title: Commission Implementing Regulation (EU) 2019/302 of 20 February 2019 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  22.2.2019

                  EN

                  Official Journal of the European Union

                  L 51/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/302
         of 20 February 2019
         amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
         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 183(b) thereof,
         Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

                     (2)

                     Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

                     (3)

                     Regulation (EC) No 1484/95 should therefore be amended accordingly.

                     (4)

                     Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day 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, 20 February 2019.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 150, 20.5.2014, p. 1.

            (3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

            ANNEX

                     ‘ANNEX I

                                 CN code

                                 Description

                                 Representative price
                                 (EUR/100 kg)

                                 Security under Article 3
                                 (EUR/100 kg)

                                 Origin (1)

                                 0207 12 90

                                 Fowls of the species Gallus domesticus, not cut in pieces, presented as ‘65 % chickens’, frozen

                                 121,0

                                 0

                                 AR

                                 0207 14 10

                                 Fowls of the species Gallus domesticus, boneless cuts, frozen

                                 242,1

                                 17

                                 AR

                                 215,0

                                 26

                                 BR

                                 311,4

                                 0

                                 CL

                                 239,2

                                 18

                                 TH

                                 0207 27 10

                                 Turkeys, boneless cuts, frozen

                                 342,1

                                 0

                                 BR

                                 354,5

                                 0

                                 CL

                                 1602 32 11

                                 Preparations of fowls of the species Gallus domesticus, uncooked

                                 264,4

                                 7

                                 BR

               ’

               (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7).


title: Commission Implementing Regulation (EU) 2019/336 of 27 February 2019 amending Regulation (EU) No 1141/2010 and Implementing Regulation (EU) No 686/2012 as regards the rapporteur Member State for the evaluation of 1-methylcyclopropene, famoxadone, mancozeb, methiocarb, methoxyfenozide, pirimicarb, pirimiphos-methyl and thiacloprid (Text with EEA relevance.)

text:
                  28.2.2019

                  EN

                  Official Journal of the European Union

                  L 60/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/336
         of 27 February 2019
         amending Regulation (EU) No 1141/2010 and Implementing Regulation (EU) No 686/2012 as regards the rapporteur Member State for the evaluation of 1-methylcyclopropene, famoxadone, mancozeb, methiocarb, methoxyfenozide, pirimicarb, pirimiphos-methyl and thiacloprid
         (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 19, thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 686/2012 (2) and Commission Regulation (EU) No 1141/2010 (3) allocated to the United Kingdom, as rapporteur Member State, the evaluation of certain active substances contained in plant protection products.

                     (2)

                     On 29 March 2017, the United Kingdom submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. The Treaties will cease to apply to the United Kingdom from the date of entry into force of a withdrawal agreement or, failing that, two years after that notification, i.e. from 30 March 2019, unless the European Council, in agreement with the United Kingdom, unanimously decides to extend that period.

                     (3)

                     The draft withdrawal agreement as agreed between the negotiators, and endorsed by the European Council (Article 50 of the Treaty on European Union), contains arrangements for the application of provisions of Union law to and in the United Kingdom during a transition period beyond the date the Treaties cease to apply to and in the United Kingdom. If that agreement enters into force Union legislation in the field of plant protection products will apply to and in the United Kingdom during the transition period in accordance with that agreement and will cease to apply at the end of that period. However, even if the withdrawal agreement is ratified by the EU and the United Kingdom, during the transition period the United Kingdom is not to act as leading authority for risk assessments, examinations, approvals or authorisations at the level of the Union or at the level of Member States acting jointly as referred to, amongst others, in Regulation (EC) No 1107/2009.

                     (4)

                     It is therefore necessary to allocate to other Member States the evaluation of the active substances for which the United Kingdom is the rapporteur Member State and where a decision on their renewal of approval is not expected before 30 March 2019. The active substances concerned are 1-methylcyclopropene, famoxadone, mancozeb, methiocarb, methoxyfenozide, pirimicarb, pirimiphos-methyl and thiacloprid.

                     (5)

                     That allocation should ensure a balance in the distribution of the responsibilities and the work between Member States.

                     (6)

                     As the evaluation of the active substances concerned are at an advanced stage and the work to be carried out is expected to be minor, a co-rapporteur Member State should not be allocated for that evaluation.

                     (7)

                     Implementing Regulation (EU) No 686/2012 and Regulation (EU) No 1141/2010 should therefore be amended accordingly.

                     (8)

                     This Regulation should apply from 30 March 2019. However, in case the two year period referred to in Article 50(3) of the Treaty on European Union is extended, this Regulation should apply from the day following that on which legislation in the field of plant protection products ceases to apply to and in the United Kingdom, as, in accordance with Article 4(3) of Council Regulation (EEC, Euratom) No 1182/71 (4), the cessation of application of acts fixed at a given date occurs on the expiry of the last hour of the day falling on that date.

                     (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
            Implementing Regulation (EU) No 686/2012 is amended in accordance with Annex I to this Regulation.

            Article 2
            Regulation (EU) No 1141/2010 is amended in accordance with Annex II to this Regulation.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 30 March 2019.
            However, where a decision has been taken to extend the two year period referred to in Article 50(3) of the Treaty on European Union, this Regulation shall apply from the day following that on which legislation in the field of plant protection products ceases to apply to and in the United Kingdom.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances (OJ L 200, 27.7.2012, p. 5).

            (3)  Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

            (4)  Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time limits (OJ L 124, 8.6.1971, p. 1).

            ANNEX I
            Part A of the Annex to Implementing Regulation (EU) No 686/2012 is amended as follows:

                        (a)

                        the entry for 1-methyl-cyclopropene is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘1-methyl-cyclopropene

                                    NL’

                        (b)

                        the entry for Mancozeb is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Mancozeb

                                    EL’

                        (c)

                        the entry for Methiocarb is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Methiocarb

                                    DE’

                        (d)

                        the entry for Methoxyfenozide is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Methoxyfenozide

                                    SK’

                        (e)

                        the entry for Pirimicarb is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Pirimicarb

                                    SE’

                        (f)

                        the entry for Pirimiphos-methyl is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Pirimiphos-methyl

                                    FR’

                        (g)

                        the entry for Thiacloprid is replaced by the following:

                                    Active substance

                                    Rapporteur Member State

                                    Co-rapporteur Member State

                                    ‘Thiacloprid

                                    DE’

            ANNEX II
            In Annex I to Regulation (EU) No 1141/2010, the entry for Famoxadone is replaced by the following:

                           Column A

                           Column B

                           Column C

                           Column D

                           ‘Famoxadone

                           2012

                           FI

                           31 August 2012’


title: Commission Implementing Regulation (EU) 2019/337 of 27 February 2019 approving the active substance mefentrifluconazole 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  28.2.2019

                  EN

                  Official Journal of the European Union

                  L 60/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/337
         of 27 February 2019
         approving the active substance mefentrifluconazole 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, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (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)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009, the United Kingdom received on 29 February 2016 an application from BASF Agro B.V. for the approval of the active substance mefentrifluconazole.

                     (2)

                     In accordance with Article 9(3) of Regulation (EC) No 1107/2009, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 30 March 2016 of the admissibility of the application.

                     (3)

                     On 25 April 2017, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 1 February 2018.

                     (5)

                     On 5 July 2018, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance mefentrifluconazole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                     (6)

                     As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (3), which became applicable on 10 November 2018 and the joint guidance document to identify endocrine disrupting substances (4), the conclusion of the Authority infers that it is unlikely that mefentrifluconazole is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic and steroidogenic modalities. Furthermore, based on the available evidence and according to the guidance for the identification of endocrine disruptors, mefentrifluconazole is unlikely to be an endocrine disruptor for fish considering that the test modalities have been appropriately covered. The Commission therefore considers that mefentrifluconazole is not to be considered as having endocrine disrupting properties.

                     (7)

                     On 12 December 2018, the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for mefentrifluconazole and on 25 January 2019, it presented a draft Regulation providing that mefentrifluconazole is approved.

                     (8)

                     The applicant was given the possibility to submit comments on the review report.

                     (9)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (10)

                     It is therefore appropriate to approve mefentrifluconazole.

                     (11)

                     In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

                     (12)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.

                     (13)

                     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
            Approval of active substance
            The active substance mefentrifluconazole, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            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 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance BAS 750 F (mefentrifluconazole). EFSA Journal 2018;16(7):5379, 32 pp, https://doi.org/10.2903/j.efsa.2018.5379

            (3)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            (4)  ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) with the technical support of the Joint Research Centre (JRC), Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A and Van der Linden S, 2018. Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311, 135 pp. https://doi.org/10.2903/j.efsa.2018.5311. ECHA-18-G-01-EN.

            (5)  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).

            ANNEX I

                        Common Name,
                        Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Mefentrifluconazole
                        CAS No: 1417782-03-6
                        CIPAC No: Not assigned

                        (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol

                        ≥ 970 g/kg
                        The impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material.
                        The impurity toluene shall not exceed 1 g/kg in the technical material
                        The impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material

                        20 March 2019

                        20 March 2029

                        For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mefentrifluconazole, and in particular Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;

                                    —

                                    the protection of aquatic organisms.

                              Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    1.

                                    the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;

                                    2.

                                    the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.

                              The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.

               (1)  Further details on identity and specification of active substance are provided in the review report.

            ANNEX II
            In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                           Common Name,
                           Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘132

                           Mefentrifluconazole
                           CAS No: 1417782-03-6
                           CIPAC No: Not assigned

                           (2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol

                           ≥ 970 g/kg
                           The impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material.
                           The impurity toluene shall not exceed 1 g/kg in the technical material
                           The impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material

                           20 March 2019

                           20 March 2029

                           For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mefentrifluconazole, and in particular Appendices I and II thereof, shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to:

                                       —

                                       the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;

                                       —

                                       the protection of aquatic organisms.

                                 Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate.
                           The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                       1.

                                       the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;

                                       2.

                                       the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.

                                 The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.’

               (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Implementing Regulation (EU) 2019/370 of 7 March 2019 amending Regulation (EC) No 1635/2006 laying down detailed rules for the application of Council Regulation (EEC) No 737/90, by reason of the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the Union (Text with EEA relevance.)

text:
                  8.3.2019

                  EN

                  Official Journal of the European Union

                  L 68/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/370
         of 7 March 2019
         amending Regulation (EC) No 1635/2006 laying down detailed rules for the application of Council Regulation (EEC) No 737/90, by reason of the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the Union
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 733/2008 of 15 July 2008 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (1), and in particular Article 4 thereof,
         Whereas:

                     (1)

                     On 29 March 2017, the United Kingdom of Great Britain and Northern Ireland (the ‘United Kingdom’) submitted the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. The Treaties will cease to apply to the United Kingdom from the date of entry into force of a withdrawal agreement or failing that, two years after that notification, that is to say from 30 March 2019, unless the European Council, in agreement with the United Kingdom, unanimously decides to extend that period. The United Kingdom will then become a third country.

                     (2)

                     Commission Regulation (EC) No 1635/2006 (2) lays down detailed rules for the application of Council Regulation (EEC) No 737/90 (3) on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station.

                     (3)

                     Since Regulation (EEC) No 737/90 has been amended several times, it was repealed by Regulation (EC) No 733/2008.

                     (4)

                     Regulation (EC) No 733/2008 lays down maximum permitted levels of radioactivity in certain agricultural products originating in third countries. It also establishes that Member States are required to carry out checks on such agricultural products, in order to ensure their compliance with the levels of radioactivity set out in that Regulation, before the product is released for free circulation.

                     (5)

                     Regulation (EC) No 1635/2006 requires Member States to ensure that the competent authorities of third countries affected by the Chernobyl accident issue export certificates which attest that the products that they accompany comply with the maximum permitted levels set out in Regulation (EC) No 733/2008. The specific third countries concerned are listed in Annex II to Regulation (EC) No 1635/2006.

                     (6)

                     The fallout of radiocaesium from the accident at the Chernobyl power station on 26 April 1986 affected a wide range of third countries. That fallout has affected some areas of the United Kingdom. Since caesium-137 has a half-life of about 30 years, contamination decreases slowly.

                     (7)

                     Certain agricultural products originating in the United Kingdom which have been affected by the Chernobyl accident could still show radioactive caesium contamination.

                     (8)

                     As soon as Union law ceases to apply to and in the United Kingdom, agricultural products originating in the United Kingdom will have to be checked in terms of radioactive contamination before they are allowed to enter the Union.

                     (9)

                     Therefore, Annex II to Regulation (EC) No 1635/2006 should be amended in order to include the United Kingdom.

                     (10)

                     Given the urgency entailed by the circumstances of the United Kingdom's departure from the European Union, it is necessary to allow for a prompt application of the measures provided for in this Regulation. Therefore, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

                     (11)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            In Annex II to Regulation (EC) No 1635/2006, the following entry is added:

               ‘United Kingdom of Great Britain and Northern Ireland’.

            Article 2
            Entry into force and period of application
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            This Regulation shall apply from the day following that on which Union law ceases to apply to and in the United Kingdom pursuant to Article 50(3) of the Treaty on European Union.
            However, this Regulation shall not apply in either of the following cases:

                        (a)

                        a withdrawal agreement concluded with the United Kingdom in accordance with Article 50(2) of the Treaty on European Union has entered into force by that date;

                        (b)

                        a decision has been taken to extend the two-year period referred to in Article 50(3) of the Treaty on European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 7 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 201, 30.7.2008, p. 1.

            (2)  Commission Regulation (EC) No 1635/2006 of 6 November 2006 laying down detailed rules for the application of Council Regulation (EEC) No 737/90 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power-station (OJ L 306, 7.11.2006, p. 3).

            (3)  Council Regulation (EEC) No 737/90 of 22 March 1990 on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power-station (OJ L 82, 29.3.1990, p. 1).


title: Commission Implementing Regulation (EU) 2019/506 of 26 March 2019 authorising the placing on the market of D-ribose 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:
                  27.3.2019

                  EN

                  Official Journal of the European Union

                  L 85/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/506
         of 26 March 2019
         authorising the placing on the market of D-ribose 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)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     On 17 March 2008, the company Bioenergy Life Science, Inc. (‘the Applicant’), submitted a request to the competent authority of the United Kingdom to place D-ribose on the Union market as a novel food ingredient within the meaning of point (d) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for the novel food to be used in a variety of foods, including foods for special medical purposes and total diet replacement for weight control, and in food supplements, the target population being adults and adolescents above 14 years of age.

                     (5)

                     The competent authority of the United Kingdom requested additional information to resolve uncertainties arising from a study on reproductive toxicity. In November 2013, the applicant submitted a revised dossier to the competent authority of the United Kingdom.

                     (6)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

                     (7)

                     While the request for placing D-ribose on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (8)

                     On 23 February 2016, the competent authority of the United Kingdom issued its initial assessment report. In that report it came to the conclusion that D-ribose meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.

                     (9)

                     On 17 May 2016, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97, in particular with regard to the lack of data on the amount of free D-ribose to be consumed as part of the normal diet, the lack of long-term studies analysing the effect of high doses of D-ribose and the low margin of exposure for toddlers.

                     (10)

                     In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 19 May 2017, asking it to carry out an additional assessment for D-ribose as a novel food ingredient in accordance with Regulation (EC) No 258/97.

                     (11)

                     In a subsequent application, submitted on 2 March 2018, the applicant 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 oral embryotoxicity/teratogenicity study with D-ribose in rats (4) and the sub-chronic (13-week) oral toxicity study with D-ribose in rats (5).

                     (12)

                     On 18 April 2018, the Authority adopted its ‘Scientific opinion on the safety of D-ribose as a novel food.’ (6) This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (13)

                     In its opinion, the Authority did not establish the safety of D-ribose at the intended uses and use levels as proposed by the applicant because the intake would exceed the level of 36 mg/kg bw per day, which is considered safe. The Authority ascertained that the data of the oral embryotoxicity/teratogenicity study with D-ribose in rats and of the sub-chronic (13-week) oral toxicity study with D-ribose in rats served as a basis to assess the safety of D-ribose. Therefore, the Authority considered that without the data from the oral embryotoxicity/teratogenicity study with D-ribose in rats and the sub-chronic (13-week) oral toxicity study with D-ribose in rats it could not have come to the conclusions on the safety of D-ribose.

                     (14)

                     In view of the Authority's opinion, on 22 August 2018, the applicant modified its request by removing some of the proposed food categories included in the original application and by reducing the maximum use levels of the remaining proposed uses of D-ribose so as to alleviate the safety concerns. Following a request from the European Commission, the Authority was asked on 4 September 2018 to carry out a supplementary safety assessment for D-ribose by considering the new proposed uses and use levels submitted by the applicant. On 24 October 2018, in its reviewed opinion on the safety of D-ribose (7), the Authority concluded that D-ribose is safe under the new proposed conditions of use for the general population. This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (15)

                     That opinion gives sufficient grounds to establish that D-ribose, under the proposed uses and use levels, when used as an ingredient in cereal bars, fine bakery wares, chocolate confectionery, milk-based drinks, drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks, meal replacement for weight control (as drinks and as bars), bars intended to meet the expenditure of intense muscular effort especially for sportsmen, confectionery, and tea and infusions complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (16)

                     Based on the Authority's opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the studies and to clarify their claim to an exclusive right of reference to those studies, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.

                     (17)

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

                     (18)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the oral embryotoxicity/teratogenicity study with D-ribose in rats and the sub-chronic (13-week) oral toxicity study with D-ribose in rats contained in the applicant's file without which D-ribose could not have been assessed by the Authority, should not be used by it for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. As a consequence, the placing on the market within the Union of D-ribose under this Regulation should be restricted to the applicant for a period of five years.

                     (19)

                     However, restricting the authorisation of this novel food and the reference to the oral embryotoxicity/teratogenicity study with D-ribose in rats and the sub-chronic (13-week) oral toxicity study with D-ribose in rats contained in the Applicant's file for the sole use of the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food ingredient provided that their application is based on legally obtained information supporting the authorisation under this Regulation.

                     (20)

                     The acceptable level of intake in food containing D-ribose, if used in conjunction with food supplements containing D-ribose, should not be exceeded. It is therefore necessary to inform the consumers with an appropriate label.

                     (21)

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

                     (22)

                     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.   D-ribose 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 five years from the date of entry into force of this Regulation only the initial Applicant:

                           Company: Bioenergy Life Science, Inc.

                           Address: 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA;

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

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

            Article 2
            The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation, without the agreement of Bioenergy Life Science, Inc.

            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, 26 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

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

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

            (4)  TNO report V2657 for Bioenergy Life Science, Inc., December 2005 (unpublished).

            (5)  TNO report V99.115 for Bioenergy Life Science, Inc., December 2005 (unpublished).

            (6)  EFSA Journal 2018; 16(5):5265.

            (7)  EFSA Journal 2018; 16(12):5485.

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

                        (1)

                        the following last column is added in Table 1 (Authorised novel foods):
                        ‘Data Protection’

                        (2)

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

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data Protection

                                    ‘D-ribose

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘D-ribose’.
                                    The labelling of foods containing D-ribose shall bear a statement that the foods should not be used if food supplements containing D-ribose are consumed the same day.

                                    Authorised on 16 April 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Bioenergy Life Science, Inc., 13840 Johnson St. NE, Minneapolis, Minnesota, 55304, USA. During the period of data protection, the novel food D-ribose is authorised for placing on the market within the Union only by Bioenergy Life Science, Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Bioenergy Life Science, Inc.
                                    End date of the data protection: 16 April 2024 (5 years).’

                                    Cereal bars

                                    0,20 g/100 g

                                    Fine bakery wares

                                    0,31 g/100 g

                                    Chocolate confectionery (excluding chocolate bars)

                                    0,17 g/100 g

                                    Milk-based drinks (excluding malts and shakes)

                                    0,08 g/100 g

                                    Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen, isotonic and energy drinks

                                    0,80 g/100 g

                                    Bars intended to meet the expenditure of intense muscular effort especially for sportsmen

                                    3,3 g/100 g

                                    Meal replacement for weight control (as drinks)'

                                    0,13 g/100 g

                                    Meal replacement for weight control (as bars)

                                    3,30 g/100 g

                                    Confectionery

                                    0,20 g/100 g

                                    Tea and infusions (in powder form to be reconstituted)

                                    0,23 g/100 g

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘D-ribose

                                       Description

                                    D-ribose is an aldopentose monosaccharide which is produced by fermentation using a transketolase-deﬁcient strain of Bacillus subtilis.
                                    Chemical formula: C5H10O5

                                    CAS No: 50-69-1
                                    Molecular mass: 150,13 Da

                                       Characteristics/Composition

                                    Appearance: Dry with powdery texture, white to slightly yellow in colour
                                    Speciﬁc rotation [α]D
                                       25: – 19,0° to – 21,0°
                                    D-ribose purity (% dry basis):
                                    -HPLC/RI (*1) Method 98,0–102,0 %
                                    Ash: < 0,2 %
                                    Loss on drying (moisture): < 0,5 %
                                    Clarity on solution: ≥ 95 % transmittance

                                       Heavy metals

                                    Lead: ≤ 0,1 mg/kg
                                    Arsenic: ≤ 0,1 mg/kg
                                    Cadmium: ≤ 0,1 mg/kg
                                    Mercury: ≤ 0,1 mg/kg

                                       Microbiological criteria

                                    Total plate count: ≤ 100 CFU (*2)/g
                                    Yeast: ≤ 100 CFU/g
                                    Moulds: ≤ 100 CFU/g
                                    Coliforms: ≤ 10 CFU/g

                                       Salmonella sp: Negative/25 g

               (*1)  HPLC/RI: High-performance liquid chromatography coupled with refractive index detection.

               (*2)  CFU: Colony-forming unit’


title: Commission Implementing Regulation (EU) 2019/507 of 26 March 2019 amending for the 297th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations

text:
                  27.3.2019

                  EN

                  Official Journal of the European Union

                  L 85/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/507
         of 26 March 2019
         amending for the 297th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (1), and in particular Article 7(1)(a) and Article 7a(1) thereof,
         Whereas:

                     (1)

                     Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

                     (2)

                     On 22 March 2019, the Sanctions Committee of the United Nations Security Council decided to add one entry to the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly.

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 March 2019.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 139 29.5.2002, p. 9.

            ANNEX
            In Annex I to Regulation (EC) No 881/2002 the following entry is added under the heading ‘Legal persons, groups and entities’:

               ‘Tariq Gidar Group (TGG) (alias: (a) Tehrik-e-Taliban-Tariq Gidar Group (b) TTP-Tariq Gidar Group (c) Tehreek-i-Taliban Pakistan Geedar Group (d) TTP Geedar Group (e) Tariq Geedar Group (f) Commander Tariq Afridi Group (g) Tariq Afridi Group (h) Tariq Gidar Afridi Group (i) The Asian Tigers. Address: (Afghanistan/Pakistan border region). Other information: Splinter group of Tehrik-e Taliban Pakistan (TTP). The group was formed in Darra Adam Khel, Federally Administered Tribal Area (FATA), Pakistan, in 2007. Date of designation referred to in Article 7d(2)(i): 22.3.2019.’