title: Commission Implementing Regulation (EU) 2019/1126 of 25 June 2019 entering a name in the register of protected designations of origin and protected geographical indications ‘Jambon du Kintoa’ (PDO)

text:
                  2.7.2019

                  EN

                  Official Journal of the European Union

                  L 177/81

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1126
         of 25 June 2019
         entering a name in the register of protected designations of origin and protected geographical indications ‘Jambon du Kintoa’ (PDO)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France's application to register the name ‘Jambon du Kintoa’ was published in the Official Journal of the European Union (2).

                     (2)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Jambon du Kintoa’ (PDO) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.2. – Meat products (cooked, salted, smoked, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 June 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 36, 29.1.2019, p. 19.

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


title: Commission Implementing Regulation (EU) 2019/1138 of 3 July 2019 approving the active substance florpyrauxifen-benzyl 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:
                  4.7.2019

                  EN

                  Official Journal of the European Union

                  L 180/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1138
         of 3 July 2019
         approving the active substance florpyrauxifen-benzyl 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 Italy received on 24 March 2016 an application from Dow AgroSciences for the approval of the active substance florpyrauxifen-benzyl.

                     (2)

                     In accordance with Article 9(3) of that Regulation, Italy, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 17 June 2016 of the admissibility of the application.

                     (3)

                     On 28 April 2017 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether the active substance florpyrauxifen-benzyl 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 in May 2018.

                     (5)

                     On 5 July 2018, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance florpyrauxifen-benzyl 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)

                     On 22 March 2019 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for florpyrauxifen-benzyl and the draft of this Regulation providing that florpyrauxifen-benzyl is approved.

                     (7)

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

                     (8)

                     As regards the new criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (3), the Commission considers that florpyrauxifen-benzyl does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment, in accordance with point 2(2)(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors (4).

                     (9)

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

                     (10)

                     It is therefore appropriate to approve florpyrauxifen-benzyl.

                     (11)

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

                     (12)

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

                     (13)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance florpyrauxifen-benzyl, 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, 3 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Conclusion of the EFSA (2018) on the peer review of the pesticide risk assessment of the active substance florpyrauxifen (variant assessed florpyrauxifen-benzyl). EFSA Journal 2018;16(8):5378. doi: 10.2903/j.efsa.2018.5378.

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

            (4)  Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. https://efsa.onlinelibrarv.wilev.eom/doi/epdt710.2903/i.efsa.2018.5311

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

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Florpyrauxifen-benzyl
                        CAS No: 1390661-72-9
                        CIPAC No: 990.227

                        benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate

                        ≥ 920 g/kg
                        The impurity toluene shall not exceed 3 g/kg in the technical material.

                        24 July 2019

                        24 July 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 22 March 2019, 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 aquatic and terrestrial non-target plants.

                              Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021.

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

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

                           No

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘139

                           Florpyrauxifen-benzyl
                           CAS No: 1390661-72-9
                           CIPAC No: 990.227

                           benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate

                           ≥ 920 g/kg
                           The impurity toluene shall not exceed 3 g/kg in the technical material.

                           24 July 2019

                           24 July 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 22 March 2019, 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 aquatic and terrestrial non-target plants.

                                 Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate.
                           The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021.

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


title: Commission Implementing Regulation (EU) 2019/1177 of 10 July 2019 amending Regulation (EU) No 142/2011 as regards imports of gelatine, flavouring innards and rendered fats (Text with EEA relevance.)

text:
                  11.7.2019

                  EN

                  Official Journal of the European Union

                  L 185/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1177
         of 10 July 2019
         amending Regulation (EU) No 142/2011 as regards imports of gelatine, flavouring innards and rendered fats
         (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 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (1), and in particular Article 29(4) and Article 41(4), thereof,
         Whereas:

                     (1)

                     Commission Regulation (EU) No 142/2011 (2) lays down public and animal health conditions for imports of gelatine, flavouring innards and rendered fats.

                     (2)

                     Table 1 of Section 1 of Chapter I and Table 2 of Section 1 of Chapter II of Annex XIV to Regulation (EU) No 142/2011 set out requirements for imports into the Union of animal by-products.

                     (3)

                     Egypt provided the Commission with sufficient guarantees for the controls by the competent authority on the production of gelatine. It is therefore justified to add Egypt to the list of third countries from where gelatine may be imported into the Union.

                     (4)

                     Flavouring innards for the manufacture of pet food may be obtained from domestic but also from wild animals slaughtered or killed for human consumption. It is opportune to align the list of third countries eligible for the import of flavouring innards with a reference to the list of third countries authorised for the imports of wild game meat for human consumption.

                     (5)

                     Commission Regulation (EU) 2017/1261 (3) introduced an alternative method, based on EFSA assessment (4), for the production of renewable fuels. It is opportune to allow imports of rendered fats referred to in Articles 8, 9 and 10 of Regulation (EC) No 1069/2009 for the use in the new alternative method since the use of the same materials is allowed in the Union. Chapter II of Annex XIV to Regulation (EU) No 142/2011 should be amended accordingly.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex XIV to Regulation (EU) No 142/2011 is amended in accordance with the text 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, 10 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 300, 14.11.2009, p. 1.

            (2)  Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

            (3)  Commission Regulation (EU) 2017/1261 of 12 July 2017 amending Regulation (EU) No 142/2011 as regards an alternative method for processing certain rendered fats (OJ L 182, 13.7.2017, p. 31).

            (4)  Scientific Opinion on a continuous multiple-step catalytic hydro-treatment for the processing of rendered animal fat (Category 1) (EFSA Journal 2015;13(11):4307).

            ANNEX
            Annex XIV to Regulation (EU) No 142/2011 is amended as follows:

                        (a)

                        in Table 1 of Section 1 of Chapter I, row 5 is replaced by the following:

                                    ‘5

                                    Gelatine and hydrolysed protein

                                    Category 3 materials referred to in Article 10(a), (b), (e), (f), (g), (i) and (j), and, in the case of hydrolysed protein: Category 3 materials referred to in Article 10(d), (h) and (k).

                                    The gelatine and the hydrolysed protein must have been produced in accordance with Section 5 of Chapter II of Annex X.

                                                (a)

                                                Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, and the following countries:

                                                            (KR) South Korea

                                                            (MY) Malaysia

                                                            (PK) Pakistan

                                                            (TW) Taiwan

                                                            (EG) Egypt

                                                (b)

                                                In the case of gelatine and hydrolysed proteins from fish: Third countries listed in Annex II to Decision 2006/766/EC.

                                                (a)

                                                In the case of gelatine: Annex XV, Chapter 11.

                                                (b)

                                                In the case of hydrolysed protein: Annex XV, Chapter 12.’

                        (b)

                        in Table 2 of Section 1 of Chapter II, row 13 is replaced by the following:

                                    ‘13

                                    Flavouring innards for the manufacture of petfood

                                    Materials referred to in Article 35(a)

                                    The flavouring innards must have been produced in accordance with Chapter III of Annex XIII.

                                    Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010, from which Member States authorise imports of fresh meat from the same species and where only bone-in meat is authorised.
                                    In the case of flavouring innards from fish materials, third countries listed in Annex II to Decision 2006/766/EC.
                                    In the case of flavouring innards of poultry origin, third countries listed in Part 1 of Annex I to Regulation (EC) No 798/2008, from which Member States authorise imports of fresh poultry meat.
                                    In the case of flavouring innards from certain wild land mammals and leporidae, third countries listed in Part 1 of Annex I to Regulation (EC) No 119/2009 from which Member States authorise imports of fresh meat from the same species.

                                    Annex XV, Chapter 3(E).’

                        (c)

                        in Table 2 of Section 1 of Chapter II, row 17 is replaced by the following:

                                    ‘17

                                    Rendered fats for certain purposes outside the feed chain for farmed animals

                                                (a)

                                                In the case of materials destined for the production of biodiesel, oleochemical products or renewable fuels referred to in point L of Section 2 of Chapter IV of Annex IV: Categories 1, 2 and 3 materials referred to in Articles 8, 9 and 10.

                                                (b)

                                                In the case of materials destined to the production of renewable fuels referred to in point J of Section 2 of Chapter IV of Annex IV: Category 2 and 3 materials referred to in Articles 9 and 10.

                                                (c)

                                                In the case of materials destined to organic fertilisers and soil improvers:
                                                Category 2 materials referred to in Article 9, points (c), (d) and (f)(i) and Category 3 materials referred to in Article 10, other than in points (c) and (p).

                                                (d)

                                                In the case of materials destined to other purposes:
                                                Category 1 materials referred to in Article 8, points (b), (c) and (d), Category 2 materials referred to in Article 9, points (c), (d) and (f)(i) and Category 3 materials referred to in Article 10, other than in points (c) and (p).

                                    The rendered fats shall comply with the requirements set out in Section 9.

                                    Third countries listed in Part 1 of Annex II to Regulation (EU) No 206/2010 and, in the case of fish materials, third countries listed in Annex II to Decision 2006/766/EC.

                                    Chapter 10(B) of Annex XV.’


title: Commission Implementing Regulation (EU) 2019/1294 of 1 August 2019 authorising the placing on the market of betaine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  2.8.2019

                  EN

                  Official Journal of the European Union

                  L 204/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1294
         of 1 August 2019
         authorising the placing on the market of betaine as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

                     On 12 June 2015, the company DuPont Nutrition Biosciences ApS. (‘the Applicant’) made a request to the competent authority of Finland to place betaine on the Union market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for betaine to be used in cereal and protein bars, drink powders, isotonic ready to-drink beverages for persons above the age of 10 engaging in sports activities, and in cereal and protein bars, and foods for special medical purposes and/or total diet replacement as defined in Regulation (EU) No 609/2013 (4) of the European Parliament and of the Council, excluding food for infants and young children.

                     (5)

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

                     (6)

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

                     (7)

                     On 21 October 2015, the competent authority of Finland issued its initial assessment report. In that report, it came to the conclusion that betaine meets the criteria for novel food ingredient set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 23 October 2015, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to adverse effects being observed at the no-observed-adverse-effect level (NOAEL) proposed by the Applicant for the chronic oral toxicity and carcinogenicity study, the small margin of exposure between the betaine doses at which effects were observed in the toxicological studies, and the proposed daily intake of betaine.

                     (9)

                     In view of those reasoned objections, the Commission consulted the European Food Safety Authority (‘the Authority’) on 4 April 2016, asking it to carry out an additional assessment for betaine as novel food ingredient in accordance with Regulation (EC) No 258/97.

                     (10)

                     On 25 October 2017, the Authority adopted its scientific opinion ‘Safety of Betaine as a novel food pursuant to Regulation (EC) No 258/97 (5)’. That opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (11)

                     In its scientific opinion, the Authority, using the Benchmark Dose Approach (BMD) (6), concluded that betaine is safe for the intended population groups when added to foods at a maximum daily dose of 400 mg/day (6 mg/kg body weight per day). In that opinion, the Authority concluded that the safety of betaine, at the proposed uses and use levels as proposed by the Applicant, which would result in intakes of 2 500 mg of betaine per day, has not been established.

                     (12)

                     On 25 January 2018, the Applicant made a request to the Commission for protection of proprietary data for nine studies submitted in support of the application, namely reports of the acute oral toxicity study (7), two sub-acute (14-day (8) and 28-day (9)), and one sub-chronic (10) (42-day) oral toxicity studies, three mutagenicity and genotoxicity studies (11), a chronic oral toxicity and carcinogenicity study (12), and a chronic (six-month) human dietary study (13).

                     (13)

                     On 18 February 2018, the Authority considered (14) that, in elaborating its opinion on betaine as a novel food, the data from the chronic oral toxicity and carcinogenicity study served as a basis for the BMD analysis and for deriving safe intake levels of betaine for the target population, the data from the chronic human dietary study served as a basis to derive the safe intake of betaine for the target population, and the data from three genotoxicity studies served as a basis to alleviate concerns with respect to the potential genotoxity of betaine. Therefore, it is considered that the conclusions on the safety of betaine, could not have been reached without the data from the unpublished reports of these studies.

                     (14)

                     Following the receipt of the Authority's considerations, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the chronic oral toxicity and carcinogenicity study, the chronic human dietary study, and the three mutagenicity and genotoxicity studies, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (15)

                     The Applicant declared that, at the time the application was submitted, it held proprietary exclusive rights to the studies under national law and that therefore third parties could not lawfully access or use these studies.

                     (16)

                     The Commission assessed all the information provided by the Applicant and considered that the Applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the chronic oral toxicity and carcinogenicity study, the chronic human dietary study, and the three genotoxicity studies contained in the Applicant's file should not be used by the Authority for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of betaine authorised by this Regulation should be restricted to the Applicant for that period.

                     (17)

                     However, restricting the authorisation of betaine and of the reference to the studies contained in the Applicant's file for the sole use of the Applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that, their application is based on legally obtained information supporting the authorisation under this Regulation.

                     (18)

                     On 2 November 2018 the Applicant made a request to the Commission within the meaning of Article 10(1) of Regulation (EU) 2015/2283 for the change in the conditions of use of betaine which were included in the 12 June 2015 request of the Applicant to the competent authority of Finland to place betaine on the Union market as a novel food ingredient. The requested changes concern modifications in the intended uses and use levels of betaine in drink powders, isotonic drinks, protein and cereal bars and meal replacement foods intended for sportsmen, and in the uses of betaine in total diet replacement foods for weight control and in foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for infants and young children. Those requested changes would ensure that the intake of betaine by the general population will not exceed the 400 mg/day (6 mg/kg body weight per day) deemed by the Authority in its 2017 opinion to be safe.

                     (19)

                     On 12 December 2018, the Commission consulted the Authority asking it to carry out an additional assessment for the changes in the intended uses and use levels of betaine as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (20)

                     On 14 March 2019, the Authority adopted its scientific opinion ‘Safety of Betaine as a novel food pursuant to Regulation (EU) 2015/2283’ (15). That scientific opinion is in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (21)

                     In that opinion the Authority concluded that betaine is safe under the new proposed conditions of use. Therefore that scientific opinion gives sufficient grounds to establish that betaine, under the proposed uses and use levels, when used as an ingredient in drink powders, isotonic drinks, protein and cereal bars and meal replacement foods intended for sportsmen, and in total diet replacement foods for weight control, and foods for special medical purposes as defined in Regulation (EU) No 609/2013, excluding foods for infants and young children, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (22)

                     The safe level of intake of betaine could be exceeded when foods containing betaine are used in conjunction with food supplements containing betaine. It is therefore necessary to inform the consumers with an appropriate label that foods containing betaine should not be used if food supplements containing betaine are also consumed on the same day.

                     (23)

                     The use of betaine should be authorised without prejudice to Regulation (EU) No 609/2013 laying down requirements on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control.

                     (24)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

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

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

                           Company: DuPont Nutrition Biosciences ApS;

                           Address: Langebrogade 1 DK-1411 Copenhagen K, Denmark,

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

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

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013.

            Article 2
            The studies contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the Applicant as proprietary and without which the novel food could not have been authorised, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement pf DuPont Nutrition Biosciences ApS.

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

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 1 August 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

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

            (4)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

            (5)  EFSA Journal 2017; 15(11):5057.

            (6)  EFSA Journal 2017; 15(1):4658.

            (7)  Life Science Research Limited, 1990, unpublished.

            (8)  TNO BIBRA, 2001, unpublished.

            (9)  TNO BIBRA, 2001, unpublished.

            (10)  Imasde Aglomentaria, 2012 unpublished.

            (11)  Asquith 1989 a, b, c. Unpublished.

            (12)  Hatano Research Institute. 2002, unpublished studies.

            (13)  Unpublished report, undated.

            (14)  EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of the 83rd Plenary held on 7-8 February 2018 and agreed on 18 February 2018 (https://www.efsa.europa.eu/sites/default/files/event/180207-1-m.pdf).

            (15)  EFSA Journal 2019; 17(4):5658.

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

                        (1)

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

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data Protection

                                    ‘Betaine

                                       Specified food category

                                       Maximum levels
                                        (*1)

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “betaine”.
                                    The labelling of foods containing betaine shall bear a statement that the foods should not be used if food supplements containing betaine are consumed the same day.

                                    Authorised on 22 August 2019. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: DuPont Nutrition Biosciences ApS, Langebrogade 1 Copenhagen K, DK-1411, Denmark. During the period of data protection, the novel food betaine is authorised for placing on the market within the Union only by DuPont Nutrition Biosciences ApS unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of DuPont Nutrition Biosciences ApS,
                                    End date of the data protection: 22 August 2024.

                                    Drink powders, isotonic and energy drinks intended for sportsmen

                                    60 mg/100 g

                                    Protein and cereal bars intended for sportsmen

                                    500 mg/100 g

                                    Meal replacements intended for sportsmen

                                    20 mg/100 g

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

                                    500 mg/100 g (bar)
                                    136 mg/100 g (soup)
                                    188 mg/100 g (porridge)
                                    60 mg/100 g (beverages)

                                    Foods for Special Medical Purposes as defined under Regulation (EU) No 609/2013 for adults

                                    400 mg/day

                        (2)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Betaine

                                       Description/Definition:

                                    Betaine (N,N,N-trimethylglycine or carboxy-N,N,N-trimethylmethanaminium), in anhydrous (CH3)3N+CH2COO– (CAS No: 107-43-7) and monohydrate (CH3)3N+CH2COO–.H2O (CAS No: 590-47-6) forms is obtained from processing of sugar beets (i.e. molasses, vinasses or betaine-glycerol).

                                       Characteristics/Composition

                                    Appearance: Free-flowing white crystals
                                    Betaine: ≥ 99,0 % (w/w on dry weight basis)
                                    Moisture: ≤ 2,0 % (anhydrous); ≤ 15,0 % (monohydrate)
                                    Ash: ≤ 0,1 %
                                    pH: 5,0-7,0
                                    Residual protein: ≤ 1,0 mg/g

                                       Heavy metals:

                                    Arsenic: < 0,1 mg/kg
                                    Mercury: < 0,005 mg/kg
                                    Cadmium: < 0,01 mg/kg
                                    Lead: < 0,05 mg/kg

                                       Microbiological criteria:

                                    Total viable count: ≤ 100 CFU/g
                                    Coliforms: Negative/10 g

                                       Salmonella sp.: Negative/25 g
                                    Yeast: ≤ 10 CFU/g
                                    Mould: ≤ 10 CFU/g

                                    CFU: Colony Forming Units.’

               (*1)  Maximum use levels in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer.’;


title: Commission Implementing Regulation (EU) 2019/1690 of 9 October 2019 renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, 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:
                  10.10.2019

                  EN

                  Official Journal of the European Union

                  L 259/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1690
         of 9 October 2019
         renewing the approval of the active substance alpha-cypermethrin, as a candidate for substitution, 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) in conjunction with Article 24(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2004/58/EC (2) included alpha-cypermethrin 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 alpha-cypermethrin, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2020.

                     (4)

                     An application for the renewal of the approval of alpha-cypermethrin 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 draft 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 7 May 2017.

                     (7)

                     The Authority communicated the draft 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 7 August 2018, the Authority communicated to the Commission its conclusion (6) on whether alpha-cypermethrin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the renewal report for alpha-cypermethrin to the Standing Committee on Plants, Animals, Food and Feed on 24 and 25 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 alpha-cypermethrin is an endocrine disrupter via the estrogenic, steroidogenic and thyroid modalities. Furthermore, the available evidence indicates that alpha-cypermethrin is unlikely to be an endocrine disruptor via the androgenic modality. Thus, the Commission considers that alpha-cypermethrin 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 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 alpha-cypermethrin is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing alpha-cypermethrin may be authorised. It is therefore appropriate not to maintain the restriction to use as an insecticide only.

                     (13)

                     The Commission, however, considers that alpha-cypermethrin is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Some of its toxicological reference values are significantly lower than those of the majority of the approved active substances within groups of substances. Alpha-cypermethrin, therefore fulfils the condition set in the first indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

                     (14)

                     It is therefore appropriate to renew the approval of alpha-cypermethrin as a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009.

                     (15)

                     In accordance with Article 14(1) 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 provide for certain conditions. It is, in particular, appropriate to require further confirmatory information.

                     (16)

                     The Commission considers that alpha-cypermethrin does not have endocrine disrupting properties based on the available scientific information summarised in the conclusion of the Authority. However, in order to increase the confidence in this conclusion, the applicant should provide an updated assessment for the androgenic modality, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 and in accordance with the guidance for the identification of endocrine disruptors (8).

                     (17)

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

                     (18)

                     Commission Implementing Regulation (EU) 2019/707 (9) extended the expiry date of alpha-cypermethrin to 31 July 2020 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.

                     (19)

                     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 the active substance as a candidate for substitution
            The approval of the active substance alpha-cypermethrin, as a candidate for substitution, is renewed as set out in Annex I.

            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 November 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 9 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2004/58/EC of 23 April 2004 amending Council Directive 91/414/EEC to include alpha-cypermethrin, benalaxyl, bromoxynil, desmedipham, ioxynil and phenmedipham as active substances (OJ L 120, 24.4.2004, p. 26).

            (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(8):5403.

            (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/10.2903/j.efsa.2018.5311

            (9)  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 (OJ L 120, 8.5.2019, p. 16).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        alpha-cypermethrin
                        CAS No 67375-30-8
                        CIPAC No 454

                        Racemate comprising:
                        (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
                        or
                        (R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
                        and (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

                        ≥ 980 g/kg
                        The manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material.

                        1 November 2019

                        31 October 2026

                        For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, 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 the conditions of use prescribe the application of adequate personal protective equipment;

                                    —

                                    the consumer risk assessment;

                                    —

                                    the protection of aquatic organisms, bees and non-target arthropods.

                              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 toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety;

                                    2.

                                    the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR);

                                    3.

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

                                    4.

                                    Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605.

                              The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 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.
                        As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021.

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

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

               (1)

                  in Part A, entry 83 on alpha-cypermethrin is deleted;

               (2)

                  in Part E, the following entry is added:

                           No

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (*)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘12

                           alpha-cypermethrin
                           CAS No 67375-30-8
                           CIPAC No 454

                           Racemate comprising:
                           (R)-α-cyano-3-phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
                           or
                           (R)-α-cyano-3 phenoxybenzyl-(1S)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate
                           and (S)-α-cyano-3 phenoxybenzyl-(1R)-cis-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate

                           ≥ 980 g/kg
                           The manufacturing impurity hexane is considered to be of toxicological concern and must not exceed 1 g/kg in the technical material

                           1 November 2019

                           31 October 2026

                           For the implementation of the uniform principles, as referred to in Article 9(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on alpha-cypermethrin, 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 the conditions of use prescribe the application of adequate personal protective equipment;

                                       —

                                       the consumer risk assessment;

                                       —

                                       the protection of aquatic organisms, bees and non-target arthropods.

                                 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 toxicological profile of the metabolites bearing the 3-phenoxybenzoyl moiety;

                                       2.

                                       the potential relative toxicity of individual cypermethrin isomers, in particular the enantiomer (1S cis αR);

                                       3.

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

                                       4.

                                       Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605.

                                 The applicant shall submit the information referred to in point 1 by 30 October 2020; the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of isomer mixtures; and the information referred to in point 3 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.
                           As regards Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605 an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of androgenic endocrine activity shall be submitted by 30 October 2021.’

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