G/TBT/N/EU/850  
11 November 2021  
(21-8527) Page: 1/4 
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/tbt/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):  Software, 
applications of information technology (for both: included when embedded in hardware); 
AI as a component of products subjects to product sa fety legislation (any code); Software 
(ICS 35.080), Applications of information technology (ICS 35.240)  
5. Title, number of pages and language(s) of the notified document:  Proposal for a 
Regulation of the European Parliament and of the Council laying down  harmonised rules 
on artificial intelligence (Artificial Intelligence act) and amending certain union legislative 
acts (COM(2021) 206 final) (108 page(s), in English; 17 page(s), in English)  
6. Description of content:  The draft Regulation defines an 'artificial intelligence system' 
(AI system) as meaning software that is developed with one or more of the techniques 
and approaches listed in Annex I and can, for a given set of human -defined objectives, 
generate outputs such as content, predictions, recommend ations, or decisions influencing 
the environments they interact with.  
The draft Regulation introduces provisions that will regulate the development, marketing 
and placing on the European Union market of AI systems. These rules are limited to the 
minimum ne cessary requirements to protect the safety and fundamental rights of persons 
considering the risks and challenges posed by AI systems, without unduly constraining or 
hindering technological development or otherwise disproportionately increasing the cost 
of placing AI solutions on the market. The draft rules differ according to the degree of risk 
AI systems are considered to present.  
AI systems considered a clear threat  to the safety, livelihoods and rights of people will be 
banned in the European Union. This includes AI systems or applications that manipulate 
human behaviour to circumvent certain users' free will (e.g. toys using voice assistance 
encouraging dangerous b ehaviour of minors) and systems that allow 'social scoring' by 
governments. The prohibitions cover practices that have a significant potential to 
manipulate persons through subliminal techniques beyond their consciousness or exploit G/TBT/N/EU/850  
 
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  vulnerabilities of spec ific vulnerable groups such as children or persons with disabilities in 
order to materially distort their behaviour in a manner that is likely to cause them or 
another person psychological or physical harm. In addition, the 'real time' use of remote 
biomet ric identification systems in publicly accessible spaces for law enforcement 
purposes is prohibited in principle. Narrow exceptions are strictly defined and regulated 
(such as where strictly necessary to search for a missing child, to prevent a specific an d 
imminent terrorist threat or to detect, locate, identify or prosecute a perpetrator or 
suspect of a serious criminal offence). When permitted, such use is subject to 
authorisation by a judicial or other independent body and to appropriate limits in time,  
geographic reach and the data bases searched.  
High-risk AI systems  will be subject to strict obligations before they can be placed on the 
European Union market.  
AI systems identified as high -risk include AI technology listed in the Annexes of the 
proposal  and used in the following broad areas:  
• Real time and ex post remote biometric identification systems;  
• Critical infrastructures (e.g. transport), that could put the life and health of 
people at risk;  
• Educational or vocational training, that may determine the access to education 
and professional course of someone's life (e.g. scoring of exams);  
• Safety components of regulated products subject to third party conformity 
assessment under EU sectoral product safety legislation (e.g. AI application in 
robot-assisted surgery);  
• Employment, workers management and access to self -employment (e.g. CV -
sorting software for recruitment procedures);  
• Essential private and public services (e.g. credit scoring denying people the 
opportunity to obtain a loan);  
• Law enf orcement that may interfere with people's fundamental rights (e.g. 
evaluation of the reliability of evidence);  
• Migration, asylum and border control management (e.g. verification of 
authenticity of travel documents);  
• Administration of justice and democratic  processes (e.g. applying the law to a 
concrete set of facts).  
Requirements for high -risk AI systems concern:  
• Adequate risk assessment and mitigation systems;  
• High quality of the datasets feeding the system to minimise risks and 
discriminatory outcomes;  
• Logging of activity to ensure traceability of results;  
• Detailed documentation providing all information necessary on the system and 
its purpose for authorities to assess its compliance;  
• Clear and adequate information to the user;  
• Appropriate human oversight measures to minimise risk;  
• High level of robustness, security and accuracy.  
Public and private providers of such high -risk AI systems will have to follow conformity 
assessment procedures to demonstrate compliance with the abovementioned 
requirements before  those systems can be placed on the Union market or used in the 
Union. To facilitate this, the draft Regulation includes provisions relating to the future 
harmonisation and drawing up of harmonised technical standards to be adopted by the 
European standard isation organisations (CEN/CENELEC and ETSI) based on a mandate 
from the European Commission. Predictable, proportionate and clear obligations are also 
placed on providers and users of high -risk AI systems to ensure safety and respect of G/TBT/N/EU/850  
 
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  existing legislati on protecting fundamental rights throughout the whole AI systems' 
lifecycle.  
AI systems with specific transparency obligations : When using AI systems such as 
chatbots, people should be aware that they are interacting with a machine so they can 
take an inf ormed decision to continue or step back. People should also be informed in 
case they are exposed to emotion recognition and biometric categorisation systems as 
well as deepfakes.  
Minimal risk : Subject to compliance with existing legislation, the proposal allows the free 
use of all other AI applications that are not prohibited, qualified as 'high -risk' or requiring 
specific transparency obligations. The vast majority of AI systems fall into thi s category. 
The draft Regulation does not intervene here, as these AI systems represent only minimal 
or no risk for peoples' rights or safety, but providers of non -high-risk AI systems can 
voluntarily adhere to voluntary codes of conduct to demonstrate tru stworthiness of their 
applications.  
In terms of governance, the Commission proposes that national competent market 
surveillance authorities supervise the new rules, while the creation of a European Artificial 
Intelligence Board will facilitate their implem entation, as well as drive the development 
of standards for AI. Additionally, specific measures are proposed to support small -scale 
providers and users as well as regulatory sandboxes to facilitate responsible innovation.  
7. Objective and rationale, inclu ding the nature of urgent problems where 
applicable:  The use of certain AI applications creates risks to safety and fundamental 
rights that the European Union considers important to be addressed. Certain 
characteristics of AI, such as the opacity of many a lgorithms that make difficult to 
ascertain how they produce results, pose specific and potentially high risks to safety and 
fundamental rights that existing legislation is unable to address or in view of which it is 
challenging to enforce existing legislat ion. For example, it is often not possible to 
determine why an AI system has arrived at a specific result or to ensure from the outset 
that certain discriminatory outputs will not be generated. As a consequence, it may 
become difficult to assess and prove whether someone has been unfairly disadvantaged 
by the use of AI systems, for example in a recruitment or promotion decision or an 
application for a public benefit scheme. The use of AI systems may leave affected people 
with significant difficulties to cor rect erroneous decisions. Facial recognition in public 
spaces can have a very intrusive effect on privacy unless properly regulated. In addition, 
poor training and design of AI systems can result in significant errors that can adversely 
affect privacy, per sonal data protection and the principle of non -discrimination. AI -
enabled robots and intelligent systems must be engineered and designed to meet the 
same high standards of safety and protection of fundamental rights applicable to 
traditional technologies u nder European law. Considering the safety objectives of the draft 
Regulation, consistency with the existing EU product safety legislation is ensured and 
administrative burden for operators minimised. For products covered by the New 
Legislative Framework (N LF) legislation (e.g. machinery, medical devices, toys), the 
requirements for high -risk AI systems set out in the draft Regulation will be checked as 
part of the existing conformity assessment procedures under the relevant NLF legislation. 
As regards high -risk AI systems related to products covered by relevant 'Old Approach' 
legislation (e.g. aviation, cars), the draft Regulation would not directly apply. However, 
the ex -ante essential requirements for high -risk AI systems set out in this proposal will 
have to be taken into account when adopting relevant implementing or delegated 
legislation under those acts. Therefore, the following objectives are pursued:  
• Prevention of deceptive practices and consumer protection  
• Protection of fundamental rights, human li fe, health or safety  
• Quality requirements  
• Harmonisation  
Prevention of deceptive practices and consumer protection; Protection of human health 
or safety; Quality requirements; Harmonization  G/TBT/N/EU/850  
 
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  8. Relevant documents:   
The draft Regulation introduces amendments to a number of other legislative acts under 
the 'Old approach' safety legislation:  
• Regulation (EC) No 300/2008  
• Regulation (EU) No 167/2013  
• Regulation (EU) No 168/201  
• Directive 2014/90/EU  
• Directive (EU) 2016/797  
• Regulation (EU) 2018/858  
• Regulation (EU) 2018/1139  
• Regulation (EU) 2019/2144  
9. Proposed date of adoption:  2-3 years from now (depending on the legislative process)  
Proposed date of entry into force:  20 days after its publication (transitional period of 
two years 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%3A52021PC0206&qid=1619620493851  
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7109_01_e.pd f 
https://members.wto.org/crnattachments/2021/TBT/EEC/21_7109_00_e.pdf