures adopted and of any additional information at their disposal relating to
the non-compliance of the machinery product concerned, and, in the event of
disagreement with the adopted national measure, of their objections.

7. Where, within three months of receipt of the information referred to in paragraph 4,
second subparagraph, no objection has been raised by either a Member State or the
Commission in respect of a provisional measure taken by a Member State, that
measure shall be deemed justified.

8. Member States shall ensure that appropriate restrictive measures, such as withdrawal
of the machinery product from the market, are taken in respect of the machinery
product concerned without delay.

_Article 42_

_**Union safeguard procedure**_

1. Where, on completion of the procedure set out in Article 41(3) and (4), objections
are raised against a measure taken by a Member State, or where the Commission
considers a national measure to be contrary to Union legislation, the Commission
shall without delay enter into consultation with the Member States and the relevant
economic operator or operators and shall evaluate the national measure. On the basis
of the results of that evaluation, the Commission shall adopt an implementing act in
the form of a decision determining whether the national measure is justified or not.

The Commission shall address its decision to all Member States and shall without
delay communicate it to them and to the relevant economic operator or operators.

That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 46(3).

2. If the national measure is considered justified, all Member States shall take the
necessary measures to ensure that the non-compliant machinery product is
withdrawn from their market, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned shall
withdraw that measure.

3. Where the national measure is considered justified and the non-compliance of the
machinery product is attributed to shortcomings in the harmonised standards or
technical specifications referred to in Article 41(5), points (b) and (c), of this
Regulation, the Commission shall apply the procedure provided for in Article 11 of
Regulation (EU) No 1025/2012.

_Article 43_

_**Compliant machinery products which present a risk**_

1. Where, having carried out an evaluation under Article 41(1), a Member State finds
that although a machinery product is in compliance with the essential health and
safety requirements set out in Annex III, it poses a risk to the health and safety of
persons and, where appropriate, domestic animals or to property and, where

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applicable, the environment, it shall require the relevant economic operator to take
all appropriate measures to ensure that the machinery product concerned, when
placed on the market, no longer presents that risk, to withdraw the machinery product
from the market or to recall it within a reasonable period which is commensurate
with the nature of the risk.

2. The economic operator shall ensure that corrective action is taken in respect of all the
machinery products concerned that the economic operator has made available on the
market throughout the Union.

3. The Member State shall immediately inform the Commission and the other Member
States. That information shall include all available details, in particular the data
necessary for the identification of the machinery product concerned, the origin and
the supply chain of the machinery product, the nature of the risk involved and the
nature and duration of the national measures taken.

4. The Commission shall without delay enter into consultation with the Member States
and the relevant economic operator or operators and shall evaluate the national
measures taken. On the basis of the results of that evaluation, the Commission shall
adopt an implementing act in the form of a decision determining whether the national
measure is justified or not and, where necessary, order appropriate measures.

That implementing act shall be adopted in accordance with the examination
procedure referred to in Article 46(3).

On duly justified imperative grounds of urgency relating to the protection of the
health and safety of persons, the Commission shall adopt an immediately applicable
implementing act in accordance with the procedure referred to in Article 46(4).

5. The Commission shall address its decision to all Member States and shall
immediately communicate it to them and to the relevant economic operator or
operators.

_Article 44_

_**Formal non-compliance**_

1. Without prejudice to Article 41, where a Member State makes one of the following
findings with regard to a machinery product, it shall require the relevant economic
operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of Article 30 of Regulation (EC)
No 765/2008 or of Article 20 of this Regulation;

(b) the CE marking has not been affixed;

(c) the identification number of the notified body involved in the production
control phase has been affixed in violation of Article 20(3) or has not been
affixed;

(d) the EU declaration of conformity has not been drawn up or has not been drawn
up correctly;

(e) the technical documentation is either not available or not complete;

(f) the information referred to in Article 10(6) or Article 12(3) is absent, false or
incomplete;

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(g) any other administrative requirement provided for in Article 10 or Article 12 is
not fulfilled.

2. Where the non-compliance referred to in paragraph 1 persists, the Member State
concerned shall take all appropriate measures to restrict or prohibit the machinery
product being made available on the market or ensure that it is recalled or withdrawn
from the market.

CHAPTER VII

**DELEGATED POWERS AND COMMITTEE PROCEDURE**

_Article 45_

_**Exercise of the delegation**_

1. The power to adopt delegated acts is conferred on the Commission subject to the
conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Articles 5(2) and 6(2) shall be
conferred on the Commission for a period of five years from … [ _the date of entry_
_into force of this Regulation_ ]. The Commission shall draw up a report in respect of
the delegation of power not later than nine months before the end of the five-year
period. The delegation of power shall be tacitly extended for periods of an identical
duration, unless the European Parliament or the Council opposes such extension not
later than three months before the end of each period.

3. Before adopting a delegated act, the Commission shall consult experts designated by
each Member State in accordance with the principles laid down in the
Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

4. The delegation of powers referred to in Articles 5(2) and 6(2) may be revoked at any
time by the European Parliament or by the Council. A decision to revoke shall put an
end to the delegation of the power specified in that decision. It shall take effect the
day following the publication of the decision in the _Official Journal of the European_
_Union_ or at a later date specified therein. It shall not affect the validity of any
delegated acts already in force.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to
the European Parliament and to the Council.

6. A delegated act adopted pursuant to Articles 5(2) and 6(2) shall enter into force only
if no objection has been expressed either by the European Parliament or the Council
within a period of two months of notification of that act to the European Parliament
and the Council or if, before the expiry of that period, the European Parliament and
the Council have both informed the Commission that they will not object. That
period shall be extended by two months at the initiative of the European Parliament
or of the Council.

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_Article 46_

_**Committee procedure**_

1. The Commission shall be assisted by a committee. That committee shall be a
committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No
182/2011 shall apply.

3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No
182/2011 shall apply.

4. Where reference is made to this paragraph, Article 8 of Regulation (EU) No
182/2011, in conjunction with Article 5 thereof, shall apply.

5. The committee shall be consulted by the Commission on any matter for which
consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by
any other Union legislation.

The committee may furthermore examine any other matter concerning the
application of this Regulation raised either by its chair or by a representative of a
Member State in accordance with its rules of procedure.

CHAPTER VIII

**CONFIDENTIALITY AND PENALTIES**

_Article 47_

_**Confidentiality**_

1. All parties shall respect the confidentiality of the following information and data
obtained in carrying out their tasks in accordance with this Regulation:

(a) personal data;

(b) commercially confidential information and trade secrets of a natural or legal
person, including intellectual property rights, unless disclosure is in the public
interest.

2. Without prejudice to paragraph 1, information exchanged on a confidential basis
between the competent national authorities and between competent national
authorities and the Commission shall not be disclosed without the prior agreement of
the originating competent national authority.

3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission,
Member States and notified bodies with regard to the exchange of information and
the dissemination of warnings, nor the obligations of the persons concerned to
provide information under criminal law.

4. The Commission and Member States may exchange confidential information with
regulatory authorities of third countries with which they have concluded bilateral or
multilateral confidentiality arrangements.

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_Article 48_

_**Penalties**_

1. Member States shall lay down the rules on penalties applicable to infringements by
economic operators of this Regulation and shall take all measures necessary to
ensure that they are enforced. The penalties provided for shall be effective,
proportionate and dissuasive and may include criminal penalties for serious
infringements.

2. Member States shall notify those rules and those measures to the Commission by …

[ _24 months after the date of entry into force of this Regulation_ ] and shall notify it
without delay of any subsequent amendment affecting them.

CHAPTER IX

_TRANSITIONAL AND FINAL PROVISIONS_

_Article 49_

_**Repeals**_

1. Directive 73/361/EEC is repealed.

References to the repealed Directive 73/361/EEC shall be construed as references to
this Regulation.

2. Directive 2006/42/EC is repealed with effect from … [30 months after the date of
entry into force of this Regulation].

References to the repealed Directive 2006/42/EC shall be construed as references to
this Regulation and shall be read in accordance with the correlation table in Annex
XI.

_Article 50_

_**Transitional provisions**_

1. Member States shall not until … [ _42 months after the date of entry into force of this_
_Regulation_ ] impede the making available on the market of machinery which was
placed on the market in conformity with Directive 2006/42/EC before … [ _the date of_
_entry into force of this Regulation_ ]. However, Chapter VI of this Regulation shall
apply _mutatis mutandis_ to such machinery instead of Article 11 of that Directive,
including machinery for which a procedure has already been initiated under Article
11 of Directive 2006/42/EC as from … [ _the date of entry into force of this_
_Regulation_ ].

2. EC type-examination certificates and approval decisions issued in accordance with
Article 14 of Directive 2006/42/EC shall remain valid until … [ _42 months after the_
_date of entry into force of this Regulation_ ], unless they expire before that date.

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_Article 51_

_**Evaluation and review**_

1. By … [ _54 months after the date of entry into force of this Regulation_ ] and every four
years thereafter, the Commission shall submit a report on the evaluation and review
of this Regulation to the European Parliament and to the Council. The reports shall
be made public.

2. Taking account of technical progress and practical experience gained in Member
States as indicated in Article 5, the Commission shall in its report include an
evaluation on the following aspects of this Regulation:

(a) the essential health and safety requirements set out in Annex III;

(b) the conformity assessment procedure applicable to high-risk machinery
products listed in Annex I.

Where appropriate, the report shall be accompanied by a legislative proposal for
amendment of the relevant provisions of this Regulation.

_Article 52_

_**Entry into force and application**_

This Regulation shall enter into force on the twentieth day following that of its publication in
the _Official Journal of the European Union_ .

It shall apply from … [30 months after the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

_For the European Parliament_ _For the Council_

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