G/TBT/N/EU/856  
26 November 2021  
(21-8929) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tb t/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Safety of 
machinery (ICS 13.110)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council on machinery products 
(COM(2021) 202 final) (55 page(s), in English; 67 page(s), in English)  
6. Description of content:  This proposal for a Regulation takes into account the result of 
the evaluation of the machinery Directive 2006/42/EC.  
Following the recommendations highlighted during the evaluation the proposal covers:  
• Clarity on the scope, exclusions and some definitions, including a new definition 
on "substantial modification" when the machine suffers a substantial modification, 
without the manufacturers agreement once is placed on the market.   
• New risks originating f rom digitalised machinery. In particular those originated 
from a direct human -robot collaboration, connected machinery, software updates 
that affects the behaviour of the machinery after its placing on the market, as 
well as the ability of manufacturers to  conduct a full risk assessment on machine 
learning applications before the product is placed on the market. As far as the 
autonomous machines, the Regulation explicitly considers the possibility of no 
driver, and sets up requirements.   
• Clarifications on a  number of requirements on "traditional machinery" 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    G/TBT/N/EU/856  
 
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  • Criteria to define high risk machinery and the possibility to adapt the current list 
of high -risk machinery to the state of the art as well as a mandatory third -party 
conformity assessment for this type of machinery.  
• Digitalisation of the machinery instructio ns and the manufacturers declaration of 
conformity with the possibility to request paper instructions at the time of buying 
the machinery product.  
• Alignment to Decision 768/2008/EC to bring together all the elements required 
for a comprehensive regulatory framework to operate effectively for the safety 
and compliance of machinery products.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The main objective is the protection of health and safety of persons and, 
where app ropriate, domestic animals or plants and property and, where applicable, the 
environment. Based on the evaluation of the Machinery Directive 2006/42/EC, new 
generation of digitalised machinery products, e.g. internet connected machinery or 
machinery with l earning capacities, may entail new risks for the health and safety of 
persons, domestic animals and property and the environment. Furthermore, clarifying 
some of the existing provisions in Directive 2006/42/EC will contribute to the main 
objective too. Pro tection of human health or safety; Protection of animal or plant life or 
health; Protection of the environment  
8. Relevant documents:  Directive 2006/42/EC of the European Parliament and of the 
Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast); OJ L 
157, 9.6.2006, p. 24 –86  
EUR-Lex - 32006L0042 - EN - EUR-Lex (europa.eu)  
9. Proposed date of adoption:  2-3 years from now  
Proposed date of entry into force:  20 days after its publication (transitional period of 
30 months until full application foreseen)  
10. Final date for comments:  90 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
 
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://eur -lex.europa.eu/legal -
content/EN/TXT/?uri=CELEX%3A52021PC0202&qid=1637865023492  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7349_00_e.pdf  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7349_01_e.pdf