title: Commission Implementing Regulation (EU) 2018/155 of 31 January 2018 amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances (Text with EEA relevance. )

text:
               1.2.2018

               EN

               Official Journal of the European Union

               L 29/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/155
   of 31 January 2018
   amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances
   (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 19, thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 686/2012 (2) allocates the evaluation of active substances to a rapporteur Member State and to a co-rapporteur Member State for the purposes of the renewal procedure. Since the evaluation of active substances whose approval expires between 1 January 2022 and 31 December 2024 has not yet been allocated to a Member State or to a co-rapporteur Member State, it is appropriate to proceed to such allocation.

               (2)

               In view of the length of the evaluation process for active substances and the recent notification by the United Kingdom pursuant to Article 50 of the Treaty on European Union (3), it is necessary to re-allocate the evaluation of the active substances listed in Part B of the Annex to Implementing Regulation (EU) No 686/2012 for which the United Kingdom is the rapporteur Member State or the co-rapporteur Member State, and for which no supplementary dossier has yet been submitted. The active substances concerned are aluminium ammonium sulphate, azoxystrobin, bupirimate, carbetamide, chlormequat, ethylene, fenbuconazole, fluopicolide, fluquinconazole, flutriafol, garlic extract, metazachlor, myclobutanil, paclobutrazol, pepper, plant oils/citronella oil, propaquizafop, quizalofop-p-ethyl, quizalofop-p-tefuryl, tri-allate and urea.

               (3)

               That allocation should be made in such a way that a balance is achieved as regards the distribution of the responsibilities and the work between Member States.

               (4)

               This Regulation should enter into force as soon as possible given that the deadline for the submission of the supplementary dossier for some of the active substances concerned is on 28 February 2018.

               (5)

               Implementing Regulation (EU) No 686/2012 should therefore be amended accordingly.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Implementing Regulation (EU) No 686/2012 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 31 January 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

      (3)  OJ C 326, 26.10.2012, p. 13.

      ANNEX
      The Annex to Implementing Regulation (EU) No 686/2012 is amended as follows:

                  (1)

                  In Part B, the entries corresponding to active substances Aluminium ammonium sulphate, Azoxystrobin, Bupirimate, Carbetamide, Chlormequat, Ethylene, Fenbuconazole, Fluopicolide, Fluquinconazole, Flutriafol, Garlic extract, Metazachlor, Myclobutanil, Paclobutrazol, Pepper, Plant oils/Citronella oil, Propaquizafop, Quizalofop-P-ethyl, Quizalofop-P-tefuryl, Tri-allate and Urea are replaced by the following corresponding entries:

                                 Active substance

                                 Rapporteur Member State

                                 Co-rapporteur Member State

                              ‘Aluminium ammonium sulphate

                              IE

                              PT’

                              ‘Azoxystrobin

                              AT

                              NO’

                              ‘Bupirimate

                              NL

                              PL’

                              ‘Carbetamide

                              SE

                              BE’

                              ‘Chlormequat

                              AT

                              IT’

                              ‘Ethylene

                              NL

                              ES’

                              ‘Fenbuconazole

                              SI

                              AT’

                              ‘Fluopicolide

                              AT

                              ES’

                              ‘Fluquinconazole

                              CZ

                              SK’

                              ‘Flutriafol

                              SK

                              CZ’

                              ‘Garlic extract

                              IE

                              DK’

                              ‘Metazachlor

                              NL

                              PT’

                              ‘Myclobutanil

                              AT

                              ES’

                              ‘Paclobutrazol

                              AT

                              RO’

                              ‘Pepper

                              BE

                              IE’

                              ‘Plant oils/Citronella oil

                              FR

                              CZ’

                              ‘Propaquizafop

                              AT

                              EE’

                              ‘Quizalofop-P-ethyl

                              FI

                              SE’

                              ‘Quizalofop-P-tefuryl

                              HR

                              AT’

                              ‘Tri-allate

                              NL

                              CZ’

                              ‘Urea

                              EL

                              FI’

                  (2)

                  The following Part C is added:
                  ‘PART C

                     ALLOCATION OF THE EVALUATION OF ACTIVE SUBSTANCES WHOSE APPROVAL EXPIRES AFTER 31 DECEMBER 2021 AND NOT LATER THAN 31 DECEMBER 2024

                                 Active substance

                                 Rapporteur Member State

                                 Co-rapporteur Member State

                              1,4-Dimethylnaphthalene

                              AT

                              PL

                              Acequinocyl

                              DE

                              NL

                                 Adoxophyes orana GV strain BV-0001

                              DE

                              FR

                              Ametoctradin

                              DE

                              NL

                              Aminopyralid

                              FI

                              DK

                              Amisulbrom

                              EL

                              FI

                              Ascorbic acid

                              NL

                              FR

                                 Aureobasidium pullulans (strains DSM 14940 and DSM 14941)

                              AT

                              DE

                                 Bacillus firmus I-1582

                              FR

                              DK

                                 Bacillus pumilus QST 2808

                              IT

                              NL

                              Benalaxyl-M

                              PT

                              IT

                              Benzovindiflupyr

                              FR

                              AT

                              Bixafen

                              CZ

                              BE

                                 Candida oleophila strain O

                              SI

                              DE

                              Chlorantraniliprole

                              IE

                              DE

                              Cyflumetofen

                              ES

                              AT

                              Disodium phosphonate

                              FR

                              EL

                              Emamectin

                              NL

                              SI

                              Esfenvalerate

                              AT

                              PT

                              Eugenol

                              ES

                              EL

                              Fenpyrazamine

                              LV

                              LT

                              Flubendiamide

                              EL

                              AT

                              Flumetralin

                              HU

                              EL

                              Fluopyram

                              AT

                              HR

                              Fluxapyroxad

                              FR

                              EL

                              Geraniol

                              ES

                              EL

                              Halosulfuron methyl

                              IT

                              PL

                                 Helicoverpa armigera nucleopolyhedrovirus (HearNPV)

                              EE

                              FR

                              Ipconazole

                              BE

                              FR

                              Isopyrazam

                              NO

                              EL

                              lambda-Cyhalothrin

                              SE

                              FR

                              Maltodextrin

                              IE

                              FR

                              Mandipropamid

                              AT

                              PT

                              Metaflumizone

                              SE

                              EL

                              Metam (incl. -potassium and -sodium)

                              BE

                              ES

                              Metobromuron

                              FR

                              NO

                              Metsulfuron-methyl

                              DK

                              SE

                              Orange oil

                              FR

                              CZ

                                 Paecilomyces fumosoroseus strain Fe9901

                              PL

                              NL

                              Penflufen

                              PL

                              IE

                              Penthiopyrad

                              SE

                              CZ

                              Phosphane

                              ES

                              DE

                              Potassium phosphonates (formerly potassium phosphite)

                              FR

                              EL

                              Prosulfuron

                              FR

                              SK

                                 Pseudomonas sp. Strain DSMZ 13134

                              NL

                              BG

                              Pyridalyl

                              NL

                              BE

                              Pyriofenone

                              LV

                              EL

                              Pyroxsulam

                              DK

                              FI

                              S-Abscisic acid

                              NL

                              DK

                              Sedaxane

                              FR

                              AT

                              Sodium silver thiosulphate

                              NL

                              LV

                              Spinetoram

                              HR

                              ES

                              Spiromesifen

                              IT

                              AT

                              Spirotetramat

                              AT

                              NO

                              Spodoptera littoralis nucleopolyhedrovirus

                              EE

                              FR

                              Streptomyces lydicus WYEC 108

                              NL

                              DE

                              Tembotrione

                              AT

                              FR

                              Thiencarbazone

                              FR

                              EL

                              Thymol

                              ES

                              EL

                                 Trichoderma asperellum (strain T34)

                              SE

                              IT

                                 Trichoderma atroviride strain I-1237

                              IT

                              SK

                              Valifenalate (formerly Valiphenal)

                              HU

                              SI

                                 Zucchini Yellow Mosaik Virus, weak strain

                              DK

                              AT’


title: Commission Implementing Regulation (EU) 2018/521 of 28 March 2018 amending Regulation (EC) No 1296/2008 laying down detailed rules for the application of tariff quotas for imports of maize and sorghum into Spain and imports of maize into Portugal

text:
               3.4.2018

               EN

               Official Journal of the European Union

               L 87/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/521
   of 28 March 2018
   amending Regulation (EC) No 1296/2008 laying down detailed rules for the application of tariff quotas for imports of maize and sorghum into Spain and imports of maize into Portugal
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular point (c) of Article 187 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1296/2008 (2) lays down the rules for the application of tariff quotas for imports of maize and sorghum into Spain and imports of maize into Portugal.

               (2)

               In accordance with Article 6 of Regulation (EC) No 1296/2008, a flat-rate reduction may be applied to the import duty fixed in accordance with Commission Regulation (EU) No 642/2010 (3). Such a reduction was fixed by Commission Delegated Regulation (EU) 2018/94 (4) for the import duty for sorghum imported into Spain from third countries. That reduction applies to the available balance of the quantities of sorghum to be imported into Spain under the tariff quota opened on 1 January 2017.

               (3)

               In order to benefit from that flat-rate reduction, those quantities are subject to specific rules. In particular, point (a) of Article 12(1) of Regulation (EC) No 1296/2008 provides that where a flat-rate reduction has been adopted by the Commission, the period of validity of licences is to correspond to the period as specified in Article 6 of Commission Regulation (EC) No 1342/2003 (5). However, the relevant point of the latter provision has been deleted by Commission Delegated Regulation (EU) 2016/1237 (6), which, together with Commission Implementing Regulation (EU) 2016/1239 (7), lays down rules for applying the system of import and export licences for agricultural products provided for in Regulation (EU) No 1308/2013. It is therefore appropriate to reintroduce a rule regarding the period of validity of licences for the purposes of Regulation (EC) No 1296/2008. For reasons of clarity, that rule should be incorporated directly into Regulation (EC) No 1296/2008.

               (4)

               Regulation (EC) No 1296/2008 should therefore be amended accordingly.

               (5)

               In the interest of legal certainty, it should be made clear that the rule regarding the period of validity applies to all the licences issued under Delegated Regulation (EU) 2018/94. This Regulation should therefore apply retroactively from the date of entry into force of Delegated Regulation (EU) 2018/94.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

         HAS ADOPTED THIS REGULATION:
   Article 1
   In Article 12 of Regulation (EC) No 1296/2008, paragraph 1 is replaced by the following:

      ‘1.   The period of validity of licences shall be:

                  (a)

                  the period from the day of issue until the end of the second month following the month of the day of issue, in cases where a flat-rate reduction has been adopted by the Commission;

                  (b)

                  the period specified in the Regulation opening the invitation to tender, in the case of licences issued under a tendering procedure for the duty reduction.’

   Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   It shall apply from 26 January 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 28 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Regulation (EC) No 1296/2008 of 18 December 2008 laying down detailed rules for the application of tariff quotas for imports of maize and sorghum into Spain and imports of maize into Portugal (OJ L 340, 19.12.2008, p. 57).

      (3)  Commission Regulation (EU) No 642/2010 of 20 July 2010 on rules of application (cereal sector import duties) for Council Regulation (EC) No 1234/2007 (OJ L 187, 21.7.2010, p. 5).

      (4)  Commission Delegated Regulation (EU) 2018/94 of 16 November 2017 fixing a flat-rate reduction for the import duty for sorghum in Spain imported from third countries (OJ L 17, 23.1.2018, p. 7).

      (5)  Commission Regulation (EC) No 1342/2003 of 28 July 2003 laying down special detailed rules for the application of the system of import and export licences for cereals and rice (OJ L 189, 29.7.2003, p. 12).

      (6)  Commission Delegated Regulation (EU) 2016/1237 of 18 May 2016 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to the rules for applying the system of import and export licences and supplementing Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the rules on the release and forfeit of securities lodged for such licences, amending Commission Regulations (EC) No 2535/2001, (EC) No 1342/2003, (EC) No 2336/2003, (EC) No 951/2006, (EC) No 341/2007 and (EC) No 382/2008 and repealing Commission Regulations (EC) No 2390/98, (EC) No 1345/2005, (EC) No 376/2008 and (EC) No 507/2008 (OJ L 206, 30.7.2016, p. 1).

      (7)  Commission Implementing Regulation (EU) 2016/1239 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to the system of import and export licences (OJ L 206, 30.7.2016, p. 44).


title: Commission Implementing Regulation (EU) 2018/1017 of 18 July 2018 amending Implementing Regulations (EU) 2017/366 and (EU) 2017/367 imposing definitive countervailing and anti-dumping duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China and Implementing Regulations (EU) 2016/184 and (EU) 2016/185 extending the definitive countervailing and anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not

text:
               19.7.2018

               EN

               Official Journal of the European Union

               L 183/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1017
   of 18 July 2018
   amending Implementing Regulations (EU) 2017/366 and (EU) 2017/367 imposing definitive countervailing and anti-dumping duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China and Implementing Regulations (EU) 2016/184 and (EU) 2016/185 extending the definitive countervailing and anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic anti-dumping Regulation’), and in particular Articles 11(4) and 13(4) thereof,
   Having regard to Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (2) (‘the basic anti-subsidy Regulation’) and in particular to Articles 23(6) and 24(5) thereof,
   Whereas:
   A.   MEASURES IN FORCE

               (1)

               On 2 December 2013, the Council imposed anti-dumping (3) and countervailing measures (4) on crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (‘the original measures’).

               (2)

               On 11 February 2016, the Commission extended those measures to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not, with the exception of imports produced by certain companies specifically exempted from those measures (‘the extended measures’) (5).

               (3)

               Following expiry review investigations of the original measures the Commission, on 1 March 2017, imposed anti-dumping and countervailing duties for a period of 18 months (‘the continued measures’) (6). On the same day it also terminated two partial interim review investigations that had been limited to the Union interest (7).

               (4)

               On 3 March 2017, the Commission initiated a partial interim review limited to the form and level of the continued measures (8). Following this review, the Commission amended the continued measures following the publication of Commission Implementing Regulation (EU) 2017/1570 (9), which entered into force on 1 October 2017.

               (5)

               On 8 November 2017, the Commission amended the extended measures by adding a new exporting producer to the list of exempted companies set out Article 1(1) of Commission Implementing Regulation (EU) 2016/184 and Commission Implementing Regulation (EU) 2016/185, respectively (10).

               (6)

               Accordingly, the countervailing and anti-dumping measures currently in force with regard to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not, are those imposed by Commission Implementing Regulation (EU) 2017/366 and Commission Implementing Regulation (EU) 2017/367, with the exception of imports produced by the companies specifically exempted from those measures as set out in Implementing Regulation (EU) 2016/184 and Implementing Regulation (EU) 2016/185, as amended by Implementing Regulation (EU) 2017/1997.

         B.   PROCEDURE

   1.   Initiation

               (7)

               By Commission Implementing Regulation (EU) 2017/1994 (11) (‘the Initiation Regulation’), the Commission initiated a review of the extended measures for the purpose of determining the possibility of granting an exemption from those measures to Longi (Kuching) SDN.BHD (‘the applicant’ or ‘Longi Kuching’), a Malaysian exporting producer of crystalline silicon photovoltaic modules and key components (i.e. cells). The Regulation initiating the review also repealed the anti-dumping duties with regard to the applicant and made imports from it subject to registration.

               (8)

               The request lodged by the applicant contained sufficient prima facie evidence to support the applicant's claim that it was a new exporting producer and fulfilled the criteria for an exemption under Articles 11(4) and 13(4) of the basic anti-dumping Regulation and Article 23(6) of the basic anti-subsidy Regulation, namely:

                           —

                           that it did not export the product under review to the Union during the investigation period used in the investigation that led to the extended measures, i.e. from 1 April 2014 to 31 March 2015,

                           —

                           that it has not been engaging in circumvention practices, and

                           —

                           that it has entered into an irrevocable contractual obligation to export a significant quantity to the Union.

         2.   Product under review

               (9)

               The product under review is crystalline silicon photovoltaic modules or panels and cells of the type used in crystalline silicon photovoltaic modules or panels (the cells have a thickness not exceeding 400 micrometres), consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not, currently falling within CN codes ex 8501 31 00, ex 8501 32 00, ex 8501 33 00, ex 8501 34 00, ex 8501 61 20, ex 8501 61 80, ex 8501 62 00, ex 8501 63 00, ex 8501 64 00 and ex 8541 40 90.

               (10)

               The following product types are excluded from the definition of the product under review:

                           —

                           solar chargers that consist of less than six cells, are portable and supply electricity to devices or charge batteries,

                           —

                           thin film photovoltaic products,

                           —

                           crystalline silicon photovoltaic products that are permanently integrated into electrical goods, where the function of the electrical goods is other than power generation, and where these electrical goods consume the electricity generated by the integrated crystalline silicon photovoltaic cell(s),

                           —

                           modules or panels with a output voltage not exceeding 50 V DC and a power output not exceeding 50 W solely for direct use as battery chargers in systems with the same voltage and power characteristics.

         3.   Reporting Period

               (11)

               The reporting period covered the period from 1 January 2017 to 31 December 2017.

         4.   Investigation

               (12)

               The Commission advised Longi Kuching, the Union industry represented by the complainant in the original investigation (EU ProSun) and the authorities of Malaysia and the People's Republic of China of the initiation of the review.

               (13)

               The Commission sought and verified all the information deemed necessary for the purposes of the review. In particular, it received a questionnaire reply from the applicant. A verification visit was carried out at the premises of the applicant in Malaysia in March 2018.

         C.   FINDINGS

               (14)

               Longi Kuching is a genuine Malaysian producer of crystalline silicon photovoltaic modules and cells that was incorporated in January 2016. It started commercial production of modules and cells in May 2016.

               (15)

               Longi Kuching had not exported the product under review to the Union during the investigation period used in the investigation that led to the extended measures, i.e. from 1 April 2014 to 31 March 2015. Longi Kuching had neither purchased the product under review from the PRC for further re-sales or transhipment to the Union up until the end of the reporting period, i.e. 31 December 2017. It had, however, entered into a contractual obligation to export the product under review to a customer in the Union.

               (16)

               During verification at the applicant's premises it was demonstrated that the contract had been fulfilled and the applicant had delivered the product under review to a customer in Poland in November 2017. No other Union sales had been made up to date.

               (17)

               The applicant is a wholly owned subsidiary of a Hong Kong based company, Longi H.K. Trading Limited, which in turn is wholly owned by the the Chinese company Longi Green Energy Technology Co., Ltd The latter company is the ultimate parent company of the Longi Group, which is active throughout the Solar PV value chain and produces, amongst others, wafers, ingots, solar cells and solar modules. The Longi Group is subject to the countervailing and anti-dumping measures currently in force on imports of crystalline silicon photovoltaic modules and cells originating in the People's Republic of China. As indicated in the Initiation Regulation, the Commission carefully examined this relationship and verified whether Longi Kuching was established or used to circumvent the existing measures.

               (18)

               The Commission found that Longi Kuching is a genuine producer of the product under review with complete and state of the art production facilities for both cells and modules, including R&D. It had not been engaged in circumvention activities, such as transhipment, assembly operations or re-sales of solar modules and cells originating in the People's Republic of China to the Union.

               (19)

               The Commission thus concluded that Longi Kuching was neither established nor used for circumventing the original measures and that the Chinese ownership, in itself, did not constitute a reason to reject the application.

               (20)

               Against this background, the Commission did not find it necessary to impose any particular monitoring conditions should the exemption be granted. In order to ensure the proper application of the exemption, the Commission considered it appropriate to apply the special measures applicable to all companies which had been granted exemptions. These special measures are the requirement of the presentation to the customs authorities of the Member States of a valid commercial invoice, which shall conform to the requirements set out in Article 1(2) of Implementing Regulation (EU) 2016/184 and Article 1(2) of Implementing Regulation (EU) 2016/185. Imports not accompanied by such an invoice shall be made subject to the extended dumping and countervailing duty respectively.

               (21)

               In the light of the findings described in recitals (13) to (19), the Commission concluded that Longi (Kuching) SDN.BHD fulfils the criteria laid down in Articles 11(4) and 13(4) of the basic anti-dumping Regulation and Article 23(6) of the basic anti-subsidy Regulation and should be exempted from the extended measures.

               (22)

               The findings above were disclosed to the applicant and other interested parties, which were given the opportunity to provide comments. No comments were received.

         D.   MODIFICATION TO THE LIST OF COMPANIES BENEFITTING FROM AN EXEMPTION TO THE EXTENDED MEASURES

               (23)

               Given the findings referred to above, the Commission concluded that the company Longi (Kuching) SDN.BHD should be added to the list of companies that are exempted from the countervailing duty and anti-dumping duty imposed by Implementing Regulation (EU) 2016/184 and Implementing Regulation (EU) 2016/185, respectively.

               (24)

               Given that the list of the exempted exporting producers from Malaysia and Taiwan was also included in Implementing Regulation (EU) 2017/366 and Implementing Regulation (EU) 2017/367, Longi (Kuching) SDN.BHD should also be added to the list of exporting producers contained in those two regulations.

               (25)

               Accordingly, Longi (Kuching) SDN.BHD should be added to the list of individually identified companies in Article 1(1) of Implementing Regulation (EU) 2016/184, Article 1(1) of Implementing Regulation (EU) 2016/185, Article 4(1) of Implementing Regulation (EU) 2017/366 and Article 4(1) of Implementing Regulation (EU) 2017/367.

               (26)

               Furthermore, the application of the exemption is conditional upon compliance with the requirement set out in Article 1(2) of Implementing Regulation (EU) 2016/184 and in Article 1(2) of Implementing Regulation (EU) 2016/185. This requirement is also reflected in Article 4(2) of Implementing Regulation (EU) 2017/366 and in Article 4(2) of Implementing Regulation (EU) 2017/367.

               (27)

               The list of individually identified companies should be identical in all implementing regulations in force. Since, by means of Implementing Regulation (EU) 2017/1997, Jinko Solar Technology SDN.BHD had been included in the list of individually identified companies in Article 1(1) of Implementing Regulation (EU) 2016/184 and Article 1(1) of Implementing Regulation (EU) 2016/185, its name has to be also inserted in the list of individually identified companies in Article 4(1) of Implementing Regulation (EU) 2017/366 and Article 4(1) of Implementing Regulation (EU) 2017/367.

               (28)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of Regulation (EU) 2016/1036,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The table set out in Article 1(1) of Implementing Regulation (EU) 2016/184, as amended, is replaced by the following table:

                  ‘Country

                  Company

                  TARIC additional code

                  Malaysia

                  AUO — SunPower Sdn. Bhd.
                  Flextronics Shah Alam Sdn. Bhd.
                  Hanwha Q CELLS Malaysia Sdn. Bhd.
                  Panasonic Energy Malaysia Sdn. Bhd.
                  TS Solartech Sdn. Bhd.
                  Jinko Solar Technology SDN.BHD
                  Longi (Kuching) SDN.BHD

                  C073
                  C074
                  C075
                  C076
                  C077
                  C203
                  C309

                  Taiwan

                  ANJI Technology Co., Ltd
                  AU Optronics Corporation
                  Big Sun Energy Technology Inc.
                  EEPV Corp.
                  E-TON Solar Tech. Co., Ltd
                  Gintech Energy Corporation
                  Gintung Energy Corporation
                  Inventec Energy Corporation
                  Inventec Solar Energy Corporation
                  LOF Solar Corp.
                  Ming Hwei Energy Co., Ltd
                  Motech Industries, Inc.
                  Neo Solar Power Corporation
                  Perfect Source Technology Corp.
                  Ritek Corporation
                  Sino-American Silicon Products Inc.
                  Solartech Energy Corp.
                  Sunengine Corporation Ltd
                  Topcell Solar International Co., Ltd
                  TSEC Corporation
                  Win Win Precision Technology Co., Ltd

                  C058
                  C059
                  C078
                  C079
                  C080
                  C081
                  C082
                  C083
                  C084
                  C085
                  C086
                  C087
                  C088
                  C089
                  C090
                  C091
                  C092
                  C093
                  C094
                  C095
                  C096 ’

   Article 2
   The table set out in Article 1(1) of Implementing Regulation (EU) 2016/185, as amended, is replaced by the following table:

                  ‘Country

                  Company

                  TARIC additional code

                  Malaysia

                  AUO — SunPower Sdn. Bhd.
                  Flextronics Shah Alam Sdn. Bhd.
                  Hanwha Q CELLS Malaysia Sdn. Bhd.
                  Panasonic Energy Malaysia Sdn. Bhd.
                  TS Solartech Sdn. Bhd.
                  Jinko Solar Technology SDN.BHD
                  Longi (Kuching) SDN.BHD

                  C073
                  C074
                  C075
                  C076
                  C077
                  C203
                  C309

                  Taiwan

                  ANJI Technology Co., Ltd
                  AU Optronics Corporation
                  Big Sun Energy Technology Inc.
                  EEPV Corp.
                  E-TON Solar Tech. Co., Ltd
                  Gintech Energy Corporation
                  Gintung Energy Corporation
                  Inventec Energy Corporation
                  Inventec Solar Energy Corporation
                  LOF Solar Corp.
                  Ming Hwei Energy Co., Ltd
                  Motech Industries, Inc.
                  Neo Solar Power Corporation
                  Perfect Source Technology Corp.
                  Ritek Corporation
                  Sino-American Silicon Products Inc.
                  Solartech Energy Corp.
                  Sunengine Corporation Ltd
                  Topcell Solar International Co., Ltd
                  TSEC Corporation
                  Win Win Precision Technology Co., Ltd

                  C058
                  C059
                  C078
                  C079
                  C080
                  C081
                  C082
                  C083
                  C084
                  C085
                  C086
                  C087
                  C088
                  C089
                  C090
                  C091
                  C092
                  C093
                  C094
                  C095
                  C096 ’

   Article 3
   The table set out in Article 4(1) of Implementing Regulation (EU) 2017/366 is replaced by the following table:

                  ‘Country

                  Company

                  TARIC additional code

                  Malaysia

                  AUO — SunPower Sdn. Bhd.
                  Flextronics Shah Alam Sdn. Bhd.
                  Hanwha Q CELLS Malaysia Sdn. Bhd.
                  Panasonic Energy Malaysia Sdn. Bhd.
                  TS Solartech Sdn. Bhd.
                  Jinko Solar Technology SDN.BHD
                  Longi (Kuching) SDN.BHD

                  C073
                  C074
                  C075
                  C076
                  C077
                  C203
                  C309

                  Taiwan

                  ANJI Technology Co., Ltd
                  AU Optronics Corporation
                  Big Sun Energy Technology Inc.
                  EEPV Corp.
                  E-TON Solar Tech. Co., Ltd
                  Gintech Energy Corporation
                  Gintung Energy Corporation
                  Inventec Energy Corporation
                  Inventec Solar Energy Corporation
                  LOF Solar Corp.
                  Ming Hwei Energy Co., Ltd
                  Motech Industries, Inc.
                  Neo Solar Power Corporation
                  Perfect Source Technology Corp.
                  Ritek Corporation
                  Sino-American Silicon Products Inc.
                  Solartech Energy Corp.
                  Sunengine Corporation Ltd
                  Topcell Solar International Co., Ltd
                  TSEC Corporation
                  Win Win Precision Technology Co., Ltd

                  C058
                  C059
                  C078
                  C079
                  C080
                  C081
                  C082
                  C083
                  C084
                  C085
                  C086
                  C087
                  C088
                  C089
                  C090
                  C091
                  C092
                  C093
                  C094
                  C095
                  C096 ’

   Article 4
   The table set out in Article 4(1) of Implementing Regulation (EU) 2017/367 is replaced by the following table:

                  ‘Country

                  Company

                  TARIC additional code

                  Malaysia

                  AUO — SunPower Sdn. Bhd.
                  Flextronics Shah Alam Sdn. Bhd.
                  Hanwha Q CELLS Malaysia Sdn. Bhd.
                  Panasonic Energy Malaysia Sdn. Bhd.
                  TS Solartech Sdn. Bhd.
                  Jinko Solar Technology SDN.BHD
                  Longi (Kuching) SDN.BHD

                  C073
                  C074
                  C075
                  C076
                  C077
                  C203
                  C309

                  Taiwan

                  ANJI Technology Co., Ltd
                  AU Optronics Corporation
                  Big Sun Energy Technology Inc.
                  EEPV Corp.
                  E-TON Solar Tech. Co., Ltd
                  Gintech Energy Corporation
                  Gintung Energy Corporation
                  Inventec Energy Corporation
                  Inventec Solar Energy Corporation
                  LOF Solar Corp.
                  Ming Hwei Energy Co., Ltd
                  Motech Industries, Inc.
                  Neo Solar Power Corporation
                  Perfect Source Technology Corp.
                  Ritek Corporation
                  Sino-American Silicon Products Inc.
                  Solartech Energy Corp.
                  Sunengine Corporation Ltd
                  Topcell Solar International Co., Ltd
                  TSEC Corporation
                  Win Win Precision Technology Co., Ltd

                  C058
                  C059
                  C078
                  C079
                  C080
                  C081
                  C082
                  C083
                  C084
                  C085
                  C086
                  C087
                  C088
                  C089
                  C090
                  C091
                  C092
                  C093
                  C094
                  C095
                  C096 ’

   Article 5
   Customs authorities are directed to cease the registration of imports carried out pursuant to Article 3 of Implementing Regulation (EU) 2017/1994. No anti-dumping duty shall be collected on the imports thus registered.
   Article 6
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation is binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 18 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 176, 30.6.2016, p. 21.

      (2)  OJ L 176, 30.6.2016, p. 55.

      (3)  Council Implementing Regulation (EU) No 1238/2013 of 2 December 2013 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (OJ L 325, 5.12.2013, p. 1).

      (4)  Council Implementing Regulation (EU) No 1239/2013 of 2 December 2013 imposing a definitive countervailing duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (OJ L 325, 5.12.2013, p. 66).

      (5)  Commission Implementing Regulation (EU) 2016/184 of 11 February 2016 extending the definitive countervailing duty imposed by Council Implementing Regulation (EU) No 1239/2013 of 2 December 2013 imposing a definitive countervailing duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (OJ L 37, 12.2.2016, p. 56) and Commission Implementing Regulation (EU) 2016/185 of 11 February 2016 extending the definitive anti-dumping duty imposed by Council Implementing Regulation (EU) No 1238/2013 of 2 December 2013 imposing a definitive anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (OJ L 37, 12.2.2016, p. 76).

      (6)  Commission Implementing Regulation (EU) 2017/366 of 1 March 2017 imposing definitive countervailing duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China following an expiry review pursuant to Article 18(2) of Regulation (EU) 2016/1037 of the European Parliament and of the Council and terminating the partial interim review investigation pursuant to Article 19(3) of Regulation (EU) 2016/1037 (OJ L 56, 3.3.2017, p. 1), and Commission Implementing Regulation (EU) 2017/367 of 1 March 2017 imposing a definitive anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council and terminating the partial interim review investigation pursuant to Article 11(3) of Regulation (EU) 2016/1036 (OJ L 56, 3.3.2017, p. 131).

      (7)  Ibid.

      (8)  Notice of initiation of a partial interim review of the anti-dumping and countervailing measures applicable to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China (OJ C 67, 3.3.2017, p. 16).

      (9)  Commission Implementing Regulation (EU) 2017/1570 of 15 September 2017 amending Implementing Regulation (EU) 2017/366 and Implementing Regulation (EU) 2017/367 imposing definitive countervailing and anti-dumping duties on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China and repealing Implementing Decision 2013/707/EU confirming the acceptance of an undertaking offered in connection with the anti-dumping and anti-subsidy proceedings concerning imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China for the period of application of definitive measures (OJ L 238, 16.9.2017, p. 22).

      (10)  Commission Implementing Regulation (EU) 2017/1997 of 7 November 2017 amending Implementing Regulations (EU) 2016/184 and (EU) 2016/185 extending the definitive countervailing and anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not (OJ L 289, 8.11.2017, p. 1).

      (11)  Commission Implementing Regulation (EU) 2017/1994 of 6 November 2017 initiating a review of Implementing Regulations (EU) 2016/184 and (EU) 2016/185 (extending the definitive countervailing and anti-dumping duty on imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) consigned from Malaysia and Taiwan, whether declared as originating in Malaysia and in Taiwan or not) for the purposes of determining the possibility of granting an exemption from those measures to one Malaysian exporting producer, repealing the anti-dumping duty with regard to imports from that exporting producer and making imports from that exporting producer subject to registration (OJ L 288, 7.11.2017, p. 30).


title: Commission Implementing Regulation (EU) 2018/1018 of 18 July 2018 authorising an extension of use of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
               19.7.2018

               EN

               Official Journal of the European Union

               L 183/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1018
   of 18 July 2018
   authorising an extension of use of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

               Commission Implementing Decision 2014/396/EU (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4) and following the European Food Safety Authority's Opinion (5), the placing on the market of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food ingredient to be used in certain foods, including yeast-leavened breads and rolls and yeast-leavened fine bakery wares, as well as in food supplements.

               (5)

               On 6 December 2016, the company Lallemand Bio-Ingredients made a request to the competent authority of Denmark for an extension of use and use levels of UV-treated baker's yeast (Saccharomyces cerevisiae). The application requested to extend the use of UV-treated baker's yeast (Saccharomyces cerevisiae) to additional food categories, namely, pre-packed fresh and dry yeast for home baking and in food supplements without indication of maximum permitted levels. In addition, the applicant requested to amend the lower specification of the vitamin D2 content in the yeast concentrate from 1 800 000 IU (450 μg/g) to 800 000 IU (200 μg/g).

               (6)

               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.

               (7)

               While the request for an extension of uses and use levels of UV-treated baker's yeast (Saccharomyces cerevisiae) was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

               (8)

               On 30 June 2017, the competent authority of Denmark issued its initial assessment report. In that report it came to the conclusion that the extension of uses and proposed maximum use levels of UV-treated baker's yeast (Saccharomyces cerevisiae) meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

               (9)

               On 7 July 2017, the Commission forwarded the initial assessment report to the other Member States. Comments were made by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to methods employed to adequately identify potential mutants, lack of justification on safety grounds to support the removal of the maximum level for food supplements, lack of information on storage stability for the new form of the novel food, lack of information on the accreditation of laboratories, and as to whether the intake of the novel food might exceed the tolerable upper intake levels for vitamin D set up by EFSA (6).

               (10)

               In view of the comments made by the other Member States, the applicant provided additional explanations which alleviated their concerns to the satisfaction of the Member States and the Commission. Those explanations give sufficient grounds to establish that the extension of use and use levels of UV-treated baker's yeast (Saccharomyces cerevisiae) complies with Article 12(1) of Regulation (EU) 2015/2283.

               (11)

               Directive 2002/46/EC of the European Parliament and of the Council (7) and Regulation (EC) No 1925/2006 of the European Parliament and of the Council (8) lay down specific provisions for the use of vitamins and minerals when added to food supplements and food. The extension of use of UV-treated baker's yeast should be authorised without prejudice to those specific provisions.

               (12)

               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 8 of Regulation (EU) 2015/2283 referring to the substance UV-treated baker's yeast (Saccharomyces cerevisiae) shall be amended as specified in the Annex to this Regulation.
   2.   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
   3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC and Regulation (EC) No 1925/2006.
   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, 18 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

      (3)  Commission Implementing Decision 2014/396/EU of 24 June 2014 authorising the placing on the market of UV-treated baker's yeast (Saccharomyces cerevisiae) as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 186, 26.6.2014, p. 108).

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

      (5)  Scientific Opinion on the safety of vitamin D-enriched UV-treated baker's yeast, EFSA Journal 2014; 12(1):3520.

      (6)  EFSA Journal 2012;10(7):2813

      (7)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

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

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

                  (1)

                  the entry for ‘UV-treated baker's yeast (Saccharomyces cerevisiae)’ in Table 1 (Authorised novel foods) is replaced by the following:

                                 Authorised novel food

                                 Conditions under which the novel food may be used

                                 Additional specific labelling requirements

                                 Other requirements

                              ‘UV-treated baker's yeast (Saccharomyces cerevisiae)

                                 Specified food category

                                 Maximum levels of vitamin D2

                              The designation of the novel food on the labelling of the foodstuffs containing it shall be “Vitamin D yeast” or “Vitamin D2 yeast”

                              Yeast-leavened breads and rolls

                              5 μg of vitamin D2/100 g

                              Yeast-leavened fine bakery wares

                              5 μg of vitamin D2/100 g

                              Food supplements as defined in Directive 2002/46/EC

                              Pre-packed fresh or dry yeast for home baking

                              45 μg/100 g for fresh yeast
                              200 μg/100 g for dried yeast

                                          1.

                                          The designation of the novel food on the labelling of the foodstuffs shall be “Vitamin D yeast” or “Vitamin D2 yeast”.

                                          2.

                                          The labelling of the novel food shall bear a statement that the foodstuff is only intended for baking and that it should not be eaten raw.

                                          3.

                                          The labelling of the novel food shall bear instructions for use for the final consumers so that a maximum concentration of 5 μg/100 g of vitamin D2 in final home-baked products is not exceeded.’

                  (2)

                  the entry for ‘UV-treated baker's yeast (Saccharomyces cerevisiae)’ in Table 2 (Specifications) is replaced by the following:

                                 Authorised Novel Food

                                 Specification

                              ‘UV-treated baker's yeast (Saccharomyces cerevisiae)

                                 Description/Definition:

                              Baker's yeast (Saccharomyces cerevisiae) is treated with ultraviolet light to induce the conversion of ergosterol to vitamin D2 (ergocalciferol). Vitamin D2 content in the yeast concentrate varies between 800 000 -3 500 000  IU vitamin D/100 g (200-875 μg/g). The yeast may be inactivated.
                              The yeast concentrate is blended with regular baker's yeast in order not to exceed the maximum level in the pre-packed fresh or dry yeast for home baking.
                              Tan-coloured, free-flowing granules.

                                 Vitamin D2:

                              Chemical name: (5Z,7E,22E)-(3S)-9,10-secoergosta-5,7,10(19),22-tetraen-3-ol
                              Synonym: Ergocalciferol
                              CAS No.: 50-14-6
                              Molecular weight: 396,65 g/mol

                                 Microbiological criteria for the yeast concentrate:

                              Coliforms: ≤ 103/g

                                 Escherichia coli: ≤ 10/g

                                 Salmonella: Absence in 25 g’


title: Commission Implementing Regulation (EU) 2018/1061 of 26 July 2018 renewing the approval of the active substance carfentrazone-ethyl 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 Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  27.7.2018

                  EN

                  Official Journal of the European Union

                  L 190/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1061
         of 26 July 2018
         renewing the approval of the active substance carfentrazone-ethyl 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 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 (1) 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, and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2003/68/EC (2) included carfentrazone-ethyl 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 carfentrazone-ethyl, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2018.

                     (4)

                     An application for the renewal of the approval of carfentrazone-ethyl 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 10 July 2015.

                     (7)

                     The Authority communicated the renewal assessment report to the applicant and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

                     (8)

                     On 22 July 2016 (6), the Authority communicated to the Commission its conclusion on whether carfentrazone-ethyl can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for carfentrazone-ethyl to the Standing Committee on Plants, Animals, Food and Feed on 24 January 2017.

                     (9)

                     The applicant was given the opportunity to submit comments on the draft renewal report.

                     (10)

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

                     (11)

                     It is therefore appropriate to renew the approval of carfentrazone-ethyl.

                     (12)

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

                     (13)

                     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 include certain conditions and restrictions. It is, in particular, appropriate to require further confirmatory information.

                     (14)

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

                     (15)

                     Taking into account that the current approval of carfentrazone-ethyl expires on 31 July 2018, this Regulation should enter into force as soon as possible.

                     (16)

                     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 carfentrazone-ethyl is renewed as set out in Annex I.

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

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 August 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (OJ L 177, 16.7.2003, p. 12).

            (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 (European Food Safety Authority), 2016. Conclusion on the peer review of the pesticide risk assessment of the active substance carfentrazone-ethyl. EFSA Journal 2016;14(8):4569. Available online: www.efsa.europa.eu

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Carfentrazone-ethyl
                        CAS No 128639-02-1
                        CIPAC No 587.202

                        Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate

                        ≥ 910 g/kg

                        1 August 2018

                        31 July 2033

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

                                    —

                                    the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions,

                                    —

                                    the protection of soil non-target organisms,

                                    —

                                    the protection of aquatic organisms,

                                    —

                                    the protection of non-target terrestrial higher plants.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    (1)

                                    the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2;

                                    (2)

                                    the effect of water treatment processes on the nature of residues present in drinking water.

                              The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.
                        The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.

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

               (2)  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).

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

                        (1)

                        in Part A, the entry 60 on carfentrazone-ethyl is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    Number

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘125

                                    Carfentrazone-ethyl
                                    CAS No 128639-02-1
                                    CIPAC No 587.202

                                    Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate

                                    ≥ 910 g/kg

                                    1 August 2018

                                    31 July 2033

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

                                                —

                                                the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;

                                                —

                                                the protection of soil non-target organisms;

                                                —

                                                the protection of aquatic organisms;

                                                —

                                                the protection of non-target terrestrial higher plants.

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                                (1)

                                                the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), in particular as carcinogen category 2;

                                                (2)

                                                the effect of water treatment processes on the nature of residues present in drinking water.

                                          The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.
                                    The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.’

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

               (2)  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).


title: Commission Implementing Regulation (EU) 2018/1090 of 31 July 2018 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH) (Text with EEA relevance.)

text:
                  1.8.2018

                  EN

                  Official Journal of the European Union

                  L 195/23

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1090
         of 31 July 2018
         concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and minor porcine species (weaned) (holder of the authorisation Kaesler Nutrition GmbH)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, all avian species reared for laying or for breeding purposes, weaned piglets and all porcine species (weaned) to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 30 November 2017 (2) that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) does not have an adverse effect on animal health, human health or the environment. It was concluded that the additive has a potential to improve zootechnical parameters in chickens for fattening, turkeys for fattening, and weaned piglets. This conclusion can be extended to chickens reared for laying and turkeys reared for breeding. The Authority also concluded that the effects of the additive on turkeys for fattening and on weaned piglets can be extrapolated respectively to all avian species up to the reared for laying and to weaned piglets of all porcine species. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 31 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2017; 15(12):5097.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        Units of activity/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: digestibility enhancers

                        4a 28

                        Kaesler Nutrition GmbH

                        Endo-1,4-beta-xylanase
                        EC 3.2.1.8
                        Endo-1,3(4)-beta-glucanase
                        EC 3.2.1.6

                           Additive composition

                        Preparation of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469) having a minimum activity of:
                        25 000  LXU (1)/g and 2 200  LGU (2)/g
                        Solid and liquid form.

                           Characterisation of the active substance

                        endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced by Komagataella pastoris (CBS 25376) and Komagataella pastoris (CBS 26469)

                           Analytical method
                            (3)

                        Determination in the feed additive, premixtures and feedingstuffs of xylanase

                                    —

                                    colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,4-β-xylanase on cross-linked wheat arabinoxylan.

                              Determination in the feed additive, premixtures and feedingstuffs of endo-1,3(4)-beta-glucanase:

                                    —

                                    colorimetric method based on the quantification of water soluble dyed fragments produced by the action of endo-1,3(4)-beta-glucanase on cross-linked azo-barley-glucan.

                        Chickens for fattening
                        Chickens reared for laying

                        —

                        4 250  LXU
                        375 LGU

                        —

                                    1.

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

                                    2.

                                    For use in weaned piglets up to 35 kg of body weight.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment.

                        21.8.2028

                        Turkeys for fattening
                        All avian species reared for laying or for breeding purposes other than chickens reared for laying

                        1 400  LXU
                        120 LGU

                        Piglets (weaned)
                        Minor porcine species (weaned)

                        700 LXU
                        60 LGU

               (1)  1 LXU is the amount of enzyme which releases one micromole of reducing sugars equivalents (as xylose) from birch xylan per minute at pH 5,5 and 50 °C.

               (2)  1 LGU is the amount of enzyme which releases one micromole of reducing sugars equivalents (as glucose) from barley glucan per minute at pH 5,5 and 50 °C.

               (3)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports


title: Commission Implementing Regulation (EU) 2018/1558 of 17 October 2018 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for cats and dogs (holder of the authorisation Centro Sperimentale del Latte) (Text with EEA relevance.)

text:
                  18.10.2018

                  EN

                  Official Journal of the European Union

                  L 261/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1558
         of 17 October 2018
         concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for cats and dogs (holder of the authorisation Centro Sperimentale del Latte)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The application concerns the authorisation of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for cats and dogs to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The preparation of Lactobacillus acidophilus (CECT 4529) belonging to the additive category of ‘zootechnical additives’, was authorised for ten years as a feed additive for laying hens by Commission Implementing Regulation (EU) 2015/38 (2) and for chickens for fattening by Commission Implementing Regulation (EU) 2017/2275 (3).

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 19 April 2018 (4) that, under the proposed conditions of use, the preparation of Lactobacillus acidophilus (CECT 4529) does not have an adverse effect on animal health, human health and the environment. It also concluded that the additive has the potential to improve the stool consistency of cats and dogs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of the preparation of Lactobacillus acidophilus (CECT 4529) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (7)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition subject to the conditions laid down in the Annex.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 17 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2015/38 of 13 January 2015 concerning the authorisation of the preparation of Lactobacillus acidophilus CECT 4529 as a feed additive for laying hens and amending Regulation (EC) No 1520/2007 (holder of authorisation Centro Sperimentale del Latte) (OJ L 8, 14.1.2015, p. 4).

            (3)  Commission Implementing Regulation (EU) 2017/2275 of 8 December 2017 concerning the authorisation of a new use of the preparation of Lactobacillus acidophilus (CECT 4529) as a feed additive for chickens for fattening (holder of the authorisation Centro Sperimentale del Latte) (OJ L 326, 9.12.2017, p. 47).

            (4)  EFSA Journal 2018; 16(5):5278.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1715

                        Centro Sperimentale del Latte

                           Lactobacillus acidophilus CECT 4529

                           Additive composition

                        Preparation of Lactobacillus acidophilus CECT 4529 containing a minimum of: 5 × 1010 CFU/g of additive (solid form).

                           Characterisation of the active substance

                        Viable cells of Lactobacillus acidophilus CECT 4529.

                           Analytical method
                            (1)

                        Enumeration: spread plate method using MRS agar (EN 15787).
                        Identification: Pulsed Field Gel Electrophoresis (PFGE).

                        Cats and dogs

                        —

                        5 × 109

                        —

                                    1.

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

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eyes, skin and breathing protection.

                        7 November 2028

               (1)  Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.