title: Commission Implementing Regulation (EU) 2021/28 of 14 January 2021 amending Council Regulation (EC) No 1362/2000 as regards the Union tariff quota for bananas originating in Mexico

text:
                  15.1.2021

                  EN

                  Official Journal of the European Union

                  L 12/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/28
         of 14 January 2021
         amending Council Regulation (EC) No 1362/2000 as regards the Union tariff quota for bananas originating in Mexico
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1362/2000 of 29 June 2000 implementing for the Community the tariff provisions of Decision No 2/2000 of the Joint Council under the Interim Agreement on Trade and Trade-related matters between the European Community and the United Mexican States (1), and in particular Article 4 thereof,
         Whereas:

                     (1)

                     To take account of the accession to the European Union of Croatia on 1 July 2013, the Council, by Decision (EU) 2019/573 (2), concluded on behalf of the European Union and its Member States the Third Additional Protocol to the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part (3), which was signed on 27 November 2018, and entered into force on 1 March 2020.

                     (2)

                     By Decision (EU) 2019/104 (4), the Council approved the position to be adopted on behalf of the European Union in the Joint Council established under the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part, on amendments to the Agreement necessary to take account of the accession of Croatia to the Union.

                     (3)

                     Decision No 1/2020 of the EU-Mexico Joint Council (5) provides for an increase of the Union tariff quota applicable to fresh bananas originating in Mexico for release for free circulation in the Union.

                     (4)

                     Regulation (EC) No 1362/2000 should therefore be amended in order to implement the increase of the tariff quota laid down in the Decision No 1/2020 of the EU-Mexico Joint Council. Given that the tariff quota for bananas for the year 2020 has been exhausted, an individual order number has to be attributed to the additional volume for that year.

                     (5)

                     In order to avoid any unnecessary delay in the application of this tariff quota, this Regulation should enter into force as a matter of urgency and should apply retroactively from the third day after the publication of the Decision No 1/2020 of the EU-Mexico Joint Council in the Official Journal of the European Union.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Regulation (EC) No 1362/2000 is amended as follows:

                        (1)

                        the row with order number 09.1834 is replaced by the following:

                                    Order No

                                    CN code

                                    Description

                                    Annual tariff quota volume (net weight, unless otherwise specified)

                                    Tariff quota duty (% reduction)

                                    ‘09.1834

                                    0803 90 10

                                    Bananas, fresh (excluding plantains)

                                    Until 31 December 2020:
                                    2 000  tonnes;
                                    from 1 January 2021:
                                    2 010  tonnes

                                    Fixed duty to be applied’

                        (2)

                        the following row is inserted between the row with order number 09.1834 and the row with order number 09.1847:

                                    Order No

                                    CN code

                                    Description

                                    Annual tariff quota volume (net weight, unless otherwise specified)

                                    Tariff quota duty (% reduction)

                                    ‘09.1838

                                    0803 90 10

                                    Bananas, fresh (excluding plantains)

                                    From 13 August 2020
                                    until 31 December 2020:
                                    10 tonnes

                                    Fixed duty to be applied’

            Article 2
            This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
            It shall apply from 13 August 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 14 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 157, 30.6.2000, p. 1.

            (2)  Council Decision (EU) 2019/573 of 8 April 2019 on the conclusion, on behalf of the European Union and its Member States, of the Third Additional Protocol to the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part, to take account of the accession of the Republic of Croatia to the European Union (OJ L 100, 11.4.2019, p. 3).

            (3)  OJ L 325, 20.12.2018, p. 3.

            (4)  Council Decision (EU) 2019/104 of 22 May 2018 on the position to be adopted, on behalf of the European Union, within the EU-Mexico Joint Council established under the Economic Partnership, Political Coordination and Cooperation Agreement between the European Community and its Member States, of the one part, and the United Mexican States, of the other part, as regards the amendment of Decisions No 2/2000 and No 2/2001 of the Joint Council to take account of the accession of the Republic of Croatia to the European Union (OJ L 21, 24.1.2019, p. 23).

            (5)  Decision No 1/2020 of the EU-Mexico Joint Council of 31 July 2020 amending Decision No 2/2000 [2020/1180] (OJ L 259, 10.8.2020, p. 40).


title: Council Implementing Regulation (EU) 2021/29 of 15 January 2021 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria

text:
                  15.1.2021

                  EN

                  Official Journal of the European Union

                  LI 12/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2021/29
         of 15 January 2021
         implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
         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 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011 (1), and in particular Article 32(1) thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 January 2012, the Council adopted Regulation (EU) No 36/2012.

                     (2)

                     In view of the gravity of the situation in Syria, and considering his recent appointment as Minister of Foreign Affairs, Faisal MEKDAD should be added to the list of natural and legal persons, entities or bodies subject to restrictive measures in Annex II to Regulation (EU) No 36/2012.

                     (3)

                     Regulation (EU) No 36/2012 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex II to Regulation (EU) No 36/2012 is amended as set out in the Annex to this Regulation.

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

                  For the Council

                  The President

               A.P. ZACARIAS

            (1)  OJ L 16, 19.1.2012, p. 1.

            ANNEX
            The following entry is added to the list set out in Section A (Persons) of Annex II to Regulation (EU) No 36/2012:

                           Name

                           Identifying information

                           Reasons

                           Date of listing

                           ‘311.

                           Faisal MEKDAD
                           (a.k.a. Fayçal, al-Mekdad, Meqdad, al-Meqdad)
                           (فيصل المقداد)

                           Date of birth: 1954;
                           Place of birth: Ghasm, Daraa Governorate, Syria;
                           Gender: Male

                           Minister of Foreign Affairs. Appointed in November 2020.
                           As a Government Minister, shares responsibility for the Syrian regime’s violent repression against the civilian population.

                           15.1.2021’


title: Commission Implementing Regulation (EU) 2021/73 of 26 January 2021 amending Implementing Regulation (EU) No 808/2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD)

text:
                  27.1.2021

                  EN

                  Official Journal of the European Union

                  L 27/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/73
         of 26 January 2021
         amending Implementing Regulation (EU) No 808/2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (1), and in particular Article 8(3), Article 12 and Article 75(5) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 808/2014 (2) lays down rules for the application of Regulation (EU) No 1305/2013. Regulation (EU) 2020/2220 of the European Parliament and of the Council (3) amended Regulation (EU) No 1305/2013 and extended the period of duration of rural development programmes supported by the European Agricultural Fund for Rural Development (‘EAFRD’) until 31 December 2022 and provided Member States with the possibility to finance their extended programmes from the corresponding budget allocation for the years 2021 and 2022. Moreover, Regulation (EU) 2020/2220 made the additional resources from the European Union Recovery Instrument established by Council Regulation (EU) 2020/2094 (4) (‘EURI’) available in the extended programmes in the years 2021 and 2022 to fund measures under Regulation (EU) No 1305/2013 with the objective to address the impact of the COVID-19 crisis and its consequences for the Union agricultural sector and rural areas. Therefore, the respective rules for the implementation of Regulation (EU) No 1305/2013 should be amended.

                     (2)

                     Article 4(2) of Implementing Regulation (EU) No 808/2014 sets the maximum number of amendments to rural development programmes that Member States may submit to the Commission. In order to increase the flexibility for Member States to use their budget allocation for the years 2021 and 2022 in the extended programmes and integrate the additional resources from the EURI, the maximum number of amendments referred to in that Article should be increased and the deadlines for submitting requests for last programme amendments postponed. Moreover, it needs to be clarified that the maximum number of amendments should not apply to requests to amend rural development programmes in case amendments are necessary following the entry into force of Regulation (EU) 2020/2220 in order to extend the duration of the rural development programmes and integrate the additional resources from the EURI.

                     (3)

                     Regulation (EU) 2020/2220 provides that for the extended rural development programmes, targets established in the context of the performance framework are to be set for the year 2025. Thus, it is necessary to specify that the performance framework indicator targets refer to the planned achievements by 31 December 2025. Furthermore, Regulation (EU) 2020/2220 excludes the application of the performance framework to the additional resources from the EURI. Therefore, outputs financed by the additional resources from the EURI should be excluded from the performance framework targets.

                     (4)

                     Regulation (EU) 2020/2220 provides that the additional resources from the EURI are to be programmed and monitored separately from the Union support for rural development, while applying in principle, the rules set out in Regulation (EU) No 1305/2013. Thus, separate specifications in the relevant measure descriptions in the rural development programmes and the national framework programmes will be required where operations are supported by the additional resources from the EURI. Financing plans of the rural development programmes, national frameworks and national rural networks should also indicate separately the additional resources from the EURI.

                     (5)

                     Moreover, in the indicator plan for the selected measures, the sub-total of the planned outputs and planned total public expenditure which is financed by the additional resources from the EURI should be indicated separately. In the annual implementation reports, the reporting on committed expenditure by measure and focus area should indicate the part of the commitments which are financed by the additional resources from the EURI.

                     (6)

                     Article 8(h)(ii) of Regulation (EU) No 1305/2013 requires that for each measure, for each type of operation with a specific EAFRD contribution rate, for the type of operation referred to in Articles 37(1), 38(3), 39(1) and Article 39a of Regulation (EU) No 1305/2013, when a Member State applies a minimum loss threshold set below 30 %; and for technical assistance, the financing plan is to contain a table indicating the total Union contribution planned and the applicable EAFRD contribution rate. Since the same rules apply to the contribution from the additional resources from the EURI, the financing plan should indicate, if applicable, for each such measure for each type of operation, the planned EURI contribution and the EURI contribution rate.

                     (7)

                     Regulation (EU) 2020/2220 has amended Articles 38 and 39 of Regulation (EU) No 1305/2013 as to the minimum loss threshold Member States can define in their rural development programmes based on which farmers may be compensated for losses under the mutual funds for adverse climatic events, animal and plant diseases, pest infestations and environmental incidents and the income stabilisation tool for farmers of all sectors. As a consequence and for the WTO reporting purposes, expenditure for all risk management tools governed by Article 36 of Regulation (EU) No 1305/2013 and where the minimum loss threshold is below 30 % need to be planned and reported separately. The indicator plan needs to specify these new programming and planning requirements accordingly.

                     (8)

                     Implementing Regulation (EU) No 808/2014 should therefore be amended accordingly.

                     (9)

                     Given the urgency related to the COVID-19 crisis, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

                     (10)

                     The measures provided for in this Regulation are in accordance with the opinion of the Rural Development Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 808/2014 is amended as follows:

                        (1)

                        Article 4 is amended as follows:

                                    (a)

                                    in paragraph 1, point (e) is deleted;

                                    (b)

                                    paragraph 2 is amended as follows:

                                                (i)

                                                the first subparagraph is replaced by the following:
                                                ‘Programme amendments of the type referred to in Article 11(a)(i) of Regulation (EU) No 1305/2013 may be proposed no more than four times during the duration of the programming period.’;

                                                (ii)

                                                the second subparagraph is replaced by the following:
                                                ‘For all other types of amendments combined:

                                                            (a)

                                                            a single amendment proposal may be submitted per calendar year and per programme, with the exception of the year 2025 in which year more than a single amendment proposal may be submitted for amendments concerning exclusively the adaptation of the financing plan, including any resulting changes to the indicator plan;

                                                            (b)

                                                            four additional amendment proposals per programme may be submitted during the duration of the programming period.’;

                                                (iii)

                                                in the third subparagraph, point (b) is replaced by the following:

                                                            ‘(b)

                                                            in case an amendment is necessary following a change to the Union legal framework, including a change related to the extension of duration of rural development programmes or a change related to the availability of the additional resources for the recovery of the Union agricultural sector and rural areas pursuant to Regulation (EU) 2020/2220 of the European Parliament and of the Council (*1);

                                                   (*1)  Regulation (EU) 2020/2220 of the European Parliament and of the Council of 23 December 2020 laying down certain transitional provisions for support from the European Agricultural Fund for Rural Development (EAFRD) and from the European Agricultural Guarantee Fund (EAGF) in the years 2021 and 2022 and amending Regulations (EU) No 1305/2013, (EU) No 1306/2013 and (EU) No 1307/2013 as regards resources and application in the years 2021 and 2022 and Regulation (EU) No 1308/2013 as regards resources and the distribution of such support in respect of the years 2021 and 2022 (OJ L 437, 28.12.2020, p. 1).’;"

                                    (c)

                                    paragraph 3 is replaced by the following:

                                       ‘3.   Member States shall submit their last programme amendment of the type referred to in Article 11(a)(iii) of Regulation (EU) No 1305/2013 to the Commission by 30 September 2022.
                                       Other types of programme amendments shall be submitted to the Commission by 30 September 2025.’;

                        (2)

                        Annex I is amended as set out in Annex I to this Regulation;

                        (3)

                        Annex VII is amended as set out in Annex II 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, 26 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487).

            (2)  Commission Implementing Regulation (EU) No 808/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 227, 31.7.2014, p. 18).

            (3)  Regulation (EU) 2020/2220 of the European Parliament and of the Council of 23 December 2020 laying down certain transitional provisions for support from the European Agricultural Fund for Rural Development (EAFRD) and from the European Agricultural Guarantee Fund (EAGF) in the years 2021 and 2022 and amending Regulations (EU) No 1305/2013, (EU) No 1306/2013 and (EU) No 1307/2013 as regards resources and application in the years 2021 and 2022 and Regulation (EU) No 1308/2013 as regards resources and the distribution of such support in respect of the years 2021 and 2022 (OJ L 437, 28.12.2020, p. 1).

            (4)  Council Regulation (EU) 2020/2094 of 14 December 2020 establishing a European Union Recovery Instrument to support the recovery in the aftermath of the COVID-19 crisis (OJ L 433 I, 22.12.2020, p. 23).

            ANNEX I
            Annex I to Implementing Regulation (EU) No 808/2014 is amended as follows:

                        (1)

                        Part 1 is amended as follows:

                                    (a)

                                    in point 7(b), point (i) is replaced by the following:

                                                ‘(i)

                                                targets for 2025. Targets shall not take into account additional national financing as referred to in point 12, and state aid in the form of additional funding as referred to in point 13, and the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013.’;

                                    (b)

                                    in point 8(2), point (c) is replaced by the following:

                                                ‘(c)

                                                scope, level of support, eligible beneficiaries, and where relevant, methodology for calculation of the amount or support rate broken down by sub-measure and/or type of operation where necessary. For each type of operation specification of eligible costs, eligibility conditions, applicable amounts and support rates and principles with regard to the setting of selection criteria. Where support is provided to a financial instrument implemented under points (a) and (b) of the first subparagraph of Article 38(4) of Regulation (EU) No 1303/2013, description of the type of financial instrument, general categories of final recipients, general categories of eligible costs and the maximum level of support. A separate description shall be provided for measures or parts of measures financed by the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013.’;

                                    (c)

                                    point 10 is amended as follows:

                                                (i)

                                                the title is replaced by the following:
                                                ‘Financing plan, comprising separate structured tables for points (a) to (d), indicating separately for the European Union Recovery Instrument the information referred to in point (e):’;

                                                (ii)

                                                in point (c), point (v) is replaced by the following:

                                                            ‘(v)

                                                            for the operations implemented in accordance with Articles 38 and 39 of Regulation (EU) No 1305/2013, where the Member State decides to set the minimum loss threshold between 20 and 30 %, and for operations implemented in accordance with Article 37(1) and Article 39a of Regulation (EU) No 1305/2013, the applicable EAFRD contribution and the indicative contribution rate.’;

                                                (iii)

                                                the following point (e) is added:

                                                            ‘(e)

                                                            For the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013:

                                                                        (i)

                                                                        the annual contribution;

                                                                        (ii)

                                                                        the contribution rate applicable to the supported measures;

                                                                        (iii)

                                                                        the breakdown by measure and focus area;

                                                                        (iv)

                                                                        contribution for technical assistance;

                                                                        (v)

                                                                        when a measure or a type of operation is implemented with the contribution of financial instruments, referred to in Article 38(1)(b) and (c) of Regulation (EU) No 1303/2013, the table shall indicate separately the contribution rates for financial instruments and an indicative support from the European Union Recovery Instrument corresponding to the planned contribution to the financial instrument;

                                                                        (vi)

                                                                        for the operations implemented in accordance with Articles 38 and 39 of Regulation (EU) No 1305/2013, where the Member State decides to set minimum loss threshold between 20 and 30 % and for operations implemented in accordance with Article 37(1) and Article 39a of Regulation (EU) No 1305/2013, the applicable European Union Recovery Instrument contribution and the indicative contribution rate.’;

                                    (d)

                                    point 11 is amended as follows:

                                                (i)

                                                point (a) is replaced by the following:

                                                            ‘(a)

                                                            by focus area, the quantified targets accompanied by planned outputs and planned total public expenditure of the measures selected to address the focus area, including sub-totals of these planned outputs and planned total expenditure financed by the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013;’;

                                                (ii)

                                                the following point (d) is added:

                                                            ‘(d)

                                                            the planned total public expenditure related to support pursuant to Article 36 of Regulation (EU) No 1305/2013, where the minimum loss threshold is below 30 %.’;

                        (2)

                        Part 2 is amended as follows:

                                    (a)

                                    point 4 is replaced by the following:

                                                ‘4.

                                                Table summarising, by region and by year, the total EAFRD contribution to the Member State for the whole programming period, without the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013, and separately the contribution of those additional resources to the Member State for the years 2021 and 2022’;

                                    (b)

                                    in point 5(2), point (c) is replaced by the following:

                                                ‘(c)

                                                Scope, level of support, eligible beneficiaries, and where relevant, methodology for calculation of the amount or support rate broken down by sub-measure and/or type of operation where necessary. For each type of operation specification of eligible costs, eligibility conditions, applicable amounts and support rates and principles with regard to the setting of selection criteria. Where support is provided to a financial instrument implemented under points (a) and (b) of the first subparagraph of Article 38(4) of Regulation (EU) No 1303/2013, description of the type of financial instrument, general categories of final recipients, general categories of eligible costs and the maximum level of support. A separate description shall be provided for measures or parts of measures financed by the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013.’;

                        (3)

                        in Part 3, point 5 is replaced by the following:

                                    ‘5.

                                    Financing plan, setting out:

                                                (a)

                                                the annual EAFRD contribution, without the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013;

                                                (b)

                                                the total Union contribution and the EAFRD contribution rate;

                                                (c)

                                                for the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013:

                                                            (i)

                                                            the annual contribution;

                                                            (ii)

                                                            the total contribution and the contribution rate.’.

            ANNEX II
            Point (b) of point 1 of Annex VII to Implementing Regulation (EU) No 808/2014 is amended as follows:

                        (1)

                        the first subparagraph is replaced by the following:
                        ‘Information on RDP implementation as measured by common and specific indicators, including the progress achieved in relation to the targets set for each focus area and on realised output compared to planned output as set out in the indicator plan. Beginning from the annual implementation report to be submitted in 2017, the achievements towards the milestones and targets set in the performance framework (Table F). Additional information on the stage of RDP implementation is provided through data on financial commitments by measure and focus area, and the related expected progress towards targets’;

                        (2)

                        in the second subparagraph, the first indent is replaced by the following:

                                    ‘—

                                    Table A: Committed expenditure by measure and focus area, indicating this information separately for the additional resources referred to in Article 58a of Regulation (EU) No 1305/2013’.


title: Commission Implementing Regulation (EU) 2021/74 of 26 January 2021 amending Implementing Regulation (EU) 2020/1191 on measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV)

text:
                  27.1.2021

                  EN

                  Official Journal of the European Union

                  L 27/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/74
         of 26 January 2021
         amending Implementing Regulation (EU) 2020/1191 on measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 30,
         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 (2), and in particular Article 22(3) and Article 52 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2020/1191 (3) entered into force on 15 August 2020. Since that date, certain Member States and professional operators have interpreted and applied the term ‘storage’, contained in paragraph 2 of Article 7 of that Regulation, in a diverging manner.

                     (2)

                     For practical reasons and as the seeds of Solanum lycopersicum L. and Capsicum spp. (‘the specified seeds’) that have been harvested before 15 August 2020 cannot fulfil the requirement for their mother plants to be produced in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest, such seeds should be exempted from the condition under Article 7(1)(a) of Implementing Regulation (EU) 2020/1191.

                     (3)

                     Paragraph 2 of Article 7 of Implementing Regulation (EU) 2020/1191 should be amended to clarify that the specified seeds that have been harvested prior to 15 August 2020 should be sampled and tested for the presence of the specified pest by the competent authority or by professional operators under official supervision of the competent authority before their first movement within the Union. Such derogation from paragraph 2 of Article 7 of that Regulation should allow seeds already accompanied by a plant passport to circulate in the Union territory without being further tested.

                     (4)

                     The specified seeds moved for the first time within the Union from 1 April 2021 onwards, and which have been tested before 30 September 2020 with the ELISA method, should be tested again with a testing method, other than ELISA, as referred to in point 3 of the Annex.

                     (5)

                     As the specified seeds, originating from third countries and harvested before 15 August 2020 cannot fulfil the condition for their mother plants to be produced in a production site where the specified pest is known not to occur, on the basis of official inspections carried out at the appropriate time to detect the specified pest, such seeds to be introduced into the Union, should be exempted from the requirement under point (a)(i) of Article 9(1).

                     (6)

                     The Commission was informed by the seed industry sector and by the Member States that the requirement to include the name of the registered production site in the phytosanitary certificate in accordance with Article 9 of Implementing Regulation (EU) 2020/1191 is causing delays and practical difficulties to the exporters, as for them it is difficult to identify the concrete production site. For the purpose of facilitating the identification of the registered production site by the competent authorities and professional operators of third countries, that requirement should be replaced by a requirement for submitting information on the traceability of the production site of the mother plants.

                     (7)

                     The specified seeds originating from third countries should be tested using the sampling and testing methods as referred in the Annex of Implementing Regulation (EU) 2020/1191. To take into account that some specified seeds may have been tested months before they are actually certified for export, it is proportionate from 1 April 2021 onwards to require carrying out of mandatory molecular testing, and give third countries time to adapt to this requirement.

                     (8)

                     In order to avoid unnecessary trade restrictions for the specified seeds harvested before 15 August 2020, this Regulation should become applicable within the shortest possible time. Therefore, this Regulation should enter into force on the third day following that of its publication.

                     (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
            Amendment of Implementing Regulation (EU) 2020/1191
            Implementing Regulation (EU) 2020/1191 is amended as follows:

                        (1)

                        Article 7 is amended as follows:

                                    (a)

                                    in paragraph 1, the following subparagraph is added:
                                    ‘Specified seeds that have been harvested before 15 August 2020 shall be exempted from the condition under point (a).’;

                                    (b)

                                    paragraph 2 of Article 7 is replaced by the following:

                                       ‘2.   By way of derogation from point (a) and from the first subparagraph of point (b) of paragraph 1, specified seeds that have been harvested prior to 15 August 2020 shall have been sampled and tested for the specified pest by the competent authority or by professional operators under official supervision of the competent authority and found free from that pest, before their first movement within the Union.
                                       The specified seeds moved for the first time within the Union from 1 April 2021 on, and which have been tested before 30 September 2020 with Elisa method, shall be tested again with a testing method, other than ELISA, as referred to in point 3 of the Annex.’;

                        (2)

                        Article 9 is amended as follows:

                                    (a)

                                    in paragraph 1, point (a), the text of point (ii) is replaced by the following:
                                    ‘the specified seeds concerned or their mother plants have undergone official sampling and testing for the specified pest as set out in the Annex and have been found, according to those tests, to be free from the specified pest;’;

                                    (b)

                                    in paragraph 1, point (b) is replaced by the following:
                                    ‘information ensuring the traceability of the production site of the mother plants.’;

                                    (c)

                                    the following paragraph 3 is added:

                                       ‘3.   By way of derogation from point (a)(i) of paragraph 1, for the specified seeds, which have been harvested prior to 15 August 2020, the Additional Declaration shall only state the fulfilment of the condition under point (a)(ii) of paragraph 1 and shall include the statement: “The seeds have been harvested before 15 August 2020.”’;

                                    (d)

                                    the following paragraph 4 is added:

                                       ‘4.   In phytosanitary certificates issued after 31 March 2021, the Additional Declaration shall confirm that specified seeds originating from third countries have been tested under one of the testing methods, other than ELISA, as referred to in point 3 of the Annex to Implementing Regulation (EU) 2020/1191.’

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 317, 23.11.2016, p. 4.

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

            (3)  Commission Implementing Regulation (EU) 2020/1191 of 11 August 2020 establishing measures to prevent the introduction into and the spread within the Union of Tomato brown rugose fruit virus (ToBRFV) and repealing Implementing Decision (EU) 2019/1615 (OJ L 262, 12.8.2020, p. 6).


title: Commission Implementing Regulation (EU) 2021/78 of 27 January 2021 amending Implementing Regulation (EU) 2020/600 derogating from Implementing Regulation (EU) 2017/892, Implementing Regulation (EU) 2016/1150, Implementing Regulation (EU) No 615/2014, Implementing Regulation (EU) 2015/1368 and Implementing Regulation (EU) 2017/39 as regards certain measures to address the crisis caused by the COVID-19 pandemic

text:
                  28.1.2021

                  EN

                  Official Journal of the European Union

                  L 29/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/78
         of 27 January 2021
         amending Implementing Regulation (EU) 2020/600 derogating from Implementing Regulation (EU) 2017/892, Implementing Regulation (EU) 2016/1150, Implementing Regulation (EU) No 615/2014, Implementing Regulation (EU) 2015/1368 and Implementing Regulation (EU) 2017/39 as regards certain measures to address the crisis caused by the COVID-19 pandemic
         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 54 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2020/600 (2) introduced a number of derogations from existing rules, inter alia, in the wine sector, aimed at providing relief to wine operators to help them cope with the impact of the COVID-19 pandemic. However, despite the usefulness of those measures, the wine market has not managed to regain its balance between supply and demand and is not expected to regain it in the short to medium term due to the ongoing pandemic.

                     (2)

                     Furthermore, the measures adopted to address the COVID-19 pandemic are being continued in most Member States and across the world. Those measures include imposing restrictions in relation to the size of social gatherings and celebrations, and in relation to the possibilities to eat and drink outside the home. Lockdowns continue to be imposed in some areas, accompanied by the cancellation of public events and private parties. The knock-on effect of these restrictions has resulted in a further decrease in the consumption of wine in the Union and in a confirmed reduction in the export of wine to third countries. In addition, the uncertainty as to the duration of the crisis, which it is anticipated will likely extend beyond the end of the year 2020, is causing long-term damage to the Union wine sector as wine consumption is unlikely to recover and export markets will be lost. This combination of factors is having a significant negative impact on pricing in the Union wine market. Stocks that were already at a record high at the beginning of the marketing year 2019-2020 have been increased. Finally, the upcoming high-yielding 2020 harvest, which is expected to exceed the 2019 harvest by approximately 10 million hectolitres of wine, will only serve to further worsen the situation.

                     (3)

                     Consequently, given the lengthy duration of the restrictions imposed by Member States to address the COVID-19 pandemic and the need to keep restrictions in place, the severe economic disruption to the main outlets for wine and the ensuing negative effect on the demand for wine are exacerbated.

                     (4)

                     In light of this exceptionally severe market disturbance and of the accumulation of difficult circumstances encountered in the wine sector, which has its origin in the imposition by the United States of tariffs on the imports of Union wines in October 2019 and which continues now with the fall-out from the on-going restrictive measures due to the worldwide COVID-19 pandemic, exceptional difficulties continue to be encountered by operators in the Union wine sector. Further assistance to the wine sector is therefore warranted.

                     (5)

                     The continued implementation of the measures to address the crisis in the Union wine sector which were introduced by Implementing Regulation (EU) 2020/600 is considered essential to provide Member States and operators with the necessary flexibilities to implement support programmes in the Union wine sector. In particular, the possibility for Member States to introduce changes to their respective national programmes whenever necessary during the year has enabled Member States to react quickly to the exceptional circumstances of the recent months and to submit changes to their support programmes as early as deemed necessary. This flexibility has allowed Member States to introduce new measures, optimise measures already in place and to adjust measures more frequently, and as necessary, taking account of the fast changing market situation. In addition, the flexibility introduced for the implementation of the green harvesting measure has afforded operators the time required to plan the measure and to find the requisite labour force to operate under the difficult conditions arising from the COVID-19 pandemic.

                     (6)

                     As the COVID-19 pandemic is expected to continue beyond the end of the year 2020 and thus during a considerable part of the financial year 2021, it is considered necessary to extend the application of the measures for the duration of the financial year 2021.

                     (7)

                     In addition, due to the difficulties encountered in the management of the national support programmes during the ongoing COVID-19 pandemic, some Member States have reported that they are not in a position to re-examine the standard scales of unit costs applied to certain measures in those programmes and established pursuant to Article 24(1) of Commission Implementing Regulation (EU) 2016/1150 (3). Therefore, during the years 2020, 2021 and 2022, Member States should have the possibility to extend the period during which such re-examination shall be carried out, from every second year following the last calculations, as provided for in Article 24(3) of that Regulation, to the fourth year following the last calculations. To avoid discrimination, this flexibility should apply retroactively as of the date of entry into force of Implementing Regulation (EU) 2020/600.

                     (8)

                     Implementing Regulation (EU) 2020/600 should therefore be amended accordingly.

                     (9)

                     In order to avoid disruption in the implementation of the measures to address the crisis in the Union wine sector and ensure a smooth transition between the two financial years, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union and apply retroactively from 16 October 2020.

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendments to Implementing Regulation (EU) 2020/600
            Article 2 of Implementing Regulation (EU) 2020/600 is amended as follows:

                        (1)

                        paragraph 1 is replaced by the following:

                           ‘1.   By way of derogation from Article 2(1) of Implementing Regulation (EU) 2016/1150, Member States may introduce, in relation to the measures referred to in Articles 45(1)(a) and 46 to 52 of Regulation (EU) No 1308/2013, whenever necessary during the financial years 2020 and 2021 but not later than 15 October 2021, changes to their national support programmes in the wine sector as referred to in Article 41(5) of Regulation (EU) No 1308/2013.’;

                        (2)

                        in paragraph 2, the introductory phrase is replaced by the following:

                           ‘2.   By way of derogation from Article 8 of Implementing Regulation (EU) 2016/1150, during the financial years 2020 and 2021, Member States may:’;

                        (3)

                        the following paragraph 3 is added:

                           ‘3.   By way of derogation from Article 24(3) of Implementing Regulation (EU) 2016/1150, during the years 2020, 2021 and 2022, Member States shall re-examine the calculations provided for in paragraph 1 of that Article at the latest in the fourth year following the previous calculations and shall, if necessary, adjust the initially established standard scales of unit costs.’.

            Article 2
            Entry into force and application
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            It shall apply from 16 October 2020. However, point (3) of Article 1 shall apply as of 4 May 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) 2020/600 of 30 April 2020 derogating from Implementing Regulation (EU) 2017/892, Implementing Regulation (EU) 2016/1150, Implementing Regulation (EU) No 615/2014, Implementing Regulation (EU) 2015/1368 and Implementing Regulation (EU) 2017/39 as regards certain measures to address the crisis caused by the COVID-19 pandemic (OJ L 140, 4.5.2020, p. 40).

            (3)  Commission Implementing Regulation (EU) 2016/1150 of 15 April 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector (OJ L 190, 15.7.2016, p. 23).


title: Commission Implementing Regulation (EU) 2021/79 of 27 January 2021 concerning the non-approval of the active substance topramezone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

text:
                  28.1.2021

                  EN

                  Official Journal of the European Union

                  L 29/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/79
         of 27 January 2021
         concerning the non-approval of the active substance topramezone, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
         (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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,
         Whereas:

                     (1)

                     According to Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) applies to the procedure and the conditions for approval of active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive, before 14 June 2011. On 9 December 2003, the Commission adopted Decision 2003/850/EC (3) on the active substance topramezone (formerly BAS 670H) in accordance with Article 6(3) of Directive 91/414/EEC.

                     (2)

                     On 12 May 2003, BASF Aktiengesellschaft (now BASF SE) submitted an application for the inclusion of topramezone in Annex I to Directive 91/414/EEC to France in accordance with Article 6(2) of that Directive. Decision 2003/850/EC confirmed that the dossier satisfied, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

                     (3)

                     The assessment of the effects of topramezone on human and animal health and the environment for the uses proposed by the applicant has been carried out in accordance with the procedure provided in Article 6(2) and (4) of Directive 91/414/EEC. France submitted a draft assessment report to the Commission and the European Food Safety Authority (‘the Authority’) on 21 July 2006.

                     (4)

                     The draft assessment report was reviewed by the Member States and the Authority. The Authority presented to the Commission its conclusion (4) on the pesticide risk assessment of the active substance topramezone on 13 January 2014.

                     (5)

                     By letter of 29 June 2020, BASF SE withdrew the application for the approval of topramezone.

                     (6)

                     Due to the withdrawal of the application, topramezone should not be approved.

                     (7)

                     This Regulation does not prevent the submission of a further application for the active substance topramezone pursuant to Article 7 of Regulation (EC) No 1107/2009.

                     (8)

                     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
            Non-approval of active substance
            The active substance topramezone is not approved.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

            (3)  Commission Decision 2003/850/EC of 4 December 2003 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of BAS 670H and silver thiosulphate in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (OJ L 322, 9.12.2003, p. 28).

            (4)  European Food Safety Authority, 2014. Conclusion on the peer review of the pesticide risk assessment of the active substance topramezone. EFSA Journal 2014;12(2):3540, 82 pp. doi:10.2903/j.efsa.2014.3540.


title: Commission Implementing Regulation (EU) 2021/80 of 27 January 2021 concerning the non-approval of carbon dioxide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

text:
                  28.1.2021

                  EN

                  Official Journal of the European Union

                  L 29/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/80
         of 27 January 2021
         concerning the non-approval of carbon dioxide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
         (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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market (1), and in particular Article 23(5) in conjunction with Article 13(2)
         Whereas:

                     (1)

                     On 27 February 2018, the Commission received an application from Dr Knoell Consult GmbH for the approval of food grade carbon dioxide (E 290) as a basic substance (CAS No 124-38-9). The application referred to a use as post-harvest fumigant against insects and mites.

                     (2)

                     Carbon dioxide is already approved as an active substance for use in plant protection products since 1 September 2009 (2) and is included in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3).

                     (3)

                     Carbon dioxide is currently authorised and placed on the market as a plant protection product in several Member States. The specification of the substance identity in the application for approval as a basic substance is identical to that of the approved active substance.

                     (4)

                     Although the third subparagraph provides that foodstuff is to be considered as a basic substance, Article 23(1)(d) of Regulation (EC) No 1107/2009 excludes the approval of food-grade carbon dioxide, because a substance can, among other criteria, be only approved as a basic substance if it is not placed on the market as a plant protection product. This is, however, currently the case for food-grade carbon dioxide.

                     (5)

                     This Regulation is without prejudice to the submission of a new application for the approval of carbon dioxide as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009 once the existing approval of carbon dioxide as an active substance has expired and once all authorisations for plant protection products consisting of carbon dioxide have been withdrawn or have expired.

                     (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 substance carbon dioxide (E 290) is not approved as a basic substance.

            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, 27 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

            (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).


title: Commission Implementing Regulation (EU) 2021/82 of 27 January 2021 authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  28.1.2021

                  EN

                  Official Journal of the European Union

                  L 29/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/82
         of 27 January 2021
         authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     On 31 January 2019, the company Glycom A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 6’-sialyllactose (‘6’-SL’) sodium salt, obtained by microbial fermentation with a genetically modified strain of Escherichia coli, strain K12 DH1, on the Union market as a novel food. The applicant requested for 6’-SL sodium salt to be used as a novel food in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), milk-based drinks and similar products intended for young children, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population, excluding infants and young children. The applicant also proposed that food supplements containing 6’-SL sodium salt should not be used if other foods with added 6’-SL sodium salt are consumed on the same day.

                     (4)

                     On 31 January 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk (5); the detailed characterisation data on the production bacterial strains (6) and their certificates (7); the specifications for the raw materials and processing aids (8); the certificates of analyses of the various 6’-SL sodium salt batches (9); the analytical methods and validation reports (10); the 6’-SL sodium salt stability reports (11); the detailed description of the production process (12); the laboratory accreditation certificates (13); the 6’-SL intake assessment reports (14); an in vitro mammalian cell micronucleus test with 6’-SL sodium salt (15); an in vitro mammalian cell micronucleus test with the related compound 3’-sialyllactose (‘3’-SL’) sodium salt (16); a bacterial reverse mutation test with 6’-SL sodium salt (17); a bacterial reverse mutation test with 3’-SL sodium salt (18); a 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt (19); a 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations (20); a 14-day oral toxicity study in the neonatal rat with 3’-SL sodium salt (21); and a 90-day oral toxicity study in the neonatal rat with 3’-SL sodium salt, including the summary table of the statistically significant observations (22).

                     (5)

                     On 16 May 2019, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 6’-SL sodium salt as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (6)

                     On 23 March 2020, the Authority adopted its scientific opinion ‘Safety of 6’-sialyllactose (6’-SL) sodium salt as a novel food pursuant to Regulation (EC) No 2015/2283’ (23).

                     (7)

                     In its scientific opinion, the Authority concluded that 6’-SL sodium salt is safe under the proposed conditions of use for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 6’-SL sodium salt, when used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013, milk-based drinks and similar products intended for young children, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 6’-SL sodium salt without the data from the proprietary analytical reports on the structure comparison via NMR of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates, the 6’-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 6’-SL sodium salt; the bacterial reverse mutation test with 6’-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations.

                     (9)

                     Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the analytical reports on the structure comparison via nuclear magnetic resonance NMR of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 6’-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 6’-SL sodium salt; the bacterial reverse mutation test with 6’-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (10)

                     The applicant declared that, at the time the application was made, they held proprietary and exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies.

                     (11)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of 6’-SL sodium salt, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of 6’-SL sodium salt should be restricted to the applicant for that period.

                     (12)

                     However, restricting the authorisation of 6’-SL sodium salt and of the reference to the data contained in the applicant’s file to the sole use by the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

                     (13)

                     In line with the conditions of use of food supplements containing 6’-SL sodium salt as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food supplements containing 6’-SL sodium salt should not be consumed the same day, if other foods with added 6’-SL sodium salt are consumed the same day.

                     (14)

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

                     (15)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   6’-sialyllactose (‘6’-SL’) sodium salt as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

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

                           Company: Glycom A/S;

                           Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,

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

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

            Article 2
            The data contained in the application file on the basis of which 6’-sialyllactose sodium salt has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the applicant.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 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)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

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

            (5)  Glykos Finland LTD 2018 (unpublished).

            (6)  Glycom 2019 (unpublished).

            (7)  Glycom/DSMZ 2018 (unpublished).

            (8)  Glycom 2019 (unpublished).

            (9)  Glycom 2019 (unpublished).

            (10)  Glycom 2019 (unpublished).

            (11)  Glycom 2019 (unpublished).

            (12)  Glycom 2018 (unpublished).

            (13)  Glycom 2019 (unpublished).

            (14)  Glycom 2019 (unpublished).

            (15)  Gilby 2018 (unpublished).

            (16)  Gilby 2019 (unpublished).

            (17)  Šoltésová, 2018a (unpublished).

            (18)  Šoltésová, 2018b (unpublished).

            (19)  Flaxmer 2018a (unpublished).

            (20)  Flaxmer 2018b (unpublished).

            (21)  Stannard 2019a (unpublished).

            (22)  Stannard 2019b (unpublished).

            (23)  EFSA Journal 2020;18(5):6097.

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

                        (1)

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

                                    ‘Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data Protection

                                       6’-Sialyllactose (6’-SL) sodium salt

                                       (microbial source)

                                          Specified food category

                                          Maximum levels (expressed as 6’-Sialyllactose)

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “6’-Sialyllactose sodium salt”.
                                    The labelling of food supplements containing 6’-Sialyllactose (6’-SL) sodium salt shall bear a statement that they should not be consumed:

                                                a)

                                                if foods containing added 6’-Sialyllactose sodium salt are consumed on the same day.

                                                b)

                                                by infants and young children

                                    Authorised on 17 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 6’-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.
                                    End date of the data protection: 17 February 2026.’

                                    Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

                                    0,5 g/L

                                    Unflavoured fermented milk-based products

                                    0,5 g/L (beverages)

                                    2,5 g/kg (products other than beverages)

                                    Flavoured fermented milk-based products including heat-treated products

                                    0,5 g/L (beverages)

                                    5,0 g/kg (products other than beverages)

                                    Beverages (flavoured drinks, excluding drinks with a pH less than 5)

                                    0,5 g/L

                                    Cereal bars

                                    5,0 g/kg

                                    Infant formula as defined under Regulation (EU) No 609/2013

                                    0,4 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Follow-on formula as defined under Regulation (EU) No 609/2013

                                    0,3 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013

                                    0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    2,5 g/kg for products other than beverages

                                    Milk based drinks and similar products intended for young children

                                    0,3 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013

                                    1,0 g/L (beverages)

                                    10,0 g/kg (products other than beverages)

                                    Food for special medical purposes as defined under Regulation (EU) No 609/2013

                                    In accordance with the particular nutritional requirements of the persons for whom the products are intended

                                    Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

                                    1,0 g/day

                        (2)

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

                                    ‘Authorised Novel Food

                                       Specification

                                       6’-Sialyllactose (“6’-SL”) sodium salt

                                       (microbial source)

                                       Description:

                                    6’-Sialyllactose (6’-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 6’-sialyl-lactulose, and sialic acid.

                                       Source: Genetically modified strain of Escherichia coli K-12 DH1

                                       Definition:

                                    Chemical formula: C23H38NO19Na
                                    Chemical name: N-Acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt
                                    Molecular mass: 655,53 Da
                                    CAS No 157574-76-0

                                       Characteristics/Composition:

                                    Appearance: White to off-white powder or agglomerate
                                    Sum of 6’-Sialyllactose sodium salt, D-Lactose and Sialic acid (% of dry matter): ≥ 94,0 % (w/w)
                                    6’-Sialyllactose sodium salt (% of dry matter): ≥ 90,0 % (w/w)
                                    D-Lactose: ≤ 5,0 % (w/w)
                                    Sialic acid: ≤ 2,0 % (w/w)
                                    6’-Sialyl-lactulose: ≤ 3,0 % (w/w)
                                    Sum of other carbohydrates: ≤ 3,0 % (w/w)
                                    Moisture: ≤ 6,0 % (w/w)
                                    Sodium: 2,5-4,5 % (w/w)
                                    Chloride: ≤ 1,0 % (w/w)
                                    pH (20 °C, 5 % solution): 4,5-6,0
                                    Residual protein: ≤ 0,01 % (w/w)

                                       Microbiological criteria:

                                    Aerobic mesophilic bacteria total plate count: ≤ 1 000  CFU/g

                                       Enterobacteriaceae: ≤ 10 CFU/g

                                       Salmonella sp.: Absence in 25 g
                                    Yeast: ≤ 100 CFU/g
                                    Mould: ≤ 100 CFU/g
                                    Residual endotoxins: ≤ 10 EU/mg

                              CFU: Colony Forming Units; EU: Endotoxin Units.’


title: Commission Implementing Regulation (EU) 2021/83 of 27 January 2021 amending Implementing Regulation (EU) 2020/466 as regards the performance of official controls and other official activities by specifically authorised natural persons and the period of application of temporary measures (Text with EEA relevance)

text:
                  28.1.2021

                  EN

                  Official Journal of the European Union

                  L 29/23

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/83
         of 27 January 2021
         amending Implementing Regulation (EU) 2020/466 as regards the performance of official controls and other official activities by specifically authorised natural persons and 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 February 2021.

                     (4)

                     Member States have also informed the Commission of other disruptions related to the capacity to deploy suitable staff, as required by Regulation (EU) 2017/625, in the context of official controls and other official activities.

                     (5)

                     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 possibility to entrust specifically authorised natural persons with official controls and other official activities, as previously laid down in Implementing Regulation (EU) 2020/466 until 1 August 2020, should be reintroduced and the period of application of Implementing Regulation (EU) 2020/466 should be prolonged until 1 July 2021.

                     (6)

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

                     (7)

                     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
            Implementing Regulation (EU) 2020/466 is amended as follows:

                        (1)

                        the following Article 3 is inserted:

                           ‘Article 3
                           Official controls and other official activities may exceptionally be performed by one or more natural persons specifically authorised by the competent authority on the basis of their qualifications, training and practical experience, who are in contact with the competent authority by any available means of communication, and who are required to follow the instructions of the competent authority for the performance of such official controls and other official activities. Such persons shall act impartially, and they shall be free from any conflict of interest as regards the official controls and other official activities performed by them.’;

                        (2)

                        in the second paragraph of Article 6, the date ‘1 February 2021’ is replaced by the date ‘1 July 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 February 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 January 2021.

                  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: Commission Implementing Regulation (EU) 2021/1370 of 6 August 2021 concerning the classification of certain goods in the Combined Nomenclature

text:
                  17.8.2021

                  EN

                  Official Journal of the European Union

                  L 294/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1370
         of 6 August 2021
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

                     In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

                     (2)

                     Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

                     (3)

                     Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

                     (4)

                     It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at three months.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 6 August 2021.

                  For the Commission

               Gerassimos THOMAS

                  Director-General

                  Directorate-General for Taxation and Customs Union

            (1)  OJ L 269, 10.10.2013, p. 1.

            (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

            ANNEX

                        Description of the goods

                        Classification (CN-code)

                        Reasons

                        (1)

                        (2)

                        (3)

                        A flat rectangular article (measuring approximately 2,50 m × 2,50 m) made of a lightweight woven textile fabric (100 % polyester fibres) coated on one side with plastics (PVC) that cannot be seen with the naked eye, with zippers sewn to the edges of three of its sides to connect it to a tent.
                        Based on the information on the packaging, the article is presented as a side wall for a tent. It is imported on its own (without roof, other walls and without a supporting structure).

                        6307 90 98

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature (GIR), note 7(f) to Section XI and by the wording of CN codes 6307 , 6307 90  and 6307 90 98 .
                        Classification of the article as a tarpaulin under CN code 6306 12 00  is excluded, because tarpaulins are generally made of a heavy fabric and are used to protect goods against bad weather (see also the Harmonized System Explanatory Note (HSEN) to heading 6306  (1)). The zippers sewn to the article and the lightweight material indicate that the article is not suitable/intended to be used as a tarpaulin of CN code 6306 12 00 .
                        Furthermore, the article cannot be classified as a tent under CN code 6306 22 00  because due to its objective characteristics, the article does not have the essential character of a complete article (tent) within the meaning of GIR 2(a). It is not evident either from its objective characteristics whether the article is to be used as part of a tent, a gazebo or another product.
                        Heading 6307  applies to other made-up articles of any textile fabric, provided they are not included in other headings of Section XI. It also covers made-up flat protective sheets other than tarpaulins and ground sheets of heading 6306  (see also the HSEN to heading 6307 , first paragraph and second paragraph, (8)).
                        The article is therefore to be classified under CN code 6307 90 98  as other made-up article.