title: Commission Implementing Regulation (EU) 2020/1030 of 15 July 2020 laying down the technical specifications of data requirements for the topic ‘ICT usage and e-commerce’ for the reference year 2021, pursuant to Regulation (EU) 2019/2152 of the European Parliament and of the Council (Text with EEA relevance)

text:
                  16.7.2020

                  EN

                  Official Journal of the European Union

                  L 227/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1030
         of 15 July 2020
         laying down the technical specifications of data requirements for the topic ‘ICT usage and e-commerce’ for the reference year 2021, pursuant to Regulation (EU) 2019/2152 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2019/2152 of the European Parliament and of the Council of 27 November 2019 on European business statistics, repealing 10 legal acts in the field of business statistics (1), and in particular Article 7(1) and Article 17(6) thereof,
         Whereas:

                     (1)

                     To ensure the correct implementation of the topic ‘ICT usage and e-commerce’ listed in Annex I to Regulation (EU) 2019/2152, the Commission should specify the variables, the measurement unit, the statistical population, the classifications and breakdowns and the data transmission deadline in order to produce data on ICT usage and e-commerce which is comparable and harmonised between Member States.

                     (2)

                     Member States should provide metadata and quality reports for the national statistical business registers and all business statistics. It is therefore necessary to define the arrangements for, content of and deadlines of those reports.

                     (3)

                     The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            For the topic ‘ICT usage and e-commerce’, as referred to in Annex I to Regulation (EU) 2019/2152, Member States shall transmit the data according to the technical specifications of data requirements for the reference year 2021 in accordance with the Annex to this Regulation.

            Article 2
            The annual metadata report for the topic ‘ICT usage and e-commerce’, as referred to in Annex I to Regulation (EU) 2019/2152, shall be transmitted to the Commission (Eurostat) by 31 May 2021.
            The annual quality report for the topic ‘ICT usage and e-commerce’, as referred to in Annex I to Regulation (EU) 2019/2152, shall be transmitted to the Commission (Eurostat) by 5 November 2021.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 15 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 327, 17.12.2019, p. 1.

            ANNEX
            Technical specifications of data requirements for the topic ‘ICT usage and e-commerce’

                        Mandatory/optional

                        Scope (filter)

                        Variable

                        Mandatory variables

                                    (i)

                                    for all enterprises:

                                    (1)

                                    main economic activity of the enterprise, in the previous calendar year

                                    (2)

                                    average number of employees and self-employed persons, in the previous calendar year

                                    (3)

                                    total value of turnover (excluding VAT), in the previous calendar year

                                    (4)

                                    number of employees and self-employed persons or percentage of the total number of employees and self-employed persons who have access to the internet for business purposes

                                    (ii)

                                    for enterprises with employees and self-employed persons who have access to the internet for business purposes:

                                    (5)

                                    internet connection: use of any type of fixed line connection

                                    (6)

                                    use of the following social media: social networks

                                    (7)

                                    use of the following social media: enterprise’s blog or microblogs

                                    (8)

                                    use of the following social media: multimedia content sharing websites or apps

                                    (9)

                                    use of the following social media: wiki based knowledge sharing tools

                                    (10)

                                    web sales of goods or services via the enterprises’ websites or apps (including extranets), in the previous calendar year

                                    (11)

                                    web sales of goods or services via e-commerce marketplace websites or apps used by several enterprises for trading goods or services, in the previous calendar year

                                    (12)

                                    EDI-type sales (receipt of orders placed via Electronic Data Interchange messages) of goods or services, in the previous calendar year

                                    (13)

                                    use of ERP (Enterprise Resource Planning) software

                                    (14)

                                    use of a CRM (Customer Relationship Management) software to manage the collection, storing and making available information on customers to various business functions

                                    (15)

                                    use of a CRM (Customer Relationship Management) software to manage the analysis of information on customers for marketing purposes (such as setting prices, sales promotion, choosing distribution channels)

                                    (16)

                                    buying cloud computing services used over the internet

                                    (17)

                                    use of interconnected devices or systems that can be monitored or remotely controlled via the internet (Internet of Things)

                                    (18)

                                    use of Artificial Intelligence technologies performing analysis of written language (text mining)

                                    (19)

                                    use of Artificial Intelligence technologies converting spoken language into machine-readable format (speech recognition)

                                    (20)

                                    use of Artificial Intelligence technologies generating written or spoken language (natural language generation)

                                    (21)

                                    use of Artificial Intelligence technologies identifying objects or persons based on images (image recognition, image processing)

                                    (22)

                                    use of machine learning (such as deep learning) for data analysis

                                    (23)

                                    use of Artificial Intelligence technologies automating different workflows or assisting in decision-making (Artificial Intelligence based software robotic process automation)

                                    (24)

                                    use of Artificial Intelligence technologies enabling physical movement of machines via autonomous decisions based on observation of surroundings (autonomous robots, self-driving vehicles, autonomous drones)

                                    (iii)

                                    for enterprises using any type of fixed line internet connection:

                                    (25)

                                    maximum contracted download speed of the fastest fixed line internet connection in the ranges: [0 Mbit/s, < 30 Mbit/s], [30 Mbit/s, < 100 Mbit/s], [100 Mbit/s, < 500 Mbit/s], [500 Mbit/s, < 1 Gbit/s], [≥ 1 Gbit/s]

                                    (iv)

                                    for enterprises which had web sales, in the previous calendar year:

                                    (26)

                                    value of web sales of goods or services, or percentage of total turnover generated by web sales of goods and services, in the previous calendar year

                                    (27)

                                    percentage of value of web sales generated by web sales to private consumers (Business to Consumers: B2C), in the previous calendar year

                                    (28)

                                    percentage of value of web sales generated by web sales to other enterprises (Business to Business: B2B) and to public sector (Business to Government: B2G), in the previous calendar year

                                    (29)

                                    web sales to customers located in the own country, in the previous calendar year

                                    (30)

                                    web sales to customers located in other Member States, in the previous calendar year

                                    (31)

                                    web sales to customers located in the rest of the world, in the previous calendar year

                                    (v)

                                    for enterprises which had web sales of goods and services via the enterprise’s websites or apps and via e-commerce marketplace websites or apps used by several enterprises for trading goods or services, in the previous calendar year:

                                    (32)

                                    percentage of value of web sales of goods or services generated by sales via the enterprise’s websites or apps, in the previous calendar year

                                    (33)

                                    percentage of value of web sales of goods or services generated by sales via e-commerce marketplace websites or apps used by several enterprises for trading goods or services, in the previous calendar year

                                    (vi)

                                    for enterprises which had web sales to customers located in at least two of the following geographic areas: own country, other Member States or rest of the world, in the previous calendar year:

                                    (34)

                                    percentage of value of web sales generated by sales to customers located in enterprise’s own country, in the previous calendar year

                                    (35)

                                    percentage of value of web sales generated by sales to customers located in other Member States, in the previous calendar year

                                    (36)

                                    percentage of value of web sales generated by sales to customers located in the rest of the world, in the previous calendar year

                                    (vii)

                                    for enterprises which had web sales to other Member States, in the previous calendar year:

                                    (37)

                                    difficulties experienced when selling to other Member States: high costs of delivering or returning products, in the previous calendar year

                                    (38)

                                    difficulties experienced when selling to other Member States: difficulties related to resolving complaints and disputes, in the previous calendar year

                                    (39)

                                    difficulties experienced when selling to other Member States: adapting product labelling for sales to other Member States, in the previous calendar year

                                    (40)

                                    difficulties experienced when selling to other Member States: lack of knowledge of foreign languages for communicating with customers in other Member States, in the previous calendar year

                                    (41)

                                    difficulties experienced when selling to other Member States: restrictions from enterprise's business partners to sell to certain Member States, in the previous calendar year

                                    (42)

                                    difficulties experienced when selling to other Member States: difficulties related to the VAT system in other Member States (such as uncertainty regarding VAT treatment in different countries), in the previous calendar year

                                    (viii)

                                    for enterprises which had EDI-type sales, in the previous calendar year:

                                    (43)

                                    value of EDI-type sales of goods or services or percentage of the total turnover generated by EDI-type sales of goods or services, in the previous calendar year

                                    (44)

                                    sales via EDI-type messages to customers located in enterprise’s own country, in the previous calendar year

                                    (45)

                                    sales via EDI-type messages to customers located in other Member States, in the previous calendar year

                                    (46)

                                    sales via EDI-type messages to customers located in the rest of the world, in the previous calendar year

                                    (ix)

                                    for enterprises buying cloud computing services used over the internet:

                                    (47)

                                    buying e-mail as a cloud computing service

                                    (48)

                                    buying office software (such as word processors or spreadsheets) as a cloud computing service

                                    (49)

                                    buying finance or accounting software applications as a cloud computing service

                                    (50)

                                    buying Enterprise Resource Planning (ERP) software applications as cloud computing service

                                    (51)

                                    buying Customer Relationship Management (CRM) software applications as a cloud computing service

                                    (52)

                                    buying security software applications (such as antivirus program, network access control) as cloud computing service

                                    (53)

                                    buying hosting the enterprise’s database(s) as a cloud computing service

                                    (54)

                                    buying storage of files as a cloud computing service

                                    (55)

                                    buying computing power to run the enterprise’s own software as a cloud computing service

                                    (56)

                                    buying computing platform providing a hosted environment for application development, testing or deployment (such as reusable software modules, application programming interfaces (APIs)) as a cloud computing service

                                    (x)

                                    for enterprises using interconnected devices or systems that can be monitored or remotely controlled via the internet (Internet of Things):

                                    (57)

                                    for energy consumption management (such as ‘smart’-meters, -thermostats or -lamps (lights))

                                    (58)

                                    for premises’ security (such as ‘smart’-alarm systems, -smoke detectors, -door locks or ‐security cameras)

                                    (59)

                                    for production processes (such as sensors or RFID tags that are monitored/controlled via the internet and used to monitor or automate the process)

                                    (60)

                                    for logistics management (such as sensors monitored/controlled via the internet for tracking products or vehicles in warehouse management)

                                    (61)

                                    for condition-based maintenance (such as sensors monitored/controlled via the internet to monitor maintenance needs of machines or vehicles)

                                    (62)

                                    for customer service (such as ‘smart’ cameras or sensors monitored/controlled via the internet to monitor customers’ activities or offer them a personalised shopping experience)

                                    (63)

                                    for other purposes

                                    (xi)

                                    For enterprises using Artificial Intelligence technologies, referring specifically to mandatory variables (18) to (24), purpose of use:

                                    (64)

                                    for marketing or sales (such as chatbots based on natural language processing for customer support, customer profiling, price optimisation, personalised marketing offers, market analysis based on machine learning)

                                    (65)

                                    for production processes (such as predictive maintenance based on machine learning, tools to classify products or find defects in products based on computer vision, autonomous drones for production surveillance, security or inspection tasks, assembly works performed by autonomous robots)

                                    (66)

                                    for organisation of business administration processes (such as business virtual assistants based on machine learning and/or natural language processing, voice to text conversion based on speech recognition for document drafting, automated planning or scheduling based on machine learning, machine translation)

                                    (67)

                                    for management of enterprises (such as machine learning to analyse data and help make investment or other decisions, sales or business forecasting based on machine learning, risk assessment based on machine learning)

                                    (68)

                                    for logistics (such as autonomous robots for pick-and-pack solutions in warehouses, route optimisation based on machine learning, autonomous robots for parcel shipping, tracing, distribution and sorting, autonomous drones for parcel delivery)

                                    (69)

                                    for ICT security (such as face recognition based on computer vision for authentication of ICT users, detection and prevention of cyber-attacks based on machine learning)

                                    (70)

                                    for human resources management or recruiting (such as candidates pre-selection screening, automation of recruiting based on machine learning, employee profiling or performance analysis based on machine learning, chatbots based on natural language processing for recruiting or supporting human resources management)

                        Optional variables

                                    (i)

                                    for enterprises with employees and self-employed persons who have access to the internet for business purposes:

                                    (1)

                                    provision of portable devices that allow a mobile connection to the internet using mobile telephone networks for business purposes

                                    (2)

                                    having a website

                                    (ii)

                                    for enterprises that provide their employees and self-employed persons portable devices that allow a mobile connection to the internet using mobile telephone networks for business purposes:

                                    (3)

                                    number of employees and self-employed persons, or percentage of the total number of employees and self-employed persons, using a portable device provided by the enterprise that allows internet connection via mobile telephone networks for business purposes

                                    (iii)

                                    for enterprises having a website:

                                    (4)

                                    enterprise’s website has a description of goods or services, price information

                                    (5)

                                    enterprise’s website has online ordering or reservation or booking, such as shopping cart

                                    (6)

                                    enterprise’s website has a possibility for visitors to customise or design online goods or services

                                    (7)

                                    enterprise’s website has tracking or status of orders placed

                                    (8)

                                    enterprise’s website has personalised content on the website for regular/recurrent visitors

                                    (9)

                                    enterprise’s website has links or references to the enterprise's social media profiles

                                    (iv)

                                    for enterprises which had web sales via e-commerce marketplace websites or apps used by several enterprises for trading goods or services, in the previous calendar year:

                                    (10)

                                    number of e-commerce marketplaces via which the enterprise had web sales in the previous calendar year: one, two, more than two

                                    (v)

                                    for enterprises which had web sales via two or more e-commerce marketplaces, in the previous calendar year:

                                    (11)

                                    information if more than half of the turnover from e-commerce marketplaces came from only one e-commerce marketplace, in the previous calendar year

                                    (vi)

                                    For enterprises using Artificial Intelligence technologies, referring specifically to mandatory variables (18) to (24):

                                    (12)

                                    use of Artificial Intelligence software or systems developed by own employees (including those employed in parent or affiliate enterprises)

                                    (13)

                                    use of commercial Artificial Intelligence software or systems modified by own employees (including those employed in parent of affiliate enterprises)

                                    (14)

                                    use of open-source Artificial Intelligence software or systems modified by own employees (including those employed in parent or affiliate enterprises)

                                    (15)

                                    use of commercial Artificial Intelligence software or systems purchased ready to use (including examples where it was already incorporated in a purchased item or system)

                                    (16)

                                    use of Artificial Intelligence software or systems developed or modified by contracted external providers

                                    (vii)

                                    For enterprises which did not use any Artificial Intelligence technologies, referring specifically to mandatory variables (18) to (24):

                                    (17)

                                    consideration of using of Artificial Intelligence technologies, referring specifically to mandatory variables (18) to (24)

                                    (viii)

                                    For enterprises which did not use but considered to use Artificial Intelligence technologies, referring specifically to mandatory variables (18) to (24):

                                    (18)

                                    Artificial Intelligence technologies not used because the costs seem too high

                                    (19)

                                    Artificial Intelligence technologies not used because there is a lack of relevant expertise in the enterprise

                                    (20)

                                    Artificial Intelligence technologies not used because of incompatibility with existing equipment, software or systems

                                    (21)

                                    Artificial Intelligence technologies not used because of difficulties with availability or quality of the necessary data

                                    (22)

                                    Artificial Intelligence technologies not used because of concerns regarding violation of data protection and privacy

                                    (23)

                                    use of artificial intelligence technologies not used because of lack of clarity about the legal consequences (such as liability in case of damage caused by the use of Artificial Intelligence)

                                    (24)

                                    Artificial Intelligence technologies not used because of ethical considerations

                                    (25)

                                    Artificial Intelligence technologies not used because they are not useful for the enterprise

                        Measurement unit

                        Absolute figures, except for characteristics related to turnover in national currency (thousands) or percentage of (total) turnover

                        Statistical population

                           Activity coverage:

                        NACE Sections C to J, L to N and group 95.1

                           Size class coverage:

                        Enterprises with 10 or more employees and self-employed persons. Enterprises with less than 10 employees and self-employed persons may be covered optionally

                        Breakdowns

                           Activity breakdown

                           for calculation of national aggregates:

                                    —

                                    aggregates of NACE sections and group C+D+E+F+G+H+I+J+L+M+N+95.1, D+E

                                    —

                                    NACE sections: C, F, G, H, I, J, L, M, N

                                    —

                                    NACE divisions: 47, 55

                                    —

                                    aggregates of NACE divisions: 10+11+12+13+14+15+16+17+18, 19+20+21+22+23, 24+25, 26+27+28+29+30+31+32+33

                                    —

                                    aggregate of the divisions and groups: 26.1+26.2+26.3+26.4+26.8+46.5+58.2+61+62+63.1+95.1

                           for contribution to the European totals only

                                    —

                                    NACE sections: D, E

                                    —

                                    NACE divisions: 19, 20, 21, 26, 27, 28, 45, 46, 61, 72, 79

                                    —

                                    NACE group: 95.1

                                    —

                                    aggregates of NACE divisions: 10+11+12, 13+14+15, 16+17+18, 22+23, 29+30, 31+32+33, 58+59+60, 62+63, 69+70+71, 73+74+75, 77+78+80+81+82

                           Size class of number of employees and self-employed persons: 10+, 10–49, 50–249, 250+; optional: 0–9, 0–1, 2–9

                        Data transmission deadline

                        5 October 2021


title: Commission Implementing Regulation (EU) 2020/1033 of 15 July 2020 concerning the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 and the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as feed additives for all animal species, and repealing Regulation (EC) No 1139/2007 (Text with EEA relevance)

text:
                  16.7.2020

                  EN

                  Official Journal of the European Union

                  L 227/27

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1033
         of 15 July 2020
         concerning the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 and the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as feed additives for all animal species, and repealing Regulation (EC) No 1139/2007
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting and renewing such authorisation.

                     (2)

                     L-arginine produced by Corynebacterium glutamicum ATCC 13870 was authorised for 10 years as a feed additive for all animal species by Commission Regulation (EC) No 1139/2007 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 as feed additive for all animal species, requesting this additive to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’. This application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003 and included a request to change the strain designation to Corynebacterium glutamicum NITE SD 00285.

                     (4)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as a feed additive for use in feed and in water for drinking for all animal species. The application concerns the authorisation of L-arginine produced by Corynebacterium glutamicum KCCM 80182 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’ and additive category ‘sensory additives’, functional group ‘flavouring compounds’. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 3 April 2019 (3) and 14 May 2019 (4) that, under the proposed conditions of use, L-arginine produced by Corynebacterium glutamicum NITE SD 00285 and by Corynebacterium glutamicum KCCM 80182 does not have an adverse effect on animal health, consumer health or the environment. It also stated for L-arginine produced by Corynebacterium glutamicum NITE SD 00285 to be irritant to skin, corrosive to eyes and hazardous upon inhalation. For L-arginine produced by Corynebacterium glutamicum KCCM 80182, it stated to be corrosive to skin and eyes. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an effective source of the amino acid arginine for all animal species and that for the supplemental L-arginine to be fully efficacious in ruminants, it should be protected against degradation in the rumen.

                     (6)

                     The Authority expressed in its opinion on L-arginine produced by Corynebacterium glutamicum KCCM 80182 a concern on the safety of the simultaneous oral administration of the amino acid via water for drinking and feed. However, the Authority did not propose a maximum content for L-arginine. Moreover, the Authority recommends supplementation with L-arginine in appropriate amounts. Thus, in the case of supplementation with L-arginine via water for drinking it is appropriate to alert the user to take into account the dietary supply with all the essential and conditionally essential amino acids.

                     (7)

                     Restrictions and conditions should be provided for to allow for a better control for L-arginine when used as flavouring. For L-arginine used as flavouring recommended content should be indicated on the label. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (8)

                     As regards the use of L-arginine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-arginine as a flavouring compound is not authorised in water for drinking. At the recommended dose, L-arginine as flavouring compound is not likely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids.

                     (9)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (10)

                     The assessment of L-arginine produced by Corynebacterium glutamicum NITE SD 00285 and by Corynebacterium glutamicum KCCM 80182 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (11)

                     As a consequence of the renewal of the authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1139/2007 should be repealed.

                     (12)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-arginine produced by Corynebacterium glutamicum ATCC 13870, it is appropriate to provide a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

                     (13)

                     The fact that the use of the L-arginine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

                     (14)

                     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.   The authorisation of L-arginine produced by Corynebacterium glutamicum ATCC 13870, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is renewed subject to the conditions laid down in the Annex.

               2.   L-arginine produced by Corynebacterium glutamicum KCCM 80182, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’ is authorised as an additive in animal nutrition subject to the conditions laid down in the Annex.

            Article 2

               1.   L-arginine produced by Corynebacterium glutamicum ATCC 13870 and premixtures containing it, which are produced and labelled before 5 February 2021 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 5 August 2021 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

               3.   Feed materials and compound feed containing the substances referred to in point 1, which are produced and labelled before 5 August 2022 in accordance with the rules applicable before 5 August 2020 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

            Article 3
            Regulation (EC) No 1139/2007 is repealed.

            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, 15 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  Commission Regulation (EC) No 1139/2007 of 1 October 2007 concerning the authorisation of L-arginine as a feed additive (OJ L 256, 2.10.2007, p. 11).

            (3)  EFSA Journal 2019;17(5):5696.

            (4)  EFSA Journal 2019;17(6):5720.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method.

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

                           mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues

                        3c364

                        -

                        L-arginine

                           Additive composition:

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 15 % water

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    3.

                                    The moisture content shall be indicated on the label of the additive.

                                    4.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                        5 August 2030

                           Characterisation of the active substance:

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum NITE SD 00285.
                        Chemical formula: C6H14N4O2
                        CAS number: 74-79-3

                           Analytical method
                            (1):
                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of arginine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F)

                        3c362

                        -

                        L-arginine

                           Additive composition:

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 0,5 % water

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive may also be used via water for drinking.

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

                                    4.

                                    Declaration to be made on the label of the additive and premixture: ‘The supplementation with L-arginine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

                                    5.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for skin and eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                        5 August 2030

                           Characterisation of the active substance:

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM 80182
                        Chemical formula: C6H14N4O2
                        CAS number: 74-79-3

                           Analytical method
                            (2):
                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive and water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of arginine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F)

                           Category: Sensory additives. Functional group: Flavouring compounds

                        3c362

                        -

                        L-arginine

                           Additive composition:

                        Powder with a minimum content of L-arginine of 98 % (on a dry matter basis) and a maximum content of 0,5 % water

                        All animal species

                        -

                        -

                                    1.

                                    L-arginine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    4.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg.’

                                    5.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                                    6.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for skin and eyes. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                        5 August 2030

                           Characterisation of the active substance:

                        L-arginine ((S)-2-amino-5-guanidinopentanoic acid) produced by fermentation with Corynebacterium glutamicum KCCM 80182
                        Chemical formula: C6H14N4O2
                        CAS number: 74-79-3
                        Flavis 17.003

                           Analytical method
                            (3):
                        For the identification of L-arginine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-arginine monograph’

                              For the quantification of arginine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                              For the quantification of arginine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009 (Annex III, F).

               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

               (2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

               (3)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2020/1034 of 15 July 2020 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for laying hens (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o) (Text with EEA relevance)

text:
                  16.7.2020

                  EN

                  Official Journal of the European Union

                  L 227/34

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1034
         of 15 July 2020
         concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for laying hens (holder of authorisation DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372). That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     This application concerns the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) as a feed additive for laying hens, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 September 2017 (2) and 13 November 2019 (3) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is considered as a potential respiratory sensitiser and that no conclusion could be drawn on dermal sensitisation potential by the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive showed an effect in improving laying performance. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition as set out in the Annex.

            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, 15 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 18.10.2003, p. 29.

            (2)  EFSA Journal 2017;15(10):5020.

            (3)  EFSA Journal 2019;17(11):5919.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

                           Units of activity/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: digestibility enhancers.

                        4a1607i

                        DSM Nutritional Products Ltd represented by DSM Nutritional Products Sp. Z o.o

                        Endo-1,4-beta-xylanase
                        (EC 3.2.1.8)

                              Additive composition

                        Preparation of endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372) having a minimum activity of:
                        Solid form: 1 000  FXU (1)/g
                        Liquid form: 650 FXU/ml

                        Laying hens

                        -

                        100 FXU

                        -

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eyes and breathing protection.

                        5.8.2030

                              Characterisation of active substance

                        Endo-1,4-beta-xylanase (EC 3.2.1.8) produced by Aspergillus oryzae (DSM 26372)

                              Analytical method

                            (2)

                        For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in a feed additive:

                                    —

                                    colorimetric method measuring coloured compound produced by the dinitro salicylic acid (DNSA) and the xylosylic moieties released by the action of xylanase on arabinoxylan.

                              For quantification of endo-1,4-beta-xylanase produced by Aspergillus oryzae (DSM 26372) in premixtures and feedingstuffs:

                                    —

                                    colorimetric method measuring water soluble dye released by action of xylanase from dye-labelled oat spelt azo-xylan.

               (1)  1 FXU is the amount of enzyme which liberates 7,8 μmol of reducing sugars (xylose equivalents) from azo-wheat arabinoxylan per minute at pH 6,0 and 50 °C.

               (2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2020/1175 of 7 August 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a feed additive for all animal species (Text with EEA relevance)

text:
                  10.8.2020

                  EN

                  Official Journal of the European Union

                  L 259/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1175
         of 7 August 2020
         concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and
            Escherichia coli KCCM 80181 as a feed additive for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     This application concerns the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 10 January 2020 (2) that, under the proposed conditions of use in feed L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 does not have adverse effects on animal health, consumer safety or the environment. In its conclusions it also considered that the applicant proposes to label the additive with the hazard statement H335 (may cause respiratory irritation) under the Regulation (EC) No 1272/2008 (3). Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular, as regards the users of the additive. The Authority further concluded that since the substance is used in food and its function in feed is the same as that in food, no further demonstration of efficacy in feed is necessary.

                     (5)

                     Restrictions and conditions should be provided for to allow for a better control. For L-cysteine hydrochloride monohydrate, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures.

                     (6)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (7)

                     The assessment of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this substance should be authorised as specified in the Annex to this Regulation.

                     (8)

                     The fact that L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181 is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

                     (9)

                     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 substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.

            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, 7 August 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 18.10.2003, p. 29..

            (2)  EFSA Journal 2020;18(2):6003.

            (3)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                           Category: Sensory additives. Functional group: Flavouring compounds

                        2b920i

                        -

                        L-cysteine hydrochloride monohydrate

                           Additive composition:
                        L-cysteine hydrochloride monohydrate

                           Characterisation of the active substance:
                        L-cysteine hydrochloride monohydrate
                        Produced by fermentation with Escherichia coli KCCM 80180 and Escherichia coli KCCM 80181
                        Purity: min. 98,5 %
                        Chemical formula: C3H7NO2S •HClH2O.
                        CAS number 7048-04-6
                        FLAVIS 17.032

                           Method of analysis
                            (1):
                        For the identification of L-cysteine hydrochloride monohydrate in the feed additive:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Ph.Eur. 6.6-2.2.56-Method 1

                              For the quantification of L-cysteine hydrochloride monohydrate in the feed additive:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD)

                              For the quantification of L-cysteine hydrochloride monohydrate in premixtures:

                                    —

                                    ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009
                                    (Annex III, F)

                        All animal species

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’.

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                        30.9.2030

               (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2020/1328 of 18 September 2020 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Fraise du Périgord’ (PGI))

text:
                  25.9.2020

                  EN

                  Official Journal of the European Union

                  L 312/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1328
         of 18 September 2020
         approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Fraise du Périgord’ (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the specification for the protected geographical indication ‘Fraise du Périgord’, registered under Commission Regulation (EC) No 135/2004 (2).

                     (2)

                     Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

                     (3)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Fraise du Périgord’ (PGI) are hereby approved.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 September 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  Commission Regulation (EC) No 135/2004 of 27 January 2004 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the Register of protected designations of origin and protected geographical indications (Fraise du Périgord and Queso de Valdeón) (OJ L 21, 28.1.2004, p. 9).

            (3)  OJ C 170, 18.5.2020, p. 38.


title: Commission Implementing Regulation (EU) 2020/1340 of 22 September 2020 entering a name in the register of protected designations of origin and protected geographical indications [‘Brački varenik’ (PGI)]

text:
                  29.9.2020

                  EN

                  Official Journal of the European Union

                  L 314/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1340
         of 22 September 2020
         entering a name in the register of protected designations of origin and protected geographical indications [‘Brački varenik’ (PGI)]
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 50(2)(a) of Regulation (EU) No 1151/2012, Croatia’s application to register the name ‘Brački varenik’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Brački varenik’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Brački varenik’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.8. – other products listed in Annex I to the Treaty (spices etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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 September 2020.

                  For the Commission

                  On behalf of the President

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 183, 3.6.2020, p. 12.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2020/1341 of 28 September 2020 amending Implementing Regulation (EU) 2020/466 as regards the period of application of temporary measures (Text with EEA relevance)

text:
                  29.9.2020

                  EN

                  Official Journal of the European Union

                  L 314/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1341
         of 28 September 2020
         amending Implementing Regulation (EU) 2020/466 as regards the period of application of temporary measures
         (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 141(1) thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2017/625 lays down rules for, inter alia, the performance of official controls and of other official activities by the competent authorities of Member States. It also empowers the Commission to adopt, by means of an implementing act, appropriate temporary measures necessary to contain risks to human, animal and plant health and animal welfare, if it has evidence of a serious disruption in a Member State’s control system.

                     (2)

                     In order to address the specific circumstances due to the ongoing crisis related to coronavirus disease (COVID-19), Commission Implementing Regulation (EU) 2020/466 (2) allows Member States to apply temporary measures in relation to official controls and other official activities.

                     (3)

                     Member States have informed the Commission that, in view of the crisis linked to COVID-19, certain serious disruptions in the functioning of their control systems, difficulties to perform official controls and other official activities on official certificates and official attestations with respect to movements of animals and goods into the Union and within the Union and difficulties to organise physical meetings with operators and their staff in the context of official controls will persist beyond 1 October 2020. In order to address these serious disruptions, which are likely to persist in the coming months, and to facilitate the planning and the performance of official controls and other official activities during the crisis linked to COVID-19, the period of application of Implementing Regulation (EU) 2020/466 should be prolonged until 1 February 2021.

                     (4)

                     Implementing Regulation (EU) 2020/466 should therefore be amended accordingly.

                     (5)

                     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
            In the second paragraph of Article 6 of Implementing Regulation (EU) 2020/466, the date ‘1 October 2020’ is replaced by the date ‘1 February 2021’.

            Article 2
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 2 October 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 September 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 95, 7.4.2017, p. 1.

            (2)  Commission Implementing Regulation (EU) 2020/466 of 30 March 2020 on temporary measures to contain risks to human, animal and plant health and animal welfare during certain serious disruptions of Member States’ control systems due to coronavirus disease (COVID-19) (OJ L 98, 31.3.2020, p. 30).


title: Council Implementing Regulation (EU) 2021/49 of 22 January 2021 implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia

text:
                  25.1.2021

                  EN

                  Official Journal of the European Union

                  L 23/5

         COUNCIL IMPLEMENTING REGULATION (EU) 2021/49
         of 22 January 2021
         implementing Regulation (EU) No 101/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 101/2011 of 4 February 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Tunisia (1), and in particular Article 12 thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 4 February 2011, the Council adopted Regulation (EU) No 101/2011.

                     (2)

                     On the basis of a review, the entries in Annex I to Regulation (EU) No 101/2011, for four persons should be deleted, and the information regarding the rights of defence and the right to effective judicial protection should be updated for two persons.

                     (3)

                     Annex I to Regulation (EU) No 101/2011 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) No 101/2011 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the 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 January 2021.

                  For the Council

                  The President

               A. P. ZACARIAS

            (1)  OJ L 31, 5.2.2011, p. 1.

            ANNEX
            In Regulation (EU) No 101/2011, Annex I is amended as follows:

                        (1)

                        in Part A (List of persons and entities referred to in Article 2), the entries for the following persons are deleted:

                                    22.

                                    Bouthaina Bent Moncef Ben Mohamed TRABELSI

                                    23.

                                    Nabil Ben Abderrazek Ben Mohamed TRABELSI

                                    41.

                                    Akrem Ben Hamed Ben Taher BOUAOUINA

                                    47.

                                    Slim Ben Tijani Ben Haj Hamda BEN ALI;

                        (2)

                        Part B (Rights of defence and right to effective judicial protection under Tunisian law) is amended as follows:

                                    (a)

                                    the entries for the following persons are deleted:

                                                22.

                                                Bouthaina Bent Moncef Ben Mohamed TRABELSI

                                                23.

                                                Nabil Ben Abderrazek Ben Mohamed TRABELSI

                                                41.

                                                Akrem Ben Hamed Ben Taher BOUAOUINA

                                                47.

                                                Slim Ben Tijani Ben Haj Hamda BEN ALI;

                                    (b)

                                    the entries concerning the following persons are replaced by the following entries:

                                                ‘14.

                                                Samira Bent Mohamed Ben Rhouma TRABELSI
                                                The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that, on 11 August 2011, Ms Samira Bent Mohamed Ben Rhouma TRABELSI was heard by an investigating judge in the presence of her lawyer.

                                                45.

                                                Montassar Ben Habib Ben Bouali LTAIEF
                                                The investigation or trial relating to the misappropriation of public funds or assets is still ongoing. The information on the Council’s file shows that the rights of defence and the right to effective judicial protection were respected in the judicial proceedings on which the Council relied. This is demonstrated in particular by the fact that in 2011 and 2013 Mr Montassar Ben Habib Ben Bouali LTAIEF was heard by an investigating judge in the presence of his lawyers.’.


title: Commission Implementing Regulation (EU) 2021/50 of 22 January 2021 authorising an extension of use and a change in the specifications of the novel food ‘2′-fucosyllactose/difucosyllactose mixture’ and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  25.1.2021

                  EN

                  Official Journal of the European Union

                  L 23/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/50
         of 22 January 2021
         authorising an extension of use and a change in the specifications of the novel food ‘2′-fucosyllactose/difucosyllactose mixture’ and amending 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 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) which establishes a Union list of authorised novel foods was adopted.

                     (3)

                     Commission Implementing Regulation (EU) 2019/1979 (3) authorised, in accordance with Regulation (EU) 2015/2283, the placing on the market of microbial source 2′-fucosyllactose/difucosyllactose mixture (‘2′-FL/DFL’) as a novel food. Therefore, 2′-FL/DFL was included in the Union list of novel foods.

                     (4)

                     On 17 March 2020, the company Glycom A/S (‘the applicant’) submitted an application to the Commission to extend the use and to change the specifications of 2′-FL/DFL in accordance with Article 10(1) of Regulation (EU) 2015/2283. The applicant requested to extend the use of 2′-FL/DFL in milk-based drinks and similar products intended for young children at levels of 1,2 g/L in the ﬁnal product ready for use, marketed as such or reconstituted as instructed by the manufacturer in the authorised uses. In addition, the applicant requested to provide for a more generic description of the production process for the novel food, in particular to remove ‘spray drying’ from the description of the final drying step in the production process as other techniques, for example, freeze drying, are also used; to remove the term ‘amorphous’ from the description of the novel food in its final form as the novel food is a powder or agglomerates depending on the drying method used; and, to include 3-fucosyllactose, one of the minor components of the novel food in the sum of the oligosaccharides comprising the novel food rather than in the sum of the other minor carbohydrates where it is currently listed.

                     (5)

                     The requested changes in the conditions of use concerning the extension of use of the novel food in milk-based drinks and similar products intended for young children, and in the specifications concerning the drying method and the appearance of the novel food were part of the original application for the authorisation of 2′-FL/DFL as a novel food in accordance with Regulation (EU) 2015/2283 that was assessed favourably by the European Food Safety Authority (‘the Authority’) in its scientific opinion ‘Safety of 2′-fucosyllactose/difucosyllactose mixture as a novel food pursuant to Regulation (EU) 2015/2283’ (4). Therefore the Commission considers that another opinion of the Authority is not necessary.

                     (6)

                     The request to include 3-fucosyllactose in the sum of the oligosaccharides comprising the novel food rather than in the sum of the other minor carbohydrates where it is currently listed, was not included in the original application that was assessed favourably by the Authority. That application made reference to the potential of DFL to be hydrolysed to produce 3-fucosyllactose, which was detected at low levels. The Commission considers that the requested change in the way that 3-fucosyllactose is included in the specifications of 2′-FL/DFL in light of the fact that it is present in the novel food at low levels and below the levels naturally found in human milk, is not liable to change the effects of this authorised novel food on human health. Therefore, the Commission considers that another opinion of the Authority is not necessary.

                     (7)

                     It is therefore appropriate to amend the Union list on the conditions of use and on the specifications of 2′-FL/DFL to authorise its use in milk-based drinks and similar products intended for young children at levels of 1,2 g/L in the ﬁnal product ready for use, marketed as such or reconstituted as instructed by the manufacturer, in the authorised uses, to provide for a generic description of the production process for the novel food and to remove ‘spray drying’ from the description of the final drying step in the production process, to remove the term ‘amorphous’ from the description of the novel food, and to include 3-fucosyllactose in the sum of the main oligosaccharides comprising the novel food.

                     (8)

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

                     (9)

                     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.   The entry in the Union list of authorised novel foods, as provided for in Article 6 of Regulation (EU) 2015/2283 referring to microbial source ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)’ shall be amended as specified in the Annex to this Regulation.

               2.   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
            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 January 2021.

                  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)  Commission implementing Regulation (EU) 2019/1979 of 26 November 2019 authorising the placing on the market of 2'-Fucosyllactose/Difucosyllactose mixture 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 (OJ L 308, 29.11.2019, p. 62).

            (4)  EFSA Journal 2019;17(6):5717.

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

                        (1)

                        in Table 1 (Authorised novel foods), the conditions under which the novel food ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source)’ may be used are added:

                                    Conditions under which the novel food may be used

                                    ‘Specified food category

                                       Maximum levels

                                    Milk-based drinks and similar products intended for young children

                                    1,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer’

                        (2)

                        in Table 2 (Specifications), the entry for 2′- Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’) (microbial source) is replaced by the following:

                                    Authorised Novel Food

                                    Specification

                                    ‘2′-Fucosyllactose/Difucosyllactose mixture (‘2′-FL/DFL’)

                                       (microbial source)

                                       Description/Definition:

                                    2′-Fucosyllactose/Difucosyllactose mixture is a purified, white to off-white powder or agglomerates thereof that is produced by a microbial process.

                                       Source: Genetically modified Escherichia coli strain K-12 DH1

                                       Characteristics/Composition:

                                    Appearance: White to off white powder or agglomerates
                                    Sum of 2′-Fucosyllactose, Difucosyllactose, D-Lactose, L-Fucose, and 3-Fucosyllactose (% of dry matter): ≥ 92,0 % (w/w)
                                    Sum of 2′-Fucosyllactose and Difucosyllactose (% of dry matter): ≥ 85,0 % (w/w)
                                    2′-Fucosyllactose (% of dry matter): ≥ 75,0 % (w/w)
                                    Difucosyllactose (% of dry matter): ≥ 5,0 % (w/w)
                                    D-Lactose: ≤ 10,0 % (w/w)
                                    L-Fucose: ≤ 1,0 % (w/w)
                                    2′-Fucosyl-D-lactulose: ≤ 2,0 (w/w)
                                    Sum of other carbohydrates (*1): ≤ 6,0 % (w/w)
                                    Moisture: ≤ 6,0 % (w/w)
                                    Ash, sulfated: ≤ 0,8 % (w/w)
                                    pH (20 °C, 5 % solution): 4,0 -6,0
                                    Residual protein: ≤ 0,01 % (w/w)

                                       Microbiological criteria:

                                    Aerobic mesophilic total plate count: ≤ 1000 CFU/g
                                    Enterobacteriaceae: ≤ 10 CFU/g

                                       Salmonella sp.: Negative/25 g
                                    Yeast: ≤ 100 CFU/g
                                    Mould: ≤ 100 CFU/g
                                    Residual endotoxins: ≤ 10 EU/mg
                                    CFU: Colony Forming Units; EU: Endotoxin Units

               (*1)  2′-Fucosyl-galactose, Glucose, Galactose, Mannitol, Sorbitol, Galactitol, Trihexose, Allo-lactose and other structurally related carbohydrates.’


title: Commission Implementing Regulation (EU) 2021/1294 of 4 August 2021 cancelling the protection of the designation of origin (‘Südburgenland (PDO)’)

text:
                  5.8.2021

                  EN

                  Official Journal of the European Union

                  L 282/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1294
         of 4 August 2021
         cancelling the protection of the designation of origin (‘Südburgenland (PDO)’)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 106 thereof,
         Whereas:

                     (1)

                     Article 19 of Commission Delegated Regulation (EU) 2019/33 (2) provides that the procedure laid down in Article 94 and Articles 96 to 99 of Regulation (EU) No 1308/2013 shall apply mutatis mutandis to the cancellation of a protected designation of origin under Article 106 of Regulation (EU) No 1308/2013.

                     (2)

                     Pursuant to Article 19 of Delegated Regulation (EU) 2019/33, Austria’s request to cancel the protected designation of origin ‘Südburgenland’ was published in the Official Journal of the European Union (3).

                     (3)

                     As no statement of objection under Article 98 of Regulation (EU) No 1308/2013 has been received by the Commission, the protected designation of origin ‘Südburgenland’ should be cancelled.

                     (4)

                     In view of the cancellation of the protection of the designation of origin ‘Südburgenland’, the entry should be deleted from the Union register of protected designations of origin and protected geographical indications for wine referred to in Article 104 of Regulation (EU) No 1308/2013.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The protection of the designation of origin ‘Südburgenland’ (PDO) is hereby cancelled.

            Article 2
            The entry for the designation of origin ‘Südburgenland’ (PDO) is hereby deleted from the register of protected designations of origin and protected geographical indications for wine.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation (OJ L 9, 11.1.2019, p. 2).

            (3)  OJ C 57, 17.2.2021, p. 30.