D3.1 - Catalogue of conformity assessment standards covered by the TEF

CATALOGUE OF CONFORMITY ASSESSMENT STANDARDS COVERED BY THE TEF 2024-12-17 Ref. Ares(2024)9286190 - 31/12/2024 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 2 Project cofunded by the European Commission within the Digital Europe Programme Dissemination Level PU Public X CO Confidential, only for members of the consortium (including the Commission Services) □ CL Classified, as referred to in Commission decision 2001/844/EC □ Deliverable number: D3.1 Deliverable name: Catalogue of conformity assessment standards covered by the TEF Work package: WP 3 Lead WP: LNE Lead Task: LNE Contributors: - 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 3 Contents Document Revision History ............................................................................................................................................... 5 List of Acronyms ................................................................................................................................................................ 6 Terminology ...................................................................................................................................................................... 6 Abstract ............................................................................................................................................................................. 8 Executive summary ........................................................................................................................................................... 9 Introduction .................................................................................................................................................................... 10 1. Regulatory Framework and Context ....................................................................................................................... 12 1.1. Need of conformity assessment for a TEF customer ....................................................................................... 12 1.2. Definitions ....................................................................................................................................................... 12 1.2.1. Standards emitted by standardization bodies ........................................................................................ 13 1.2.2. Conformity assessment (focus on EU AI Act) .......................................................................................... 14 1.3. Roles and Responsibilities of Stakeholders ...................................................................................................... 16 1.4. Regulatory framework ..................................................................................................................................... 17 1.4.1. Overview of European Union (EU) AI Regulation ................................................................................... 17 1.4.2. EU Machinery Regulation 2023/1230 ..................................................................................................... 18 1.4.3. EU Cybersecurity Act 2019/881 and EU Cybersecurity Certification Scheme on Common Criteria (EUCC 2024/482) ................................................................................................................................................................ 19 1.4.4. Proposal of EU AI Liability Directive (AILD) ............................................................................................. 20 1.4.5. EU General Product Safety Regulation 2023/988 ................................................................................... 20 1.4.6. EU General Data Protection Regulation 2016/679 ................................................................................. 21 1.4.7. Proposal for EU Data Governance Act .................................................................................................... 21 1.4.8. EU Data Act 2023/2854 ........................................................................................................................... 22 1.4.9. Interoperable Europe Act ........................................................................................................................ 22 1.4.10. EU Digital Services Act 2022/2065 .......................................................................................................... 23 1.4.11. EU Regulation on electronic identification and trust services (eIDAS2) 910/2014 ................................ 23 1.4.12. Others New Legislative Framework (NLF) directives and regulations .................................................... 24 1.5. Relevant regulation considered by AgrifoodTEF .............................................................................................. 25 2. Catalogue of conformity assessment standards covered by AgrifoodTEF ............................................................. 26 2.1. Description of the catalogue ........................................................................................................................... 26 2.2. Catalogue of standards covered by AgrifoodTEF services ............................................................................... 27 2.2.1. Conformity assessment against normative standards ................................................................................ 27 2.2.1.1. ISO 42001 certification (AI Management System) .............................................................................. 27 2.2.1.2. ISO/IEC 25010:2023 ............................................................................................................................ 27 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 4 2.2.1.3. ISO 12100:2010 ................................................................................................................................... 28 2.2.1.4. ISO 18497:2024 (Part I, II, III, IV) ......................................................................................................... 29 2.2.1.5. ISO 19206-2: 2018 ............................................................................................................................... 30 2.2.1.6. CB Scheme certification ...................................................................................................................... 30 2.2.1.7. Compliance tests for CE marking ........................................................................................................ 31 2.2.2. Conformity assessment against other technical references ................................................................... 32 2.2.2.1. AI Processes certification .................................................................................................................... 32 2.2.2.2. Ethical design guidelines (Value Sensitive Design) ............................................................................. 32 2.2.2.3. Ethical, Legal, Social aspects assessment ............................................................................................ 33 2.2.2.4. Cybersecurity testing .......................................................................................................................... 33 2.3. Cartography of covered standards .................................................................................................................. 34 Conclusion ....................................................................................................................................................................... 36 Summary of key insights ............................................................................................................................................. 36 Next steps ................................................................................................................................................................... 36 References and Bibliography .......................................................................................................................................... 37 Annex 1: Agrifood Sector-Specific Regulation and Policy ............................................................................................... 38 1. Agricultural and forestry tractors ....................................................................................................................... 38 2. Common Agricultural Policy (CAP) ...................................................................................................................... 38 3. Food Safety and Quality ...................................................................................................................................... 39 4. Environmental standards .................................................................................................................................... 40 5. Quality labels (geographical, traditional) ............................................................................................................ 40 6. GMO regulations ................................................................................................................................................. 41 7. Animal welfare .................................................................................................................................................... 41 Annex 2: Other relevant regulations and standards not covered by AgrifoodTEF ......................................................... 43 Annex 3: Future relevant regulations and standards ..................................................................................................... 44 Annex 4: Categorisation of WP 3 services ...................................................................................................................... 45 Acknowledgements to co-funding agencies ................................................................................................................... 46 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 5 Document Revision History Date Issue Author/Editor/Contributor Summary of main change 2024-09-14 V0.1 Author: Ankur MAHTANI - LNE Document Draft 2024-11-21 V0.2 Contributors: Krzysztof Sieczkarek (L-PIT) Agnes Delaborde (LNE) Editor: Ankur MAHTANI - LNE Document sent for internal review 2024-12-17 V1.0 Ankur MAHTANI - LNE Document sent for external review 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 6 List of Acronyms AGV Automated Guided Vehicles AI Artificial Intelligence CAP Common Agricultural Policy CEN European Committee for Standardization CENELEC European Committee for Electrotechnical Standardization EC European Commission ELSA Ethical, Legal, Societal Aspects ETSI European Telecommunications Standards Institute EU European Union HRAIS High-Risk Artificial Intelligence System IEC International Electrotechnical Commission IEEE Institute of Electrical and Electronics Engineers ISO International Organization for Standardization LCA Life-cycle Assessment MR Machinery Regulation (EU) 2023/1230 NLF New Legislative Framework SME Small and Medium-sized Enterprise TEF Testing and Experimentation Facilities WP Work Package Terminology Accreditation [1] Third party attestation related to a conformity assessment body conveying a formal demonstration of its competence to carry out specific conformity assessment tasks. Certification [1] Third party attestation related to products, processes, or persons that conveys assurance that specified requirements have been demonstrated. Conformity Assessment [1] Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled. First, Second, and Third Party [1] The first party is generally the person or organization that provides the object, such as the supplier. The second party is usually a person or organization that has a user interest in the product, such as the customer. The third party is a person or body that is recognized as being independent of the person or organization that is independent of the provider of the object of conformity assessment and has no user interest in the object. Harmonised standard [6] A European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation. EU Regulation [6] Binding legal force throughout every Member State and enter into force on a set date in all the Member States. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 7 EU Directives [6] Lay down certain results that must be achieved but each Member State is free to decide how to transpose directives into national laws. EU Decisions [6] Decisions are EU laws relating to specific cases and directed to individual or several Member States, companies or private individuals. They are binding upon those to whom they are directed. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 8 Abstract AgrifoodTEF establishes a network of test and validation infrastructures across Europe to support agrifood technology companies in advancing AI and Robotics solutions for efficient and sustainable agriculture. This initiative bridges the gap between cutting-edge research and practical products by leveraging existing experimental farms and facilities in key European agricultural regions. These facilities are clustered to enhance scalability, foster stakeholder collaboration, and strengthen Europe’s role in ensuring global food security through standardized testing and validation frameworks. This deliverable focuses on the regulatory and standardization aspects critical to the implementation of AI and Robotics in the agrifood sector. It provides an in-depth analysis of applicable standards and regulations, mapping them to the services offered within AgrifoodTEF. Key sectors examined include AI, Cybersecurity, Machinery, Liability, Product Safety, Interoperability, and Digital Services, among others under the New Legislative Framework (NLF). The analysis highlights existing alignments and identifies gaps requiring further action to ensure comprehensive coverage. Additionally, this document synthesizes complex regulatory texts, outlining explicit requirements to facilitate their application by stakeholders. The findings contribute to the design and enhancement of AgrifoodTEF services, ensuring specific alignment with the EU AI Act, Machinery Regulation, Data Act, and Cybersecurity Act. This report is periodically updated to reflect evolving standards, regulatory changes, and advancements in AgrifoodTEF services, thereby maintaining relevance and broadening regulatory compliance across the agrifood domain. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 9 Executive summary AgrifoodTEF is a network of test and validation infrastructures in Europe that supports Agrifood technology companies to do near product development of their AI and Robotics solutions in real-world facilities. The overall aim is to close the gap between excellent research in these fields and actual products that support an efficient and sustainable agriculture, while meeting stringent usability and economic requirements of their end-users. AgrifoodTEF foundations are solidly rooted in existing experimental farms and facilities for AI and Robotics in Agriculture, already operational in various regions highly representative of European Agrifood production. These have been clustered to build scale and further enhance EU role in guaranteeing world food security with testing and validation facilities that will engage all relevant stakeholders with the best experts in the AI and Robotics technology domains. While each TEF-node will promote independent operations with a sustainable business model that will be optimized for the specialties and territorial needs, all TEF-nodes will share common guidelines, standards and support each other with services that can be offered across the different regions represented by nodes and satellites. While other work packages (WP) of the project focus on physical and digital facilities for technical assessment of AI and Robotics solutions, mainly aiming at performance, quality and safety, WP 3 emphasizes aspects such as ethical, legal, societal, lifecycle, and cybersecurity assessments. These aspects are essential within the existing regulatory and standardization framework, particularly in the AI Act, the Data Act, and the Cybersecurity Act. The objective of WP 3 is to conduct a detailed analysis of the associated requirements and enable the project to offer a range of services that effectively address these aspects. This deliverable provides a comprehensive analysis of the standards and regulations applicable to the agrifood domain, with a focus on their relevance to AI-based solutions. Building on this analysis, the document maps these standards and regulations to the services offered within AgrifoodTEF, highlighting gaps and opportunities for alignment. The analysis identifies key sectors of interest for the agrifood domain, including AI, Data, Cybersecurity, Machinery, Liability, Product Safety, Interoperability, Digital Services, and additional regulations under the New Legislative Framework (NLF) related to machinery testing. AgrifoodTEF currently addresses AI, Cybersecurity, Machinery, Product Safety, the EU Cybersecurity Common Criteria, and certain directives of the NLF. This mapping reveals both areas of alignment and gaps where additional actions or services are needed to ensure comprehensive coverage. An added value of this work is its ability to clarify and synthesize the various texts, explicitly detailing the requirements to facilitate their understanding and application. This report will be periodically updated to reflect the evolving landscape of standards and regulations, the development of new project services, and the implementation of actions to address identified gaps, thereby broadening the coverage of applicable standards and regulations. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 16 Upon the successful completion of the conformity assessment, the notified entity is required to issue an EU Technical Documentation Certificate (Article 44). This certificate is valid for a period of four years and may be subsequently renewed for a maximum period of four years, based on re-assessments. However, if the notified entity finds that the AI system in question no longer satisfies the requirements for HRAIS, it is required to suspend or withdraw this certificate unless corrective actions to re-ensure compliance are taken by the provider within an appropriate timeline established by the notified body. Following this, the provider has to draft the EU Declaration of Conformity and affix a physical or digital CE mark. Should the notified entity discover that the HRAIS does not meet the conformity requirements, it must offer a detailed explanation of the non-compliance to the provider. The provider then must undertake relevant corrective measures to ensure compliance – failing which, it must withdraw the system from the market. The EU AI Act provides a remediation mechanism in this instance, where, under Article 44, the provider is empowered to appeal against the notified body’s determination. Deviation from the conformity assessment procedure The EU AI Act outlines specific scenarios where deviation from the normal conformity assessment procedure is permissible, and a high-risk AI system may be introduced to the market or put into operation even before the assessment process is completed. This exemption applies solely to cases involving public security, safeguarding life and health, environmental conservation, and protecting critical industrial and infrastructural assets. When should an AI manufacturer do a conformity assessment? Conformity assessment is required at different stages of placing the product on the market:  Ex ante (pre-market): The assessment has to be conducted before the AI system gets placed on the EU market – meaning before making it available for public use;  Ex post (post-market): After a high-risk system has been placed on the market, a new assessment is required when/if the system undergoes substantial modifications. It’s worth noting that this does not concern models that continue to learn after being placed on the market; rather, it refers to any changes in the specifications that would significantly affect the system’s compliance with the requirements. Delegated Acts In accordance with Article 97 of the EU AI Act, the Commission is empowered to adopt delegated legislations to make changes to conformity assessment provisions considering technical progress, as well as update Annexes VI and VII. In doing so, the Commission will be required to consult the proposed AI Office and relevant stakeholders affected. 1.3. Roles and Responsibilities of Stakeholders All stakeholders expect that conformity assessment bodies are accreditated to deliver transparency and confidence in the competence and integrity of the conformity assessment infrastructure and the conformity assessment results. In addition to its important role in facilitating trade and business in Europe, accreditation has a specific role in support of regulation and should provide a single source of assessment (conformity assessment bodies) with regard to the safeguard of public protection issues, such as product safety, legal metrology and environmental integrity. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 17 For AgrifoodTEF’s conformity assessments, stakeholders (see Figure 2) are the TEF users, e.g. AI product manufacturers, the TEF partners and the service providers. Service providers may be a notified body, or simply an organization providing conformity assessment or assessment facility. Figure 2. Relations between TEF users and WP 3 TEF service providers 1.4. Regulatory framework This section introduces and describes the most prevalent regulations for the products (software, devices) presented by AgrifoodTEF customers. This selection is based on the listing of already completed services (WP4), the list of devices and use cases analysed by WP 1 (deliverable D1.1), and from a consultation among regulatory experts of WP 3. Annex 1 present a more exhaustive list of regulations and standards that are linked to the agrifood domain, but which are either too specific to a sector or type of application, or not at all related with AI-based systems and robotics, or at a too early stage. 1.4.1. Overview of European Union (EU) AI Regulation The AI Act [4] put forward by the European Commission and adopted in March 2024, is the first initiative towards a comprehensive legal framework on AI in the world. It aims to set rules on specific AI applications in certain contexts. According to its Preamble, it is a legal instrument primarily targeted at ensuring a well-functioning internal market in the EU that respects and upholds fundamental rights. As AI is a fast-evolving technology, the AI Act has a future-proof approach, allowing rules to adapt to technological change. AI applications should remain trustworthy even after they have been placed on the market. This requires ongoing quality and risk management by providers. Add to this the fact that many AI systems will be considered highrisk AI (HRAIS) justifies the necessity of development and long-term sustainability of conformity assessment tests for agrifood technologies. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 18 Article 3 of the AI Act defines conformity assessments as the process of verifying and/or demonstrating that a highrisk system complies with certain requirements laid out in the Act. These requirements are divided into 7 fields of application:  Risk management system (Recital 65, Article 9)  Data governance: quality of data sets that have to be relevant, representative, free of errors and complete (Recitals 44 and 45, and Article 10)  Technical documentation (Recital 46, Article 11, and Annex IV)  Record keeping in the form of automatic recording of events (Article 12)  Transparency and provision of information to users (Recital 47 and Article 13)  Human oversight (Recital 48 and Article 14)  Accuracy, robustness, and cybersecurity (Recital 49 to 51, and Article 15). Suppliers of high-risk AI systems have to meet the requirements before their system can be put on the market, protecting individuals from the potential harms a high-risk system poses. Unless specified otherwise, all these requirements should be met before the AI system is put into use or enters the market. Once the system is on the market, the provider must also ensure continuous compliance throughout the system’s lifecycle. Current AI-specific standards lack the concrete requirements found in other fields. A study conducted by the European Commission’s Joint Research Centre [7] [5] evaluated eight promising AI standards and found that all exhibited only moderate or low “maturity and level of detail,” making compliance assessment challenging for nearly all of them. Similarly, the EU Agency for Fundamental Rights [8] [6] highlights that while discussions about AI often stress the importance of “high-quality data,” they rarely provide clear definitions or guidelines. This lack of clarity, the report explains, stems from the absence of a standardized framework for describing datasets in the AI domain. Link : https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1689 1.4.2. EU Machinery Regulation 2023/1230 Conformity assessment for robots falls under the scope of the EU Machinery Regulation (MR) 2023/1230 [9], which replaces the Machinery Directive 2006/42/EC. The MR aims to address emerging technologies such as autonomous mobile machinery (robots), the Internet of Things with connected devices, and Artificial Intelligence (AI), particularly when AI modules with learning capabilities are used to ensure safety functions. While the AI Act focuses on managing the safety risks of AI systems, the MR emphasizes their safe integration into machines. Consequently, robots incorporating AI systems that qualify as “machines” must comply with the MR’s essential health and safety requirements and undergo the corresponding conformity assessment procedures. Key updates introduced by the Machinery Regulation include:  Legal Status: As a regulation, the MR ensures greater harmonization and direct application across the EU, eliminating the need for national transposition that could impose varying requirements.  New Legislative Framework: The MR adheres to principles of the New Legislative Framework, which governs accreditation rules for conformity assessment bodies and the market surveillance system.  Digital Documentation: Manufacturers can provide instructions digitally. For non-professional users, a printed document with key safety information must accompany the machine. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 19  Common Specifications: The MR establishes guidelines for developing common specifications when harmonized standards cannot be agreed upon for specific machines.  Substantial Modification: A new concept of “substantial modification” targets significant hazard changes caused by end-user alterations or upgrades to machines.  Conformity Assessment: While self-compliance remains the general rule, certain machines or components now require validation by notified bodies (external accredited entities). The MR also removes the option for self-compliance in cases where harmonized standards fully cover relevant hazards for specific machinery or components.  Machine Learning Systems: Machinery incorporating “fully or partially self-evolving behavior” using machine learning must now undergo validation by notified bodies. The forthcoming AI Regulation will classify these systems as high-risk AI and impose additional requirements.  Partly Completed Machinery: Machines assembled from incomplete components must meet the MR’s requirements before integration into the final product. Link: https://eur-lex.europa.eu/eli/reg/2023/1230/oj 1.4.3. EU Cybersecurity Act 2019/881 and EU Cybersecurity Certification Scheme on Common Criteria (EUCC 2024/482) The AI Act and the Machinery Regulation (MR) both address risks associated with cyberattacks and malware, particularly those that could compromise machine safety due to faults or intentional external attacks. Manufacturers are required to implement measures ensuring that safety-related control circuits are designed to prevent malicious interference that could lead to hazardous machine behavior. To safeguard computer systems from corruption, the regulations mandate that machines be designed and built so that their connection to external devices does not create dangerous situations. Hardware components critical to connectivity or software access must be adequately protected against accidental or intentional system corruption. The AI Act places particular emphasis on cybersecurity risks linked to training data, training models, and model vulnerabilities, requiring AI system providers to adopt appropriate safeguards considering the underlying information and communications technology infrastructure. The MR and AI Act align with EU cybersecurity policies, integrating the Cybersecurity Regulation (EU) 2019/881 [5] into their compliance frameworks. Certifications and conformity declarations under the EU cybersecurity certification system can extend to meet the MR’s essential health and safety requirements (Annex III, sections 1.1.9 and 1.2.1, addressing protection against corruption and the security of control systems) and the cybersecurity requirements in Article 15 of the AI Act. The European Commission has also announced the adoption of a Delegated Act 2022/30 to the Radio Equipment Directive (RED 2014/53/EU), which establishes different cybersecurity requirements that manufacturers, importers and distributors must meet to market their wireless devices and products in the European Union. This CE RED Delegated Act will enter into force in August, 2025 and will also apply to electronic agrifood equipment connected to the Internet using radio modules (e.g. GSM, LTE, Wi-Fi, Bluetooth, etc.). "Network protection", "Personal data and privacy" and "Anti-fraud measures" as new essential requirements of RED 2014/53/EU are being introduced to the Radio Equipment Directive (RED 2014/53/EU) by this cybersecurity CE RED Delegated Act. Link: https://eur-lex.europa.eu/eli/reg/2019/881/oj 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 20 1.4.4. Proposal of EU AI Liability Directive (AILD) Safety and liability frameworks aim to ensure that all products, including those utilizing advanced digital technologies, operate reliably, consistently, and without causing harm, while also providing clear remedies for any damages. However, these frameworks face new challenges when addressing the liability of economic operators—such as manufacturers, authorized representatives, importers, and distributors—in cases where robots or machines powered by AI systems cause harm. For instance, AI-driven machinery like tractors or robots may inadvertently damage crops, livestock, or even injure farmworkers. This raises a pressing question: who should be held accountable for harm caused by AI-driven actions? Should responsibility fall on the manufacturer, the programmer, or the user? Proving a direct causal link between an AI system’s actions and the resulting harm can be particularly difficult due to the complexity and ever-evolving nature of such systems. Recognizing these issues, the European Union has taken steps to address AI-related liability through initiatives like the AI Act and the AI Liability Directive (AILD). To manage these complexities, liability can be addressed through contractual agreements between farmers and AI solution providers, particularly for AgriTech applications. This approach is especially crucial in jurisdictions lacking specific laws on AI liability. Such contracts often include provisions that limit the service provider’s liability while requiring farmers to supply high-quality, sufficient data. Additionally, they typically outline compensation mechanisms to address any damages resulting from the use of AI technologies. Link: https://commission.europa.eu/business-economy-euro/doing-business-eu/contract-rules/digitalcontracts/liability-rules-artificial-intelligence_en 1.4.5. EU General Product Safety Regulation 2023/988 The General Product Safety Regulation (GPSR), which came into force in December 2022 and replaced the General Product Safety Directive (GPSD), strengthens the EU's framework for product safety across sectors, including the agrifood sector. While the agrifood industry is already heavily regulated, primarily under EU food safety laws such as the General Food Law Regulation (Regulation (EC) No 178/2002) and sector-specific regulations for food, the GPSR introduces several implications for the sector. Here's how it might impact the agrifood industry:  Enhanced Responsibilities for Food Packaging and Non-food Items  Product Traceability Requirements  Enhanced Recall and Withdrawal Obligations  Consumer Rights and Transparency  Obligations for Importers and Distributors  Increased Liability and Penalties  Alignment with Sustainability Goals While the EU's General Product Safety Regulation primarily impacts non-food products, agrifood businesses must still take careful note of its provisions. Food packaging materials, kitchen utensils, food-related machinery, and equipment used in food processing and handling are subject to stricter rules around product safety, traceability, and market surveillance. As such, agrifood businesses need to update their compliance strategies, improve their product safety assessments, and ensure they can meet these more stringent regulatory requirements. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 21 This will also have implications for importers and distributors in the agrifood supply chain, who will face increased scrutiny to ensure compliance with the GPSR when selling non-food products that interact with food. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0988&qid=1727107789769 1.4.6. EU General Data Protection Regulation 2016/679 AI systems are highly dependent on data, and in the agri-tech sector, this frequently includes sensitive details about farming practices, land utilization, and crop production. To uphold ethical standards, it is crucial to implement strong data privacy protections that safeguard farmers' rights. Establishing clear policies regarding data ownership, obtaining informed consent, and ensuring secure data storage is essential to prevent misuse and empower farmers with control over their information. The EU holds that, as a general principle, data generated by an agri-chain operator (people and activities that operates in an agrifood value chain) through their activities or commissioned by them is attributed to that operator as the data originator. This operator retains the right to decide who can access and utilize the data. However, this principle does not extend to information derived from the processing or aggregation of data from multiple sources. The use of data for such purposes should be governed by a formal agreement. For example, data generated on a farm or during farming activities is considered to belong to the farmer, granting them extensive rights to use it as they see fit. As good practice, data users could appoint a data protection officer, who could play an important role in assuring that data originators’ rights are respected, as stated in the EU General Data Protection Regulation (GDPR). Its core principles include ensuring data protection, transparency, privacy, security, liability and intellectual property rights. The GDPR supersedes the Data Protection Directive 95/46/EC and has global influence, inspiring similar laws worldwide. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0679 1.4.7. Proposal for EU Data Governance Act The Data Governance Act (DGA) is a comprehensive framework designed to govern the reuse of protected data held by public authorities. By regulating innovative data intermediaries and promoting data sharing for altruistic purposes, the DGA is pivotal in advancing Europe’s digital transformation. It aims to build trust, ensure neutrality in data access, and enhance data portability and interoperability. As a cornerstone of the European data strategy, the DGA seeks to strengthen the data economy while ensuring that its advantages are accessible to all EU citizens. Effective data management and sharing are key drivers of innovation, enabling industries to create cutting-edge products and services while enhancing the efficiency and sustainability of various economic sectors. These practices are also critical for training AI systems. Expanding data availability can empower the public sector to craft more informed policies, resulting in greater transparency and improved public services. Data-driven advancements benefit both businesses and individuals by increasing efficiency in our daily lives and work, particularly through:  Environmental data: Supporting efforts to combat climate change, lower CO₂ emissions, and respond to emergencies like floods and wildfires. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 22  Agricultural data: Facilitating precision farming, introducing innovative products in the agrifood industry, and providing new services to rural communities. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52020PC0767 1.4.8. EU Data Act 2023/2854 The Data Act is a comprehensive EU regulation that enhances the data economy and fosters a competitive data market. Its primary objective is to make data, particularly industrial data, more accessible, usable, and available. By encouraging data-driven innovation and increasing data availability, the Data Act aims to position Europe as a leader in the digital economy. Key provisions include ensuring fairness in the allocation of data value among actors in the data economy, clarifying data usage rights, and empowering users of connected products (such as IoT devices). The Act also establishes general conditions for data sharing between businesses, enhances fairness and competition in the European cloud market, and protects companies from unfair contractual terms related to data sharing. Additionally, it introduces mechanisms for public sector bodies to request data in exceptional situations (e.g., emergencies) and safeguards against third-country government access to non-personal data. The Data Act defines essential requirements for interoperability, facilitating seamless data flow across sectors and Member States. Published in the Official Journal of the EU in December 2023, the Data Act will become applicable on September 12, 2025, complementing the Data Governance Act in shaping Europe's data landscape. Link: https://eur-lex.europa.eu/eli/reg/2023/2854 1.4.9. Interoperable Europe Act The EU Interoperability Act, proposed in 2022, primarily focuses on enhancing the digital ecosystem by ensuring better interoperability between digital services and platforms across different sectors. Although the Act is not specifically aimed at the food and agricultural sector, its implications are still significant, as the digitalization of agriculture (commonly referred to as Agriculture 4.0) is a growing trend. The Act could accelerate the adoption and integration of new technologies in the agrifood sector, while also addressing challenges related to data sharing, efficiency, and competition. Here are the key implications of the EU Interoperability Act on the food and agricultural sector:  Facilitating Smart Agriculture by encouraging standardization and interoperability of data between various platforms and systems, and Precision Farming with better operability to allow smooth integration of precision agriculture tools.  Enhanced Supply Chain Transparency with easier and more secure data sharing across the entire food supply chain from producers to distributors to retailers by enhancing traceability of food products, by helping ensure compliance with safety and sustainability standards, and by allowing real-time tracking of goods (with an indirect encouragement of the adoption of technologies like blockchain.  Supporting Sustainable Farming and Climate Goals by enabling better sharing and integration of climate and environmental data into farming systems.  Boosting Agri-Tech innovation by lowering barriers for new digital services to enter the market and by fostering cross-sector collaborations including agriculture, technology and logistics.  Simplifying Compliance and Regulatory Reporting by establishing interoperable platforms across the EU/  Improving access to Digital Markets 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 23  Strengthening cybersecurity and data protection The EU Interoperability Act will have a transformative impact on the food and agricultural sector by accelerating the digitalization of farming practices, improving supply chain transparency, and supporting sustainability goals. The Act enables better integration of data and technologies, allowing the agrifood sector to leverage advanced tools like precision farming, AI-driven decision-making, and real-time monitoring to boost productivity, sustainability, and competitiveness. However, adaptation costs and technical complexity could present challenges, particularly for smallscale farmers and businesses with limited resources. Link: https://www.europarl.europa.eu/RegData/etudes/BRIE/2023/745711/EPRS_BRI(2023)745711_EN.pdf 1.4.10. EU Digital Services Act 2022/2065 The EU Digital Services Act (DSA), which came into force in November 2022, primarily aims to create a safer and more transparent online environment for users and businesses. While the DSA is largely focused on digital platforms, online services, and the tech sector, it has important implications for the food and agricultural sector, particularly due to the increasing digitalization of agriculture and the growing use of online platforms for sales, marketing, and supply chain management. Here are the main ways the DSA impacts the food and agriculture industry:  Impact on E-commerce and online sales of food products  Enhanced traceability and accountability in online sales  Impact on digital advertising and marketing in the agrifood sector  Combating disinformation in the food sector  Safer online platforms for agrifood supply chain solutions  Protection for consumers and small agrifood businesses  Cross-border sales and market access  Data governance and cybersecurity The EU Digital Services Act introduces significant changes that will impact the food and agricultural sector as digital platforms become increasingly important for both consumer sales and business operations. Agrifood businesses will need to adapt to new rules on online transparency, seller accountability, and product safety, ensuring that their digital presence complies with the new standards. The DSA also promotes consumer protection and aims to level the playing field for small and medium-sized agrifood businesses in the digital marketplace, while enhancing supply chain transparency and cybersecurity. By fostering a safer and more transparent digital environment, the DSA can help agrifood businesses expand their online operations while maintaining compliance with EU regulations, particularly around food safety, product claims, and advertising. However, it also brings new responsibilities, especially in managing online sales, digital marketing, and consumer interactions. Link: https://eur-lex.europa.eu/eli/reg/2022/2065/oj 1.4.11. EU Regulation on electronic identification and trust services (eIDAS2) 910/2014 The eIDAS Regulation (EU Regulation No 910/2014), which stands for Electronic Identification, Authentication, and Trust Services, is designed to create a framework for electronic identification (eID) and trust services across EU 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 24 member states. It aims to foster secure, seamless digital interactions for businesses, citizens, and public authorities across borders. Although the regulation is primarily focused on enabling cross-border electronic transactions, it has important implications for the food and agricultural sector, especially as the sector becomes increasingly digitalized and integrated with e-commerce, supply chain management, and agri-tech services. Here are the main implications of the eIDAS Regulation for the food and agricultural sector:  Streamlining cross-border trade and compliance  Improving supply chain transparency and security  Enhancing compliance with regulatory requirements  Secure digital transactions for agribusinesses  Supporting innovation in agri-tech  Boosting trust in digital transactions  Simplifying access to agricultural subsidies and financial services  Support for sustainable farming and traceability initiatives The eIDAS Regulation significantly impacts the food and agricultural sector by facilitating secure, efficient digital transactions and cross-border trade, improving supply chain transparency, and enhancing trust in certifications and ecommerce. Agribusinesses can benefit from streamlined regulatory compliance, contract management, and access to subsidies, while also gaining secure access to financial services and simplifying interactions with public authorities. By leveraging trusted digital identities, electronic signatures, and qualified trust services, the eIDAS Regulation supports the digital transformation of agriculture and the broader agrifood sector, helping businesses adopt innovative technologies and meet the growing demands for sustainability and traceability in the EU market. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0910 1.4.12. Others New Legislative Framework (NLF) directives and regulations Adopted in 2008, the New Legislative Framework (NLF) aims to improve the internal market for goods and strengthen the conditions for placing a wide range of products on the EU market. It is a package of measures that aim to improve market surveillance and boost the quality of conformity assessments. It also clarifies the use of CE marking and creates a toolbox of measures for use in product legislation. One of the aims of NFL is to better protect both consumers and professionals from unsafe products to be placed on the European internal market. These directives and regulations contain only "essential requirements" and the detailed requirements are defined in the so-called harmonized standards with these directives and regulations. Apart from MR and the AI Act, there are some others NLF directives and regulations under which products lying within the scope of our AgrifoodTEF project are subjected. They are often "smart devices" used in agrifood industry and include, for example, robots automating the spraying of garden plants, systems for measuring soil composition, control and gas content controls used in animal husbandry, intelligent hives for production of honey and others. They use sophisticated AI/IT algorithms and most often have their physical implementation in the form of electronic devices. The following acts are also consistent with the NLF:  Electromagnetic Compatibility - Directive 2014/30/EU  Radio equipment - Directive 2014/53/EU 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 25  Low Voltage - Directive 2014/35/EU  Drones - Commission Delegated Regulation (EU) 2019/945 on unmanned aircraft systems and on third-country operators of unmanned aircraft systems  Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU  Pressure equipment - Directive 2014/68/EU  Simple Pressure Vessels - Directive 2014/29/EU  Non-automatic Weighing Instruments - Directive 2014/31/EU  Measuring Instruments - Directive 2014/32/EU  Eco-design requirements for sustainable products - Regulation (EU) 2024/1781 Link: https://single-market-economy.ec.europa.eu/single-market/goods/new-legislative-framework_en 1.5. Relevant regulation considered by AgrifoodTEF Figure 3. Overview of relevant European regulation for AgrifoodTEF project 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 32 Related service in AgrifoodTEF catalogue S00214 ; Services to be added in the catalogue. 2.2.2. Conformity assessment against other technical references The following services are compliance tests against other kind of standards that remain external to the TEF client such as technical specifications, guides, labels and so on. 2.2.2.1. AI Processes certification Name LNE certification of AI processes Region of application International Editor/publisher LNE Harmonized standard/not Not harmonized Applicability AI solution provider Sector All agrifood sectors Description of the content In response to the growing number of AI solutions, LNE has created a certification that provides users with objective criteria for making their selection and enables developers to demonstrate that they have mastered all the stages of the AI life cycle and meet the performance, regulatory, confidentiality and ethical requirements of their customers. This standard aims to define common requirements for the design, development, evaluation and maintenance processes of all types of AI functionalities using machine learning. It therefore covers all business sectors in which AI is used, in order to ensure the application of best practices that promote confidence in AI. It is not intended to define requirements for AI functionalities and therefore specific to their uses. Nature of the standard Technical requirements on AI processes Related service in AgrifoodTEF catalogue S00097 2.2.2.2. Ethical design guidelines (Value Sensitive Design) Name Value Sensitive Design support in AI-and Robotic developments Region of application International Editor/publisher WUR – ELSA Lab Harmonized standard/not Not harmonized Applicability AI solution provider and end-users Sector All AgrifoodTEF sectors Description of the content We explore ethical and societal values of potential end-users of new technology during its development. Based on this, we explore possibilities to attend to these values in the 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 33 further development or design of the technology, or in the development of an implementation trajectory. Nature of the standard ELSA assessment based on scans, questionnaire and technical desk assessment Related service in AgrifoodTEF catalogue S00139 2.2.2.3. Ethical, Legal, Social aspects assessment Name Scan for Ethical, Legal and Social Aspects (ELSA) Region of application International Editor/publisher WUR – ELSA Lab Harmonized standard/not Not harmonized Applicability AI solution provider and end-users Sector All AgrifoodTEF sectors Description of the content What are the ethical, legal and social aspects (ELSA) of AI driven technology in agrifood? Mitigation of potential risks and finding opportunities are easier by identifying ELSA aspects in early development stages, when the technology is still in the making. Examples of ELSA aspects are autonomy, transparency and bias, but also data privacy and other legal aspects. How does your AI technology deal with ELSA aspects? A combined survey and interview help AI developers to identify opportunities and issues with ELSA in the agrifood context from the perspective of end users and more broadly; for society. For example, to better align with the sustainability objectives of the AI-driven technology. The outcomes of the ELSA scan are a list of identified key ELSA aspects and high-level recommendations to further improve the AI technology. The ELSA lab develops, tests and applies a methodology for (re)designing AI for Sustainable Food Systems (SFS). The methodology involves (a) the systematic identification and exploration of ethical, legal, and social aspects of AI in specific domains in the food sector, and (b) the co-creation with quadruple helix stakeholders of responsible and human-centred AI for SFS. This R&D ecosystem for the Dutch food system where ELSA aspects become an integral part of AI (re)design in the knowledge chain of fundamental, applied and practice-oriented R&D involving representatives from all members of society: public authorities, industry, academia, and citizens. Nature of the standard ELSA assessment based on scans, questionnaire and technical desk assessment Related service in AgrifoodTEF catalogue S00138 2.2.2.4. Cybersecurity testing Name Vulnerability scan of agrifood related AI or robotics software systems Region of application International Harmonized standard/not Not directly related to a standard 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 34 Applicability AI solution Sector All agrifood sectors Description of the content Ensuring the safe, reliable, and secure operation of AI and robotic systems demands a testing that extends beyond basic functionality. This should incorporate tests for error handling, where the system gracefully deals with unexpected situations and recovers on its own. Then, continuous failure monitoring through sensor data, system logs, and performance metrics is crucial to identify potential problems before they escalate. Additionally, robust cybersecurity threat assessments involving simulated hacking attempts help expose weaknesses and enable the implementation of strong safety measures. Finally, software systems (like AI and robotics systems developed for agrifood environments) are usually developed using third-party libraries. Regular updates on both proprietary and third-party libraries are strongly recommended to address potential vulnerabilities in the code. Related service in AgrifoodTEF catalogue S00289; S00215; S00196 2.3. Cartography of covered standards Currently, AgrifoodTEF services propose to assess compliance with some standards and referential documents that answer several of the EU regulations cited in Chapter 1.4. A summarized overview of the addressed standards and regulations is presented in Figure 4. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 35 Figure 4. Regulations and standards covered in AgrifoodTEF. In gray: regulations identified in Erreur ! Source du renvoi introuvable. but not c overed yet. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 36 Conclusion Summary of key insights In the context of the WP 3, this deliverable D3.1 puts on paper the conformity assessment services considered in the AgrifoodTEF project with respect to applicable European regulations. It is important to note that many recent EU Regulations like the AI Act does not provide harmonized standards yet. The first chapter presents the regulatory mapping of regulations considered in EU that apply to AI and robotics solutions for all agrifood sectors. Each regulation and its implications in agrifood is described in a short paragraph with a Eur-Lex link directing to the complete text. AgrifoodTEF considers that WP 3 subjects of interest are around AI, Data, Cybersecurity, Machine, Liability, Product Safety, Interoperability, and Digital Services. We completed this state-ofthe-art with the New Legislative Framework that considers a bunch of regulations around machines testing. The second chapter specifies the catalogue of standards already provided as services by TEF partners. We studied the catalogue of services from November 2024 to produce summarized tables for each standard addressed by WP 3 services. We note that AgrifoodTEF services currently covers the following EU regulations: the AI Act, General Product Safety, Machinery Regulation, Cybersecurity and EU Common Criteria, and some directives of the New Legislative Framework. These services will be further investigated in future works. The overview of AgrifoodTEF services highlights that, if ELSA and LCA services are represented in almost all regions of the partners, cybersecurity is almost not represented (only one partner). Next steps As this deliverable only deals with describing the current state of conformity assessment services, next phases of WP 3 focus on improving the testing protocols of existing conformity assessment services and implement new services to cover more standards and regulations (for example, among the ones identified in Annex 2 and 3), but also ensure an appropriate regional coverage in terms of ELSA, LCA and cybersecurity services. The deliverable D3.2 outlines the requirements of EU regulations related to AI, Data, Machine and Cybersecurity and the expression of interests of TEF partners willing to implement and develop new conformity assessment services. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 37 References and Bibliography [1] ISO/IEC 17000:2020, Conformity assessment - Vocabulary and general principles. [2] Naudé, W, Barten, O. (2023) Artificial General Intelligence: can we avoid the ultimate existential threat? In OECD Policy Observatory, January 26, 2023. https://oecd.ai/en/wonk/existential-threat [3] Thakur, R., & Singh, B. K. (2021). Importance of Artificial intelligence in agriculture. Agriblossom, 1(12), 23-29. [4] Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act), https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX%3A32024R1689&qid=1733752191180. [5] 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), https://eur-lex.europa.eu/eli/reg/2019/881/oj. [6] Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation. [7] European Commission, Joint Research Centre, Soler Garrido, J., Tolan, S., Hupont Torres, I. et al., AI Watch – Artificial intelligence standardisation landscape update, Publications Office of the European Union, 2023, https://data.europa.eu/doi/10.2760/131984. [8] Data quality and artificial intelligence – mitigating bias and error to protect fundamental rights, European Union Agency for fundamental rights, FRA Focus. [9] Regulation (EU) 2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC. 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 38 Annex 1: Agrifood Sector-Specific Regulation and Policy This annex lists all agrifood regulations and policies that apply to end-products from farming or food processing systems. They do not apply directly to TEF clients which are more likely to be European SMEs that develop AI or Robotics systems. Hence, a copy of their online short description is added in annex and aims to provide information between AgrifoodTEF partners who may provide services that draws an agrifood regulation landscape and a compliance roadmap to TEF clients. 1. Agricultural and forestry tractors The regulation (EU) No 167/2013 applies to EU type-approval of agricultural and forestry tractors, trailers and interchangeable towed equipment. However, manufacturers may choose to comply instead with national requirements in the case of track-laying, high-clearance or extra-wide tractors, as well as trailers and interchangeable towed equipment. In the case of tractors, this regulation covers all relevant safety requirements, while for trailers, interchangeable towed equipment or any machinery installed on the tractors, Directive 2006/42/EC applies for those risks not covered by this regulation. Manufacturers are responsible for vehicles and components complying with the regulation in terms of safety and minimising the impact on the environment, including, but not limited to structural integrity, protection and roll-over structures, operating space and access to the driving position, visibility and controls, including emergency stop, lighting, exterior design, tyres, brakes and accessories, external and internal noise, pollutant emissions. Manufacturers should also provide dealers and repairers with easy access to repair and maintenance information websites, training material and working tools. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32013R0167 2. Common Agricultural Policy (CAP) Farming is unlike most other businesses, as the following special considerations apply:  Despite the importance of food production, farmers’ income is around 40% lower compared to nonagricultural income ;  Agriculture depends more on the weather and the climate than many other sectors ;  There is an inevitable time gap between consumer demand and farmers being able to supply – growing more wheat or producing more milk inevitably takes time. While being cost-effective, farmers should work in a sustainable and environmentally friendly manner and maintain our soils and biodiversity. Business uncertainties and the environmental impact of farming justify the significant role that the public sector plays for our farmers. The CAP takes action with the following measures:  Income support through direct payments ensures income stability, and remunerates farmers for environmentally friendly farming and delivering public services not normally paid for by the markets, such as taking care of the countryside ; 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 39  Market measures to deal with difficult market situations such as a sudden drop in demand due to a health scare, or a fall in prices as a result of a temporary oversupply on the market ;  Rural development measures with national and regional programmes to address the specific needs and challenges facing rural areas. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021R2115&qid=1727273071623 3. Food Safety and Quality An important need mentioned in the EU General Food Law (GFL) is to create a coherent and transparent set of food safety rules. With the publication of the GFL, the European Union has made a new legal framework laying down the principles to ensure a coherent approach and to fix the principles, obligations and definitions that apply in the field of food safety. It defines the common principles underlying food legislation and the establishment of a food safety policy as a primary objective of EU food law. This Regulation also provides the general frame for those areas not covered by specific harmonized rules but where the functioning of the Internal Market is ensured by mutual recognition. Under this principle, in the absence of Community harmonization, Member States may only restrict the placing on the market of products lawfully marketed in another Member State when and to the extent that this can be justified by a legitimate interest such as the protection of public health and only when the measures taken are proportionate. The General Food Law consists of three parts. The first part lays down the general principles and requirements of food legislation, the second part defines the establishment of the European Food Safety Authority and the last part lays down procedures in matters of food safety. A general principle of food law is that operators in the feed and food business have the primary responsibility for food safety. Competent authorities monitor, enforce and verify this responsibility through the operation of national surveillance and control systems at all stages of production, processing and distribution. Member States are also obliged to lay down rules on measures and penalties applicable to infringements of food and feed law. They shall be effective, proportionate and dissuasive. The Commission concentrates on evaluating the ability of competent authorities to deliver these systems through audits and inspections at the national level. A successful food policy demands the traceability of feed and food and their ingredients. This is an important requirement of the GFL. It includes the obligation for feed and food businesses to ensure that adequate procedures are in place to recall products that might pose a possible health risk. Operators should also keep adequate records of suppliers of raw materials and ingredients so that the source of a problem can be identified. Link: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32002R0178 Regulation (EC) No 852/2004 on the hygiene of foodstuffs establishes a comprehensive framework for ensuring food safety throughout all stages of food production, processing, and distribution within the EU. It requires food businesses to implement hazard analysis and critical control points (HACCP) principles, focusing on identifying and controlling food safety risks. The regulation mandates that all food handlers maintain high standards of personal hygiene, cleanliness, and sanitation in food preparation environments. It also emphasizes the importance of proper temperature control, the safety of water used in food production, and the maintenance of clean facilities. This regulation aims to protect consumers by ensuring that food products are produced under safe and hygienic conditions across the EU. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32004R0852 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 40 Regulation (EC) No 853/2004 sets specific hygiene rules for the production and handling of food of animal origin within the EU. It complements general food hygiene regulations, focusing on stricter controls for products like meat, fish, dairy, and eggs to prevent contamination and ensure food safety. The regulation requires that operators of animalorigin food businesses meet specific standards, such as approved facilities, traceability, and veterinary checks for certain products. It also outlines requirements for labelling, storage conditions, and the handling of by-products. Overall, the regulation ensures that food of animal origin is processed in a way that protects public health and complies with EU safety standards. Link: https://eur-lex.europa.eu/eli/reg/2004/853/oj 4. Environmental standards The Nitrates Directive (91/676/EEC) aims to protect water quality across the EU by preventing nitrate pollution from agricultural sources. It requires Member States to identify areas vulnerable to nitrate contamination, known as Nitrate Vulnerable Zones (NVZs), where specific measures must be applied to limit the use of nitrogen fertilizers and manage livestock manure. The directive mandates action programs in these zones, including restrictions on the timing and application rates of fertilizers to reduce nitrate leaching into water bodies. It also promotes the adoption of good agricultural practices to balance nutrient input and minimize environmental impact. Ultimately, the directive seeks to improve water quality by reducing the incidence of eutrophication and preserving aquatic ecosystems. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31991L0676 The Regulation (EC) No 1107/2009 governs the authorization, sale, and use of plant protection products (PPPs) within the EU, aiming to safeguard human health, the environment, and biodiversity. It sets strict criteria for the approval of active substances used in PPPs, ensuring that only those that pose minimal risk to people, animals, and the environment are permitted. The regulation also outlines procedures for assessing potential impacts, including longterm environmental effects, and mandates periodic reviews of approved substances. It encourages the development and use of safer alternatives, such as non-chemical and low-risk products, promoting sustainable agriculture. By ensuring high safety standards, the regulation aims to protect ecosystems while enabling effective pest management in farming. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32009R1107 5. Quality labels (geographical, traditional) Protected Designation of Origin (PDO) is an EU quality scheme that protects the names of agricultural products and foodstuffs that are produced, processed, and prepared within a specific geographical area, following strict traditional methods. Products with PDO status must have characteristics that are uniquely tied to their place of origin, such as local climate, soil, or know-how, ensuring authenticity and preserving regional heritage. To be granted PDO status, both raw materials and production techniques must originate from the designated region. This label helps protect producers from imitation and ensures consumers are buying genuine, high-quality products with a recognized origin. Protected Geographical Indication (PGI) is a designation used within the European Union to protect the names of specific agricultural products and foodstuffs that possess qualities, reputation, or characteristics intrinsically linked to their geographical origin. To qualify for PGI status, a product must be produced, processed, and prepared in a specific 101100622/agrifoodTEF AGRIFOOD TEF D3.1 December 17th, 2024 41 region, ensuring that the geographical area contributes to its unique attributes. This designation helps preserve traditional methods and promote regional economic development by safeguarding local products against imitation and misuse. PGI protection not only enhances consumer confidence by guaranteeing authenticity and quality but also supports rural communities by encouraging sustainable agricultural practices. The Traditional Speciality Guaranteed (TSG) is a European Union designation that recognizes and protects traditional food products with specific qualities, characteristics, or production methods. Unlike Protected Designation of Origin (PDO) and Protected Geographical Indication (PGI), TSG does not require the product to be linked to a specific geographical area, focusing instead on the traditional aspects of the product. To qualify for TSG status, food products must demonstrate a traditional composition or method of production that has been established for at least 30 years. This designation aims to promote and preserve regional food heritage while providing consumers with assurance of authenticity and quality. Products bearing the TSG label benefit from increased visibility and protection against imitation in the market. Link: https://agriculture.ec.europa.eu/farming/geographical-indications-and-quality-schemes/geographicalindications-and-quality-schemes-explained_en 6. GMO regulations Directive 2001/18/EC regulates the deliberate release of genetically modified organisms (GMOs) into the environment and their marketing in the EU. It establishes a framework for risk assessment and management, requiring thorough evaluations of the potential effects of GMOs on human health and the environment before any release. The directive emphasizes the importance of public consultation and transparency, ensuring that stakeholders and the public are informed and can participate in decision-making processes regarding GMOs. It also mandates labeling and traceability for GMOs and products derived from them, enabling consumers to make informed choices. Overall, the directive aims to ensure a high level of protection for human health and the environment while allowing for the safe use of biotechnology in agriculture. Link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32001L0018 Regulation (EC) No 1829/2003 governs the authorization and labelling of genetically modified organisms (GMOs) and GM food and feed within the European Union. It establishes a comprehensive framework for the risk assessment of GM products to ensure they are safe for human and animal health, as well as the environment, before they can be marketed. The regulation mandates that all GM food and feed must be clearly labelled to inform consumers and enable them to make informed choices. Additionally, it requires traceability measures to track GMOs throughout the supply chain, from production to retail. Ultimately, Regulation (EC) No 1829/2003 aims to maintain high standards of safety while fostering transparency and consumer confidence regarding GM products in the EU. Link: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32003R1829 7. Animal welfare Directive 98/58/EC establishes minimum standards for the protection of animals kept for farming purposes within the European Union. It sets out basic welfare requirements related to housing, feeding, and management practices to ensure the well-being of farm animals such as cattle, pigs, sheep, and poultry. The directive emphasizes the importance