title: Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 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, and repealing Commission Implementing Regulation (EU) No 844/2012 (Text with EEA relevance)

text:
                  23.11.2020

                  EN

                  Official Journal of the European Union

                  L 392/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1740
         of 20 November 2020
         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, and repealing Commission Implementing Regulation (EU) No 844/2012
         (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 39f thereof,
         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 (2), and in particular Article 19 thereof,
         Whereas:

                     (1)

                     Article 14(1) of Regulation (EC) No 1107/2009 provides that on application the approval of an active substance may be renewed if it is established that the approval criteria in Article 4 of that Regulation are fulfilled.

                     (2)

                     Commission Implementing Regulation (EU) No 844/2012 (3) sets out the provisions necessary for the implementation of the procedure for the renewal of approval of active substances. In particular, it sets out rules for the different steps of the renewal procedure from the preparation to the submission of the application for the renewal of the approval of an active substance (‘the application for renewal’), its content and format, on confidentiality and public disclosure of the application for renewal, and on the adoption of a regulation on the renewal or non-renewal of the approval of active substances.

                     (3)

                     Implementing Regulation (EU) No 844/2012 has been substantially amended three times (4). Further amendments are to be made to it following the adoption of Regulation (EU) 2019/1381 of the European Parliament and the Council (5).

                     (4)

                     Therefore, Implementing Regulation (EU) No 844/2012 should be repealed and replaced by this Regulation for the sake of clarity.

                     (5)

                     It is appropriate to set out new provisions necessary for the implementation of the renewal procedure, in particular the periods for the different steps of the renewal procedure.

                     (6)

                     Regulation (EU) 2019/1381 amended, among others, Regulations (EC) No 178/2002 and (EC) No 1107/2009. Those amendments strengthen the transparency and the sustainability of the Union risk assessment in all areas of the food chain where the European Food Safety Authority (‘the Authority’) conducts a scientific risk assessment.

                     (7)

                     Regulation (EU) 2019/1381 introduced provisions that are pertinent for the renewal procedure for active substances provided for in Regulation (EC) No 1107/2009. Those include, amongst others, the provision of pre-submission advice on intended tests and studies for the purposes of a renewal, preceded by a specific notification by the potential applicant and consultation of third parties, the provision of general pre-submission advice on the rules applicable to the application for renewal, and its content, a notification obligation imposed on business operators, laboratories and testing facilities when studies are commissioned or carried out by them to support an application, the public disclosure of all scientific data, studies and other information supporting an admissible application by the Authority, and a consultation of third parties on the submitted scientific data, studies and other information supporting an admissible application. To ensure proper implementation of those provisions in the context of the procedure for the renewal of approval of active substances, detailed rules should be set out.

                     (8)

                     An application for renewal should include the necessary data and risk assessments and demonstrate why any new data and risk assessments are necessary.

                     (9)

                     In order to implement the requirement set out in point (c) of Article 38(1) of Regulation (EC) No 178/2002 as amended by Regulation (EU) 2019/1381, its Article 39f(2) provides for the adoption of standard data formats to allow documents to be submitted, searched, copied and printed, while ensuring compliance with regulatory requirements set out in Union law. Consequently, it is necessary to adopt a standard data format.

                     (10)

                     Rules should be set out as regards the establishment of the admissibility of the application for renewal by the rapporteur Member State.

                     (11)

                     Where all applications for renewal submitted are inadmissible, the Commission should adopt a Regulation on the non-renewal of the active substance concerned to provide clarity on the status of the active substance.

                     (12)

                     Regulation (EU) 2019/1381 also introduced additional requirements relating to transparency and confidentiality as well as specific procedural requirements for the submission of confidentiality requests in relation to information submitted by an applicant. To ensure a proper implementation of those requirements, the conditions for the assessment of confidentiality requests in the context of applications for renewal should be set out. That assessment should be performed by the Authority in accordance with Regulation (EU) 2019/1381 once the relevant application for renewal has been considered admissible by the rapporteur Member State.

                     (13)

                     The applicant, the Member States, with the exception of the rapporteur Member State, and the public should be given the opportunity to submit comments on the draft renewal assessment report prepared by the rapporteur Member States and co-rapporteur Member State, or by Member States acting jointly as rapporteur.

                     (14)

                     In accordance with Article 36(2) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6), active substances within the meaning of Regulation (EC) No 1107/2009 are normally to be subject to harmonised classification and labelling. It is therefore appropriate to set detailed rules of procedure regarding the submission of proposals to the European Chemicals Agency in accordance with Article 37(1) of Regulation (EC) No 1272/2008 by the rapporteur Member State during the renewal of approval of active substances pursuant to Article 14 of Regulation (EC) No 1107/2009.

                     (15)

                     The Authority should organise consultations of experts and provide conclusions, except where the Commission informs it that a conclusion is not necessary.

                     (16)

                     Rules should be set out as regards the renewal report and the adoption of a regulation on the renewal or non-renewal of the approval of the active substance.

                     (17)

                     Given that this Regulation implements certain provisions of Regulation (EU) 2019/1381, which applies from 27 March 2021 , this Regulation should apply from the same date. Since applications for renewal pursuant to this Regulation are to be submitted at least three years before the expiry of the approval period of an active substance, this Regulation should apply with respect to the renewal of the approval of active substances for which the approval period ends on or after 27 March 2024, even if an application for renewal has already been submitted in accordance with Implementing Regulation (EU) No 844/2012.

                     (18)

                     Transitional measures should be provided for active substances for which the approval period ends before 27 March 2024 to ensure that the renewal procedure for those substances can continue. Implementing Regulation (EU) No 844/2012 should continue to apply to active substances whose approval period on the date of application of this Regulation expires before 27 March 2024 or for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later 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:
         CHAPTER 1

            SUBJECT MATTER AND SCOPE

            Article 1
            Subject matter
            This Regulation establishes rules on the procedure for the renewal of the approval of active substances within the meaning of Regulation (EC) No 1107/2009.

            Article 2
            Scope
            This Regulation shall apply to the renewal of the approval of active substances whose approval period ends on or after 27 March 2024.
            However, it shall not apply to the renewal of the approval of the active substances for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.

         CHAPTER 2

            NOTIFICATION AND ADVICE PRIOR TO THE SUBMISSION OF THE APPLICATION FOR RENEWAL

            Article 3
            Notification of intended studies and advice on intended studies

               1.   Notifications of studies intended to be conducted to support a future application for renewal in accordance with Article 32c(1) of Regulation (EC) No 178/2002 shall be submitted sufficiently ahead of the date for submission of the application for renewal in accordance with Article 5(1) of this Regulation in order to allow public consultation to be performed and comprehensive advice to be provided by the Authority and the studies required in support of a future application for renewal to be carried out in a timely and proper manner.

               2.   The pre-submission advice by the Authority pursuant to Article 32c(1) of Regulation (EC) No 178/2002 shall be provided with the participation of the rapporteur Member State and the co-rapporteur Member State, taking into account any existing experience and knowledge relevant for the active substance, including, where appropriate, available studies from the earlier approval or renewal of approval.

            Article 4
            General pre-submission advice

               1.   A potential applicant may request from the staff of the Authority general pre-submission advice at any time before the submission of the application for renewal. The Authority shall inform the rapporteur Member State of the request and together they shall decide if the co-rapporteur Member State is required to participate in providing the general pre-submission advice.

               2.   Where several potential applicants request general pre-submission advice, the Authority shall suggest that they submit a joint application for renewal and disclose their contact details to each other for that purpose.

         CHAPTER 3

            SUBMISSION AND ADMISSIBILITY OF THE APPLICATION FOR RENEWAL

            Article 5
            Submission of the application for renewal

               1.   An application for renewal shall be submitted electronically via a central submission system using the format as set out in Article 7 by a producer of the active substance no later than three years before the expiry of the approval.
               The rapporteur Member State as set out in the second column of the Annex to Commission Implementing Regulation (EU) No 686/2012 (7) or each of the Member States in a group of Member States acting jointly as rapporteur Member State as set out in the fourth column of that Annex, the co-rapporteur Member State as set out in the third column of that Annex, the other Member States, the Authority and the Commission shall be informed via the central submission system referred to in Article 7.
               Where a group of Member States jointly assumes the role of the rapporteur Member State, as set out in the fourth column of the tables in Part B and Part C of the Annex to Implementing Regulation (EU) No 686/2012, no co-rapporteur Member State shall be appointed. In this case, all references to ‘the rapporteur Member State’ in this Regulation shall be deemed to be references to ‘the group of Member States acting jointly as rapporteur Member State’.
               Prior to the expiry of the deadline for submission of the application for renewal, the Member States acting jointly as rapporteur Member State shall agree on the repartition of all tasks and workload.
               Member States forming part of the group of Member States acting jointly as rapporteur Member State shall endeavour to reach consensus during the evaluation.

               2.   A joint application for renewal may be submitted by an association of producers designated by the producers.
               Where there is more than one applicant requesting the renewal of the approval of the same active substance, those applicants shall take all reasonable steps to submit their dossiers jointly. Where contrary to the advice of the Authority as referred to in Article 4 such dossiers are not submitted jointly by all the applicants concerned, the reasons for that shall be set out in the dossiers.

            Article 6
            Content of the application for renewal

               1.   An application for renewal shall consist of a renewal dossier in the format as set out in Article 7.

               2.   The renewal dossier shall include the following:

                           (a)

                           the name and address of the applicant responsible for the application for renewal and for the obligations under this Regulation;

                           (b)

                           where the applicant is joined by one or more other applicants, the name and address of that or those other applicants and, if applicable, the name of the association of producers mentioned in Article 5(2);

                           (c)

                           information with respect to one or more representative uses on a widely grown crop in each zone of at least one plant protection product containing the active substance, demonstrating that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are fulfilled;

                           (d)

                           data and risk assessments which are necessary:

                                       (i)

                                       to reflect changes in legal requirements since the approval or last renewal of the approval of the active substance concerned;

                                       (ii)

                                       to reflect changes in scientific and technical knowledge since the approval or last renewal of the approval of the active substance concerned;

                                       (iii)

                                       to reflect changes to representative uses; or

                                       (iv)

                                       because the application is for an amended renewal;

                           (e)

                           for each of the data requirements for the active substance, as set out in Commission Regulation (EU) No 283/2013 (8), the full text of each test or study report and summaries thereof, including those that were part of the approval dossier or subsequent renewal dossiers;

                           (f)

                           for each of the data requirements for the plant protection product, as set out in Commission Regulation (EU) No 284/2013 (9), the full text of each test or study report and summaries thereof, including where relevant, those that were part of the approval dossier or subsequent renewal dossiers;

                           (g)

                           where relevant, documented evidence as referred to in Article 4(7) of Regulation (EC) No 1107/2009;

                           (h)

                           for each test or study involving vertebrate animals, a description of the steps taken to avoid animal testing on vertebrate animals;

                           (i)

                           where relevant, a copy of an application for maximum residue levels as referred to in Article 7 of Regulation (EC) No 396/2005 of the European Parliament and of the Council (10);

                           (j)

                           a proposal for classification where it is considered that the substance has to be classified or reclassified in accordance with Regulation (EC) No 1272/2008;

                           (k)

                           a checklist demonstrating that the renewal dossier is complete in view of the uses applied for and indicating which data are new;

                           (l)

                           the summaries and results of scientific peer-reviewed open literature, as referred in Article 8(5) of Regulation (EC) No 1107/2009;

                           (m)

                           an assessment according to the current scientific and technical knowledge of all information submitted, including, where relevant, a reassessment of studies and information that were part of the approval dossier or subsequent renewal dossiers;

                           (n)

                           a consideration and proposal for any necessary and appropriate risk mitigation measures;

                           (o)

                           all relevant information related to the notification of the studies in accordance with Article 32b of Regulation (EC) No 178/2002.

                     The information referred to in point (o) of the first subparagraph shall be clearly identifiable.
               The renewal dossier shall not contain any reports of tests or studies involving the deliberate administration of the active substance or the plant protection product containing it to humans.

               3.   Applicants shall make their best efforts to obtain access to and provide the studies which were part of the approval dossier or subsequent renewal dossiers as required under points (e) and (f) of paragraph 2.
               The Member State that acted as rapporteur for the previous approval and/or subsequent renewal dossiers or the Authority shall endeavour to make available such studies where the applicant provides evidence that its attempts to obtain access from the study owner have failed.

               4.   If the information submitted in accordance with point (c) of paragraph 2 does not cover all zones or does not concern a widely grown crop, a justification shall be submitted.

               5.   The uses referred to in point (c) of paragraph 2 shall, where appropriate, include the uses evaluated for the approval or subsequent renewals. At least one plant protection product referred to in point (c) of paragraph 2 shall contain no other active substance, where such a product exists for a representative use.

               6.   The applicant shall identify and list the new data it submits, including any new studies involving vertebrate animals in a separate list. It shall demonstrate that the new data is necessary in accordance with the first subparagraph of Article 15(2) of Regulation (EC) No 1107/2009 and, where applicable, refer to advice received during the pre-submission phase in accordance with Articles 32a and 32c of Regulation (EC) No 178/2002.

               7.   When requesting certain information to be kept confidential in accordance with Article 63(1), (2) and (2a) of Regulation (EC) No 1107/2009, the applicant shall identify the confidential and a non-confidential versions of the information submitted.

               8.   The applicant may submit any data protection claims pursuant to Article 59 of Regulation (EC) No 1107/2009.

            Article 7
            Format and software for the submission of the application for renewal

               1.   The Authority shall establish and make available online a central submission system. The Authority shall ensure that the central submission system facilitates the verification of admissibility performed by Member States in accordance with Article 8.

               2.   The standard data formats proposed by the Authority as part of the IUCLID software package pursuant to Article 39f of Regulation (EC) No 178/2002 are hereby adopted.

               3.   The application for renewal shall be submitted via the central submission system using the IUCLID software package.

               4.   The applicant, when requesting certain information to be kept confidential in accordance with Article 63(1), (2) and (2a) of Regulation (EC) No 1107/2009, shall indicate such information using the relevant IUCLID functionality.
               The Authority shall assess such a request only if the application is considered admissible in accordance with Article 8 of this Regulation.

            Article 8
            Admissibility of the application for renewal

               1.   The rapporteur Member State shall consider an application for renewal admissible, provided that all the following requirements are met:

                           (a)

                           the application for renewal has been submitted within the period provided for in Article 5(1) and in accordance with the format and using the software provided for in Article 7;

                           (b)

                           the application for renewal contains all the elements provided for in Article 6;

                           (c)

                           the application for renewal contains all studies, in full, that have been previously notified in accordance with Article 32b of Regulation (EC) No 178/2002 and no additional ones apart from those contained in the approval dossier or subsequent renewal dossiers or conducted before the obligation under Article 32b of Regulation (EC) No 178/2002 applied, unless a valid justification is provided;

                           (d)

                           the relevant fee has been paid.

               2.   The rapporteur Member State shall, within a period of one month from the date provided for in Article 5(1), inform the applicant, the co-rapporteur Member State, the Commission and the Authority of the date of receipt of the application for renewal and of its admissibility.

               3.   Where an application for renewal has been submitted in accordance with point (a) of paragraph 1, but one or more elements provided for in point (b) or (d) of paragraph 1 are missing, the rapporteur Member State shall, within a period of one month from the date of receipt of the application for renewal, inform the applicant which elements are missing and set a period of 14 days for the submission of those elements via the central submission system referred to in Article 7. Upon expiry of that period, the rapporteur Member State shall, without delay, proceed in accordance with either paragraph 4 or paragraph 5.

               4.   Where the application for renewal does not comply with point (c) of paragraph 1, the rapporteur Member State shall, in coordination with the Authority, within a period of one month from date of receipt of the application for renewal, inform the applicant accordingly and set a period of 14 days for providing a valid justification for this non-compliance. Upon expiry of that period and where a valid justification has not been provided, the application for renewal shall be considered inadmissible and Article 32b(4) or Article 32b(5) of Regulation (EC) No 178/2002 shall apply. The assessment of the admissibility of a resubmitted application for renewal shall only commence after the expiry of the six-month period mentioned in Article 32b(4) or Article 32b(5) of Regulation (EC) No 178/2002 following the notification of the relevant studies and/or submission of studies as necessary and provided that that point in time is no later than three years before the expiry of the approval of the active substance. If that point in time is later than three years before the expiry of the approval of the active substance, the resubmitted application for renewal shall be considered inadmissible.

               5.   Where the application for renewal has not been submitted within the period referred to in point (a) of paragraph 1, or where at the end of the 14-day period set for the submission of the missing elements in accordance with paragraphs 3 and 4 the application for renewal still does not contain all the elements provided for in Article 6, the rapporteur Member State shall, without delay, inform the applicant, the co-rapporteur Member State, the Commission, the other Member States and the Authority that the application for renewal is inadmissible and of the reasons for inadmissibility.

            Article 9
            Adoption of a non-renewal Regulation
            Where all applications for renewal submitted for an active substance are inadmissible in accordance with Article 8, a Regulation on the non-renewal of the approval of that active substance shall be adopted in accordance with point (b) of Article 20(1) of Regulation (EC) No 1107/2009.

            Article 10
            Public access to the information in the application for renewal and consultation of third parties
            The Authority shall allow a period of 60 days from the date the application for renewal is made public in accordance with point (c) of Article 38(1) of Regulation (EC) No 178/2002 for the submission of written comments on that information and on whether other relevant scientific data or studies are available on the subject matter concerned by the application for renewal. This paragraph does not apply to the submission of any supplementary information submitted by the applicant during the evaluation process.

         CHAPTER 4

            ASSESSMENT AND RENEWAL REPORT AND REGULATION

            Article 11
            Assessment by the rapporteur Member State and the co-rapporteur Member State

               1.   Where the application is admissible in accordance with Article 8, the rapporteur Member State shall, after consulting the co-rapporteur Member State, at the latest 13 months after the date of submission of the application for renewal in accordance with Article 5(1), submit to the Commission and to the Authority, a report assessing whether the active substance can still be expected to meet the approval criteria, as provided for in Article 4 of Regulation (EC) No 1107/2009 (‘the draft renewal assessment report’).

               2.   The draft renewal assessment report shall include the following:

                           (a)

                           a recommendation with regard to the renewal of the approval, including any necessary conditions and restrictions;

                           (b)

                           a recommendation on whether the substance is to be considered a ‘low-risk’ substance;

                           (c)

                           a recommendation on whether the substance is to be considered a candidate for substitution;

                           (d)

                           a proposal to set maximum residue levels or a justification in case such proposal is not relevant;

                           (e)

                           a suggestion for the classification, or its confirmation, where applicable or reclassification of the active substance in accordance with the criteria of Regulation (EC) No 1272/2008, as specified in and consistent with the dossier to be submitted pursuant to paragraph 9 of this Article;

                           (f)

                           a conclusion on which of the studies included in the renewal dossier are relevant for the assessment;

                           (g)

                           a recommendation as to the parts of the report on which a consultation of experts is to be organised in accordance with Article 13(1);

                           (h)

                           where relevant, the points on which the co-rapporteur Member State did not agree with the assessment by the rapporteur Member State or, where applicable, the points where there is no agreement between Member States forming a group of Member States acting jointly as rapporteur Member State; and

                           (i)

                           the results of the public consultation performed pursuant to Article 10 and how they have been taken into account.

               3.   The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the application for renewal. It shall take into account all the information submitted as part of the application for renewal, including the dossiers submitted for the approval and subsequent renewals of approval. The rapporteur Member State shall also identify and consider, where appropriate, risk mitigation measures and take into account the written comments received during the public consultation pursuant to Article 10). Where despite the best efforts made the applicant could not submit the full text and summary of each test and study report which were part of the approval dossier or subsequent renewal dossiers and required in accordance with points (e) and (f) of Article 6(2), the rapporteur Member State shall ensure that the respective studies are evaluated and taken into account in their overall assessment.

               4.   In its assessment, the rapporteur Member State shall first establish whether the approval criteria set out in points 3.6.2, 3.6.3, 3.6.4 and 3.7 of Annex II to Regulation (EC) No 1107/2009 are satisfied.
               Where those criteria are not satisfied, the draft renewal assessment report shall be limited to the parts of the assessment corresponding to them, unless Article 4(7) of Regulation (EC) No 1107/2009 applies.

               5.   Where the rapporteur Member State requires additional information, it shall set a period for the applicant to supply that information. That period shall not lead to an extension of the period of 13 months provided for in paragraph 1. Any confidentiality request pursuant to Article 63 of Regulation (EC) No 1107/2009 shall be addressed to the Authority in accordance with Article 6(7) of this Regulation.

               6.   The rapporteur Member State may consult the Authority and request additional technical or scientific information from other Member States. Such consultations and requests shall not lead to an extension of the period of 13 months provided for in paragraph 1.

               7.   Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with paragraph 5 of this Article, shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.

               8.   When submitting the draft renewal assessment report to the Commission and the Authority, the rapporteur Member State shall request the applicant to submit the renewal dossier, updated to include the additional information requested by the rapporteur Member State in accordance with paragraph 5 of this Article or submitted in accordance with Article 56 of Regulation (EC) No 1107/2009, without delay, via the central submission system referred to in Article 7 of this Regulation.
               Any confidentiality requests pursuant to Article 63 of Regulation (EC) No 1107/2009 shall be addressed to the Authority in accordance with Article 6(7) of this Regulation.

               9.   The rapporteur Member State shall at the latest at the time of submission of the draft renewal assessment report submit a proposal to the European Chemicals Agency pursuant to Article 37(1) of Regulation (EC) No 1272/2008 and in accordance with the Agency’s requirements to obtain an opinion on a harmonised classification of the active substance at least for the following hazard classes:

                           (a)

                           explosives;

                           (b)

                           acute toxicity;

                           (c)

                           skin corrosion/irritation;

                           (d)

                           serious eye damage/eye irritation;

                           (e)

                           respiratory or skin sensitisation;

                           (f)

                           germ cell mutagenicity;

                           (g)

                           carcinogenicity;

                           (h)

                           reproductive toxicity;

                           (i)

                           specific target organ toxicity – single exposure;

                           (j)

                           specific target organ toxicity – repeated exposure;

                           (k)

                           hazardous to the aquatic environment.

                     The rapporteur Member State shall duly justify its view that the criteria for classification for one or more of these hazard classes are not fulfilled.
               Where a proposal for classification of an active substance has already been submitted to the Agency and its assessment is ongoing, the rapporteur Member State shall submit an additional proposal for classification, limited to any hazard classes listed in the first subparagraph that are not covered by the pending proposal unless new information has become available that was not part of the pending dossier as regards those listed hazard classes.
               For the hazard classes, which are already covered by an existing opinion of the Committee for Risk Assessment of the Agency set up pursuant to point (c) of Article 76(1) of Regulation (EC) No 1907/2006, whether or not this opinion has formed the basis of a decision concerning an entry for harmonised classification and labelling of a substance in Annex VI to Regulation (EC) No 1272/2008, it is sufficient that the rapporteur Member State duly justifies in its submission to the Agency that the existing opinion, or where it has already formed the basis of a decision concerning the inclusion in Annex VI, the existing classification remains valid as regards the hazard classes listed in the first subparagraph of this paragraph. The Agency may provide its views regarding the rapporteur Member State’s submission.

               10.   The Committee for Risk Assessment shall endeavour to adopt the opinion referred to in Article 37(4) of Regulation (EC) No 1272/2008 within 13 months from the submission referred to in the first subparagraph of paragraph 9 of this Article.

            Article 12
            Comments on the draft renewal assessment report

               1.   The Authority shall examine whether the draft renewal assessment report received from the rapporteur Member State contains all the relevant information in the agreed format and circulate it to the applicant and to the other Member States at the latest three months after its receipt.

               2.   Upon receipt of the draft renewal assessment report pursuant to paragraph 1 of this Article, the applicant may, within a period of two weeks, submit a request to the Authority for certain information in the draft renewal assessment report originating from its application to be kept confidential pursuant to Article 63 of Regulation (EC) No 1107/2009 and in accordance with Article 6(7) of this Regulation.
               The Authority shall make the draft renewal assessment report publicly available with the exception of the information for which the confidentiality request has been accepted as justified.

               3.   The Authority shall allow a period of 60 days from the date the draft report is made available to the public for the submission of written comments. Such comments shall be communicated to the Authority, which shall collate and forward those comments, together with its own comments, to the rapporteur Member States or group of Member States acting jointly as rapporteur Member State and where relevant the co-rapporteur Member State. The Authority shall provide its view to the Commission on whether it is not necessary in the light of the comments received to continue the procedure in accordance with Article 13.

               4.   The Authority shall make the updated renewal dossier available to the public at the same time as making the draft renewal assessment report available in accordance with Article 10.

            Article 13
            Conclusion by the Authority

               1.   The Authority shall establish a conclusion in the light of current scientific and technical knowledge using guidance documents applicable at the date of the submission of the application for renewal and in the light of the opinion of the Committee for Risk Assessment on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority shall, where appropriate, organise a consultation of experts, including experts from the rapporteur Member State and co-rapporteur Member State.
               The Authority shall draft the conclusion provided for in the first subparagraph within five months from the expiry of the period referred to in Article 12(3) of this Regulation, or within two weeks from the adoption of the opinion of the Committee for Risk Assessment referred to in Article 37(4) of Regulation (EC) No 1272/2008, if any adopted, whichever occurs later.
               Where appropriate, the Authority shall address in its draft conclusion the risk mitigation options identified in the draft renewal assessment report or during the peer review.
               The Commission may inform the Authority without delay after the period referred to in Article 12(3) has expired that a conclusion is not necessary.

               2.   Where the Authority considers that additional information from the applicant is necessary, it shall, in consultation with the rapporteur Member State, set a period not exceeding one month for the applicant to supply such information to the Member States, the Commission and the Authority. The rapporteur Member State shall, within 60 days from the date of receipt of the additional information evaluate the information received and send its evaluation to the Authority.
               Where the first subparagraph applies, the period referred to in paragraph 1 shall be extended by the two periods referred to in that subparagraph.

               3.   The Authority may ask the Commission to consult a European Union reference laboratory designated, pursuant to Regulation (EU) 2017/625 of the European Parliament and of the Council (11) for the purposes of verifying whether the analytical method for the determination of the residues proposed by the applicant is satisfactory and complies with the requirements provided for in point (g) of Article 29(1) of Regulation (EC) No 1107/2009. The applicant shall, if requested by the European Union reference laboratory, provide samples and analytical standards.

               4.   The Authority shall communicate the draft conclusion to the applicant, the Member States and the Commission and give the applicant a possibility to submit comments within a period of two weeks.
               Where in its draft conclusion the Authority identifies critical issues and/or critical data gaps such that it is expected that there is no representative use of at least one plant protection product containing the active substance for which the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 would be fulfilled, and which the applicant could not have known about at the time of submission of the application and did not have the possibility to address following a request for additional information in accordance with Article 13(2), the applicant may also submit additional information on those issues to the Member States, the Commission and the Authority within the two-week period.
               Comments and new information shall be considered by the Authority in cooperation with the rapporteur Member State and the co-rapporteur Member State. The Authority shall finalise the conclusion within 75 days from the expiry of the two-week period referred to in the first subparagraph.
               In cases where the Authority drafted the conclusion before the expiry of the five months period referred to in the first paragraph of this Article the remaining time may be added to the 75 days mentioned in the previous subparagraph.

               5.   The Authority shall communicate its final conclusion to the applicant, the Member States and the Commission.

               6.   After giving the applicant two weeks to request certain information in the conclusion originating from its application to be kept confidential, pursuant to Article 63 of Regulation (EC) No 1107/2009, and in accordance with Article 6(7) of this Regulation, the Authority shall make its conclusion available to the public, excluding any information in respect of which confidentiality has been granted by the Authority.

               7.   Information submitted by the applicant without having been requested, or provided after the expiry of the period set for its submission in accordance with the first subparagraph of paragraph 2 and the second subparagraph of paragraph 4 of this Article shall not be taken into account, unless it is submitted in accordance with Article 56 of Regulation (EC) No 1107/2009.

            Article 14
            Renewal report and renewal Regulation

               1.   The Commission shall present to the Committee referred to in Article 79(1) of Regulation (EC) No 1107/2009 a draft renewal report and a draft Regulation within six months from the date of receipt of the conclusion of the Authority or in cases where there is no such conclusion of the Authority, from the expiry of the period referred to in Article 12(3) of this Regulation.
               The draft renewal report and the draft Regulation shall take into account the draft renewal assessment report, the comments referred to in Article 12(3) of this Regulation and the conclusion of the Authority, where such a conclusion has been submitted, and the opinion of the Committee for Risk Assessment, if any, referred to in Article 37(4) of Regulation (EC) No 1272/2008.
               The applicant shall be given the possibility to submit comments on the draft renewal report within a period of 14 days.

               2.   On the basis of the renewal report and taking into account comments submitted by the applicant within the period referred to in the third subparagraph of paragraph 1 of this Article as well as other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, the Commission shall adopt a Regulation in accordance with Article 20(1) of Regulation (EC) No 1107/2009.

         CHAPTER 5

            REPLACEMENT OF THE APPLICANT, FEES AND CHARGES

            Article 15
            Replacement of the applicant
            An applicant may be replaced by another producer in respect of all of its rights and obligations under this Regulation by informing the rapporteur Member State, by a joint declaration made by both of them. In that case, both shall, at the same time, inform of the replacement the co-rapporteur Member State, the Commission, the other Member States, the Authority and any other applicants that have submitted an application for renewal for the same active substance.

            Article 16
            Fees and charges

               1.   Member States may require payment of fees and charges in accordance with Article 74 of Regulation (EC) No 1107/2009 to recover the costs associated with any work they carry out within the scope of this Regulation.

               2.   In case of simultaneous applications for renewal for more than one active substance, for which at least part of the risk assessment can be considered applicable to all of the active substance applications for renewal, fees shall be proportionate and applied taking into consideration that a common risk assessment might be performed.
               The first subparagraph shall in particular apply to such simultaneous applications for renewal concerning strains of microorganisms with genetic, biological and/or ecological similarity, or to pheromones with similar chemical structures acting on the same taxonomic group of target organisms.

         CHAPTER 6

            FINAL PROVISIONS

            Article 17
            Repeal
            Implementing Regulation (EU) No 844/2012 is repealed.
            However, it shall continue to apply to the procedure for the renewal of the approval of the active substances:

                        (1)

                        whose approval period ends before 27 March 2024;

                        (2)

                        for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.

            Article 18
            Entry into force and 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 27 March 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  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).

            (4)  Commission Implementing Regulation (EU) 2018/1659 of 7 November 2018 amending Implementing Regulation (EU) No 844/2012 in view of the scientific criteria for the determination of endocrine disrupting properties introduced by Regulation (EU) 2018/605 (OJ L 278, 8.11.2018, p. 3); Commission Implementing Regulation (EU) 2019/724 of 10 May 2019 amending Implementing Regulation (EU) No 686/2012 as regards the nomination of rapporteur Member States and co-rapporteur Member States for the active substances glyphosate, lambda-cyhalothrin, imazamox and pendimethalin and amending Implementing Regulation (EU) No 844/2012 as regards the possibility that a group of Member States assumes jointly the role of the rapporteur Member (OJ L 124, 13.5.2019, p. 32) and Commission Implementing Regulation (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances (OJ L 19, 24.1.2020, p. 1).

            (5)  Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and the sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC (OJ L 231, 6.9.2019, p. 1).

            (6)  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).

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

            (8)  Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, 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 (OJ L 93, 3.4.2013, p. 1).

            (9)  Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, 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 (OJ L 93, 3.4.2013, p. 85).

            (10)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

            (11)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (OJ L 95, 7.4.2017, p. 1).


title: Commission Implementing Regulation (EU) 2020/1752 of 23 November 2020 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Australia in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (Text with EEA relevance)

text:
                  24.11.2020

                  EN

                  Official Journal of the European Union

                  L 394/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1752
         of 23 November 2020
         amending Annex I to Regulation (EC) No 798/2008 as regards the entry for Australia in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point 1 of Article 8, point 4 of Article 8 and Article 9(4) thereof,
         Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

                     (2)

                     Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

                     (3)

                     Australia is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of the commodities are not restricted due to the presence of HPAI.

                     (4)

                     On 31 July 2020, Australia confirmed to the World Organisation for Animal Health (OIE) the presence of HPAI of subtype H7N7 in a poultry holding in Lethbridge, Victoria. Due to that confirmed outbreak of HPAI, Australia can no longer be considered as free from that disease and the veterinary authorities of Australia are not in the position to certify consignments of the commodities intended for import into or transit through the Union.

                     (5)

                     The entry for Australia in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the current epidemiological situation in that third country due to the current outbreak of HPAI. For reasons of clarity and legal certainty, it is appropriate to indicate in the same Annex, the date as of which that third country could no longer be considered as free from HPAI. This also ensures that, where Australia eventually regains freedom from HPAI and an opening date is established, consignments of such products produced after the closing date and before that opening date will not be eligible for introduction into the Union.

                     (6)

                     Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

                     (7)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 343, 22.12.2009, p. 74.

            (3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

            ANNEX
            In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for Australia is replaced by the following:

                           ISO code and name of third country or territory

                           Code of third country, territory, zone or compartment

                           Description of third country, territory, zone or compartment

                           Veterinary certificate

                           Specific conditions

                           Specific conditions

                           Avian influenza surveillance status

                           Avian influenza vaccination status

                           Salmonella Control Status(6)

                           Model(s)

                           Additional guarantees

                           Closing date(1)

                           Opening date(2)

                           1

                           2

                           3

                           4

                           5

                           6

                           6A

                           6B

                           7

                           8

                           9

                           ‘AU – Australia

                           AU-0

                           Whole country

                           SPF

                           EP, E

                           S4

                           BPP, DOC, HEP, SRP, LT20

                           31.7.2020

                           S0, ST0’

                           BPR

                           I

                           DOR

                           II

                           HER

                           III

                           POU

                           VI

                           RAT

                           VII


title: Commission Implementing Regulation (EU) 2020/1753 of 18 November 2020 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication ‘Ribeiro’ (PDO)

text:
                  25.11.2020

                  EN

                  Official Journal of the European Union

                  L 395/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1753
         of 18 November 2020
         approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication ‘Ribeiro’ (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 has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Ribeiro’, forwarded by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

                     (2)

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

                     (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 the 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 ‘Ribeiro’ (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, 18 November 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

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

            (2)  OJ C 196, 11.6.2020, p. 33.


title: Commission Implementing Regulation (EU) 2020/1755 of 24 November 2020 concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH) (Text with EEA relevance)

text:
                  25.11.2020

                  EN

                  Official Journal of the European Union

                  L 395/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1755
         of 24 November 2020
         concerning the authorisation of a preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds (holder of authorisation Biochem Zusatzstoffe Handels- und Produktionsges. mbH)
         (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 Bacillus coagulans DSM 32016. 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 the preparation of Bacillus coagulans DSM 32016 as a feed additive for suckling and weaned Suidae piglets, poultry for fattening and ornamental birds, to be classified in the category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2020 (2) that, under the proposed conditions of use, the preparation of Bacillus coagulans DSM 32016 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that is not a skin/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation has the potential to be efficacious as zootechnical additive in feedingstuffs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of Bacillus coagulans DSM 32016 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of the product should be authorised as specified in the Annex to this Regulation.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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, 24 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(6):6158.

            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

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1900

                        Biochem Zusatzstoffe Handels- und Produktionsges. mbH

                           Bacillus coagulans DSM 32016

                           Additive composition

                        Preparation of Bacillus coagulans DSM 32016 containing a minimum of 2 × 1010 CFU/g additive
                        Solid form

                        Suckling and weaned Suidae piglets

                        -

                        1 × 109

                        -

                                    1.

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

                                    2.

                                    May be used in feed containing the following permitted coccidiostats: halofuginone and diclazuril.

                                    3.

                                    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.

                        15.12.2030

                           Characterisation of the active substance

                        Viable spores of cells of Bacillus coagulans DSM 32016

                        Poultry for fattening

                           Analytical method
                            (1)

                        Enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on MRS agar (based on EN 15787 method).
                        Identification: Pulsed Field Gel Electrophoresis (PFGE).

                        Ornamental birds

               (1)  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) 2020/1760 of 25 November 2020 concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

text:
                  26.11.2020

                  EN

                  Official Journal of the European Union

                  L 397/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1760
         of 25 November 2020
         concerning the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets (holder of authorisation Chr. Hansen A/S)
         (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, two applications were submitted for the authorisation of the preparation of Bacillus subtilis DSM 25841. Those applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     The applications concern the authorisation of the preparation of Bacillus subtilis DSM 25841 as a feed additive for all porcine species, including sows, other than lactating sows in order to have a benefit in suckling piglets to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 20 February 2018 (2), 4 October 2019 (3) and 4 October 2019 (4), under the proposed conditions of use, the preparation of Bacillus subtilis DSM 25841 does not have an adverse effect on animal health, consumer safety or the environment. It also stated that this preparation should be considered a potential respiratory sensitiser and that it cannot conclude on its irritancy potential to skin and eyes or its dermal sensitisation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the preparation has the potential to be efficacious in improving zootechnical parameters in the target species. 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.

                     (5)

                     The assessment of the preparation of Bacillus subtilis DSM 25841 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised.

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

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2018;16(4):5199.

            (3)  EFSA Journal 2019;17(11):5882.

            (4)  EFSA Journal 2019;17(11):5884.

            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

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                        CFU/l of water for drinking

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1900

                        Chr. Hansen A/S

                           Bacillus subtilis

                        DSM 25841

                           Additive composition

                        Preparation of Bacillus subtilis DSM 25841 containing a minimum of 1,25 × 1010 CFU/g of additive
                        Solid form

                        All porcine species, including sows,
                        other than lactating sows in order to have a benefit in suckling piglets

                        —

                        5 × 108

                        —

                        1,7 × 108

                        —

                                    1.

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

                                    2.

                                    The additive may be used in water for drinking.

                                    3.

                                    For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

                                    4.

                                    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: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser. 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:

                        16.12.2030

                           Characterisation of the active substance

                        Viable spores of Bacillus subtilis DSM 25841

                           Analytical method
                            (1)

                        For identification of Bacillus subtilis DSM 25841: Identification: Pulsed Field Gel Electrophoresis (PFGE)
                        For enumeration of Bacillus subtilis DSM 25841 in the feed additive, premixtures and feedingstuffs: Spread plate method using tryptone soya agar – EN 15784

               (1)  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) 2020/1761 of 25 November 2020 concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species (Text with EEA relevance)

text:
                  26.11.2020

                  EN

                  Official Journal of the European Union

                  L 397/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1761
         of 25 November 2020
         concerning the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species
         (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 L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     This application concerns the authorisation of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 as a feed additive for all animal species. The applicant requested this additive to be classified in the additive category ‘sensory additives’.

                     (4)

                     The applicant requested the feed additive to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the use of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 in water for drinking should not be allowed. The fact that of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 is not authorised for use as a flavouring in water for drinking does not preclude its use in compound feed administered via water.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 March 2020 (2) that, under the proposed conditions of use L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 do not have adverse effects on animal health, consumer health or the environment. The Authority concluded for L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia
                        coli KCCM 80109 and KCCM 80197 that although users’ exposure via inhalation is unlikely due to the low dusting potential, the product is proposed to be classified as respiratory irritant due to its low pH when in solution. In addition, based on the results of the studies provided, it should be classified as skin irritant and that it can cause serious eye damage. L-cysteine hydrochloride monohydrate is not a dermal sensitiser. The Authority also concluded, that since L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 is used in food as flavouring, it is to be expected that it can provide a similar function in feed and no further demonstration of efficacy is necessary when used in feed. 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of L-cysteine hydrochloride monohydrate produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197 should be authorised as specified in the Annex to this Regulation.

                     (7)

                     Restrictions and conditions should be provided for to allow better control. In particular, a recommended content should be indicated on the label of the feed additive. Where such content is exceeded, certain information should be indicated on the label of premixtures.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed 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, 25 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(4):6101.

            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

                           mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

                        Category: Sensory additives. Functional group: Flavouring compounds

                        2b920i

                        -

                        L-cysteine hydrochloride monohydrate

                           Additive composition

                        L-cysteine hydrochloride monohydrate

                           Characterisation of the active substance

                        L-cysteine hydrochloride monohydrate
                        Produced by fermentation with Escherichia coli KCCM 80109 and KCCM 80197
                        Purity: ≥ 98,5 % assay
                        Chemical formula: C3H7NO2S•HClH2O
                        CAS number: 7048-04-6.
                        FLAVIS number: 17.032

                           Method of analysis
                            (1)

                        For the identification of L-cysteine hydrochloride monohydrate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Ph.Eur. 6.6-2.2.56-Method 1
                        For the quantification of L-cysteine hydrochloride monohydrate in the feed additive: ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD)
                        For the quantification of L-cysteine hydrochloride monohydrate in premixtures: ion-exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (2)Annex III, F)

                        All animal species

                        -

                        -

                        -

                                    1.

                                    The additive shall be incorporated into the feed in the form of a premixture.

                                    2.

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

                                    3.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg’

                                    4.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. 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, safety glasses and gloves

                        16.12.2030

               (1)  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

               (2)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).


title: Commission Implementing Regulation (EU) 2020/1762 of 25 November 2020 concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S) (Text with EEA relevance)

text:
                  26.11.2020

                  EN

                  Official Journal of the European Union

                  L 397/14

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1762
         of 25 November 2020
         concerning the authorisation of a preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding (holder of authorisation Chr. Hansen A/S)
         (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 Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840. 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 Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 as a feed additive for all poultry species for fattening or reared for laying or reared for breeding to be classified in the category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 20 March 2020 (2) that, under the proposed conditions of use, the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that in the absence of data, no conclusions on the skin/eye irritancy or skin sensitisation of the additive can be made, and due to the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the product has the potential to be efficacious as zootechnical additive in feedingstuffs and water for drinking. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of product should be authorised as specified in the Annex to this Regulation.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, 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, 25 November 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(4):6094.

            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

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                        CFU/l of water for drinking

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1894

                        Chr. Hansen A/S

                           Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

                           Additive composition

                        Preparation of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 containing a minimum of: 3,2 × 109 CFU/g additive (1,6 × 109 CFU B. subtilis DSM 32324/g; 1,0 × 109 CFU B. subtilis DSM 32325/g and 0,6 × 109 CFU B. amyloliquefaciens DSM 25840/g)

                        All poultry species for fattening or reared for laying or reared for breeding

                        —

                        1,6 × 109

                        —

                        5,4 × 108

                        —

                                    1.

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

                                    2.

                                    For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

                                    3.

                                    May be used in feed containing the permitted coccidiostats: diclazuril, decoquinate and halofuginone.

                                    4.

                                    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, glasses and gloves.

                        16.12.2030

                           Characterisation of the active substance

                        Viable spores of cells of Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840

                           Analytical method
                            (1)

                        Enumeration in the feed additive, premixtures, feedingstuffs and water: Spread plate method on tryptone soya agar (EN 15784).
                        Identification: Pulsed Field Gel Electrophoresis (PFGE) method.

               (1)  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