+Artikolu 54 Rappreżentanti awtorizzati tal-fornituri ta' mudelli tal-IA bi skop ġenerali
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Artikolu 54 Rappreżentanti awtorizzati tal-fornituri ta' mudelli tal-IA bi skop ġenerali

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1. Ħarsa ġenerali

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Titlu	Regolamentazzjoni
Artikolu 54 1.	Qabel ma jintroduċu mudell tal-IA bi skop ġenerali fis-suq tal-Unjoni, il-fornituri stabbiliti f'pajjiżi terzi għandhom, b'mandat bil-miktub, jaħtru rappreżentant awtorizzat li jkun stabbilit fl-Unjoni.
Artikolu 54 2.	Il-fornitur għandu jippermetti lir-rappreżentant awtorizzat tiegħu jwettaq il-kompiti speċifikati fil-mandat li jirċievi mingħand il-fornitur.
Artikolu 54 3.	Ir-rappreżentant awtorizzat għandu jwettaq il-kompiti speċifikati fil-mandat li jirċievi mingħand il-fornitur. Huwa għandu jipprovdi kopja tal-mandat lill-Uffiċċju għall-IA fuq talba, b'waħda mil-lingwi uffiċjali tal-istituzzjonijiet tal-Unjoni. Għall-finijiet ta' dan ir-Regolament, il-mandat għandu jagħti s-setgħa lir-rappreżentant awtorizzat biex iwettaq il-kompiti li ġejjin: (a) jivverifika li d-dokumentazzjoni teknika speċifikata fl-Anness XI tkun tfasslet u l-obbligi kollha msemmija fl-Artikolu 53 u, fejn applikabbli, l-Artikolu 55, ikunu ġew issodisfati mill-fornitur; (b) iżomm kopja tad-dokumentazzjoni teknika speċifikata fl-Anness XI għad-dispożizzjoni tal-Uffiċċju għall-IA u tal-awtoritajiet nazzjonali kompetenti, għal perjodu ta' 10 snin wara li l-mudell tal-IA bi skop ġenerali jkun ġie introdott fis-suq, u d-dettalji ta' kuntatt tal-fornitur li jkun ħatar ir-rappreżentant awtorizzat; (c) jipprovdi lill-Uffiċċju għall-IA, fuq talba motivata, bl-informazzjoni u d-dokumentazzjoni kollha, inkluż dik imsemmija fil-punt (b), meħtieġa biex tintwera l-konformità mal-obbligi f'dan il-Kapitolu; (d) jikkoopera mal-Uffiċċju għall-IA u mal-awtoritajiet kompetenti, fuq talba motivata, fi kwalunkwe azzjoni li huma jieħdu fir-rigward tal-mudell tal-IA bi skop ġenerali, inkluż meta l-mudell jiġi integrat f'sistemi tal-IA introdotti fis-suq jew imqiegħda fis-servizz fl-Unjoni.
Artikolu 54 4.	Il-mandat għandu jagħti s-setgħa lir-rappreżentant awtorizzat li jiġi indirizzat, flimkien mal-fornitur jew minfloku, mill-Uffiċċju għall-IA jew mill-awtoritajiet kompetenti, dwar il-kwistjonijiet kollha relatati mal-iżgurar tal-konformità ma' dan ir-Regolament.
Artikolu 54 5.	Ir-rappreżentant awtorizzat għandu jtemm il-mandat jekk iqis jew ikollu raġuni biex iqis li l-fornitur qed jaġixxi kontra l-obbligi tiegħu skont dan ir-Regolament. F'każ bħal dan, għandu wkoll jinforma minnufih lill-Uffiċċju għall-IA dwar it-terminazzjoni tal-mandat u r-raġunijiet għaliha.
Artikolu 54 6.	L-obbligu stipulat f'dan l-Artikolu ma għandux japplika għall-fornituri ta' mudelli tal-IA bi skop ġenerali li jiġu rilaxxati b'liċenzja libera u b’sors miftuħ li tippermetti l-aċċess, l-użu, il-modifika u d-distribuzzjoni tal-mudell, u li l-parametri tagħhom, inkluż il-piżijiet, l-informazzjoni dwar l-arkitettura tal-mudell, u l-informazzjoni dwar l-użu tal-mudell, ikunu disponibbli għall-pubbliku, dment li l-mudelli tal-IA bi skop ġenerali ma jippreżentawx riskji sistemiċi.

1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti
Sors	Rekwiżit

3. Standards relatati

Standards
Sors	Rekwiżit
SCF	Localized Representation Description Mechanisms exist to appoint localized representation with a physical presence in the host country, as required by applicable laws and/or regulations. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Document applicable regulatory requirements in a checklist Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Compliance checklist ∙ Annual compliance review Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Compliance management program ∙ Regulatory mapping ∙ Compliance calendar Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Compliance team Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Dedicated compliance team ∙ Automated compliance monitoring SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Compliance (CPL) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations. Level 3 Well Defined Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners. ▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to appoint localized representation with a physical presence in localities, as required by applicable laws and/or regulations. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Representative Powers Description Mechanisms exist to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters in the host country. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Document applicable regulatory requirements in a checklist Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Compliance checklist ∙ Annual compliance review Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Compliance management program ∙ Regulatory mapping ∙ Compliance calendar Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Compliance team Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Dedicated compliance team ∙ Automated compliance monitoring SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Compliance (CPL) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations. Level 3 Well Defined Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners. ▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Representative Powers Description Mechanisms exist to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters in the host country. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Document applicable regulatory requirements in a checklist Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Compliance checklist ∙ Annual compliance review Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Compliance management program ∙ Regulatory mapping ∙ Compliance calendar Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Compliance team Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Dedicated compliance team ∙ Automated compliance monitoring SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Compliance (CPL) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations. Level 3 Well Defined Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners. ▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF	Representative Powers Description Mechanisms exist to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters in the host country. Possible Solutions & Considerations Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2 ∙ Document applicable regulatory requirements in a checklist Small Business (10-49 staff) / BLS Firm Size Classes 3-4 ∙ Compliance checklist ∙ Annual compliance review Medium Business (50-249 staff) / BLS Firm Size Classes 5-6 ∙ Compliance management program ∙ Regulatory mapping ∙ Compliance calendar Large Business (250-999 staff) / BLS Firm Size Classes 7-8 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Compliance team Enterprise (> 1,000 staff) / BLS Firm Size Class 9 ∙ GRC solution (e.g., SCFConnect, Cyturus, SureCloud, SimpleRisk, Ignyte, ZenGRC, Galvanize, MetricStream, Archer, etc.) ∙ Dedicated compliance team ∙ Automated compliance monitoring SCR-CMM Level 0 Not Performed Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed. Level 1 Performed Informally SCR-CMM Level 1 criteria definitions are not available for this control: ▪ A reasonable person would conclude this control requires a structured process. ▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality. Level 2 Planned Tracked Compliance (CPL) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are documented and maintained by process owners. ▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD). ▪ Compliance management controls-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines). ▪ Compliance management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel. ▪ External compliance requirements for cybersecurity and data privacy are identified and documented, based on applicable laws, regulations and contractual obligations. Level 3 Well Defined Compliance (CPL) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist: ▪ Policies and standards associated with CPL domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function. ▪ Standardized Operating Procedures (SOP) associated with CPL domain capabilities are well-documented and kept current by process owners. ▪ A Governance, Risk & Compliance (GRC) team, or similar function, is appropriately staffed and supported to implement and maintain CPL domain capabilities. ▪ Technology is leveraged to enhance the efficiency and accuracy of governance, risk management and compliance operations (e.g., GRC platform). ▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with CPL domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls). ▪ An implemented and operational capability exists to contract localized representation to perform specified functions in regard to representing statutory and/or regulatory compliance matters. Level 4 Quantitatively Controlled Utilize SCR-CMM Level 3 criteria definitions: ▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control. ▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define. Level 5 Continuously Improving Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions: ▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control. ▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies. ▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.

Builddate: 27.07.2026 00:00:00 -Doknr: CELEX:32024R1689
EULAW -
European Regulation published on http://eur-lex.europa.eu/