Commission Notice – Guidance to the Member States for the collection of the data and the information referred to in Article 6 (5), points (a) to (d), of Regulation (EU) 2023/1230 of the European Parliament and the Council
Date: 2024-10-14
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: EC conformity marking, European standard, data collection, exchange of information, machinery, market approval, product design, product safety, safety standard, technical standard








C_202406142EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2024/6142


14.10.2024







            COMMISSION NOTICE
         
Guidance to the Member States for the collection of the data and the information referred to in Article 6 (5), points (a) to (d), of Regulation (EU) 2023/1230 of the European Parliament and the Council
(Text with EEA relevance)
(C/2024/6142)


TABLE OF CONTENTS






Important Statement
1








Introduction
2








Guidance on how to fill in the Template
2








General instructions
2








Specific instructions
3








Annex A – Template column numbering
13








Annex B – List of codes following the ESAW classification of Material Agents, under which categories of machinery or related products in scope of Annex I of the Regulation could be found.
14




IMPORTANT STATEMENT

The purpose of this document, which is based on Article 6(10), second subparagraph, of Regulation (EU) 2023/1230 on machinery (1) (‘the Regulation’), is to provide guidance only on matters related to the collection of the data and the information referred to in Article 6(5), points (a) to (d), of that Regulation and on the filling of the standardised template set out in the Annex to Commission Implementing Regulation (EU) 2024/1922 (2) (‘the Template’).
This document is addressed to Member States, but it also concerns third countries, i.e. countries which are not Member States of the European Union (EU), that concluded an agreement with the EU for extending the applicability of the Regulation to those countries. References in this document to ‘Member States’ or ‘the EU’ are, accordingly, to be understood as referring to those third countries, as well.
This document is intended purely as a guidance document. Only the text of the Union harmonisation act itself has legal force.
The binding interpretation of Union legislation is the exclusive competence of the Court of Justice of the European Union. The views expressed in this document cannot prejudge the position that the Commission might take before the Court of Justice.
This document reflects the legislation at the time of the drafting of this document and the guidance offered may be subject to later modification.

INTRODUCTION

The Regulation entered into force on 19 July 2023 and will apply as of 20 January 2027. It lays down health and safety requirements for the design and construction of machinery, related products and partly completed machinery to allow them to be made available on the EU market or put into service in the EU, while ensuring a high level of protection of the health and safety. It will also repeal and replace, from 20 January 2027, Directive 2006/42/EC (3).
Under Article 6(10), first subparagraph, of the Regulation, the Commission is to provide for a standardised template for the collection by Member States of the data and the information referred to in Article 6(5), points (a) to (d) of the Regulation, including the information referred to in Article 6(9) of the same Regulation. Such standardised template aims at ensuring uniform conditions for the collection of data and information for the purpose of adding a category of machinery or related products to Annex I to that Regulation or withdrawing a category of machinery or related products from that Annex.
The current standardised template is laid down in the Annex to Implementing Regulation (EU) 2024/1922 (‘the Template’).
In addition, under Article 6(10), second subparagraph, of the Regulation, the Commission shall issue guidance to Member States on the collection and transmission of comparable, high-quality data and information. The purpose of this document is to provide guidance to Member States, as provided for in Article 6(10), second subparagraph, of the Regulation.

GUIDANCE ON HOW TO FILL IN THE TEMPLATE


General instructions

Pursuant to Article 6(9) of the Regulation, the Template shall be filled-in and submitted by 20 July 2025, and every five years thereafter.
The Template, submitted in a given year (Y), covers data and information concerning a period of five years as indicated in the relevant columns of the Template.
In the context of the Template:






 


Y-2 (year of submission minus 2): covers the second calendar year, from 1 January to 31 December, preceding the year of submission of the report;










 


Y-3 (year of submission minus 3): covers the third calendar year (from 1 January to 31 December) preceding the year of submission of the report;










 


Y-4 (year of submission minus 4): covers the fourth calendar year (from 1 January to 31 December) preceding the year of submission of the report;










 


Y-5 (year of submission minus 5): covers the fifth calendar year (from 1 January to 31 December) preceding the year of submission of the report;










 


Y-6 (year of submission minus 6): covers the sixth calendar year (from 1 January to 31 December) preceding the year of submission of the report;










 


EU legislation on machinery means: the Regulation or Directive 2006/42/EC or the EU legislation on machinery applicable prior to Directive 2006/42/EC;




It is preferable that the Template is filled-in in the English language.
Each Member State should fill-in and submit only one template, in excel format, including all data related to that Member State.
The template can be submitted electronically via the relevant functional mailbox.

Specific instructions


Top of the Template (from left to right)

—   Year (’Y’) of submission of report [whole number field]
In this field it is to be indicated the calendar year in which the Member State submits the filled-in Template to the Commission.
—   Member State [text field, maximum 10 words]
In this field it is to be indicated the name of the Country submitting the data and information.

Main Table of the Template (from left to right)


To facilitate the reading of the column order, the columns are numbered in Annex A to this guidance.

—   First Column (1): Category in Annex I to the Regulation [scroll down choice]

                     ‘Category’ relates to categories of machinery and related products listed in Annex I to the Regulation at the moment of the submission of the Template to the Commission (under the first column: 'Yes'), or to other categories that, according to Member States, should potentially be included in that Annex (under the first column: 'No').
All data and information in the subsequent columns (second to thirty-ninth) refer to the category of machinery or related product as described in this first column.
The spaces in the Template can be extended to cover as many additional categories of machinery and related products as necessary, which may potentially, in future via relevant delegated act, be added to Annex I to the Regulation.
In case of amendments to Annex I to the Regulation, via relevant delegated acts, this first column should be adapted accordingly.
—   Second Column (2): Category in Part of Annex I to the Regulation [scroll down choice]
For the categories of machinery and related products listed in Annex I to the Regulation (under the first column: 'Yes') it should be indicated which part of that Annex they are listed in: either in the Part A (under the second column: ‘A’) or in the Part B (under the second column: 'B').
For the categories of machinery and related products not listed in Annex I to the Regulation (under the first column: ‘No’), it should be indicated that this information is not applicable (under the second column: ‘N/A’).
In case of amendments to Annex I to the Regulation, via relevant delegated acts, this second column should be adapted accordingly.
—   Third Column (3): Category Number (if the category is included in Annex I to the Regulation) [scroll down choice]
For the categories of machinery and related products listed in Annex I to the Regulation, Part A or B, the number assigned to each category of machinery and related products in that Annex should be indicated.
At the moment of writing this guidance, there are six (6) categories of machinery and related products in Part A of Annex I and nineteen (19) categories of machinery and related products in Part B of Annex I.
For the categories of machinery and related products not listed in Annex I to the Regulation (under the first column: ‘No’) it should be indicated that this information is not applicable (under the second column: ‘N/A’).
In case of amendments to Annex I to the Regulation, via relevant delegated acts, this third column should be adapted accordingly.
—   Fourth Column (4): Category Description (if the category is not included in Annex I to the Regulation) [text field, maximum 100 words]
For the categories of machinery and related products listed in Annex I to the Regulation, Part A or B, nothing needs to be indicated in this column, because the description of such category of machinery and related products is included in that Annex.
For the categories of machinery and related products not listed in Annex I to the Regulation (under the first column: ‘No’ and under the second column: ‘N/A’), a short but clear description of each new category of machinery or related product proposed for addition to that Annex should be given.
In case of amendments to Annex I to the Regulation, via relevant delegated acts, this fourth column should be adapted accordingly.
—   Fifth Column (5): Article 6(5)(a) of the Regulation: indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or any reasonably foreseeable misuse (Y-2 to Y-6) [text field, maximum 500 words]

                     ‘Indications of harm’ relates to the information such as:






—


the nature of the hazard causing the harm, inherent to the function of the category of machinery or related product, taking into account the intended use and any reasonably foreseeable misuse;










—


the duration of the exposure to the hazard;










—


the severity of harm suffered, including the degree of reversibility of that harm;










—


the number of persons affected by the harm;










—


other relevant information.




—   Sixth to Tenth Column (6-10): Article 6(5)(b) of the Regulation: information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission, i.e. corrective action taken (brought into conformity), withdrawn or recalled / Number of units of machinery or related product found to be defective per year [whole number field]
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: the Information and Communication System on Market Surveillance (ICSMS) and Safety Gate Rapid Alert System; the European Injury Database (EU-IDB); national statistics on accidents at work; the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
No cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column eleventh whether there is a lack of data or there are no occurrences.
—   Eleventh Column (11): Article 6(5)(b) of the Regulation: information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission, i.e. corrective action taken (brought into conformity), withdrawn or recalled / Explanations [text field, maximum 500 words]
For each category of machinery or related product, relevant information on the data sources used as well as the quality and the coverage of the data by source should be provided.
When the number of occurrences in a given year is indicated to be zero, it should be made clear whether there is a lack of data or there are no occurrences.
The description of the main defects and origins of faults found and the potential harm that these defects or faults might cause should also be given in this field.
—   Twelfth Column (12): Article 6(5)(c) of the Regulation: information about known accidents (at work or non-occupational) and serious close calls, including the characteristics of those accidents or close calls (Y-2 to Y-6) [text field, maximum 500 words]
In this field, a description of the main characteristics of accidents or close calls (also known as near accidents) should be given, such as:






—


main accident scenarios;










—


main causes for the accidents;










—


identification of residual risks during accidents;










—


number of victims;










—


other relevant information.




—   Thirteenth to Seventeenth Column (13-17): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/ Number of accidents at work (fatal) per year [whole number field]

                     ‘Accident at work’ refers to a discrete occurrence in the course of work which leads to physical or mental harm caused by the machinery or related product used as intended, including any reasonably foreseeable misuse.
’Fatal accident' refers to an accident caused by the machinery or related product used as intended, including any reasonably foreseeable misuse, which leads to the death of a victim within 1 year of the accident.
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: European Injury Database (EU-IDB); Eurostat’s European Statistics on Accidents at Work (ESAW); the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
This field includes all types of injuries, such as: wounds and superficial injuries; dislocations, sprains and strains; concussions and internal injuries, bone fractures, poisonings and infections; shocks; burns, scalds and frostbites; amputations (loss of body parts); effects of sound, vibration and pressure; effects of extremes temperatures, light and radiation; drownings and asphyxiations; multiple injuries; psychological injuries.
No cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column thirty-eighth whether there is a lack of data or there are no occurrences.
Accidents should be reported in the thirteenth to seventeenth column and in relation to the category description (first to fourth column) when:






—


such machinery or related product is the ‘Material Agent’ associated to: the ‘Specific Physical Activity’ (that is to say: the tool, object, or instrument being used by the victim when the accident happened, just before the accident); or the ‘Deviation’ (that is to say, where the circumstances of the accident differed from normal practice and the machinery or related product was the tool, object, or instrument involved in the abnormal event); or the ‘Contact - Mode of Injury’ (that is to say, where the machinery or related product was the tool, object, or instrument which caused the victim a physical or psychological injury; and










—


such accident is imputable to the machinery or related product, used as intended, including any reasonably foreseeable misuse, as long as such reasonably foreseeable misuse does not involve the elimination of safety measures foreseen by the manufacturer, such as the removal of protective guards; an accident may be imputable to the machinery or related product if any of the following occurs:






—


it is caused by the design or construction of the machinery or related product, irrespectively of whether the machinery or related product is compliant with relevant harmonised standards or whether such harmonised standards present or not shortcomings as regards their ability to confer presumption of conformity with the EU legislation on machinery applicable when the machinery or related product was placed on the EU market;










—


it is caused by operator’s errors, if such errors are reasonably foreseeable, or aggravated by poor ergonomics;










—


it is caused by poor maintenance resulting from maintenance instructions which were inaccurate or incomplete.









                     ‘Material Agent’: It is defined in the newest edition of the EUROSTAT document ‘European statistics on accidents at work (ESAW) — Summary Methodology’ as published on the Eurostat website. The current version of this document is the ‘2013 edition’
                      (4).
The Table in Annex B to this document lists the codes following the ESAW classification of Material Agents, under which certain categories of machinery or related products in scope of Annex I to the Regulation could be found, at the moment of writing this guidance. The codes listed in Annex B to this document have an indicative role and should be used if extended national data collected in the framework of ESAW is used as data source and the ESAW material agent description corresponds exactly to the data reported in the relevant row of the template. The codes may also be used for the purposes of facilitating the understanding of and/or searching in the relevant data bases for the categories of machinery or related products that are currently listed in Annex I to the Regulation. It should be noted that the 8-digit classification of the ESAW variable ‘material agent’ is currently not used in the ESAW database (only the 4-digit classification is used). Although there are no 8-digit codes in the ESAW database, these 8-digit codes can be used to understand better what should be included in the related 4-digit codes. In any case, data and information provided in the Template should relate precisely to the category of machinery or related product, as described in the third or fourth column of the Template.
—   Eighteenth to Twenty-second Column (18-22): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/ Number of accidents at work (serious) per year [whole number field]

                     ‘Accident at work’ refers to a discrete occurrence in the course of work which leads to physical or mental harm caused by the machinery or related product used as intended, including any reasonably foreseeable misuse.

                     ‘Serious accident’ refers to an accident (not fatal) caused by the machinery or related product used as intended, including any reasonably foreseeable misuse, which leads to the permanent damage of a victim, or to significant bodily damage such as amputation of a body part.
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: European Injury Database (EU-IDB); Eurostat’s European Statistics on Accidents at Work (ESAW); the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
This field includes all types of injuries, such as: wounds and superficial injuries; dislocations, sprains and strains; concussions and internal injuries, bone fractures, poisonings and infections; shocks; burns, scalds and frostbites; amputations (loss of body parts); effects of sound, vibration and pressure; effects of extremes temperatures, light and radiation; drownings and asphyxiations; multiple injuries; psychological injuries.
No cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column thirty-eighth whether there is a lack of data or there are no occurrences.
Accidents should be reported in the eighteenth to twenty-second column and in relation to the category description (first to fourth column) when:






—


such machinery or related product is the ‘Material Agent’ associated to: the ‘Specific Physical Activity' (that is to say: the tool, object, or instrument being used by the victim when the accident happened, just before the accident); or the “Deviation” (that is to say, where the circumstances of the accident differed from normal practice and the machinery or related product was the tool, object, or instrument involved in the abnormal event); or the “Contact - Mode of Injury” (that is to say, where the machinery or related product was the tool, object, or instrument which caused the victim a physical or psychological injury; and










—


such accident is imputable to the machinery or related product, used as intended, including any reasonably foreseeable misuse, as long as such reasonably foreseeable misuse does not involve the elimination of safety measures foreseen by the manufacturer, such as the removal of protective guards; an accident may be imputable to the machinery or related product if any of the following occurs:






—


it is caused by the design or construction of the machinery or related product, irrespectively of whether the machinery or related product is compliant with relevant harmonised standards or whether such harmonised standards present or not shortcomings as regards their ability to confer presumption of conformity with the EU legislation on machinery applicable when the machinery or related product was placed on the EU market;










—


it is caused by operator’s errors, if such errors are reasonably foreseeable or aggravated by poor ergonomics;










—


it is caused by poor maintenance resulting from maintenance instructions which were inaccurate or incomplete.









                     “Material Agent”: It is defined in the newest edition of the EUROSTAT document “European statistics on accidents at work (ESAW) — Summary Methodology” as published on the Eurostat website. The current version of this document is the “2013 edition”
                      (5).
The Table in Annex B to this document lists the codes following the ESAW classification of Material Agents, under which certain categories of machinery or related products in scope of Annex I to the Regulation could be found, at the moment of writing this guidance. The codes listed in Annex B to this document have an indicative role and should be used if extended national data collected in the framework of ESAW is used as data source and the ESAW material agent description corresponds exactly to the data reported in the relevant row of the template. The codes may also be used for the purposes of facilitating the understanding of and/or searching in the relevant data bases for the categories of machinery or related products that are currently listed in Annex I to the Regulation. It should be noted that the 8-digit classification of the ESAW variable “material agent” is currently not used in the ESAW database (only the 4-digit classification is used). Although there are no 8-digit codes in the ESAW database, these 8-digit codes can be used to understand better what should be included in the related 4-digit codes. In any case, data and information provided in the Template should relate precisely to the category of machinery or related product, as described in the third or fourth column of the Template.
—   Twenty-third to Twenty-seventh Column (23-27): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/ Number of accidents at work (other) per year [whole number field]
’Accident at work’ means a discrete occurrence in the course of work which leads to physical or mental harm caused by the machinery or related product used as intended, including any reasonably foreseeable misuse.
’Other accident' means any accident (not fatal nor serious) caused by the machinery or related product used as intended, including any reasonably foreseeable misuse, requiring hospitalisation and/or absence from work of 4 days or more.
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: European Injury Database (EU-IDB); Eurostat’s European Statistics on Accidents at Work (ESAW); the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
This field includes all types of injuries, such as: wounds and superficial injuries; dislocations, sprains and strains; concussions and internal injuries, bone fractures, poisonings and infections; shocks; burns, scalds and frostbites; amputations (loss of body parts); effects of sound, vibration and pressure; effects of extremes temperatures, light and radiation; drownings and asphyxiations; multiple injuries; psychological injuries.
No cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column thirty-eighth whether there is a lack of data or there are no occurrences.
Accidents should be reported in the twenty-third to twenty-seventh column and in relation to the category description (first to fourth column) when:






—


such machinery or related product is the ‘Material Agent’ associated to: the ‘Specific Physical Activity’ (that is to say: the tool, object, or instrument being used by the victim when the accident happened, just before the accident); or the ‘Deviation’ (that is to say, where the circumstances of the accident differed from normal practice and the machinery or related product was the tool, object, or instrument involved in the abnormal event); or the ‘Contact - Mode of Injury’ (that is to say, where the machinery or related product was the tool, object, or instrument which caused the victim a physical or psychological injury; and










—


such accident is imputable to the machinery or related product, used as intended, including any reasonably foreseeable misuse, as long as such reasonably foreseeable misuse does not involve the elimination of safety measures foreseen by the manufacturer, such as the removal of protective guards; an accident may be imputable to the machinery or related product if any of the following occurs:






—


it is caused by the design or construction of the machinery or related product, irrespectively of whether the machinery or related product is compliant with relevant harmonised standards or whether such harmonised standards present or not shortcomings as regards their ability to confer presumption of conformity with the EU legislation on machinery applicable when the machinery or related product was placed on the EU market;










—


it is caused by operator’s errors, if such errors are reasonably foreseeable or aggravated by poor ergonomics;










—


it is caused by poor maintenance resulting from maintenance instructions which were inaccurate or incomplete.









                     ‘Material Agent’: It is defined in the newest edition of the EUROSTAT document ‘European statistics on accidents at work (ESAW) — Summary Methodology’ as published on the Eurostat website. The current version of this document is the ‘2013 edition’
                      (6).
The Table in Annex B to this document lists the codes following the ESAW classification of Material Agents, under which certain categories of machinery or related products in scope of Annex I to the Regulation could be found, at the moment of writing this guidance. The codes listed in Annex B to this document have an indicative role and should be used if extended national data collected in the framework of ESAW is used as data source and the ESAW material agent description corresponds exactly to the data reported in the relevant row of the template. The codes may also be used for the purposes of facilitating the understanding of and/or searching in the relevant data bases for the categories of machinery or related products that are currently listed in Annex I to the Regulation. It should be noted that the 8-digit classification of the ESAW variable ‘material agent’ is currently not used in the ESAW database (only the 4-digit classification is used). Although there are no 8-digit codes in the ESAW database, these 8-digit codes can be used to understand better what should be included in the related 4-digit codes. In any case, data and information provided in the Template should relate precisely to the category of machinery or related product, as described in the third or fourth column of the Template.
—   Twenty-eighth to Thirty-second Column (28-32): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/ Number of non-occupational accidents (fatal) per year [whole number field]
’Non-occupational accident' refers to a discrete occurrence during non-professional use, which leads to physical or mental harm caused by the machinery or related product used as intended, including any reasonably foreseeable misuse.
’Fatal accident' refers to a non-occupational accident caused by the machinery or related product used as intended, including any reasonably foreseeable misuse, which leads to the death of a victim within 1 year of the non-occupational accident.
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: European Injury Database (EU-IDB); the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
This field includes all types of injuries, such as: wounds and superficial injuries; dislocations, sprains and strains; concussions and internal injuries, bone fractures, poisonings and infections; shocks; burns, scalds and frostbites; amputations (loss of body parts); effects of sound, vibration and pressure; effects of extremes temperatures, light and radiation; drownings and asphyxiations; multiple injuries; psychological injuries.
The greyed cells cover categories of machinery or related products for which non-professional uses are not found. Therefore, they should not be filled in. Other than those, no cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column thirty-eighth whether there is a lack of data or there are no occurrences.
For an accident to be reported under a category of machinery or related product, it is necessary that such accident is imputable to the machinery or related product, used as intended, including any reasonably foreseeable misuse, as long as such reasonably foreseeable misuse does not involve the elimination of safety measures foreseen by the manufacturer, such as the removal of protective guards. An accident may be imputable to the machinery or related product if any of the following occurs:






—


it is caused by the design or construction of the machinery or related product, irrespectively of whether the machinery or related product is compliant with relevant harmonised standards or whether such harmonised standards present or not shortcomings as regards their ability to confer presumption of conformity with the EU legislation on machinery applicable when the machinery or related product was placed on the EU market;










—


it is caused by operator’s errors, if such errors are reasonably foreseeable or aggravated by poor ergonomics;










—


it is caused by poor maintenance resulting from maintenance instructions which were inaccurate or incomplete.




—   Thirty-third to Thirty-seventh Column (33-37): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/Number of non-occupational accidents (serious or other) per year [whole number field]

                     ‘Non-occupational accident’ refers to a discrete occurrence during non-professional use, which leads to physical or mental harm caused by the machinery or related product used as intended, including any reasonably foreseeable misuse.

                     ‘Serious or other’ refers to a non-occupational accident caused by the machinery or related product used as intended, including any reasonably foreseeable misuse, which is not a fatal accident.
For each category of machinery or related product, the number of occurrences in a given year should be indicated. Data sources can be all or any of the following: European Injury Database (EU-IDB); the Machinery Administrative Cooperation Group (AdCo); other relevant sources.
This field includes all types of injuries, such as: wounds and superficial injuries; dislocations, sprains and strains; concussions and internal injuries, bone fractures, poisonings and infections; shocks; burns, scalds and frostbites; amputations (loss of body parts); effects of sound, vibration and pressure; effects of extremes temperatures, light and radiation; drownings and asphyxiations; multiple injuries; psychological injuries.
The greyed cells cover categories of machinery or related products for which non-professional uses are not found. Therefore, they should not be filled in. Other than those, no cells should be left empty. When the number of occurrences in a given year is indicated to be zero, it should be clarified in column thirty-eighth whether there is a lack of data or there are no occurrences.
For an accident to be reported in the thirty-third to thirty-seventh column and in relation to a category of machinery or related product (first to fourth column), it is necessary that such accident is imputable to the machinery or related product, used as intended, including any reasonably foreseeable misuse, as long as such reasonably foreseeable misuse does not involve the elimination of safety measures foreseen by the manufacturer, such as the removal of protective guards.
An accident may be imputable to the machinery or related product if any of the following occurs:






—


it is caused by the design or construction of the machinery or related product, irrespectively of whether the machinery or related product is compliant with relevant harmonised standards or whether such harmonised standards present or not shortcomings as regards their ability to confer presumption of conformity with the EU legislation on machinery applicable when the machinery or related product was placed on the EU market;










—


it is caused by operator’s errors, if such errors are reasonably foreseeable or aggravated by poor ergonomics;










—


it is caused by poor maintenance resulting from maintenance instructions which were inaccurate or incomplete.




—   Thirty-eighth Column (38): Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years (Y-2 to Y-6)/Explanations [text field, maximum 500 words]
For each category of machinery or related product, relevant information on the data sources used as well as the quality and the coverage of the data by source should be provided.
When the number of occurrences in a given year is indicated to be zero, it should be made clear whether there is a lack of data or there are no occurrences.
The description of the main reasons why the machinery or related product was at fault should also be provided in this field.
—   Thirty-ninth Column (39): Additional relevant information [text field, maximum 500 words]
This field may include information (to the extent that is available and is considered by the Member State that can further facilitate the assessment to be carried out by the Commission), per each category of machinery or related product, such as:






—


the number of units of machinery or related products sold in the Member State territory;










—


the number of workers in the sector;










—


when the machinery or related product was placed on the EU market;










—


whether there was lack of harmonised standards (and, as regards the Regulation, common specifications established under the Regulation) covering the relevant essential health and safety requirements;










—


the residual risks, including those which, according to the manufacturer, could be reduced by particular training or personal protective equipment, leading to recurrent serious or fatal accidents or damage to health;










—


the wrongful application of the relevant harmonised standards or common specifications and for which the market surveillance activities that were carried out have not led to major improvements of the market situation, in a reasonable period;










—


the uncertainty in the existing risk assessment methods related to new technologies;










—


the compliance or not of the machinery or related product with the EU legislation on machinery applicable when it was placed on the EU market; if non-compliant: whether the relevant harmonised standards cited under that EU legislation (or, as regards the Regulation, any common specifications established under the Regulation) have been applied; or whether non-compliance was due to shortcomings in the relevant harmonised standards cited under that EU legislation (or, as regards the Regulation, in any common specifications established under the Regulation);










—


In relation with the total number of defective machinery or related products, reported under Article 6(5)(b) of the Regulation:






—


the percentage (%) of machinery or related products:






—


which have not undergone modifications after their placing on the EU market;










—


which have undergone non-substantial modifications after their placing on the EU market;










—


which have undergone substantial modifications after their placing on the EU market;














—


the percentage (%) of machinery or related products placed on the EU market during the applicability of:






—


the Regulation;










—


Directive 2006/42/EC;










—


the EU legislation on machinery applicable prior to Directive 2006/42/EC;














—


the number of manufacturers producing the reported machinery or related products;










—


the percentage (%) of machinery or related products for which a Notified Body was involved;














—


In relation with the total number of accidents reported under Article 6(5)(d) of the Regulation:






—


the percentage (%) of accidents with machinery or related products:






—


which have not undergone modifications after their placing on the EU market;










—


which have undergone non-substantial modifications after their placing on the EU market;










—


which have undergone substantial modifications after their placing on the EU market;














—


the percentage (%) of accidents with machinery or related products placed on the EU market during the applicability of:






—


the Regulation;










—


Directive 2006/42/EC;










—


the EU legislation on machinery applicable prior to Directive 2006/42/EC;














—


the number of manufacturers producing the machinery or related products involved in the reported accidents;










—


the percentage (%) of accidents with machinery or related products for which a Notified Body was involved;














—


other relevant information.






(1)  Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (OJ L 165, 29.6.2023, p. 1, ELI: http://data.europa.eu/eli/reg/2023/1230/oj).

(2)  Commission Implementing Regulation (EU) 2024/1922 of 12 July 2024 setting out the template for the collection by the Member States of the data and the information referred to in Article 6(5), points (a) to (d), of Regulation (EU) 2023/1230 of the European Parliament and of the Council (OJ L, 2024/1922, 15.7.2024, ELI: http://data.europa.eu/eli/reg_impl/2024/1922/oj).

(3)  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, ELI: http://data.europa.eu/eli/dir/2006/42/oj).

(4)  
            https://ec.europa.eu/eurostat/web/products-statistical-working-papers/-/ks-ra-12-002.

(5)  
            https://ec.europa.eu/eurostat/web/products-statistical-working-papers/-/ks-ra-12-002.

(6)  
            https://ec.europa.eu/eurostat/web/products-statistical-working-papers/-/ks-ra-12-002.




ANNEX A
Template column numbering
















































1


2


3


4


5


6


7


8


9


10


11


12


13


14


15


16


17


18


19


20


21


22


23


24


25


26


27


28


29


30


31


32


33


34


35


36


37


38


39




Year (’Y’) of submission of report:


 


Member State:


 


 


 




 


 




Category in Annex I to the Regulation


Category in Part of Annex I to the Regulation


Category Number (if the category is included in Annex I to the Regulation)


Category Description (if the category is not included in Annex I to the Regulation)


Article 6(5)(a) of the Regulation: indications of harm that have been caused in the past by machinery or related products which have been used for their intended use or any reasonably foreseeable misuse (Y-2 to Y-6)


Article 6(5)(b) of the Regulation: information about safety defects detected in the course of market surveillance, and material possibly available in the information systems administered by the Commission, i.e. corrective action taken (brought into conformity), withdrawn or recalled


Article 6(5)(c) of the Regulation: information about known accidents (at work or non- occupational) and serious close calls, including the characteristics of those accidents or close calls (Y-2 to Y- 6)


Article 6(5)(d) of the Regulation: data on accidents or damage to health caused by the machinery or related product for the preceding years


Additional relevant information


 




Number of units of machinery or related product found to be defective per year


Explanations


Number of accidents at work (fatal) per year


Number of accidents at work (serious) per year


Number of accidents at work (other) per year


Number of non- occupational accidents (fatal) per year


Number of non- occupational accidents (serious or other) per year


Explanations


 


 




Y-6


Y-5


Y-4


Y-3


Y-2


Y-6


Y-5


Y-4


Y-3


Y-2


Y-6


Y-5


Y-4


Y-3


Y-2


Y-6


Y-5


Y-4


Y-3


Y-2


Y-6


Y-5


Y-4


Y-3


Y-2


Y-6


Y-5


Y-4


Y-3


Y-2


 




Yes


A


1


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


A


2


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


A


3


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


A


4


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


A


5


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


A


6


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


1


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


2


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


3


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


4


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


5


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


6


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


7


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


8


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


9


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


10


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


11


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


12


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


13


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


14


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


15


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


16


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


17


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


18


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




Yes


B


19


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




No


N/A


N/A


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




No


N/A


N/A


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 




No


N/A


N/A


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 


 









ANNEX B
List of 8- and 4-digit (1) codes following the ESAW classification of Material Agents, under which categories of machinery or related products in scope of Annex I to the Regulation could be found






Category in Annex I to the Regulation


ESAW material agent




Part A


 










1.


Removable mechanical transmission devices including their guards.






05.02.01.07 Shaft, sleeve, cotter










2.


Guards for removable mechanical transmission devices.






16.01.00.00 Safety devices - on machines










3.


Vehicle servicing lifts.






11.02.02.01 Equipment for raising vehicles, vehicle lift, hydraulic lift










4.


Portable cartridge-operated fixing and other impact machinery.






07.06.06.00 Stud gun with explosive cartridges










5.


Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.






16.01.00.00 Safety devices - on machines










6.


Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed independently on the market, in respect only of those systems.






16.01.00.00 Safety devices - on machines




PART B


 










1.


Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:






07.01.02.00 Circular saws
07.01.02.0X Circular saws
10.11.01.00 Circular saw
10.11.01.0X Circular saw










1.1.


sawing machinery with fixed blade(s) during cutting, having a fixed bed or support with manual feed of the workpiece or with a demountable power feed;














1.2.


sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage;














1.3.


sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;














1.4.


sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading.














2.


Hand-fed surface planing machinery for woodworking.






10.10.02.0X Planing machine, planer (Since there is not code for thicknessers, we understand they are included within the planing machines)










3.


Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading for woodworking.














4.


Band-saws with manual loading and/or unloading for working with wood and material with similar physical characteristics or for working with meat and material with similar physical characteristics, of the following types:






10.11.02.00 Band saw, ribbon saw
10.11.02.0X Band saw, ribbon saw (excluding log saw)
10.11.04.0C Band saw, ribbon saw for logs










4.1.


sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece;














4.2.


sawing machinery with blade(s) assembled on a carriage with reciprocating motion.














5.


Combined machinery of the types referred to in points 1 to 4 and in point 7 for working with wood and material with similar physical characteristics.






See codes for Part B items 1 to 4










6.


Hand-fed tenoning machinery with several tool holders for woodworking.






10.10.12.00 Spindle-moulding machine, tenon-making machine










7.


Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.






10.10.12.00 Spindle-moulding machine, tenon-making machine










8.


Portable chainsaws for woodworking.






07.01.04.0X Portable chainsaws










9.


Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s.






10.07.01.0X Cold press
10.07.01.0X Pneumatic press
10.07.05.0X Hydraulic press (without specifying)










10.


Injection or compression plastics-moulding machinery with manual loading or unloading.






10.09.01.00 Injection machine, extrusion machine
10.09.01.0X Injection machine, injection press, extrusion press, injection moulding or extrusion machine
10.09.02.00 Machines for pressing, moulding










11.


Injection or compression rubber-moulding machinery with manual loading or unloading.






10.09.01.00 Injection machine, extrusion machine
10.09.01.0X Injection machine, injection press, extrusion press, injection moulding or extrusion machine
10.09.02.00 Machines for pressing, moulding
10.09.02.0D Machine for making composite materials
10.09.02.0D Vulcanising press










12.


Machinery for underground working of the following types:






‘13.01 Vehicles – on rails, including suspended monorails: goods’ could also apply










12.1.


locomotives and brake-vans;






13.01.00.00 Vehicles on rails
13.01.01.00 Trains, wagons, etc.: goods
13.01.99.00 Other vehicles on rails: goods










12.2.


hydraulic-powered roof supports.






09.01.09.00 Equipment for underground works










13.


Manually loaded trucks for the collection of household refuse incorporating a compression mechanism.






12.01.99.00 Other types of heavy vehicle
10.07 .04.0X Waste press, baling press (paper, textiles, metal waste, etc.)










14.


Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 m.






11.02.01.00 Goods lifts
11.02.01.01 Passenger lifts
11.02.01.03 Equipment for raising persons (cradles, baskets, lifting platforms)










15.


Protective devices designed to detect the presence of persons.






16.01.00.00 Safety devices - on machines










16.


Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this Part.






16.01.00.00 Safety devices - on machines










17.


Logic units to ensure safety functions.






16.01.00.00 Safety devices - on machines










18.


Roll-over protective structures (ROPS).






09.01 Portable or mobile machines - for extracting materials or working the ground - mines/quarries, building and civil engineering works
09.02 Portable or mobile machines - for working the ground - farming
09.04 Mobile floor/ground-cleaning machines
09.99 Other portable or mobile machines and equipment in group 09 not listed above










19.


Falling-object protective structures (FOPS).






09.01 Portable or mobile machines - for extracting materials or working the ground - mines/quarries, building and civil engineering works
09.02 Portable or mobile machines - for working the ground - farming
09.04 Mobile floor/ground-cleaning machines
09.99 Other portable or mobile machines and equipment in group 09 not listed above






(1)  The 8-digit classification of the ESAW variable ‘material agent’ is currently not used in the ESAW database (only the 4-digit classification is used) but was established at the beginning of the ESAW project. Such classification may facilitate the understanding and/or search of some of the machinery categories.



ELI: http://data.europa.eu/eli/C/2024/6142/oj
ISSN 1977-091X (electronic edition)