ISSN 1977-0677 |
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Official Journal of the European Union |
L 65 |
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English edition |
Legislation |
Volume 66 |
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Corrigenda |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/1 |
COMMISSION DELEGATED REGULATION (EU) 2023/444
of 16 December 2022
supplementing Directive (EU) 2018/1972 of the European Parliament and of the Council with measures to ensure effective access to emergency services through emergency communications to the single European emergency number ‘112’
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing the European Electronic Communications Code (1), and in particular Article 109(8) thereof,
Whereas:
(1) |
Pursuant to Article 109(8) of Directive (EU) 2018/1972, in order to ensure effective access to emergency services through emergency communications to the single European emergency number ‘112’ in the Member States, the Commission shall adopt delegated acts, with the first such act to be adopted by 21 December 2022. These delegated acts are to supplement paragraphs 2, 5 and 6 of Article 109 of the Directive on measures necessary to ensure the compatibility, interoperability, quality, reliability and continuity of emergency communications in the Union with regard to caller location information solutions, access for end-users with disabilities and routing to the most appropriate public safety answering point (PSAP). |
(2) |
Emergency communications are an important element for the pursuit of public safety, security and health. For more than 30 years, citizens of the Union have relied on access to emergency services using the single European Emergency number ‘112. They should continue to be able to do so in the digital world. Citizens should benefit from comprehensive and timely delivery of contextual information necessary for addressing an emergency situation. The high level of connectivity that is targeted by Europe’s digital transformation, as reflected in the Decision establishing the Digital Decade Policy Programme 2030 (2), is bringing about a technological migration to all-IP technologies of electronic communication services used by citizens, in particular by persons with disabilities. The migration from circuit-switched to packet-switched technologies in electronic communication networks triggers the deployment of voice services through IP Multimedia Subsystem based fixed and mobile managed VoIP technologies such as Voice over Long Term Evolution (VoLTE), Voice over New Radio (VoNR in 5G) and Voice over Wi-Fi (VoWiFi). Packet-switched technologies also enable text and video-based services like real time text and total conversation services. Those IP-based communication services cannot be supported by the legacy circuit-switched networks, such as 2G and 3G networks that are in the process of being decommissioned. Therefore, there is a need to migrate emergency communications to packet-switched technologies as well. This Regulation aims to ensure that in this transformational process the quality and reliability of emergency communications are ensured. |
(3) |
The goal of emergency services is to avoid, alleviate or manage the effects of emergency incidents through emergency intervention. The time necessary for emergency intervention has a fundamental impact on the outcome of emergency incidents. Effective emergency intervention requires rapid mobilisation of the intervention resources that could effectively address the emergency incident, and the fast arrival at the intervention scene. |
(4) |
The goal of emergency communications is to enable end-users to access emergency services to request and receive emergency relief from emergency services. While emergency communications are set up between the end-user and the PSAP, it should be the role of the most appropriate PSAP to process the information received and convey the request to the emergency services, hence ensuring access to emergency services. Depending on the national organisation of PSAP systems and emergency services systems, PSAPs and emergency services can be overlapping or autonomous entities. |
(5) |
In order to enable access to emergency services, effective emergency communications should ensure both the timely communication between the end-user and the most appropriate PSAP and the making available in a timely manner of contextual information, including caller location information. The contextual information contributes to the description of the emergency incident, for example, the physical environment, the condition and abilities of the persons involved, the localisation of the incident, etc. The availability and accuracy of contextual information enables the timely identification of the appropriate intervention resources and the quick arrival at the intervention scene, e.g. when an accurate caller location is available. This information may be conveyed to the emergency services through emergency communications by the end-user, or derived automatically from the device of the end-user or the network. |
(6) |
Caller location is one of the most important types of contextual information associated with emergency communications and it has a high impact on their effectiveness. The accuracy and reliability of caller location information influences the time necessary to identify the site of the emergency and the on-site arrival of emergency services. |
(7) |
Directive (EU) 2018/1972 requires competent regulatory authorities to establish the caller location accuracy and reliability criteria. Those criteria represent the minimum levels of accuracy and reliability of caller location information that have to be implemented on the territory of the Member State through network-based and handset-derived technologies. According to the case-law of the European Court of Justice (3), the criteria should ensure, within the limits of technical feasibility, that the end-user’s position is located as reliably and accurately as is necessary to enable the emergency services to usefully come to the end-user’s assistance. The mix of these technologies ensures that even where a handset-derived caller location solution fails to make the caller location information available to the most appropriate PSAP, emergency services can rely on network-based location to usefully come to the end-user’s assistance, in line with the caller location accuracy and reliability criteria established by Member States. Caller location criteria, which do not allow the establishment of minimum levels of accuracy and reliability may lead to implementation that does not ensure that emergency services receive caller location information, which they can effectively use. It should be for the Member States to assess the combined effect of the technically feasible caller location solutions, and to establish minimum criteria for both accuracy and reliability of caller location, which, if implemented, would enable emergency services to usefully intervene. The usefulness of the accuracy of caller location information might vary depending on the area from which the emergency communication is originated (e.g. urban or rural) and could be reflected accordingly in the criteria set. In order to ensure a harmonised approach within the Union to the setting of the accuracy and reliability criteria which ensures a minimum level of contextual information, it is necessary to define the parameters that competent regulatory authorities should take into account when laying down such criteria. Moreover, it is important to recall that pursuant to the principle of sincere cooperation laid down in Article 4(3) of the Treaty on European Union, competent regulatory authorities are to cooperate among each other when laying down the criteria for the accuracy and reliability of the caller location information by consulting the Body of European Regulators for Electronic Communications (BEREC) or other relevant fora competent to provide guidance in this regard, in order to ensure the full effectiveness of Article 109(6) of Directive (EU) 2018/1972. |
(8) |
The accuracy of caller location information may be expressed as a maximum radius of the search area for the intervention that is presented to the emergency services. Emergency intervention times could be significantly reduced when accurate and reliable network-based and handset-derived caller location information is available to the most appropriate PSAP, especially when end-users requesting emergency assistance are not able to specify their location. Therefore, for fixed networks, Member States should express the minimum levels of accuracy to be implemented on their territory as caller location information related to the physical address of the network termination point, for example by reference to the concrete street address, apartment, floor or similar information. For mobile networks the minimum levels of accuracy should be expressed in metres to indicate the maximum radius of the horizontal search area that is presented to the emergency services for intervention purposes. If applicable and technically feasible, the elevation or vertical accuracy criterion should be expressed in metres as well. Member States should assess whether these parameters are feasible to be applied to network independent providers of number-based interpersonal communication services when these are used in fixed or mobile networks. |
(9) |
The reliability of caller location should pertain to two aspects of the caller location information: the establishment and the transmission. The reliability of caller location information should be established according to the statistical measurements that indicate the success rate with which the actual location of the device originating the emergency communication matches the physical area indicated on the basis of the caller location information. An emergency communication should trigger both network-based and handset-derived caller location information, when the latter is available. The reliability of the caller location information for the emergency services should be established as a combined effect of these two technologies. The reliability of transmission of caller location information should be expressed as the success rate of the technical solution to transmit the caller location information to the most appropriate PSAP. The success rate is dependent on the capabilities of the network to convey the information, in case of network-based caller location, or the interoperability between the handset and the network resources to allow the transmission, in case of handset derived caller location, as well as the most appropriate PSAP capabilities to receive the information. |
(10) |
In order to enable the Commission to monitor the caller location criteria established in accordance with this Regulation, Member States should report on the adoption of the criteria and explain how they have taken into account the parameters established in this Regulation. |
(11) |
Directive (EU) 2018/1972 requires access to emergency services through emergency communications for end-users with disabilities to be equivalent to that enjoyed by other end-users. The principle of equivalence implies that end-users with disabilities should be able to access emergency services through emergency communications in a functionally equivalent manner to that in which other end-users access emergency services, in particular by calling the ‘112’ number via voice-based services. Since there is no common understanding of the functional equivalence requirements, the requirements that replicate the functionalities of emergency communications enjoyed by other end-users, mainly voice-based services, should be established. If for technical reasons, Member States are not able to comply with the functional equivalence requirements established by this Regulation, they should inform the Commission of the specific reasons why this is not possible. Member States should inform the Commission when the technical design of the mandated means of access to emergency services does not require or allow the use of the single European emergency number ‘112’ and how it is ensured that the same or higher awareness is reached amongst end-users with disabilities with regard to that means of access. |
(12) |
In order to enable the Commission to monitor the compatibility, quality, reliability, interoperability and continuity of the means of access to emergency services for end-users with disabilities, Member States should report the means of access to emergency services mandated in their jurisdiction for end-users with disabilities, including those using roaming services. The report should contain a first assessment of the compliance of the reported means of access with the functional equivalence requirements in accordance with this Regulation. The migration to all-IP networks will enable the implementation of new, accessible communication services like real time text and total conversation services. Member States should therefore report interoperability, compatibility or continuity issues encountered when deploying such services, in particular for roaming end-users. In order to fulfil their obligation under Article 16 of Regulation (EU) 2022/612 of the European Parliament and of the Council (4) to report to BEREC the means of access to emergency services that are mandated in their Member State and that are technically feasible to be used by roaming customers, national regulatory authorities or other competent authorities should establish, if applicable, the technical reasons for the lack of availability of the emergency communication service for roaming end-users where those services are available for domestic end-users. The first report, as well as information provided in the following years will enable the Commission to assess the necessity of adopting further measures, including standardisation mandates, to address such issues. |
(13) |
Emergency communications and caller location information have to be routed to the most appropriate PSAP to enable the appropriate answering and handling of the emergency communications. Effective routing of emergency communications should be ensured also in the context of the technological migration from circuit-switched to packet-switched technologies. The most appropriate PSAP is normally determined by the Member State on the basis of a territorial competence to handle emergency communications or the competence to handle a certain type of communication, for example a PSAP equipped to handle real time text or sign-language communication. The interpersonal communication services provided through packet-switched technologies providing voice, text – including real time text –, and video may be routed in the public network domain or PSAP domain. Depending on the national organisation of PSAPs, while the emergency communication reaches PSAP system through the public networks, further routing may be necessary within the PSAP domain to reach the most appropriate PSAP. In order to guarantee the availability of effective emergency communications to the benefit of all end-users, Member States should ensure the timeliness of routing to the most appropriate PSAP of all types of emergency communications and of caller location information mandated on their territory. |
(14) |
The effectiveness of access to emergency services is dependent on the timeliness of the conveyance of the contextual information to the emergency services. Member States should ensure that the most appropriate PSAP to which the emergency communication is routed, is technically capable of transmitting in a timely manner the contextual information to the emergency services from the moment those services are alerted by that PSAP. According to the national organisation of PSAPs, the most appropriate PSAP may assess the usefulness of the contextual data and filter the information to be provided to emergency services. |
(15) |
In order to enable the monitoring by the Commission of the effectiveness of routing to the most appropriate PSAP, Member States should report on the performance of the routing of emergency communications to the most appropriate PSAP in terms of their timeliness, including when using voice, text, or video services. |
(16) |
Ensuring seamless access to emergency services, without pre-registration, for end-users, including end-users with disabilities, travelling in another Member State might not be under the sole control of a Member State and would require compliance with commonly agreed interoperability requirements. Without prejudice to the implementation of real time text and total conversation services pursuant to Directive (EU) 2019/882 of the European Parliament and of the Council (5), it should be possible to implement access to emergency services through voice, text or video services through emergency communications via mobile applications. Mobile applications may enable the transmission of rich contextual data to the most appropriate PSAP. Once a mobile application is downloaded and installed, the end-user may communicate with the most appropriate PSAP across the Union if the common interoperability requirements make that possible, and the mobile application providers and the national PSAP systems comply with those requirements. Member States should cooperate with the Commission in good faith to identify the common interoperability requirements the implementation of which would enable the use of such emergency communications to the most appropriate PSAP via mobile applications across the Union. |
(17) |
PSAP systems that were developed to answer and handle circuit-switched communications may not be able to answer, handle and process all features of emergency communications initiated through packet-switched technology. In order to ensure transparency with relevant stakeholders, in particular electronic communications services and network providers, as well as to ensure a coherent and timely upgrade of PSAPs systems within their territory, Member States should prepare a roadmap for the upgrade of the capabilities of their PSAP systems to answer, handle and process emergency communications provided through packet-switched technologies. The roadmap should contain the expected timeline and date of deployment of novel means of access to emergency services through emergency communications through packet-switched technologies, whether these are enabled in the core network as number-based interpersonal communication services or deployed via a mobile application. The roadmap should contain information on the timeline of the upgrade of the capabilities of the PSAP systems, taking account of the obligations set in Directive (EU) 2019/882 and the legal deadlines provided therein. This concerns in particular the appropriate answering by the most appropriate PSAP the emergency communications to the single European emergency number ‘112’, by using synchronised voice and text (including real time text), or, where video is provided, voice, text (including real time text) and video synchronised as total conversation. If applicable, the expected legal mandate to deploy emergency communications through packet-switched technologies under national legislation should be indicated. The roadmap should refer to the intermediary milestones, for example public and stakeholder consultations, legislative measures, interoperability, continuity and reliability testing, public procurement, etc. Member States should provide the roadmap to the Commission and provide updates on its implementation. Member States should also report the interoperability and continuity issues encountered with regard to the provision of electronic communication services used for accessing emergency services to enable the Commission to assess the necessity of adopting further measures, including standardisation mandates, that would address such bottlenecks. |
(18) |
A regular and structured gathering of information from Member States regarding several aspects pertaining to the effectiveness of emergency communications in the Union is necessary to enable the Commission to monitor their implementation and compliance with obligations set out in Article 109 of Directive (EU) 2018/1972, as supplemented by this Regulation. Following the first report as provided for in this Regulation, Member States should provide the Commission with updated information as requested in the context of each data gathering that the Commission initiates for the purposes of fulfilling its obligation to report to the European Parliament and the Council pursuant to Article 109(4) of Directive (EU) 2018/1972. |
(19) |
The Body of European Regulators for Electronic Communications was consulted in accordance with Article 109(8) of Directive (EU) 2018/1972 and delivered an opinion on 14 October 2022. |
(20) |
The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council (6) and delivered an opinion on 15 November 2022, |
HAS ADOPTED THIS REGULATION:
CHAPTER 1
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
This Regulation establishes measures to ensure effective access to emergency services through emergency communications with regard to caller location information solutions, access for end-users with disabilities and routing to the most appropriate PSAP.
Article 2
For the purposes of this Regulation, the following definitions apply:
(1) |
‘effective emergency communication’ means emergency communication as defined in Article 2, point (38) of Directive (EU) 2018/1972 that ensures:
|
(2) |
‘contextual information’ means the information conveyed through an emergency communication by the end-user or derived and transmitted automatically from the device of the end-user or the relevant network in order to enable the timely identification of the intervention resources of the emergency services and the fast arrival of the emergency services at the intervention scene. |
CHAPTER 2
CALLER LOCATION INFORMATION
Article 3
1. When laying down criteria for the accuracy and reliability of caller location information pursuant to Article 109(6) of Directive (EU) 2018/1972, competent regulatory authorities shall ensure, within the limits of technical feasibility, that the end-user’s position is located as reliably and accurately as is necessary to enable the emergency services to come to the end-user’s assistance. Competent regulatory authorities shall lay down the criteria taking into account the parameters specified in paragraphs 2 and 3 of this Article.
2. With respect to the fixed networks:
(a) |
the accuracy criterion for caller location information shall be expressed as information related to the physical address of the network termination point; |
(b) |
the reliability criterion for caller location information shall be expressed as the success rate, in percentage, of the technical solution or mix of technical solutions to establish and transmit to the most appropriate PSAP a caller location information corresponding to the accuracy criterion. |
3. With respect to the mobile networks:
(a) |
the accuracy criterion for caller location information shall be expressed in metres. If applicable, the elevation or vertical accuracy criterion shall be expressed in metres as well; |
(b) |
the reliability criterion for caller location information shall be expressed as the success rate, in percentage, of the technical solution or mix of technical solutions to establish and transmit to the most appropriate PSAP a search area corresponding to the accuracy criterion. |
CHAPTER 3
ACCESS TO EMERGENCY SERVICES FOR END-USERS WITH DISABILITIES
Article 4
When implementing means of access to emergency services through emergency communications for end-users with disabilities, Member States shall ensure that, subject to technical feasibility, the following functional equivalence requirements are met:
(a) |
the emergency communication enables two-way interactive communication between the end-user with disabilities and the PSAP; |
(b) |
the emergency communication is available in a seamless way, without pre-registration, to end-users with disabilities travelling in another Member State; |
(c) |
the emergency communication is provided to end-users with disabilities free of charge; |
(d) |
the emergency communication is routed without delay to the most appropriate PSAP that is qualified and equipped to appropriately answer and process the emergency communication from end-users with disabilities; |
(e) |
equivalent levels of accuracy and reliability of caller location information are ensured for the emergency communication for end-users with disabilities as for emergency calls by other end-users; |
(f) |
the end-users with disabilities are enabled to reach at least the same level of awareness about the means of access to emergency services through emergency communications as other end-users about emergency calls to ‘112’, either by the design of the means of access or through awareness raising measures. |
CHAPTER 4
ROUTING TO THE MOST APPROPRIATE PUBLIC SAFETY ANSWERING POINT
Article 5
Member States shall ensure that emergency communications and caller location information are routed without delay to the most appropriate PSAP that is technically capable to convey the contextual information to the emergency services when alerting those services.
Article 6
For the purpose of ensuring the technical feasibility of the seamless access to emergency services as provided in Article 4(1), point (b) of this Regulation, without prejudice to the implementation of Directive (EU) 2019/882, Member States shall cooperate with the Commission to identify common interoperability requirements that enable the emergency communication to the most appropriate PSAP via a mobile application anywhere in the Union.
CHAPTER 5
REPORTING
Article 7
1. Member States shall regularly report to the Commission the performance of the routing to the most appropriate PSAP under Article 5, implemented for emergency communications and caller location information.
2. Member States shall prepare and report to the Commission no later than on 5 November 2023 a roadmap for upgrading the national PSAP system in order to be able to receive, answer and process emergency communications through packet-switched technology. The roadmap shall indicate the date of the expected deployment of voice, text or video based emergency communications through packet-switched technologies. The roadmap shall also include the indicative date by when PSAPs will be ready to receive such emergency communications. Member States shall provide updated information on the implementation of the intermediary milestones of the roadmap in accordance with Article 8.
Article 8
1. Member States shall report to the Commission no later than on 5 March 2024:
(a) |
the criteria for the accuracy and reliability of caller location information expressed according to the parameters referred to in Article 3, |
(b) |
the means of access to emergency services through emergency communications to be used by end-users with disabilities, including those using roaming services, and the assessment of their compliance with the functional equivalence requirements in Article 5. |
2. Member States shall provide the Commission with the information referred to in this article and Article 7 without prejudice to the initial deadlines provided therein, in the context of each data gathering that the Commission initiates for the purposes of fulfilling its obligation to report to the European Parliament and the Council pursuant to Article 109(4) of Directive (EU) 2018/1972.
CHAPTER 6
FINAL PROVISIONS
Article 9
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 December 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 321, 17.12.2018, p. 36.
(2) Decision (EU) 2022/2481 of the European Parliament and of the Council of 14 December 2022 establishing the Digital Decade Policy Programme 2030 (OJ L 323, 19.12.2022, p. 4).
(3) Case C 417/18; Judgment of the Court (Fourth Chamber) of 5 September 2019, AW and Others v Lietuvos valstybė.
(4) Regulation (EU) 2022/612 of the European Parliament and of the Council of 6 April 2022 on roaming on public mobile communications networks within the Union (recast) (OJ L 115, 13.4.2022, p. 1).
(5) Directive (EU) 2019/882 of the European Parliament and of the Council of 17 April 2019 on the accessibility requirements for products and services (OJ L 151, 7.6.2019, p. 70).
(6) Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/9 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/445
of 23 February 2023
approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Colli Bolognesi Classico Pignoletto’ (PDO))
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,
Whereas:
(1) |
The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Colli Bolognesi Classico Pignoletto’, forwarded by Italy in accordance with Article 105 of Regulation (EU) No 1308/2013. The changes include a change of name from ‘Colli Bolognesi Classico Pignoletto’ to ‘Colli Bolognesi Pignoletto’. |
(2) |
The Commission has published the application for the approval of the amendments to the specification in the Official Journal of the European Union (2), as required by Article 97(3) of Regulation (EU) No 1308/2013. |
(3) |
No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013. |
(4) |
The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013. |
(5) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets, |
HAS ADOPTED THIS REGULATION:
Article 1
The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Colli Bolognesi Classico Pignoletto’ (PDO) are hereby approved.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 23 February 2023.
For the Commission,
On behalf of the President,
Janusz WOJCIECHOWSKI
Member of the Commission
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/11 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/446
of 27 February 2023
amending Implementing Regulation (EU) 2018/2019 as regards certain plants for planting of Ligustrum delavayanum and Ligustrum japonicum originating in the United Kingdom and Implementing Regulation (EU) 2020/1213 as regards the phytosanitary measures for the introduction of those plants for planting into the Union territory
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 42(4), the third subparagraph, thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) 2018/2019 (2) establishes, on the basis of a preliminary risk assessment, a list of high risk plants, plant products and other objects. |
(2) |
Commission Implementing Regulation (EU) 2018/2018 (3) lays down specific rules concerning the procedure to be followed in order to carry out the risk assessment referred to in Article 42(4) of Regulation (EU) 2016/2031 for high risk plants, plant products and other objects. |
(3) |
Following a preliminary assessment, 34 genera and one species of plants for planting originating from third countries were provisionally listed in Implementing Regulation (EU) 2018/2019 as high risk plants. That list includes the genus Ligustrum L. |
(4) |
Commission Implementing Regulation (EU) 2020/1213 (4) sets out the phytosanitary measures for the introduction into the Union territory of certain plants, plant products and other objects, which have been removed from the Annex to Implementing Regulation (EU) 2018/2019, but for which phytosanitary risks are not yet fully assessed. This is because one or more pests hosted by those plants are not yet included in the list of Union quarantine pests of Commission Implementing Regulation (EU) 2019/2072 (5), but they may fulfil the conditions to be included following a further complete risk assessment. |
(5) |
On 3 December 2021, the United Kingdom (6) submitted to the Commission, a request for export to the Union of large topiary evergreen plants of Ligustrum delavayanum grafted onto Ligustrum japonicum rootstocks grown in pots that are up to 20 years old and having a maximum diameter of 18 cm at the base of the stem. That request was supported by the relevant technical dossier. |
(6) |
On 28 September 2022, the European Food Safety Authority (‘the Authority’) adopted a scientific opinion covering the risk assessment of plants for planting of Ligustrum delavayanum and of plants for planting of Ligustrum japonicum, in growing medium, that are up to 20 years old and with a maximum diameter of 18 cm at the base of the stem, irrespective of whether they are grafted or not (‘the relevant plants’) (7). The Authority identified Bemisia tabaci, Diaprepes abbreviatus, Epiphyas postvittana and Scirtothrips dorsalis as pests relevant for those plants and estimated the likelihood of freedom of the commodity from the pests. |
(7) |
On the basis of that opinion, the phytosanitary risk from the introduction into the Union territory of the relevant plants is considered to be reduced to an acceptable level, provided that appropriate measures are applied to address the risk of pests related to those plants and the corresponding special requirements of Annex VII to Implementing Regulation (EU) 2019/2072 are complied with. |
(8) |
The measures described by the United Kingdom in the technical dossier are considered sufficient to reduce the risk from the introduction into the Union territory of the relevant plants to an acceptable level. Those measures should therefore be adopted as phytosanitary import requirements to ensure the phytosanitary protection of the Union territory from introduction of the relevant plants into it. |
(9) |
Consequently, the relevant plants should no longer be considered high risk plants. |
(10) |
Implementing Regulation (EU) 2018/2019 should therefore be amended accordingly. |
(11) |
Bemisia tabaci is listed as a protected zone quarantine pest in Annex III to Implementing Regulation (EU) 2019/2072 and Scirtothrips dorsalis is listed as a Union quarantine pest in Annex II to that Implementing Regulation. |
(12) |
Diaprepes abbreviatus is not yet included in the list of Union quarantine pests of Implementing Regulation (EU) 2019/2072, therefore the measures for that pest are based on those described by the United Kingdom in the dossier. When a complete risk assessment on that pest becomes available, it will be established if that pest fulfils the conditions to be listed in Annex II to Implementing Regulation (EU) 2019/2072 and the relevant plants in Annex VII to that Regulation, together with the respective measures. |
(13) |
Implementing Regulation (EU) 2020/1213 should therefore be amended accordingly. |
(14) |
Epiphyas postvittana is not included in the list of Union quarantine pests. The pest is present in a number of Member States and no official control measures are applied. Furthermore, the impact of the pest in the Union is not considered to be significant. For these reasons, no import requirements are necessary with respect to that pest. |
(15) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) 2018/2019 is amended in accordance with Annex I to this Regulation.
Article 2
The Annex to Implementing Regulation (EU) 2020/1213 is amended in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 27 February 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 317, 23.11.2016, p. 4.
(2) Commission Implementing Regulation (EU) 2018/2019 of 18 December 2018 establishing a provisional list of high risk plants, plant products or other objects, within the meaning of Article 42 of Regulation (EU) 2016/2031 and a list of plants for which phytosanitary certificates are not required for introduction into the Union, within the meaning of Article 73 of that Regulation (OJ L 323, 19.12.2018, p. 10).
(3) Commission Implementing Regulation (EU) 2018/2018 of 18 December 2018 laying down specific rules concerning the procedure to be followed in order to carry out the risk assessment of high risk plants, plant products and other objects within the meaning of Article 42(1) of Regulation (EU) 2016/2031 of the European Parliament and of the Council (OJ L 323, 19.12.2018, p. 7).
(4) Commission Implementing Regulation (EU) 2020/1213 of 21 August 2020 concerning the phytosanitary measures for the introduction into the Union of certain plants, plant products and other objects which have been removed from the Annex to Implementing Regulation (EU) 2018/2019 (OJ L 275, 24.8.2020, p. 5).
(5) Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and of the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ L 319, 10.12.2019, p. 1).
(6) In accordance with the Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community, and in particular Article 5(4) of the Protocol on Ireland/Northern Ireland in conjunction with Annex 2 to that Protocol, for the purposes of this act, references to the United Kingdom do not include Northern Ireland.
(7) EFSA PLH Panel (EFSA Panel on Plant Health), 2022. Scientific Opinion on the commodity risk assessment of Ligustrum delavayanum topiary plants grafted on Ligustrum japonicum from the UK. EFSA Journal 2022;20(11):7593.
ANNEX I
In the Annex to Implementing Regulation (EU) 2018/2019, in the table in point 1, in the second column ‘Description’, the entry ‘ Ligustrum L.’ is replaced by the following:
‘ Ligustrum L., other than up to 20-year-old plants for planting of Ligustrum delavayanum and Ligustrum japonicum in growing medium, with a maximum diameter of 18 cm at the base of the stem, originating in the UK’.
ANNEX II
In the table in the Annex to Implementing Regulation (EU) 2020/1213, the following entry is inserted after ‘ Juglans regia L., up to 2-year-old plants for planting which are bare-rooted, free of leaves, and with a maximum diameter of 2 cm at the base of the stem.’:
Plants, plant products or other objects |
CN Code |
Third countries of origin |
Measures |
||||||||||||||
‘Ligustrum delavayanum and Ligustrum japonicum, up to 20-year-old plants for planting in growing medium, with a maximum diameter of 18 cm at the base of the stem. |
ex 0602 10 90 |
United Kingdom |
|
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/16 |
COMMISSION REGULATION (EU) 2023/447
of 1 March 2023
amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards the use of glucosylated steviol glycosides as sweetener
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) and Article 14 thereof,
Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,
Whereas:
(1) |
Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in foods and their conditions of use. |
(2) |
Commission Regulation (EU) No 231/2012 (3) lays down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008. |
(3) |
Those lists may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application. |
(4) |
In January 2019, an application was submitted for the authorisation of glucosylated steviol glycosides as a new food additive for use as a sweetener. The application was made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008. |
(5) |
Glucosylated steviol glycosides are produced via enzymatic bioconversion using a cyclomaltodextrin glucanotransferase that catalyses the transfer of glucose from starch to mixtures enriched in one or more individual steviol glycosides from purified Stevia Rebaudiana leaf extracts. They consist of a mixture of glucosylated steviol glycosides, containing 1–20 additional glucose units bound to the parent steviol glycosides. They have an improved sweetness profile as compared to the other authorised sweeteners including steviol glycosides from Stevia (E 960a). |
(6) |
The European Food Safety Authority (‘the Authority’) evaluated the safety of glucosylated steviol glycosides and expressed its opinion on 15 December 2021 (4). The Authority considered that the metabolism of glucosylated steviol glycosides is sufficiently similar to the already authorised steviol glycosides, and thus the toxicological data previously assessed by the Authority for steviol glycosides (E 960a) were considered to support their safety as a food additive. The enzyme cyclomaltodextrin glucanotransferase (EC 2.4.1.19) derived from a non-genetically modified strain of Anoxybacillus caldiproteolyticus and intended to be used in the manufacture of modified steviol glycosides does not give rise to safety concerns under the intended conditions of use based on the data provided to the Authority (5). The Authority concluded that there is no safety concern for the use of glucosylated steviol glycosides as a food additive for the same proposed uses and use levels as steviol glycosides (E 960a–960c) used as sweeteners. |
(7) |
Therefore, it is appropriate to authorise the food additive ‘glucosylated steviol glycosides’ (E 960d) as a sweetener in the food categories where steviol glycosides (E 960a–960c) are currently authorised and at the same the maximum levels. |
(8) |
The specifications for the food additive glucosylated steviol glycosides should be included in Regulation (EU) No 231/2012 as it is included in the Union list of food additives laid down in Annex II to Regulation (EC) No 1333/2008 for the first time. |
(9) |
Regulations (EC) No 1333/2008 and (EU) No 231/2012 should therefore be amended accordingly. |
(10) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex II to Regulation (EC) No 1333/2008 is amended in accordance with Annex I to this Regulation.
Article 2
The Annex to Regulation (EU) No 231/2012 is amended in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 354, 31.12.2008, p. 16.
(2) OJ L 354, 31.12.2008, p. 1.
(3) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).
(4) EFSA Journal 2022;20(2):7066.
(5) EFSA Journal 2022;20(1):7004.
ANNEX I
Annex II to Regulation (EC) No 1333/2008 is amended as follows:
(a) |
In Part B, 2. Sweeteners, the following entry is inserted after the entry for E 960c:
|
(b) |
In Part C, (5) Other additives that may be regulated combined, point (v) is replaced by the following:
|
(c) |
Part E is amended as follows:
|
ANNEX II
In the Annex to Regulation (EU) No 231/2012 the following entry is inserted after the entry for food additive E 960c(iv):
‘E 960d GLUCOSYLATED STEVIOL GLYCOSIDES
Synonyms |
|
||
Definition |
Mixture of larger glycosides of steviol derived by glucosylation of steviol glycosides extracted from leaves of Stevia rebaudiana Bertoni plant. The mixture is composed of glucosylated steviol glycosides and residual parent steviol glycosides from Stevia leaf. Glucosylated steviol glycosides are produced by treating the steviol glycosides, extracted from Stevia leaf, and starch suitable for human consumption with Cyclomaltodextrin glucanotransferase (EC 2.4.1.19) derived from a non-GMO strain of Anoxybacillus caldiproteolyticus St-88. The enzyme transfers glucose units from the starch to the steviol glycosides. The resulting material is heated and treated with activated carbon to remove the enzyme, then passed through adsorption/desorption resin to remove residual hydrolysed starch (dextrin), followed by purification and preparation of the final product using processes that may include decolourisation, concentration and spray drying. |
||
Chemical name |
Steviolbioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid Rubusoside: 13-β-D-glucopyranosyloxykaur-16-en-18-oic acid, β-D-glucopyranosyl ester Dulcoside A: 13-[(2-O-α–L-rhamnopyranosyl-β–D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D- glucopyranosyl ester Rebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid Rebaudioside C: 13-[(2-O-α–L-rhamnopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside E: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester Rebaudioside F: 13-[(2-O-β-D-xylofurananosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester And their glucosylated derivatives (1-20 added glucose units) |
||
Molecular formula |
Trivial name |
Formula |
Conversion factor |
|
n-Glucosylated Steviolbioside |
C(32+n*6)H(50+n*10)O(13+n*5) |
|
n-Glucosylated Rubusoside |
C(32+n*6)H(50+n*10)O(13+n*5) |
|
|
n-Glucosylated Dulcoside A |
C(38+n*6)H(60+n*10)O(17+n*5) |
|
|
n-Glucosylated Stevioside |
C(38+n*6)H(60+n*10)O(18+n*5) |
|
|
n-Glucosylated Rebaudioside A |
C(44+n*6)H(70+n*10)O(23+n*5) |
|
|
n-Glucosylated Rebaudioside B |
C(38+n*6)H(60+n*10)O(18+n*5) |
|
|
n-Glucosylated Rebaudioside C |
C(44+n*6)H(70+n*10)O(22+n*5) |
|
|
n-Glucosylated Rebaudioside D |
C(50+n*6)H(80+n*10)O(28+n*5) |
|
|
n-Glucosylated Rebaudioside E |
C(44+n*6)H(70+n*10)O(23+n*5) |
|
|
n-Glucosylated Rebaudioside F |
C(43+n*6)H(68+n*10)O(22+n*5) |
|
|
n-Glucosylated Rebaudioside M |
C(56+n*6)H(90+n*10)O(33+n*5) |
|
|
n: number of glucose units enzymatically added to the parent steviol glycoside (n = 1-20) Typical conversion factor for glucosylated steviol glycosides mixtures = 0,20 (on the dried, dextrin-free, basis) |
|||
|
Steviol |
C20H30O3 |
1,00 |
|
Steviolbioside |
C32H50O13 |
0,50 |
Rubusoside |
C32H50O13 |
0,50 |
|
Dulcoside A |
C38H60O17 |
0,40 |
|
Stevioside |
C38H60O18 |
0,40 |
|
Rebaudioside A |
C44H70O23 |
0,33 |
|
Rebaudioside B |
C38H60O18 |
0,40 |
|
Rebaudioside C |
C44H70O22 |
0,34 |
|
Rebaudioside D |
C50H80O28 |
0,29 |
|
Rebaudioside E |
C44H70O23 |
0,33 |
|
Rebaudioside F |
C43H68O22 |
0,34 |
|
Rebaudioside M |
C56H90O33 |
0,25 |
|
Molecular weight and CAS No |
Trivial name |
CAS Number |
Molecular weight (g/mol) |
n-Glucosylated Steviolbioside |
Not available |
642,73+n*162,15 |
|
n-Glucosylated Rubusoside |
Not available |
642,73+n*162,15 |
|
n-Glucosylated Dulcoside A |
Not available |
788,87+n*162,15 |
|
n-Glucosylated Stevioside |
Not available |
804,88+n*162,15 |
|
n-Glucosylated Rebaudioside A |
Not available |
967,01+n*162,15 |
|
n-Glucosylated Rebaudioside B |
Not available |
804,88+n*162,15 |
|
n-Glucosylated Rebaudioside C |
Not available |
951,02+n*162,15 |
|
n-Glucosylated Rebaudioside D |
Not available |
1129,15+n*162,15 |
|
n-Glucosylated Rebaudioside E |
Not available |
967,01+n*162,15 |
|
n-Glucosylated Rebaudioside F |
Not available |
936,99+n*162,15 |
|
n-Glucosylated Rebaudioside M |
Not available |
1291,30+n*162,15 |
|
Steviol |
|
318,46 |
|
Steviolbioside |
41093-60-1 |
642,73 |
|
Rubusoside |
64849-39-4 |
642,73 |
|
Dulcoside A |
64432-06-0 |
788,87 |
|
Stevioside |
57817-89-7 |
804,88 |
|
Rebaudioside A |
58543-16-1 |
967,01 |
|
Rebaudioside B |
58543-17-2 |
804,88 |
|
Rebaudioside C |
63550-99-2 |
951,02 |
|
Rebaudioside D |
63279-13-0 |
1 129,15 |
|
Rebaudioside E |
63279-14-1 |
967,01 |
|
Rebaudioside F |
438045-89-7 |
936,99 |
|
Rebaudioside M |
1220616-44-3 |
1 291,30 |
|
Assay |
Not less than 95 % of total steviol glycosides, comprised of above mentioned steviol glycosides along with their glucosylated derivatives (1-20 added glucose units), on the dried, dextrin-free, basis. |
||
Description |
White to light yellow powder, approximately between 100 and 200 times sweeter than sucrose (at 5 % sucrose equivalency). |
||
Identification |
|||
Solubility |
Soluble in water |
||
pH |
Between 4,5 and 7,0 (1 in 100 solution) |
||
Purity |
|||
Total ash |
Not more than 1 % |
||
Loss on drying |
Not more than 6 % (105 °C, 2 h) |
||
Residual solvent |
Not more than 200 mg/kg methanol Not more than 3 000 mg/kg ethanol |
||
Arsenic |
Not more than 0,015 mg/kg |
||
Lead |
Not more than 0,1 mg/kg |
||
Cadmium |
Not more than 0,1 mg/kg |
||
Mercury |
Not more than 0,1 mg/kg |
||
Microbiological criteria |
|||
Total (aerobic) plate count |
Not more than 1 000 CFU/g |
||
Yeast and moulds |
Not more than 200 CFU/g |
||
E. coli |
Negative in 1 g |
||
Salmonella |
Negative in 25 g’. |
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/28 |
COMMISSION IMPLEMENTING REGULATION (EU) 2023/448
of 1 March 2023
amending Implementing Regulation (EU) 2018/574 on technical standards for the establishment and operation of a traceability system for tobacco products
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), and in particular Article 15(11) thereof,
Whereas:
(1) |
Commission Implementing Regulation (EU) 2018/574 (2) sets out the rules for the establishment and operation of a traceability system for tobacco products. The traceability system aims to provide Member States and the Commission with an effective tool that enables the tracking and tracing of tobacco products throughout the Union and the identification of fraudulent activities that result in illicit products being available to consumers. |
(2) |
In this regard, the operational rules of the traceability system play an important role in ensuring that the Commission and the Member States receive the data they need in order to ensure the proper functioning of the tobacco traceability system and control of the application of the tobacco traceability legislation as well as enforce this legislation respectively. |
(3) |
The traceability system established in accordance with Implementing Regulation (EU) 2018/574 started collecting data on tobacco products’ movements and transactional data on 20 May 2019. Experience in its implementation has further demonstrated the importance of high quality, accuracy, completeness and comparability of the data that need to be recorded and transmitted to the system in a timely manner. |
(4) |
In its report on the application of Directive 2014/40/EU of 20 May 2021 (3), the Commission stressed that the Member States and the Commission had considerable problems with the quality of traceability data, for example in relation to value added tax numbers, information on production machines or information on last movements of products to retail outlets. In particular, the current definition of machines should be amended to reflect the various machines’ configurations adopted in the sector and address the observed bad quality of information on machines. The report also concluded that data quality remains critical for enforcing the tobacco traceability legislation and for fully attaining the traceability system’s objectives. |
(5) |
The discussions between the Commission and the Member States taking place on a regular basis in the framework of the Expert Subgroup on Traceability and Security Features have further demonstrated that only robust, complete and good-quality data can ensure a fully functional and successful traceability system. For the monitoring and use of these data, the Member States and the Commission need to be equipped with effective analytical tools and technical solutions, in particular necessary interfaces that enable them to access and query the data stored in the repositories system. |
(6) |
Based on the gathered experience and knowledge, there is a need to amend certain technical rules laid down by Implementing Regulation (EU) 2018/574 in order to facilitate the reporting by all actors involved in the trade of tobacco products, reinforce the good practices in terms of data management and analysis, and consequently, improve the functioning of the traceability system for tobacco products. These technical rules concern the operation of the various components of the repositories system, the tasks of and the procedures to be followed by the ID issuers as well as the reporting activities of the economic operators and the technical tools available to the Member States in the context of their enforcement duties, in particular all access interfaces including for mobile inspections. |
(7) |
The amendments address a number of exceptions and special cases that were encountered after the launch of the traceability system, including the presence of economic operators solely involved in non-logistic trading operations, the involvement of non-EU entities in the EU supply chain, the existence of facilities combining non-retail and retail functions, cases of lost identifiers, cases of recovery of stolen goods, IT incidents necessitating data reprocessing, and the presence of atypical non-trade destinations such as laboratories or waste disposal centres. The actual operations of the traceability system also helped obtain a better picture of the size of data sets stored and processed in the repositories system, which in turn necessitates certain changes to the rules concerning the possibilities and characteristics of the repositories system and the tasks of the provider of the secondary repository. |
(8) |
Annex I to Implementing Regulation (EU) 2018/574 sets out the procedures for selecting the primary and secondary repositories’ operators. To ensure consistency in the manner in which notifications of the identity of the proposed provider are submitted to the Commission by group of undertakings, and by importers and non-Union manufacturers, and the relevant data storage contracts are signed, it is appropriate to further clarify certain rules on the submission of notifications and the signature of data storage contracts. In addition, given the fact that the extension of the tobacco traceability system to all tobacco products that is foreseen by Article 15(13) of Directive 2014/40/EU, may increase the number of these notifications and data storage contracts, it is also necessary to lay down further details of the procedure for the approval of amendments to the key elements of data storage contracts, including the explicit possibility for the Commission to tacitly approve such amendments. |
(9) |
It is also appropriate to amend the period within which the contracts between each primary repository provider and the provider of the secondary repository shall be signed and submitted to the Commission to ensure that these entities have sufficient time to comply with their obligations. With regard to the requirements that apply to the procedure concerning the termination of the contractual relationship between the Commission and the provider of the secondary repository, it is necessary to lay down further details on the notice period that needs to be respected by the provider of the secondary repository, so that business continuity and an uninterrupted flow of data are fully ensured in the system. |
(10) |
The Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control (4), which provides for a package of measures to be taken by its Parties to eliminate the illicit trade in tobacco products entered into force on 25 September 2018. It is appropriate for the traceability system established in the EU to be up to date with the technical developments concerning the establishment of a global tracking and tracing regime. |
(11) |
Implementing Regulation (EU) 2018/574 should therefore be amended accordingly. |
(12) |
Some provisions of this Regulation should start to apply at a later date than its entry into force, in order to allow ID issuers as well as providers of repository services and of anti-tampering devices and other economic operators to prepare for the requirements introduced by these provisions. |
(13) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 25 of Directive 2014/40/EU, |
HAS ADOPTED THIS REGULATION:
Article 1
Implementing Regulation (EU) 2018/574 is amended as follows:
(1) |
Article 2 is replaced by the following: ‘Article 2 Definitions For the purposes of this Regulation, in addition to the definitions laid down in Article 2 of Directive 2014/40/EU, the following definitions shall apply:
|
(2) |
in Article 3, paragraph 9 is replaced by the following: ‘9. The ID issuer may establish and charge fees to economic operators for generating and issuing unique identifiers. Fees are to be non-discriminatory, cost-based and proportionate to the number of unique identifiers generated and issued to economic operators taking into account the mode of delivery. Fees may reflect all fixed and variable costs incurred by the ID issuer in meeting its requirements under this Regulation.’ |
(3) |
in Article 7, paragraph 2 is replaced by the following: ‘2. The process referred to in paragraph 1 shall be protected with an anti-tampering device supplied and installed by an independent third party who shall provide a declaration to the relevant Member States and the Commission that the installed device meets the requirements of this Regulation. The record generated by the device shall provide proof of correct application and readability of each unit level unique identifier. The device shall ensure that any omission in the marking process referred to in Article 6 is recorded.’ |
(4) |
in Article 8, paragraph 2 is replaced by the following: ‘2. ID issuers shall be responsible for the generation of a code consisting of the elements listed in paragraph 1, points (a), (b), and (c). ID issuers shall prepare and make publicly available instructions for encoding and decoding unit level UIs in accordance with Annex III.’ |
(5) |
Article 9 is amended as follows:
|
(6) |
in Article 11, paragraph 2 is replaced by the following: ‘2. ID issuers shall be responsible for the generation of a code consisting of the elements listed in paragraph 1, points (a), (b), and (c). ID issuers shall prepare and make publicly available instructions for encoding and decoding aggregated level UIs.’ |
(7) |
Article 14 is amended as follows:
|
(8) |
Article 15 is amended as follows:
|
(9) |
Article 16 is amended as follows:
|
(10) |
in Article 17, paragraph 3 is replaced by the following: ‘3. All the information submitted to the ID issuer in accordance with Article 16(2), and the corresponding identifier codes shall form part of a registry to be established, managed and kept up to date by the competent ID issuer. The competent ID issuer shall keep a record of the information stored in the register for as long as the traceability system is operational.’ |
(11) |
Article 18 is amended as follows:
|
(12) |
in Article 19, paragraph 3 is replaced by the following: ‘3. All the information submitted to the ID issuer in accordance with Article 18(2), and the corresponding identifier codes shall form part of a registry to be established, managed and kept up to date by the competent ID issuer. The competent ID issuer shall keep a record of the information stored in the register for as long as the traceability system is operational.’ |
(13) |
in Article 20, the following paragraph 5 is added: ‘5. ID issuers shall provide a secure online service for economic operators and operators of first retail outlets allowing them to consult the registries referred to in paragraph 1 as far as their own economic operator, facility and machine identifier codes are concerned. This service shall include a secure procedure for economic operators and operators of first retail outlets to reclaim their own economic operator identifier codes.’ |
(14) |
Article 21 is amended as follows:
|
(15) |
Article 25(1), point (g), is replaced by the following:
|
(16) |
Article 27 is amended as follows:
|
(17) |
Article 28 is amended as follows:
|
(18) |
In Article 29, the following paragraphs 5 and 6 are added: ‘5. Manufacturers and importers who doubt the correct functioning of their primary repositories shall have the possibility to verify against the router, by consulting the operator of the router, whether messages concerning the final dispatch of products out of their physical possession that are sent to the primary repositories, have been transmitted correctly. The operator of the router may set a daily limit on the use of this functionality. 6. The provider of the secondary repository shall establish and communicate to economic operators and IT service providers the terms and conditions, including the fair use policy, applicable to the use of the secondary repository and the router. The terms and conditions shall guarantee the right of economic operators to use the secondary repository and the router in line with their business needs and shall prevent repeated cases of negligent use.’. |
(19) |
Article 30 is replaced by the following: ‘Article 30 Costs of the repositories system 1. All ordinary costs related to the repositories system referred to in Article 24(1), including those that arise from its establishment, operation and maintenance, shall be borne by manufacturers and importers of tobacco products. Those costs shall be fair, reasonable, and proportionate:
2. The ordinary costs, as applicable, of establishing, operating and maintaining the secondary repository and the router shall be passed onto the manufacturers and importers of tobacco products through the costs charged to them by the providers of the primary repositories. 3. All extraordinary costs related to the reprocessing operations referred to in Article 28(4) charged by the provider of the secondary repository to the provider of the primary repository that made the request shall be fair, reasonable and proportionate to the services rendered. The provider of the secondary repository shall however itself bear any extraordinary costs of the reprocessing operations referred to in Article 28(4) to the extent that it is responsible for the causes leading to the reprocessing operations.’. |
(20) |
Article 32 is amended as follows:
|
(21) |
In Article 33, paragraph 3 is replaced by the following: ‘3. The responsibility for recording and transmitting the information referred to in paragraph 2 shall lie with the economic operator who is the vendor. To this end, all the reporting activities shall use the identifier code of this economic operator. IT service providers may also transmit this information on behalf of the economic operator who is the vendor of the tobacco products.’. |
(22) |
Article 34 is amended as follows:
|
(23) |
Article 36(1), point (a), is replaced by the following:
|
(24) |
The following Article 36a is inserted: ‘Article 36a Quality of data 1. The Member States may, issue reports on the inadequate quality of data reported by economic operators to the repositories system. These reports shall be addressed to the concerned economic operators and include examples of misreporting. 2. Member States shall require ID issuers to perform checks of addresses and other electronically verifiable data that are provided to the system by economic operators and operators of first retail outlets through ID issuers.’. |
(25) |
Annexes I and II are amended in accordance with the Annex to this Regulation. |
(26) |
Annex III is added in accordance with the Annex to this Regulation. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 1 shall apply from 21 December 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 1 March 2023.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 127, 29.4.2014, p. 1.
(2) Commission Implementing Regulation (EU) 2018/574 of 15 December 2017 on technical standards for the establishment and operation of a traceability system for tobacco products (OJ L 96, 16.4.2018, p. 7).
(3) Report from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of Directive 2014/40/EU concerning the manufacture, presentation and sale of tobacco and related products, COM(2021) 249 final.
(4) Protocol to Eliminate Illicit Trade in Tobacco Products to the World Health Organisation’s Framework Convention on Tobacco Control (OJ L 268, 1.10.2016, p. 1).
ANNEX
Implementing Regulation (EU) 2018/574 is amended as follows:
(1) |
Annex I is amended as follows:
|
(2) |
Annex II is amended as follows:
|
(3) |
The following Annex III is added: ‘ANNEX III Structure of a unit-level unique identifier
|
Corrigenda
2.3.2023 |
EN |
Official Journal of the European Union |
L 65/58 |
Corrigendum to Commission Implementing Directive (EU) 2022/1647 of 23 September 2022 amending Directive 2003/90/EC as regards a derogation for organic varieties of agricultural plant species suitable for organic production
( Official Journal of the European Union L 248 of 26 September 2022 )
On page 47, in Article 1, point (1)(b) (amending Article 1(3) of Directive 2003/90/EC), first subparagraph:
for:
‘By way of derogation from the first subparagraph, as regards the value for cultivation or use, organic varieties suitable for organic production, which belong to the species listed in Annex IV, Part A, may, comply instead with the conditions laid down in Part B of that Annex.;’,
read:
‘By way of derogation from the first subparagraph, as regards the value for cultivation or use, organic varieties suitable for organic production, which belong to the species listed in Annex V, Part A, may comply instead with the conditions laid down in Part B of that Annex.’