title: Commission Implementing Regulation (EU) 2020/24 of 13 January 2020 authorising an extension of use of chia seeds (Salvia hispanica) as a novel food and the change of the conditions of use and the specific labelling requirements of chia seeds (Salvia hispanica) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  14.1.2020

                  EN

                  Official Journal of the European Union

                  L 8/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/24
         of 13 January 2020
         authorising an extension of use of chia seeds (Salvia hispanica) as a novel food and the change of the conditions of use and the specific labelling requirements of chia seeds (Salvia hispanica) under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to submit a draft implementing act authorising placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     Commission Decision 2009/827/EC (3) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market in the Union of chia seeds (Salvia hispanica) as a novel food to be used in bread products.

                     (5)

                     Commission Implementing Decision 2013/50/EU (4) authorised, in accordance with Regulation (EC) No 258/97, an extension of use of chia seeds (Salvia hispanica) as a novel food to be used in additional food categories as follows: baked products; breakfast cereals; fruit, nut and seed mixes, and pre-packed chia seeds as such.

                     (6)

                     On 18 September 2015, an authorisation letter was issued by the competent authority of Ireland (5), in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (6), for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food categories, namely, in fruit juice and fruit/vegetable blend beverages.

                     (7)

                     On 17 October 2017, an authorisation letter was issued by the competent authority of Austria (7), in accordance with Regulation (EC) No 258/97, for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food category, namely, fruit spreads.

                     (8)

                     On 02 November 2017, an authorisation letter was issued by the competent authority of Spain (8), in accordance with Regulation (EC) No 258/97, for an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food categories, namely, sterilised ready meals based on cereal grains, pseudocereal grains and/or pulses.

                     (9)

                     Commission Implementing Decision (EU) 2017/2354 (9) authorised, in accordance with Regulation (EC) No 258/97, an extension of use of the novel food chia seeds (Salvia hispanica) to be used in additional food category, namely, in yoghurt.

                     (10)

                     On 13 April 2017, the company Zentis GmbH & Co. KG submitted a request in accordance with Article 4 of Regulation (EC) No 258/97 to the competent authority of Germany to change the conditions of use of the novel food chia seeds (Salvia hispanica). The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, fruit desserts, mixed fruits with coconut milk for a twin pot, fruit-preparations to underlay dairy products and fruit-preparations to be mixed with dairy products, and to increase maximum use level of chia seeds (Salvia hispanica) in an already authorised food category, namely fruit spreads.

                     (11)

                     On 12 September 2017, the company Sanchis Mira S.A. submitted a request in accordance with Article 4 of Regulation (EC) No 258/97 to the competent authority of Spain for an extension of use of the novel food chia seeds (Salvia hispanica) in chocolate. On 25 September 2017, the competent authority of Spain issued its initial assessment report. In that report, it came to the conclusion that the extension of use and proposed maximum use level of chia seeds (Salvia hispanica) meet the criteria for novel foods set out in Article 3(1) of Regulation (EC) No 258/97.

                     (12)

                     On 17 October 2017, the Commission forwarded the initial assessment report to the other Member States. One Member State raised objections, questioning the overall safety of the novel food in light of the 2009 European Food Safety Authority (‘the Authority’) NDA Panel assessment (10) as a result of the increasing dietary intake of chia seeds (Salvia hispanica) from the growing number of authorised uses. The objecting Member State underlined that while individual uses, including the proposed use in chocolate at 3 %, may be safe, there is a need to assess the overall dietary intake from all authorised uses since 2009 including the current request for the extension of use and if necessary, revise the 2009 NDA Panel safety assessment.

                     (13)

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

                     (14)

                     While the requests for an extension of use of chia seeds (Salvia hispanica) were submitted to the Member States in accordance with Article 4 of Regulation (EC) No 258/97, the applications also meet the requirements laid down in Regulation (EU) 2015/2283.

                     (15)

                     On 2 February 2018, the company Parry’s Pots Limited (PPL) submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to increase maximum use level of chia seeds (Salvia hispanica) in an already authorised food category, namely fruit spreads.

                     (16)

                     On 12 June 2018, the company Naturkost Übelhör GmbH & Co. KG submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, chocolate and chocolate products.

                     (17)

                     On 15 June 2018, the company Majami Sp.zo.o.Sp.k. submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food category, namely, confectionery.

                     (18)

                     On 16 July 2018, the company The Chia Co submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories as follows: confectionery, excluding chewing gums; dairy products and analogues; edible ices; fruit and vegetable products; cereal and cereal products; bakery wares; herbs, spices, seasonings, soups and broths, sauces, salads and savoury based sandwich spreads and protein products; total diet replacement foods for weight control; foods bearing statements on the absence or reduced presence of gluten; non-alcoholic beverages; ready-to-eat savouries and snacks; and desserts.

                     (19)

                     On 3 August 2018, the company Materne SAS submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food categories, namely, compotes from fruit and/or vegetables and/or with cereals.

                     (20)

                     On 9 January 2019, the company RFH Produktion AB submitted a request to the Commission to change the conditions of use of the novel food chia seeds (Salvia hispanica) within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The application requested to extend the use of chia seeds (Salvia hispanica) in additional food category, namely, puddings.

                     (21)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283 and in the light of the growing number of requests for the authorisation of a number of extended uses of chia seeds (Salvia hispanica), the new authorised uses in recent years, and the resulting potential increase in the dietary intake of chia seeds (Salvia hispanica), the Commission consulted the Authority on 16 July 2018, asking it to carry out an assessment on the overall dietary exposure for all the potential extensions of use of chia seeds (Salvia hispanica) as a novel food.

                     (22)

                     On 14 March 2019, the Authority adopted the scientific opinion ‘Safety of chia seeds (Salvia hispanica L.) as a novel food for extended uses pursuant to Regulation (EU) 2015/2283’ (11). That opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (23)

                     In that opinion the Authority concluded, in reply to the Commission’s request for a general assessment of the safety without restrictions or precautions regarding the use levels, that the use of chia seeds (Salvia hispanica) in foods which do not require heat treatment at or above 120 °C in their manufacture, processing or preparation, including chocolate, fruit spreads, fruit desserts, mixed fruit with coconut milk in twin pot, fruit-preparations to underlay dairy products, fruit-preparations to be mixed with dairy products, confectionery (excluding chewing gums), dairy products and analogues, edible ices, fruit and vegetables products, non-alcoholic beverages and compotes from fruit and/or vegetables and/or with cereals, are safe without any specific restrictions and precautions regarding their use levels. Therefore, that scientific opinion gives sufficient grounds to establish that the above-mentioned uses of chia seeds (Salvia hispanica) comply with the requirements of Article 12(1) of Regulation (EU) 2015/2283. It is therefore appropriate that the conditions of use of chia seeds (Salvia hispanica) as listed in the Union list of authorised novel foods are amended by including all of the above food categories and to remove the setting of maximum levels and the corresponding specific labelling requirement relating to the maximum daily intake. In addition, although the use of chia seeds (Salvia hispanica) in puddings was not explicitly included in the assessment of the Authority, the opinion gives sufficient grounds to also authorise the extension of use of chia seeds (Salvia hispanica) to puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation. Puddings are to be understood as a subcategory of products commonly known as desserts, which are usually flavoured and sweet in taste.

                     (24)

                     In the same opinion, the Authority considered one study, retrieved by the Authority itself from the publicly available scientific literature, and which was not part of the evidence submitted by applicants in support of the proposed extensions of use of chia seeds (Salvia hispanica), which pointed to the possible formation of acrylamide when chia seeds (Salvia hispanica) are used in foods which require heat treatment at or above 120 °C in their manufacture, processing or preparation.

                     (25)

                     In that opinion, the Authority considered that additional information is needed from applicants and/or from the public domain, to address the potential for acrylamide formation when foods containing chia seeds (Salvia hispanica) undergo heat treatment at or above 120 °C. In accordance with Article 11(4) of Regulation (EU) 2015/2283 the Authority has requested additional information from the relevant applicant relating to potential formation of process contaminants which may be formed during processing and production of a food (at the level of the manufacturer) and/or when a food with added chia seeds (Salvia hispanica) is subjected to cooking (heat treatment at consumer level). The period set established for the provision of the additional information ends in March 2020. In the absence of such information in the submitted applications, the Authority deferred the evaluation of those extensions of use of chia seeds (Salvia hispanica) in foods which require heat treatment at or above 120 °C in their manufacture, processing or preparation (bakery wares, cereal and cereal products, herbs, spices, seasonings, soups and broths, sauces, salads and savoury based sandwich spreads and protein products, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (12), foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014 (13), ready to eat savouries and snacks and desserts) to when the additional information becomes available. It follows, that the Commission, at this stage, does not dispose of the opinion of the Authority necessary pursuant to Article 12(1)(a) and (c) of Regulation (EU) 2015/2283 for the approval of the extension of uses involving the treatment of chia seeds (Salvia hispanica) at or above 120 °C. Therefore, a further decision about such uses will be taken after the publication of the relevant opinion of the Authority.

                     (26)

                     The opinion of the Authority also identified two case reports from the available scientific literature which linked the consumption of chia seeds (Salvia hispanica) to allergic reactions and concluded on the basis of this evidence that allergic reactions upon consumption of chia seeds (Salvia hispanica) may occur. Considering that, to date, only those two allergic cases have been reported, in light of the widespread consumption of chia seeds (Salvia hispanica) and their presence on the Union and global market for many years, the Commission considers that no specific labelling requirements concerning potential allergic reactions upon consumption of chia seeds (Salvia hispanica) should be included in the Union list of authorised novel foods, until further scientific evidence on the allergenic potential of chia seeds (Salvia hispanica) is obtained and assessed by the Authority.

                     (27)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and included in Implementing Regulation (EU) 2017/2470, referring to the novel food chia seeds (Salvia hispanica) is amended as specified in the Annex to this Regulation.

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

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 13 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  Commission Decision 2009/827/EC of 13 October 2009 authorising the placing on the market of Chia seed (Salvia hispanica) as novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 294, 11.11.2009, p. 14).

            (4)  Commission Implementing Decision 2013/50/EU of 22 January 2013 authorising an extension of use of Chia (Salvia hispanica) seed as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 21, 24.1.2013, p. 34).

            (5)  Letter of 18 September 2015 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2015_auth-letter_chia-seeds-2_en.pdf).

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

            (7)  Letter of 17 October 2017 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2017_auth-letter_chia-seeds_en.pdf).

            (8)  Letter of 2 November 2017 (https://ec.europa.eu/food/sites/food/files/safety/docs/novel-food_authorisation_2017_auth-letter_chia-seeds-ext-steri_en.pdf).

            (9)  Commission Implementing Decision (EU) 2017/2354 of 14 December 2017 authorising an extension of use of Chia seeds (Salvia hispanica) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 336, 16.12.2017, p. 49).

            (10)  EFSA Journal 2009;7(4):996.

            (11)  EFSA Journal 2019;17(4):5657.

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

            (13)  Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food (OJ L 228, 31.7.2014, p. 5).

            ANNEX
            The entry for ‘Chia seeds (Salvia hispanica)’ in Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470 is replaced by the following:

                        Authorised novel food

                        Conditions under which the novel food may be used

                        Additional specific labelling requirements

                        Other requirements

                        ‘Chia seeds (Salvia hispanica)

                           Specified food category

                           Maximum levels

                        The designation of the novel food on the labelling of the foodstuffs containing it shall be “Chia seeds (Salvia hispanica)”’

                        Bread products

                        5 % (whole or ground chia seeds)

                        Baked products

                        10 % whole chia seeds

                        Breakfast cereals

                        10 % whole chia seeds

                        Sterilised ready to eat meals based on cereal grains, pseudocereals grains and/or pulses

                        5 % whole chia seeds

                        Fruit, nut and seed mixes

                        Pre-packaged Chia seed as such

                        Confectionery (including chocolate and chocolate products), excluding chewing gums

                        Dairy products (including yoghurt) and analogues

                        Edible ices

                        Fruit and vegetables products (including fruit spreads, compotes with/without cereals, fruit-preparations to underlay or to be mixed with dairy products, fruit desserts, mixed fruits with coconut milk for a twin pot)

                        Non-alcoholic beverages (including fruit juice and fruit/vegetable blend beverages)

                        Puddings that do not require heat treatment at or above 120 °C in their manufacture, processing or preparation


title: Council Implementing Regulation (EU) 2020/19 of 13 January 2020 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2019/1337

text:
                  14.1.2020

                  EN

                  Official Journal of the European Union

                  LI 8/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2020/19
         of 13 January 2020
         implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2019/1337
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 2580/2001 of 27 December 2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism (1), and in particular Article 2(3) thereof,
         Having regard to the proposal of the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 8 August 2019, the Council adopted Implementing Regulation (EU) 2019/1337 (2) implementing Article 2(3) of Regulation (EC) No 2580/2001, establishing an updated list of persons, groups and entities to which Regulation (EC) No 2580/2001 applies (‘the list’).

                     (2)

                     The Council has provided, where practically possible, all the persons, groups and entities with statements of reasons explaining why they were entered into the list.

                     (3)

                     By way of a notice published in the Official Journal of the European Union, the Council informed the persons, groups and entities on the list that it had decided to keep them thereon. The Council also informed those persons, groups and entities concerned that it was possible to request a statement of the Council's reasons for entering them into the list where such a statement had not already been communicated to them.

                     (4)

                     The Council has reviewed the list as required by Article 2(3) of Regulation (EC) No 2580/2001. When carrying out that review, the Council took into account the observations submitted to it by those concerned as well as the updated information received from the competent national authorities on the status of listed individuals and entities at the national level.

                     (5)

                     The Council has verified that competent authorities, as referred to in Article 1(4) of Council Common Position 2001/931/CFSP (3), have taken decisions with regard to all persons, groups and entities on the list to the effect that they have been involved in terrorist acts within the meaning of Article 1(2) and (3) of Common Position 2001/931/CFSP. The Council has also concluded that the the persons, groups and entities to which Articles 2, 3 and 4 of Common Position 2001/931/CFSP apply should continue to be subject to the specific restrictive measures provided for in Regulation (EC) No 2580/2001.

                     (6)

                     The list should be updated accordingly, and Implementing Regulation (EU) 2019/1337 should be repealed,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The list provided for in Article 2(3) of Regulation (EC) No 2580/2001 is set out in the Annex to this Regulation.

            Article 2
            Implementing Regulation (EU) 2019/1337 is hereby repealed.

            Article 3
            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, 13 January 2020.

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  OJ L 344, 28.12.2001, p. 70.

            (2)  Council Implementing Regulation (EU) 2019/1337 of 8 August 2019 implementing Article 2(3) of Regulation (EC) No 2580/2001 on specific restrictive measures directed against certain persons and entities with a view to combating terrorism, and repealing Implementing Regulation (EU) 2019/24 (OJ L 209, 9.8.2019, p. 1).

            (3)  Council Common Position 2001/931/CFSP of 27 December 2001 on the application of specific measures to combat terrorism (OJ L 344, 28.12.2001, p. 93).

            ANNEX

               LIST OF PERSONS, GROUPS AND ENTITIES REFERRED TO IN ARTICLE 1

            I.   PERSONS

                        1.

                        ABDOLLAHI Hamed (a.k.a. Mustafa Abdullahi), born 11.8.1960 in Iran. Passport number: D9004878.

                        2.

                        AL-NASSER, Abdelkarim Hussein Mohamed, born in Al Ihsa (Saudi Arabia), citizen of Saudi Arabia.

                        3.

                        AL YACOUB, Ibrahim Salih Mohammed, born 16.10.1966 in Tarut (Saudi Arabia), citizen of Saudi Arabia.

                        4.

                        ARBABSIAR Manssor (a.k.a. Mansour Arbabsiar), born 6.3.1955 or 15.3.1955 in Iran. Iranian and US national, Passport number: C2002515 (Iran); Passport number: 477845448 (USA). National ID number: 07442833, expiry date 15.3.2016 (USA driving licence).

                        5.

                        ASADI Assadollah, born 22.12.1971 in Teheran (Iran), Iranian national. Iranian diplomatic passport number: D9016657.

                        6.

                        BOUYERI, Mohammed (a.k.a. Abu ZUBAIR, a.k.a. SOBIAR, a.k.a. Abu ZOUBAIR), born 8.3.1978 in Amsterdam (The Netherlands).

                        7.

                        EL HAJJ, Hassan Hassan, born 22.3.1988 in Zaghdraiya, Sidon, Lebanon, Canadian citizen. Passport number: JX446643 (Canada).

                        8.

                        HASHEMI MOGHADAM Saeid, born 6.8.1962 in Teheran (Iran), Iranian national. Passport number: D9016290, valid until 4.2.2019.

                        9.

                        IZZ-AL-DIN, Hasan (a.k.a. GARBAYA, Ahmed, a.k.a. SA-ID, a.k.a. SALWWAN, Samir), Lebanon, born 1963 in Lebanon, citizen of Lebanon.

                        10.

                        MELIAD, Farah, born 5.11.1980 in Sydney (Australia), Australian citizen. Passport number: M2719127 (Australia).

                        11.

                        MOHAMMED, Khalid Shaikh (a.k.a. ALI, Salem, a.k.a. BIN KHALID, Fahd Bin Adballah, a.k.a. HENIN, Ashraf Refaat Nabith, a.k.a. WADOOD, Khalid Adbul), born 14.4.1965 or 1.3.1964 in Pakistan, passport number 488555.

                        12.

                        ŞANLI, Dalokay (a.k.a. Sinan), born 13.10.1976 in Pülümür (Turkey).

                        13.

                        SHAHLAI Abdul Reza (a.k.a. Abdol Reza Shala'i, a.k.a. Abd-al Reza Shalai, a.k.a. Abdorreza Shahlai, a.k.a. Abdolreza Shahla'i, a.k.a. Abdul-Reza Shahlaee, a.k.a. Hajj Yusef, a.k.a. Haji Yusif, a.k.a. Hajji Yasir, a.k.a. Hajji Yusif, a.k.a. Yusuf Abu-al-Karkh), born circa 1957 in Iran. Addresses: (1) Kermanshah, Iran, (2) Mehran Military Base, Ilam Province, Iran.

                        14.

                        SHAKURI Ali Gholam, born circa 1965 in Tehran, Iran.

                        15.

                        SOLEIMANI Qasem (deceased) (a.k.a. Ghasem Soleymani, a.k.a. Qasmi Sulayman, a.k.a. Qasem Soleymani, a.k.a. Qasem Solaimani, a.k.a. Qasem Salimani, a.k.a. Qasem Solemani, a.k.a. Qasem Sulaimani, a.k.a. Qasem Sulemani), born 11.3.1957 in Iran. Iranian national, Passport number: 008827 (Iran Diplomatic), issued 1999. Title: Major General.

                  II.   GROUPS AND ENTITIES

                        1.

                        ‘Abu Nidal Organisation’ — ‘ANO’ (a.k.a. ‘Fatah Revolutionary Council’, a.k.a. ‘Arab Revolutionary Brigades’, a.k.a. ‘Black September’, a.k.a. ‘Revolutionary Organisation of Socialist Muslims’).

                        2.

                        ‘Al-Aqsa Martyrs’ Brigade’.

                        3.

                        ‘Al-Aqsa e.V’.

                        4.

                        ‘Babbar Khalsa’.

                        5.

                        ‘Communist Party of the Philippines’, including ‘New People's Army’ — ‘NPA’, Philippines.

                        6.

                        Directorate for Internal Security of the Iranian Ministry for Intelligence and Security.

                        7.

                        ‘Gama'a al-Islamiyya’ (a.k.a. ‘Al-Gama'a al-Islamiyya’) (‘Islamic Group’ — ‘IG’).

                        8.

                        ‘İslami Büyük Doğu Akıncılar Cephesi’ — ‘IBDA-C’ (‘Great Islamic Eastern Warriors Front’).

                        9.

                        ‘Hamas’, including ‘Hamas-Izz al-Din al-Qassem’.

                        10.

                        ‘Hizballah Military Wing’ (a.k.a. ‘Hezbollah Military Wing’, a.k.a. ‘Hizbullah Military Wing’, a.k.a. ‘Hizbollah Military Wing’, a.k.a. ‘Hezballah Military Wing’, a.k.a. ‘Hisbollah Military Wing’, a.k.a. ‘Hizbu'llah Military Wing’ a.k.a. ‘Hizb Allah Military Wing’, a.k.a. ‘Jihad Council’ (and all units reporting to it, including the External Security Organisation)).

                        11.

                        ‘Hizbul Mujahideen’ — ‘HM’.

                        12.

                        ‘Khalistan Zindabad Force’ — ‘KZF’.

                        13.

                        ‘Kurdistan Workers’ Party’ — ‘PKK’ (a.k.a. ‘KADEK’, a.k.a. ‘KONGRA-GEL’).

                        14.

                        ‘Liberation Tigers of Tamil Eelam’ — ‘LTTE’.

                        15.

                        ‘Ejército de Liberación Nacional’ (‘National Liberation Army’).

                        16.

                        ‘Palestinian Islamic Jihad’ — ‘PIJ’.

                        17.

                        ‘Popular Front for the Liberation of Palestine’ — ‘PFLP’.

                        18.

                        ‘Popular Front for the Liberation of Palestine — General Command’ (a.k.a. ‘PFLP — General Command’).

                        19.

                        ‘Devrimci Halk Kurtuluș Partisi-Cephesi’ — ‘DHKP/C’ (a.k.a. ‘Devrimci Sol’ (‘Revolutionary Left’), a.k.a. ‘Dev Sol’) (‘Revolutionary People's Liberation Army/Front/Party’).

                        20.

                        ‘Sendero Luminoso’ — ‘SL’ (‘Shining Path’).

                        21.

                        ‘Teyrbazen Azadiya Kurdistan’ — ‘TAK’ (a.k.a. ‘Kurdistan Freedom Falcons’, a.k.a. ‘Kurdistan Freedom Hawks’).


title: Commission Implementing Regulation (EU) 2020/23 of 13 January 2020 concerning the non-renewal of the approval of the active substance thiacloprid, 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:
                  14.1.2020

                  EN

                  Official Journal of the European Union

                  L 8/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/23
         of 13 January 2020
         concerning the non-renewal of the approval of the active substance thiacloprid, 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) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2004/99/EC (2) included thiacloprid 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 thiacloprid as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 30 April 2020.

                     (4)

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

                     (5)

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

                     (6)

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

                     (7)

                     The Authority made the supplementary summary dossier available to the public. The Authority also circulated the 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 22 January 2019 the Authority communicated to the Commission its conclusion (6) on whether thiacloprid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (9)

                     The Authority identified a critical concern in relation to the contamination of groundwater by metabolites of thiacloprid. In particular, metabolites M30, M34 and M46 are predicted to occur above the parametric drinking water limit of 0,1 μg/L in all pertinent scenarios for all proposed uses of thiacloprid. These metabolites are considered a priori of concern since it cannot be excluded that they share the same carcinogenic properties of the parent active substance thiacloprid, which is classified in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as carcinogenic category 2. Therefore, it cannot currently be established that the presence of metabolites of thiacloprid in groundwater will not result in unacceptable effects on groundwater and in harmful effects on human health. The Authority also concluded that the assessment of the risks to aquatic organisms, bees and non-target terrestrial plants could not be finalised based on the information provided in the dossier.

                     (10)

                     Additionally, thiacloprid is classified in accordance with Regulation (EC) No 1272/2008 also as toxic for reproduction category 1B. The applicant provided information attempting to demonstrate that exposure of humans to thiacloprid can be considered negligible. The Authority presented the outcome of the assessment of that information in its conclusion. Nevertheless, given the concerns identified in recital 9, a conclusion on whether exposure to humans is negligible for the purposes of point 3.6.4 of Annex II to Regulation (EC) No 1107/2009, is not necessary for the decision on whether the approval of thiacloprid can be renewed.

                     (11)

                     Furthermore, given the concerns identified, it is also not possible to provide for an approval in accordance with Article 4(7) to Regulation (EC) No 1107/2009.

                     (12)

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

                     (13)

                     However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

                     (14)

                     Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance thiacloprid in accordance with Article 20(1)(b) of that Regulation.

                     (15)

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

                     (16)

                     Member States should be given sufficient time to withdraw authorisations for plant protection products containing thiacloprid.

                     (17)

                     For plant protection products containing thiacloprid, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months.

                     (18)

                     Commission Implementing Regulation (EU) 2019/168 (8) extended the approval period of thiacloprid to 30 April 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

                     (19)

                     This Regulation does not prevent the submission of a further application for the approval of thiacloprid pursuant to Article 7 of Regulation (EC) No 1107/2009.

                     (20)

                     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
            Non-renewal of the approval of the active substance
            The approval of the active substance thiacloprid is not renewed.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011 row 92, on thiacloprid, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing thiacloprid as active substance by 3 August 2020.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 3 February 2021.

            Article 5
            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, 13 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances (OJ L 309, 6.10.2004, p. 6).

            (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 (2019). Conclusion on the peer review of the pesticide risk assessment of the active substance thiacloprid. EFSA Journal 2019;17(3):5595. doi: 10.2903/j.efsa.2019.5595.

            (7)  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).

            (8)  Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (OJ L 33, 5.2.2019, p. 1).