title: Commission Implementing Regulation (EU) 2021/842 of 26 May 2021 amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny (Text with EEA relevance)

text:
                  27.5.2021

                  EN

                  Official Journal of the European Union

                  L 186/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/842
         of 26 May 2021
         amending Implementing Regulation (EU) No 307/2012 as regards transparency and confidentiality requirements for the EU risk assessment of substances under scrutiny
         (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 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (1), and in particular Article 8(6) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1925/2006 harmonises the national rules in Member States on the addition of vitamins and minerals and of certain other substances to foods.

                     (2)

                     Commission Implementing Regulation (EU) No 307/2012 (2) lays down, in particular, implementing rules for the application of the procedure referred to in Article 8(4) and (5) of Regulation (EC) No 1925/2006 concerning the safety assessment by the European Food Safety Authority (‘the Authority’) of the substances under scrutiny listed in Part C of Annex III thereto.

                     (3)

                     Regulation (EU) 2019/1381 of the European Parliament and the Council (3) amended Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Those amendments are aimed at strengthening the transparency and the sustainability of the EU risk assessment in all areas of the food chain where the Authority delivers a scientific risk assessment.

                     (4)

                     The amendments to Regulation (EC) No 178/2002 introduced new provisions concerning, amongst others, general pre-submission advice by the staff of the Authority at the request of a potential applicant and the obligation to notify studies commissioned or carried out by business operators to support an application and the consequences in case of non-compliance with that obligation. The amendments also introduced provisions on the public disclosure, by the Authority, of all scientific data, studies and other information supporting applications, with the exception of duly justified confidential information, early on in the risk assessment process, followed up by a consultation of third parties.

                     (5)

                     Although Regulation (EU) 2019/1381 does not contain any provisions concerning the risk assessment of substances or ingredients, which had been listed to Annex III to Regulation (EC) No 1925/2006, its provisions are of direct relevance to that procedure, as outlined in Article 8(4) and (5) of Regulation (EC) No 1925/2006. These provisions concern the pre-submission phase, as regards pre-submission advice and the notification of commissioned studies, as well as the risk assessment phase, as regards transparency and confidentiality requirements and public consultations. They govern mainly application-based processes initiated by food business operators.

                     (6)

                     Regulation (EC) No 1925/2006 gives an important role in demonstrating the safety of a particular substance under scrutiny listed in Part C of Annex III thereto not only to food business operators, but also to other interested parties, such as industry or consumer organisations. Therefore, the evaluation of a substance under scrutiny does not require the submission of an application by a designated applicant, but all interested business operators and other interested parties may submit data and information to that end.

                     (7)

                     It is necessary to ensure that the procedure for the safety assessment of the substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 is governed by provisions comparable to those in Regulation (EU) 2019/1381 both for the pre-submission and the risk assessment phases.

                     (8)

                     In view of the above, Implementing Regulation (EU) No 307/2012 should be aligned with the amendments to Regulation (EC) No 178/2002 introduced by Regulation (EU) 2019/1381, in particular as regards (i) the possibility, provided for in Article 32a, to request pre-submission advice from the staff of the Authority, whenever the Authority is required or requested to provide an opinion; (ii) the obligation, set out in Article 32b, to notify relevant studies to the Authority; (iii) the obligation of the Authority to consult third parties set out in Article 32c, (iv) the obligations as regards the form of the submissions set out in Article 39f, and (v) the confidentiality rules provided for in Article 39.

                     (9)

                     The provision by the Authority, upon request, of pre-submission advice on the rules applicable to, and the content required for the submission of the files demonstrating the safety of a substance under scrutiny, listed in Part C of Annex III to Regulation (EC) No 1925/2006, can improve the quality of the submissions, and thus provide support to the safety assessment. However, food business operators and any other interested parties may not be able to make full use of the pre-submission advice due to the deadline for the submission of their files. In the interest of the improved quality of the scientific assessment, food business operators and other interested parties should be able to request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2)(b) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance, but acknowledges that scientific uncertainty persists.

                     (10)

                     The studies required to prove the safety of a substance under scrutiny, listed in Part C to Annex III to Regulation (EC) No 1925/2006, take in account a number of factors and therefore may vary significantly. Extending the period for food business operators or interested parties to submit files from 18 to 24 months from the date on which a substance has been listed in Part C of Annex III to Regulation (EC) No 1925/2006 can facilitate the preparation and submission of files, and therefore provide support to the safety assessment.

                     (11)

                     The obligation to notify relevant studies set out in Article 32b of Regulation (EC) No 178/2002 should apply also to food business operators or interested parties who intend to submit for evaluation the file as defined in Article 2 of Implementing Regulation (EU) No 307/2012. A further adaptation to the procedure of Article 32b of Regulation (EC) No 178/2002 is however, required. The procedural consequences provided for by Article 32b of Regulation (EC) No 178/2002 in case of non-compliance with its provisions result in delays in the assessment of the file. However, given the imperative time limit of 4 years prescribed by Article 8(5) of Regulation (EC) No 1925/2006 delays in the evaluation could mean that the prescribed time limit would not be respected. Therefore, those procedural consequences are not appropriate in the context of the evaluation procedure for substances placed in part C of Annex III to Regulation (EC) No 1925/2006 and should not be provided for. In order to allow the Commission to take a decision concerning a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006 within the required deadline, only files submitted within 24 months from the date on which a substance has been listed in that Annex should be taken into consideration.

                     (12)

                     Regulation (EU) 2019/1381 shall apply from 27 March 2021. Therefore, in order to ensure legal certainty and clarity with regard to transparency requirements for procedure under Article 8(4) of Regulation (EC) No 1925/2006 and to allow for uniform implementation of the transparency and confidentiality requirements for the EU risk assessment for all concerned sectors, it is necessary that this Regulation enters into force on the third day following that of its publication. For the reasons of legal certainty this Regulation should apply to the files submitted to the Authority from that date onwards.

                     (13)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendments to Implementing Regulation (EU) No 307/2012
            Implementing Regulation (EU) No 307/2012 is amended as follows:

                        (1)

                        Article 5 is replaced by the following:

                           ‘Article 5
                           Substance listed in Part C of Annex III to Regulation (EC) No 1925/2006

                              1.   Until the adoption of standard data formats pursuant to Article 39f of Regulation (EC) No 178/2002, the Authority shall only consider valid a file, presented in an electronic format, which allows downloading, printing and searching of documents.
                              After the adoption of standard data formats, the file shall be presented in accordance with those standard data formats to be considered valid.
                              Where the Authority considers a file not valid, it shall inform the food business operator or interested party that has submitted the file and the Commission of the reasons why it considers that file not valid.

                              2.   The Authority shall only take into consideration, for the purposes of the decision referred to in Article 8(5) of Regulation (EC) No 1925/2006, files submitted within 24 months from the entry into force of a decision listing a substance in Part C of Annex III to that Regulation, pursuant to Article 8(2) thereof.’;

                        (2)

                        the following Articles are inserted:

                           ‘Article 5a
                           Pre-submission advice
                           At the request of a food business operator or any other interested party, the staff of the Authority shall provide advice on the rules applicable to, and the content required for, the submission of a file containing the scientific data aiming to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006.
                           Food business operators and other interested parties may request pre-submission advice for a potential submission from the day of the adoption of an opinion by the Authority under Article 8(2) of Regulation (EC) No 1925/2006, which identifies the possibility of harmful effects on health associated with the intake of a substance.
                           Such pre-submission advice shall be provided in accordance with Article 32a of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.

                           Article 5b
                           Notification of studies

                              1.   Food business operators and other interested parties shall notify to the Authority, without delay, the title, the scope, and the starting and planned completion dates of any study commissioned or carried out by them to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, as well as the laboratory or testing facility located in the Union carrying out that study.

                              2.   Laboratories and other testing facilities located in the Union shall also, without delay, notify the Authority of the title and the scope of any study commissioned by food business operators and other interested parties, carried out by such laboratories or other testing facilities to demonstrate the safety of a substance listed in Part C of Annex III to Regulation (EC) No 1925/2006, its starting and planned completion dates, as well as the name of the food business operator or interested party who has commissioned that study.

                              3.   Studies notified in accordance with this article shall be included by the Authority in the database referred to in Article 32b(1) of Regulation (EC) No 178/2002.

                           Article 5c
                           Transparency
                           Where the Authority is to deliver an opinion on a substance under scrutiny listed in Part C of Annex III to Regulation (EC) No 1925/2006, on the basis of a valid file, it shall:

                                       (a)

                                       make public the data submitted in that file in accordance with Article 38(1)(c) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis;

                                       (b)

                                       consult stakeholders and the public, pursuant to Article 32c(2) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis, on the basis of the non-confidential version of the data submitted in accordance with this Regulation.

                           Article 5d
                           Confidentiality
                           Upon the submission of a file, the food business operator or other interested party may request the treatment as confidential of certain parts of the information or data submitted.
                           Such a confidentiality request shall be accompanied by a verifiable justification that demonstrates that the disclosure of such information or data significantly harms the interests of the requestor, within the meaning of Article 39(2) and (3) of Regulation (EC) No 178/2002, which shall apply mutatis mutandis.’

            Article 2
            Entry into force and application
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply to the files submitted to the Authority from that date.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 May 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 404, 30.12.2006, p. 26.

            (2)  Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods (OJ L 102, 12.4.2012, p. 2).

            (3)  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).

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


title: Commission Implementing Regulation (EU) 2021/843 of 26 May 2021 renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

text:
                  27.5.2021

                  EN

                  Official Journal of the European Union

                  L 186/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/843
         of 26 May 2021
         renewing the approval of the active substance cyazofamid, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2003/23/EC (2) included cyazofamid as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

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

                     (3)

                     The approval of the active substance cyazofamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021.

                     (4)

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

                     (5)

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

                     (6)

                     The rapporteur Member State prepared a draft renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 23 June 2015.

                     (7)

                     The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

                     (8)

                     On 23 May 2016, the Authority communicated to the Commission its conclusion (6) on whether cyazofamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. Following a mandate from the Commission due to uncertainties related to non-target arthropods, the Authority updated its conclusion on 28 July 2020 (7). The Commission presented a renewal report regarding cyazofamid to the Standing Committee on Plants, Animals, Food and Feed on 3 December 2020 and a draft Regulation on 26 January 2021.

                     (9)

                     As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (8), the conclusion of the Authority indicates that, based on the scientific evidence, it is highly unlikely that cyazofamid is an endocrine disrupter via the estrogenic, androgenic, thyroidogenic or steroidogenic modalities. Based on the available data and current knowledge summarised in the conclusion of the Authority no adverse effects that could be related to an endocrine disruptor mode of action were observed. Therefore, the Commission concludes that cyazofamid is not to be considered as having endocrine disrupting properties.

                     (10)

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

                     (11)

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

                     (12)

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

                     (13)

                     It is therefore appropriate to renew the approval of cyazofamid.

                     (14)

                     In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions. It is, in particular, appropriate to require further confirmatory information.

                     (15)

                     In order to increase the confidence in the conclusion that cyazofamid does not have endocrine disrupting properties, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, and in accordance with the guidance for the identification of endocrine disruptors (9).

                     (16)

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

                     (17)

                     Commission Implementing Regulation (EU) 2020/869 (10) extended the approval period of cyazofamid to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. As the date of entry into force of this Regulation would be close to the date of expiry of the approval of cyazofamid this Regulation should apply from the day after the date of expiry of the approval of cyazofamid.

                     (18)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Renewal of the approval of the active substance
            The approval of the active substance cyazofamid, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.

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

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 May 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Directive 2003/23/EC of 25 March 2003 amending Council Directive 91/414/EEC to include imazamox, oxasulfuron, ethoxysulfuron, foramsulfuron, oxadiargyl and cyazofamid as active substances (OJ L 81, 28.3.2003, p. 39).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

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

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

            (6)  EFSA Journal 2016;14(6):4503 [24 pp.]. Available online:www.efsa.europa.eu

            (7)  Updated peer review of the pesticide risk assessment of the active substance cyazofamid; EFSA Journal 2020;18(9):6232.

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

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

            (10)  Commission Implementing Regulation (EU) 2020/869 of 24 June 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (OJ L 201, 25.6.2020, p. 7).

            ANNEX I

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity  (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                        Cyazofamid
                        CAS No: 120116-88-3
                        CIPAC No: 653

                        4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

                        ≥ 935 g/kg

                        1.8.2021

                        31.7.2036

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

                                    (a)

                                    the specification of the technical material as commercially manufactured;

                                    (b)

                                    the impact of processing on the consumer risk assessment;

                                    (c)

                                    the protection of non-target arthropods and earthworms.

                              The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    1.

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

                                    2.

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

                              The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
                        As regards point 2, the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023.

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

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

                        (1)

                        in Part A, entry 46 on cyazofamid is deleted;

                        (2)

                        in Part B, the following entry is added:

                                       No

                                       Common Name, Identification Numbers

                                       IUPAC Name

                                       Purity  (1)

                                       Date of approval

                                       Expiration of approval

                                       Specific provisions

                                    ‘146

                                    Cyazofamid
                                    CAS No: 120116-88-3
                                    CIPAC No: 653

                                    4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide

                                    ≥ 935 g/kg

                                    01/08/2021

                                    31/07/2036

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

                                                (a)

                                                the specification of the technical material as commercially manufactured;

                                                (b)

                                                the impact of processing on the consumer risk assessment;

                                                (c)

                                                the protection of non-target arthropods and earthworms.

                                          The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                                1.

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

                                                2.

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

                                          The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
                                    As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023’

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


title: Council Implementing Regulation (EU) 2021/848 of 27 May 2021 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria

text:
                  28.5.2021

                  EN

                  Official Journal of the European Union

                  L 188/18

         COUNCIL IMPLEMENTING REGULATION (EU) 2021/848
         of 27 May 2021
         implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011 (1), and in particular Article 32 thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 18 January 2012 the Council adopted Regulation (EU) No 36/2012.

                     (2)

                     On the basis of a review of the measures set out in Regulation (EU) No 36/2012, the entries for 25 natural persons and three entities in the list of natural and legal persons, entities or bodies set out in Annex II to Regulation (EU) No 36/2012 should be updated.

                     (3)

                     The entries for five deceased individuals should be deleted from the list of natural and legal persons, entities or bodies set out in Annex II to Regulation (EU) No 36/2012.

                     (4)

                     Annex II to Regulation (EU) No 36/2012 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex II to Regulation (EU) No 36/2012 is amended as set out in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 May 2021.

                  For the Council

                  The President

               P. SIZA VIEIRA

            (1)  OJ L 16, 19.1.2012, p. 1.

            ANNEX
            Annex II to Regulation (EU) No 36/2012 is amended as follows:

                        (1)

                        in Section A (Persons), the following entries are deleted:

                                    115.

                                    General Ali Habib MAHMOUD;

                                    153.

                                    Waleed AL MO'ALLEM;

                                    180.

                                    Ahmad AL-QADRI;

                                    274.

                                    Nader QALEI;

                                    281.

                                    Mohammad Maen Zein Jazba AL-ABIDIN;

                        (2)

                        in Section A (Persons), the following entries replace the corresponding entries in the list:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘14.

                                    Brigadier General Mohammed BILAL
                                    (a.k.a. Lieutenant Colonel Muhammad Bilal)

                                    Gender: male

                                    As a senior officer in the Syrian Air Force Intelligence Service, he supports the Syrian regime and is responsible for the violent repression of the civilian population. He is also associated with the listed Scientific Studies Research Centre (SSRC).

                                    21.10.2014

                                    22.

                                    Ihab MAKHLOUF
                                    (a.k.a. Ehab, Iehab)
                                    (ايهاب مخلوف)

                                    Date of birth: 21.1.1973;
                                    Place of birth: Damascus, Syria;
                                    Passport no: N002848852;
                                    Gender: male

                                    Leading businessman operating in Syria. He has business interests in several Syrian companies and entities, including Ramak Construction Co and Syrian International Private University for Science and Technology (SIUST).
                                    He is an influential member of the Makhlouf family and closely connected to the Assad family; cousin of President Bashar al-Assad. In 2020, Ehab Makhlouf took over Rami Makhlouf’s business activities and the Syrian government granted him the contracts to operate and manage the duty-free markets across the country.

                                    23.5.2011

                                    48.

                                    Samir HASSAN
                                    (سمير حسن)

                                    Gender: male

                                    Leading businessperson operating in Syria, with interests and/or activities in multiple sectors of Syria’s economy. He holds interests in and/or has significant influence in the Amir Group and Cham Holding, two conglomerates with interests in the real estate, tourism, transport and finance sectors. President of the Syrian-Russian business council.
                                    Samir Hassan supports the Syrian regime’s war effort with cash donations.
                                    Samir Hassan is associated with persons benefitting from or supporting the regime. In particular, he is associated with Rami Makhlouf and Issam Anbouba, who have been designated by the Council and benefit from the Syrian regime.

                                    27.9.2014

                                    61.

                                    George CHAOUI
                                    (جورج شاوي)

                                    Gender: male

                                    Member of the Syrian electronic army (territorial army intelligence service). Involved in the violent crackdown and call for violence against the civilian population across Syria.

                                    14.11.2011

                                    78.

                                    Ali BARAKAT
                                    (a.k.a. Barakat Ali Barakat)
                                    ( علي بركات; بركات علي بركات)

                                    Gender: male

                                    Military official involved in the violence in Homs. Currently serves in the 30th Mobile Infantry Division of the Republican Guard.

                                    1.12.2011

                                    96.

                                    Brigadier General Jamal YUNES
                                    (a.k.a. Younes)
                                    (جمال يونس)

                                    Position: Commander of the 555th Regiment;
                                    Gender: male

                                    Gave orders to troops to shoot at protestors in Mo'adamiyeh.
                                    Head of the Military Security Committee in Hama in 2018.

                                    23.1.2012

                                    114.

                                    Emad Abdul-Ghani SABOUNI
                                    (a.k.a. Imad Abdul Ghani Al Sabuni)
                                    (عماد عبدالغني صابوني)

                                    Date of birth: 1964;
                                    Place of birth: Damascus, Syria;
                                    Gender: male

                                    Former Minister of Telecommunications and Technology, in office until at least April 2014. As a former Government Minister, shares responsibility for the Syrian regime’s violent repression of the civilian population. Appointed in July 2016 as the Head of Planning and International Cooperation Agency (PICC). The PICC is a government agency, affiliated to the Prime Ministry and produces, in particular, the five-year plans that provide the broad guidelines for the Government’s economic and development policies.

                                    27.2.2012

                                    117.

                                    Adnan Hassan MAHMOUD
                                    (عدنان حسن محمود)

                                    Date of birth: 1966;
                                    Place of birth: Tartous, Syria;
                                    Gender: male

                                    Former Syrian Ambassador to Iran until 2020. Former Minister of Information in power after May 2011. As a former Government Minister, shares responsibility for the Syrian regime’s violent repression of the civilian population.

                                    23.9.2011

                                    132.

                                    Brigadier General Abdul-Salam Fajr MAHMOUD
                                    (عبدالسلام فجر محمود)

                                    Date of birth: 1959
                                    Gender: male

                                    Head of the Security Committee of the Southern Region since December 2020. Former Head of the Bab Tuma (Damascus) Branch of the Syrian Air Force Intelligence Service. Former Head of the Mezze Airport Air Force intelligence investigation branch. Responsible for the torture of opponents in custody. Under international arrest warrant for “complicity in acts of torture”, “complicity in crimes against humanity” and “complicity in war crimes”.

                                    24.7.2012

                                    134.

                                    Colonel Qusay Ibrahim MIHOUB
                                    (قصي إبراهيم ميهوب )

                                    Date of birth: 1961;
                                    Place of birth: Derghamo, Jableh, Lattakia, Syria;
                                    Gender: male

                                    High-ranking officer at the Syrian Air Force Intelligence Service. Former Head of the Deraa branch of the air force’s intelligence service (sent from Damascus to Deraa at the start of demonstrations there). Responsible for the torture of opponents in custody as well as the violent repression of peaceful protests in the southern region.

                                    24.7.2012

                                    137.

                                    Brigadier General Ibrahim MA'ALA
                                    (a.k.a. Maala, Maale, Ma'la)
                                    ( معلى;معلا (ابراهيم

                                    Gender: male

                                    Head of Branch 285 (Damascus) of the General Intelligence Directorate (replaced Brigadier General Hussam Fendi at the end of 2011). Responsible for the torture of opponents in custody.

                                    24.7.2012

                                    139.

                                    Major General Hussam LUQA
                                    (a.k.a. Husam, Housam, Houssam; Louqa, Louca, Louka, Luka)
                                    (حسام لوقا)

                                    Date of birth: 1964;
                                    Place of birth: Damascus, Syria;
                                    Gender: male

                                    Former Head of the Security Committee of the Southern Region from 2018 to 2020. Former Head of the General Security Directorate. Major General. From April 2012 to 2.12.2018, was head of the Homs branch of the Political Security Directorate (succeeded Brigadier General Nasr al-Ali). Since 3.12.2018, head of the Political Security Directorate. Responsible for the torture of opponents in custody.

                                    24.7.2012

                                    140.

                                    Brigadier General Taha TAHA
                                    (طه طه)

                                    Gender: male

                                    Deputy assistant to the Head of the Political Security Division. Former site manager of the Latakia branch of the Political Security Directorate. Responsible for the torture of opponents in custody.

                                    24.7.2012

                                    144.

                                    Major General Ahmed AL-JARROUCHEH (a.k.a. Ahmad; al-Jarousha, al-Jarousheh, al-Jaroucha, al-Jarouchah, al-Jaroucheh)
                                    (احمد الجروشة)

                                    Date of birth: 1957;
                                    Gender: male

                                    Former head of the foreign branch of General Intelligence (Branch 279). As such, responsible for General Intelligence arrangements in Syrian embassies.

                                    24.7.2012

                                    146.

                                    General Ghassan Jaoudat ISMAIL
                                    (a.k.a. Ismael)
                                    (غسان جودت اسماعيل)

                                    Date of birth: 1960;
                                    Place of birth: Junaynat Ruslan – Darkoush, Tartous region, Syria;
                                    Gender: male

                                    Head of the Syrian Air Force Intelligence Service since 2019. Former deputy director of the Air Force Intelligence Service and previously in charge of the missions branch of the Air Force Intelligence Service which, in cooperation with the special operations branch, manages the elite troops of the Air Force Intelligence Service, who play an important role in the repression conducted by the Syrian regime. As such, Ghassan Jaoudat Ismail is one of the top military leaders directly implementing the violent repression of opponents conducted by the Syrian regime as well as practices of disappearance of civilians.

                                    24.7.2012

                                    147.

                                    Major General Amer AL-ACHI
                                    (a.k.a. Amer Ibrahim al-Achi; Amis al Ashi; Ammar Aachi; Amer Ashi)
                                    (عامر ابراهيم العشي)

                                    Gender: male

                                    Former Governor of the Sweida Governorate, appointed by President Bashar al-Assad in July 2016. Former Head of the intelligence branch of the Syrian Air Force Intelligence Service (2012-2016). Through his role in the Air Force Intelligence Service, Amer al-Achi is implicated in the repression of the Syrian opposition.

                                    24.7.2012

                                    156.

                                    Hala Mohammad
                                    (a.k.a. Mohamed, Muhammad, Mohammed) AL NASSER
                                    (هاله محمد الناصر)

                                    Date of birth: 1964;
                                    Place of birth: Raqqa, Syria;
                                    Gender: female

                                    Former Minister of Tourism. As a former Government Minister, shares responsibility for the Syrian regime’s violent repression of the civilian population.

                                    16.10.2012

                                    172.

                                    Ali HADAR (a.k.a. HAIDAR)

                                    Date of birth: 1962;
                                    Gender: male

                                    Head of the National Reconciliation Agency and former State Minister for National Reconciliation Affairs. Chair of the Intifada wing of the Syrian Social Nationalist Party. As a former Government Minister, shares responsibility for the Syrian regime’s violent repression of the civilian population.

                                    16.10.2012

                                    204.

                                    Emad HAMSHO
                                    (a.k.a. Imad Hmisho; Hamchu; Hamcho; Hamisho; Hmeisho; Hemasho, حميشو)
                                    (حمشو عماد)

                                    Address: Hamsho Building 31 Baghdad Street, Damascus, Syria;
                                    Gender: male

                                    Occupies a senior management position in Hamsho Trading. As a result of his senior position in Hamsho Trading, a subsidiary of Hamsho International, which has been designated by the Council, he provides support to the Syrian regime. He is also associated with a designated entity, Hamsho International. He is also vice-president of the Syrian Council of Iron and Steel alongside designated regime businessmen such as Ayman Jaber. He is also an associate of President Bashar al-Assad.

                                    7.3.2015

                                    241.

                                    Salam Mohammad AL-SAFFAF

                                    Date of birth: 1979;
                                    Gender: female

                                    Administrative Development Minister. Appointed in March 2017.

                                    30.5.2017

                                    265.

                                    Mohamad Amer MARDINI
                                    (a.k.a. Mohammad Amer Mardini, Mohamed Amer MARDINI, Mohamad Amer AL-MARDINI, Mohamed Amer AL-MARDINI, Mohammad Amer AL-MARDINI)

                                    Date of birth: 1959;
                                    Place of birth: Damascus, Syria;
                                    Gender: male

                                    Former Minister of Higher Education in power after May 2011 (appointed 27.8.2014). As a former Government Minister, shares responsibility for the Syrian regime’s violent repression of the civilian population.

                                    21.10.2014

                                    268.

                                    Ghassan Ahmed GHANNAM
                                    (a.k.a. Major General Ghassan Ghannan, Brigadier General Ghassan Ahmad Ghanem)

                                    Rank: Major General;
                                    Position: Commander of the 155th Missile Brigade;
                                    Gender: male

                                    Member of the Syrian Armed Forces of the rank of Colonel and the equivalent or higher in post after May 2011. Major General and Commander of the 155th Missile Brigade. Associated with Maher al-Assad through his role in the 155th Missile Brigade. As Commander of the 155th Missile Brigade, he is supporting the Syrian regime and he is responsible for the violent repression of the civilian population. Responsible for firing scud missiles at various civilian sites between January and March 2013.

                                    21.10.2014

                                    285.

                                    Samer FOZ
                                    (a.k.a. Samir Foz/Fawz; Samer Zuhair Foz; Samer Foz bin Zuhair)
                                    (سامر فوز)

                                    Date of birth: 20 May 1973;
                                    Place of birth: Homs, Syria / Latakia, Syria;
                                    Nationalities: Syrian, Turkish;
                                    Turkish passport number: U 09471711 (place of issue: Turkey; expiry date: 21.7.2024);
                                    Syrian national number: 06010274705
                                    Address: Platinum Tower, office no. 2405, Jumeirah Lake Towers, Dubai, UAE
                                    Position: CEO of Aman Group;
                                    Gender: male

                                    Leading businessperson operating in Syria, with interests and activities in multiple sectors of Syria’s economy, including a regime-backed joint venture involved in the development of Marota City, a luxury residential and commercial development. Samer Foz provides financial and other support to the Syrian regime, including funding the Military Security Shield Forces in Syria and brokering grain deals. He also benefits financially from access to commercial opportunities through the wheat trade and reconstruction projects as a result of his links to the regime.

                                    21.1.2019

                                    Other information:
                                    Executive President of Aman Group. Subsidiaries: Foz for Trading, Al-Mohaimen for Transportation & Contracting. Aman Group is the private sector partner in joint venture Aman Damascus JSC with Damascus Cham Holding, in which Foz is an individual shareholder. Emmar Industries is a joint venture between Aman Group and the Hamisho Group, in which Foz has the majority stake and is the Chairman.

                                    291.

                                    Amer FOZ
                                    (a.k.a. Amer Zuhair Fawz)
                                    (عامر فوز)

                                    Date of birth: 11.3.1976;
                                    Nationality: Syrian; Saint Kitts and Nevis;
                                    National no: 06010274747;
                                    Passport no: 002-14-L169340
                                    UAE resident card: 784-1976-7135283-5

                                    Leading businessperson with personal and family business interests and activities in multiple sectors of the Syrian economy. He benefits financially from access to commercial opportunities and supports the Syrian regime. Between 2012 and 2019, he was General Manager of ASM International Trading LLC.
                                    He is also associated with his brother Samer Foz, who has been designated by the Council since January 2019 as a leading businessperson operating in Syria and for supporting or benefiting from the regime. Together with his brother, he implements a number of commercial projects, notably in the Adra al-Ummaliyya area (Damascus suburbs). These projects include a factory that manufactures cables and cable accessories as well as a project to produce electricity using solar power. They also engaged in various activities with ISIL (Da'esh) on behalf of the Assad regime, including the provision of weapons and ammunitions in exchange for wheat and oil.

                                    17.2.2020

                                    Position: Founder of District 6 Company; Founding partner of Easy life Company;
                                    Relatives/business associates/entities or partners/links: Samer Foz; Vice Chairman of Asas Steel Company; Aman Holding;
                                    Gender: male

                                    295.

                                    Adel Anwar AL-OLABI
                                    (a.k.a. Adel Anouar el-Oulabi, Adil Anwar al-Olabi)
                                    (عادل أنور العلبي)

                                    Date of birth: 1976;
                                    Nationality: Syrian;
                                    Position: Chairman of Damascus Cham Holding Company (DCHC); Governor of Damascus;
                                    Gender: male

                                    Leading businessperson benefiting from and supporting the Syrian regime. Chairman of Damascus Cham Holding Company (DCHC), the investment arm of the Governorate of Damascus managing the properties of the Governorate of Damascus and implementing the Marota City project.
                                    Adel Anwar al-Olabi is also the Governor of Damascus, appointed by President Bashar al-Assad in November 2018. As Governor of Damascus and Chair of DCHC, he is responsible for efforts to implement regime policies of developing expropriated land in Damascus (including Decree No 66 and Law No 10), most notably through the Marota City project.

                                    17.2.2020’

                        (3)

                        in Section B (Entities), the following entries replace the corresponding entries in the list:

                                    Name

                                    Identifying information

                                    Reasons

                                    Date of listing

                                    ‘1.

                                    Bena Properties

                                    Cham Holding Building, Daraa Highway, Ashrafiyat Sahnaya Rif Dimashq, Syria, P.O.Box 9525

                                    Controlled by Rami Makhlouf. Syria’s largest real estate company and the real estate and investment arm of Cham Holding; provides funding to the Syrian regime.

                                    23.6.2011

                                    77.

                                    Al Qatarji Company
                                    (a.k.a. Qatarji International Group; Al-Sham and Al-Darwish Company; Qatirji/Khatirji/Katarji/Katerji Group)
                                    (مجموعة/شركة قاطرجي)

                                    Type of entity: private company;
                                    Business sector: import/export; trucking; supply of oil and commodities;
                                    Name of Director/Management: Hussam al-Qatirji, CEO (designated by the Council);

                                    Prominent company operating across multiple sectors of the Syrian economy. By facilitating fuel, arms and ammunition trade between the regime and various actors including ISIL (Da'esh) under the pretext of importing and exporting food items, supporting militias fighting alongside the regime and taking advantage of its ties with the regime to expand its commercial activity, Al Qatarji Company – whose board is headed by designated person Hussam al-Qatirji, a member of the Syrian People’s Assembly – supports and benefits from the Syrian regime.

                                    17.2.2020

                                    Ultimate beneficial owner: Hussam al-Qatirji (designated by the Council);
                                    Registered address: Mazzah, Damascus, Syria;
                                    Relatives/business associates/entities or partners/links: Arvada/Arfada Petroleum Company JSC

                                    78.

                                    Damascus Cham Holding Company
                                    (a.k.a. Damascus Cham Private Joint Stock Company)
                                    (القابضة الشام دمشق)

                                    Type of entity: public-owned company under private law;
                                    Business sector: real estate development;
                                    Name of Director/Management: Adel Anwar al-Olabi, Chairman of the Board of Directors and Governor of Damascus (designated by the Council);
                                    Ultimate beneficial owner: Governorate of Damascus;

                                    Damascus Cham Holding Company was established by the regime as the investment arm of the Governorate of Damascus in order to manage the properties of the Governorate of Damascus and implement the Marota City project, a luxurious real estate project based on expropriated land under Decree No 66 and Law No 10 in particular.
                                    By managing the implementation of Marota City, Damascus Cham Holding (whose Chairman is the Governor of Damascus) supports and benefits from the Syrian regime and provides benefits to businesspeople with close ties to the regime who have struck lucrative deals with this entity through public-private partnerships.

                                    17.2.2020’

                                    Relatives/business associates/entities or partners/links: Rami Makhlouf (designated by the Council); Samer Foz (designated by the Council); Mazen Tarazi (designated by the Council); Talas Group, owned by businessman Anas Talas (designated by the Council);
                                    Khaled al-Zubaidi (designated by the Council); Nader Qalei (designated by the Council)