Machinery Directive 2006/42/EC
On March 13, 2026, Implementing Decision (EU) 2026/546 was published and entered into force on the same day. Pursuant to this decision, the annex to Implementing Decision (EU) 2023/1586 is amended. Unfortunately, this implementing decision also omits the B-standards already ratified by CEN and CENELEC and submitted to the Commission, such as EN 60204-32:2008, EN ISO 13855:2010, EN 61800-5-2:2007, EN ISO 14119:2013, and EN ISO 11691:2009, as well as a Type C standard.
Consequently, some harmonized standards listed in Annex I, Part 3, Number 2 will be published in the Official Journal of the EU with a restriction on the presumption of conformity (the hENs marked with footnote 1) or will remain unchanged.
General note regarding the Commission’s informative Excel tables:
In some cases, “restrictions” were entered twice (e.g., EN 15997:2011).
Furthermore, the Implementing Decision uses the term “Restriction” and not “Warning” (incorrectly used in the Excel table).
And The Excel tables are not uniformly formatted (e.g., the EMC Directive compared to the Machinery Directive: different column headings).
In this regard, please note once again: The European Commission assumes no liability for errors in the Excel table. The official publication platform “EUR-Lex” is the only authoritative source.
Here is the list of current hENs that are subject to a restriction on the presumption of conformity:
| 24a1) | EN 474-1:2022 Earth-moving machinery – Safety – Part 1: General requirements Restriction: For the purpose of the presumption of conformity of this harmonised standard, the value in its clause 4.12.7.2 “at 125 % of Q1 and Q2” shall be read as “at least at 100 % or up to a value of 125 % of Q1 and Q2 insofar as the tested machine can indeed attain a higher load”, as well as the value in its clause 4.12.7.3 “at 110 % of Q1 and Q2” shall be read as ‘at least at 100 % or up to a value of 110 % of Q1 and Q2 insofar as the tested machine can indeed attain a higher load. |
| 121 | EN 1495:1997+A2:2009 Lifting platforms - Mast climbing work platforms EN 1495:1997+A2:2009/AC:2010 Restriction: This publication does not concern paragraph 5.3.2.4, the last subparagraph of 7.1.2.12, table 8 and figure 9 of standard EN 1495:1997, in respect of which it grants no presumption of conformity to the provisions of Directive 2006/42/EC. |
| 126a1) | EN 1501-5:2021 Refuse collection vehicles – General requirements and safety requirements – Part 5: Lifting devices for refuse collection vehicles Restriction: This harmonised standard does not confer a presumption of conformity with the essential health and safety requirements set out in: point 1.1.7 of Annex I to Directive 2006/42/EC, which requires that machinery is designed and constructed in such a way as to provide adequate means to ensure that the operator has good working conditions and is protected against any foreseeable hazards; point 1.2.1 of that Annex, which requires that safety and reliability of control systems apply in a coherent way to the whole of an assembly of machinery, notably in case of reasonably foreseeable human error during operation, so that this does not lead to hazardous situations; and point 1.5.11 of that Annex, which requires that all machinery must be designed and constructed in such a way that external radiation does not interfere with its operation.. |
| 266 | EN ISO 11850:2011 Machinery for forestry - General safety requirements (ISO 11850:2011) EN ISO 11850:2011/A1:2016 EN ISO 11850:2011/A2:2022 Restriction: With regard to paragraph 4.4 a), first paragraph, first indentation, as well as reference to standard EN ISO 2867:2011, table 6 to paragraphs 8 and 9, maximum dimension for “A” and note a) maximum first step height dimension, this publication does not confer a presumption of conformity to the essential health and safety requirements 1.1.6., 1.5.15. and 1.6.2. of Annex I to Directive 2006/42/EC. |
| 324a | EN 12525:2000+A2:2010 Agricultural machinery - Front loaders - Safety Restriction: This harmonised standard does not confer a presumption of conformity with the essential health and safety requirements set out in point 1.1.2. of Annex I to Directive 2006/42/EC, which requires technical measures, and not organisational ones such as protective structures specifically mitigating falling objects instead of addressing other accident scenarios including vehicle roll-over events, and point 1.7.4.2 (l) of Annex I to Directive 2006/42/EC, which requires information about the residual risks that remain despite the inherent safe design measures, safeguarding and complementary protective measures adopted. |
| 343 | EN 12635:2002+A1:2008 Industrial, commercial and garage doors and gates - Installation and use Restriction: With regard to paragraph 5.1 and Annex D, this publication does not concern the reference to EN 12453:2000, the application of which does not confer a presumption of conformity to the essential health and safety requirements 1.1.2, 1.1.6, 1.2.1, 1.3.7, 1.3.8.2, 1.4.1, 1.4.3 and 1.5.14 of Annex I to Directive 2006/42/EC. |
| 405 | EN 13241:2003+A2:2016 Industrial, commercial and garage doors and gates - Product standard - Part 1: Products without fire resistance or smoke control characteristics Restriction: With regard to paragraphs 4.2.2, 4.2.6, 4.3.2, 4.3.3, 4.3.4, 4.3.6, this publication does not concern the reference to EN 12453:2000, the application of which does not confer a presumption of conformity to the essential health and safety requirements 1.3.7 and 1.4.3 of Annex I to Directive 2006/42/EC. |
| 495 | EN 15194:2017 Cycles – Electrically power assisted cycles – EPAC Bicycles Restriction 1: Harmonised standard EN 15194:2017 does not confer a presumption of conformity with the essential health and safety requirements set out in points 1.5.5, 1.5.6 and 1.5.7 of Annex I to Directive 2006/42/EC, which require machinery to be designed and constructed to take into account the risks associated with extreme temperatures, fire and explosion. Restriction 2: Harmonised standard EN 15194:2017 does not confer a presumption of conformity with the essential health and safety requirements set out in points 1.5.9 and 3.6.3.1 of Annex I to Directive 2006/42/EC, which require machinery to be designed and constructed to take into account the risks resulting from vibrations, and that machinery must be provided with the measurement of vibrations transmitted by the machinery to the operator of the machinery. |
| 495a | EN 15194:2017+A1:2023 Cycles - Electrically power assisted cycles - EPAC Bicycles Restriction: Harmonised standard EN 15194:2017+A1:2023 does not confer a presumption of conformity with the essential health and safety requirements set out in points 1.5.9 and 3.6.3.1 of Annex I to Directive 2006/42/EC, which require machinery to be designed and constructed to take into account the risks resulting from vibrations, and that machinery must be provided with the measurement of vibrations transmitted by the machinery to the operator of the machinery. |
| 502a | EN 15700:2023 Safety for conveyor belts for winter sport or tourist use Restriction: With regard to paragraph 7.3 of this harmonised standard, compliance with this harmonised standard does not confer a presumption of conformity to the essential health and safety requirement 1.7.4.2. (u) of Annex I to Directive 2006/42/EC. |
| 513a | EN 15997:2011 All terrain vehicles (ATVs - Quads) - Safety requirements and test methods EN 15997:2011/AC:2012 Restriction: This harmonised standard does not confer a presumption of conformity with the essential health and safety requirements set out in point 1.1.2. of Annex I to Directive 2006/42/EC, which requires compliance with the principles of safety integration and reasonably foreseeable misuse of the vehicle, point 1.3.1. of Annex I to Directive 2006/42/EC, which requires lateral and longitudinal stability mitigation, and point 3.4.1. of Annex I to Directive 2006/42/EC, which requires prevention of uncontrolled movement. |
| 622a | EN 50434:2014 Safety of household and similar appliances - Particular requirements for mains operated shredders and chippers Restriction: This harmonised standard does not confer a presumption of conformity, limited to machines where the shredding means can rotate at speeds exceeding 300 r*min-1, with the essential health and safety requirements set out in point 1.1.2. (a) of Annex I to Directive 2006/42/EC, which requires that machinery must be designed and constructed so that it is fitted for its function, and can be operated without putting persons at risk when these operations are carried out under the conditions foreseen, but also taking into account any reasonably foreseeable misuse thereof, as well as point 1.3.3. of Annex I to Directive 2006/42/EC, as regards precautions that must be taken to prevent risks from ejected objects, which shall also consider long objects such as tall branches. |
| 671a | EN 62841-1:2015 Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery - Safety - Part 1: General requirements EN 62841-1:2015/AC:2015 EN 62841-1:2015/A11:2022 Restriction: This harmonised standard does not confer a presumption of conformity with the essential health and safety requirements set out in point 1.2.3. (second paragraph, first indent, applied with the first paragraph) and point 2.2.1. (first paragraph, third indent) of Annex I to Directive 2006/42/EC, which require sufficient protection against unintentional starting regardless of the cause. |
| 681a | EN 62841-2-11:2016 Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery - Safety - Part 2-11: Particular requirements for hand-held reciprocating saws EN 62841-2-11:2016/A1:2020 Restriction: This harmonised standard does not confer a presumption of conformity with the essential health and safety requirements set out in point 1.2.3. (second paragraph, first indent, applied with the first paragraph) and point 2.2.1. (first paragraph, third indent) of Annex I to Directive 2006/42/EC, which require sufficient protection against unintentional starting regardless of the cause. |
1) First publication with this restriction in the OJEU.
Items 5, 18, 113, 115, 301, 365, 368, 372, 401, 403, 437, 457, 509, 511 and 512 will be deleted from the OJEU as of January 20, 2027.
| Item | Titel | Start of legal effect | End of legal effect |
| 5 | EN 81-43:2009 Safety rules for the construction and installation of lifts — Special lifts for the transport of persons and goods — Part 43: Lifts for cranes | January 20, 2027 | |
| 5-a. | EN 81-43:2025 Safety rules for the construction and installation of lifts – Special lifts for the transport of persons and goods – Part 43: Lifts for cranes | March 13, 2026 | |
| 13a. | EN 415-2:2025 Safety of packaging machines – Part 2: Packaging machines for pre-formed rigid containers” | March 13, 2026 | |
| 18 | EN 415-8:2008 Safety of packaging machines — Part 8: Strapping machines | January 20, 2027 | |
| 18a. | EN 415-8:2025 Safety of packaging machines – Part 8: Strapping machines | March 13, 2026 | |
| 113 | EN 1459-1:2017 Rough-terrain trucks — Safety requirements and verification — Part 1: Variable-reach trucks | January 20, 2027 | |
| 113a. | EN 1459-1:2025 Rough-terrain trucks – Safety requirements and verification – Part 1: Variable-reach trucks | March 13, 2026 | |
| 114a. | EN 1459-4:2020+A1:2025 Rough-terrain trucks – Safety requirements and verification – Part 4: Additional requirements for variable-reach trucks handling freely suspended loads | March 13, 2026 | |
| 115 | EN 1459-5:2020 Rough-terrain trucks - Safety requirements and verification - Part 5: Attachment interface | January 20, 2027 | |
| 115a. | EN 1459-5:2020+A1:2025 Rough-terrain trucks – Safety requirements and verification – Part 5: Attachment interface | March 13, 2026 | |
| 301 | EN 12312-15:2006+A1:2009 Aircraft ground support equipment - Specific requirements - Part 15: Baggage and equipment tractors | January 20, 2027 | |
| 301a. | EN 12312-15:2020+A2:2025 Aircraft ground support equipment – Specific requirements – Part 15: Baggage and equipment tractors | March 13, 2026 | |
| 365 | EN 12965:2019 Tractors and machinery for agriculture and forestry - Power take-off (PTO) drive shafts and their guards - Safety | January 20, 2027 | |
| 365a. | EN 12965:2019+A1:2025 Tractors and machinery for agriculture and forestry – Power take-off (PTO) drive shafts and their guards – Safety | March 13, 2026 | |
| 368 | EN 12999:2020 Cranes - Loader cranes | January 20, 2027 | |
| 368a. | EN 12999:2020+A1:2025 Cranes – Loader cranes | March 13, 2026 |
|
| 372 | EN 13001-3-1:2012+A2:2018 Cranes - General Design - Part 3-1: Limit States and proof competence of steel structure | January 20, 2027 | |
| 372a. | EN 13001-3-1:2025 Cranes – General design – Part 3-1: Limit states and proof competence of steel structure’ | March 13, 2026 | |
| 401 | EN 13155:2003+A2:2009 Cranes - Safety - Non-fixed load lifting attachments | January 20, 2027 | |
| 401a. | EN 13155:2020+A1:2025 Crane – Safety – Non-fixed load lifting attachments’ | March 13, 2026 | |
| 403 | EN 13204:2016 Double acting hydraulic rescue tools for fire and rescue service use - Safety and performance requirements | January 20, 2027 | |
| 403a. | EN 13204:2025 Powered rescue tools for fire and rescue service use – Safety and performance requirements’ | March 13, 2026 | |
| 437 | EN 13852-1:2013 Cranes - Offshore cranes - Part 1: General-purpose offshore cranes | January 20, 2027 | |
| 437a. | EN 13852-1:2025 Cranes - Offshore cranes - Part 1: General-purpose offshore cranes | March 13, 2026 | |
| 457 | EN 14439:2006+A2:2009 Cranes - Safety - Tower cranes | January 20, 2027 | |
| 457a. | EN 14439:2025 Cranes – Tower cranes | March 13, 2026 | |
| 494a. | EN 15180:2025 Food processing machinery – Food depositors – Safety and hygiene requirements | March 13, 2026 | |
| 509 | EN 15895:2011+A1:2018 Cartridge operated hand-held tools - Safety requirements - Fixing and hard marking tools | January 20, 2027 | |
| 509a. | EN 15895:2025 Powder actuated hand-held fixing and hard marking tools – Safety requirements | March 13, 2026 | |
| 511 | EN 15954-2:2013 Railway applications - Track - Trailers and associated equipment - Part 2: General safety requirements | January 20, 2027 | |
| 512 | EN 15954-2:2013 Railway applications - Track - Trailers and associated equipment - Part 2: General safety requirements | January 20, 2027 | |
| 512a. | EN 15955-2:2025 Railway applications – Infrastructure – Demountable machines, trailers and associated equipment – Part 2: General safety requirements | March 13, 2026 | |
| 563a. | EN 17076:2020+A1:2025 Tower cranes – Anti-collision systems – Safety requirements | March 13, 2026 | |
| 572-a. | EN 17639:2025 Safety of machinery – Cableway installations designed for the transport of material and specially designated persons – General safety requirements | March 13, 2026 | |
| 572b. | EN 17744:2025 Agricultural and forestry machinery – Environmental requirements for dusters | March 13, 2026 | |
| 573-a. | EN 17923:2025 Equipment for vine cultivation and wine making – Safety – Must and grape harvest pumps | March 13, 2026 |
Link to the implementation decision: https://eur-lex.europa.eu/eli/dec_impl/2026/546/oj
Directive 2013/53/EU on recreational craft and personal watercraft
On March 13, 2026, Implementing Decision (EU) 2026/550 was published and entered into force on the same day. Pursuant to this decision, the annex to Implementing Decision (EU) 2022/1954 is amended.
New added rows:
| 9a | EN ISO 8665-2:2024 „Small craft - Power measurements and declarations - Part 2: Electric marine propulsion (ISO 8665-2:2024)” |
| 50a. | EN ISO 15085:2024 “Small craft – Protection from falling overboard and means of reboarding (ISO 15085:2024)” |
| Row 50. | EN ISO 15085:2003, EN ISO 15085:2003/A1:2009, EN ISO 15085:2003/A2:2018 will be deleted on 13.08.2027 |
Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32026D0550&qid=1775718427783
Medical Device Regulation 2017/745
On April 7, 2026, Implementing Decision (EU) 2026/760 was published and entered into force on the same day. Pursuant to this decision, the annex to Implementing Decision (EU) 2021/1182 is amended.
The following entries are added to the Annex to Implementing Decision (EU) 2021/1182:
| 49. | EN 13060:2025 „Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing“ |
| 50. | EN 14222:2021+A1:2025 „Stainless steel steam boilers“ |
| 51. | EN IEC 60118-0:2024 „Electroacoustics – Hearing aids – Part 0: Measurement of the performance characteristics of hearing aids“ |
Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32026D0760&qid=1775718478624
If you have any questions about the updates or standards listed above, please do not hesitate to contact us.
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Author's note
This article has been machine translated into English.
