1. This Regulation applies to:
1. Ta uredba se uporablja za:
(a)
providers placing on the market or putting into service AI systems or placing on the market general-purpose AI models in the Union, irrespective of whether those providers are established or located within the Union or in a third country;
(a)
ponudnike, ki dajejo na trg ali v uporabo sisteme UI ali dajejo na trg modele UI za splošne namene v Uniji, ne glede na to, ali imajo ti ponudniki sedež ali se nahajajo v Uniji ali v tretji državi;
(b)
deployers of AI systems that have their place of establishment or are located within the Union;
(b)
uvajalce sistemov UI, ki imajo sedež ali se nahajajo v Uniji;
(c)
providers and deployers of AI systems that have their place of establishment or are located in a third country, where the output produced by the AI system is used in the Union;
(c)
ponudnike in uvajalce sistemov UI, ki imajo sedež ali se nahajajo v tretji državi, kadar se izhodni podatki, ki jih sistem UI ustvari, uporabljajo v Uniji;
(d)
importers and distributors of AI systems;
(d)
uvoznike in distributerje sistemov UI;
(e)
product manufacturers placing on the market or putting into service an AI system together with their product and under their own name or trademark;
(e)
proizvajalce proizvodov, ki dajejo sistem UI na trg ali v uporabo skupaj s svojim proizvodom in pod svojim imenom ali znamko;
(f)
authorised representatives of providers, which are not established in the Union;
(f)
pooblaščene zastopnike ponudnikov, ki nimajo sedeža v Uniji;
(g)
affected persons that are located in the Union.
(g)
osebe, ki jih zadeva in se nahajajo v Uniji.
2. For AI systems classified as high-risk AI systems in accordance with Article 6(1) related to products covered by the Union harmonisation legislation listed in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 apply. Article 57 applies only in so far as the requirements for high-risk AI systems under this Regulation have been integrated in that Union harmonisation legislation.
2. Za sisteme UI, ki so razvrščeni med visoko tvegane sisteme UI v skladu s členom 6(1) v povezavi s proizvodi, zajetimi v harmonizacijski zakonodaji Unije s seznama v Prilogi I, oddelek B, se uporablja samo člen 6(1), členi 102 do 109 in člen 112. Člen 57 se uporablja le, če so bile zahteve za visokotvegane sisteme UI iz te uredbe vključene v to harmonizacijsko zakonodajo Unije.
3. This Regulation does not apply to areas outside the scope of Union law, and shall not, in any event, affect the competences of the Member States concerning national security, regardless of the type of entity entrusted by the Member States with carrying out tasks in relation to those competences.
3. Ta uredba se ne uporablja za področja, ki ne spadajo na področje uporabe prava Unije, in v nobenem primeru ne vpliva na pristojnosti držav članic v zvezi z nacionalno varnostjo, ne glede na vrsto subjekta, ki ga države članice pooblastijo za opravljanje nalog v zvezi s temi pristojnostmi.
This Regulation does not apply to AI systems where and in so far they are placed on the market, put into service, or used with or without modification exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.
Ta uredba se ne uporablja za sisteme UI, kadar in kolikor so s spremembami ali brez njih dani na trg ali v uporabo oziroma se uporabljajo izključno za vojaške, obrambne ali nacionalne varnostne namene, ne glede na vrsto subjekta, ki izvaja te dejavnosti.
This Regulation does not apply to AI systems which are not placed on the market or put into service in the Union, where the output is used in the Union exclusively for military, defence or national security purposes, regardless of the type of entity carrying out those activities.
Ta uredba se ne uporablja za sisteme UI, ki niso dani na trg ali v uporabo v Uniji, kadar se izhodni podatki uporabljajo v Uniji izključno za vojaške, obrambne ali nacionalne varnostne namene, ne glede na vrsto subjekta, ki izvaja te dejavnosti.
4. This Regulation applies neither to public authorities in a third country nor to international organisations falling within the scope of this Regulation pursuant to paragraph 1, where those authorities or organisations use AI systems in the framework of international cooperation or agreements for law enforcement and judicial cooperation with the Union or with one or more Member States, provided that such a third country or international organisation provides adequate safeguards with respect to the protection of fundamental rights and freedoms of individuals.
4. Ta uredba se ne uporablja za javne organe v tretji državi in mednarodne organizacije, ki spadajo na področje uporabe te uredbe na podlagi odstavka 1, kadar ti organi ali organizacije uporabljajo sisteme UI v okviru mednarodnega sodelovanja ali sporazumov za sodelovanje na področju preprečevanja, odkrivanja in preiskovanja kaznivih dejanj ter za sodelovanje na področju pravosodja z Unijo ali z eno ali več državami članicami, pod pogojem, da ta tretja država ali mednarodna organizacija zagotovi ustrezne zaščitne ukrepe v zvezi z varstvom temeljnih pravic in svoboščin posameznikov.
5. This Regulation shall not affect the application of the provisions on the liability of providers of intermediary services as set out in Chapter II of Regulation (EU) 2022/2065.
5. Ta uredba ne vpliva na uporabo določb o odgovornosti ponudnikov posredniških storitev iz poglavja II Uredbe (EU) 2022/2065.
6. This Regulation does not apply to AI systems or AI models, including their output, specifically developed and put into service for the sole purpose of scientific research and development.
6. Ta uredba se ne uporablja za sisteme UI ali modele UI, vključno z njihovimi izhodnimi podatki, posebej razvite in dane v uporabo zgolj za namene znanstvenih raziskav in razvoja.
7. Union law on the protection of personal data, privacy and the confidentiality of communications applies to personal data processed in connection with the rights and obligations laid down in this Regulation. This Regulation shall not affect Regulation (EU) 2016/679 or (EU) 2018/1725, or Directive 2002/58/EC or (EU) 2016/680, without prejudice to Article 10(5) and Article 59 of this Regulation.
7. Pravo Unije o varstvu osebnih podatkov, zasebnosti in zaupnosti komunikacij se uporablja za osebne podatke, ki se obdelujejo v zvezi s pravicami in obveznostmi iz te uredbe. Brez poseganja v člen 10(5) in člen 59 te uredbe ta uredba ne vpliva na Uredbo (EU) 2016/679 ali (EU) 2018/1725 ali Direktivo 2002/58/ES ali (EU) 2016/680.
8. This Regulation does not apply to any research, testing or development activity regarding AI systems or AI models prior to their being placed on the market or put into service. Such activities shall be conducted in accordance with applicable Union law. Testing in real world conditions shall not be covered by that exclusion.
8. Ta uredba se ne uporablja za raziskovalne dejavnosti, dejavnosti testiranja ali razvojne dejavnosti v zvezi z sistemi UI ali modeli UI, preden se ti dajo na trg ali v uporabo. Te dejavnosti se morajo izvajati v skladu z veljavnim pravom Unije. Ta izključitev ne zajema testiranja v realnih razmerah.
9. This Regulation is without prejudice to the rules laid down by other Union legal acts related to consumer protection and product safety.
9. Ta uredba ne posega v pravila, določena v drugih pravnih aktih Unije v zvezi z varstvom potrošnikov in varnostjo proizvodov.
10. This Regulation does not apply to obligations of deployers who are natural persons using AI systems in the course of a purely personal non-professional activity.
10. Ta uredba se ne uporablja za obveznosti uvajalcev, ki so fizične osebe in uporabljajo sisteme UI v okviru povsem osebne nepoklicne dejavnosti.
11. This Regulation does not preclude the Union or Member States from maintaining or introducing laws, regulations or administrative provisions which are more favourable to workers in terms of protecting their rights in respect of the use of AI systems by employers, or from encouraging or allowing the application of collective agreements which are more favourable to workers.
11. Ta uredba Uniji ali državam članicam ne preprečuje, da ohranijo ali uvedejo zakone ali druge predpise, ki so za delavce ugodnejši v smislu varstva njihovih pravic v zvezi z delodajalčevo uporabo sistemov UI, ali da spodbujajo ali dovolijo uporabo kolektivnih pogodb, ki so za delavce ugodnejše.
12. This Regulation does not apply to AI systems released under free and open-source licences, unless they are placed on the market or put into service as high-risk AI systems or as an AI system that falls under Article 5 or 50.
12. Ta uredba se ne uporablja za sisteme UI, objavljene na podlagi prostih in odprtokodnih licenc, razen če so dani na trg ali v uporabo kot visokotvegani sistemi UI ali sistem UI iz člena 5 ali 50.
1. The following AI practices shall be prohibited:
1. Prepovedane so naslednje prakse UI:
(a)
the placing on the market, the putting into service or the use of an AI system that deploys subliminal techniques beyond a person’s consciousness or purposefully manipulative or deceptive techniques, with the objective, or the effect of materially distorting the behaviour of a person or a group of persons by appreciably impairing their ability to make an informed decision, thereby causing them to take a decision that they would not have otherwise taken in a manner that causes or is reasonably likely to cause that person, another person or group of persons significant harm;
(a)
dajanje na trg, dajanje v uporabo ali uporaba sistema UI, ki uporablja subliminalne tehnike, ki presegajo zavest osebe, ali namerno manipulativne ali zavajajoče tehnike, s ciljem ali učinkom bistvenega izkrivljanja vedenja osebe ali skupine oseb, tako da se znatno zmanjša njihova sposobnost, da sprejmejo informirano odločitev, zaradi česar sprejmejo odločitev, ki je sicer ne bi sprejeli, na način, ki tej osebi, drugi osebi ali skupini oseb povzroči znatno škodo ali za katerega obstaja razumna verjetnost, da bo povzročil znatno škodo;
(b)
the placing on the market, the putting into service or the use of an AI system that exploits any of the vulnerabilities of a natural person or a specific group of persons due to their age, disability or a specific social or economic situation, with the objective, or the effect, of materially distorting the behaviour of that person or a person belonging to that group in a manner that causes or is reasonably likely to cause that person or another person significant harm;
(b)
dajanje na trg, dajanje v uporabo ali uporaba sistema UI, ki izkorišča katere koli šibke točke fizične osebe ali določene skupine oseb zaradi njihove starosti, invalidnosti ali posebnega socialnega ali ekonomskega položaja, s ciljem ali učinkom, bistvenega izkrivljanja vedenja te osebe ali osebe iz te skupine na način, ki tej ali drugi osebi povzroči znatno škodo ali za katerega obstaja razumna verjetnost, da bo povzročil znatno škodo;
(c)
the placing on the market, the putting into service or the use of AI systems for the evaluation or classification of natural persons or groups of persons over a certain period of time based on their social behaviour or known, inferred or predicted personal or personality characteristics, with the social score leading to either or both of the following:
(c)
dajanje na trg, dajanje v uporabo ali uporaba sistemov UI za ocenjevanje ali razvrščanje fizičnih oseb ali skupin, ki jim pripadajo, v določenem časovnem obdobju na podlagi njihovega družbenega vedenja ali znanih, predpostavljenih ali predvidenih osebnih ali osebnostnih značilnosti, pri čemer število družbenih točk privede do ene ali obeh naslednjih možnosti:
(i)
detrimental or unfavourable treatment of certain natural persons or groups of persons in social contexts that are unrelated to the contexts in which the data was originally generated or collected;
(i)
škodljiva ali neugodna obravnava nekaterih fizičnih oseb ali skupin oseb v družbenih okoliščinah, ki niso povezane s konteksti, v katerih so bili podatki prvotno ustvarjeni ali zbrani;
(ii)
detrimental or unfavourable treatment of certain natural persons or groups of persons that is unjustified or disproportionate to their social behaviour or its gravity;
(ii)
škodljiva ali neugodna obravnava nekaterih fizičnih oseb ali skupin oseb, ki je neupravičena ali nesorazmerna z njihovim družbenim vedenjem ali resnostjo njihovega družbenega vedenja;
(d)
the placing on the market, the putting into service for this specific purpose, or the use of an AI system for making risk assessments of natural persons in order to assess or predict the risk of a natural person committing a criminal offence, based solely on the profiling of a natural person or on assessing their personality traits and characteristics; this prohibition shall not apply to AI systems used to support the human assessment of the involvement of a person in a criminal activity, which is already based on objective and verifiable facts directly linked to a criminal activity;
(d)
dajanje na trg, dajanje v uporabo za ta posebni namen ali uporaba sistema UI za ocenjevanje tveganja v zvezi s fizičnimi osebami, da se oceni ali predvidi, kakšno je tveganje, da bo fizična oseba storila kaznivo dejanje, izključno na podlagi oblikovanja profila fizične osebe ali ocenjevanja njenih osebnostnih lastnosti in značilnosti; ta prepoved se ne uporablja za sisteme UI, ki se uporabljajo za podporo človeški oceni vpletenosti osebe v kriminalno dejavnost, ki že temelji na objektivnih in preverljivih dejstvih, neposredno povezanih s kriminalno dejavnostjo;
(e)
the placing on the market, the putting into service for this specific purpose, or the use of AI systems that create or expand facial recognition databases through the untargeted scraping of facial images from the internet or CCTV footage;
(e)
dajanje na trg, dajanje v uporabo za ta posebni namen ali uporaba sistemov UI, ki z neciljnim odvzemom podob obraza z interneta ali s posnetkov kamer CCTV ustvarjajo ali širijo podatkovne zbirke za prepoznavanje obraza;
(f)
the placing on the market, the putting into service for this specific purpose, or the use of AI systems to infer emotions of a natural person in the areas of workplace and education institutions, except where the use of the AI system is intended to be put in place or into the market for medical or safety reasons;
(f)
dajanje na trg, dajanje v uporabo za ta posebni namen ali uporaba sistemov UI za sklepanje o čustvih fizične osebe na delovnem mestu in v izobraževalnih ustanovah, razen kadar je uporaba sistema UI namenjena uvedbi ali dajanju na trg iz zdravstvenih ali varnostnih razlogov;
(g)
the placing on the market, the putting into service for this specific purpose, or the use of biometric categorisation systems that categorise individually natural persons based on their biometric data to deduce or infer their race, political opinions, trade union membership, religious or philosophical beliefs, sex life or sexual orientation; this prohibition does not cover any labelling or filtering of lawfully acquired biometric datasets, such as images, based on biometric data or categorizing of biometric data in the area of law enforcement;
(g)
dajanje na trg, dajanje v uporabo za ta posebni namen ali uporaba sistemov za biometrično kategorizacijo, ki posameznike razvrščajo na podlagi njihovih biometričnih podatkov, da bi prišli do sklepov ali ugotovitev glede njihove rase, političnega prepričanja, članstva v sindikatu, verskega ali filozofskega prepričanja, spolnega življenja ali spolne usmerjenosti; ta prepoved ne zajema označevanja ali filtriranja zakonito pridobljenih naborov biometričnih podatkov, kot so slike, na podlagi biometričnih podatkov ali kategorizacije biometričnih podatkov na področju preprečevanja, odkrivanja in preiskovanja kaznivih dejanj;
(h)
the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement, unless and in so far as such use is strictly necessary for one of the following objectives:
(h)
uporaba sistemov za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj, razen če je taka uporaba nujno potrebna za enega od naslednjih ciljev:
(i)
the targeted search for specific victims of abduction, trafficking in human beings or sexual exploitation of human beings, as well as the search for missing persons;
(i)
ciljno usmerjeno iskanje določenih žrtev ugrabitev, trgovine z ljudmi ali spolnega izkoriščanja ljudi ter iskanje pogrešanih oseb;
(ii)
the prevention of a specific, substantial and imminent threat to the life or physical safety of natural persons or a genuine and present or genuine and foreseeable threat of a terrorist attack;
(ii)
preprečitev konkretne, znatne in neposredne nevarnosti za življenje ali fizično varnost fizičnih oseb ali resnične in sedanje ali resnične in predvidljive grožnje terorističnega napada;
(iii)
the localisation or identification of a person suspected of having committed a criminal offence, for the purpose of conducting a criminal investigation or prosecution or executing a criminal penalty for offences referred to in Annex II and punishable in the Member State concerned by a custodial sentence or a detention order for a maximum period of at least four years.
(iii)
lokalizacija ali identifikacija osebe, osumljene storitve kaznivega dejanja, za namen izvajanja kazenske preiskave ali pregona ali izvršitve kazenske sankcije za kazniva dejanja iz Priloge II, za katera je v zadevni državi članici predpisana zgornja meja zaporne kazni ali ukrepa, vezanega na odvzem prostosti, najmanj štiri leta.
Point (h) of the first subparagraph is without prejudice to Article 9 of Regulation (EU) 2016/679 for the processing of biometric data for purposes other than law enforcement.
Točka (h) prvega pododstavka ne posega v člen 9 Uredbe (EU) 2016/679 v zvezi z obdelavo biometričnih podatkov za namene, ki niso preprečevanje, odkrivanje in preiskovanje kaznivih dejanj.
2. The use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), shall be deployed for the purposes set out in that point only to confirm the identity of the specifically targeted individual, and it shall take into account the following elements:
2. Sistemi za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj za katerega koli od ciljev iz odstavka 1, prvi pododstavek, točka (h), se uporabljajo za namene iz navedene točke, samo da se potrdi identiteta točno določenega posameznika, pri čemer se upoštevajo naslednji elementi:
(a)
the nature of the situation giving rise to the possible use, in particular the seriousness, probability and scale of the harm that would be caused if the system were not used;
(a)
narava razmer, ki povzročajo morebitno uporabo, zlasti resnost, verjetnost in obseg škode, ki bi bila povzročena, če se sistem ne bi uporabljal;
(b)
the consequences of the use of the system for the rights and freedoms of all persons concerned, in particular the seriousness, probability and scale of those consequences.
(b)
posledice uporabe sistema za pravice in svoboščine vseh zadevnih oseb, zlasti resnost, verjetnost in obseg teh posledic.
In addition, the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement for any of the objectives referred to in paragraph 1, first subparagraph, point (h), of this Article shall comply with necessary and proportionate safeguards and conditions in relation to the use in accordance with the national law authorising the use thereof, in particular as regards the temporal, geographic and personal limitations. The use of the ‘real-time’ remote biometric identification system in publicly accessible spaces shall be authorised only if the law enforcement authority has completed a fundamental rights impact assessment as provided for in Article 27 and has registered the system in the EU database according to Article 49. However, in duly justified cases of urgency, the use of such systems may be commenced without the registration in the EU database, provided that such registration is completed without undue delay.
Poleg tega mora biti uporaba sistemov za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj za katerega koli od ciljev iz odstavka 1, prvi pododstavek, točka (h), tega člena skladna s potrebnimi in sorazmernimi zaščitnimi ukrepi in pogoji v zvezi z uporabo po nacionalnem pravu, ki dovoljuje njihovo uporabo, zlasti kar zadeva časovne, geografske in osebne omejitve. Uporaba sistema za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih se dovoli le, če je organ za preprečevanje, odkrivanje in preiskovanje kaznivih dejanj opravil oceno učinka na temeljne pravice iz člena 27 in sistem registriral v podatkovni zbirki EU v skladu s členom 49. Vendar se lahko v ustrezno utemeljenih nujnih primerih uporaba takšnih sistemov začne brez registracije v podatkovni zbirki EU, če se takšna registracija zaključi brez nepotrebnega odlašanja.
3. For the purposes of paragraph 1, first subparagraph, point (h) and paragraph 2, each use for the purposes of law enforcement of a ‘real-time’ remote biometric identification system in publicly accessible spaces shall be subject to a prior authorisation granted by a judicial authority or an independent administrative authority whose decision is binding of the Member State in which the use is to take place, issued upon a reasoned request and in accordance with the detailed rules of national law referred to in paragraph 5. However, in a duly justified situation of urgency, the use of such system may be commenced without an authorisation provided that such authorisation is requested without undue delay, at the latest within 24 hours. If such authorisation is rejected, the use shall be stopped with immediate effect and all the data, as well as the results and outputs of that use shall be immediately discarded and deleted.
3. Za namene odstavka 1, prvi pododstavek, točka (h), in odstavka 2 je za vsako uporabo sistema za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj treba pridobiti predhodno dovoljenje sodnega organa ali neodvisnega upravnega organa, katerega odločitev je zavezujoča za državo članico, v kateri bo potekala uporaba, izdano na podlagi obrazložene zahteve in v skladu s podrobnimi pravili nacionalnega prava iz odstavka 5. Vendar se lahko v ustrezno utemeljenih nujnih primerih uporaba takšnega sistema začne brez dovoljenja, pod pogojem, da se takšno dovoljenje zahteva brez nepotrebnega odlašanja in najpozneje v 24 urah. Če se takšno dovoljenje zavrne, se njegova uporaba takoj ustavi, vsi podatki ter izhodni podatki in izsledki, ki izhajajo iz te uporabe, pa se takoj zavržejo in izbrišejo.
The competent judicial authority or an independent administrative authority whose decision is binding shall grant the authorisation only where it is satisfied, on the basis of objective evidence or clear indications presented to it, that the use of the ‘real-time’ remote biometric identification system concerned is necessary for, and proportionate to, achieving one of the objectives specified in paragraph 1, first subparagraph, point (h), as identified in the request and, in particular, remains limited to what is strictly necessary concerning the period of time as well as the geographic and personal scope. In deciding on the request, that authority shall take into account the elements referred to in paragraph 2. No decision that produces an adverse legal effect on a person may be taken based solely on the output of the ‘real-time’ remote biometric identification system.
Pristojni sodni organ ali neodvisni upravni organ, katerega odločitev je zavezujoča, izda dovoljenje samo v primeru, kadar se na podlagi objektivnih dokazov ali jasnih navedb, ki so mu bili predloženi, prepriča, da je uporaba zadevnega sistema za biometrično identifikacijo na daljavo v realnem času potrebna in sorazmerna za doseganje enega od ciljev iz odstavka 1, prvi pododstavek, točka (h), kot je opredeljeno v zahtevi, in zlasti ostaja omejena na to, kar je nujno potrebno v zvezi z obdobjem ter geografskim in osebnim področjem uporabe. Pri odločanju o zahtevi ta organ upošteva elemente iz odstavka 2. Nobena odločitev, ki ima škodljiv pravni učinek na osebo, se ne sme sprejeti samo na podlagi izhodnih podatkov sistema za biometrično identifikacijo na daljavo v realnem času.
4. Without prejudice to paragraph 3, each use of a ‘real-time’ remote biometric identification system in publicly accessible spaces for law enforcement purposes shall be notified to the relevant market surveillance authority and the national data protection authority in accordance with the national rules referred to in paragraph 5. The notification shall, as a minimum, contain the information specified under paragraph 6 and shall not include sensitive operational data.
4. Brez poseganja v odstavek 3 je treba o vsaki uporabi sistema za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj uradno obvestiti ustrezni organ za nadzor trga in nacionalni organ za varstvo podatkov v skladu z nacionalnimi pravili iz odstavka 5. Obvestilo vsebuje vsaj informacije iz odstavka 6 in ne vključuje občutljivih operativnih podatkov.
5. A Member State may decide to provide for the possibility to fully or partially authorise the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for the purposes of law enforcement within the limits and under the conditions listed in paragraph 1, first subparagraph, point (h), and paragraphs 2 and 3. Member States concerned shall lay down in their national law the necessary detailed rules for the request, issuance and exercise of, as well as supervision and reporting relating to, the authorisations referred to in paragraph 3. Those rules shall also specify in respect of which of the objectives listed in paragraph 1, first subparagraph, point (h), including which of the criminal offences referred to in point (h)(iii) thereof, the competent authorities may be authorised to use those systems for the purposes of law enforcement. Member States shall notify those rules to the Commission at the latest 30 days following the adoption thereof. Member States may introduce, in accordance with Union law, more restrictive laws on the use of remote biometric identification systems.
5. Država članica se lahko odloči, da v okviru omejitev in pod pogoji iz odstavka 1, prvi pododstavek, točka (h), ter odstavkov 2 in 3 v celoti ali delno dovoli uporabo sistemov za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj. Zadevne države članice v svojem nacionalnem pravu določijo potrebna podrobna pravila v zvezi z vložitvijo zahteve za dovoljenja iz odstavka 3, izdajo, izvrševanjem in spremljanjem teh dovoljenj ter poročanjem v zvezi z njimi. V teh pravilih je tudi določeno, za katere od ciljev iz odstavka 1, prvi pododstavek, točka (h), med drugim tudi, za katera kazniva dejanja iz točke (h)(iii) navedenega odstavka, se lahko pristojnim organom dovoli uporaba teh sistemov za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj. Države članice obvestijo Komisijo o teh pravilih najpozneje 30 dni po njihovem sprejetju. Države članice lahko v skladu s pravom Unije uvedejo strožje zakone o uporabi sistemov za biometrično identifikacijo na daljavo.
6. National market surveillance authorities and the national data protection authorities of Member States that have been notified of the use of ‘real-time’ remote biometric identification systems in publicly accessible spaces for law enforcement purposes pursuant to paragraph 4 shall submit to the Commission annual reports on such use. For that purpose, the Commission shall provide Member States and national market surveillance and data protection authorities with a template, including information on the number of the decisions taken by competent judicial authorities or an independent administrative authority whose decision is binding upon requests for authorisations in accordance with paragraph 3 and their result.
6. Nacionalni organi za nadzor trga in nacionalni organi za varstvo podatkov držav članic, ki so bili na podlagi odstavka 4 obveščeni o uporabi sistemov za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj, Komisiji predložijo letna poročila o taki uporabi. V ta namen Komisija državam članicam ter nacionalnim organom za nadzor trga in varstvo podatkov zagotovi predlogo, ki vključuje informacije o številu odločitev, ki jih glede zahtevkov za dovoljenja v skladu z odstavkom 3 sprejmejo pristojni sodni organi ali neodvisni upravni organ, katerega odločitev je zavezujoča, in o njihovih rezultatih.
7. The Commission shall publish annual reports on the use of real-time remote biometric identification systems in publicly accessible spaces for law enforcement purposes, based on aggregated data in Member States on the basis of the annual reports referred to in paragraph 6. Those annual reports shall not include sensitive operational data of the related law enforcement activities.
7. Komisija objavi letna poročila o uporabi sistemov za biometrično identifikacijo na daljavo v realnem času v javno dostopnih prostorih za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj na podlagi zbirnih podatkov v državah članicah, ki temeljijo na letnih poročilih iz odstavka 6. Ta letna poročila ne vključujejo občutljivih operativnih podatkov o povezanih dejavnostih preprečevanja, odkrivanja in preiskovanja kaznivih dejanj.
8. This Article shall not affect the prohibitions that apply where an AI practice infringes other Union law.
8. Ta člen ne vpliva na prepovedi, ki se uporabljajo, kadar praksa UI krši drugo pravo Unije.
Sistem za obvladovanje tveganja
1. A risk management system shall be established, implemented, documented and maintained in relation to high-risk AI systems.
1. V zvezi z visokotveganimi sistemi UI se vzpostavi, izvaja, dokumentira in vzdržuje sistem za obvladovanje tveganja.
2. The risk management system shall be understood as a continuous iterative process planned and run throughout the entire lifecycle of a high-risk AI system, requiring regular systematic review and updating. It shall comprise the following steps:
2. Sistem za obvladovanje tveganja pomeni neprekinjen in ponavljajoč se proces, ki se načrtuje in izvaja v celotnem življenjskem ciklu visokotveganega sistema UI in ga je treba redno sistematično pregledovati in posodabljati. Vključuje naslednje korake:
(a)
the identification and analysis of the known and the reasonably foreseeable risks that the high-risk AI system can pose to health, safety or fundamental rights when the high-risk AI system is used in accordance with its intended purpose;
(a)
opredelitev in analizo znanih in razumno predvidljivih tveganj, ki jih lahko visokotvegani sistem UI pomeni za zdravje, varnost ali temeljne pravice, kadar se uporablja v skladu s predvidenim namenom;
(b)
the estimation and evaluation of the risks that may emerge when the high-risk AI system is used in accordance with its intended purpose, and under conditions of reasonably foreseeable misuse;
(b)
oceno in ovrednotenje tveganj, ki se lahko pojavijo pri uporabi visokotveganega sistema UI v skladu s predvidenim namenom in v razmerah razumno predvidljive napačne uporabe;
(c)
the evaluation of other risks possibly arising, based on the analysis of data gathered from the post-market monitoring system referred to in Article 72;
(c)
ovrednotenje drugih morebitnih tveganj na podlagi analize podatkov, zbranih iz sistema spremljanja po dajanju na trg iz člena 72;
(d)
the adoption of appropriate and targeted risk management measures designed to address the risks identified pursuant to point (a).
(d)
sprejetje ustreznih in ciljno usmerjenih ukrepov za obvladovanje tveganja, namenjenih obravnavanju tveganj, opredeljenih na podlagi točke (a).
3. The risks referred to in this Article shall concern only those which may be reasonably mitigated or eliminated through the development or design of the high-risk AI system, or the provision of adequate technical information.
3. Tveganja iz tega člena se nanašajo samo na tista, ki jih je mogoče razumno zmanjšati ali odpraviti z razvojem ali zasnovo visokotveganega sistema UI ali z zagotovitvijo ustreznih tehničnih informacij.
4. The risk management measures referred to in paragraph 2, point (d), shall give due consideration to the effects and possible interaction resulting from the combined application of the requirements set out in this Section, with a view to minimising risks more effectively while achieving an appropriate balance in implementing the measures to fulfil those requirements.
4. Pri ukrepih za obvladovanje tveganja iz odstavka 2, točka (d), se ustrezno upoštevajo učinki in morebitna interakcija, ki izhajajo iz skupne uporabe zahtev iz tega oddelka 2, da bi učinkoviteje in čim bolj zmanjšali tveganja in hkrati dosegli ustrezno ravnovesje pri izvajanju ukrepov za izpolnjevanje teh zahtev.
5. The risk management measures referred to in paragraph 2, point (d), shall be such that the relevant residual risk associated with each hazard, as well as the overall residual risk of the high-risk AI systems is judged to be acceptable.
5. Ukrepi za obvladovanje tveganja iz odstavka 2, točka (d), so taki, da zadevno preostalo tveganje, povezano z vsako posamezno nevarnostjo, in celotno preostalo tveganje visokotveganih sistemov UI štejeta za sprejemljiva.
In identifying the most appropriate risk management measures, the following shall be ensured:
Pri določanju najustreznejših ukrepov za obvladovanje tveganja se zagotovi naslednje:
(a)
elimination or reduction of risks identified and evaluated pursuant to paragraph 2 in as far as technically feasible through adequate design and development of the high-risk AI system;
(a)
odpravljanje ali zmanjševanje tveganj ugotovljenih in ocenjenih na podlagi odstavka 2, kolikor je to tehnično izvedljivo z ustrezno zasnovo in razvojem visokotveganega sistema UI;
(b)
where appropriate, implementation of adequate mitigation and control measures addressing risks that cannot be eliminated;
(b)
po potrebi izvajanje ustreznih ukrepov za zmanjšanje in nadzor tveganj, ki jih ni mogoče odpraviti;
(c)
provision of information required pursuant to Article 13 and, where appropriate, training to deployers.
(c)
zagotavljanje zahtevanih informacij na podlagi člena 13 in po potrebi usposabljanje uvajalcev.
With a view to eliminating or reducing risks related to the use of the high-risk AI system, due consideration shall be given to the technical knowledge, experience, education, the training to be expected by the deployer, and the presumable context in which the system is intended to be used.
Da bi odpravili ali zmanjšali tveganja, povezana z uporabo visokotveganega sistema UI, se ustrezno upoštevajo tehnično znanje, izkušnje, izobraževanje, usposabljanje, ki ga lahko pričakuje uvajalec, in predvideni okvir, v katerem naj bi se sistem uporabljal.
6. High-risk AI systems shall be tested for the purpose of identifying the most appropriate and targeted risk management measures. Testing shall ensure that high-risk AI systems perform consistently for their intended purpose and that they are in compliance with the requirements set out in this Section.
6. Visokotvegani sistemi UI se testirajo, da se določijo najustreznejši in ciljno usmerjeni ukrepi za obvladovanje tveganja. S testiranjem se zagotovi, da visokotvegani sistemi UI dosledno delujejo za predvideni namen in so skladni z zahtevami iz tega oddelka.
7. Testing procedures may include testing in real-world conditions in accordance with Article 60.
7. Postopki testiranja lahko vključujejo testiranje v realnih razmerah v skladu s členom 60.
8. The testing of high-risk AI systems shall be performed, as appropriate, at any time throughout the development process, and, in any event, prior to their being placed on the market or put into service. Testing shall be carried out against prior defined metrics and probabilistic thresholds that are appropriate to the intended purpose of the high-risk AI system.
8. Testiranje visokotveganih sistemov UI se po potrebi izvaja kadar koli med celotnim postopkom razvoja in v vsakem primeru pred njihovim dajanjem na trg ali v uporabo. Testiranje se opravi na podlagi predhodno opredeljenih metrik in verjetnostnih pragov, ki ustrezajo predvidenemu namenu visokotveganega sistema UI.
9. When implementing the risk management system as provided for in paragraphs 1 to 7, providers shall give consideration to whether in view of its intended purpose the high-risk AI system is likely to have an adverse impact on persons under the age of 18 and, as appropriate, other vulnerable groups.
9. Ponudniki pri izvajanju sistema za obvladovanje tveganja iz odstavkov 1 do 7 preučijo, ali je verjetno, da bo visokotvegani sistem UI glede na predvideni namen negativno vplival na osebe, mlajše od 18 let, in po potrebi na druge ranljive skupine.
10. For providers of high-risk AI systems that are subject to requirements regarding internal risk management processes under other relevant provisions of Union law, the aspects provided in paragraphs 1 to 9 may be part of, or combined with, the risk management procedures established pursuant to that law.
10. Pri ponudnikih visokotveganih sistemov UI, za katere veljajo zahteve v zvezi z notranjimi procesi za obvladovanje tveganj v skladu z drugimi ustreznimi določbami prava Unije, so lahko vidiki, opisani v odstavkih 1 do 9, del postopkov za obvladovanje tveganj, vzpostavljenih na podlagi navedenega prava, ali so v kombinaciji s temi postopki.
Obligations of deployers of high-risk AI systems
Obveznosti uvajalcev visokotveganih sistemov UI
1. Deployers of high-risk AI systems shall take appropriate technical and organisational measures to ensure they use such systems in accordance with the instructions for use accompanying the systems, pursuant to paragraphs 3 and 6.
1. Uvajalci visokotveganih sistemov UI sprejmejo ustrezne tehnične in organizacijske ukrepe, s katerimi zagotovijo, da uporabljajo take sisteme v skladu s priloženimi navodili za uporabo, na podlagi odstavkov 3 in 6.
2. Deployers shall assign human oversight to natural persons who have the necessary competence, training and authority, as well as the necessary support.
2. Uvajalci dodelijo človeški nadzor fizičnim osebam, ki imajo potrebne kompetence, usposobljenost in pooblastila ter potrebno podporo.
3. The obligations set out in paragraphs 1 and 2, are without prejudice to other deployer obligations under Union or national law and to the deployer’s freedom to organise its own resources and activities for the purpose of implementing the human oversight measures indicated by the provider.
3. Obveznosti iz odstavkov 1 in 2 ne posegajo v druge obveznosti uvajalca v skladu s pravom Unije ali nacionalnim pravom ter v pravico uvajalca, da organizira lastna sredstva in dejavnosti za izvajanje ukrepov za človeški nadzor, ki jih navede ponudnik.
4. Without prejudice to paragraphs 1 and 2, to the extent the deployer exercises control over the input data, that deployer shall ensure that input data is relevant and sufficiently representative in view of the intended purpose of the high-risk AI system.
4. Brez poseganja v odstavka 1 in 2, če uvajalec izvaja nadzor nad vhodnimi podatki, ta uvajalec zagotovi, da so vhodni podatki ustrezni in dovolj reprezentativni glede na predvideni namen visokotveganega sistema UI.
5. Deployers shall monitor the operation of the high-risk AI system on the basis of the instructions for use and, where relevant, inform providers in accordance with Article 72. Where deployers have reason to consider that the use of the high-risk AI system in accordance with the instructions may result in that AI system presenting a risk within the meaning of Article 79(1), they shall, without undue delay, inform the provider or distributor and the relevant market surveillance authority, and shall suspend the use of that system. Where deployers have identified a serious incident, they shall also immediately inform first the provider, and then the importer or distributor and the relevant market surveillance authorities of that incident. If the deployer is not able to reach the provider, Article 73 shall apply mutatis mutandis. This obligation shall not cover sensitive operational data of deployers of AI systems which are law enforcement authorities.
5. Uvajalci spremljajo delovanje visoko tveganega sistem UI na podlagi navodil za uporabo in po potrebi obvestijo ponudnike v skladu s členom 72. Kadar imajo uvajalci razlog za domnevo, da bi uporaba visoko tveganega sistema UI v skladu z navodili lahko povzročila, da bi visokotvegani sistem UI predstavljal tveganje v smislu člena 79(1), o tem brez nepotrebnega odlašanja obvestijo ponudnika ali distributerja in ustrezni organ za nadzor trga ter začasno prekinejo uporabo tega sistema. Kadar uvajalci odkrijejo resen incident, o tem incidentu takoj obvestijo najprej ponudnika in nato uvoznika ali distributerja in ustrezne organe za nadzor trga. Če uvajalec ne more priti v stik s ponudnikom, se smiselno uporablja člen 73. Ta obveznost ne zajema občutljivih operativnih podatkov uvajalcev sistemov UI, ki so organi za preprečevanje, odkrivanje in preiskovanje kaznivih dejanj.
For deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law, the monitoring obligation set out in the first subparagraph shall be deemed to be fulfilled by complying with the rules on internal governance arrangements, processes and mechanisms pursuant to the relevant financial service law.
Za uvajalce, ki so finančne institucije in za katere veljajo zahteve v zvezi z njihovim notranjim upravljanjem, ureditvami ali postopki na podlagi prava Unije o finančnih storitvah, se šteje, da je obveznost spremljanja iz prvega pododstavka izpolnjena z upoštevanjem pravil o ureditvah, procesih in mehanizmih notranjega upravljanja na podlagi ustreznega prava o finančnih storitvah.
6. Deployers of high-risk AI systems shall keep the logs automatically generated by that high-risk AI system to the extent such logs are under their control, for a period appropriate to the intended purpose of the high-risk AI system, of at least six months, unless provided otherwise in applicable Union or national law, in particular in Union law on the protection of personal data.
6. Uvajalci visokotveganih sistemov UI vodijo dnevnike, ki jih samodejno ustvari ta visokotvegani sistem UI, če so ti dnevniki pod njihovim nadzorom, v obdobju, ki ustreza predvidenemu namenu visokotveganega sistema UI, in sicer vsaj šest mesecev, razen če je v veljavnem pravu Unije ali nacionalnem pravu, zlasti v pravu Unije o varstvu osebnih podatkov, določeno drugače.
Deployers that are financial institutions subject to requirements regarding their internal governance, arrangements or processes under Union financial services law shall maintain the logs as part of the documentation kept pursuant to the relevant Union financial service law.
Uvajalci, ki so finančne institucije in za katere veljajo zahteve v zvezi z njihovim notranjim upravljanjem, ureditvami ali postopki na podlagi prava Unije o finančnih storitvah, vodijo dnevnike kot del dokumentacije, ki se hrani na podlagi ustreznega prava Unije o finančnih storitvah.
7. Before putting into service or using a high-risk AI system at the workplace, deployers who are employers shall inform workers’ representatives and the affected workers that they will be subject to the use of the high-risk AI system. This information shall be provided, where applicable, in accordance with the rules and procedures laid down in Union and national law and practice on information of workers and their representatives.
7. Uvajalci, ki so delodajalci, pred dajanjem v uporabo ali pred uporabo visokotveganega sistema UI na delovnem mestu obvestijo predstavnike delavcev in delavce, na katere se to nanaša, da se bo zanje uporabljal visokotvegani sistem UI. Te informacije se po potrebi zagotovijo v skladu s pravili in postopki, določenimi v pravu Unije in nacionalnem pravu ter praksi v zvezi z obveščanjem delavcev in njihovih predstavnikov.
8. Deployers of high-risk AI systems that are public authorities, or Union institutions, bodies, offices or agencies shall comply with the registration obligations referred to in Article 49. When such deployers find that the high-risk AI system that they envisage using has not been registered in the EU database referred to in Article 71, they shall not use that system and shall inform the provider or the distributor.
8. Uvajalci visokotveganih sistemov UI, ki so javni organi ali institucije, organi, uradi in agencije Unije, izpolnjujejo obveznosti registracije iz člena 49. Če ti uvajalci ugotovijo, da visokotvegani sistem UI, ki ga nameravajo uporabljati, ni bil registriran v podatkovni zbirki EU iz člena 71, tega sistema ne uporabljajo in o tem obvestijo ponudnika ali distributerja.
9. Where applicable, deployers of high-risk AI systems shall use the information provided under Article 13 of this Regulation to comply with their obligation to carry out a data protection impact assessment under Article 35 of Regulation (EU) 2016/679 or Article 27 of Directive (EU) 2016/680.
9. Uvajalci visokotveganih sistemov UI po potrebi uporabijo informacije iz člena 13 te uredbe, da izpolnijo svojo obveznost izvedbe ocene učinka v zvezi z varstvom podatkov na podlagi člena 35 Uredbe (EU) 2016/679 ali člena 27 Direktive (EU) 2016/680.
10. Without prejudice to Directive (EU) 2016/680, in the framework of an investigation for the targeted search of a person suspected or convicted of having committed a criminal offence, the deployer of a high-risk AI system for post-remote biometric identification shall request an authorisation, ex ante, or without undue delay and no later than 48 hours, by a judicial authority or an administrative authority whose decision is binding and subject to judicial review, for the use of that system, except when it is used for the initial identification of a potential suspect based on objective and verifiable facts directly linked to the offence. Each use shall be limited to what is strictly necessary for the investigation of a specific criminal offence.
10. Brez poseganja v Direktivo (EU) 2016/680 v okviru preiskave za ciljno iskanje osebe, ki je osumljena ali obsojena storitve kaznivega dejanja, uvajalec visokotveganega sistema UI za naknadno biometrično identifikacijo na daljavo predhodno ali brez nepotrebnega odlašanja in najpozneje v 48 urah zaprosi sodni organ ali upravni organ, katerega odločitev je zavezujoča in je predmet sodnega nadzora, za uporabo tega sistema, razen če se ta uporablja za prvotno identifikacijo morebitnega osumljenca na podlagi objektivnih in preverljivih dejstev, neposredno povezanih s kaznivim dejanjem. Vsaka uporaba mora biti omejena na tisto, kar je nujno potrebno za preiskavo določenega kaznivega dejanja.
If the authorisation requested pursuant to the first subparagraph is rejected, the use of the post-remote biometric identification system linked to that requested authorisation shall be stopped with immediate effect and the personal data linked to the use of the high-risk AI system for which the authorisation was requested shall be deleted.
Če se dovoljenje, zahtevano na podlagi prvega pododstavka, zavrne, je treba takoj prenehati uporabljati sistem za naknadno biometrično identifikacijo na daljavo, povezan z zahtevanim dovoljenjem, osebni podatki, povezani z uporabo visokotveganega sistema UI, za katerega je bilo zaprošeno dovoljenje, pa se izbrišejo.
In no case shall such high-risk AI system for post-remote biometric identification be used for law enforcement purposes in an untargeted way, without any link to a criminal offence, a criminal proceeding, a genuine and present or genuine and foreseeable threat of a criminal offence, or the search for a specific missing person. It shall be ensured that no decision that produces an adverse legal effect on a person may be taken by the law enforcement authorities based solely on the output of such post-remote biometric identification systems.
V nobenem primeru se tak visokotvegani sistem UI za naknadno biometrično identifikacijo na daljavo ne sme uporabljati za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj na neciljen način, brez kakršne koli povezave s kaznivim dejanjem, kazenskim postopkom, resnično in sedanjo ali resnično in predvidljivo grožnjo kaznivega dejanja ali iskanjem določene pogrešane osebe. Zagotovi se, da organi za preprečevanje, odkrivanje in preiskovanje kaznivih dejanj izključno na podlagi izhodnih podatkov sistema za naknadno biometrično identifikacijo na daljavo ne smejo sprejeti nobene odločitve, ki bi imela negativen pravni učinek na osebo.
This paragraph is without prejudice to Article 9 of Regulation (EU) 2016/679 and Article 10 of Directive (EU) 2016/680 for the processing of biometric data.
Ta odstavek ne posega v člen 9 Uredbe (EU) 2016/679 in člen 10 Direktive (EU) 2016/680 za obdelavo biometričnih podatkov.
Regardless of the purpose or deployer, each use of such high-risk AI systems shall be documented in the relevant police file and shall be made available to the relevant market surveillance authority and the national data protection authority upon request, excluding the disclosure of sensitive operational data related to law enforcement. This subparagraph shall be without prejudice to the powers conferred by Directive (EU) 2016/680 on supervisory authorities.
Ne glede na namen ali uvajalca se vsaka uporaba takih visokotveganih sistemov UI dokumentira v ustrezni policijski datoteki ter se na zahtevo da na voljo ustreznemu organu za nadzor trga in nacionalnemu organu za varstvo podatkov, razen razkritja občutljivih operativnih podatkov, povezanih s preprečevanjem, odkrivanjem in preiskovanjem kaznivih dejanj. Ta pododstavek ne posega v pooblastila, ki so z Direktivo (EU) 2016/680 dodeljena nadzornim organom.
Deployers shall submit annual reports to the relevant market surveillance and national data protection authorities on their use of post-remote biometric identification systems, excluding the disclosure of sensitive operational data related to law enforcement. The reports may be aggregated to cover more than one deployment.
Uvajalci ustreznim organom za nadzor trga in nacionalnim organom za varstvo podatkov predložijo letna poročila o uporabi sistemov za naknadno biometrično identifikacijo na daljavo, razen razkritja občutljivih operativnih podatkov v zvezi z organi za preprečevanje, odkrivanje in preiskovanje kaznivih dejanj. Poročila se lahko združijo tako, da zajemajo več kot eno uvedbo.
Member States may introduce, in accordance with Union law, more restrictive laws on the use of post-remote biometric identification systems.
Države članice lahko v skladu s pravom Unije uvedejo strožje zakone o uporabi sistemov za naknadno biometrično identifikacijo na daljavo.
11. Without prejudice to Article 50 of this Regulation, deployers of high-risk AI systems referred to in Annex III that make decisions or assist in making decisions related to natural persons shall inform the natural persons that they are subject to the use of the high-risk AI system. For high-risk AI systems used for law enforcement purposes Article 13 of Directive (EU) 2016/680 shall apply.
11. Brez poseganja v člen 50 te uredbe uvajalci visokotveganih sistemov UI iz Priloge III, ki sprejemajo odločitve ali pomagajo pri njihovem odločanju v zvezi s fizičnimi osebami, slednje obvestijo, da se zanje uporablja visokotvegani sistem UI. Za visokotvegane sisteme UI, ki se uporabljajo za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj, se uporablja člen 13 Direktive (EU) 2016/680.
12. Deployers shall cooperate with the relevant competent authorities in any action those authorities take in relation to the high-risk AI system in order to implement this Regulation.
12. Uvajalci sodelujejo z ustreznimi pristojnimi organi pri vseh ukrepih, ki jih ti organi sprejmejo v zvezi z visokotveganim sistemom UI, da bi uresničili to uredbo.
Requirements relating to notified bodies
Zahteve v zvezi s priglašenimi organi
1. A notified body shall be established under the national law of a Member State and shall have legal personality.
1. Priglašeni organ mora biti ustanovljen na podlagi nacionalnega prava države članice in imeti pravno osebnost.
2. Notified bodies shall satisfy the organisational, quality management, resources and process requirements that are necessary to fulfil their tasks, as well as suitable cybersecurity requirements.
2. Priglašeni organi morajo izpolnjevati organizacijske zahteve, zahteve glede upravljanja kakovosti, virov in procesov, potrebnih za izpolnjevanje njihovih nalog, ter ustrezne zahteve glede kibernetske varnosti.
3. The organisational structure, allocation of responsibilities, reporting lines and operation of notified bodies shall ensure confidence in their performance, and in the results of the conformity assessment activities that the notified bodies conduct.
3. Organizacijska struktura, dodelitev pristojnosti, poročanje in delovanje priglašenih organov morajo zagotavljati zaupanje v učinkovitost priglašenih organov in v rezultate dejavnosti ugotavljanja skladnosti, ki jih izvajajo.
4. Notified bodies shall be independent of the provider of a high-risk AI system in relation to which they perform conformity assessment activities. Notified bodies shall also be independent of any other operator having an economic interest in high-risk AI systems assessed, as well as of any competitors of the provider. This shall not preclude the use of assessed high-risk AI systems that are necessary for the operations of the conformity assessment body, or the use of such high-risk AI systems for personal purposes.
4. Priglašeni organi morajo biti neodvisni od ponudnika visokotveganega sistema UI, v zvezi s katerim izvajajo dejavnosti ugotavljanja skladnosti. Neodvisni morajo biti tudi od vseh drugih operaterjev, ki imajo gospodarski interes pri ocenjevanem visoko tveganem sistemu UI, in od vseh konkurentov ponudnika. To ne izključuje uporabe ocenjenih visokotveganih sistemov UI, nujnih za delovanje organa za ugotavljanje skladnosti, ali uporabe teh sistemov v zasebne namene.
5. Neither a conformity assessment body, its top-level management nor the personnel responsible for carrying out its conformity assessment tasks shall be directly involved in the design, development, marketing or use of high-risk AI systems, nor shall they represent the parties engaged in those activities. They shall not engage in any activity that might 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.
5. Niti organ za ugotavljanje skladnosti in njegovo najvišje vodstvo niti osebje, pristojno za opravljanje nalog ugotavljanja skladnosti, ne smejo neposredno sodelovati pri zasnovi, razvoju, trženju ali uporabi visokotveganih sistemov UI in tudi ne zastopati strani, ki sodelujejo pri teh dejavnostih. Ne smejo sodelovati pri nobeni dejavnosti, ki bi lahko vplivala na njihovo neodvisno presojo ali integriteto v zvezi z dejavnostmi ugotavljanja skladnosti, za katere so priglašeni. To zlasti velja za svetovalne storitve.
6. Notified bodies shall be organised and operated so as to safeguard the independence, objectivity and impartiality of their activities. Notified bodies shall document and implement a structure and procedures to safeguard impartiality and to promote and apply the principles of impartiality throughout their organisation, personnel and assessment activities.
6. Priglašeni organi s svojo organizacijo in delovanjem zagotavljajo neodvisnost, objektivnost in nepristranskost pri izvajanju svojih dejavnosti. Dokumentirajo in izvajajo strukturo in postopke za zagotovitev nepristranskosti ter za spodbujanje in uporabo načel nepristranskosti v svoji organizaciji, med osebjem in v dejavnostih ocenjevanja.
7. Notified bodies shall have documented procedures in place ensuring that their personnel, committees, subsidiaries, subcontractors and any associated body or personnel of external bodies maintain, in accordance with Article 78, the confidentiality of the information which comes into their possession during the performance of conformity assessment activities, except when its disclosure is required by law. The staff of notified bodies shall be bound to observe professional secrecy with regard to all information obtained in carrying out their tasks under this Regulation, except in relation to the notifying authorities of the Member State in which their activities are carried out.
7. Priglašeni organi morajo imeti vzpostavljene dokumentirane postopke za zagotovitev, da njihovo osebje, odbori, odvisne družbe, podizvajalci, kateri koli povezan organ ali osebje zunanjih organov v skladu s členom 78 ohranjajo zaupnost informacij, pridobljenih med opravljanjem dejavnosti ugotavljanja skladnosti, razen kadar njihovo razkritje zahteva zakon. Njihovo osebje je zavezano varovanju poklicnih skrivnosti v zvezi z vsemi informacijami, pridobljenimi med izvajanjem nalog na podlagi te uredbe, razen v zvezi s priglasitvenimi organi države članice, v kateri izvajajo svoje dejavnosti.
8. Notified bodies shall have procedures for the performance of activities which take due account of the size of a provider, the sector in which it operates, its structure, and the degree of complexity of the AI system concerned.
8. Priglašeni organi morajo imeti vzpostavljene postopke za izvajanje dejavnosti, pri katerih se ustrezno upoštevajo velikost ponudnika, sektor, v katerem deluje, njegova struktura in stopnja zahtevnosti zadevnega sistema UI.
9. Notified bodies shall take out appropriate liability insurance for their conformity assessment activities, unless liability is assumed by the Member State in which they are established in accordance with national law or that Member State is itself directly responsible for the conformity assessment.
9. Priglašeni organi sklenejo ustrezno zavarovanje odgovornosti za svoje dejavnosti ugotavljanja skladnosti, razen če odgovornost prevzame država članica, v kateri imajo sedež, v skladu z nacionalnim pravom ali če je ta država članica sama neposredno pristojna za ugotavljanje skladnosti.
10. Notified bodies shall be capable of carrying out all their tasks under this Regulation with the highest degree of professional integrity and the requisite competence in the specific field, whether those tasks are carried out by notified bodies themselves or on their behalf and under their responsibility.
10. Priglašeni organi morajo biti sposobni izvajati vse naloge na podlagi te uredbe z najvišjo stopnjo profesionalne integritete in potrebno usposobljenostjo na določenem področju, ne glede na to, ali navedene naloge izvajajo priglašeni organi sami ali se izvajajo v njihovem imenu in pod njihovo odgovornostjo.
11. Notified bodies shall have sufficient internal competences to be able effectively to evaluate the tasks conducted by external parties on their behalf. The notified body shall have permanent availability of sufficient administrative, technical, legal and scientific personnel who possess experience and knowledge relating to the relevant types of AI systems, data and data computing, and relating to the requirements set out in Section 2.
11. Priglašeni organi morajo imeti zadostne notranje kompetence, da lahko učinkovito ocenijo naloge, ki jih opravljajo zunanje stranke v njihovem imenu. Stalno morajo imeti na voljo dovolj upravnega, tehničnega, pravnega in znanstvenega osebja, ki ima izkušnje in znanje v zvezi z ustreznimi vrstami sistemov UI, podatki in računalniško obdelavo podatkov ter v zvezi z zahtevami iz oddelka 2.
12. Notified bodies shall participate in coordination activities as referred to in Article 38. They shall also take part directly, or be represented in, European standardisation organisations, or ensure that they are aware and up to date in respect of relevant standards.
12. Priglašeni organi sodelujejo v usklajevalnih dejavnostih iz člena 38. Sodelujejo tudi neposredno v evropskih organizacijah za standardizacijo ali so v njih zastopani oziroma zagotavljajo, da so seznanjeni z ustreznimi standardi in na tekočem z njimi.
1. The notifying authority shall notify the Commission and the other Member States of any relevant changes to the notification of a notified body via the electronic notification tool referred to in Article 30(2).
1. Priglasitveni organ uradno obvesti Komisijo in druge države članice o vseh pomembnih spremembah priglasitve priglašenega organa z uporabo elektronskega orodja za priglasitev iz člena 30(2).
2. The procedures laid down in Articles 29 and 30 shall apply to extensions of the scope of the notification.
2. Postopki iz členov 29 in 30 se uporabljajo za razširitev področja uporabe priglasitve.
For changes to the notification other than extensions of its scope, the procedures laid down in paragraphs (3) to (9) shall apply.
Za druge spremembe priglasitve, razen za razširitev njenega področja uporabe, se uporabljajo postopki iz odstavkov 3 do 9.
3. Where a notified body decides to cease its conformity assessment activities, it shall inform the notifying authority and the providers concerned as soon as possible and, in the case of a planned cessation, at least one year before ceasing its activities. The certificates of the notified body may remain valid for a period of nine months after cessation of the notified body’s activities, on condition that another notified body has confirmed in writing that it will assume responsibilities for the high-risk AI systems covered by those certificates. The latter notified body shall complete a full assessment of the high-risk AI systems affected by the end of that nine-month-period before issuing new certificates for those systems. Where the notified body has ceased its activity, the notifying authority shall withdraw the designation.
3. Kadar priglašeni organ sklene, da bo prenehal izvajati dejavnosti za ugotavljanje skladnosti, o tem obvesti priglasitveni organ in zadevne ponudnike čim prej, v primeru načrtovanega prenehanja pa vsaj eno leto pred prenehanjem izvajanja svojih dejavnosti. Certifikati priglašenega organa lahko ostanejo veljavni devet mesecev po prenehanju njegovih dejavnosti, pod pogojem da je drug priglašeni organ pisno potrdil, da bo prevzel odgovornost za visokotvegane sisteme UI, na katere se ti certifikati nanašajo. Slednji priglašeni organ opravi celovito oceno zadevnih visokotveganih sistemov UI do konca tega devetmesečnega obdobja, preden izda nove certifikate za te sisteme. Kadar priglašeni organ preneha opravljati svojo dejavnost, priglasitveni organ imenovanje umakne.
4. Where a notifying authority has sufficient reason to consider that a notified body no longer meets the requirements laid down in Article 31, or that it is failing to fulfil its obligations, the notifying authority shall without delay investigate the matter with the utmost diligence. In that context, it shall inform the notified body concerned about the objections raised and give it the possibility to make its views known. If the notifying authority comes to the conclusion that the notified body no longer meets the requirements laid down in Article 31 or that it is failing to fulfil its obligations, it shall restrict, suspend or withdraw the designation 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.
4. Kadar ima priglasitveni organ zadosten razlog za domnevo, da priglašeni organ ne izpolnjuje več zahtev iz člena 31 ali da ne izpolnjuje svojih obveznosti, zadevo brez odlašanja razišče z največjo skrbnostjo. V tem okviru obvesti zadevni priglašeni organ o vloženih ugovorih in mu omogoči, da izrazi svoja stališča. Če priglasitveni organ ugotovi, da priglašeni organ ne izpolnjuje več zahtev iz člena 31 ali ne izpolnjuje svojih obveznosti, omeji, začasno prekliče ali umakne imenovanje, odvisno od resnosti neizpolnjevanja navedenih zahtev ali neizpolnjevanja navedenih obveznosti. O tem nemudoma obvesti Komisijo in druge države članice.
5. Where its designation has been suspended, restricted, or fully or partially withdrawn, the notified body shall inform the providers concerned within 10 days.
5. Kadar se imenovanje priglašenega organa začasno prekliče, omeji oziroma v celoti ali delno umakne, priglašeni organ o tem obvesti zadevne ponudnike v desetih dneh.
6. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall take appropriate steps to ensure that the files of the notified body concerned are kept, and to make them available to notifying authorities in other Member States and to market surveillance authorities at their request.
6. V primeru omejitve, začasnega preklica ali umika imenovanja priglasitveni organ izvede ustrezne ukrepe za zagotovitev, da se dokumentacija zadevnega priglašenega organa ohrani in je na voljo priglasitvenim organom v drugih državah članicah ter organom, pristojnim za nadzor trga, če to zahtevajo.
7. In the event of the restriction, suspension or withdrawal of a designation, the notifying authority shall:
7. V primeru omejitve, začasnega preklica ali umika imenovanja priglasitveni organ:
(a)
assess the impact on the certificates issued by the notified body;
(a)
oceni vpliv na certifikate, ki jih je izdal priglašeni organ;
(b)
submit a report on its findings to the Commission and the other Member States within three months of having notified the changes to the designation;
(b)
Komisiji in drugim državam članicam v treh mesecih od uradnega obvestila o spremembah imenovanja predloži poročilo o svojih ugotovitvah;
(c)
require the notified body to suspend or withdraw, within a reasonable period of time determined by the authority, any certificates which were unduly issued, in order to ensure the continuing conformity of high-risk AI systems on the market;
(c)
od priglašenega organa zahteva, da v razumnem časovnem roku, ki ga določi organ, začasno prekliče ali umakne vse neupravičeno izdane certifikate, da se zagotovi kontinuirana skladnost visokotveganih sistemov UI na trgu;
(d)
inform the Commission and the Member States about certificates the suspension or withdrawal of which it has required;
(d)
Komisijo in države članice obvesti o certifikatih, katerih začasni preklic ali umik je zahteval;
(e)
provide the national competent authorities of the Member State in which the provider has its registered place of business with all relevant information about the certificates of which it has required the suspension or withdrawal; that authority shall take the appropriate measures, where necessary, to avoid a potential risk to health, safety or fundamental rights.
(e)
pristojnim nacionalnim organom države članice, v kateri ima ponudnik registriran sedež poslovanja, zagotovi vse ustrezne informacije o certifikatih, katerih začasni preklic ali umik je zahteval; ta organ sprejme ustrezne ukrepe za preprečitev morebitnega tveganja za zdravje, varnost ali temeljne pravice, kadar je to potrebno.
8. With the exception of certificates unduly issued, and where a designation has been suspended or restricted, the certificates shall remain valid in one of the following circumstances:
8. Razen neupravičeno izdanih certifikatov ostanejo certifikati, kadar je bilo imenovanje začasno preklicano ali omejeno, veljavni v naslednjih okoliščinah:
(a)
the notifying authority has confirmed, within one month of the suspension or restriction, that there is no risk to health, safety or fundamental rights in relation to certificates affected by the suspension or restriction, and the notifying authority has outlined a timeline for actions to remedy the suspension or restriction; or
(a)
priglasitveni organ je v enem mesecu od začasnega preklica ali omejitve potrdil, da v zvezi s certifikati, za katere velja začasni preklic ali omejitev, ni nobenega tveganja za zdravje, varnost ali temeljne pravice, ter določil časovni potek za ukrepe, potrebne za odpravo začasnega preklica ali omejitve, ali
(b)
the notifying authority has confirmed that no certificates relevant to the suspension will be issued, amended or re-issued during the course of the suspension or restriction, and states whether the notified body has the capability of continuing to monitor and remain responsible for existing certificates issued for the period of the suspension or restriction; in the event that the notifying authority determines that the notified body does not have the capability to support existing certificates issued, the provider of the system covered by the certificate shall confirm in writing to the national competent authorities of the Member State in which it has its registered place of business, within three months of the suspension or restriction, that another qualified notified body is temporarily assuming the functions of the notified body to monitor and remain responsible for the certificates during the period of suspension or restriction.
(b)
priglasitveni organ je potrdil, da v obdobju začasnega preklica ali omejitve ne bo izdan, spremenjen ali ponovno izdan noben certifikat, povezan z začasnim preklicem, hkrati pa navedel, ali je priglašeni organ v obdobju začasnega preklica ali omejitve še vedno sposoben spremljati veljavne izdane certifikate in zanje odgovarjati; če priglasitveni organ ugotovi, da priglašeni organ ni sposoben zagotavljati podpore za veljavne izdane certifikate, ponudnik sistema, na katerega se nanaša certifikat, pristojnim nacionalnim organom države članice, v kateri ima registrirani sedež poslovanja, v treh mesecih od začasnega preklica ali omejitve pisno potrdi, da drug kvalificiran priglašeni organ začasno prevzema naloge priglašenega organa v smislu spremljanja certifikatov in odgovarjanja zanje v obdobju začasnega preklica ali omejitve.
9. With the exception of certificates unduly issued, and where a designation has been withdrawn, the certificates shall remain valid for a period of nine months under the following circumstances:
9. Razen v primeru neupravičeno izdanih certifikatov in kadar je bilo imenovanje umaknjeno, ostanejo certifikati v naslednjih okoliščinah veljavni še devet mesecev:
(a)
the national competent authority of the Member State in which the provider of the high-risk AI system covered by the certificate has its registered place of business has confirmed that there is no risk to health, safety or fundamental rights associated with the high-risk AI systems concerned; and
(a)
pristojni nacionalni organ države članice, v kateri ima ponudnik visoko tveganega sistema UI, na katerega se nanaša certifikat, registrirani sedež poslovanja, je potrdil, da v povezavi z zadevnimi visokotveganimi sistemi UI ni tveganja za zdravje, varnost ali temeljne pravice, ter
(b)
another notified body has confirmed in writing that it will assume immediate responsibility for those AI systems and completes its assessment within 12 months of the withdrawal of the designation.
(b)
drug priglašeni organ je pisno potrdil, da bo takoj prevzel odgovornost za te sisteme UI in v 12 mesecih od umika imenovanja zaključi njihovo ocenjevanje.
In the circumstances referred to in the first subparagraph, the national competent authority of the Member State in which the provider of the system covered by the certificate has its place of business may extend the provisional validity of the certificates for additional periods of three months, which shall not exceed 12 months in total.
V okoliščinah iz prvega pododstavka sme pristojni nacionalni organ države članice, v kateri ima ponudnik sistema, na katerega se nanaša certifikat, sedež poslovanja, podaljšati začasno veljavnost certifikatov za nadaljnja obdobja treh mesecev, ki pa skupaj ne smejo trajati dlje kot dvanajst mesecev.
The national competent authority or the notified body assuming the functions of the notified body affected by the change of designation shall immediately inform the Commission, the other Member States and the other notified bodies thereof.
Pristojni nacionalni organ ali priglašeni organ, ki prevzame naloge priglašenega organa, na katerega se nanaša sprememba imenovanja, o tem takoj obvesti Komisijo, druge države članice in druge priglašene organe.
1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall opt for one of the following conformity assessment procedures based on:
1. Za visokotvegane sisteme UI iz Priloge III, točka 1, pri katerih je ponudnik pri dokazovanju skladnosti visokotveganega sistema UI z zahtevami iz oddelka 2 uporabil harmonizirane standarde iz člena 40 ali, kadar je to primerno, skupne specifikacije iz člena 41, ponudnik izbere enega od naslednjih postopkov za ugotavljanje skladnosti na podlagi:
(a)
the internal control referred to in Annex VI; or
(a)
notranjega nadzora iz Priloge VI ali
(b)
the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
(b)
ocenjevanja sistema upravljanja kakovosti in ocenjevanja tehnične dokumentacije s sodelovanjem priglašenega organa iz Priloge VII.
In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:
Pri dokazovanju skladnosti visokotveganega sistema UI z zahtevami iz oddelka 2 ponudnik opravi postopek ugotavljanja skladnosti iz Priloge VII, kadar:
(a)
harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;
(a)
harmonizirani standardi iz člena 40 ne obstajajo in skupne specifikacije iz člena 41 niso na voljo;
(b)
the provider has not applied, or has applied only part of, the harmonised standard;
(b)
ponudnik ni uporabil harmoniziranega standarda ali ga je uporabil le delno;
(c)
the common specifications referred to in point (a) exist, but the provider has not applied them;
(c)
skupne specifikacije iz točke (a) obstajajo, vendar jih ponudnik ni uporabil;
(d)
one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.
(d)
je bil eden ali več harmoniziranih standardov iz točke (a) objavljen z omejitvijo in samo za tisti del standarda, ki je bil omejen.
For the purposes of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, where the high-risk AI system is intended to be put into service by law enforcement, immigration or asylum authorities or by Union institutions, bodies, offices or agencies, the market surveillance authority referred to in Article 74(8) or (9), as applicable, shall act as a notified body.
Za namene postopka ugotavljanja skladnosti iz Priloge VII lahko ponudnik izbere katerega koli od priglašenih organov. Kadar pa naj bi visokotvegani sistem UI dali v uporabo organi za preprečevanje, odkrivanje in preiskovanje kaznivih dejanj, organi, pristojni za priseljevanje, ali azilni organi ali institucije, organi, uradi in agencije Unije, je priglašeni organ organ za nadzor trga iz člena 74(8) ali (9), kot je ustrezno.
2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI, which does not provide for the involvement of a notified body.
2. Za visokotvegane sisteme UI iz Priloge III, točke 2 do 8, ponudniki upoštevajo postopek ugotavljanja skladnosti na podlagi notranje kontrole iz Priloge VI, ki ne predvideva sodelovanja priglašenega organa.
3. For high-risk AI systems covered by the Union harmonisation legislation listed in Section A of Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts. The requirements set out in Section 2 of this Chapter shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.
3. Za visokotvegane sisteme UI, zajete v harmonizacijski zakonodaji Unije iz Priloge I, oddelek A, ponudnik upošteva ustrezni postopek ugotavljanja skladnosti, kot se zahteva v navedenih pravnih aktih. Za te visokotvegane sisteme UI se uporabljajo zahteve iz oddelka 2 tega poglavja, ki so del te ocene. Uporablja se tudi Priloga VII, točke 4.3, 4.4, 4.5 in peti odstavek točke 4.6.
For the purposes of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Section 2, provided that the compliance of those notified bodies with requirements laid down in Article 31(4), (5), (10) and (11) has been assessed in the context of the notification procedure under those legal acts.
Za namene te ocene so priglašeni organi, ki so priglašeni na podlagi teh pravnih aktov, upravičeni nadzorovati skladnost visokotveganih sistemov UI z zahtevami iz oddelka 2, če je bila skladnost teh priglašenih organov z zahtevami iz člena 31(4), (5), (10) in (11) ocenjena v okviru postopka priglasitve na podlagi teh pravnih aktov.
Where a legal act listed in Section A of Annex I enables the product manufacturer to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may use that option only if it has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering all requirements set out in Section 2 of this Chapter.
Kadar pravni akt iz Priloge I, oddelek A, proizvajalcu proizvoda omogoča, da se odloči za izvzetje iz ugotavljanja skladnosti s strani tretjih oseb, pod pogojem, da je ta proizvajalec uporabil vse harmonizirane standarde, ki zajemajo vse ustrezne zahteve, lahko ta proizvajalec uporabi to možnost le, če je uporabil harmonizirane standarde ali, kadar je to primerno, skupne specifikacije iz člena 41, ki zajemajo vse zahteve iz oddelka 2 tega poglavja.
4. High-risk AI systems that have already been subject to a conformity assessment procedure shall undergo a new conformity assessment procedure in the event of a substantial modification, regardless of whether the modified system is intended to be further distributed or continues to be used by the current deployer.
4. Pri visokotveganih sistemih UI, pri katerih je bil že opravljen postopek ugotavljanja skladnosti, se v primeru bistvene spremembe opravi nov postopek ugotavljanja skladnosti, ne glede na to, ali je spremenjeni sistem namenjen nadaljnji distribuciji ali ga še naprej uporablja sedanji uvajalec.
For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.
Za visokotvegane sisteme UI, ki se po dajanju na trg ali v uporabo še naprej učijo, spremembe visokotveganega sistema UI in njegove zmogljivosti, ki jih je ponudnik vnaprej določil ob začetnem ugotavljanju skladnosti in so del informacij iz tehnične dokumentacije iz Priloge IV, točka 2(f), ne pomenijo bistvene spremembe.
5. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend Annexes VI and VII by updating them in light of technical progress.
5. Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 97, da zaradi tehničnega napredka spremeni s posodobitvijo prilogi VI in VII.
6. The Commission is empowered to adopt delegated acts in accordance with Article 97 in order to amend paragraphs 1 and 2 of this Article in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimising the risks to health and safety and protection of fundamental rights posed by such systems, as well as the availability of adequate capacities and resources among notified bodies.
6. Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 97 za spremembo odstavkov 1 in 2 tega člena, da se za visokotvegane sisteme UI iz Priloge III, točke 2 do 8, v celoti ali deloma uvede postopek ugotavljanja skladnosti iz Priloge VII. Komisija take delegirane akte sprejme ob upoštevanju učinkovitosti postopka ugotavljanja skladnosti na podlagi notranje kontrole iz Priloge VI pri preprečevanju ali čim večjem zmanjševanju tveganj za zdravje in varnost ter varstvo temeljnih pravic, ki jih predstavljajo taki sistemi, ter razpoložljivosti ustreznih zmogljivosti in virov med priglašenimi organi.
Transparency obligations for providers and deployers of certain AI systems
Obveznosti ponudnikov in uvajalcev nekaterih sistemov UI glede preglednosti
1. Providers shall ensure that AI systems intended to interact directly with natural persons are designed and developed in such a way that the natural persons concerned are informed that they are interacting with an AI system, unless this is obvious from the point of view of a natural person who is reasonably well-informed, observant and circumspect, taking into account the circumstances and the context of use. This obligation shall not apply to AI systems authorised by law to detect, prevent, investigate or prosecute criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, unless those systems are available for the public to report a criminal offence.
1. Ponudniki zagotovijo, da so sistemi UI, namenjeni neposredni interakciji s fizičnimi osebami, zasnovani in razviti tako, da so zadevne fizične osebe obveščene, da so v interakciji s sistemom UI, razen če je to očitno z vidika razmeroma dobro obveščene, pozorne in preudarne fizične osebe ob upoštevanju okoliščin in konteksta uporabe. Ta obveznost se ob upoštevanju ustreznih zaščitnih ukrepov za pravice in svoboščine tretjih oseb ne uporablja za sisteme UI, ki so z zakonom odobreni za odkrivanje, preprečevanje, preiskovanje ali pregon kaznivih dejanj, razen če so ti sistemi na voljo javnosti za prijavo kaznivega dejanja.
2. Providers of AI systems, including general-purpose AI systems, generating synthetic audio, image, video or text content, shall ensure that the outputs of the AI system are marked in a machine-readable format and detectable as artificially generated or manipulated. Providers shall ensure their technical solutions are effective, interoperable, robust and reliable as far as this is technically feasible, taking into account the specificities and limitations of various types of content, the costs of implementation and the generally acknowledged state of the art, as may be reflected in relevant technical standards. This obligation shall not apply to the extent the AI systems perform an assistive function for standard editing or do not substantially alter the input data provided by the deployer or the semantics thereof, or where authorised by law to detect, prevent, investigate or prosecute criminal offences.
2. Ponudniki sistemov UI, vključno s sistemi UI za splošne namene, ki ustvarjajo sintetično zvočno, slikovno, video ali besedilno vsebino, zagotovijo, da so izhodni podatki sistema UI označeni v strojno berljivi obliki in jih je mogoče prepoznati kot umetno ustvarjene ali prirejene. Ponudniki zagotovijo, da so njihove tehnične rešitve učinkovite, interoperabilne, robustne in zanesljive, kolikor je to tehnično izvedljivo, pri čemer upoštevajo posebnosti in omejitve različnih vrst vsebin, stroške izvajanja in splošno priznane najsodobnejše tehnološke dosežke, kar se lahko odraža v ustreznih tehničnih standardih. Ta obveznost se ne uporablja, kolikor sistemi UI zagotavljajo podporno funkcijo za standardno urejanje ali ne spreminjajo bistveno vhodnih podatkov, ki jih zagotovi uvajalec, ali njihove semantike ali kadar so z zakonom dovoljeni za odkrivanje, preprečevanje, preiskovanje ali pregon kaznivih dejanj.
3. Deployers of an emotion recognition system or a biometric categorisation system shall inform the natural persons exposed thereto of the operation of the system, and shall process the personal data in accordance with Regulations (EU) 2016/679 and (EU) 2018/1725 and Directive (EU) 2016/680, as applicable. This obligation shall not apply to AI systems used for biometric categorisation and emotion recognition, which are permitted by law to detect, prevent or investigate criminal offences, subject to appropriate safeguards for the rights and freedoms of third parties, and in accordance with Union law.
3. Uvajalci sistema za prepoznavanje čustev ali sistema za biometrično kategorizacijo o delovanju sistema obvestijo fizične osebe, ki so mu izpostavljene, in obdelujejo osebne podatke v skladu z uredbama (EU) 2016/679 in (EU) 2018/1725 ter Direktivo (EU) 2016/680, kot je ustrezno. Ta obveznost se ob upoštevanju ustreznih zaščitnih ukrepov za pravice in svoboščine tretjih oseb ter v skladu s pravom Unije ne uporablja za sisteme UI, ki se uporabljajo za biometrično kategorizacijo in prepoznavanje čustev ter so z zakonom dovoljeni za odkrivanje, preprečevanje ali preiskovanje kaznivih dejanj.
4. Deployers of an AI system that generates or manipulates image, audio or video content constituting a deep fake, shall disclose that the content has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offence. Where the content forms part of an evidently artistic, creative, satirical, fictional or analogous work or programme, the transparency obligations set out in this paragraph are limited to disclosure of the existence of such generated or manipulated content in an appropriate manner that does not hamper the display or enjoyment of the work.
4. Uvajalci sistema UI, ki ustvarja ali prireja slikovno, zvočno ali video vsebino, ki je globoki ponaredek, morajo razkriti, da je bila vsebina umetno ustvarjena ali prirejena. Ta obveznost se ne uporablja, kadar je uporaba zakonsko dovoljena za odkrivanje, preprečevanje, preiskovanje ali pregon kaznivih dejanj. Kadar je vsebina del očitno umetniškega, ustvarjalnega, satiričnega, fiktivnega ali podobnega dela ali programa, so obveznosti glede preglednosti iz tega odstavka omejene na razkritje obstoja take ustvarjene ali prirejene vsebine na ustrezen način, ki ne ovira prikazovanja ali uživanja dela.
Deployers of an AI system that generates or manipulates text which is published with the purpose of informing the public on matters of public interest shall disclose that the text has been artificially generated or manipulated. This obligation shall not apply where the use is authorised by law to detect, prevent, investigate or prosecute criminal offences or where the AI-generated content has undergone a process of human review or editorial control and where a natural or legal person holds editorial responsibility for the publication of the content.
Uvajalci sistema UI, ki ustvarja ali prireja besedilo, ki se objavi z namenom obveščanja javnosti o zadevah javnega interesa, morajo razkriti, da je bilo besedilo umetno ustvarjeno ali prirejeno. Ta obveznost se ne uporablja, kadar je uporaba zakonsko dovoljena za odkrivanje, preprečevanje, preiskovanje ali pregon kaznivih dejanj ali kadar je bila vsebina, ustvarjena z UI, predmet človeške preverbe ali uredniškega pregleda in kadar ima fizična ali pravna oseba uredniško odgovornost za objavo vsebine.
5. The information referred to in paragraphs 1 to 4 shall be provided to the natural persons concerned in a clear and distinguishable manner at the latest at the time of the first interaction or exposure. The information shall conform to the applicable accessibility requirements.
5. Informacije iz odstavkov 1 do 4 se dajo na voljo zadevnim fizičnim osebam na jasen in razpoznaven način ter najpozneje ob prvi interakciji ali izpostavljenosti. Informacije morajo biti skladne z veljavnimi zahtevami glede dostopnosti.
6. Paragraphs 1 to 4 shall not affect the requirements and obligations set out in Chapter III, and shall be without prejudice to other transparency obligations laid down in Union or national law for deployers of AI systems.
6. Odstavki 1 do 4 ne vplivajo na zahteve in obveznosti iz poglavja III in ne posegajo v druge obveznosti glede preglednosti, ki so za uvajalce sistemov UI določene v pravu Unije ali nacionalnem pravu.
7. The AI Office shall encourage and facilitate the drawing up of codes of practice at Union level to facilitate the effective implementation of the obligations regarding the detection and labelling of artificially generated or manipulated content. The Commission may adopt implementing acts to approve those codes of practice in accordance with the procedure laid down in Article 56 (6). If it deems the code is not adequate, the Commission may adopt an implementing act specifying common rules for the implementation of those obligations in accordance with the examination procedure laid down in Article 98(2).
7. Urad za UI spodbuja in olajšuje pripravo kodeksov prakse na ravni Unije, da se omogoči učinkovito izvajanje obveznosti glede odkrivanja in označevanja umetno ustvarjenih ali prirejenih vsebin. Komisija lahko sprejme izvedbene akte za odobritev teh kodeksov prakse v skladu s postopkom iz člena 56(6). Če meni, da kodeks ni ustrezen, lahko Komisija sprejme izvedbeni akt, s katerim določi skupna pravila za izvajanje navedenih obveznosti v skladu s postopkom pregleda iz člena 98(2).
Regulativni peskovniki za UI
1. Member States shall ensure that their competent authorities establish at least one AI regulatory sandbox at national level, which shall be operational by 2 August 2026. That sandbox may also be established jointly with the competent authorities of other Member States. The Commission may provide technical support, advice and tools for the establishment and operation of AI regulatory sandboxes.
1. Države članice zagotovijo, da njihovi pristojni organi na nacionalni ravni vzpostavijo vsaj en regulativni peskovnik za UI, ki začne delovati najpozneje 2. avgusta 2026. Ta peskovnik se lahko vzpostavi skupaj s pristojnimi organi drugih držav članic. Komisija lahko za vzpostavitev in delovanje regulativnih peskovnikov za UI zagotovi tehnično podporo, svetovanje in orodja.
The obligation under the first subparagraph may also be fulfilled by participating in an existing sandbox in so far as that participation provides an equivalent level of national coverage for the participating Member States.
Obveznost iz prvega pododstavka se lahko izpolni tudi s sodelovanjem v obstoječem peskovniku, če tako sodelovanje zagotavlja enakovredno nacionalno zastopanost sodelujočih držav članic.
2. Additional AI regulatory sandboxes at regional or local level, or established jointly with the competent authorities of other Member States may also be established.
2. Na regionalni ali lokalni ravni ali skupaj s pristojnimi organi drugih držav članic se lahko vzpostavijo tudi dodatni regulativni peskovniki za UI.
3. The European Data Protection Supervisor may also establish an AI regulatory sandbox for Union institutions, bodies, offices and agencies, and may exercise the roles and the tasks of national competent authorities in accordance with this Chapter.
3. Evropski nadzornik za varstvo podatkov lahko vzpostavi tudi regulativni peskovnik za UI za institucije, organe, urade in agencije Unije ter lahko opravlja vloge in naloge pristojnih nacionalnih organov v skladu s tem poglavjem.
4. Member States shall ensure that the competent authorities referred to in paragraphs 1 and 2 allocate sufficient resources to comply with this Article effectively and in a timely manner. Where appropriate, national competent authorities shall cooperate with other relevant authorities, and may allow for the involvement of other actors within the AI ecosystem. This Article shall not affect other regulatory sandboxes established under Union or national law. Member States shall ensure an appropriate level of cooperation between the authorities supervising those other sandboxes and the national competent authorities.
4. Države članice zagotovijo, da pristojni organi iz odstavkov 1 in 2 dodelijo zadostna sredstva za učinkovito in pravočasno izpolnjevanje tega člena. Kadar je primerno, pristojni nacionalni organi sodelujejo z drugimi ustreznimi organi in lahko dopustijo udeleženost drugih akterjev ekosistema UI. Ta člen ne vpliva na druge regulativne peskovnike, vzpostavljene na podlagi prava Unije ali nacionalnega prava. Države članice zagotovijo ustrezno raven sodelovanja med organi, ki nadzorujejo te druge peskovnike, in pristojnimi nacionalnimi organi.
5. AI regulatory sandboxes established under paragraph 1 shall provide for a controlled environment that fosters innovation and facilitates the development, training, testing and validation of innovative AI systems for a limited time before their being placed on the market or put into service pursuant to a specific sandbox plan agreed between the providers or prospective providers and the competent authority. Such sandboxes may include testing in real world conditions supervised therein.
5. Regulativni peskovniki za UI, vzpostavljeni na podlagi odstavka 1, zagotavljajo nadzorovano okolje, ki spodbuja inovacije ter omogoča razvoj, učenje, testiranje in validacijo inovativnih sistemov UI za določen čas, preden se dajo na trg ali v uporabo, v skladu s posebnim načrtom peskovnika, o katerem se dogovorijo ponudniki ali potencialni ponudniki in pristojni organ. Taki peskovniki lahko vključujejo testiranje v realnih razmerah, ki se v njih nadzoruje.
6. Competent authorities shall provide, as appropriate, guidance, supervision and support within the AI regulatory sandbox with a view to identifying risks, in particular to fundamental rights, health and safety, testing, mitigation measures, and their effectiveness in relation to the obligations and requirements of this Regulation and, where relevant, other Union and national law supervised within the sandbox.
6. Pristojni organi v regulativnem peskovniku za UI po potrebi zagotovijo smernice, nadzor in podporo, kar zadeva opredeljevanje tveganja – zlasti za temeljne pravice, zdravje in varnost –, testiranje, ukrepe za zmanjšanje tveganj in njihovo učinkovitost glede na obveznosti in zahteve iz te uredbe ter po potrebi iz drugega prava Unije in nacionalnega prava, katerih upoštevanje se nadzoruje v peskovniku.
7. Competent authorities shall provide providers and prospective providers participating in the AI regulatory sandbox with guidance on regulatory expectations and how to fulfil the requirements and obligations set out in this Regulation.
7. Pristojni organi ponudnikom in potencialnim ponudnikom, ki sodelujejo v regulativnem peskovniku za UI, zagotovijo smernice o regulativnih pričakovanjih ter o tem, kako izpolniti zahteve in obveznosti iz te uredbe.
Upon request of the provider or prospective provider of the AI system, the competent authority shall provide a written proof of the activities successfully carried out in the sandbox. The competent authority shall also provide an exit report detailing the activities carried out in the sandbox and the related results and learning outcomes. Providers may use such documentation to demonstrate their compliance with this Regulation through the conformity assessment process or relevant market surveillance activities. In this regard, the exit reports and the written proof provided by the national competent authority shall be taken positively into account by market surveillance authorities and notified bodies, with a view to accelerating conformity assessment procedures to a reasonable extent.
Pristojni organ na zahtevo ponudnika ali potencialnega ponudnika sistema UI predloži pisno dokazilo o dejavnostih, ki so bile uspešno izvedene v peskovniku. Predloži tudi poročilo o izstopu, v katerem podrobno opiše dejavnosti, izvedene v peskovniku, ter povezane rezultate in učne izide. Ponudniki lahko tako dokumentacijo uporabijo za to, da s postopkom ugotavljanja skladnosti ali z ustreznimi dejavnostmi nadzora trga dokažejo skladnost s to uredbo. V zvezi s tem organi za nadzor trga in priglašeni organi pozitivno upoštevajo poročila o izstopu in pisna dokazila, ki jih predloži pristojni nacionalni organ, da bi v razumni meri pospešili postopke ugotavljanja skladnosti.
8. Subject to the confidentiality provisions in Article 78, and with the agreement of the provider or prospective provider, the Commission and the Board shall be authorised to access the exit reports and shall take them into account, as appropriate, when exercising their tasks under this Regulation. If both the provider or prospective provider and the national competent authority explicitly agree, the exit report may be made publicly available through the single information platform referred to in this Article.
8. Komisija in Odbor sta ob upoštevanju določb o zaupnosti iz člena 78 in s soglasjem ponudnika ali potencialnega ponudnika pooblaščena za dostop do poročil o izstopu in jih, če je to primerno, upoštevata pri izvajanju svojih nalog na podlagi te uredbe. Če se ponudnik ali potencialni ponudnik in pristojni nacionalni organ izrecno strinjata, se lahko poročilo o izstopu objavi na enotni informacijski platformi iz tega člena.
9. The establishment of AI regulatory sandboxes shall aim to contribute to the following objectives:
9. Namen vzpostavitve regulativnih peskovnikov za UI je prispevati k naslednjim ciljem:
(a)
improving legal certainty to achieve regulatory compliance with this Regulation or, where relevant, other applicable Union and national law;
(a)
izboljšanju pravne varnosti, da se doseže regulativna skladnost s to uredbo ali po potrebi z drugim veljavnim pravom Unije in nacionalnim pravom;
(b)
supporting the sharing of best practices through cooperation with the authorities involved in the AI regulatory sandbox;
(b)
podpiranju izmenjave najboljših praks s sodelovanjem z organi, vključenimi v regulativni peskovnik za UI;
(c)
fostering innovation and competitiveness and facilitating the development of an AI ecosystem;
(c)
spodbujanju inovacij in konkurenčnosti ter olajšanju razvoja ekosistema UI;
(d)
contributing to evidence-based regulatory learning;
(d)
prispevanju k regulativnemu učenju, ki temelji na dokazih;
(e)
facilitating and accelerating access to the Union market for AI systems, in particular when provided by SMEs, including start-ups.
(e)
olajšanju in pospešitvi dostopa sistemov UI do trga Unije, zlasti če so njihovi ponudniki MSP, vključno z zagonskimi podjetji.
10. National competent authorities shall ensure that, to the extent the innovative AI systems involve the processing of personal data or otherwise fall under the supervisory remit of other national authorities or competent authorities providing or supporting access to data, the national data protection authorities and those other national or competent authorities are associated with the operation of the AI regulatory sandbox and involved in the supervision of those aspects to the extent of their respective tasks and powers.
10. Če inovativni sistemi UI vključujejo obdelavo osebnih podatkov ali kako drugače spadajo v nadzorno pristojnost drugih nacionalnih organov ali pristojnih organov, ki zagotavljajo ali podpirajo dostop do podatkov, nacionalni pristojni organi zagotovijo, da so nacionalni organi za varstvo podatkov in ti drugi nacionalni ali pristojni organi povezani z delovanjem regulativnega peskovnika za UI in vključeni v nadzor omenjenih vidikov v okviru svojih nalog in pooblastil.
11. The AI regulatory sandboxes shall not affect the supervisory or corrective powers of the competent authorities supervising the sandboxes, including at regional or local level. Any significant risks to health and safety and fundamental rights identified during the development and testing of such AI systems shall result in an adequate mitigation. National competent authorities shall have the power to temporarily or permanently suspend the testing process, or the participation in the sandbox if no effective mitigation is possible, and shall inform the AI Office of such decision. National competent authorities shall exercise their supervisory powers within the limits of the relevant law, using their discretionary powers when implementing legal provisions in respect of a specific AI regulatory sandbox project, with the objective of supporting innovation in AI in the Union.
11. Regulativni peskovniki za UI ne vplivajo na pooblastila pristojnih organov, ki nadzirajo peskovnike, za nadzor ali popravne ukrepe, tudi na regionalni ali lokalni ravni ne. Vsa pomembna tveganja za zdravje in varnost ter temeljne pravice, prepoznana med razvojem in testiranjem takih sistemov UI, se ustrezno zmanjšajo. Nacionalni pristojni organi so pooblaščeni, da začasno ali trajno prekinejo postopek testiranja ali sodelovanje v peskovniku, če tveganj ni mogoče učinkovito zmanjšati, in o taki odločitvi obvestijo Urad za UI. Nacionalni pristojni organi svoja nadzorna pooblastila izvajajo v mejah ustreznega prava in pri izvajanju pravnih določb v zvezi z določenim projektom peskovnika za UI uporabljajo svoja diskrecijska pooblastila, da bi podprli inovacije na področju UI v Uniji.
12. Providers and prospective providers participating in the AI regulatory sandbox shall remain liable under applicable Union and national liability law for any damage inflicted on third parties as a result of the experimentation taking place in the sandbox. However, provided that the prospective providers observe the specific plan and the terms and conditions for their participation and follow in good faith the guidance given by the national competent authority, no administrative fines shall be imposed by the authorities for infringements of this Regulation. Where other competent authorities responsible for other Union and national law were actively involved in the supervision of the AI system in the sandbox and provided guidance for compliance, no administrative fines shall be imposed regarding that law.
12. Ponudniki in potencialni ponudniki, ki sodelujejo v regulativnem peskovniku za UI, so na podlagi veljavnega prava Unije in nacionalnega prava o odgovornosti še naprej odgovorni za škodo, povzročeno tretjim osebam zaradi eksperimentov, ki se izvajajo v peskovniku. Kadar pa potencialni ponudniki spoštujejo posebni načrt in pogoje za sodelovanje ter v dobri veri sledijo smernicam nacionalnih pristojnih organov, organi ne naložijo upravnih kazni za kršitev te uredbe. Kadar so bili v nadzor sistema UI v peskovniku dejavno vključeni drugi pristojni organi, odgovorni za drugo pravo Unije in nacionalno pravo, in so zagotovili smernice za skladnost, se v zvezi s tem pravom ne naložijo upravne kazni.
13. The AI regulatory sandboxes shall be designed and implemented in such a way that, where relevant, they facilitate cross-border cooperation between national competent authorities.
13. Regulativni peskovniki za UI so zasnovani in se izvajajo tako, da po potrebi olajšujejo čezmejno sodelovanje med pristojnimi nacionalnimi organi.
14. National competent authorities shall coordinate their activities and cooperate within the framework of the Board.
14. Nacionalni pristojni organi usklajujejo svoje dejavnosti in sodelujejo v okviru Odbora.
15. National competent authorities shall inform the AI Office and the Board of the establishment of a sandbox, and may ask them for support and guidance. The AI Office shall make publicly available a list of planned and existing sandboxes and keep it up to date in order to encourage more interaction in the AI regulatory sandboxes and cross-border cooperation.
15. Pristojni nacionalni organi o vzpostavitvi peskovnika obvestijo Urad za UI in Odbor ter ju lahko zaprosijo za podporo in smernice. Urad za UI objavi seznam načrtovanih in obstoječih peskovnikov ter ga posodablja, da bi spodbudil večjo interakcijo v regulativnih peskovnikih za UI in čezmejno sodelovanje.
16. National competent authorities shall submit annual reports to the AI Office and to the Board, from one year after the establishment of the AI regulatory sandbox and every year thereafter until its termination, and a final report. Those reports shall provide information on the progress and results of the implementation of those sandboxes, including best practices, incidents, lessons learnt and recommendations on their setup and, where relevant, on the application and possible revision of this Regulation, including its delegated and implementing acts, and on the application of other Union law supervised by the competent authorities within the sandbox. The national competent authorities shall make those annual reports or abstracts thereof available to the public, online. The Commission shall, where appropriate, take the annual reports into account when exercising its tasks under this Regulation.
16. Pristojni nacionalni organi Uradu za UI in Odboru predložijo letna poročila, najprej eno leto po vzpostavitvi regulativnega peskovnika za UI, nato pa vsako leto do njegove ukinitve, tako kot tudi končno poročilo. Ta poročila vsebujejo informacije o napredku in rezultatih izvajanja teh peskovnikov, vključno z najboljšimi praksami, incidenti, pridobljenimi izkušnjami in priporočili o njihovi vzpostavitvi ter po potrebi o uporabi in morebitni reviziji te uredbe, vključno s povezanimi delegiranimi in izvedbenimi akti, in o uporabi drugega prava Unije, ki ga v peskovniku nadzorujejo pristojni organi. Pristojni nacionalni organi ta letna poročila ali njihove povzetke objavijo na spletu. Komisija pri izvajanju svojih nalog na podlagi te uredbe, kadar je primerno, upošteva ta letna poročila.
17. The Commission shall develop a single and dedicated interface containing all relevant information related to AI regulatory sandboxes to allow stakeholders to interact with AI regulatory sandboxes and to raise enquiries with competent authorities, and to seek non-binding guidance on the conformity of innovative products, services, business models embedding AI technologies, in accordance with Article 62(1), point (c). The Commission shall proactively coordinate with national competent authorities, where relevant.
17. Komisija razvije enotni in namenski vmesnik, ki vsebuje vse ustrezne informacije v zvezi z regulativnimi peskovniki za UI, da bi lahko deležniki vstopali v interakcijo z regulativnimi peskovniki za UI in vlagali poizvedbe pri pristojnih organih ter zaprošali za nezavezujoče smernice glede skladnosti inovativnih proizvodov, storitev in poslovnih modelov, ki vključujejo tehnologije UI, v skladu s členom 62(1), točka (c). Komisija se po potrebi proaktivno usklajuje s pristojnimi nacionalnimi organi.
Reporting of serious incidents
Poročanje o resnih incidentih
1. Providers of high-risk AI systems placed on the Union market shall report any serious incident to the market surveillance authorities of the Member States where that incident occurred.
1. Ponudniki visokotveganih sistemov UI, ki so dani na trg Unije, organom za nadzor trga držav članic, v katerih je prišlo do navedenega incidenta, poročajo o vsakem resnem incidentu.
2. The report referred to in paragraph 1 shall be made immediately after the provider has established a causal link between the AI system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the provider or, where applicable, the deployer, becomes aware of the serious incident.
2. Poročilo iz odstavka 1 se sestavi takoj, ko ponudnik ugotovi obstoj vzročne zveze med sistemom UI in resnim incidentom ali razumno verjetnost take zveze, v vsakem primeru pa najpozneje 15 dni po tem, ko ponudnik ali, kadar je ustrezno, uvajalec izve za resen incident.
The period for the reporting referred to in the first subparagraph shall take account of the severity of the serious incident.
Pri roku za poročanje iz prvega pododstavka se upošteva resnost incidenta.
3. Notwithstanding paragraph 2 of this Article, in the event of a widespread infringement or a serious incident as defined in Article 3, point (49)(b), the report referred to in paragraph 1 of this Article shall be provided immediately, and not later than two days after the provider or, where applicable, the deployer becomes aware of that incident.
3. Ne glede na odstavek 2 tega člena se v primeru močno razširjene kršitve ali resnega incidenta, kakor je opredeljen v členu 3, točka 49(b), poročilo iz odstavka 1 predloži nemudoma, najpozneje pa dva dni po tem, ko ponudnik ali, kadar je ustrezno, uvajalec izve za ta incident.
4. Notwithstanding paragraph 2, in the event of the death of a person, the report shall be provided immediately after the provider or the deployer has established, or as soon as it suspects, a causal relationship between the high-risk AI system and the serious incident, but not later than 10 days after the date on which the provider or, where applicable, the deployer becomes aware of the serious incident.
4. Ne glede na odstavek 2 se v primeru smrti osebe poročilo predloži takoj, ko ponudnik ali uvajalec ugotovi ali posumi, da obstaja vzročna zveza med visokotveganim sistemom UI in resnim incidentom, vendar najpozneje 10 dni po datumu, ko ponudnik ali, kadar je ustrezno, uvajalec izve za resen incident.
5. Where necessary to ensure timely reporting, the provider or, where applicable, the deployer, may submit an initial report that is incomplete, followed by a complete report.
5. Kadar je to potrebno zaradi pravočasnega poročanja, lahko ponudnik ali, kadar je ustrezno, uvajalec najprej predloži nepopolno začetno poročilo, nato pa predloži še popolnega.
6. Following the reporting of a serious incident pursuant to paragraph 1, the provider shall, without delay, perform the necessary investigations in relation to the serious incident and the AI system concerned. This shall include a risk assessment of the incident, and corrective action.
6. Po poročanju o resnem incidentu na podlagi odstavka 1 ponudnik nemudoma izvede potrebne preiskave v zvezi z resnim incidentom in zadevnim sistemom UI. To vključuje oceno tveganja incidenta in popravne ukrepe.
The provider shall cooperate with the competent authorities, and where relevant with the notified body concerned, during the investigations referred to in the first subparagraph, and shall not perform any investigation which involves altering the AI system concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the competent authorities of such action.
Ponudnik med preiskavami iz prvega pododstavka sodeluje s pristojnimi organi in po potrebi z zadevnim priglašenim organom ter brez predhodne obvestitve pristojnih organov ne izvede nobene raziskave, ki vključuje spremembo zadevnega sistema UI na način, ki bi lahko vplival na poznejšo oceno vzrokov za incident.
7. Upon receiving a notification related to a serious incident referred to in Article 3, point (49)(c), the relevant market surveillance authority shall inform the national public authorities or bodies referred to in Article 77(1). The Commission shall develop dedicated guidance to facilitate compliance with the obligations set out in paragraph 1 of this Article. That guidance shall be issued by 2 August 2025, and shall be assessed regularly.
7. Zadevni organ za nadzor trga po prejemu uradnega obvestila o resnem incidentu iz člena 3, točka 49(c), obvesti nacionalne javne organe ali telesa iz člena 77(1). Komisija pripravi posebne smernice za lažje izpolnjevanje obveznosti iz odstavka 1 tega člena. Navedene smernice se izdajo do 2. avgusta 2025 in se redno ocenjujejo.
8. The market surveillance authority shall take appropriate measures, as provided for in Article 19 of Regulation (EU) 2019/1020, within seven days from the date it received the notification referred to in paragraph 1 of this Article, and shall follow the notification procedures as provided in that Regulation.
8. Organ za nadzor trga sprejme ustrezne ukrepe, kot je določeno v členu 19 Uredbe (EU) 2019/1020, v sedmih dneh od datuma prejema uradnega obvestila iz odstavka 1 tega člena in upošteva postopke uradnega obveščanja iz navedene uredbe.
9. For high-risk AI systems referred to in Annex III that are placed on the market or put into service by providers that are subject to Union legislative instruments laying down reporting obligations equivalent to those set out in this Regulation, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c).
9. Za visokotvegane sisteme UI iz Priloge III, ki jih dajejo na trg ali v uporabo ponudniki, za katere veljajo zakonodajni instrumenti Unije, v katerih so določene obveznosti glede poročanja, enakovredne tistim iz te uredbe, se uradno obveščanje o resnih incidentih zahteva le za incidente iz člena 3, točka 49(c).
10. For high-risk AI systems which are safety components of devices, or are themselves devices, covered by Regulations (EU) 2017/745 and (EU) 2017/746, the notification of serious incidents shall be limited to those referred to in Article 3, point (49)(c) of this Regulation, and shall be made to the national competent authority chosen for that purpose by the Member States where the incident occurred.
10. Za visokotvegane sisteme UI, ki so varnostne komponente pripomočkov ali so sami pripomočki, zajeti v uredbah (EU) 2017/745 in (EU) 2017/746, je uradno obvestilo o resnih incidentih omejeno na tiste iz člena 3, točka 49(c), te uredbe in se pošlje pristojnemu nacionalnemu organu, ki ga v ta namen izberejo države članice, v katerih se je navedeni incident zgodil.
11. National competent authorities shall immediately notify the Commission of any serious incident, whether or not they have taken action on it, in accordance with Article 20 of Regulation (EU) 2019/1020.
11. Pristojni nacionalni organi v skladu s členom 20 Uredbe (EU) 2019/1020 nemudoma uradno obvestijo Komisijo o vsakem resnem incidentu, ne glede na to, ali so v zvezi z njim ukrepali ali ne.
Market surveillance and control of AI systems in the Union market
Nadzor trga in nadzor sistemov UI na trgu Unije
1. Regulation (EU) 2019/1020 shall apply to AI systems covered by this Regulation. For the purposes of the effective enforcement of this Regulation:
1. Za sisteme UI, zajete s to uredbo, se uporablja Uredba (EU) 2019/1020. Za učinkovito izvrševanje te uredbe velja naslednje:
(a)
any reference to an economic operator under Regulation (EU) 2019/1020 shall be understood as including all operators identified in Article 2(1) of this Regulation;
(a)
vsako sklicevanje na gospodarski subjekt na podlagi Uredbe (EU) 2019/1020 se razume kot sklicevanje na vse operaterje, opredeljene v členu 2(1) te uredbe;
(b)
any reference to a product under Regulation (EU) 2019/1020 shall be understood as including all AI systems falling within the scope of this Regulation.
(b)
vsako sklicevanje na proizvod na podlagi Uredbe (EU) 2019/1020 se razume kot sklicevanje na vse sisteme UI, ki spadajo na področje uporabe te uredbe.
2. As part of their reporting obligations under Article 34(4) of Regulation (EU) 2019/1020, the market surveillance authorities shall report annually to the Commission and relevant national competition authorities any information identified in the course of market surveillance activities that may be of potential interest for the application of Union law on competition rules. They shall also annually report to the Commission about the use of prohibited practices that occurred during that year and about the measures taken.
2. Organi za nadzor trga v okviru svojih obveznosti poročanja na podlagi člena 34(4) Uredbe (EU) 2019/1020 Komisiji in ustreznim nacionalnim organom za konkurenco vsako leto poročajo o vseh informacijah, ugotovljenih med dejavnostmi nadzora trga, ki bi lahko bile zanimive za uporabo prava Unije o pravilih konkurence. Komisiji vsako leto poročajo tudi o primerih uporabe prepovedanih praks, do katerih je prišlo v zadevnem letu, in o sprejetih ukrepih.
3. For high-risk AI systems related to products covered by the Union harmonisation legislation listed in Section A of Annex I, the market surveillance authority for the purposes of this Regulation shall be the authority responsible for market surveillance activities designated under those legal acts.
3. Za visokotvegane sisteme UI, ki so povezani s proizvodi, zajetimi v harmonizacijski zakonodaji Unije iz Priloge I, oddelek A, je organ za nadzor trga za namene te uredbe organ, odgovoren za dejavnosti nadzora trga in imenovan v skladu z navedenimi pravnimi akti.
By derogation from the first subparagraph, and in appropriate circumstances, Member States may designate another relevant authority to act as a market surveillance authority, provided they ensure coordination with the relevant sectoral market surveillance authorities responsible for the enforcement of the Union harmonisation legislation listed in Annex I.
Z odstopanjem od prvega pododstavka in v ustreznih okoliščinah lahko države članice imenujejo drug ustrezen organ, ki deluje kot organ za nadzor trga, če zagotovijo usklajevanje z ustreznimi sektorskimi organi za nadzor trga, odgovornimi za izvrševanje harmonizacijske zakonodaje Unije iz Priloge I.
4. The procedures referred to in Articles 79 to 83 of this Regulation shall not apply to AI systems related to products covered by the Union harmonisation legislation listed in section A of Annex I, where such legal acts already provide for procedures ensuring an equivalent level of protection and having the same objective. In such cases, the relevant sectoral procedures shall apply instead.
4. Postopki iz členov 79 do 83 te uredbe se ne uporabljajo za sisteme UI, ki so povezani s proizvodi, zajetimi v harmonizacijski zakonodaji Unije iz Priloge I, oddelek A, če so v takih pravnih aktih že določeni postopki, na podlagi katerih se zagotovi enakovredna raven zaščite in ki imajo isti cilj. V takih primerih se namesto tega uporabijo ustrezni sektorski postopki.
5. Without prejudice to the powers of market surveillance authorities under Article 14 of Regulation (EU) 2019/1020, for the purpose of ensuring the effective enforcement of this Regulation, market surveillance authorities may exercise the powers referred to in Article 14(4), points (d) and (j), of that Regulation remotely, as appropriate.
5. Brez poseganja v pooblastila organov za nadzor trga na podlagi člena 14 Uredbe (EU) 2019/1020 lahko organi za nadzor trga, da se zagotovi učinkovito izvrševanje te uredbe, pooblastila iz člena 14(4), točki (d) in (j), navedene uredbe po potrebi izvajajo na daljavo.
6. For high-risk AI systems placed on the market, put into service, or used by financial institutions regulated by Union financial services law, the market surveillance authority for the purposes of this Regulation shall be the relevant national authority responsible for the financial supervision of those institutions under that legislation in so far as the placing on the market, putting into service, or the use of the AI system is in direct connection with the provision of those financial services.
6. Za visokotvegane sisteme UI, ki jih dajo na trg ali v uporabo oziroma jih uporabljajo finančne institucije, ki jih ureja pravo Unije o finančnih storitvah, je organ za nadzor trga za namene te uredbe zadevni nacionalni organ, odgovoren za finančni nadzor navedenih institucij na podlagi navedene zakonodaje, če je dajanje sistema UI na trg ali v uporabo oziroma njegova uporaba neposredno povezana z zagotavljanjem navedenih finančnih storitev.
7. By way of derogation from paragraph 6, in appropriate circumstances, and provided that coordination is ensured, another relevant authority may be identified by the Member State as market surveillance authority for the purposes of this Regulation.
7. Z odstopanjem od odstavka 6 lahko država članica v ustreznih okoliščinah in pod pogojem, da je zagotovljeno usklajevanje, za organ za nadzor trga za namene te uredbe določi drug zadevni organ.
National market surveillance authorities supervising regulated credit institutions regulated under Directive 2013/36/EU, which are participating in the Single Supervisory Mechanism established by Regulation (EU) No 1024/2013, should report, without delay, to the European Central Bank any information identified in the course of their market surveillance activities that may be of potential interest for the prudential supervisory tasks of the European Central Bank specified in that Regulation.
Nacionalni organi za nadzor trga, ki nadzorujejo regulirane kreditne institucije, ki jih ureja Direktiva 2013/36/EU, in sodelujejo v enotnem mehanizmu nadzora, vzpostavljenem z Uredbo (EU) št. 1024/2013, bi morali Evropski centralni banki brez odlašanja sporočiti vse informacije, ugotovljene v okviru svojih dejavnosti nadzora trga, ki bi lahko bile zanimive za naloge bonitetnega nadzora Evropske centralne banke, kot so določene v navedeni uredbi.
8. For high-risk AI systems listed in point 1 of Annex III to this Regulation, in so far as the systems are used for law enforcement purposes, border management and justice and democracy, and for high-risk AI systems listed in points 6, 7 and 8 of Annex III to this Regulation, Member States shall designate as market surveillance authorities for the purposes of this Regulation either the competent data protection supervisory authorities under Regulation (EU) 2016/679 or Directive (EU) 2016/680, or any other authority designated pursuant to the same conditions laid down in Articles 41 to 44 of Directive (EU) 2016/680. Market surveillance activities shall in no way affect the independence of judicial authorities, or otherwise interfere with their activities when acting in their judicial capacity.
8. Za visokotvegane sisteme UI iz točke 1 Priloge III k tej uredbi, če se sistemi uporabljajo za namene preprečevanja, odkrivanja in preiskovanja kaznivih dejanj, upravljanja meja ter pravosodja in demokracije, in za visokotvegane sisteme UI iz Priloge III, točke 6, 7 in 8, k tej uredbi države članice kot organe za nadzor trga za namene te uredbe imenujejo bodisi pristojne nadzorne organe za varstvo podatkov na podlagi Uredbe (EU) 2016/679 ali Direktive (EU) 2016/680 bodisi kateri koli drugi organ, ki je imenovan na podlagi enakih pogojev iz členov 41 do 44 Direktive (EU) 2016/680. Dejavnosti nadzora trga nikakor ne vplivajo na neodvisnost pravosodnih organov in tudi drugače ne posegajo v njihove dejavnosti, kadar delujejo v okviru svoje sodne pristojnosti.
9. Where Union institutions, bodies, offices or agencies fall within the scope of this Regulation, the European Data Protection Supervisor shall act as their market surveillance authority, except in relation to the Court of Justice of the European Union acting in its judicial capacity.
9. Kadar institucije, organi, uradi in agencije Unije spadajo na področje uporabe te uredbe, Evropski nadzornik za varstvo podatkov deluje kot njihov organ za nadzor trga, razen v zvezi s Sodiščem Evropske unije, kadar to izvaja svojo sodno pristojnost.
10. Member States shall facilitate coordination between market surveillance authorities designated under this Regulation and other relevant national authorities or bodies which supervise the application of Union harmonisation legislation listed in Annex I, or in other Union law, that might be relevant for the high-risk AI systems referred to in Annex III.
10. Države članice olajšujejo usklajevanje med organi za nadzor trga, imenovanimi na podlagi te uredbe, in drugimi ustreznimi nacionalnimi organi ali telesi, ki nadzorujejo uporabo harmonizacijske zakonodaje Unije iz Priloge I ali drugega prava Unije, ki bi lahko bilo pomembno za visokotvegane sisteme UI iz Priloge III.
11. Market surveillance authorities and the Commission shall be able to propose joint activities, including joint investigations, to be conducted by either market surveillance authorities or market surveillance authorities jointly with the Commission, that have the aim of promoting compliance, identifying non-compliance, raising awareness or providing guidance in relation to this Regulation with respect to specific categories of high-risk AI systems that are found to present a serious risk across two or more Member States in accordance with Article 9 of Regulation (EU) 2019/1020. The AI Office shall provide coordination support for joint investigations.
11. Organi za nadzor trga in Komisija lahko predlagajo skupne dejavnosti – vključno s skupnimi preiskavami, ki jih izvajajo organi za nadzor trga sami ali skupaj s Komisijo –, katerih cilj je spodbujanje skladnosti, odkrivanje neskladnosti, ozaveščanje ali zagotavljanje smernic v zvezi s to uredbo, kar zadeva posebne kategorije visokotveganih sistemov UI, za katere se ugotovi, da predstavljajo resno tveganje v dveh ali več državah članicah v skladu s členom 9 Uredbe (EU) 2019/1020. Urad za UI zagotavlja usklajevalno podporo za skupne preiskave.
12. Without prejudice to the powers provided for under Regulation (EU) 2019/1020, and where relevant and limited to what is necessary to fulfil their tasks, the market surveillance authorities shall be granted full access by providers to the documentation as well as the training, validation and testing data sets used for the development of high-risk AI systems, including, where appropriate and subject to security safeguards, through application programming interfaces (API) or other relevant technical means and tools enabling remote access.
12. Brez poseganja v pooblastila na podlagi Uredbe (EU) 2019/1020 ter kadar je to ustrezno in omejeno na to, kar je potrebno za izpolnjevanje njihovih nalog, ponudniki organom za nadzor trga omogočijo polni dostop do dokumentacije ter naborov učnih, testnih in validacijskih podatkov, ki se uporabljajo za razvoj visokotveganih sistemov UI, vključno z vmesniki za aplikacijsko programiranje (API) ali drugimi ustreznimi tehničnimi sredstvi in orodji, ki omogočajo oddaljeni dostop, kadar je to primerno in ob upoštevanju varnostnih zaščitnih ukrepov.
13. Market surveillance authorities shall be granted access to the source code of the high-risk AI system upon a reasoned request and only when both of the following conditions are fulfilled:
13. Organom za nadzor trga se dostop do izvorne kode visokotveganega sistema UI odobri na podlagi obrazložene zahteve in samo, če sta izpolnjena oba naslednja pogoja:
(a)
access to source code is necessary to assess the conformity of a high-risk AI system with the requirements set out in Chapter III, Section 2; and
(a)
dostop do izvorne kode je potreben za oceno skladnosti visokotveganega sistema UI z zahtevami iz poglavja III, oddelek 2, in
(b)
testing or auditing procedures and verifications based on the data and documentation provided by the provider have been exhausted or proved insufficient.
(b)
postopki testiranja ali revizije in preverjanja na podlagi podatkov in dokumentacije, ki jih je predložil ponudnik, so bili izčrpani ali so se izkazali za nezadostne.
14. Any information or documentation obtained by market surveillance authorities shall be treated in accordance with the confidentiality obligations set out in Article 78.
14. Vse informacije ali dokumentacija, ki jih pridobijo organi za nadzor trga, se obravnavajo v skladu z obveznostmi glede zaupnosti iz člena 78.
Procedure at national level for dealing with AI systems presenting a risk
Nacionalni postopek za obravnavo sistemov UI, ki predstavljajo tveganje
1. AI systems presenting a risk shall be understood as a ‘product presenting a risk’ as defined in Article 3, point 19 of Regulation (EU) 2019/1020, in so far as they present risks to the health or safety, or to fundamental rights, of persons.
1. Sistemi UI, ki predstavljajo tveganje, se štejejo za „proizvod, ki predstavlja tveganje“, kot je opredeljen v členu 3, točka 19, Uredbe (EU) 2019/1020, če predstavljajo tveganje za zdravje, varnost ali temeljne pravice oseb.
2. Where the market surveillance authority of a Member State has sufficient reason to consider an AI system to present a risk as referred to in paragraph 1 of this Article, it shall carry out an evaluation of the AI system concerned in respect of its compliance with all the requirements and obligations laid down in this Regulation. Particular attention shall be given to AI systems presenting a risk to vulnerable groups. Where risks to fundamental rights are identified, the market surveillance authority shall also inform and fully cooperate with the relevant national public authorities or bodies referred to in Article 77(1). The relevant operators shall cooperate as necessary with the market surveillance authority and with the other national public authorities or bodies referred to in Article 77(1).
2. Kadar ima organ za nadzor trga države članice zadosten razlog za domnevo, da sistem UI predstavlja tveganje iz odstavka 1 tega člena, izvede ocenjevanje skladnosti zadevnega sistema UI z vsemi zahtevami in obveznostmi iz te uredbe. Posebno pozornost nameni sistemom UI, ki predstavljajo tveganje za ranljive skupine. Kadar so ugotovljena tveganja za temeljne pravice, organ za nadzor trga obvesti tudi ustrezne nacionalne javne organe ali telesa iz člena 77(1) in z njimi polno sodeluje. Zadevni operaterji po potrebi sodelujejo z organom za nadzor trga in drugimi nacionalnimi javnimi organi ali telesi iz člena 77(1).
Where, in the course of that evaluation, the market surveillance authority or, where applicable the market surveillance authority in cooperation with the national public authority referred to in Article 77(1), finds that the AI system does not comply with the requirements and obligations laid down in this Regulation, it shall without undue delay require the relevant operator to take all appropriate corrective actions to bring the AI system into compliance, to withdraw the AI system from the market, or to recall it within a period the market surveillance authority may prescribe, and in any event within the shorter of 15 working days, or as provided for in the relevant Union harmonisation legislation.
Kadar organ za nadzor trga sam ali, kadar je ustrezno, v sodelovanju z nacionalnim javnim organom iz člena 77(1) med navedenim ocenjevanjem ugotovi, da sistem UI ni skladen z zahtevami in obveznostmi iz te uredbe, od zadevnega operaterja brez nepotrebnega odlašanja zahteva, da sprejme vse ustrezne popravne ukrepe, da zagotovi skladnost sistema UI, ga umakne s trga ali odpokliče v roku, ki ga lahko določi organ za nadzor trga, v vsakem primeru pa najpozneje v 15 delovnih dneh ali kot je določeno v ustrezni harmonizacijski zakonodaji Unije.
The market surveillance authority shall inform the relevant notified body accordingly. Article 18 of Regulation (EU) 2019/1020 shall apply to the measures referred to in the second subparagraph of this paragraph.
Organ za nadzor trga o tem obvesti zadevni priglašeni organ. Za ukrepe iz drugega pododstavka tega odstavka se uporablja člen 18 Uredbe (EU) 2019/1020.
3. Where the market surveillance authority considers that the non-compliance is not restricted to its national territory, it shall inform the Commission and the other Member States without undue delay of the results of the evaluation and of the actions which it has required the operator to take.
3. Kadar organ za nadzor trga meni, da neskladnost ni omejena na njegovo nacionalno ozemlje, Komisijo in druge države članice brez nepotrebnega odlašanja obvesti o rezultatih ocenjevanja in ukrepih, ki jih je zahteval od operaterja.
4. The operator shall ensure that all appropriate corrective action is taken in respect of all the AI systems concerned that it has made available on the Union market.
4. Operater zagotovi sprejetje vseh ustreznih popravnih ukrepov glede vseh zadevnih sistemov UI, katerih dostopnost je omogočil na trgu Unije.
5. Where the operator of an AI system does not take adequate corrective action within the period referred to in paragraph 2, the market surveillance authority shall take all appropriate provisional measures to prohibit or restrict the AI system’s being made available on its national market or put into service, to withdraw the product or the standalone AI system from that market or to recall it. That authority shall without undue delay notify the Commission and the other Member States of those measures.
5. Kadar operater sistema UI ne sprejme ustreznih popravnih ukrepov v roku iz odstavka 2, organ za nadzor trga sprejme vse ustrezne začasne ukrepe za prepoved ali omejitev dostopnosti sistema UI na svojem nacionalnem trgu ali njegovega dajanja v uporabo, za umik proizvoda ali samostojnega sistema UI z navedenega trga ali za njegov odpoklic. Zadevni organ brez nepotrebnega odlašanja uradno obvesti Komisijo in druge države članice o teh ukrepih.
6. The notification referred to in paragraph 5 shall include all available details, in particular the information necessary for the identification of the non-compliant AI system, the origin of the AI system and the supply chain, 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 operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to one or more of the following:
6. Uradno obvestilo iz odstavka 5 vsebuje vse razpoložljive podrobnosti, zlasti informacije, potrebne za identifikacijo neskladnega sistema UI, poreklo sistema UI in dobavno verigo, naravo domnevne neskladnosti in tveganja, naravo in trajanje sprejetih nacionalnih ukrepov ter argumente zadevnega operaterja. Organi za nadzor trga zlasti navedejo, ali je neskladnost posledica enega ali več naslednjih elementov:
(a)
non-compliance with the prohibition of the AI practices referred to in Article 5;
(a)
neupoštevanja prepovedi praks UI iz člena 5;
(b)
a failure of a high-risk AI system to meet requirements set out in Chapter III, Section 2;
(b)
neizpolnjevanja zahtev iz poglavja III, oddelek 2, s strani visokotveganega sistema UI;
(c)
shortcomings in the harmonised standards or common specifications referred to in Articles 40 and 41 conferring a presumption of conformity;
(c)
pomanjkljivosti harmoniziranih standardov ali skupnih specifikacij iz členov 40 in 41, na katerih temelji domneva o skladnosti;
(d)
non-compliance with Article 50.
(d)
neskladnosti s členom 50.
7. The market surveillance authorities other than the market surveillance authority of the Member State initiating the procedure shall, without undue 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 AI system concerned, and, in the event of disagreement with the notified national measure, of their objections.
7. Organi za nadzor trga, ki niso organi za nadzor trga države članice, ki je začela postopek, brez nepotrebnega odlašanja obvestijo Komisijo in druge države članice o vseh sprejetih ukrepih in vseh dodatnih informacijah, ki so jim na voljo v zvezi z neskladnostjo zadevnega sistema UI, v primeru nestrinjanja s priglašenim nacionalnim ukrepom pa tudi o svojih ugovorih.
8. Where, within three months of receipt of the notification referred to in paragraph 5 of this Article, no objection has been raised by either a market surveillance authority of a Member State or by the Commission in respect of a provisional measure taken by a market surveillance authority of another Member State, that measure shall be deemed justified. This shall be without prejudice to the procedural rights of the concerned operator in accordance with Article 18 of Regulation (EU) 2019/1020. The three-month period referred to in this paragraph shall be reduced to 30 days in the event of non-compliance with the prohibition of the AI practices referred to in Article 5 of this Regulation.
8. Kadar organ za nadzor trga države članice ali Komisija v treh mesecih po prejemu uradnega obvestila iz odstavka 5 ne poda ugovora glede začasnega ukrepa, ki ga je sprejel organ za nadzor trga druge države članice, se šteje, da je ukrep upravičen. To ne posega v postopkovne pravice zadevnega operaterja v skladu s členom 18 Uredbe (EU) 2019/1020. Trimesečno obdobje iz tega odstavka se skrajša na 30 dni v primeru neupoštevanja prepovedi praks UI iz člena 5 te uredbe.
9. The market surveillance authorities shall ensure that appropriate restrictive measures are taken in respect of the product or the AI system concerned, such as withdrawal of the product or the AI system from their market, without undue delay.
9. Organi za nadzor trga zagotovijo, da so ustrezni omejevalni ukrepi v zvezi z zadevnim proizvodom ali sistemom UI, kot je umik proizvoda ali sistema UI s trga, sprejeti brez nepotrebnega odlašanja.
1. In accordance with the terms and conditions laid down in this Regulation, Member States shall lay down the rules on penalties and other enforcement measures, which may also include warnings and non-monetary measures, applicable to infringements of this Regulation by operators, and shall take all measures necessary to ensure that they are properly and effectively implemented, thereby taking into account the guidelines issued by the Commission pursuant to Article 96. The penalties provided for shall be effective, proportionate and dissuasive. They shall take into account the interests of SMEs, including start-ups, and their economic viability.
1. Države članice v skladu s pogoji iz te uredbe določijo pravila o kaznih in drugih izvršilnih ukrepih, ki lahko vključujejo tudi opozorila in nedenarne ukrepe, ki se uporabljajo za kršitve te uredbe s strani operaterjev, ter sprejmejo vse potrebne ukrepe za zagotovitev njihovega pravilnega in učinkovitega izvajanja, pri čemer upoštevajo smernice, ki jih izda Komisija na podlagi člena 96. Te kazni morajo biti učinkovite, sorazmerne in odvračilne. Upoštevajo interese MSP, vključno z zagonskimi podjetji, in njihovo ekonomsko sposobnost.
2. The Member States shall, without delay and at the latest by the date of entry into application, notify the Commission of the rules on penalties and of other enforcement measures referred to in paragraph 1, and shall notify it, without delay, of any subsequent amendment to them.
2. Države članice brez odlašanja in najpozneje do datuma začetka uporabe uradno obvestijo Komisijo o pravilih o kaznih in drugih izvršilnih ukrepih iz odstavka 1 ter o vseh naknadnih spremembah teh pravil.
3. Non-compliance with the prohibition of the AI practices referred to in Article 5 shall be subject to administrative fines of up to EUR 35 000 000 or, if the offender is an undertaking, up to 7 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
3. Neupoštevanje prepovedi praks UI iz člena 5 se kaznuje z upravnimi globami v višini do 35 000 000 EUR ali, če je kršitelj podjetje, do 7 % njegovega skupnega svetovnega letnega prometa za preteklo poslovno leto, odvisno od tega, kateri znesek je višji.
4. Non-compliance with any of the following provisions related to operators or notified bodies, other than those laid down in Articles 5, shall be subject to administrative fines of up to EUR 15 000 000 or, if the offender is an undertaking, up to 3 % of its total worldwide annual turnover for the preceding financial year, whichever is higher:
4. Neskladnost s katero koli od naslednjih določb, ki se nanašajo na operaterje in priglašene organe, razen tistih iz člena 5, se kaznuje z upravnimi globami v višini do 15 000 000 EUR ali, če je kršitelj podjetje, do 3 % njegovega skupnega svetovnega letnega prometa za preteklo poslovno leto, odvisno od tega, kateri znesek je višji:
(a)
obligations of providers pursuant to Article 16;
(a)
obveznosti ponudnikov na podlagi člena 16;
(b)
obligations of authorised representatives pursuant to Article 22;
(b)
obveznosti pooblaščenih zastopnikov na podlagi člena 22;
(c)
obligations of importers pursuant to Article 23;
(c)
obveznosti uvoznikov na podlagi člena 23;
(d)
obligations of distributors pursuant to Article 24;
(d)
obveznosti distributerjev na podlagi člena 24;
(e)
obligations of deployers pursuant to Article 26;
(e)
obveznosti uvajalcev na podlagi člena 26;
(f)
requirements and obligations of notified bodies pursuant to Article 31, Article 33(1), (3) and (4) or Article 34;
(f)
zahteve in obveznosti priglašenih organov na podlagi člena 31, člena 33(1), (3) in (4) ali člena 34;
(g)
transparency obligations for providers and deployers pursuant to Article 50.
(g)
obveznosti ponudnikov in uvajalcev glede preglednosti na podlagi člena 50.
5. The supply of incorrect, incomplete or misleading information to notified bodies or national competent authorities in reply to a request shall be subject to administrative fines of up to EUR 7 500 000 or, if the offender is an undertaking, up to 1 % of its total worldwide annual turnover for the preceding financial year, whichever is higher.
5. Če se priglašenim organom ali pristojnim nacionalnim organom v odgovor na zahtevo predložijo nepravilne, nepopolne ali zavajajoče informacije, se izrečejo upravne globe do 7 500 000 EUR ali, če je kršitelj podjetje, do 1 % njegovega skupnega svetovnega letnega prometa za preteklo poslovno leto, odvisno od tega, kateri znesek je višji.
6. In the case of SMEs, including start-ups, each fine referred to in this Article shall be up to the percentages or amount referred to in paragraphs 3, 4 and 5, whichever thereof is lower.
6. V primeru MSP, vključno z zagonskimi podjetji, višina vsake globe iz tega člena ne presega višine odstotkov ali zneska iz odstavkov 3, 4 in 5, odvisno od tega, kateri znesek je nižji.
7. When deciding whether to impose an administrative fine and when deciding on the amount of the administrative fine in each individual case, all relevant circumstances of the specific situation shall be taken into account and, as appropriate, regard shall be given to the following:
7. Pri odločanju o naložitvi upravne globe in o znesku upravne globe v vsakem posameznem primeru se upoštevajo vse zadevne okoliščine konkretnega primera, po potrebi pa tudi naslednje:
(a)
the nature, gravity and duration of the infringement and of its consequences, taking into account the purpose of the AI system, as well as, where appropriate, the number of affected persons and the level of damage suffered by them;
(a)
vrsta, resnost in trajanje kršitve ter njene posledice, pri čemer se upoštevajo namen sistema UI ter po potrebi število prizadetih oseb in raven škode, ki so jo utrpele;
(b)
whether administrative fines have already been applied by other market surveillance authorities to the same operator for the same infringement;
(b)
ali so drugi organi za nadzor trga že naložili upravne globe istemu operaterju za isto kršitev;
(c)
whether administrative fines have already been applied by other authorities to the same operator for infringements of other Union or national law, when such infringements result from the same activity or omission constituting a relevant infringement of this Regulation;
(c)
ali so drugi organi istemu operaterju že naložili upravne globe za kršitve drugega prava Unije ali nacionalnega prava, kadar so take kršitve posledica iste dejavnosti ali opustitve dejanja, ki pomeni zadevno kršitev te uredbe;
(d)
the size, the annual turnover and market share of the operator committing the infringement;
(d)
velikost, letni promet in tržni delež operaterja, ki je storil kršitev;
(e)
any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement;
(e)
morebitni drugi obteževalni ali olajševalni dejavniki v zvezi z okoliščinami primera, kot so pridobljene finančne koristi ali preprečene izgube, ki neposredno ali posredno izhajajo iz kršitve;
(f)
the degree of cooperation with the national competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;
(f)
stopnja sodelovanja z nacionalnimi pristojnimi organi za odpravo kršitve in zmanjšanje morebitnih škodljivih učinkov kršitve;
(g)
the degree of responsibility of the operator taking into account the technical and organisational measures implemented by it;
(g)
stopnja odgovornosti operaterja ob upoštevanju tehničnih in organizacijskih ukrepov, ki jih izvaja;
(h)
the manner in which the infringement became known to the national competent authorities, in particular whether, and if so to what extent, the operator notified the infringement;
(h)
način, na katerega so nacionalni pristojni organi seznanjeni s kršitvijo, zlasti pa, ali in v kakšnem obsegu operater kršitev priglasi;
(i)
the intentional or negligent character of the infringement;
(i)
ali je kršitev naklepna ali posledica malomarnosti;
(j)
any action taken by the operator to mitigate the harm suffered by the affected persons.
(j)
ukrepi, ki jih operater sprejme za zmanjšanje škode, ki so jo utrpele prizadete osebe.
8. Each Member State shall lay down rules on to what extent administrative fines may be imposed on public authorities and bodies established in that Member State.
8. Vsaka država članica določi pravila o tem, v kolikšni meri se lahko javnim organom in telesom s sedežem v zadevni državi članici naložijo upravne globe.
9. Depending on the legal system of the Member States, the rules on administrative fines may be applied in such a manner that the fines are imposed by competent national courts or by other bodies, as applicable in those Member States. The application of such rules in those Member States shall have an equivalent effect.
9. Glede na pravni sistem držav članic se lahko pravila o upravnih globah uporabljajo tako, da globe naložijo pristojna nacionalna sodišča ali drugi organi, kot velja v teh državah članicah. Uporaba takih pravil v teh državah članicah ima enakovreden učinek.
10. The exercise of powers under this Article shall be subject to appropriate procedural safeguards in accordance with Union and national law, including effective judicial remedies and due process.
10. Za izvajanje pooblastil na podlagi tega člena veljajo ustrezna postopkovna jamstva v skladu s pravom Unije in nacionalnim pravom, vključno z učinkovitimi pravnimi sredstvi in ustreznim pravnim postopkom.
11. Member States shall, on an annual basis, report to the Commission about the administrative fines they have issued during that year, in accordance with this Article, and about any related litigation or judicial proceedings.
11. Države članice Komisiji vsako leto poročajo o upravnih globah, ki so jih v skladu s tem členom naložile v tistem letu, in o vseh povezanih pravnih sporih ali sodnih postopkih.
1. The Commission shall assess the need for amendment of the list set out in Annex III and of the list of prohibited AI practices laid down in Article 5, once a year following the entry into force of this Regulation, and until the end of the period of the delegation of power laid down in Article 97. The Commission shall submit the findings of that assessment to the European Parliament and the Council.
1. Komisija enkrat letno po začetku veljavnosti te uredbe in do konca trajanja prenosa pooblastila iz člena 97 oceni potrebo po spremembi seznama iz Priloge III in seznama prepovedanih praks UI iz člena 5. Komisija ugotovitve te ocene predloži Evropskemu parlamentu in Svetu.
2. By 2 August 2028 and every four years thereafter, the Commission shall evaluate and report to the European Parliament and to the Council on the following:
2. Komisija do 2. avgusta 2028 in nato vsaka štiri leta oceni ter Evropskemu parlament in Svetu poroča o naslednjem:
(a)
the need for amendments extending existing area headings or adding new area headings in Annex III;
(a)
potrebi po spremembah za razširitev obstoječih razdelkov področij ali dodajanje novih razdelkov področij v Prilogi III;
(b)
amendments to the list of AI systems requiring additional transparency measures in Article 50;
(b)
spremembah seznama sistemov UI, pri katerih so potrebni dodatni ukrepi za preglednost, iz člena 50;
(c)
amendments enhancing the effectiveness of the supervision and governance system.
(c)
spremembah za povečanje učinkovitosti sistema nadzora in upravljanja.
3. By 2 August 2029 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 report shall include an assessment with regard to the structure of enforcement and the possible need for a Union agency to resolve any identified shortcomings. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation. The reports shall be made public.
3. Komisija do 2. avgusta 2029 ter nato vsaka štiri leta Evropskemu parlamentu in Svetu predloži poročilo o oceni in pregledu te uredbe. Poročilo vključuje oceno strukture izvrševanja in morebitno potrebo, da agencija Unije odpravi vse ugotovljene pomanjkljivosti. Temu poročilu na podlagi ugotovitev po potrebi priloži predlog za spremembo te uredbe. Poročila se objavijo.
4. The reports referred to in paragraph 2 shall pay specific attention to the following:
4. V poročilih iz odstavka 2 se posebna pozornost nameni naslednjemu:
(a)
the status of the financial, technical and human resources of the national competent authorities in order to effectively perform the tasks assigned to them under this Regulation;
(a)
stanju finančnih, tehničnih in človeških virov pristojnih nacionalnih organov, da se zagotovi učinkovito izvajanje nalog, dodeljenih s to uredbo;
(b)
the state of penalties, in particular administrative fines as referred to in Article 99(1), applied by Member States for infringements of this Regulation;
(b)
stanju kazni, zlasti upravnih glob iz člena 99(1), ki jih države članice uporabljajo za kršitve te uredbe;
(c)
adopted harmonised standards and common specifications developed to support this Regulation;
(c)
sprejetim harmoniziranim standardom in skupnim specifikacijam, razvitim v podporo tej uredbi;
(d)
the number of undertakings that enter the market after the entry into application of this Regulation, and how many of them are SMEs.
(d)
številu podjetij, ki vstopijo na trg po začetku uporabe te uredbe, in koliko od njih je MSP.
5. By 2 August 2028, the Commission shall evaluate the functioning of the AI Office, whether the AI Office has been given sufficient powers and competences to fulfil its tasks, and whether it would be relevant and needed for the proper implementation and enforcement of this Regulation to upgrade the AI Office and its enforcement competences and to increase its resources. The Commission shall submit a report on its evaluation to the European Parliament and to the Council.
5. Komisija do 2. avgusta 2028 oceni delovanje Urada za UI, ali je Urad za UI dobil zadostna pooblastila in pristojnosti za izpolnjevanje svojih nalog ter ali bi bilo ustrezno in potrebno za pravilno izvajanje in izvrševanje te uredbe nadgraditi Urad za UI in njegove pristojnosti izvrševanja ter povečati njegove vire. Komisija poročilo o svoji oceni predloži Evropskemu parlamentu in Svetu.
6. By 2 August 2028 and every four years thereafter, the Commission shall submit a report on the review of the progress on the development of standardisation deliverables on the energy-efficient development of general-purpose AI models, and asses the need for further measures or actions, including binding measures or actions. The report shall be submitted to the European Parliament and to the Council, and it shall be made public.
6. Komisija do 2. avgusta 2028 in nato vsaka štiri leta predloži poročilo o pregledu napredka pri razvoju standardizacijskih dokumentov o energetsko učinkovitem razvoju modelov UI za splošne namene in oceni potrebo po nadaljnjih ukrepih ali dejavnostih, vključno z zavezujočimi ukrepi ali dejavnostmi. Poročilo predloži Evropskemu parlamentu in Svetu ter ga objavi.
7. By 2 August 2028 and every three years thereafter, the Commission shall evaluate the impact and effectiveness of voluntary codes of conduct to foster the application of the requirements set out in Chapter III, Section 2 for AI systems other than high-risk AI systems and possibly other additional requirements for AI systems other than high-risk AI systems, including as regards environmental sustainability.
7. Komisija do 2. avgusta 2028 ter nato vsaka tri leta oceni vpliv in učinkovitost prostovoljnih kodeksov ravnanja za spodbujanje uporabe zahtev iz poglavja III, oddelek 2, za sisteme UI, ki niso visokotvegani sistemi UI, in morebitnih drugih dodatnih zahtev za sisteme UI, ki niso visokotvegani sistemi UI, tudi kar zadeva okoljsko trajnostnost.
8. For the purposes of paragraphs 1 to 7, the Board, the Member States and national competent authorities shall provide the Commission with information upon its request and without undue delay.
8. Za namene odstavkov 1 do 7 Odbor, države članice in pristojni nacionalni organi Komisiji na njeno zahtevo in brez nepotrebnega odlašanja zagotovijo informacije.
9. In carrying out the evaluations and reviews referred to in paragraphs 1 to 7, the Commission shall take into account the positions and findings of the Board, of the European Parliament, of the Council, and of other relevant bodies or sources.
9. Komisija pri izvajanju ocenjevanj in pregledov iz odstavkov 1 do 7 upošteva stališča in ugotovitve Odbora, Evropskega parlamenta, Sveta ter drugih ustreznih organov ali virov.
10. The Commission shall, if necessary, submit appropriate proposals to amend this Regulation, in particular taking into account developments in technology, the effect of AI systems on health and safety, and on fundamental rights, and in light of the state of progress in the information society.
10. Komisija po potrebi predloži ustrezne predloge za spremembo te uredbe, zlasti ob upoštevanju razvoja tehnologije, učinkov sistemov UI na zdravje in varnost ter na temeljne pravice in glede na stanje napredka v informacijski družbi.
11. To guide the evaluations and reviews referred to in paragraphs 1 to 7 of this Article, the AI Office shall undertake to develop an objective and participative methodology for the evaluation of risk levels based on the criteria outlined in the relevant Articles and the inclusion of new systems in:
11. Urad za UI se zaveže, da bo za usmerjanje ocenjevanj in pregledov iz odstavkov 1 do 7 tega člena razvil objektivno in participativno metodologijo za ocenjevanje stopenj tveganja na podlagi meril iz ustreznih členov ter za vključitev novih sistemov na:
(a)
the list set out in Annex III, including the extension of existing area headings or the addition of new area headings in that Annex;
(a)
seznam iz Priloge III, vključno z razširitvijo obstoječih razdelkov področij ali dodajanjem novih razdelkov področij v navedeni prilogi;
(b)
the list of prohibited practices set out in Article 5; and
(b)
seznam prepovedanih praks iz člena 5 in
(c)
the list of AI systems requiring additional transparency measures pursuant to Article 50.
(c)
seznam sistemov UI, pri katerih so potrebni dodatni ukrepi za preglednost na podlagi člena 50.
12. Any amendment to this Regulation pursuant to paragraph 10, or relevant delegated or implementing acts, which concerns sectoral Union harmonisation legislation listed in Section B of Annex I shall take into account the regulatory specificities of each sector, and the existing governance, conformity assessment and enforcement mechanisms and authorities established therein.
12. Pri vsaki spremembi te uredbe na podlagi odstavka 10 ali zadevnih delegiranih ali izvedbenih aktov, ki se nanašajo na sektorsko harmonizacijsko zakonodajo Unije iz oddelka B Priloge I se upoštevajo regulativne posebnosti vsakega sektorja in obstoječi mehanizmi upravljanja, ugotavljanja skladnosti in izvrševanja ter organi, ki so določeni v njih.
13. By 2 August 2031, the Commission shall carry out an assessment of the enforcement of this Regulation and shall report on it to the European Parliament, the Council and the European Economic and Social Committee, taking into account the first years of application of this Regulation. On the basis of the findings, that report shall, where appropriate, be accompanied by a proposal for amendment of this Regulation with regard to the structure of enforcement and the need for a Union agency to resolve any identified shortcomings.
13. Komisija do 2. avgusta 2031 oceni izvajanje te uredbe, pri čemer upošteva prva leta njene uporabe, ter o tem poroča Evropskemu parlamentu, Svetu in Evropskemu ekonomsko-socialnemu odboru. Na podlagi ugotovitev se navedenemu poročilu po potrebi priloži predlog za spremembo te uredbe v zvezi s strukturo izvrševanja in potrebo, da agencija Unije odpravi vse ugotovljene pomanjkljivosti.
Entry into force and application
Začetek veljavnosti in uporaba
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
It shall apply from 2 August 2026.
Uporablja se od 2. avgusta 2026.
(a)
Chapters I and II shall apply from 2 February 2025;
(a)
poglavji I in II začneta uporabljati od 2. februarja 2025;
(b)
Chapter III Section 4, Chapter V, Chapter VII and Chapter XII and Article 78 shall apply from 2 August 2025, with the exception of Article 101;
(b)
poglavje III, oddelek 4, poglavje V, poglavje VII in poglavje XII ter člen 78 uporabljajo od 2. avgusta 2025, razen člena 101;
(c)
Article 6(1) and the corresponding obligations in this Regulation shall apply from 2 August 2027.
(c)
člen 6(1) in ustrezne obveznosti iz te uredbe uporabljajo od 2. avgusta 2027.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Done at Brussels, 13 June 2024.
V Bruslju, 13. junija 2024
For the European Parliament
(1) OJ C 517, 22.12.2021, p. 56.
(1) UL C 517, 22.12.2021, str. 56.
(2) OJ C 115, 11.3.2022, p. 5.
(2) UL C 115, 11.3.2022, str. 5.
(3) OJ C 97, 28.2.2022, p. 60.
(3) UL C 97, 28.2.2022, str. 60.
(4) Position of the European Parliament of 13 March 2024 (not yet published in the Official Journal) and decision of the Council of 21 May 2024.
(4) Stališče Evropskega parlamenta z dne 13. marca 2024 (še ni objavljeno v Uradnem listu) in odločitev Sveta z dne 21. maja 2024.
(5) European Council, Special meeting of the European Council (1 and 2 October 2020) — Conclusions, EUCO 13/20, 2020, p. 6.
(5) Evropski svet, izredno zasedanje Evropskega sveta (1. in 2. oktobra 2020) – sklepi, EUCO 13/20, 2020, str. 6.
(6) European Parliament resolution of 20 October 2020 with recommendations to the Commission on a framework of ethical aspects of artificial intelligence, robotics and related technologies, 2020/2012(INL).
(6) Resolucija Evropskega parlamenta z dne 20. oktobra 2020 s priporočili Komisiji o okviru etičnih vidikov umetne inteligence, robotike in sorodnih tehnologij (dok. 2020/2012(INL)).
(7) Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(7) Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in razveljavitvi Uredbe (EGS) št. 339/93 (UL L 218, 13.8.2008, str. 30).
(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, 13.8.2008, p. 82).
(8) Sklep št. 768/2008/ES Evropskega parlamenta in Sveta z dne 9. julija 2008 o skupnem okviru za trženje proizvodov in razveljavitvi Sklepa Sveta 93/465/EGS (UL L 218, 13.8.2008, str. 82).
(9) 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 L 169, 25.6.2019, p. 1).
(9) Uredba (EU) 2019/1020 Evropskega parlamenta in Sveta z dne 20. junija 2019 o nadzoru trga in skladnosti proizvodov ter spremembi Direktive 2004/42/ES in uredb (ES) št. 765/2008 in (EU) št. 305/2011 (UL L 169, 25.6.2019, str. 1).
(10) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ L 210, 7.8.1985, p. 29).
(10) Direktiva Sveta 85/374/EGS z dne 25. julija 1985 o približevanju zakonov in drugih predpisov držav članic v zvezi z odgovornostjo za proizvode z napako (UL L 210, 7.8.1985, str. 29).
(11) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).
(11) Uredba (EU) 2016/679 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov in o prostem pretoku takih podatkov ter o razveljavitvi Direktive 95/46/ES (Splošna uredba o varstvu podatkov) (UL L 119, 4.5.2016, str. 1).
(12) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
(12) Uredba (EU) 2018/1725 Evropskega parlamenta in Sveta z dne 23. oktobra 2018 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah, organih, uradih in agencijah Unije in o prostem pretoku takih podatkov ter razveljavitvi Uredbe (ES) št. 45/2001 in Sklepa št. 1247/2002/ES (UL L 295, 21.11.2018, str. 39).
(13) Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89).
(13) Direktiva (EU) 2016/680 Evropskega parlamenta in Sveta z dne 27. aprila 2016 o varstvu posameznikov pri obdelavi osebnih podatkov, ki jih pristojni organi obdelujejo za namene preprečevanja, preiskovanja, odkrivanja ali pregona kaznivih dejanj ali izvrševanja kazenskih sankcij, in o prostem pretoku takih podatkov ter o razveljavitvi Okvirnega sklepa Sveta 2008/977/PNZ (UL L 119, 4.5.2016, str. 89).
(14) Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).
(14) Direktiva 2002/58/ES Evropskega parlamenta in Sveta z dne 12. julija 2002 o obdelavi osebnih podatkov in varstvu zasebnosti na področju elektronskih komunikacij (UL L 201, 31.7.2002, str. 37).
(15) Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (OJ L 277, 27.10.2022, p. 1).
(15) Uredba (EU) 2022/2065 Evropskega parlamenta in Sveta z dne 19. oktobra 2022 o enotnem trgu digitalnih storitev in spremembi Direktive 2000/31/ES (Akt o digitalnih storitvah) (UL L 277, 27.10.2022, str. 1).
(16) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).
(16) Direktiva (EU) 2019/882 Evropskega parlamenta in Sveta z dne 17. aprila 2019 o zahtevah glede dostopnosti za proizvode in storitve (UL L 151, 7.6.2019, str. 70).
(17) Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (OJ L 149, 11.6.2005, p. 22).
(17) Direktiva Evropskega parlamenta in Sveta 2005/29/ES z dne 11. maja 2005 o nepoštenih poslovnih praksah podjetij v razmerju do potrošnikov na notranjem trgu ter o spremembi Direktive Sveta 84/450/EGS, direktiv Evropskega parlamenta in Sveta 97/7/ES, 98/27/ES in 2002/65/ES ter Uredbe (ES) št. 2006/2004 Evropskega parlamenta in Sveta (Direktiva o nepoštenih poslovnih praksah) (UL L 149, 11.6.2005, str. 22).
(18) Council Framework Decision 2002/584/JHA of 13 June 2002 on the European arrest warrant and the surrender procedures between Member States (OJ L 190, 18.7.2002, p. 1).
(18) Okvirni sklep Sveta 2002/584/PNZ z dne 13. junija 2002 o evropskem nalogu za prijetje in postopkih predaje med državami članicami (UL L 190, 18.7.2002, str. 1).
(19) Directive (EU) 2022/2557 of the European Parliament and of the Council of 14 December 2022 on the resilience of critical entities and repealing Council Directive 2008/114/EC (OJ L 333, 27.12.2022, p. 164).
(19) Direktiva (EU) 2022/2557 Evropskega parlamenta in Sveta z dne 14. decembra 2022 o odpornosti kritičnih subjektov in razveljavitvi Direktive Sveta 2008/114/ES (UL L 333, 27.12.2022, str. 164).
(20) OJ C 247, 29.6.2022, p. 1.
(20) UL C 247, 29.6.2022, str. 1.
(21) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(21) Uredba (EU) 2017/745 Evropskega parlamenta in Sveta z dne 5. aprila 2017 o medicinskih pripomočkih, spremembi Direktive 2001/83/ES, Uredbe (ES) št. 178/2002 in Uredbe (ES) št. 1223/2009 ter razveljavitvi direktiv Sveta 90/385/EGS in 93/42/EGS (UL L 117, 5.5.2017, str. 1).
(22) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(22) Uredba (EU) 2017/746 Evropskega parlamenta in Sveta z dne 5. aprila 2017 o in vitro diagnostičnih medicinskih pripomočkih ter razveljavitvi Direktive 98/79/ES in Sklepa Komisije 2010/227/EU (UL L 117, 5.5.2017, str. 176).
(23) 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).
(23) Direktiva 2006/42/ES Evropskega parlamenta in Sveta z dne 17. maja 2006 o strojih in spremembah Direktive 95/16/ES (UL L 157, 9.6.2006, str. 24).
(24) Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008, p. 72).
(24) Uredba (ES) št. 300/2008 Evropskega parlamenta in Sveta z dne 11. marca 2008 o skupnih pravilih na področju varovanja civilnega letalstva in o razveljavitvi Uredbe (ES) št. 2320/2002 (UL L 97, 9.4.2008, str. 72);
(25) 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).
(25) Uredba (EU) št. 167/2013 Evropskega parlamenta in Sveta z dne 5. februarja 2013 o odobritvi in tržnem nadzoru kmetijskih in gozdarskih vozil (UL L 60, 2.3.2013, str. 1).
(26) 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).
(26) Uredba (EU) št. 168/2013 Evropskega parlamenta in Sveta z dne 15. januarja 2013 o odobritvi in tržnem nadzoru dvo- ali trikolesnih vozil in štirikolesnikov (UL L 60, 2.3.2013, str. 52).
(27) Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC (OJ L 257, 28.8.2014, p. 146).
(27) Direktiva 2014/90/EU Evropskega parlamenta in Sveta z dne 23. julija 2014 o pomorski opremi in razveljavitvi Direktive Sveta 96/98/ES (UL L 257, 28.8.2014, str. 146).
(28) Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).
(28) Direktiva (EU) 2016/797 Evropskega parlamenta in Sveta z dne 11. maja 2016 o interoperabilnosti železniškega sistema v Evropski uniji (UL L 138, 26.5.2016, str. 44).
(29) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
(29) Uredba (EU) 2018/858 Evropskega parlamenta in Sveta z dne 30. maja 2018 o odobritvi in tržnem nadzoru motornih vozil in njihovih priklopnikov ter sistemov, sestavnih delov in samostojnih tehničnih enot, namenjenih za taka vozila, spremembi uredb (ES) št. 715/2007 in (ES) št. 595/2009 ter razveljavitvi Direktive 2007/46/ES (UL L 151, 14.6.2018, str. 1).
(30) Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).
(30) Uredba (EU) 2018/1139 Evropskega parlamenta in Sveta z dne 4. julija 2018 o skupnih pravilih na področju civilnega letalstva in ustanovitvi Agencije Evropske unije za varnost v letalstvu ter spremembi uredb (ES) št. 2111/2005, (ES) št. 1008/2008, (EU) št. 996/2010, (EU) št. 376/2014 ter direktiv 2014/30/EU in 2014/53/EU Evropskega parlamenta in Sveta ter razveljavitvi uredb (ES) št. 552/2004 in (ES) št. 216/2008 Evropskega parlamenta in Sveta ter Uredbe Sveta (EGS) št. 3922/91 (UL L 212, 22.8.2018, str. 1).
(31) Regulation (EU) 2019/2144 of the European Parliament and of the Council of 27 November 2019 on type-approval requirements for motor vehicles and their trailers, and systems, components and separate technical units intended for such vehicles, as regards their general safety and the protection of vehicle occupants and vulnerable road users, amending Regulation (EU) 2018/858 of the European Parliament and of the Council and repealing Regulations (EC) No 78/2009, (EC) No 79/2009 and (EC) No 661/2009 of the European Parliament and of the Council and Commission Regulations (EC) No 631/2009, (EU) No 406/2010, (EU) No 672/2010, (EU) No 1003/2010, (EU) No 1005/2010, (EU) No 1008/2010, (EU) No 1009/2010, (EU) No 19/2011, (EU) No 109/2011, (EU) No 458/2011, (EU) No 65/2012, (EU) No 130/2012, (EU) No 347/2012, (EU) No 351/2012, (EU) No 1230/2012 and (EU) 2015/166 (OJ L 325, 16.12.2019, p. 1).
(31) Uredba (EU) 2019/2144 Evropskega parlamenta in Sveta z dne 27. novembra 2019 o zahtevah za homologacijo motornih vozil in njihovih priklopnikov ter sistemov, sestavnih delov in samostojnih tehničnih enot, namenjenih za taka vozila, v zvezi z njihovo splošno varnostjo in zaščito potnikov v vozilu ter izpostavljenih udeležencev v cestnem prometu in o spremembi Uredbe (EU) 2018/858 Evropskega parlamenta in Sveta ter razveljavitvi uredb (ES) št. 78/2009, (ES) št. 79/2009 in (ES) št. 661/2009 Evropskega parlamenta in Sveta in uredb Komisije (ES) št. 631/2009, (EU) št. 406/2010, (EU) št. 672/2010, (EU) št. 1003/2010, (EU) št. 1005/2010, (EU) št. 1008/2010, (EU) št. 1009/2010, (EU) št. 19/2011, (EU) št. 109/2011, (EU) št. 458/2011, (EU) št. 65/2012, (EU) št. 130/2012, (EU) št. 347/2012, (EU) št. 351/2012, (EU) št. 1230/2012 in (EU) 2015/166 (UL L 325, 16.12.2019, str. 1).
(32) Regulation (EC) No 810/2009 of the European Parliament and of the Council of 13 July 2009 establishing a Community Code on Visas (Visa Code) (OJ L 243, 15.9.2009, p. 1).
(32) Uredba (ES) št. 810/2009 Evropskega parlamenta in Sveta z dne 13. julija 2009 o vizumskem zakoniku Skupnosti (Vizumski zakonik) (UL L 243, 15.9.2009, str. 1).
(33) Directive 2013/32/EU of the European Parliament and of the Council of 26 June 2013 on common procedures for granting and withdrawing international protection (OJ L 180, 29.6.2013, p. 60).
(33) Direktiva 2013/32/EU Evropskega parlamenta in Sveta z dne 26. junija 2013 o skupnih postopkih za priznanje ali odvzem mednarodne zaščite (UL L 180, 29.6.2013, str. 60).
(34) Regulation (EU) 2024/900 of the European parliament and of the Council of 13 March 2024 on the transparency and targeting of political advertising (OJ L, 2024/900, 20.3.2024, ELI: http://data.europa.eu/eli/reg/2024/900/oj).
(34) Uredba (EU) 2024/900 Evropskega parlamenta in Sveta z dne 13. Marca 2024 o preglednosti in ciljanem političnem oglaševanju (UL L, 2024/900, 20.3.2024, ELI: http://data.europa.eu/eli/reg/2024/900/oj).
(35) Directive 2014/31/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 non-automatic weighing instruments (OJ L 96, 29.3.2014, p. 107).
(35) Direktiva 2014/31/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaj držav članic v zvezi z omogočanjem dostopnosti neavtomatskih tehtnic na trgu (UL L 96, 29.3.2014, str. 107).
(36) Directive 2014/32/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 measuring instruments (OJ L 96, 29.3.2014, p. 149).
(36) Direktiva 2014/32/EU Evropskega parlamenta in Sveta z dne 26. februarja 2014 o harmonizaciji zakonodaj držav članic v zvezi z omogočanjem dostopnosti neavtomatskih tehtnic na trgu (UL L 96, 29.3.2014, str. 149).
(37) 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).
(37) Uredba (EU) 2019/881 Evropskega parlamenta in Sveta z dne 17. aprila 2019 o Agenciji Evropske unije za kibernetsko varnost (ENISA) in o certificiranju informacijske in komunikacijske tehnologije na področju kibernetske varnosti ter razveljavitvi Uredbe (EU) št. 526/2013 (Akt o kibernetski varnosti) (UL L 151, 7.6.2019, str. 15).
(38) Directive (EU) 2016/2102 of the European Parliament and of the Council of 26 October 2016 on the accessibility of the websites and mobile applications of public sector bodies (OJ L 327, 2.12.2016, p. 1).
(38) Direktiva (EU) 2016/2102 Evropskega parlamenta in Sveta z dne 26. oktobra 2016 o dostopnosti spletišč in mobilnih aplikacij organov javnega sektorja (UL L 327, 2.12.2016, str. 1).
(39) Directive 2002/14/EC of the European Parliament and of the Council of 11 March 2002 establishing a general framework for informing and consulting employees in the European Community (OJ L 80, 23.3.2002, p. 29).
(39) Direktiva 2002/14/ES Evropskega parlamenta in Sveta z dne 11. marca 2002 o določitvi splošnega okvira za obveščanje in posvetovanje z delavci v Evropski skupnosti (UL L 80, 23.3.2002, str. 29).
(40) Directive (EU) 2019/790 of the European Parliament and of the Council of 17 April 2019 on copyright and related rights in the Digital Single Market and amending Directives 96/9/EC and 2001/29/EC (OJ L 130, 17.5.2019, p. 92).
(40) Direktiva (EU) 2019/790 Evropskega parlamenta in Sveta z dne 17. aprila 2019 o avtorski in sorodnih pravicah na enotnem digitalnem trgu in spremembi direktiv 96/9/ES in 2001/29/ES (UL L 130, 17.5.2019, str. 92).
(41) 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, 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).
(41) Uredba (EU) št. 1025/2012 Evropskega parlamenta in Sveta z dne 25. oktobra 2012 o evropski standardizaciji, spremembi direktiv Sveta 89/686/EGS in 93/15/EGS ter direktiv 94/9/ES, 94/25/ES, 95/16/ES, 97/23/ES, 98/34/ES, 2004/22/ES, 2007/23/ES, 2009/23/ES in 2009/105/ES Evropskega parlamenta in Sveta ter razveljavitvi Sklepa Sveta 87/95/EGS in Sklepa št. 1673/2006/ES Evropskega parlamenta in Sveta (UL L 316, 14.11.2012, str. 12).
(42) Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152, 3.6.2022, p. 1).
(42) Uredba (EU) 2022/868 Evropskega parlamenta in Sveta z dne 30. maja 2022 o evropskem upravljanju podatkov in spremembi Uredbe (EU) 2018/1724 (Akt o upravljanju podatkov) (UL L 152, 3.6.2022, str. 1).
(43) Regulation (EU) 2023/2854 of the European Parliament and of the Council of 13 December 2023 on harmonised rules on fair access to and use of data and amending Regulation (EU) 2017/2394 and Directive (EU) 2020/1828 (Data Act) (OJ L, 2023/2854, 22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj).
(43) Uredba (EU) 2023/2854 Evropskega parlamenta in Sveta z dne 13. decembra 2023 o harmoniziranih pravilih za pravičen dostop do podatkov in njihovo uporabo ter spremembi Uredbe (EU) 2017/2394 in Direktive (EU) 2020/1828 (akt o podatkih) (UL L, 2023/2854, 22.12.2023, ELI: http://data.europa.eu/eli/reg/2023/2854/oj).
(44) Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).
(44) Priporočilo Komisije z dne 6. maja 2003 o opredelitvi mikro, malih in srednjih podjetij (UL L 124, 20.5.2003, str. 36).
(45) Commission Decision of 24.1.2024 establishing the European Artificial Intelligence Office C(2024) 390.
(45) Sklep Komisije z dne 24. januarja 2024 o ustanovitvi Evropskega urada za umetno inteligenco C(2024) 390 final.
(46) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
(46) Uredba (EU) št. 575/2013 Evropskega parlamenta in Sveta z dne 26. junija 2013 o bonitetnih zahtevah za kreditne institucije in o spremembi Uredbe (EU) št. 648/2012 (UL L 176, 27.6.2013, str. 1).
(47) Directive 2008/48/EC of the European Parliament and of the Council of 23 April 2008 on credit agreements for consumers and repealing Council Directive 87/102/EEC (OJ L 133, 22.5.2008, p. 66).
(47) Direktiva 2008/48/ES Evropskega parlamenta in Sveta z dne 23. aprila 2008 o potrošniških kreditnih pogodbah in razveljavitvi Direktive Sveta 87/102/EGS (UL L 133, 22.5.2008, str. 66).
(48) Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1).
(48) Direktiva 2009/138/ES Evropskega parlamenta in Sveta z dne 25. novembra 2009 o začetku opravljanja in opravljanju dejavnosti zavarovanja in pozavarovanja (Solventnost II) (UL L 335, 17.12.2009, str. 1).
(49) Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).
(49) Direktiva 2013/36/EU Evropskega parlamenta in Sveta z dne 26. junija 2013 o dostopu do dejavnosti kreditnih institucij in bonitetnem nadzoru kreditnih institucij, spremembi Direktive 2002/87/ES ter razveljavitvi direktiv 2006/48/ES in 2006/49/ES (UL L 176, 27.6.2013, str. 338).
(50) Directive 2014/17/EU of the European Parliament and of the Council of 4 February 2014 on credit agreements for consumers relating to residential immovable property and amending Directives 2008/48/EC and 2013/36/EU and Regulation (EU) No 1093/2010 (OJ L 60, 28.2.2014, p. 34).
(50) Direktiva 2014/17/ЕU Evropskega parlamenta in Sveta z dne 4. februarja 2014 o potrošniških kreditnih pogodbah za stanovanjske nepremičnine in spremembi direktiv 2008/48/ES in 2013/36/EU ter Uredbe (EU) št. 1093/2010 (UL L 60, 28.2.2014, str. 34).
(51) Directive (EU) 2016/97 of the European Parliament and of the Council of 20 January 2016 on insurance distribution (OJ L 26, 2.2.2016, p. 19).
(51) Direktiva (EU) 2016/97 Evropskega parlamenta in Sveta z dne 20. januarja 2016 o distribuciji zavarovalnih produktov (UL L 26, 2.2.2016, str. 19).
(52) Council Regulation (EU) No 1024/2013 of 15 October 2013 conferring specific tasks on the European Central Bank concerning policies relating to the prudential supervision of credit institutions (OJ L 287, 29.10.2013, p. 63).
(52) Uredba Sveta (EU) št. 1024/2013 z dne 15. oktobra 2013 o prenosu posebnih nalog, ki se nanašajo na politike bonitetnega nadzora kreditnih institucij, na Evropsko centralno banko (UL L 287, 29.10.2013, str. 63).
(53) Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC (OJ L 135, 23.5.2023, p. 1).
(53) Uredba (EU) 2023/988 Evropskega parlamenta in Sveta z dne 10. maja 2023 o splošni varnosti proizvodov, spremembi Uredbe (EU) št. 1025/2012 Evropskega parlamenta in Sveta in Direktive (EU) 2020/1828 Evropskega parlamenta in Sveta ter razveljavitvi Direktive 2001/95/ES Evropskega parlamenta in Sveta in Direktive Sveta 87/357/EGS (UL L 135, 23.5.2023, str. 1).
(54) Directive (EU) 2019/1937 of the European Parliament and of the Council of 23 October 2019 on the protection of persons who report breaches of Union law (OJ L 305, 26.11.2019, p. 17).
(54) Direktiva (EU) 2019/1937 Evropskega parlamenta in Sveta z dne 23. oktobra 2019 o zaščiti oseb, ki prijavijo kršitve prava Unije (UL L 305, 26.11.2019, str. 17).
(55) OJ L 123, 12.5.2016, p. 1.
(55) UL L 123, 12.5.2016, str. 1.
(56) 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).
(56) Uredba (EU) št. 182/2011 Evropskega parlamenta in Sveta z dne 16. februarja 2011 o določitvi splošnih pravil in načel, na podlagi katerih države članice nadzirajo izvajanje izvedbenih pooblastil Komisije (UL L 55, 28.2.2011, str. 13).
(57) Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use and disclosure (OJ L 157, 15.6.2016, p. 1).
(57) Direktiva (EU) 2016/943 Evropskega parlamenta in Sveta z dne 8. junija 2016 o varstvu nerazkritega strokovnega znanja in izkušenj ter poslovnih informacij (poslovnih skrivnosti) pred njihovo protipravno pridobitvijo, uporabo in razkritjem (UL L 157, 15.6.2016, str. 1).
(58) Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on representative actions for the protection of the collective interests of consumers and repealing Directive 2009/22/EC (OJ L 409, 4.12.2020, p. 1).
(58) Direktiva (EU) 2020/1828 Evropskega parlamenta in Sveta z dne 25. novembra 2020 o zastopniških tožbah za varstvo kolektivnih interesov potrošnikov in razveljavitvi Direktive 2009/22/ES (UL L 409, 4.12.2020, str. 1).