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Document L:2022:122:FULL

Official Journal of the European Union, L 122, 25 April 2022


Display all documents published in this Official Journal
 

ISSN 1977-0677

Official Journal

of the European Union

L 122

European flag  

English edition

Legislation

Volume 65
25 April 2022


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2022/670 of 2 February 2022 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of EU-wide real-time traffic information services ( 1 )

1

 

*

Commission Delegated Regulation (EU) 2022/671 of 4 February 2022 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards specific rules on official controls performed by the competent authorities on animals, products of animal origin and germinal products, follow-up action to be taken by the competent authority in case of non-compliance with identification and registration rules for bovine, ovine and caprine animals or of non-compliance during transit through the Union of certain bovine animals, and repealing Commission Regulation (EC) No 494/98 ( 1 )

17

 

*

Commission Implementing Regulation (EU) 2022/672 of 22 April 2022 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food trans-resveratrol (from microbial source) ( 1 )

24

 

*

Commission Implementing Regulation (EU) 2022/673 of 22 April 2022 authorising the placing on the market of mung bean (Vigna radiata) protein as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 ( 1 )

27

 

*

Commission Implementing Regulation (EU) 2022/674 of 22 April 2022 correcting Implementing Regulation (EU) 2022/95 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

31

 

 

DECISIONS

 

*

Council Decision (EU) 2022/675 of 11 April 2022 on the position to be taken on behalf of the European Union at the 57th session of the Committee of Experts for the Carriage of Dangerous Goods of the Intergovernmental Organisation for International Carriage by Rail as regards certain amendments to Appendix C to the Convention concerning International Carriage by Rail

33

 


 

(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

25.4.2022   

EN

Official Journal of the European Union

L 122/1


COMMISSION DELEGATED REGULATION (EU) 2022/670

of 2 February 2022

supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of EU-wide real-time traffic information services

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (1), and in particular Article 7 thereof,

Whereas:

(1)

Article 3(b) of Directive 2010/40/EU sets as a priority action the provision of EU-wide real-time traffic information services for the development and use of specifications and standards.

(2)

Article 6(1) of Directive 2010/40/EU requires the Commission to adopt specifications necessary to ensure compatibility, interoperability and continuity for the deployment and operational use of Intelligent Transport Systems (ITS) for the provision of EU-wide real-time traffic information services. The Commission establishes these specifications in Commission Delegated Regulation (EU) 2015/962 (2), with a view to improving the accessibility, exchange, re-use and update of data required for the provision of high quality and continuous real-time traffic information services across the Union.

(3)

Data continues to provide the contextual basis for the generation of real-time traffic information. As the deployment of ITS accelerates across the Union, it requires continued support in the form of increased and seamless access to existing and new data types relevant to the provision of real-time traffic information services, with a higher geographical coverage. Therefore, an update of the requirements on data provision is necessary to continue ensuring effective re-use in information services to end users. These updated requirements can potentially affect the entire data chain, from data sourcing, formatting and aggregation to distribution and inclusion in traffic information services.

(4)

Article 5 of Directive 2010/40/EU provides that specifications adopted in accordance with Article 6 of this Directive should apply to the ITS applications and services when these are deployed without prejudice to the right of each Member State to decide on the deployment of such applications and services on its territory.

(5)

These specifications should apply to the provision of all real-time traffic information services without prejudice to particular specifications adopted in other acts under Directive 2010/40/EU, notably Commission Delegated Regulation (EU) No 885/2013 (3) and Commission Delegated Regulation (EU) No 886/2013 (4).

(6)

A market for the provision of real-time traffic information services already exists in the Union and it is in the interest of both the users and customers as well as the providers of those services that the right conditions are created for this market in order to be preserved and further developed in innovative ways. As regards the provision of real-time traffic information services, Directive (EU) 2019/1024 of the European Parliament and of the Council (5) sets out minimum rules for the re-use of public sector information throughout the Union. With respect to the re-use of data held by road authorities and public road operators, the rules established by this Regulation, in particular the ones concerning data updates, are applicable without prejudice to the rules established by the Directive (EU) 2019/1024. With respect to the re-use of data held by private data holders, the rules established by this Regulation do not impose sharing data free of charge. Data held by private data holders may be subject to licence agreements to regulate their re-use.

(7)

Directive 2007/2/EC of the European Parliament and of the Council (6) creates a European Union spatial data infrastructure in order to enable the sharing of and public access to spatial information (including the spatial data theme ‘transport networks’) across the Union with a view to supporting Union environmental policies, and policies or activities which may have an impact on the environment. The specifications set out in this Regulation should be compatible with the specifications established by Directive 2007/2/EC and its implementing acts, in particular Commission Regulation (EU) No 1089/2010 (7). The extension of the application of these specifications to all data types on infrastructure might also promote further harmonisation in this field.

(8)

Regulation (EU) No 1315/2013 of the European Parliament and of the Council (8) defines the road transport infrastructure that is part of the core and the comprehensive trans-European transport network. Recurring traffic externalities and other traffic management difficulties, such as congestion, air pollution or noise, are not limited to the trans-European road network or to motorways. In fact a significant share of recurring traffic congestion occurs in urban areas. Furthermore, EU-wide real-time traffic information services should allow door-to-door travel and should not be limited to the comprehensive network trans-European road network and other motorways. Member States should therefore apply these specifications to the entire road network, with the exception of roads not owned by a public road or transport authority. Roads owned by a public road or transport authority but assigned to a private entity in the form of a management concession should not be part of this exception.

(9)

Specific data types considered crucial for the further development of reliable traffic information services and to improve traffic safety, such as traffic regulations, restrictions and road or lane closures, should be made available by road authorities or road operators. Due to their importance, those data types need to be made accessible as an earlier milestone compared to other data types.

(10)

To allow the necessary developments in the field of data accessibility and standardisation to take place, a phased implementation should be considered. This phasing should provide a feasible and gradual increase in geographical coverage and accessibility to data. For that purpose, Member States should define a primary road network within their territory. To define this primary road network, Member States may re-use the network definition as required by Article 1 of Directive 2008/96/EC of the European Parliament and of the Council (9).

(11)

Given the diversity of data sources ranging from infrastructure based sensors to vehicles acting as sensors, it is important that the specifications are aligned to the relevant data categories and data types, covering multiple possible sources of the data and technology used to create or update the data.

(12)

Where the measures provided for in this Regulation entail the processing of personal data, they should be carried out in accordance with Union law on the protection of personal data and privacy, in particular Regulation (EU) 2016/679 of the European Parliament and of the Council (10), and, where applicable, Directive 2002/58/EC of the European Parliament and of the Council (11). Parts of Directive 2002/58/EC also apply for the processing of non-personal data.

(13)

In order to develop a harmonised and seamless provision of real-time traffic information services, Member States should rely on existing technical solutions and standards, provided by the European and international standardisation organisations, such as DATEX II (CEN/TS 16157 and subsequently upgraded versions) and ISO standards. For data types for which no standardised format is available, Member States and stakeholders should be encouraged to cooperate in order to reach an agreement on data definition, data format and metadata.

(14)

Several dynamic location referencing methods already exist in the Union and are being applied in Member States. The use of different location referencing methods should continue to be allowed. Member States and stakeholders, however, should be encouraged to cooperate with a view to reaching an agreement on allowed methods for location referencing, if necessary through European standardisation bodies.

(15)

The accessibility and regular update of data by road authorities and road operators are essential for enabling the production of up-to-date and accurate digital maps that are a key asset for reliable ITS applications. The digital map producers should be encouraged to integrate relevant data updates into their existing map and map update services in a timely manner. In order to comply with public policies such as road safety, service providers and digital map producers should collaborate with public authorities to correct inaccuracies in their data.

(16)

The accessibility of accurate and up-to-date data are essential for the provision of real-time traffic information services across the Union. The relevant data are collected and stored by road authorities, road operators, holders of in-vehicle generated data, recharging and refuelling-related stakeholders, tolling operators and real-time traffic information service providers. In order to facilitate the easy exchange and re-use of these data for the provision of such services, road authorities, road operators, holders of in-vehicle generated data, recharging and refuelling-related stakeholders, tolling operators and real-time traffic information service providers should make the data, corresponding metadata and information on the quality of the data discoverable and accessible to other road authorities, road operators, recharging and refuelling-related stakeholders, tolling operators, real-time traffic information service providers, digital map producers via the national or common access point. The access point can take the form of a repository, registry, web portal or similar depending on the type of data. National or common access points may also point to other locations where the data can be accessed, without hosting the data itself. Member States should regroup the existing public and private access points in a single point enabling access to all the types of relevant available data that fall within the scope of these specifications. Member States may continue using the access points set up under Delegated Regulation (EU) 2015/962 and they should be free to decide to use the access points established under other delegated acts adopted under Directive 2010/40/EU as the national access points for the data falling within the scope of this Regulation.

(17)

In order to allow road authorities, road operators, recharging and refuelling-related stakeholders, tolling operators, service providers and digital map producers to successfully and cost-efficiently discover and use the relevant data, it is necessary to properly describe the content and structure of this data using appropriate metadata.

(18)

Real-time traffic information services need to be accurate in order to provide the best possible information to end-users in terms of reliability and timeliness. To improve the benefits for road users in terms of increased road safety and less traffic congestion, these services should also reflect the priorities of road authorities, as expressed for example through digitally accessible traffic circulation plans.

(19)

These specifications should not oblige any stakeholder to start collecting any data that they are not already collecting or to digitise any data that is not already available in a digital machine-readable format. The specific requirements regarding the updates of data should only apply to the data that is actually collected and available in a digital machine-readable format. At the same time Member States should be encouraged to look for cost-effective ways that are appropriate for their needs to digitise existing data on infrastructure and data on regulations and restrictions.

(20)

These specifications should not oblige road authorities or road operators to define or implement traffic circulation plans and temporary traffic management measures. They should not oblige service providers to share any of their data with other service providers. Service providers should be free to conclude commercial agreements between themselves for the re-use of relevant data.

(21)

Member States and ITS stakeholders should be encouraged to cooperate to agree on common definitions of data quality with a view to use common data quality indicators throughout the traffic data value chain, such as the completeness, accuracy and up-to-dateness of the data, the acquisition method and location referencing method used, as well as quality checks applied. They should also be encouraged to work further to establish associated methods of quality measurement and monitoring of the different data types. Member States should be encouraged to share with each other their knowledge, experience and best practices in this field in the on-going and future coordination projects.

(22)

It is acknowledged that the use of data and real-time traffic information services generated by private service providers and holders of in-vehicle generated data can represent a cost-effective way for road authorities and road operators to improve traffic management, road safety as well as infrastructure management and maintenance. Common FRAND terms should be used by public authorities when receiving these data or services for the above-mentioned tasks, in order to lower the barriers for access and create transparency on the conditions for re-use. Member States and relevant stakeholders are encouraged to define the common FRAND terms applicable to the re-use of the relevant data types for the execution of these public tasks.

(23)

Private service providers may use data collected by road authorities and road operators as input data for their own real-time traffic information services. The specific terms and conditions applicable for such re-use of these data should be left to the parties concerned without prejudice to the provisions of Directive (EU) 2019/1024 (12). Certain data types provided by road authorities and road operators, such as traffic circulation plans, traffic regulations and restrictions and temporary traffic management measures, should be re-used by private services providers in order to ensure the accessibility for road users to the relevant information via real-time traffic information services.

(24)

In order to make sure that these specifications are correctly implemented, Member States should assess the compliance with the requirements concerning the accessibility, exchange, re-use and update of the data by the road authorities, road operators, digital map producers, tolling operators, recharging and refuelling-related stakeholders, holders of in-vehicle generated data and service providers. To that end the competent authorities should be free to rely on evidence-based declarations of compliance submitted by road authorities, road operators, digital map producers, tolling operators, recharging and refuelling-related stakeholders, holders of in-vehicle generated data and service providers. Member States should work together to harmonise their approach towards the assessment of compliance in the on-going and future coordination projects, which help to implement the specifications of this Regulation.

(25)

These specifications do not limit the freedom of expression of radio broadcasters insofar as they do not oblige them to take any specific position with respect to the information to be disseminated, and leave sufficient room for the Member States to take account of their national constitutional traditions as regards the freedom of expression of radio broadcasters.

(26)

Taking into account the extent of the required changes, Delegated Regulation (EU) 2015/962 should be repealed,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation establishes the specifications necessary in order to ensure the accessibility, exchange, re-use and update of data by data holders and data users for the provision of EU-wide real-time traffic information services, and to ensure that these services are accurate and available across borders to end-users.

2.   This Regulation applies to the entire road network that is publicly accessible to motorised traffic. By way of exception, it shall not apply to private roads, unless they are part of the comprehensive TEN-T network or they are designated as a motorway or as a primary road.

3.   This Regulation shall apply in accordance with Article 5 of Directive 2010/40/EU.

Article 2

Definitions

For the purposes of this Regulation, the definitions in Article 4 of Directive 2010/40/EU shall apply.

The following definitions shall also apply:

(1)

‘core trans-European road network’ means the road transport infrastructure that is part of the core network as defined in Regulation (EU) No 1315/2013;

(2)

‘comprehensive trans-European road network’ means the road transport infrastructure that is part of the comprehensive network as defined in Regulation (EU) No 1315/2013;

(3)

‘motorway’ means a road which is designated as such by the Member State in which it is located;

(4)

‘accessibility of the data’ means a possibility to request and obtain the data at any time in a digital machine-readable format;

(5)

‘static data’ means data that do not change often or on a regular basis;

(6)

‘dynamic data’ means data that change often or on a regular basis;

(7)

‘data update’ means any modification of the existing data, including its deletion or insertion of new or additional elements;

(8)

‘real-time traffic information’ means information derived from any data on the infrastructure, data on regulations and restrictions, data on the state of the network and data on the real-time use of the network, or the combination thereof;

(9)

‘real-time traffic information service’ means an ITS service that provides end-users immediately with real-time traffic information;

(10)

‘road authority’ means any public authority responsible for the planning, control or management of roads falling within its territorial competence;

(11)

‘road operator’ means any public or private entity that is responsible for the maintenance and management of the road and management of traffic flows;

(12)

‘service provider’ means any public or private provider of a real-time traffic information service, excluding a mere conveyer of data to data users;

(13)

‘tolling operator’ means any public or private entity taking the role of toll service provider or toll charger as defined in Directive (EU) 2019/520 of the European Parliament and of the Council (13);

(14)

‘data holder’ means any legal person, data subject or public or private entity who has the right to grant access to or to share the data types listed in the Annex under its control, in accordance with applicable Union or national law;

(15)

‘data user’ means any road authority, road operator, tolling operator, service provider and digital map producer or any other entity using data to create real-time traffic information or, where allowed by the terms and conditions determined by the data holder, using the data for other mobility related purposes;

(16)

‘end-user’ means any road user, natural or legal person, who has access to real-time traffic information services;

(17)

‘access point’ means a digital interface where data listed in the Annex, together with the corresponding metadata, are made accessible for re-use to data users, or where the sources and metadata of these data are made accessible for re-use to data users;

(18)

‘metadata’ means a structured description of the contents of the data facilitating the discovery and use of this data;

(19)

‘discovery services’ means services allowing for the search of the requested data using the contents of the corresponding metadata and displaying such contents;

(20)

‘temporary traffic management measures’ means temporary measures intended to solve a given traffic disturbance and designed for example to control and guide traffic flows;

(21)

‘traffic circulation plans’ means permanent traffic management measures that are designed by traffic managers to control and guide traffic flows in response to permanent or recurring traffic disturbances;

(22)

‘traffic signs’ means any road sign, signal, device, notice or road marking that identifies a danger, advises persons of the precautions to be taken against such danger, indicates the existence of a road regulation or implements such a regulation, following the Vienna Convention on Road Signs and Signals;

(23)

‘primary roads’ means a road outside urban areas that connects major cities or regions, or both, not classified as part of the comprehensive trans-European road network or as a motorway;

(24)

‘private roads’ means a road not owned by a public road or transport authority, excluding roads owned by a public road or transport authority but assigned to a private entity in the form of a management concession;

(25)

‘data on infrastructure’ means data that describes the road network or facilities on or along the road network;

(26)

‘data on regulations and restrictions’ means data that relates to a traffic regulation or a restriction applicable to vehicles on the road network;

(27)

‘data on the state of the network’ means data that describes temporary situations which could prevent or slow travel or can inform the end-user in dangerous situations;

(28)

‘data on the real-time use of the network’ means data that describes the current use of the road network and usage options on the road network;

(29)

‘crucial data types’ means data types which are considered crucial for the benefit of increased reliability of real-time traffic information services, supporting safe and efficient door-to-door travel and future mobility services;

(30)

‘in-vehicle generated data’ means any data created by the vehicle or by an on-board device embedded in the vehicle or personal devices offering ITS-applications while the vehicle is in use;

(31)

‘holder of in-vehicle generated data’ means any entity engaged in in-vehicle generated data collection, aggregation or other types of processing to fulfil privacy requirements;

(32)

‘FRAND (Fair, Reasonable and Non-Discriminatory) conditions’ means licence terms negotiated in good faith, allowing access to services or data in exchange of a fair reward, under the same or similar terms as determined with other users.

Article 3

National Access Points

1.   Each Member State shall set up a national access point. The national access point shall constitute a single point of access for data users to the data listed in the Annex, including data updates, provided by the data holders as referred to in Articles 4 to 11 and concerning the territory of a given Member State.

2.   Existing national or common access points that have been set up to comply with Article 3 of Delegated Regulation (EU) 2015/962 or with the requirements arising from other delegated acts adopted under Directive 2010/40/EU may be used as national access points for the purposes of this Regulation if deemed appropriate by the Member States.

3.   National access points shall provide discovery services to data users, for example services allowing for the search of the requested data using the contents of the corresponding metadata and displaying such contents.

4.   Public and private data holders shall ensure that they provide the metadata in order to allow data users to discover and use datasets via national access points.

5.   Two or more Member States may set up a common access point.

6.   Any entity providing data via the National Access Point can do so by proxy in accordance with applicable agreements, for example through a third party database or aggregator. This does not relieve the original data holder of responsibilities regarding the quality of the original data being provided.

Article 4

Accessibility, exchange and re-use of data on infrastructure

1.   For the purpose of facilitating the provision of compatible, interoperable, and continuous real-time traffic information services across the Union, road authorities, road operators, tolling operators and recharging and refuelling-related stakeholders shall provide the data on infrastructure listed in the Annex they collect in a standardised format such as the INSPIRE data specification on transport networks, TN-ITS (CEN/TS17268 and subsequently upgraded versions) or DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions). Any update to this data shall be carried out pursuant to Article 8.

If additional or alternative standards are to be defined, the following conditions shall apply:

Member States shall cooperate in order to define these additional or alternative standards;

digital machine-readable formats shall be compatible with existing standards referred to in the first sentence of this paragraph.

2.   The data referred to in paragraph 1 and the corresponding metadata including information on the quality thereof shall be accessible for exchange and re-use by any data user within the Union:

(a)

on a non-discriminatory basis;

(b)

following minimum quality requirements that Member States shall agree upon in cooperation with relevant stakeholders;

(c)

within a time-frame fitting to the reliable and effective use of the data to create real-time traffic information;

(d)

via the national or common access point referred to in Article 3.

3.   Data users using the data referred to in paragraph 1 and data holders shall collaborate in order to ensure that any inaccuracies related to the data are signalled without delay to the data holder from which the data originates.

Article 5

Accessibility, exchange and re-use of data on regulations and restrictions

1.   For the purpose of facilitating the provision of compatible, interoperable, and continuous real-time traffic information services across the Union, road authorities, road operators and tolling operators shall provide the data on regulations and restrictions listed in the Annex they collect in DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions) or TN-ITS (CEN/TS 17268 and subsequently upgraded versions) format. Any update to this data shall be carried out pursuant to Article 9.

If additional or alternative standards are to be defined, the following conditions shall apply:

Member States shall cooperate in order to define these additional or alternative standards;

digital machine-readable formats shall be compatible with existing standards referred to in the first sentence of this paragraph.

2.   The data referred to in paragraph 1 and the corresponding metadata including information on the quality thereof shall be accessible for exchange and re-use by any data user within the Union:

(a)

on a non-discriminatory basis;

(b)

following minimum quality requirements that Member States shall agree upon in cooperation with relevant stakeholders;

(c)

within a time-frame fitting to the reliable and effective use of the data to create real-time traffic information;

(d)

via the national or common access point referred to in Article 3.

3.   Data users using the data referred to in paragraph 1 and data holders shall collaborate in order to ensure that any inaccuracies related to the data are signalled without delay to the data holder from which the data originates.

4.   Service providers shall process and include, in the relevant services they provide, without additional costs to the end-user, data on any traffic circulation plans and traffic regulations and restrictions developed by the competent authorities and made accessible via the national or common access point in a digital machine-readable format.

Article 6

Accessibility, exchange and re-use of data on the state of the network

1.   For the purpose of facilitating the provision of compatible, interoperable, and continuous real-time traffic information services across the Union, road authorities, road operators, holders of in-vehicle generated data and service providers shall provide the data on the state of the network listed in the Annex they collect in DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions) format. Any update to this data shall be carried out pursuant to Article 10.

If additional or alternative standards are to be defined, the following conditions shall apply:

Member States shall cooperate in order to define these additional or alternative standards;

digital machine-readable formats shall be compatible with existing standards referred to in the first sentence of this paragraph.

2.   The data referred to in paragraph 1 and the corresponding metadata including information on the quality thereof shall be accessible for exchange and re-use by any data user within the Union:

(a)

on a non-discriminatory basis when provided by road authorities and road operators;

(b)

following minimum quality requirements that Member States shall agree upon in cooperation with relevant stakeholders;

(c)

within a time-frame fitting to the reliable and effective use of the data to create real-time traffic information;

(d)

via the national or common access point referred to in Article 3;

(e)

without any obligation on holders of in-vehicle generated data and private service providers to grant access to or share any of their data with private data users. Exchange and re-use of their data may be subject to terms and conditions determined by the private data holder.

3.   Data users using the data referred to in paragraph 1 and data holders shall collaborate in order to ensure that any inaccuracies related to the data are signalled without delay to the data holder from which the data originates.

4.   Service providers shall process and include, without additional costs to the end-user, in the relevant services they provide, any temporary traffic management measures developed by the competent authorities and made accessible via the national or common access point in a digital machine-readable format.

5.   For the purpose of providing appropriate information directly to the end-users and optimising road maintenance and road safety, road authorities and road operators may request holders of in-vehicle generated data and service providers to provide the data types on the state of the network they collect and update pursuant to Article 10. Where, in response to a request from a road authority or road operator, the data holder makes the data accessible, FRAND (Fair, Reasonable And Non-Discriminatory) conditions shall apply. The data shall be provided in DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions) format or any digital machine-readable format agreed upon by Member States, accompanied by the corresponding metadata including information on the quality thereof.

6.   Data on the state of the network that has been archived by road authorities or road operators may be used for purposes of road infrastructure safety management and network-wide road safety assessments. Unless prohibited by licence agreements, this data shall be made accessible for exchange and re-use, on a non-discriminatory basis, via the national or common access point referred to in Article 3.

7.   Within the limits of applicable licence agreements, predictive data on the state of the network that has been computed by road authorities or road operators, shall be made accessible for exchange and re-use, on a non-discriminatory basis, via the national or common access point referred to in Article 3.

8.   Member States shall collaborate on defining common standards for the exchange and re-use of data referenced in paragraphs 6 and 7.

Article 7

Accessibility, exchange and re-use of data on the real-time use of the network

1.   For the purpose of facilitating the provision of compatible, interoperable, and continuous real-time traffic information services across the Union, road authorities, road operators, service providers, holders of in-vehicle generated data and recharging and refuelling-related stakeholders shall provide the data on the real-time use of the network listed in the Annex they collect in DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions) format. Any update to this data shall be carried out pursuant to Article 11.

If additional or alternative standards are to be defined, the following conditions shall apply:

Member States shall cooperate in order to define these additional or alternative standards;

digital machine-readable formats shall be compatible with existing standards referred to in the first sentence of this paragraph.

2.   The data referred to in paragraph 1 and the corresponding metadata including information on the quality thereof shall be accessible for exchange and re-use by any data users within the Union:

(a)

on a non-discriminatory basis when provided by road authorities and road operators;

(b)

following minimum quality requirements that Member States shall agree upon in cooperation with relevant stakeholders;

(c)

within a time-frame fitting to the reliable and effective use of the data to create real-time traffic information;

(d)

via the national or common access point referred to in Article 3;

(e)

without any obligation on holders of in-vehicle generated data and private service providers to grant access to or share any of their data with private data users. Exchange and re-use of their data may be subject to terms and conditions determined by the private data holder.

3.   For the purpose of providing appropriate information directly to end-users and optimising traffic management and road safety, road authorities and road operators may request holders of in-vehicle generated data and service providers to provide the data types on the real-time use of the network they collect and update pursuant to Article 11. Where, in response to a request from a road authority or road operator, the data holder makes the data accessible, FRAND (Fair, Reasonable And Non-Discriminatory) conditions shall apply. The data shall be provided in DATEX II (EN 16157, CEN/TS 16157 and subsequently upgraded versions) format or any digital machine-readable format agreed upon by Member States, accompanied by the corresponding metadata including information on the quality thereof.

4.   Data on the real-time use of the network that has been archived by road authorities or road operators may be used for purposes of road infrastructure safety management and network-wide road safety assessments. Unless prohibited by licence agreements, this data shall be made accessible for exchange and re-use, on a non-discriminatory basis, via the national or common access point referred to in Article 3.

5.   Within the limits of applicable licence agreements, predictive data on the real-time use of the network that has been computed by road authorities or road operators, shall be made accessible for exchange and re-use on a non-discriminatory basis, via the national or common access point referred to in Article 3.

6.   Member States shall collaborate on defining common standards for the exchange and re-use of data referenced in paragraphs 4 and 5.

Article 8

Updating data on infrastructure

1.   The updates of the data on infrastructure shall concern as a minimum the following parameters:

(a)

the type of data as set out in point 1 of the Annex concerned by the update;

(b)

the location of the condition concerned by the update;

(c)

the type of update (modification, insertion or deletion);

(d)

the description of the update, containing the updated value(s) and field(s) and updated information, and where relevant, the reasons for replacing the outdated value(s) and field(s);

(e)

the date on which the data has been updated;

(f)

the date and time when the change in a given condition has occurred or is planned to occur;

(g)

the quality of the data update as defined in quality requirements that Member States shall agree upon in cooperation with relevant stakeholders.

The location of the condition concerned by the update shall be determined using a standardised or any other widely used and generally accepted dynamic location referencing method that enables unambiguous decoding and interpretation of that location.

2.   The relevant data holders shall ensure the update of data on infrastructure within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services and, where known and possible, provide those updates to data users in advance.

3.   The relevant data holders shall in a timely manner correct any inaccuracies detected by them in their data or signalled to them by any data users and end-users.

4.   When digital map producers and service providers present information to end users, they shall ensure that relevant data updates on infrastructure are processed within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services.

Article 9

Updating data on regulations and restrictions

1.   The updates of the data on regulations and restrictions shall concern as a minimum the following parameters:

(a)

the type of data as set out in points 2 and 3 of the Annex concerned by the update;

(b)

the location of the condition concerned by the update;

(c)

the type of update (modification, insertion or deletion);

(d)

the description of the update, including the period of occurrence of the event and condition(s) imposed, for example on certain types of vehicles, concerned by the update;

(e)

the date on which the data has been updated;

(f)

the date and time when the change in a given condition has occurred or is planned to occur;

(g)

the quality of the data update as defined in quality requirements that Member States shall agree upon in cooperation with relevant stakeholders.

The location of the condition concerned by the update shall be determined using a standardised or any other widely used and generally accepted dynamic location referencing method that enables unambiguous decoding and interpretation of this location.

2.   The relevant data holders shall ensure the update of data on regulations and restrictions within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services and, where known and possible, provide these updates to data users in advance.

3.   The relevant data holders shall in a timely manner correct any inaccuracies detected by them in their data or signalled to them by any data users and end-users.

4.   When digital map producers and service providers present information to end users, they shall ensure that relevant data updates on regulations and restrictions are processed within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services.

5.   The real-time traffic information shall be modified accordingly or withdrawn as soon as possible after the status of the data concerned has changed.

Article 10

Updating data on the state of the network

1.   The updates of the data on the state of the network shall concern as a minimum the following parameters:

(a)

the type of data as set out in points 4 and 5 of the Annex concerned by the update and, where appropriate, a short description of it;

(b)

the location of the event or condition concerned by the update;

(c)

the period of occurrence of the event or condition concerned by the update;

(d)

the quality of the data update as defined in quality requirements that Member States shall agree upon in cooperation with relevant stakeholders.

The location of the event or condition concerned by the update shall be determined using a standardised or any other widely used and generally accepted dynamic location referencing method that enables unambiguous decoding and interpretation of this location.

2.   The relevant data holders shall ensure the update of data on the state of the network within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services and, where known and possible, provide these updates in advance.

3.   The relevant data holders shall in a timely manner correct any inaccuracies detected by them in their data or signalled to them by any data users and end-users.

4.   The real-time traffic information shall be modified accordingly or withdrawn as soon as possible after the status of data concerned has changed.

5.   When service providers present information to end users, they shall ensure that relevant data updates on the state of the network are processed within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services.

Article 11

Updating data on the real-time use of the network

1.   The updates of the data on the real-time use of the network shall include as a minimum the following parameters:

(a)

the type of data as set out in point 6 of the Annex concerned by the update and, where appropriate, a short description of it;

(b)

the location of the event or condition concerned by the update;

(c)

the quality of the data update as defined in quality requirements that Member States shall agree upon in cooperation with relevant stakeholders.

The location of the event or condition concerned by the update shall be determined using a standardised or any other widely used and generally accepted dynamic location referencing method that enables unambiguous decoding and interpretation of this location.

2.   The real-time traffic information or related data shall be modified accordingly or withdrawn as soon as possible after the status of the data concerned has changed.

3.   When service providers present information to end users, they shall ensure that data updates on the real-time use of the network are processed within a timeframe fitting to the reliable and effective use of the data in real-time traffic information services.

Article 12

Assessment of compliance

1.   Member States shall assess whether the requirements set out in Articles 3 to 11 are complied with by the data holders and data users to which these articles apply in accordance with paragraphs 2 and 3.

2.   In order to proceed to the assessment, the competent authorities of Member States may request from any data holders and data users the following documents:

(a)

a description of the data, digital map or real-time traffic information services they provide as well as the information on the quality thereof and the conditions of re-use of these data;

(b)

an evidence-based declaration of compliance with the requirements set out in Articles 3 to 11.

3.   Member States shall randomly check the correctness of the declarations referred to in point (b) of paragraph 2.

Article 13

Reporting

1.   By 1 January 2023 at the latest, Member States shall provide the Commission with the list and map visualisation of roads included in the primary road network.

2.   Member States shall provide the Commission with the following information as part of the progress reports provided for in Article 17(3) of Directive 2010/40/EU:

(a)

the progress made in terms of the accessibility, exchange and re-use of the data types set out in the Annex;

(b)

the geographical scope of the data accessible via the National Access Point, changes to the primary road network and to the data content of real-time traffic information services and their quality, including the criteria used to define this quality and the means used to monitor it;

(c)

the results of the assessment of compliance referred to in Article 12 with the requirements set out in Articles 3 to 11;

(d)

where relevant, a description of changes to the national or common access point.

Article 14

Transitional provisions

For a transitional period ending on 31 December 2027, obligations related to data types under points 1, 3, 5 and 6 of the Annex shall not apply with respect to roads other than the following:

(a)

comprehensive trans-European road network;

(b)

other motorways not included in comprehensive trans-European road network;

(c)

primary roads.

Article 15

Repeal

Delegated Regulation (EU) 2015/962 is repealed from 1 January 2025.

Article 16

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2025.

However, Article 13 shall apply from 1 January 2023.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 2 February 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  (OJ L 207, 6.8.2010, p. 1).

(2)  Commission Delegated Regulation (EU) 2015/962 of 18 December 2014 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of EU-wide real-time traffic information services (OJ L 157, 23.6.2015, p. 21).

(3)  Commission Delegated Regulation (EU) No 885/2013 of 15 May 2013 supplementing ITS Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of information services for safe and secure parking places for trucks and commercial vehicles (OJ L 247, 18.9.2013, p. 1).

(4)  Commission Delegated Regulation (EU) No 886/2013 of 15 May 2013 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to data and procedures for the provision, where possible, of road safety-related minimum universal traffic information free of charge to users (OJ L 247, 18.9.2013, p. 6).

(5)  Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

(6)  Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE) (OJ L 108, 25.4.2007, p. 1).

(7)  Commission Regulation (EU) No 1089/2010 of 23 November 2010 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards interoperability of spatial data sets and services (OJ L 323, 8.12.2010, p. 11).

(8)  Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1).

(9)  Directive 2008/96/EC of the European Parliament and of the Council of 19 November 2008 on road infrastructure safety management (OJ L 319, 29.11.2008, p. 59).

(10)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

(11)  Directive 2002/58/EC of the European Parliament and of the Council of 12 July 2002 concerning the processing of personal data and the protection of privacy in the electronic communications sector (Directive on privacy and electronic communications) (OJ L 201, 31.7.2002, p. 37).

(12)  Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

(13)  Directive (EU) 2019/520 of the European Parliament and of the Council of 19 March 2019 on the interoperability of electronic road toll systems and facilitating cross-border exchange of information on the failure to pay road fees in the Union (OJ L 91, 29.3.2019, p. 45).


ANNEX

(as referred to in Articles 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13 and 14)

(1)   

The types of data on infrastructure:

(a)

road network links and their physical attributes:

(i)

geometry;

(ii)

road width;

(iii)

number of lanes;

(iv)

gradients;

(v)

junctions;

(b)

road classification;

(c)

location of tolling stations;

(d)

location of service areas and rest areas;

(e)

location of recharging points for electric vehicles and the conditions for their use;

(f)

location of compressed natural gas, liquefied natural gas, liquefied petroleum gas stations;

(g)

location of refuelling points and stations for all other fuel types;

(h)

location of delivery areas.

(2)   

The crucial types of data on regulations and restrictions:

(a)

static and dynamic traffic regulations, where applicable:

(i)

access conditions for tunnels;

(ii)

access conditions for bridges;

(iii)

permanent access restrictions;

(iv)

speed limits;

(v)

freight delivery regulations;

(vi)

overtaking bans on heavy goods vehicles;

(vii)

weight/length/width/height restrictions;

(viii)

one-way streets;

(ix)

boundaries of restrictions, prohibitions or obligations with zonal validity, current access status and conditions for circulation in regulated traffic zones;

(x)

direction of travel on reversible lanes;

(b)

traffic circulation plans.

(3)   

Other types of data on regulations and restrictions:

(a)

the location and identification of traffic signs reflecting traffic regulations and identifying dangers:

(i)

access conditions for tunnels;

(ii)

access conditions for bridges;

(iii)

permanent access restrictions;

(iv)

other traffic signs reflecting traffic regulations;

(b)

static and dynamic traffic regulations, where applicable, other than traffic regulations referred to in point (2);

(c)

identification of tolled roads, applicable fixed user charges and available payment methods (including retail channels and fulfilment methods);

(d)

variable road user charges and available payment methods, including retail channels and fulfilment methods.

(4)   

The crucial types of data on the state of the network:

(a)

road closures;

(b)

lane closures;

(c)

roadworks;

(d)

temporary traffic management measures.

(5)   

Other types of data on the state of the network:

(a)

bridge closures;

(b)

accidents and incidents;

(c)

poor road conditions;

(d)

weather conditions affecting road surface and visibility.

(6)   

The types of data on the real-time use of the network:

(a)

traffic volume;

(b)

traffic speed;

(c)

location and length of traffic queues;

(d)

travel times;

(e)

waiting time at border crossings;

(f)

availability of delivery areas;

(g)

availability of recharging points and stations for electric vehicles;

(h)

availability of refuelling points and stations for alternative fuel types;

(i)

price of ad hoc recharging/refuelling.


25.4.2022   

EN

Official Journal of the European Union

L 122/17


COMMISSION DELEGATED REGULATION (EU) 2022/671

of 4 February 2022

supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards specific rules on official controls performed by the competent authorities on animals, products of animal origin and germinal products, follow-up action to be taken by the competent authority in case of non-compliance with identification and registration rules for bovine, ovine and caprine animals or of non-compliance during transit through the Union of certain bovine animals, and repealing Commission Regulation (EC) No 494/98

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 20, paragraph (2), points (a) and (c) thereof,

Whereas:

(1)

Regulation (EU) 2017/625 lays down general rules for official controls performed by the competent authorities for the verification of compliance with rules in a number of areas, including animal health requirements. That Regulation also lays down methods and techniques for official controls, which include inspections of premises, animals and goods under the control of operators. In addition, Regulation (EU) 2017/625 lays down possible actions to be taken by the competent authorities in case of established non-compliance with, among others, animal health requirements referred to in Article 1, paragraph (2), point (d), of that Regulation.

(2)

Regulation (EU) 2016/429 of the European Parliament and of the Council (2) repealed and replaced 39 acts in the area of animal health as from 21 April 2021. Some of the requirements in the acts repealed by or pursuant to the Regulation (EU) 2016/429 relate, however, to certain animal health-related specificities of official controls and follow-up action to be taken in case of established non-compliances under Regulation (EU) 2017/625 as set out in Article 138 thereof. Such specific rules on official controls and follow-up actions to be taken by the competent authority in case of established non-compliance should therefore be laid down in this Regulation.

(3)

Specificities of official controls and follow-up actions in case of established non-compliances related to animal health are interrelated. They apply to subsequent stages of a given situation and very often, apply to the same types of operators and establishments. Where specific follow-up actions are needed, they should be laid down together with the requirements for specificities of official controls related to animal health. This provides for a comprehensive set of measures enabling an easier implementation and contributing to the overall simplification of the legal framework in this area.

(4)

Performance of official controls and follow-up actions in establishments approved in accordance with Commission Delegated Regulations (EU) 2019/2035 (3), (EU) 2020/686 (4), (EU) 2020/688 (5) or (EU) 2020/990 (6) requires specific qualifications and competencies in the veterinary field. Official controls in those approved establishments involve assessment and verification of a wide variety of specific data and information related to animals kept therein. Some of these data and information are the results of observations made in animals, while others are collected and recorded by operators, animal health professionals, veterinarians, or aquatic animal health professionals. Such data and information can concern among other things the physiological or pathological state of animals, epidemiological factors, the results of physical, clinical or post-mortem examinations and laboratory tests, and data and information collected in relation to biosecurity measures in establishments and the appropriate use and maintence of equipment and facilities.

(5)

In addition, in germinal product establishments, the complexity and technicality of this particular sector requires specialised knowledge from the competent authority responsible for official controls in order to ensure an efficient and effective execution of its duties.

(6)

It is therefore appropriate that official veterinarians should perform the official controls in approved establishments that keep animals or handle germinal products in accordance with Regulation (EU) 2016/429. Rules on the performance of official controls in those establishments should be set out in this Regulation.

(7)

In addition, in some Member States for historical reasons, or due to the lack of veterinarians dealing with aquatic diseases, there exists a specialised profession called ‘aquatic animal health professionals’. These professionals are traditionally not veterinarians but they practice aquatic animal medicine. This Regulation should therefore respect the decision of those Member States, which recognise that profession. In those cases, official aquatic animal health professionals should be able to undertake activities assigned to official veterinarians when performing official controls in approved aquaculture establishments. In accordance with Article 12(2) of Regulation (EU) 2016/429 these aquatic animal health professionals may undertake activities assigned to veterinarians in animal health area, provided, that they are authorised to do so by the Member State concerned under national law. This principle should apply also in this Regulation.

(8)

Among the establishments approved pursuant to Regulation (EU) 2016/429, confined establishments are particular as they often keep a wide variety of animal species permanently and exchange them with other confined establishments. Requirements for approval and the safe operation of confined establishments in relation to quarantine, isolation and other biosecurity measures, disease surveillance and control measures under the responsibility of the establishment’s veterinarians, play an important role to ensure that exchanges of animals do not pose a risk in spreading listed or emerging animal diseases between or within Member States. It is therefore appropriate to specify the official controls that should take place in confined establishments.

(9)

As regards official controls to verify compliance with rules on identification and registration of bovine, ovine and caprine animals, specific criteria should be laid down to assist the competent authorities with the risk analysis for the selection of the animals and establishments to be inspected. When those official controls are performed on a representative sample of animals and those official controls identify non-compliance with identification and registration requirements, the competent authorities should inspect all animals in that establishment as a follow-up action.

(10)

Union rules authorise the transit through the Union of bovine animals for breeding and production which otherwise do not comply with the animal health requirements for entry into the Union, under specific derogations and conditions laid down in Commission Delegated Regulations (EU) 2019/2124 (7) and (EU) 2020/692 (8). Such transit should not jeopardise animal and public health in the Union. In case of non-compliance, irregularity or emergency during transit, the competent authority should therefore order the slaughter or killing of those animals, as that is the most appropriate measure to safeguard animal and public health and animal welfare. In those cases, the competent authority should also order the safe disposal of the resulting animal by-products in accordance with Regulation (EC) No 1069/2009 of the European Parliament and of the Council (9).

(11)

Commission Regulation (EC) No 494/98 (10) lays down administrative sanctions to be applied when non-compliances with the conditions or requirements for the identification and registration of bovine animals is established. Delegated Regulation (EU) 2019/2035 did not expressly repeal that Regulation. In addition, the administrative sanctions laid down in Regulation (EC) No 494/98 have become redundant in view of the measures set out in Article 138(2) of Regulation (EU) 2017/625. To ensure legal certainty and consistency, this Regulation should repeal Regulation (EC) No 494/98.

(12)

The rules laid down in this Regulation should apply to the United Kingdom in respect of Northern Ireland, in accordance with Article 5(4) of the Protocol on Ireland/Northern Ireland to 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 in conjunction with Annex 2 to that Protocol,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation supplements Regulation (EU) 2017/625 as regards certain specific rules on official controls by the competent authorities of Member States (11) in relation to animals, products of animal origin and germinal products to verify compliance with animal health requirements referred to in Article 1, paragraph (2), point (d), of that Regulation and, where necessary, as regards certain actions taken by the competent authorities following official controls:

(a)

in certain establishments keeping animals;

(b)

in certain establishments collecting, producing, processing or storing germinal products.

2.   This Regulation supplements Regulation (EU) 2017/625 as regards a specific action taken by the competent authorities of Member States following official controls in relation to certain bovine animals in transit.

Article 2

Definitions

For the purposes of this Regulation, the following definitions laid down in Regulation (EU) 2016/429, in Delegated Regulation (EU) 2019/2035, Delegated Regulation (EU) 2020/686, Delegated Regulation (EU) 2020/688, Delegated Regulation (EU) 2020/692 and Delegated Regulation (EU) 2020/990 shall apply:

(a)

‘establishment’ as defined in Article 4, point (27), of Regulation (EU) 2016/429;

(b)

‘hatchery’ as defined in Article 4, point (47), of Regulation (EU) 2016/429;

(c)

‘assembly operation’ as defined in Article 4, point (49), of Regulation (EU) 2016/429;

(d)

‘assembly centre of dogs, cats and ferrets’ as defined in Article 2, point (7), of Delegated Regulation (EU) 2019/2035;

(e)

‘animal shelter’ as defined in Article 2, point (8), of Delegated Regulation (EU) 2019/2035;

(f)

‘control post’ as defined in Article 2, point (9), of Delegated Regulation (EU) 2019/2035;

(g)

‘environmentally isolated production establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2019/2035;

(h)

‘approved quarantine establishment’ as defined in Article 3, point (9), of Delegated Regulation (EU) 2020/688;

(i)

‘confined establishment’ as defined in Article 4, point (48), of Regulation (EU) 2016/429;

(j)

‘approved germinal product establishment’ as defined in Article 2, point (2), of Regulation (EU) 2020/686;

(k)

‘approved aquaculture establishment’ as defined in Article 2, point (10), of Delegated Regulation (EU) 2020/990;

(l)

‘approved group of aquaculture establishments’ as defined in Article 2, point (11), of Delegated Regulation (EU) 2020/990.

(m)

‘establishment veterinarian’ as defined in Article 2(14) of Delegated Regulation (EU) 2019/2035;

(n)

‘bovine animal’ as defined in Article 2, point (5), of Delegated Regulation (EU) 2020/692.

Article 3

Official controls in certain approved establishments

1.   Official veterinarians, or in the case of approved aquaculture establishments and approved groups of aquaculture establishments, official veterinarians or official aquatic animal health professionals, shall perform official controls to verify compliance with animal health requirements referred to in Article 1, paragraph (2), point (d), of Regulation (EU) 2017/625 and laid down in and pursuant to Regulation (EU) 2016/429, in the following types of establishments that have obtained approval from the competent authority:

(a)

hatcheries and establishments keeping poultry;

(b)

establishments for assembly operations for ungulates and poultry;

(c)

assembly centres of dogs, cats and ferrets;

(d)

animal shelters for dogs, cats and ferrets;

(e)

control posts;

(f)

environmentally isolated production establishments for bumble bees;

(g)

approved quarantine establishments;

(h)

confined establishments;

(i)

approved germinal product establishments;

(j)

approved aquaculture establishments

(k)

approved groups of aquaculture establishments.

The official controls referred to in the first subparagraph shall in particular verify that the operators responsible for the approved establishments continue to comply with the approval requirements for those establishments.

2.   The official controls referred to in paragraph 1 of this Article shall include inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625 that shall be performed in accordance with at least the minimum frequencies, where such frequencies are set out in Commission Implementing Regulation (EU) 2022/160 (12).

3.   The inspections referred to in paragraph 2 may be combined with:

(a)

official controls referred to in Article 9, paragraph (3) of Regulation (EU) 2017/625;

(b)

other official controls to verify compliance with requirements referred to in Article 1, paragraph (2), of Regulation (EU) 2017/625; or

(c)

other official controls, inspections or visits provided for in Union rules.

Article 4

Specific rules on official controls in confined establishments of terrestrial animals

When performing official controls in confined establishments of terrestrial animals, the official veterinarian shall in particular:

(a)

verify through the examination of the movement records that the animals entering the given confined establishment come only from another confined establishment or are quarantined in accordance with Part 9, point 1, of Annex I to Delegated Regulation (EU) 2019/2035;

(b)

verify that the results of the clinical, laboratory and post-mortem examinations carried out by the confined establishment’s veterinarian rule out any suspicion of listed or emerging diseases;

(c)

verify that if the presence of listed or emerging diseases is suspected, the operator responsible for the confined establishment notifies that suspicion to the competent authority and mitigates the potential risks to spread such diseases within and outside the confined establishment; and

(d)

audit the activity of the confined establishment’s veterinarian and the implementation and results of the disease surveillance plan referred to in Part 9, point 2(a), of Annex I to Delegated Regulation (EU) 2019/2035 and in particular verify that the disease surveillance plan has been reviewed and updated at least annually in accordance with those requirements.

Article 5

Specific rules on official controls to verify compliances with requirements on identification and registration of bovine, ovine or caprine animals and on follow-up action in case of non-compliance therewith

1.   Official controls to verify compliance with requirements on identification and registration of bovine, ovine or caprine animals shall include inspections referred to in Article 14, point (b), of Regulation (EU) 2017/625 of bovine, ovine or caprine animals in establishments keeping those animals, performed in accordance with at least the minimum frequency set out in Article 6 of Implementing Regulation (EU) 2022/160.

2.   The inspections referred to in paragraph 1 may be combined with:

(a)

official controls referred to in Article 9, paragraph (3), of Regulation (EU) 2017/625;

(b)

other official controls to verify compliance with requirements referred to in Article 1, paragraph (2), of Regulation (EU) 2017/625; or

(c)

other official controls, inspections or visits provided for in Union rules.

3.   When selecting the establishments to be inspected, the competent authority shall take into account the following criteria in its risk analysis in addition to those set out in Article 9, paragraph (1), of Regulation (EU) 2017/625:

(a)

the number of animals in an establishment;

(b)

the species of animals present and identified in an establishment;

(c)

significant changes in comparison with the number or species of animals in the establishment during the last 5 years; and

(d)

any other relevant criteria defined by its Member State.

4.   Where an inspection referred to in paragraph 1 is performed, the competent authority shall inspect all bovine, ovine and caprine animals in that establishment.

5.   By way of derogation from paragraph 4, where the number of animals to be inspected in the establishment exceeds 20, the competent authority may decide to inspect a representative sample of those animals if the number of inspected animals is sufficient to detect 5 % of cases of non-compliance at a 95 % confidence level.

6.   Where an inspection referred to in paragraph 1 is performed on a representative sample of animals in an establishment in accordance with paragraph 5 and that inspection confirms non-compliance with the requirements concerning identification and registration, the competent authority shall inspect all other bovine, ovine and caprine animals in the establishment.

7.   By way of derogation from paragraph 6, the competent authority may decide to inspect a representative sample of animals in that establishment ensuring that the number of inspected animals is sufficient for the estimation of non-compliance over 5 % with precision of plus or minus 2 % for a 95 % confidence level.

Article 6

Follow-up action in case of non-compliance during transit through the Union of certain bovine animals

When consignments of bovine animals, which comply with specific animal health conditions for entry into the Union are in transit through the Union pursuant to Article 176, paragraph (1), point (b), of Delegated Regulation (EU) 2020/692 in conjunction with Article 34, paragraph (1), point (a) of Delegated Regulation (EU) 2019/2124, the competent authority shall order the slaughter or killing of the animals and their disposal as a Category 2 material referred to in Article 9, point (f)(i) of Regulation (EC) No 1069/2009, in case of any non-compliance during the movement between the border control post of entry into the Union and the border control post where the consignments leave the Union territory.

Article 7

Repeal

Regulation (EC) No 494/98 is repealed.

Article 8

Entry into force

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, 4 February 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 95, 7.4.2017, p. 1.

(2)  Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’) (OJ L 84, 31.3.2016, p. 1).

(3)  Commission Delegated Regulation (EU) 2019/2035 of 28 June 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for establishments keeping terrestrial animals and hatcheries, and the traceability of certain kept terrestrial animals and hatching eggs (OJ L 314 5.12.2019, p. 115).

(4)  Commission Delegated Regulation (EU) 2020/686 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards the approval of germinal product establishments and the traceability and animal health requirements for movements within the Union of germinal products of certain kept terrestrial animals (OJ L 174, 3.6.2020, p. 1).

(5)  Commission Delegated Regulation (EU) 2020/688 of 17 December 2019 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health requirements for movements within the Union of terrestrial animals and hatching eggs (OJ L 174, 3.6.2020, p. 140).

(6)  Commission Delegated Regulation (EU) 2020/990 of 28 April 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council, as regards animal health and certification requirements for movements within the Union of aquatic animals and products of animal origin from aquatic animals (OJ L 221, 10.7.2020, p. 42).

(7)  Commission Delegated Regulation (EU) 2019/2124 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for official controls of consignments of animals and goods in transit, transhipment and onward transportation through the Union, and amending Commission Regulations (EC) No 798/2008, (EC) No 1251/2008, (EC) No 119/2009, (EU) No 206/2010, (EU) No 605/2010, (EU) No 142/2011, (EU) No 28/2012, Commission Implementing Regulation (EU) 2016/759 and Commission Decision 2007/777/EC (OJ L 321, 12.12.2019, p. 73).

(8)  Commission Delegated Regulation (EU) 2020/692 of 30 January 2020 supplementing Regulation (EU) 2016/429 of the European Parliament and of the Council as regards rules for entry into the Union, and the movement and handling after entry of consignments of certain animals, germinal products and products of animal origin (OJ L 174, 3.6.2020, p. 379).

(9)  Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (OJ L 300, 14.11.2009, p. 1).

(10)  Commission Regulation (EC) No 494/98 of 27 February 1998 laying down detailed rules for the implementation of Council Regulation (EC) No 820/97 as regards the application of minimum administrative sanctions in the framework of the system for the identification and registration of bovine animals (OJ L 060, 28.2.1998, p. 78).

(11)  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 Regulation references to ‘Member States’ include the United Kingdom in respect of Northern Ireland.

(12)  Commission Implementing Regulation (EU) 2022/160 of 4 February 2022 laying down uniform minimum frequencies of certain official controls to verify compliance with Union animal health requirements in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council and repealing Regulations (EC) No 1082/2003 and (EC) No 1505/2006 (OJ L 26, 7.2.2022, p. 11).


25.4.2022   

EN

Official Journal of the European Union

L 122/24


COMMISSION IMPLEMENTING REGULATION (EU) 2022/672

of 22 April 2022

amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food trans-resveratrol (from microbial source)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list of novel foods may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) has established a Union list of novel foods.

(3)

The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes trans-resveratrol from synthetic and microbial sources as an authorised novel food.

(4)

The novel food trans-resveratrol from a microbial source has been authorised as a novel food ingredient under pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), in capsule or tablet form, for the adult population on the basis of its substantial equivalence to resveratrol with a history of consumption before 15 May 1997 extracted from the Japanese knotweed (Fallopia japonica).

(5)

Commission Implementing Decision (EU) 2016/1190 (5) authorised the placing on the Union market of synthetic trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97, also to be used in food supplements as defined in Directive 2002/46/EC in capsule or tablet form, for the adult population.

(6)

Commission Implementing Regulation (EU) 2021/51 (6) amended the conditions of use of trans-resveratrol. In particular, the restrictions on the delivery formats of food supplements containing the novel food have been lifted.

(7)

On 29 July 2021, the company Evolva AG (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of trans-resveratrol from a microbial source. The applicant requested to remove the requirement that 100 % of the particles of the novel food produced by S. cerevisiae should be of a size less than 62,23 micrometres (< 62,23 μm).

(8)

The applicant justifies the request by indicating that the change is necessary in order to take account of the variation in the particle sizes of trans-resveratrol from a microbial source in the course of its production process and processing for use in food supplements. In support of the request, the applicant provided analytical data demonstrating that the particle size profile of trans-resveratrol from a microbial source is comparable to the particle size profile of the chemically synthesised trans-resveratrol that was evaluated by the European Food Safety Authority (‘the Authority’) (7), and for which no particle size requirements are included in the Union list of novel foods.

(9)

The Commission considers that the requested update of the Union list is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary as the requested removal of the particle size requirement for trans-resveratrol from a microbial source does not alter its safety profile because the analytical evidence submitted by the applicant demonstrates that its particle size distribution profile is comparable to that of the chemically synthesised trans-resveratrol which was evaluated by the Authority.

(10)

The information provided in the application gives sufficient grounds to establish that the requested changes to the specifications of trans-resveratrol are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

(11)

The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is amended 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 April 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

(4)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

(5)  Commission Implementing Decision (EU) 2016/1190 of 19 July 2016 authorising the placing on the market of trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 21.7.2016, p. 53).

(6)  Commission Implementing Regulation (EU) 2021/51 of 22 January 2021 authorising a change of the conditions of use of the novel food ‘trans-resveratrol’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ, L 23, 25.1.2021, p. 10).

(7)  EFSA Journal 2016;14(1):4368.


ANNEX

In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for trans-resveratrol is replaced by the following:

Authorised Novel Food

Specifications

Trans-resveratrol

Description/Definition:

Synthetic: Trans-resveratrol is off-white to beige crystals.

Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol

Chemical formula: C14H12O3

Molecular weight: 228,25 Da

CAS No: 501-36-0

Purity:

Trans-resveratrol: ≥ 98 %-99 %

Total by-products (related substances): ≤ 0,5 %

Any single related substance: ≤ 0,1 %

Sulphated ash: ≤ 0,1 %

Loss on drying: ≤ 0,5 %

Heavy metals:

Lead: ≤ 1,0 ppm

Mercury: ≤ 0,1 ppm

Arsenic: ≤ 1,0 ppm

Impurities:

Diisopropylamine: ≤ 50 mg/kg

Microbial source: A genetically modified strain of Saccharomyces cerevisiae

Appearance: Off-white to slight yellow powder

Trans-resveratrol content: Min. 98 % w/w (dry weight basis)

Ash: Max. 0,5 % w/w

Moisture: Max. 3 % w/w’


25.4.2022   

EN

Official Journal of the European Union

L 122/27


COMMISSION IMPLEMENTING REGULATION (EU) 2022/673

of 22 April 2022

authorising the placing on the market of mung bean (Vigna radiata) protein as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,

Whereas:

(1)

Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

(2)

Pursuant to Article 8 of Regulation (EU) 2015/2283 Commission Implementing Regulation (EU) 2017/2470 (2) establishing a Union list of authorised novel foods, was adopted.

(3)

On 10 March 2020, the company Eat Just, Inc. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place mung bean protein on the Union market as a novel food. The applicant requested for mung bean protein, extracted from seeds of the plant Vigna radiata, to be used in protein products, excluding dairy analogues and beverage whiteners, intended for the general population. The category protein products refer to protein analogues or substitutes for standard products, such as meat, fish, or egg.

(4)

On 10 March 2020, the applicant also made a request to the Commission for the protection of proprietary data for a number of data submitted in support of their application, namely analytical data on phytic acid, lectins, trypsin inhibitors, cyanogenic glycosides and tannins (3).

(5)

In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 5 August 2020, with a request to provide a scientific opinion by carrying out an assessment for the suitability of mung bean protein as a novel food.

(6)

On 14 September 2021, the Authority adopted its scientific opinion ‘Safety of mung bean protein as a novel food pursuant to Regulation (EU) 2015/2283’ (4), in accordance with Article 11 of Regulation (EU) 2015/2283.

(7)

In its opinion, the Authority concluded that mung bean protein, is safe under the proposed in the application conditions of use. Therefore, the Authority’s opinion gives sufficient grounds to establish that mung bean protein, when used as a food ingredient added to protein products, excluding dairy analogues and beverage whiteners, within the general population, complies with requirements set in Article 12(1) of Regulation (EU) 2015/2283.

(8)

In its opinion the Authority concluded on the basis of limited published evidence on food allergy related to the consumption of mung bean proteins and on the basis of evidence demonstrating that mung bean proteins contain a number of potentially allergenic proteins that consumption of this novel food may trigger sensitisation. Considering that to date, evidence directly linking the consumption of mung bean protein to cases of primary sensitisation is equivocal, the Commission considers that no specific labelling requirements concerning the potential of mung bean proteins to cause primary sensitisation should be included in the Union list of authorised novel foods.

(9)

By using a weight of evidence approach on the basis of limited studies and one protein sequence homology analysis performed by the applicant between mung bean protein and those of soybean, peanut and lupin, the Authority in its opinion considered that the consumption of mung bean protein has the potential capacity to induce allergic reactions in persons that are allergic to soybean, peanut, lupin and birch pollen. However, additional in vivo experimental or epidemiological evidence normally needed to confirm or exclude the likelihood that the identified potential cross-reactivity may manifest itself in the population, is lacking. Taking the lack of such evidence, the Commission considers that at present the potential of mung bean proteins to cause cross-reactivity to soybean, peanut, lupin and birch pollen is unlikely to manifest itself in the population and consequently no specific labelling requirement should be included in the Union list of authorised novel foods in this regard.

(10)

In their opinion, the Authority considered that it could not have reached their conclusions on the safety of the mung bean protein without the proprietary analytical data on phytic acid, lectins, trypsin inhibitors, cyanogenic glycosides and tannins submitted by the applicant.

(11)

The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to the scientific evidence provided at the time they submitted the application. Therefore, third parties cannot lawfully access or use those data or refer to those data.

(12)

The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of mung bean protein, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of mung bean protein should be restricted to the applicant for that period.

(13)

However, restricting the authorisation of mung bean protein and of the reference to the data contained in the applicant’s file to the sole use by the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

(14)

The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

1.   Mung bean protein as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

2.   For a period of 5 years from the date of entry into force of this Regulation only the initial applicant:

Company: Eat Just, Inc.;

Address: 2000 Folsom Street San Francisco, CA 94110 USA,

is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of the applicant.

3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex.

Article 2

The data contained in the application file on the basis of which mung bean protein has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, therefore fulfil the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, and shall not be used for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the applicant.

Article 3

The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

Article 4

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, 22 April 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 327, 11.12.2015, p. 1.

(2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

(3)  Analytical results Cyanogenic Glycosides (unpublished)

Sayre_2021 cyanogenic glycosde exec sum (unpublished)

Analytical results lectins (unpublished)

CoAs Phytic acid MB flour 5 batches (unpublished)

CoAs Phytic acid MBP 5 batches (unpublished)

Analytical results tannins (unpublished)

CoAs Trypsin Inhibitors MB flour 5 batches (unpublished)

CoAs Trypsin Inhibitors MBP 5 batches (unpublished).

(4)  EFSA Journal 2021;19(10):6846.


ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

(1)

in Table 1 (Authorised novel foods), the following entry is inserted:

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

Data protection

Mung bean (Vigna radiata) protein

Specified food category

Maximum levels

The designation of the novel food on the labelling of the foodstuffs containing it shall be “mung bean protein from Vigna radiata”.

 

Authorised on 15 May 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.

Applicant: Eat Just, Inc., 2000 Folsom Street San Francisco, CA 94110 USA. During the period of data protection, the novel mung bean protein is authorised for placing on the market within the Union only by Eat Just, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Eat Just, Inc.

End date of the date protection: 15 May 2027.’

Protein products

20 g/100 g

(2)

in Table 2 (Specifications), the following entry is inserted:

Authorised Novel Food

Specification

Mung bean (Vigna radiata) protein

Description/Definition:

The novel food is mung bean protein powder extracted from seeds of the plant Vigna radiata by several processing steps followed by pasteurization and spray drying.

Characteristics/composition:

Moisture: ≤ 6 %

Protein (w/w)(a): ≥ 84 %

Ash (w/w): ≤ 6,0 %

Fat (w/w): ≤ 5,5 %

Carbohydrate (w/w): ≤ 5,0 by calculation

Microbiological criteria:

Aerobic plate count: < 5 000 CFU/g (b)

Yeasts and moulds: < 100 CFU/g

Coliforms: < 100 CFU/g

Escherichia coli: < 10 CFU/g

Listeria monocytogenes: Not detected in 25 g

Salmonella spp.: Not detected in 25 g

(a)

w/w: weight per weight.

(b)

CFU: colony forming units.’


25.4.2022   

EN

Official Journal of the European Union

L 122/31


COMMISSION IMPLEMENTING REGULATION (EU) 2022/674

of 22 April 2022

correcting Implementing Regulation (EU) 2022/95 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (the basic Regulation), and in particular Article 11(2) thereof,

Whereas:

(1)

By Commission Implementing Regulation (EU) 2022/95 (2), the Commission imposed a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China (‘PRC’), as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not.

(2)

By Article 1 of Council Regulation (EC) No 763/2000 (3), three Taiwanese producers, Chup Hsin Enterprise Co. Ltd, Niang Hong Pipe Fittings Co. Ltd, and Rigid Industries Co. Ltd were exempted from the extension of the duty, as it was found that the said companies did not circumvent the measures.

(3)

However, the exemption from the extension of the duty to imports of the fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100) was repealed by Council Regulation (EC) No 803/2009 (4).

(4)

Article 2(1) of Implementing Regulation (EU) 2022/95 erroneously states that imports of fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and by Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100) continue to be exempted from the application of the anti-dumping duties.

(5)

Therefore, the Commission has decided to correct Article 2(1) of Implementing Regulation (EU) 2022/95 in order to rectify the error mentioned in recital (4). This rectification should take effect as from the entry into force of Implementing Regulation (EU) 2022/95, namely 26 January 2022.

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee, established by Article 15(1) of Regulation (EU) 2016/1036,

HAS ADOPTED THIS REGULATION:

Article 1

Article 2(1) of Implementing Regulation (EU) 2022/95 is replaced by the following:

‘1.   The definitive anti-dumping duty imposed by Article 1 on imports originating in the People’s Republic of China is hereby extended to imports of the same fittings (currently classified under TARIC codes: 7307931191; 7307931991; 7307998092) consigned from Taiwan (TARIC additional code A999), whether declared as originating in Taiwan or not, with the exception of those produced by Rigid Industries Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A099).’.

Article 2

Members States’ customs authorities shall correct the customs declarations accepted from 26 January 2022 impacted by Article 1 of this Regulation and retroactively collect the anti-dumping duties on imports of the fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100).

Article 3

This Regulation shall enter into force with retroactive effect as from 26 January 2022.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 22 April 2022.

For the Commission

The President

Ursula VON DER LEYEN


(1)  OJ L 176, 30.6.2016, p. 21.

(2)  Commission Implementing Regulation (EU) 2022/95 of 24 January 2022 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not, following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 16, 25.1.2022, p. 36).

(3)  Council Regulation (EC) No 763/2000 of 10 April 2000 extending the definitive anti-dumping duty, imposed by Regulation (EC) No 584/96 on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China to imports of certain tube and pipe fittings, of iron or steel, consigned from Taiwan, whether declared as originating in Taiwan or not, and terminating the investigation in respect of imports from three Taiwanese exporters (OJ L 94, 14.4.2000, p. 1).

(4)  Council Regulation (EC) No 803/2009 of 27 August 2009 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China and Thailand, and those consigned from Taiwan, whether declared as originating in Taiwan, or not, and repealing the exemption granted to Chup Hsin Enterprise Co. Ltd and Nian Hong Pipe Fittings Co. Ltd (OJ L 233, 4.9.2009, p. 1).


DECISIONS

25.4.2022   

EN

Official Journal of the European Union

L 122/33


COUNCIL DECISION (EU) 2022/675

of 11 April 2022

on the position to be taken on behalf of the European Union at the 57th session of the Committee of Experts for the Carriage of Dangerous Goods of the Intergovernmental Organisation for International Carriage by Rail as regards certain amendments to Appendix C to the Convention concerning International Carriage by Rail

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91, in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

(1)

The Union acceded to the Convention concerning International Carriage by Rail of 9 May 1980, as amended by the Vilnius Protocol of 3 June 1999 (‘COTIF’), by means of Council Decision 2013/103/EU (1).

(2)

According to Article 6 of the COTIF, international rail traffic and admission of railway material in international traffic are to be governed by rules listed in that Article, in particular the ‘Regulation concerning the International Carriage of Dangerous Goods by Rail (RID)’ which form Appendix C to COTIF.

(3)

Directive 2008/68/EC of the European Parliament and of the Council (2) lays down requirements for the transport of dangerous goods by road, by rail or by inland waterway within or between Member States, by referring to RID.

(4)

Pursuant to letter d) of Article 13 § 1 and Article 33 § 5 of the COTIF, the Committee of Experts for the Carriage of Dangerous Goods (‘RID Expert Committee’) of the Intergovernmental Organisation for International Carriage by Rail (‘OTIF’) may adopt amendments to the Annex to the RID.

(5)

The RID Expert Committee, during its 57th session on 24 May 2022, is to adopt amendments to adapt the Annex to the RID to scientific and technical progress.

(6)

It is appropriate to establish the position to be taken on the Union’s behalf in the RID Expert Committee, as the amendments to the RID will be binding on the Union.

(7)

The envisaged amendments aim at ensuring the safe and efficient transport of dangerous goods, while taking into account scientific and technical progress in the sector and the development of new substances and articles that could pose danger while being transported.

(8)

The envisaged amendments are considered to be appropriate for the safe transport of dangerous goods in a cost-effective manner and can therefore be supported.

(9)

It may be necessary to agree minor changes to the documents referred to in the Annex at technical level at the 14th session of the RID Committee of Experts’ standing working group on 23 May 2022, including on the basis of recommendations of the United Nations Economic Commission for Europe Joint Meeting of the RID Committee of Experts and the Working Party on the Transport of Dangerous Goods,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken on the Union’s behalf at the 57th session of the Committee of Experts for the Carriage of Dangerous Goods (‘RID Expert Committee’) of the Intergovernmental Organisation for International Carriage by Rail in the framework of the Convention concerning International Carriage by Rail of 9 May 1980, as amended by the Vilnius Protocol of 3 June 1999, shall be as set out in the Annex to this Decision.

The representatives of the Union in the RID Expert Committee may agree to minor changes to the documents referred to in the Annex without further decision from the Council.

Article 2

The decisions of the RID Expert Committee, once adopted, shall be published in the Official Journal of the European Union, indicating the date of their entry into force.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Luxembourg, 11 April 2022.

For the Council

The President

J. BORRELL FONTELLES


(1)  Council Decision 2013/103/EU of 16 June 2011 on the signing and conclusion of the Agreement between the European Union and the Intergovernmental Organisation for International Carriage by Rail on the Accession of the European Union to the Convention concerning International Carriage by Rail (COTIF) of 9 May 1980, as amended by the Vilnius Protocol of 3 June 1999 (OJ L 51, 23.2.2013, p. 1).

(2)  Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13).


ANNEX

Proposal

Reference document

Issue

Comments

EU position

1.

OTIF/RID/CE/GTP/2021/2

Alignment between the Agreement concerning the International Carriage of Dangerous Goods by Road, concluded at Geneva on 30 September 1957 (ADR) and RID to include new means of containment in the accident report model

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

2.

OTIF/RID/CE/GTP/2021/3 and OTIF/RID/CE/GTP/2021/INF.3

Alignment between ADR and RID of the requirements concerning the information displayed

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

3.

OTIF/RID/CE/GTP/2021/4

Fitting safety valves to tanks for flammable liquefied gases

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

4.

OTIF/RID/CE/GTP/2021/5

Consolidated texts adopted by the Joint Meeting in 2020 and 2021 and by the RID Committee of Experts’ standing working group in November 2020

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

5.

OTIF/RID/CE/GTP/2021/6

Alignment between ADR and RID, among others on design, construction and initial inspection and test of non-UN pressure receptacles designed, constructed and tested according to referenced standards

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

6.

OTIF/RID/CE/GTP/2021/INF.4

Transitional measure in relation to 6.8.2.4.6 (procedures used by the competent authority for the approval of experts, the performance of inspections concerning tank-wagons and for the mutual recognition of such inspections)

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

7.

OTIF/RID/CE/GTP/2021/INF.11

Proposals on how to adjust RID Chapter 6.8 to consider extra-large tank-containers

Technical consensus at the RID Committee of Experts’ standing working group to adopt the text as amended

Agree

All the documents above are available on the OTIF’s website (http://otif.org/en/?page_id=1119) and shall be understood as comprising the amendments discussed in the RID Committee of Experts’ standing working group of November 2021 and reflected in Annex I to document OTIF/RID/CE/GTP/2021-A (Final report of the 13th session of the RID Committee of Experts’ standing working group – Geneva/hybrid, 15 to 18 November 2021), also available on the OTIF’s website (http://otif.org/en/?page_id=254).


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