title: Commission Implementing Regulation (EU) 2019/144 of 28 January 2019 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding (holder of authorisation Fertinagro Biotech S.L.) (Text with EEA relevance.)

text:
                  31.1.2019

                  EN

                  Official Journal of the European Union

                  L 27/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/144
         of 28 January 2019
         concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding (holder of authorisation Fertinagro Biotech S.L.)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

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

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) belonging to the additive category of ‘zootechnical additives’, was authorised for 10 years as a feed additive for chickens for fattening and laying hens by Commission Implementing Regulation (EU) 2017/895 (2).

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 21 February 2018 (3) that, under the proposed conditions of use, 3-phytase produced by Komagataella pastoris (CECT 13094) does not have an adverse effect on animal health, human health or the environment. It has also concluded that the additive has a potential to be efficacious in improving phosphorus retention in chickens for fattening and that conclusion can be extended to chickens reared for laying. Since the mode of action can reasonably be assumed to be the same in poultry species, the Authority has extrapolated the conclusion on the efficacy to minor poultry species for fattening and reared for laying or breeding purposes. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of the 3-phytase shows that the conditions for authorisation of 3-phytase produced by Komagataella pastoris (CECT 13094), as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (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
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 January 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.) (OJ L 138, 25.5.2017, p. 120).

            (3)  EFSA Journal 2018;16(3):5203.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: digestibility enhancers

                        4a25

                        Fertinagro Nutrientes S.L.

                        3-phytase
                        EC 3.1.3.8

                           Additive composition:

                        Preparation of 3-phytase
                        produced by Komagataella pastoris (CECT 13094) having a minimum activity of: 1 000  FTU (1)/ml
                        Liquid form

                           Characterisation of the active substance:

                        3-phytase (EC 3.1.3.8) produced by Komagataella pastoris (CECT 13094)

                           Analytical method
                            (2)

                        For the quantification of 3-phytase activity in the feed additive:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate

                              For the quantification of 3-phytase activity in feedingstuffs:

                                    —

                                    colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024

                        Chickens reared for laying
                        Minor poultry species for fattening or reared for laying or for breeding

                        —

                        500 FTU

                                    1.

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

                                    2.

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

                        20 February 2029

               (1)  1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °C.

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


title: Commission Implementing Regulation (EU) 2019/238 of 8 February 2019 amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit (Text with EEA relevance.)

text:
                  11.2.2019

                  EN

                  Official Journal of the European Union

                  L 39/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/238
         of 8 February 2019
         amending Regulation (EU) No 37/2010 to classify the substance ovotransferrin as regards its maximum residue limit
         (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 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,
         Having regard to the opinion of the European Medicines Agency formulated on 19 July 2018 by the Committee for Medicinal Products for Veterinary Use,
         Whereas:

                     (1)

                     Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

                     (2)

                     Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

                     (3)

                     The substance ovotransferrin is not included in that table.

                     (4)

                     An application for the establishment of MRLs for ovotransferrin in chicken tissues and eggs has been submitted to the European Medicines Agency (‘EMA’).

                     (5)

                     The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended that the establishment of an MRL for ovotransferrin in chicken is not necessary for the protection of human health.

                     (6)

                     According to Article 5 of Regulation (EC) No 470/2009, the EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

                     (7)

                     The EMA has considered that the extrapolation of the ‘no MRL required’ classification for ovotransferrin from chicken tissue to the tissue of other poultry species is appropriate.

                     (8)

                     Regulation (EU) No 37/2010 should therefore be amended accordingly.

                     (9)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Regulation (EU) No 37/2010 is amended as set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 8 February 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 152, 16.6.2009, p. 11.

            (2)  Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ L 15, 20.1.2010, p. 1).

            ANNEX
            In Table 1 of the Annex to Regulation (EU) No 37/2010, an entry for the following substance is inserted in alphabetical order:

                           Pharmacologically active substance

                           Marker residue

                           Animal Species

                           MRLs

                           Target Tissues

                           Other Provisions (according to Article 14(7) of Regulation (EC) No 470/2009)

                           Therapeutic Classification

                           ‘Ovotransferrin

                           NOT APPLICABLE

                           Chicken

                           No MRL required

                           NOT APPLICABLE

                           For inhalation use only

                           Anti-infectious agent’

                           All poultry except chicken

                           No MRL required

                           NOT APPLICABLE

                           For inhalation use only
                           Not for use in animals from which eggs are produced


title: Council Implementing Regulation (EU) 2019/270 of 18 February 2019 implementing Regulation (EU) 2016/1686 imposing additional restrictive measures directed against ISIL (Da'esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them

text:
                  18.2.2019

                  EN

                  Official Journal of the European Union

                  LI 46/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2019/270
         of 18 February 2019
         implementing Regulation (EU) 2016/1686 imposing additional restrictive measures directed against ISIL (Da'esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) 2016/1686 of 20 September 2016 imposing additional restrictive measures directed against ISIL (Da'esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them (1), and in particular Article 4(1) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 20 September 2016 the Council adopted Regulation (EU) 2016/1686.

                     (2)

                     In view of the continued threat posed by ISIL (Da'esh) and Al-Qaeda and natural and legal persons, entities or bodies associated with them, one person should be added to the list of natural and legal persons, entities and bodies set out in Annex I to Regulation (EU) 2016/1686.

                     (3)

                     Annex I to Regulation (EU) 2016/1686 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) 2016/1686 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, 18 February 2019.

                  For the Council

                  The President

               F. MOGHERINI

            (1)  OJ L 255, 21.9.2016, p. 1.

            ANNEX
            The following person is added to the list set out in Annex I to Regulation (EU) 2016/1686:

                           ‘4.

                           Brahim el KHAYARI; date of birth: 7 May 1992; place of birth: Nîmes (France); nationality: French.’


title: Commission Implementing Regulation (EU) 2019/481 of 22 March 2019 approving the active substance flutianil, 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:
                  25.3.2019

                  EN

                  Official Journal of the European Union

                  L 82/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/481
         of 22 March 2019
         approving the active substance flutianil, 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 23 February 2011 an application from Otsuka AgriTechno Co., Ltd for the approval of the active substance flutianil.

                     (2)

                     In accordance with Article 9(3) of that Regulation, 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 21 October 2011 of the admissibility of the application.

                     (3)

                     On 19 June 2013, 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 2 June 2014.

                     (5)

                     On 29 July 2014, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance flutianil 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)

                     The Authority concluded that flutianil should be classified as carcinogen category 2 and reproductive toxicant (for the development) category 2. The active substance was therefore deemed not to fulfil the approval criteria referred to in Article 4(1) of Regulation (EC) No 1107/2009.

                     (7)

                     On 4 December 2014, the rapporteur Member State notified its intention to launch a request for harmonised classification under the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3). According to that proposal, it was not appropriate to classify flutianil as carcinogen or reproductive toxicant and therefore flutianil was deemed to fulfil the approval criteria referred to in Article 4(1) of Regulation (EC) No 1107/2009. The application was submitted by the United Kingdom to the European Chemicals Agency on 23 February 2015.

                     (8)

                     On 10 December 2015, the Commission presented a draft review report for non-approval of flutianil to the Standing Committee on Plants, Animals, Food and Feed. Given the potential implication for decision-making, the Commission decided to await the outcome of the classification process under Regulation (EC) No 1272/2008 before presenting a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed.

                     (9)

                     In March 2016, the Risk Assessment Committee of the European Chemicals Agency proposed no classification as carcinogenic or toxic to reproduction for the active substance flutianil (4). On request of the European Commission, the Authority published on 5 July 2018 a ‘Statement on the impact of the harmonised classification on the conclusion on the peer review of the pesticide risk assessment of the active substance flutianil’ (5). In that statement, the Authority acknowledged that the harmonised classification proposed by the Risk Assessment Committee of the European Chemicals Agency was, based on new additional information, different from the provisional classification used in the Authority's conclusion. On 4 October 2018, the active substance flutianil was included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 with no classification as carcinogenic or toxic to reproduction (6).

                     (10)

                     The Commission revised the draft review report in order to align it with the outcome of the classification process and submitted it for comments to the applicant together with a draft Regulation on 20 March 2018. The documents were presented to the Standing Committee on Plants, Animals, Food and Feed on 21 March 2018.

                     (11)

                     Following the publication of the Authority's statement, on 24 October 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed a revised review report and a draft Regulation providing that flutianil is approved.

                     (12)

                     The applicant was given the possibility to submit comments on the revised review report and on the Authority's statement.

                     (13)

                     As regards the new criteria to identify endocrine disrupting properties set in Commission Regulation (EU) 2018/605 (7), which became applicable on 10 November 2018, and the Joint guidance document to identify endocrine disrupting substances (8), the information contained in the conclusions of the Authority allow to infer that it is highly unlikely that flutianil is an endocrine disruptor via the estrogenic, androgenic, thyroidogenic and steroidogenic modalities. Although effects on the thyroid (weight increase) were observed, these occurred only at the top doses exceeding the maximum recommended doses for the type of study where the effects were observed. Testicular, prostate and uterus effects observed (histopathological changes) were within the historical control values or they were not replicated in the two-generation reproductive toxicity study, nor affected fertility parameters. The two-generation reproductive toxicity study was performed following the test protocol according to the latest OECD Guidelines (9), as prescribed by the Joint guidance document to identify endocrine disrupting substances and did not detect any endocrine sensitive reproductive and developmental parameters such as oestrous cycle length, mating index, mean number of implantation sites, preputial separation and vaginal opening.

                     (14)

                     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.

                     (15)

                     It is therefore appropriate to approve flutianil.

                     (16)

                     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, amongst others to confirm that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, in order to increase the confidence, in accordance with Point 2(2)(b) of Annex II to Regulation (EC) No 1107/2009, in the conclusion drawn by the Commission in recital 13.

                     (17)

                     In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (10) should be amended accordingly.

                     (18)

                     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 flutianil, 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, 22 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2014;12(8):3805 [89 pp.]. doi: 10.2903/j.efsa.2014.3805.

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

            (4)  Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of Flutianil (ISO);(2Z)-{[2-fluoro-5-(trifluoromethyl)phenyl]thio}[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene] acetonitrile, EC Number: -, CAS Number: 958647-10-4 CLH-O-0000001412-86-101/F. Adopted 10 March 2016.
         https://echa.europa.eu/documents/10162/efc05a0b-a819-51d6-6f43-5396ee76e29f.

            (5)  EFSA Journal 2018;16(7):5383 [19 pp.]. doi: 10.2903/j.efsa.2018.5383.

            (6)  Commission Regulation (EU) 2018/1480 of 4 October 2018 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures and correcting Commission Regulation (EU) 2017/776 (OJ L 251, 5.10.2018, p. 1).

            (7)  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).

            (8)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009, https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5311.

            (9)  OECD (Organisation for Economic Cooperation and Development), 2001. Test No 416: Two-Generation Reproduction Toxicity. In: OECD Guidelines for the Testing of Chemicals, Section 4. OECD Publishing, Paris. 13 pp. https://doi.org/10.1787/9789264070868-en.

            (10)  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

                        Flutianil
                        CAS No [958647-10-4]
                        CIPAC No 835

                        (Z)-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro-m-tolylthio)acetonitrile

                        ≥ 985 g/kg

                        14 April 2019

                        14 April 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 flutianil, 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 and workers,

                                    —

                                    the risk to aquatic organisms,

                                    —

                                    the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.

                              Conditions of use shall include risk mitigation measures, 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;

                                    3.

                                    an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors (2).

                              The applicant shall submit the information:

                                    —

                                    referred to in point 1 by 14 April 2020;

                                    —

                                    referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater; and

                                    —

                                    referred to in point 3 by 14 April 2021.

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

               (2)  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; ECHA-18-G-01-EN.

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

                           ‘133

                           Flutianil
                           CAS No [958647-10-4]
                           CIPAC No 835

                           (Z)-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro-m-tolylthio)acetonitrile

                           ≥ 985 g/kg

                           14 April 2019

                           14 April 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 flutianil, 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 and workers,

                                       —

                                       the risk to aquatic organisms,

                                       —

                                       the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.

                                 Conditions of use shall include risk mitigation measures, 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;

                                       3.

                                       an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors (*1).

                                 The applicant shall submit the information:

                                       —

                                       referred to in point 1 by 14 April 2020;

                                       —

                                       referred to in point 2 within two years from the date of publication, from the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater; and

                                       —

                                       referred to in point 3 by 14 April 2021.

               (*1)  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; ECHA-18-G-01-EN.’


title: Commission Implementing Regulation (EU) 2019/482 of 22 March 2019 amending Commission Implementing Regulation (EU) 2016/1368 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (Text with EEA relevance.)

text:
                  25.3.2019

                  EN

                  Official Journal of the European Union

                  L 82/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/482
         of 22 March 2019
         amending Commission Implementing Regulation (EU) 2016/1368 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014 (1), and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Benchmarks play an important role in the determination of the price of many financial instruments and financial contracts and in the measurement of performance for many investment funds. The contribution to and administration of benchmarks are in many cases vulnerable to manipulation and persons involved often face conflicts of interest.

                     (2)

                     In order to fulfil their economic role, benchmarks need to be representative of the underlying market or economic reality they intend to measure. Should a benchmark no longer be representative of an underlying market, such as interbank offered rates, there is a risk of negative effects on, inter alia, market integrity, the financing of households (loans and mortgages) and businesses in the Union.

                     (3)

                     Risks to users, markets and the economy of the Union generally increase where the total value of financial instruments, financial contracts and investment funds referencing a specific benchmark is high. Regulation (EU) 2016/1011 therefore establishes different categories of benchmarks and provides for additional requirements ensuring the integrity and robustness of certain benchmarks considered as being critical, including the power of competent authorities to mandate, under certain conditions, contributions to or the administration of a critical benchmark.

                     (4)

                     Pursuant to Article 20(1) of Regulation (EU) 2016/1011, the Commission is empowered to adopt implementing acts to establish and review at least every two years a list of critical benchmarks.

                     (5)

                     Commission Implementing Regulation (EU) 2016/1368 (2) established a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011.

                     (6)

                     According to point (b) of Article 20(1) of Regulation (EU) 2016/1011, benchmarks may be included in the list of critical benchmarks where those benchmarks are based on input data submitted by contributors the majority of which are located in one Member State and are recognised as being critical in that Member State.

                     (7)

                     On 10 October 2018, the Polish competent authority, Komisja Nadzoru Finansowego (‘KNF’), notified the European Securities and Markets Authority (‘ESMA’) of its proposal to recognise the Warsaw Interbank Offered Rate (‘WIBOR’) as a critical benchmark, under point (b) of Article 20(1) of Regulation (EU) 2016/1011, because it is critical in Poland and it is based on submissions of contributors, all of which are located in Poland.

                     (8)

                     WIBOR is a reference rate based on an average of the interest rates at which banks operating in the Polish money market are willing to lend unsecured funds to each other at different maturities. As of 10 October 2018, eleven banks participate in the WIBOR panel, all of which are located in Poland.

                     (9)

                     In its assessment submitted to ESMA, the KNF concluded that the cessation of WIBOR, or its provision on the basis of input data or of a panel of contributors no longer representative of the underlying market or economic reality, could have a significant adverse impact on the functioning of financial markets in Poland.

                     (10)

                     The assessment by the KNF illustrates that WIBOR is used as a reference in 60 % of total loans to households in Poland, and in 70,1 % of outstanding mortgages. In mortgages subscribed since 2013, WIBOR's prevalence has increased to 98,5 %. In addition, WIBOR serves as a reference for the coupon payments for nearly 26 % of the total nominal value of Polish bonds. KNF also presented data showing that WIBOR is used as a reference in OTC interest rate derivatives for an outstanding notional amount of EUR 366 billion. Finally, KNF concluded on the basis of a survey that WIBOR is referenced in investment funds with a total net asset value of EUR 2,6 billion. The total value of financial instruments and financial contracts referencing WIBOR is therefore larger than the gross national product of Poland. The assessment concludes that WIBOR is of vital importance for financial stability and market integrity in Poland, and that WIBOR's discontinuity or unreliability could have a significant adverse impact on the functioning of financial markets in Poland and on companies and consumers as it is used in loans, consumer credit products and investment funds.

                     (11)

                     On 8 November 2018, ESMA sent the Commission its opinion setting out that the KNF had taken into consideration all the elements and criteria included in Article 20(3) of Regulation (EU) 2016/1011 and that it had provided quantitative data to support the case for the recognition of WIBOR as a critical benchmark, as well as analytical reasoning highlighting the crucial role of WIBOR in the Polish economy.

                     (12)

                     Implementing Regulation (EU) 2016/1368 should therefore be amended accordingly.

                     (13)

                     In light of the crucial importance of WIBOR, its widespread use and its role in the allocation of capital in Poland, this Regulation should enter into force as a matter of urgency.

                     (14)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) 2016/1368 is replaced by the text in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 March 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 171, 29.6.2016, p. 1.

            (2)  Commission Implementing Regulation (EU) 2016/1368 of 11 August 2016 establishing a list of critical benchmarks used in financial markets pursuant to Regulation (EU) 2016/1011 of the European Parliament and of the Council (OJ L 217, 12.8.2016, p. 1).

            ANNEX

                     ‘ANNEX

                        List of critical benchmarks pursuant to Article 20(1) of Regulation (EU) 2016/1011

                                 No

                                 Benchmark

                                 Administrator

                                 Location

                                 1

                                 Euro Interbank Offered Rate (EURIBOR®)

                                 European Money Markets Institute (EMMI)

                                 Brussels, Belgium

                                 2

                                 Euro Overnight Index Average (EONIA®)

                                 European Money Markets Institute (EMMI)

                                 Brussels, Belgium

                                 3

                                 London Interbank Offered Rate (LIBOR)

                                 ICE Benchmark Administration (IBA)

                                 London, United Kingdom

                                 4

                                 Stockholm Interbank Offered Rate (STIBOR)

                                 Swedish Bankers' Association (Svenska Bankföreningen)

                                 Stockholm, Sweden

                                 5

                                 Warsaw Interbank Offered Rate (WIBOR)

                                 GPW Benchmarks S.A.

                                 Warsaw, Poland

               ’


title: Commission Implementing Regulation (EU) 2019/706 of 7 May 2019 renewing the approval of the active substance carvone 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:
                  8.5.2019

                  EN

                  Official Journal of the European Union

                  L 120/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/706
         of 7 May 2019
         renewing the approval of the active substance carvone 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 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2008/44/EC (2) included carvone as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance carvone, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2019.

                     (4)

                     An application for the renewal of the approval of the active substance carvone was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 31 May 2017.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (8)

                     On 12 July 2018 the Authority communicated to the Commission its conclusion (6) on whether carvone can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented an initial draft renewal report for carvone to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2019.

                     (9)

                     The applicant was given the opportunity to submit comments on the draft renewal report.

                     (10)

                     As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (7), the conclusion of the Authority indicates that it is highly unlikely that carvone is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic and steroidogenic modalities. Furthermore, the available data and the scientific risk assessment performed by the Authority indicate that carvone is unlikely to have endocrine disruptive effects. Thus, the Commission considers that carvone is not to be considered as having endocrine disrupting properties.

                     (11)

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

                     (12)

                     The risk assessment for the renewal of the approval of carvone is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing carvone may be authorised. It is therefore appropriate not to maintain the restriction to use as a plant growth regulator. It is therefore appropriate to renew the approval of carvone.

                     (13)

                     Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (14)

                     This Regulation should apply from the day after the date of expiry of the approval of the active substance carvone.

                     (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
            Renewal of the approval of active substance
            The approval of the active substance carvone, as specified in Annex I, is renewed 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 and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2019.

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

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2008/44/EC of 4 April 2008 amending Council Directive 91/414/EEC to include benthiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus and prothioconazole as active substances (OJ L 94, 5.4.2008, p. 13).

            (3)  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).

            (4)  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).

            (5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            (6)  EFSA Journal 2018;16(7):5390. EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance carvone. Available online: www.efsa.europa.eu.

            (7)  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).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        carvone
                        244-16-8 (d-carvone = S-carvone = (+)-carvone)
                        Carvone: 602
                        d-carvone: not allocated

                        (S)-5-isopropenyl-2-methylcyclohex-2-en-1-one
                        Or
                        (S)-p-mentha-6,8-dien-2-one

                        923 g/kg d-carvone

                        1 August 2019

                        31 July 2034

                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, 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.

                              Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    —

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

                              The applicant shall submit that information 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 the identity and the specification of the active substance are provided in the renewal report.

            ANNEX II
            The Annex to Commission Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in Part A, entry 165 on carvone is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No.

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘135

                                    carvone
                                    244-16-8 (d-carvone = S-carvone = (+)-carvone)
                                    Carvone: 602
                                    d-carvone: not allocated

                                    (S)-5-isopropenyl-2-methylcyclohex-2-en-1-one
                                    Or
                                    (S)-p-mentha-6,8-dien-2-one

                                    923 g/kg d-carvone

                                    1 August 2019

                                    31 July 2034

                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, 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.

                                          Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                                —

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

                                          The applicant shall submit that information 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 the identity and the specification of the active substance are provided in the renewal report.


title: Commission Implementing Regulation (EU) 2019/707 of 7 May 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole (Text with EEA relevance.)

text:
                  8.5.2019

                  EN

                  Official Journal of the European Union

                  L 120/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/707
         of 7 May 2019
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole
         (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 the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

                     Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

                     (2)

                     The approval periods of the active substances famoxadone, flumioxazine and metalaxyl-m were extended until 30 June 2019 by Commission Implementing Regulation (EU) 2018/917 (3). Applications for the renewal of the inclusion of the active substances famoxadone, flumioxazin and metalaxyl-m in Annex I to Council Directive 91/414/EEC (4) were submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5).

                     (3)

                     The approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, ethephon, etoxazole, fenamiphos, fluoxastrobin, folpet, foramsulfuron, formetanate, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and s-metolachlor were extended until 31 July 2019 by Implementing Regulation (EU) 2018/917.

                     (4)

                     The approval period of the active substance diuron was extended until 30 September 2019 by Commission Implementing Regulation (EU) 2018/1262 (6).

                     (5)

                     The approval period of the active substance tebuconazole will expire on 31 August 2019 (7).

                     (6)

                     Applications for the renewal of the approvals of the substances referred to in recitals 3 to 5 were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (8).

                     (7)

                     Due to the fact that the assessment of the substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

                     (8)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (9)

                     Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

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

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

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  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).

            (3)  Commission Implementing Regulation (EU) 2018/917 of 27 June 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, carvone, chlorpropham, cyazofamid, desmedipham, dimethoate, dimethomorph, diquat, ethephon, ethoprophos, etoxazole, famoxadone, fenamidone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, Gliocladium catenulatum strain: J1446, isoxaflutole, metalaxyl-m, methiocarb, methoxyfenozide, metribuzin, milbemectin, oxasulfuron, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, pymetrozine and s-metolachlor (OJ L 163, 28.6.2018, p. 13).

            (4)  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).

            (5)  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).

            (6)  Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (OJ L 238, 21.9.2018, p. 62).

            (7)  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).

            (8)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            ANNEX
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in the sixth column, expiration of approval, of row 35, Famoxadone, the date is replaced by ‘30 June 2020’;

                        (2)

                        in the sixth column, expiration of approval, of row 37, Metalaxyl-M, the date is replaced by ‘30 June 2020’;

                        (3)

                        in the sixth column, expiration of approval, of row 39, Flumioxazine, the date is replaced by ‘30 June 2020’;

                        (4)

                        in the sixth column, expiration of approval, of row 44, Foramsulfuron, the date is replaced by ‘31 July 2020’;

                        (5)

                        in the sixth column, expiration of approval, of row 46, Cyazofamid, the date is replaced by ‘31 July 2020’;

                        (6)

                        in the sixth column, expiration of approval, of row 83, Alpha-cypermethrin, the date is replaced by ‘31 July 2020’;

                        (7)

                        in the sixth column, expiration of approval, of row 84, Benalaxyl, the date is replaced by ‘31 July 2020’;

                        (8)

                        in the sixth column, expiration of approval, of row 85, Bromoxynil, the date is replaced by ‘31 July 2020’;

                        (9)

                        in the sixth column, expiration of approval, of row 86, Desmedipham, the date is replaced by ‘31 July 2020’;

                        (10)

                        in the sixth column, expiration of approval, of row 88, Phenmedipham, the date is replaced by ‘31 July 2020’;

                        (11)

                        in the sixth column, expiration of approval, of row 97, S-metolachlor, the date is replaced by ‘31 July 2020’;

                        (12)

                        in the sixth column, expiration of approval, of row 99, Etoxazole, the date is replaced by ‘31 July 2020’;

                        (13)

                        in the sixth column, expiration of approval, of row 109, Bifenazate, the date is replaced by ‘31 July 2020’;

                        (14)

                        in the sixth column, expiration of approval, of row 110, Milbemectin, the date is replaced by ‘31 July 2020’;

                        (15)

                        in the sixth column, expiration of approval, of row 141, Fenamiphos, the date is replaced by ‘31 July 2020’;

                        (16)

                        in the sixth column, expiration of approval, of row 142, Ethephon, the date is replaced by ‘31 July 2020’;

                        (17)

                        in the sixth column, expiration of approval, of row 145, Captan, the date is replaced by ‘31 July 2020’;

                        (18)

                        in the sixth column, expiration of approval, of row 146, Folpet, the date is replaced by ‘31 July 2020’;

                        (19)

                        in the sixth column, expiration of approval, of row 147, Formetanate, the date is replaced by ‘31 July 2020’;

                        (20)

                        in the sixth column, expiration of approval, of row 148, Methiocarb, the date is replaced by ‘31 July 2020’;

                        (21)

                        in the sixth column, expiration of approval, of row 149, Dimethoate, the date is replaced by ‘31 July 2020’;

                        (22)

                        in the sixth column, expiration of approval, of row 150, Dimethomorph, the date is replaced by ‘31 July 2020’;

                        (23)

                        in the sixth column, expiration of approval, of row 152, Metribuzin, the date is replaced by ‘31 July 2020’;

                        (24)

                        in the sixth column, expiration of approval, of row 153, Phosmet, the date is replaced by ‘31 July 2020’;

                        (25)

                        in the sixth column, expiration of approval, of row 154, Propamocarb, the date is replaced by ‘31 July 2020’;

                        (26)

                        in the sixth column, expiration of approval, of row 156, Pirimiphos-methyl, the date is replaced by ‘31 July 2020’;

                        (27)

                        in the sixth column, expiration of approval, of row 158, Beflubutamid, the date is replaced by ‘31 July 2020’;

                        (28)

                        in the sixth column, expiration of approval, of row 163, Benthiavalicarb, the date is replaced by ‘31 July 2020’;

                        (29)

                        in the sixth column, expiration of approval, of row 164, Boscalid, the date is replaced by ‘31 July 2020’;

                        (30)

                        in the sixth column, expiration of approval, of row 166, Fluoxastrobin, the date is replaced by ‘31 July 2020’;

                        (31)

                        in the sixth column, expiration of approval, of row 167, Paecilomyces lilacinus strain 251, the date is replaced by ‘31 July 2020’;

                        (32)

                        in the sixth column, expiration of approval, of row 168, Prothioconazole, the date is replaced by ‘31 July 2020’;

                        (33)

                        in the sixth column, expiration of approval, of row 192, Diuron, the date is replaced by ‘30 September 2020’;

                        (34)

                        in the sixth column, expiration of approval, of row 268, Tebuconazole, the date is replaced by ‘31 August 2020’.


title: Commission Implementing Regulation (EU) 2019/889 of 22 May 2019 approving amendments to the specification for a protected designation of origin or a protected geographical indication ‘Barbera d'Asti’ (PDO)

text:
                  29.5.2019

                  EN

                  Official Journal of the European Union

                  L 142/47

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/889
         of 22 May 2019
         approving amendments to the specification for a protected designation of origin or a protected geographical indication ‘Barbera d'Asti’ (PDO)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,
         Whereas:

                     (1)

                     The Commission examined Italy's application pursuant to Article 105 of Regulation (EU) No 1308/2013 for the approval of amendments to the specification for the protected designation of origin ‘Barbera d'Asti’.

                     (2)

                     The Commission published the application for the approval of amendments to the specification in the Official Journal of the European Union (2), as required by Article 97(3) of Regulation (EU) No 1308/2013.

                     (3)

                     No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

                     (4)

                     The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Barbera d'Asti’ (PDO) are hereby approved.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 May 2019.

                  For the Commission

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 60, 15.2.2019, p. 4.


title: Commission Implementing Regulation (EU) 2019/890 of 27 May 2019 imposing special conditions governing the import of groundnuts from Gambia and Sudan and amending Regulation (EC) No 669/2009 and Implementing Regulation (EU) No 884/2014 (Text with EEA relevance.)

text:
                  29.5.2019

                  EN

                  Official Journal of the European Union

                  L 142/48

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/890
         of 27 May 2019
         imposing special conditions governing the import of groundnuts from Gambia and Sudan and amending Regulation (EC) No 669/2009 and Implementing Regulation (EU) No 884/2014
         (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 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (1), and in particular Article 53(1)(b)(ii) thereof,
         Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (2), and in particular Article 15(5) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 669/2009 (3) provides for an increased level of official controls to be carried out on imports of certain feed and food of non-animal origin listed in Annex I to that Regulation. Groundnuts from Gambia are already subject to an increased level of official controls as regards the presence of aflatoxins since October 2015. In addition, groundnuts from Sudan have been subject to an increased level of official controls regarding the presence of aflatoxins since April 2014.

                     (2)

                     The official controls carried out on those commodities by the Member States pursuant to Regulation (EC) No 669/2009 show either a persistent, high rate of non-compliance with prescribed maximum levels of aflatoxins or have resulted in a significant reduction in the number of consignments presented for import into the Union following initial high levels of non-compliance. Those results provide evidence that the import of those foods and feeds constitutes a risk for animal and human health. No improvement of the situation has been observed following several years of increased frequency of controls at Union borders.

                     (3)

                     Commission Implementing Regulation (EU) No 884/2014 (4) imposes special conditions on the import of certain feed and food from certain third countries due to a risk of contamination by aflatoxins. Currently it does not apply to the import of groundnuts from Gambia and Sudan.

                     (4)

                     In order to protect human and animal health in the Union, it is necessary to provide, in addition to an increased level of official controls, for special conditions in relation to that food and feed from Gambia and Sudan. All consignments of groundnuts from Gambia and Sudan should be accompanied by a health certificate stating that the products have been sampled and analysed for the presence of aflatoxins and have been found to be compliant with Union legislation. The results of the sampling and analysis should be attached to the accompanying health certificate.

                     (5)

                     Having regard to the high rate of non-compliance with prescribed maximum levels of aflatoxins, found in dried figs from Turkey, it is appropriate to increase the frequency of identity and physical checks of aflatoxin in dried figs from Turkey from 10 to 20 %. Furthermore, frequent findings of high levels of ochratoxin A in dried figs from Turkey have also been reported.

                     (6)

                     An existing exemption excludes consignments destined for a private person for personal consumption and use from the scope of Implementing Regulation (EU) No 884/2014. It is also appropriate to exclude consignments of feed and food sent as trade samples or as display items for exhibitions that are not intended to be placed on the market or are sent to be used for scientific purposes. This relates to very small consignments of certain feed and food but it is not appropriate to fix a specific weight, given the variety of products covered. However to avoid misuse, in addition to the abovementioned conditions for exemption, a maximum weight is established. Having regard to the low risk that such consignments pose to public health, it would be disproportionate to impose a requirement that these consignments be accompanied by a health certificate or by the results of the sampling and analytical tests.

                     (7)

                     The Brazilian, Ethiopian, Argentinian and Azerbaijani authorities have informed the Commission of a change of the competent authority whose authorised representative is entitled to sign the health certificate. Therefore, these changes should be introduced in Implementing Regulation (EU) No 884/2014 accordingly.

                     (8)

                     Furthermore, it is appropriate to update the relevant CN codes for Capsicum annuum due to recent changes of the CN code, and to add CN codes to hazelnut paste and also to figs prepared or preserved including mixtures because products corresponding to the description are traded under these codes.

                     (9)

                     Regulation (EC) No 669/2009 and Implementing Regulation (EU) No 884/2014 should therefore be amended accordingly.

                     (10)

                     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
            Annex I to Regulation (EC) No 669/2009 is amended in accordance with Annex I to this Regulation.

            Article 2
            Implementing Regulation (EU) No 884/2014 is amended as follows:

                        (1)

                        the following points (o) and (p) are added to Article 1(1):

                                    ‘(o)

                                    groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from Gambia;

                                    (p)

                                    groundnuts in shell and shelled, peanut butter, groundnuts otherwise prepared or preserved (feed and food) originating in or consigned from Sudan;’;

                        (2)

                        Article 1(3) is replaced by the following:

                           ‘3.   This Regulation shall not apply to consignments of feed and food referred to in paragraphs 1 and 2 which are destined for a private person for personal consumption and use only. In case of doubt, the burden of proof shall be borne by the recipient of the consignment. This Regulation shall also not apply to consignments of feed and food sent as trade samples, laboratory samples or as display items for exhibitions, that are not intended to be placed on the market or are sent to be used for scientific purposes.
                           The gross weight of the consignments referred to in the first subparagraph shall in any case not exceed 30 kg.’;

                        (3)

                        Article 5(2) is amended as follows:

                                    (a)

                                    point (a) is replaced by the following:

                                                ‘(a)

                                                the Ministry of Agriculture, Livestock and Food Supply (MAPA) (Ministério da Agricultura, Pecuária e Abastecimento (MAPA)) and Sistema Nacional de Vigilância Sanitária (SNVS) for feed and food from Brazil.’;

                                    (b)

                                    points (j), (k) and (l) are replaced by the following:

                                                ‘(j)

                                                the Ethiopian Food, Medicine and Health Care Administration and Control Authority (FMHACA) for food from Ethiopia;

                                                (k)

                                                the National Agri-Food Health and Quality Service (Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA)) and the National Institute of Nutrition (Instituto Nacional de Alimentos (INAL)) for feed and food from Argentina;

                                                (l)

                                                the Food Safety Agency of the Republic of Azerbaijan for food from Azerbaijan.’;

                                    (c)

                                    the following points (m) and (n) are added:

                                                ‘(m)

                                                the Food Safety and Quality Authority for feed and food from Gambia;

                                                (n)

                                                the Ministry of Agriculture and Forestry for feed and food from Sudan’;

                        (4)

                        Annex I to Implementing Regulation (EU) No 884/2014 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.
            Consignments of feed and food referred to in Article 2(1) having left the country of origin prior to the date of entry into force may be imported into the Union without being accompanied by a health certificate and the results of sampling and analysis.

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

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 31, 1.2.2002, p. 1.

            (2)  OJ L 165, 30.4.2004, p. 1.

            (3)  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 11).

            (4)  Commission Implementing Regulation (EU) No 884/2014 of 13 August 2014 imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009 (OJ L 242, 14.8.2014, p. 4).

            ANNEX I
            In Annex I to Regulation (EC) No 669/2009 the following entries are deleted:

                           Feed and food
                           (intended use)

                           CN code (1)

                           TARIC sub-division

                           Country of origin

                           Hazard

                           Frequency of physical and identity checks (%) at import

                                       ‘—

                                       Groundnuts (peanuts), in shell

                                       —

                                    1202 41 00

                           Gambia (GM)

                           Aflatoxins

                           50

                                       —

                                       Groundnuts (peanuts), shelled

                                       —

                                    1202 42 00

                                       —

                                       Peanut butter

                                       —

                                    2008 11 10

                                       —

                                       Groundnuts (peanuts), otherwise prepared or preserved

                                       —

                                       2008 11 91 ;
                                       2008 11 96 ;
                                       2008 11 98

                                 (Feed and food)

                                       —

                                       Groundnuts (peanuts), in shell

                                       —

                                    1202 41 00

                           Sudan (SD)

                           Aflatoxins

                           50’

                                       —

                                       Groundnuts (peanuts), shelled

                                       —

                                    1202 42 00

                                       —

                                       Peanut butter

                                       —

                                    2008 11 10

                                       —

                                       Groundnuts (peanuts), otherwise prepared or preserved

                                       —

                                       2008 11 91 ;
                                       2008 11 96 ;
                                       2008 11 98

                                 (Feed and food)

            ANNEX II
            Annex I to Implementing Regulation (EU) No 884/2014 is amended as follows:

                        (1)

                        The following entries are added:

                                    Feed and food
                                    (intended use)

                                    CN code (1)

                                    TARIC sub-division

                                    Country of origin or country of consignment

                                    Frequency of physical and identity checks (%)

                                                ‘—

                                                Groundnuts (peanuts), in shell

                                                —

                                             1202 41 00

                                    Gambia (GM)

                                    50

                                                —

                                                Groundnuts (peanuts), shelled

                                                —

                                             1202 42 00

                                                —

                                                Peanut butter

                                                —

                                             2008 11 10

                                                —

                                                Groundnuts (peanuts), otherwise prepared or preserved

                                                —

                                                2008 11 91 ;
                                                2008 11 96 ;
                                                2008 11 98

                                          (Feed and food)

                                                —

                                                Groundnuts (peanuts), in shell

                                                —

                                             1202 41 00

                                    Sudan (SD)

                                    50’

                                                —

                                                Groundnuts (peanuts), shelled

                                                —

                                             1202 42 00

                                                —

                                                Peanut butter

                                                —

                                             2008 11 10

                                                —

                                                Groundnuts (peanuts), otherwise prepared or preserved

                                                —

                                                2008 11 91 ;
                                                2008 11 96 ;
                                                2008 11 98

                                          (Feed and food)

                        (2)

                        The fifth entry as regards dried figs; mixtures of nuts or dried fruits containing figs; fig paste; and figs, prepared or preserved, including mixtures, from Turkey, is replaced by the following:

                                                ‘—

                                                Dried figs

                                                —

                                             0804 20 90

                                    Turkey (TR)

                                    20’

                                                —

                                                Mixtures of nuts or dried fruits containing figs

                                                —

                                             ex 0813 50

                                                —

                                                Dried fig paste

                                                —

                                                ex 2007 10  or
                                                ex 2007 99

                                                —

                                                Dried figs, prepared or preserved, including mixtures

                                                —

                                                ex 2008 99  or
                                                ex 2008 97

                                                —

                                                Flour, meal or powder of dried figs

                                                —

                                             ex 1106 30 90

                                          (Food)

                        (3)

                        The sixth entry as regards hazelnuts; mixtures of nuts or dried fruits containing hazelnuts; hazelnut paste; hazelnuts, otherwise prepared or preserved, including mixtures; flour, meal and powder of hazelnuts; cut, sliced or broken hazelnuts; and hazelnut oil, from Turkey, is replaced by the following:

                                                ‘—

                                                Hazelnuts (Corylus spp.) in shell

                                                —

                                             0802 21 00

                                    Turkey (TR)

                                    5’

                                                —

                                                Hazelnuts(Corylus spp.) shelled

                                                —

                                             0802 22 00

                                                —

                                                Mixtures of nuts or dried fruits containing hazelnuts

                                                —

                                             ex 0813 50

                                                —

                                                Hazelnut paste

                                                —

                                                ex 2007 10  or
                                                ex 2007 99  or
                                                ex 2008 97  or
                                                ex 2008 99

                                                —

                                                Hazelnuts, otherwise prepared or preserved, including mixtures

                                                —

                                             ex 2008 19

                                                —

                                                Flour, meal and powder of hazelnuts

                                                —

                                             ex 1106 30 90

                                                —

                                                Cut, sliced or broken hazelnuts

                                                —

                                             ex 0802 22 00

                                                —

                                                Cut, sliced or broken hazelnuts, otherwise prepared or preserved

                                                —

                                             ex 2008 19

                                                —

                                                Hazelnut oil

                                                —

                                             ex 1515 90 99

                                          (Food)

                        (4)

                        The twelfth entry as regards Capsicum annuum, whole, crushed or ground; dried fruit of the genus Capsicum, whole, other than sweet peppers (Capsicum annuum); and nutmeg (Myristica fragrans), from India, is replaced by the following:

                                                ‘—

                                                   Capsicum annuum, whole

                                                —

                                             0904 21 10

                                    India (IN)

                                    20’

                                                —

                                                   Capsicum annuum, crushed or ground

                                                —

                                             ex 0904 22 00

                                    11; 19

                                                —

                                                Dried fruit of the genus Capsicum, whole, other than sweet peppers (Capsicum annuum)

                                                —

                                             ex 0904 21 90

                                    20

                                                —

                                                Nutmeg (Myristica fragrans)

                                                —

                                                0908 11 00 ;
                                                0908 12 00

                                          (Food - dried spices)