title: Commission Implementing Regulation (EU) 2021/1451 of 3 September 2021 concerning the non-approval of dimethyl sulphide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

text:
                  6.9.2021

                  EN

                  Official Journal of the European Union

                  L 313/28

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1451
         of 3 September 2021
         concerning the non-approval of dimethyl sulphide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof,
         Whereas:

                     (1)

                     On 17 January 2019, the Commission received an application from the company Probodelt S. L. for the approval of dimethyl sulphide as a basic substance to be used as a non-lethal attractant for truffle beetle (Leiodes cinnamomeus). Revised applications, received on 24 July 2019 and on 25 November 2019, were accompanied by the information required under the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

                     (2)

                     Two relevant evaluations, carried out in accordance with other Union legislation as referred to in Article 23(2) of Regulation (EC) No 1107/2009 were available, namely, an evaluation from the EFSA FEEDAP Panel (2) and one from the EFSA CEF Panel (3). The outcome of these evaluations have been taken into account by EFSA as well as by the Commission.

                     (3)

                     The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The Authority provided the Commission with a technical report on dimethyl sulphide on 17 July 2020 (4). The Authority concluded that the available information on dimethyl sulphide has not been properly considered by the applicant. The available published information indicates that dimethyl sulphide is an irritant to skin, eyes and the respiratory tract and a skin sensitiser. The Authority stated that details on acute toxicity, irritation, skin sensitisation and short-term inhalation are publicly available on the European Chemicals Agency (ECHA) website and they should have been integrated in the application to have a complete overview of the basic substance. Toxicological data on two metabolites of dimethyl sulphide are also publicly available on the ECHA website, but have not been properly integrated in the dossier.

                     (4)

                     The Authority also noted that a scientific justification for the absence of long-term toxicity and carcinogenicity concerns, considering the overall toxicity profile of the substance, was not provided.

                     (5)

                     Additionally, the Authority concluded that, although residues in crops are expected to be low due to the type of application (a vapour releasing product in a trap), further data should have been provided to show that there is no concern for consumers via dietary intake.

                     (6)

                     The Commission presented the review report and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 25 March 2021.

                     (7)

                     The Commission invited the applicant to submit its comments on the technical report of the Authority and on the Commission’s draft review report. The applicant submitted its comments, which have been carefully examined.

                     (8)

                     However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

                     (9)

                     Consequently, it has not been established that the conditions laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve dimethyl sulphide as a basic substance.

                     (10)

                     This Regulation does not prevent the submission of a further application for the approval of dimethyl sulphide as a basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

                     (11)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The substance dimethyl sulphide is not approved as a basic substance.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 September 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 2013. Scientific Opinion on the safety and efficacy of aliphatic and aromatic mono- and di-thiols and mono-, di-, tri-, and polysulphides with or without additional oxygenated functional groups (chemical group 20) when used as flavourings for all animal species. EFSA Journal 2013;11(5):3208, 34 pp. doi:10.2903/j.efsa.2013.3208.

            (3)  EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids), 2013. Scientific Opinion on Flavouring Group Evaluation 74, Revision 4 (FGE.74Rev4): Consideration of aliphatic sulphides and thiols evaluated by JECFA (53rd and 61st meeting) structurally related to aliphatic and alicyclic mono-, di-, tri- and polysulphides with or without additional oxygenated functional groups from chemical group 20 evaluated by EFSA in FGE.08Rev5. EFSA Journal 2018;16(3):5167, 58 pp. https://doi.org/10.2903/j.efsa.2018.5167.

            (4)  EFSA (European Food Safety Authority), 2020. Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for approval of dimethyl sulfide to be used in plant protection as a non-lethal food attractant for truffle beetle. EFSA supporting publication 2020:EN-1911. 54 pp. doi:10.2903/sp.efsa.2020.EN-1911.


title: Commission Implementing Regulation (EU) 2021/1452 of 3 September 2021 renewing the approval of the active substance potassium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
                  6.9.2021

                  EN

                  Official Journal of the European Union

                  L 313/30

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1452
         of 3 September 2021
         renewing the approval of the active substance potassium hydrogen carbonate as a low-risk substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, 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 22(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2008/127/EC (2) included potassium hydrogen carbonate on 1 September 2009 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 potassium hydrogen carbonate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 August 2022.

                     (4)

                     Applications for the renewal of the approval of the active substance potassium hydrogen carbonate were 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 applicants 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 19 December 2019. The Authority made the supplementary summary dossier available to the public and launched a public consultation on the draft renewal assessment report. The Authority also circulated the draft renewal assessment report to the applicants and to the Member States for comments and forwarded the comments received to the Commission.

                     (7)

                     On 20 April 2021, the Authority communicated to the Commission its conclusion (6) on whether potassium hydrogen carbonate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (8)

                     The Commission presented a renewal report and a draft Regulation regarding potassium hydrogen carbonate to the Standing Committee on Plants, Animals, Food and Feed on 5 and 6 July 2021.

                     (9)

                     The Commission invited the applicants to submit their comments on the conclusion of the Authority and, in accordance with Article 14(1), third paragraph, of Implementing Regulation (EU) No 844/2012, on the renewal report. The applicants submitted their comments, which were carefully examined.

                     (10)

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

                     (11)

                     The risk assessment for the renewal of the approval of the active substance potassium hydrogen carbonate is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing potassium hydrogen carbonate may be authorised. It is therefore appropriate not to maintain the restriction to use as a fungicide or insecticide.

                     (12)

                     The Commission further considers that potassium hydrogen carbonate is a low-risk active substance pursuant to Article 22 of Regulation (EC) No 1107/2009. Potassium hydrogen carbonate is not a substance of concern and fulfils the conditions set in point 5.1 of Annex II to Regulation (EC) No 1107/2009. It is therefore appropriate to renew the approval of potassium hydrogen carbonate as a low-risk substance.

                     (13)

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

                     (14)

                     Commission Implementing Regulation (EU) 2021/745 (7) extended the approval period of potassium hydrogen carbonate until 31 August 2022, in order to allow the completion of the renewal process before the expiry of that approval period. However, given that a decision to renew the approval has been taken ahead of that extended expiry date, this Regulation should start to apply earlier than that date.

                     (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 the active substance
            The approval of the active substance potassium hydrogen carbonate as low risk substance 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 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 September 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  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)  Conclusion on the peer review of the pesticide risk assessment of the active substance potassium hydrogen carbonate: EFSA Journal 2021; 10.2903/j.efsa.2021.6593. Available online: www.efsa.europa.eu.

            (7)  Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distilation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/ sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (OJ L 160, 7.5.2021, p. 89).

            ANNEX I

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity
                            (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                        Potassium hydrogen carbonate
                        CAS No 298-14-6
                        CIPAC No 853

                        Potassium hydrogen carbonate

                        990 g/kg

                        1 November 2021

                        31 October 2036

                        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 of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account.

               (1)  Further details on the identity and the specification of the 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 244 on potassium hydrogen carbonate is deleted;

                        (2)

                        in Part D, the following entry is added:

                                       Number

                                       Common Name, Identification Numbers

                                       IUPAC Name

                                       Purity

                                       Date of approval

                                       Expiration of approval

                                       Specific provisions

                                    ‘32

                                    Potassium hydrogen carbonate
                                    CAS No
                                    298-14-6
                                    CIPAC No 853

                                    IUPAC name: Potassium hydrogen carbonate

                                    990 g/kg

                                    1 November 2021

                                    31 October 2036

                                    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 of potassium hydrogen carbonate, and in particular Appendices I and II thereto, shall be taken into account.’