EUCC-3087-2026-0006 for Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2 issued by BSI Administration ID: BSI-CC-PP-0105-V4-2026 BSI - Bundesamt für Sicherheit in der Informationstechnik, Postfach 20 03 63, D-53133 Bonn Phone +49 (0)228 99 9582-0, Fax +49 (0)228 9582-5477, Infoline +49 (0)228 99 9582-11 Certification Report V1.0 EUCC-PP-414_V1.0 Certification Report BSI-CC-PP-0105-V4-2026 Contents A. Certification.......................................................................................................................4 1. Preliminary Remarks.....................................................................................................4 2. Specifications of the Certification Procedure................................................................4 3. Mutual Recognition........................................................................................................5 4. Performance of Evaluation and Certification.................................................................6 5. Validity of the Certification Result..................................................................................6 6. Publication.....................................................................................................................7 B. Certification Results..........................................................................................................8 1. Protection Profile Overview...........................................................................................9 2. Security Functional Requirements................................................................................9 3. Assurance Requirements..............................................................................................9 4. Results of the PP-Evaluation......................................................................................10 5. Obligations and notes for the usage...........................................................................10 6. Identification of the PP.................................................................................................11 7. Protection Profile.........................................................................................................11 8. Definitions....................................................................................................................11 9. Bibliography.................................................................................................................12 C. Annexes..........................................................................................................................15 3 / 15 Certification Report EUCC-3087-2026-0006 A. Certification 1. Preliminary Remarks The Implementing Regulation (EU) 2024/482 of the European Parliament and of the Council of 31 January 2024 [IR] establishes a Union-wide cybersecurity certification scheme for ICT products and Protection Profiles for conformity assessments using the requirements of Common Criteria. By implementing the Cybersecurity Act [CSA], certification activities at assurance level ‘high’ and in duly justified cases at assurance level ‘substantial’ are reserved to the National Cybersecurity Certification Agency of a Member State. In accordance to BSIG Act [BSIG], the Federal Office for Information Security (BSI) issues certificates for information technology products as well as for Protection Profiles (PP). A PP defines an implementation-independent set of IT security requirements for a category of products which are intended to meet common consumer needs for IT security. A PP claimed by a user, consumer or stakeholder for IT gives them the possibility to express their IT security needs without referring to a specific product. Product certifications can be based on Protection Profiles. For products which have been certified based on a Protection Profile an individual certificate will be issued but the results from a PP certification can be re-used for the Security Target evaluation within a product evaluation when conformance to the PP has been claimed. Certification of the Protection Profile is carried out on the instigation of the BSI or a sponsor. A part of the procedure is the technical examination (evaluation) of the product according to the security criteria referenced in the above mentioned Implementing Regulation (EU) 2024/482 as well as relevant application notes and interpretations published by the certification body of the BSI. Evaluation facilities notified by the German National Cybersecurity Certification Authority carry out the evaluation. This Certification Report is the result of the certification activities carried out by the certification body of the BSI in conclusion of the technical evaluation. This report contains among others the certificate (summarised assessment) and the detailed Certification Results. The certification is not an endorsement of the Protection Profile by the Federal Office for Information Security or any other organisation that recognises or gives effect to this certificate, and no warranty of the Protection Profile by the Federal Office for Information Security or any other organisation that recognises or gives effect to this certificate, is either expressed or implied. 2. Specifications of the Certification Procedure The certification body carries out its activities according to the criteria laid down in the following: ● Implementing Regulation (EU) 2024/482 of the European Parliament and of the Council of 31 January 2024 laying down rules for the application of Regulation (EU) 2019/881 of the European Parliament and of the Council as regards the adoption of the European Common Criteria-based cybersecurity certification scheme (EUCC) [IR] 4 / 15 EUCC-3087-2026-0006 Certification Report ● EUCC state-of-the-art documents of relevance to the TOE [SotA] ● Act on the Federal Office for Information Security [BSIG] ● BSI Certification and Approval Ordinance [ZertV] ● BMI Regulations on Ex-parte Costs [GebV] ● Special decrees issued by the Bundesministerium des Innern (Federal Ministry of the Interior and Community) ● ISO/IEC 15408 as published on the day of issuance of this certificate and as mirrored by the Common Criteria for IT Security Evaluation [CC] ● ISO/IEC 18045 as published on the day of issuance of this certificate and as mirrored by the Common Methodology for IT Security Evaluation [CEM] ● DIN EN ISO/IEC 17065 standard ● EUCC programme: Scheme documentation describing the certification process (EUCC) [EUCC] ● BSI certification: Application Notes and Interpretation of the Scheme (AIS) [AIS] 3. Mutual Recognition 3.1. EU Cybersecurity Certification Scheme on Common Criteria (EUCC) Certificates issued under EUCC are recognised according to Implementing Regulation (EU) 2024/482 [IR]. Details of EUCC can be found at https://certification.enisa.europa.eu/certification-library/eucc-certification-scheme_en. 3.2. International Recognition of CC – Certificates (CCRA) In order to avoid multiple certification of the same Protection Profile in different countries a mutual recognition of IT security certificates - as far as such certificates are based on CC - under certain conditions was agreed. Therefore, the results of this evaluation and certification procedure can be re-used by the product certificate issuing scheme in the evaluation of a Security Target within a subsequent product evaluation and certification procedure. The international Common Criteria Recognition Arrangement (CCRA) became effective in September 2014 in its current version. It defines the recognition of certificates for IT- products based on collaborative Protection Profiles (cPP) (exact use), CC certificates based on assurance components up to and including EAL 2 or the assurance family Flaw Remediation (ALC_FLR) and CC certificates for Protection Profiles and for collaborative Protection Profiles (cPP). The Common Criteria Recognition Arrangement logo printed on the certificate indicates that this certification is recognised under the terms of this agreement by the related bodies of the signatory nations. A disclaimer beneath the logo indicates the specific scope of recognition. Details on recognition, the signatory nations and the agreement itself can be found at https://www.commoncriteriaportal.org. 5 / 15 Certification Report EUCC-3087-2026-0006 4. Performance of Evaluation and Certification ● The Protection Profile Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2 has been certified under the EUCC scheme in accordance to the provisions of the Implementing Regulation (EU) 2024/482. This is a re-certification based on BSI-CC-PP-0105-V3-2025. Specific results from the evaluation process BSI-CC-PP-0105-V3-2025 were re-used. ● The evaluation of the Protection Profile Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2, was conducted by TÜV Informationstechnik GmbH. The evaluation was completed on 11 May 2026. TÜV Informationstechnik GmbH is a notified evaluation facility (ITSEF). ● The Evaluation Technical Report [ETR] was provided by the ITSEF according to the Common Criteria [CC], the Methodology [CEM], and the requirements of the Scheme [IR]. ● CC Version and Release: see [CC] and [CEM] ● Claimed Assurance level according to the CSA [CSA]: substantial ● For this certification procedure the sponsor and applicant is: Bundesamt für Sicherheit in der Informationstechnik. ● The certification body monitors each individual evaluation to ensure a uniform application and interpretation of the criteria as well as uniform ratings. ● The certification activities are concluded with the comparability check and the production of this Certification Report. This work was completed by the certification body of the BSI. 5. Validity of the Certification Result This Certification Report applies only to the version of the PP as identified in this document. In case of changes to the certified version of the Protection Profile, the validity can be extended to new versions and releases, provided the sponsor applies for assurance continuity (i.e. re-certification or maintenance) of the modified Protection Profile, in accordance with the procedural requirements, and the evaluation does not reveal any security deficiencies. For the meaning of the CC concepts and terms please refer to CC [CC] Part 1 through 5. The validity of this certificate ends as outlined on the certificate. The applicant and the sponsor of this certificate are recommended to review the technical content of the Protection Profile certified according to the evolvement of the technology and of the intended operational environment of the type of product concerned as well as according to the evolvement of the evaluation criteria. Such review should result in an update and a re- certification of the Protection Profile accordingly. Typically, technical standards are reviewed on a five years basis. The limitation of validity of this PP certificate does not necessarily impact the validity period of a product certificate referring to this Protection Profile, but the certification body issuing a product certificate based on this Protection Profile should take it into its consideration on validity. 6 / 15 EUCC-3087-2026-0006 Certification Report 6. Publication The PP Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2, has been notified to ENISA for publication on the website on European cybersecurity certification schemes https://certification.enisa.europa.eu/. Further information can be obtained from BSI-Infoline +49 228 9582-111. This holder of the certificate1 has to publish on its website this Certification Report and supplementary information. The Certification Report may also be obtained in electronic form at the internet address stated above. 1 BSI Godesberger Allee 87 53175 Bonn 7 / 15 Certification Report EUCC-3087-2026-0006 B. Certification Results The following chapters summarise the assessment results of the ● the certified Protection Profile, ● the relevant evaluation results from the evaluation facility, and ● complementary notes, statements and indications from the certification body. 8 / 15 EUCC-3087-2026-0006 Certification Report 1. Protection Profile Overview The Protection Profile Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2 [PP] is established by Bundesamt für Sicherheit in der Informationstechnik as a basis for the development of Security Targets in order to perform a certification of an IT-product, the Target of Evaluation (TOE). The TOE type is a security module application implemented as software. The security module is part of a certified technical security system (CTSS) for electronic record-keeping systems (ERS). The TOE application is either running on the platform of a CSP (referred to as platform- architecture), or running on a separate device communicating with the CSP via a trusted channel (referred to as client-server architecture). Depending on the overall architecture, different security requirements exist for a CSP. The assets to be protected by a TOE claiming conformance to this PP are defined in [PP], chapter 3.1. Based on these assets the security problem definition is defined in terms of assumptions, threats and organisational security policies. This is outlined in [PP], chapter 3. These assumptions, threats and organisational security policies are split into security objectives to be fulfilled by a TOE claiming conformance to this PP and security objectives to be fulfilled by the operational environment of a TOE claiming conformance to this PP. These objectives are outlined in [PP], chapter 4. The Protection Profile [PP] requires a Security Target based on this PP or another PP claiming this PP to fulfil the CC requirements for strict conformance. To support proper and consistent usage of the PP, it is supplemented by the TR and Supporting Documents [TR] [SD]. For the proper usage of the CSP in support of the PP [PP] refer to the Supporting Documents [PP CSP]. 2. Security Functional Requirements Based on the security objectives to be fulfilled by a TOE claiming conformance to this PP the security policy is expressed by the set of security functional requirements (SFR) to be implemented by a TOE. It covers the following issues: • Cryptographic Support, • User Data Protection• User Identification and Authentication,• Security Management,• Protection of the TSF,• Trusted Path/Channels (applied by Package Trusted Channel between TOE and CSP only)• Security Audit,• Update Code Package – Upgrade Functionality These TOE security functional requirements are outlined in the PP [5], chapter 5.1. They are selected from Common Criteria Part 2. Thus the SFR claim is called: Common Criteria Part 2 conformant 3. Assurance Requirements The TOE security assurance package claimed in the PP is based entirely on the assurance components defined in part 3 of the Common Criteria. Thus, this assurance package is called: 9 / 15 Certification Report EUCC-3087-2026-0006 Common Criteria Part 3 conformant EAL 2 augmented by ALC_LCD.1, ALC_FLR.1 and ALC_CMS.3 (for the definition and scope of assurance packages according to CC see [CC], part 3 for details). 4. Results of the PP-Evaluation As a result of the evaluation the verdict PASS is confirmed for the assurance components of the class APE (Protection Profile evaluation). The following assurance components were used: APE_INT.1 PP introduction APE_CCL.1 Conformance claims APE_SPD.1 Security problem definition APE_OBJ.2 Security objectives APE_ECD.1 Extended components definition APE_REQ.2 Derived security requirements As the evaluation work performed for this certification procedure was carried out as a re- evaluation based on the certificate BSI-CC-PP-0105-V3-2025, re-use of specific evaluation tasks was possible. The focus of this re-evaluation was on changing to EUCC. The results of the evaluation are only applicable to the Protection Profile as defined in chapter 1. 5. Obligations and notes for the usage The following aspects need to be fulfilled when using the Protection Profile: The PP [PP] defines several Application Notes that shall be considered when creating a security target and implementing a TOE that claims conformance to the PP [PP]. Also, as the PP [PP] was created to offer great flexibility with respect to different architectural designs, individual solutions of a SMAERS and CSP shall consider Chapter 1.2 (Non-TOE Hardware/Software/Firmware available to the TOE). A TOE that is based on this PP [PP] can only be run together with a CC certified CSP component. Additionally, individual Evaluation Activities (EA) associated with the augmentations ALC_LCD.1 and ALC_CMS.3 shall be performed as specified in the Assurance Refinements in Chapter 5.2.1 of the PP [PP]. Further, additional Evaluation Activities associated with the life cycle of the security module of the TSS shall be performed according to the Supporting Document for Protection Profile SMAERS [SD]. Please note that the Supporting Document for Protection Profile SMAERS [SD] is not in the scope of this certification. Also to support proper and consistent usage of the PP, it is supplemented by the TR and Supporting Documents [TR], [SD]. For the proper usage of the CSP in support of the PP [PP] refer to the Supporting Documents [PP CSP]. The certification results apply only to the version of the PP indicated in the certificate and on the condition that all the statements and indications are kept as detailed in this Certification Report. Neither the BSI nor any other organisation that recognises or gives effect to this certificate implicitly or explicitly guarantee or endorse the certified PP. 10 / 15 EUCC-3087-2026-0006 Certification Report 6. Identification of the PP The Target of Evaluation (TOE) is identified as follows: Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2 Holder of the certificate: BSI Godesberger Allee 87 53175 Bonn 7. Protection Profile For the purpose of publishing, the Protection Profile [PP] is provided within a separate document as Annex A of this report. SHA256 hash of the PP: e7cfb2b46da1cb7f72c313008f7ea70d872a9f234fd60850bc305b0620c25725 8. Definitions 8.1. Acronyms BSI Bundesamt für Sicherheit in der Informationstechnik / Federal Office for Information Security, Bonn, Germany CCRA Common Criteria Recognition Arrangement EAL Evaluation Assurance Level ETR Evaluation Technical Report IT Information Technology ITSEF Information Technology Security Evaluation Facility PP Protection Profile SAR Security Assurance Requirement SFP Security Function Policy SFR Security Functional Requirement ST Security Target TOE Target of Evaluation TSF TOE Security Functionality 8.2. Glossary Augmentation - The addition of one or more requirement(s) to a package. Collaborative Protection Profile - A Protection Profile collaboratively developed by an International Technical Community endorsed by the CCRA Management Committee. Extension - The addition to an ST or PP of functional requirements not contained in CC part 2 and/or assurance requirements not contained in CC part 3. 11 / 15 Certification Report EUCC-3087-2026-0006 Formal - Expressed in a restricted syntax language with defined semantics based on well- established mathematical concepts. Object - A passive entity in the TOE, that contains or receives information, and upon which subjects perform operations. Package - named set of either security functional or security assurance requirements Protection Profile - A formal document defined in CC, expressing an implementation independent set of security requirements for a category of IT Products that meet specific consumer needs. Security Target - An implementation-dependent statement of security needs for a specific identified TOE. Subject - An active entity in the TOE that performs operations on objects. Target of Evaluation - An IT Product and its associated administrator and user guidance documentation that is the subject of an Evaluation. TOE Security Functionality - Combined functionality of all hardware, software, and firmware of a TOE that must be relied upon for the correct enforcement of the SFRs. 9. Bibliography [CSA] 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) [IR] Implementing Regulation (EU) 2024/482 of the European Parliament and of the Council of 31 January 2024 laying down rules for the application of Regulation (EU) 2019/881 of the European Parliament and of the Council as regards the adoption of the European Common Criteria-based cybersecurity certification scheme and related amendments (EUCC) [BSIG] Act on the Federal Office for Information Security (BSI-Gesetz - BSIG) of 02 December 2025, Bundesgesetzblatt 2025 I Nr. 301, S. 2 [ZertV] Ordinance on the Procedure for Issuance of Security Certificates and approval by the Federal Office for Information Security (BSI-Zertifizierungs- und Anerkennungsverordnung - BSIZertV) of 17 December 2014, Bundesgesetzblatt 2014, part I, no. 61, p. 2231 [GebV] BMI Regulations on Ex-parte Costs - Besondere Gebührenverordnung des BMI für individuell zurechenbare öffentliche Leistungen in dessen Zuständigkeits- bereich (BMIBGebV), Abschnitt 7 (BSI-Gesetz) - dated 2 September 2019, Bundesgesetzblatt I p. 1365 [CC] ISO 15408:2022, Common Criteria for Information Technology Security Evaluation - Part 1: Introduction and general model - Part 2: Security functional components - Part 3: Security assurance components - Part 4: Framework for the specification of evaluation methods and activities - Part 5: Pre-defined packages of security requirements https://www.iso.org/standard/72891.html 12 / 15 EUCC-3087-2026-0006 Certification Report https://www.iso.org/standard/72892.html https://www.iso.org/standard/72906.html https://www.iso.org/standard/72913.html https://www.iso.org/standard/72917.html as mirrored by CCRA’s edition: CC:2022 R1, Common Criteria for Information Technology Security Evaluation - Part 1: Introduction and general model - Part 2: Security functional components - Part 3: Security assurance components - Part 4: Framework for the specification of evaluation methods and activities - Part 5: Pre-defined packages of security requirements https://www.commoncriteriaportal.org [CEM] ISO 18045:2022: Information technology Security techniques Methodology for IT security evaluation https://www.iso.org/standard/72889.html as mirrored by CCRA’s edition: CEM:2022 R1, Common Methodology for Information Technology Security Evaluation https://www.commoncriteriaportal.org [EUCC] EUCC program of the BSI: Scheme documentation describing the certification process (EUCC), https://www.bsi.bund.de/zertifizierung [SotA] EUCC state-of-the-art documents, https://certification.enisa.europa.eu/ [PUB] EUCC Certificates, periodically updated list published on ENISA’s website on European cybersecurity certification schemes, https://certification.enisa.europa.eu/ [AIS] Application Notes and Interpretations of the Scheme (AIS) as relevant for the TOE, https://www.bsi.bund.de/AIS [PP] Protection Profile Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) Version 3.0.2, 2026-04-10, Bundesamt für Sicherheit in der Informationstechnik [ETR] Evaluation Technical Report Common Criteria Protection Profile Security Module Application for Electronic Record-keeping Systems (SMAERS) 3.0.2“, Version 1, 2026-04-10, “EVALUATION TECHNICAL REPORT SUMMARY (ETR SUMMARY)”, TÜV Informationstechnik GmbH (confidential document) [TR] Technical Guideline BSI TR-03151-1 Secure Element API (SE API), Version 1.1.1, 2024-01-08, Bundesamt für Sicherheit in der Informationstechnik Technische Richtlinie BSI TR-03116 Kryptographische Vorgaben für Projekte der Bundesregierung Teil 5: Anwendungen der Secure Element API, Stand 2023, 2023-04-24, Bundesamt für Sicherheit in der Informationstechnik [SD] Supporting Document for Common Criteria Protection Profile SMAERS, Version 1.0, 2023-05-16, Bundesamt für Sicherheit in der Infromationstechnik 13 / 15 Certification Report EUCC-3087-2026-0006 [PP CSP]Protection Profile “Cryptographic Service Provider (CSP)“, BSI-CC-PP-0104- 2019, Version 0.9.8, 2019-02-19, Bundesamt für Sicherheit in der Informationstechnik Protection Profile “Configuration Cryptographic Service Provider – Time Stamp Service and Audit“, BSI-CC-PP-0107-2019, Version 0.9.5, 2019-04-08, Bundesamt für Sicherheit in der Informationstechnik Protection Profile “Configuration Cryptographic Service Provider – Time Stamp Service and Audit - Clustering“, BSI-CC-PP-0108-2019, Version 0.9.4, 2019-04- 08, Bundesamt für Sicherheit in der Informationstechnik Protection Profile “Cryptographic Service Provider Light“, BSI-CC-PP-0111-2019, Version 1.0, 2019-11-12, Bundesamt für Sicherheit in der Informationstechnik Protection Profile “Configuration Cryptographic Service Provider Light – Time Stamp Service and Audit“, BSI-CC-PP-0113-2019, Version 1.0, 2020-07-15, Bundesamt für Sicherheit in der Informationstechnik 14 / 15 EUCC-3087-2026-0006 Certification Report C. Annexes List of annexes of this certification report Annex A: Protection Profile provided within a separate document. 15 / 15