title: Commission Implementing Regulation (EU) 2019/892 of 28 May 2019 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (Text with EEA relevance.)

text:
                  29.5.2019

                  EN

                  Official Journal of the European Union

                  L 142/57

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/892
         of 28 May 2019
         concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species (holder of authorisation Danstar Ferment AG represented by Lallemand SAS)
         (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 the preparation of Saccharomyces cerevisiae CNCM I-1079. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     That application concerns the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for all pigs other than weaned piglets and sows and all minor porcine species to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     That preparation was already authorised as a zootechnical additive for 10 years by Commission Implementing Regulation (EU) 2018/347 (2) for use with weaned piglets and sows, and by Commission Implementing Regulation (EU) 2017/1905 (3) for use with chickens for fattening and minor poultry species for fattening.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 November 2018 (4) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae CNCM I-1079 does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive has the potential to be efficacious in all pigs. 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 Saccharomyces cerevisiae CNCM I-1079 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 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, 28 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Implementing Regulation (EU) 2018/347 of 5 March 2018 concerning the authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for piglets and sows and amending Regulations (EC) No 1847/2003 and (EC) No 2036/2005 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (OJ L 67, 9.3.2018, p. 21).

            (3)  Commission Implementing Regulation (EU) 2017/1905 of 18 October 2017 concerning an authorisation of the preparation of Saccharomyces cerevisiae CNCM I-1079 as a feed additive for chickens for fattening and for minor poultry species for fattening (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (OJ L 269, 19.10.2017, p. 30).

            (4)  EFSA Journal 2019;17(1):5535.

            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.

                        4d1703

                        Danstar Ferment AG represented by Lallemand SAS

                           Saccharomyces cerevisiae CNCM I-1079

                           Additive composition

                        Preparation of Saccharomyces cerevisiae CNCM I-1079 containing a minimum of:

                                    —

                                    1 × 1010 CFU/g of additive (coated form);

                                    —

                                    2 × 1010 CFU/g of additive (not-coated form).

                           Characterisation of the active substance

                        Viable cells of Saccharomyces cerevisiae CNCM I-1079

                           Analytical method
                            (1)

                        Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
                        Identification: polymerase chain reaction (PCR) method (CEN/TS) 15790:2008

                        All pigs other than sows and weaned piglets
                        All minor porcine species

                        —

                        1 × 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 breathing protection.

                        18 June 2029

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


title: Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office) (Text with EEA relevance.)

text:
                  29.5.2019

                  EN

                  Official Journal of the European Union

                  L 142/60

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/893
         of 28 May 2019
         concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the Union by Asahi Calpis Wellness Co. Ltd Europe Representative Office)
         (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 and renewing such authorisation.

                     (2)

                        Bacillus subtilis C-3102 (DSM 15544) was authorised for 10 years as a feed additive for chickens for fattening by Commission Regulation (EC) No 1444/2006 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens for fattening, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 June 2018 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation.

                     (5)

                     The assessment of Bacillus subtilis C-3102 (DSM 15544) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 1444/2006 should be repealed.

                     (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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EC) No 1444/2006 is repealed.

            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, 28 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Regulation (EC) No 1444/2006 of 29 September 2006 concerning the authorisation of Bacillus subtilis C-3102 (Calsporin) as a feed additive (OJ L 271, 30.9.2006, p. 19).

            (3)  EFSA Journal 2018;16(7):5340.

            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

                        4b1820

                        Asahi Calpis Wellness Co. Ltd, represented by Asahi Calpis Wellness Co. Ltd Europe Representative Office

                           Bacillus subtilis C-3102 (DSM 15544)

                           Additive composition:

                           Bacillus subtilis C-3102 (DSM 15544) with minimum of 1 × 1010 CFU/g

                           Characterisation of the active substance:

                        Viable spores (CFU) of Bacillus subtilis C-3102 (DSM 15544)

                           Analytical method
                            (1)

                        Enumeration: spread plate method using tryptone soya agar (EN 15784:2009)
                        Identification: pulsed-field gel electrophoresis (PFGE).

                        Chickens for fattening

                        —

                        5 × 108

                        —

                                    1.

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

                                    2.

                                    The use is permitted in feed containing one of the following authorised coccidiostats: monensin sodium, salinomycin sodium, seduramycin sodium, lasalocid sodium, maduramycin ammonium, narasin/nicarbazin, diclazuril.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from 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 eye and breathing protection.

                        18 June 2029

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


title: Commission Implementing Regulation (EU) 2019/894 of 28 May 2019 concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species (Text with EEA relevance.)

text:
                  29.5.2019

                  EN

                  Official Journal of the European Union

                  L 142/63

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/894
         of 28 May 2019
         concerning the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

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

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for use in feed for all animal species. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation (EC).

                     (3)

                     That application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 7.232 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 October 2018 (2) that, under the proposed conditions of use, L-threonine produced by Escherichia coli CGMCC 7.232 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive is considered as a potential skin sensitiser and an eye and skin irritant and stated a risk for the users of the additive upon inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of the amino-acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of L-threonine produced by Escherichia coli CGMCC 7.232 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive 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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, 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, 28 May 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2018;16(10):5458.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method.

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

                        mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues.

                        3c410

                        —

                        L-threonine

                           Additive composition:

                        Powder with a minimum of 98 % L-threonine (on a dry matter basis).

                           Characterisation of the active substance:

                        L-threonine produced by fermentation with

                                       Escherichia coli CGMCC 7.232

                                    Chemical formula: C4H9NO3

                                    CAS Number: 72-19-5.

                           Analytical methods
                            (1):
                        For the determination of L-threonine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-threonine monograph’ and

                                    —

                                    Ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD) – EN ISO 17180.

                              For the determination of threonine in premixtures:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD) – EN ISO 17180 and

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

                              For the determination of threonine in compound feed and feed materials:

                                    —

                                    Ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS): Commission Regulation (EC) No 152/2009 (Annex III, F).

                              For the determination of threonine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FD).

                        All species

                        —

                        —

                        —

                                    1.

                                    L- threonine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600  IU endotoxins/m3 air (2).

                                    4.

                                    L-threonine may be used via water for drinking.

                                    5.

                                    The labelling of the additive shall indicate the moisture content.

                                    6.

                                    The labelling of the additive and premixtures shall indicate the following:
                                    ‘If the additive is administered via water for drinking, protein excess should be avoided.’

                        18 June 2029

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

               (2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).


title: Council Implementing Regulation (EU) 2017/2459 of 5 December 2017 amending Implementing Regulation (EU) No 282/2011 laying down implementing measures for Directive 2006/112/EC on the common system of value added tax

text:
                  29.12.2017

                  EN

                  Official Journal of the European Union

                  L 348/32

            COUNCIL IMPLEMENTING REGULATION (EU) 2017/2459
      of 5 December 2017
      amending Implementing Regulation (EU) No 282/2011 laying down implementing measures for Directive 2006/112/EC on the common system of value added tax
      THE COUNCIL OF THE EUROPEAN UNION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (1), and in particular Article 397 thereof,
      Having regard to the proposal from the European Commission,
      Whereas:

                  (1)

                  Council Implementing Regulation (EU) No 282/2011 (2) lays down detailed provisions for the presumption of the location of the customer for determining the place of supply of telecommunications, broadcasting or electronically supplied services provided to non-taxable person.

                  (2)

                  The evaluation of the requirements for the application of those presumptions has shown that for the taxable person established in a Member State and supplying such services to a non-taxable person in other Member States, to obtain, under certain circumstances, two items of non-contradictory evidence of the place where his customer is established or has his permanent address or usually resides, is extremely burdensome.

                  (3)

                  The burden is particularly onerous for small and medium-sized companies. The requirement for one piece of evidence should simplify the obligations for such companies whose intra-Community supplies to consumers in other Member States are below a certain threshold.

                  (4)

                  The simplification of the requirement to prove the customer's location is complementary to the amendments introduced by Article 1 of Council Directive (EU) 2017/2455 (3) to the special schemes laid down in Chapter 6 of Title XII of Directive 2006/112/EC and should therefore apply from the same date.

                  (5)

                  Implementing Regulation (EU) No 282/2011 should therefore be amended accordingly,

            HAS ADOPTED THIS REGULATION:
      Article 1
      Article 24b of Implementing Regulation (EU) No 282/2011 is replaced by the following:

         ‘Article 24b
         For the application of Article 58 of Directive 2006/112/EC, where telecommunications, broadcasting or electronically supplied services are supplied to a non-taxable person:

                     (a)

                     through his fixed land line, it shall be presumed that the customer is established, has his permanent address or usually resides at the place of installation of the fixed land line;

                     (b)

                     through mobile networks, it shall be presumed that the place where the customer is established, has his permanent address or usually resides is the country identified by the mobile country code of the SIM card used when receiving those services;

                     (c)

                     for which the use of a decoder or similar device or a viewing card is needed and a fixed land line is not used, it shall be presumed that the customer is established, has his permanent address or usually resides at the place where that decoder or similar device is located, or if that place is not known, at the place to which the viewing card is sent with a view to being used there;

                     (d)

                     under circumstances other than those referred to in Article 24a and in points (a), (b) and (c) of this Article, it shall be presumed that the customer is established, has his permanent address or usually resides at the place identified as such by the supplier on the basis of two items of non-contradictory evidence as listed in Article 24f of this Regulation.

               Without prejudice to point (d) of the first paragraph, for supplies of services falling under that point, where the total value of such supplies, exclusive of VAT, provided by a taxable person from his business establishment or a fixed establishment located in a Member State, does not exceed EUR 100 000, or the equivalent in national currency, in the current and the preceding calendar year, the presumption shall be that the customer is established, has his permanent address or usually resides at the place identified as such by the supplier on the basis of one item of evidence provided by a person involved in the supply of the services other than the supplier or the customer, as listed in points (a) to (e) of Article 24f.
         Where, during a calendar year, the threshold provided in the second paragraph has been exceeded, that paragraph shall not apply as of that time and until such time as the conditions provided in that paragraph are fulfilled again.
         The corresponding value in national currency of the amount shall be calculated by applying the exchange rate published by the European Central Bank on the date of adoption of Council Implementing Regulation (EU) 2017/2459 (*1).

      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.
      It shall apply from 1 January 2019.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 5 December 2017.

               For the Council

               The President

            T. TÕNISTE

         (1)  OJ L 347, 11.12.2006, p. 1.

         (2)  Council Implementing Regulation (EU) No 282/2011 of 15 March 2011 laying down implementing measures for Directive 2006/112/EC on the common system of value added tax (OJ L 77, 23.3.2011, p. 1).

         (3)  Council Directive (EU) 2017/2455 of 5 December 2017 amending Directive 2006/112/EC and Directive 2009/132/EC as regards certain value added tax obligations for supplies of services and distance sales of goods (OJ L 348, 29.12.2017, p. 7).


title: Commission Implementing Regulation (EU) 2018/3 of 4 January 2018 fixing the trigger volumes for the years 2018 and 2019 for the purposes of possible application of additional import duties on certain fruit and vegetables

text:
               5.1.2018

               EN

               Official Journal of the European Union

               L 2/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/3
   of 4 January 2018
   fixing the trigger volumes for the years 2018 and 2019 for the purposes of possible application of additional import duties on certain fruit and vegetables
   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 (b) of the first paragraph of Article 183 thereof,
   Whereas:

               (1)

               Article 39 of Commission Implementing Regulation (EU) 2017/892 (2) provides that an additional import duty as referred to in Article 182(1) of Regulation (EU) No 1308/2013 may be applied to the products and during the periods listed in Annex VII to that Implementing Regulation. That additional import duty has to apply if the quantity of any of the products put into free circulation for any of the periods of application set out in that Annex exceeds the trigger volume of imports in a year for that product. Additional import duties shall not be imposed where the imports are unlikely to disturb the Union market, or where the effects would be disproportionate to the intended objective.

               (2)

               In accordance with the second subparagraph of Article 182(1) of Regulation (EU) No 1308/2013 the trigger volumes of imports for the possible application of additional import duties on certain fruit and vegetables are based on import data and domestic consumption data for the previous three years. On the basis of the data notified by the Member States for the years 2014, 2015 and 2016, the trigger volumes for certain fruit and vegetables should be fixed for the years 2018 and 2019.

               (3)

               Taking into account that the period of application of possible additional import duties as set out in Annex VII to Implementing Regulation (EU) 2017/892 starts for a number of products on 1 January, this Regulation should apply from 1 January 2018 and therefore it should enter into force as soon as possible,

         HAS ADOPTED THIS REGULATION:
   Article 1
   For the years 2018 and 2019, the trigger volumes referred to in point (b) of the first subparagraph of Article 182(1) of Regulation (EU) No 1308/2013 for the products listed in Annex VII to Implementing Regulation (EU) 2017/892 are set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2018.
   It shall expire on 30 June 2019.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 January 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Implementing Regulation (EU) 2017/892 of 13 March 2017 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to the fruit and vegetables and processed fruit and vegetables sectors (OJ L 138, 25.5.2017, p. 57).

      ANNEX

         Trigger volumes for the products and periods set out in Annex VII to Implementing Regulation (EU) 2017/892, for the possible application of additional import duties

      Without prejudice to the rules on the interpretation of the Combined Nomenclature, the description of the products is deemed to be indicative only. For the purposes of this Annex, the scope of the additional import duties is determined by the scope of the CN codes as they stand at the time of adoption of this Regulation.

                  Order number

                  CN code

                  Description of products

                  Period of application

                  Trigger volume (tonnes)

                  2018

                  2019

                  78.0015

                  0702 00 00

                  Tomatoes

                  From 1 June to 30 September

                  39 326

                  78.0020

                  From 1 October

                  to 31 May

                  483 376

                  78.0065

                  0707 00 05

                  Cucumbers

                  From 1 May to 31 October

                  26 505

                  78.0075

                  From 1 November

                  to 30 April

                  20 482

                  78.0085

                  0709 91 00

                  Artichokes

                  From 1 November

                  to 30 June

                  6 587

                  78.0100

                  0709 93 10

                  Courgettes

                  From 1 January to 31 December

                  55 037

                  78.0110

                  0805 10 22
                  0805 10 24
                  0805 10 28

                  Oranges

                  From 1 December

                  to 31 May

                  302 643

                  78.0120

                  0805 22 00

                  Clementines

                  From 1 November

                  to end of February

                  90 771

                  78.0130

                  0805 21
                  0805 29 00

                  Mandarins (including tangerines and satsumas); wilkings and similar citrus hybrids

                  From 1 November

                  to end of February

                  86 317

                  78.0155

                  0805 50 10

                  Lemons

                  From 1 January to 31 May

                  32 823

                  78.0160

                  From 1 June to 31 December

                  306 804

                  78.0170

                  0806 10 10

                  Table grapes

                  From 16 July to 16 November

                  78 324

                  78.0175

                  0808 10 80

                  Apples

                  From 1 January to 31 August

                  432 630

                  78.0180

                  From 1 September to 31 December

                  39 724

                  78.0220

                  0808 30 90

                  Pears

                  From 1 January to 30 April

                  155 417

                  78.0235

                  From 1 July to 31 December

                  19 187

                  78.0250

                  0809 10 00

                  Apricots

                  From 1 June to 31 July

                  4 630

                  78.0265

                  0809 29 00

                  Cherries other than sour

                  From 16 May to 15 August

                  33 718

                  78.0270

                  0809 30

                  Peaches, including nectarines

                  From 16 June to 30 September

                  3 150

                  78.0280

                  0809 40 05

                  Plums

                  From 16 June to 30 September

                  17 254


title: Commission Implementing Regulation (EU) 2018/151 of 30 January 2018 laying down rules for application of Directive (EU) 2016/1148 of the European Parliament and of the Council as regards further specification of the elements to be taken into account by digital service providers for managing the risks posed to the security of network and information systems and of the parameters for determining whether an incident has a substantial impact

text:
               31.1.2018

               EN

               Official Journal of the European Union

               L 26/48

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/151
   of 30 January 2018
   laying down rules for application of Directive (EU) 2016/1148 of the European Parliament and of the Council as regards further specification of the elements to be taken into account by digital service providers for managing the risks posed to the security of network and information systems and of the parameters for determining whether an incident has a substantial impact
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (1), and in particular Article 16(8) thereof,
   Whereas:

               (1)

               In accordance with Directive (EU) 2016/1148, digital service providers remain free to take technical and organisational measures they consider appropriate and proportionate to manage the risk posed to the security of their network and information systems, as long as those measures ensure an appropriate level of security and take into account the elements provided for in that Directive.

               (2)

               When identifying the appropriate and proportionate technical and organisational measures, the digital service provider should approach information security in a systematic way, using a risk-based approach.

               (3)

               In order to ensure the security of systems and facilities, digital service providers should perform assessment and analysis procedures. These activities should concern the systematic management of network and information systems, the physical and environmental security, the security of supplies and the access controls.

               (4)

               When carrying out a risk analysis within the systematic management of network and information systems, digital service providers should be encouraged to identify specific risks and quantify their significance, for example by identifying threats to critical assets and how they may affect the operations, and determining how best to mitigate those threats based on current capabilities and resource requirements.

               (5)

               Policies on human resources could refer to the management of skills, including aspects related to the development of security related skills and awareness-raising. When deciding on an appropriate set of policies on security of operation, the digital service providers should be encouraged to take into account aspects of change management, vulnerability management, formalisation of operating and administrative practices and system mapping.

               (6)

               Policies on security architecture could comprise in particular the segregation of networks and systems as well as specific security measures for critical operations such as administration operations. The segregation of networks and systems could enable a digital service provider to distinguish between elements such as data flows and computing resources that belong to a client, group of clients, the digital service provider or third parties.

               (7)

               The measures taken with regard to the physical and environmental security should ensure the security of an organisation's network and information systems from damage caused by incidents such as theft, fire, flood or other weather effects, telecommunications or power failures.

               (8)

               The security of supplies such as electrical power, fuel or cooling could encompass the security of the supply chain that includes in particular the security of third party contractors and subcontractors and their management. The traceability of critical supplies refers to the ability of the digital service provider to identify and record sources of those supplies.

               (9)

               The users of digital services should encompass natural and legal persons who are customers of or are subscribers to an online marketplace or a cloud computing service, or who are visitors to an online search engine website in order to undertake keyword searches.

               (10)

               When defining the substantiality of the impact of an incident, the cases laid down in this regulation should be considered as a non-exhaustive list of substantial incidents. Lessons should be drawn from the implementation of this Regulation and from the work of the Cooperation Group as regards the collection of best practice information on risks and incidents and the discussions on modalities for reporting notifications of incidents as referred to in points (i) and (m) of Article 11(3) of Directive (EU) 2016/1148. The result could be comprehensive guidelines on quantitative thresholds of notification parameters that may trigger the notification obligation for digital service providers under Article 16(3) of Directive (EU) 2016/1148. Where appropriate, the Commission could also consider reviewing the thresholds currently laid down in this Regulation.

               (11)

               In order to enable competent authorities to be informed about potential new risks, the digital service providers should be encouraged to voluntarily report any incident whose characteristics have been previously unknown to them such as new exploits, attack-vectors or threat actor, vulnerabilities and hazards.

               (12)

               This Regulation should apply on the day following the expiry of the deadline for transposition of Directive (EU) 2016/1148.

               (13)

               The measures provided for in this Regulation are in accordance with the opinion of the Network and Information Systems Security Committee referred to Article 22 of Directive (EU) 2016/1148,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Subject matter
   This Regulation specifies further the elements to be taken into account by digital service providers when identifying and taking measures to ensure a level of security of network and information systems which they use in the context of offering services referred to in Annex III to Directive (EU) 2016/1148 and specifies further the parameters to be taken into account to determine whether an incident has a substantial impact on the provision of those services.
   Article 2
   Security elements
   1.   Security of systems and facilities referred to in point (a) of Article 16(1) of Directive (EU) 2016/1148 means the security of network and information systems and of their physical environment and shall include the following elements:

               (a)

               the systematic management of network and information systems, which means a mapping of information systems and the establishment of a set of appropriate policies on managing information security, including risk analysis, human resources, security of operations, security architecture, secure data and system life cycle management and where applicable, encryption and its management;

               (b)

               physical and environmental security, which means the availability of a set of measures to protect the security of digital service providers' network and information systems from damage using an all-hazards risk-based approach, addressing for instance system failure, human error, malicious action or natural phenomena;

               (c)

               the security of supplies, which means the establishment and maintenance of appropriate policies in order to ensure the accessibility and where applicable the traceability of critical supplies used in the provision of the services;

               (d)

               the access controls to network and information systems, which means the availability of a set of measures to ensure that the physical and logical access to network and information systems, including administrative security of network and information systems, is authorised and restricted based on business and security requirements.

         2.   With regard to incident handling referred to in point (b) of Article 16(1) of Directive (EU) 2016/1148, the measures taken by the digital service provider shall include:

               (a)

               detection processes and procedures maintained and tested to ensure timely and adequate awareness of anomalous events;

               (b)

               processes and policies on reporting incidents and identifying weaknesses and vulnerabilities in their information systems;

               (c)

               a response in accordance with established procedures and reporting the results of the measure taken;

               (d)

               an assessment of the incident's severity, documenting knowledge from incident analysis and collection of relevant information which may serve as evidence and support a continuous improvement process.

         3.   Business continuity management referred to in point (c) of Article 16(1) of Directive (EU) 2016/1148 means the capability of an organisation to maintain or as appropriate restore the delivery of services at acceptable predefined levels following a disruptive incident and shall include:

               (a)

               the establishment and the use of contingency plans based on a business impact analysis for ensuring the continuity of the services provided by digital service providers which shall be assessed and tested on a regular basis for example, through exercises;

               (b)

               disaster recovery capabilities which shall be assessed and tested on a regular basis for example, through exercises.

         4.   The monitoring, auditing and testing referred to in point (d) of Article 16(1) of Directive (EU) 2016/1148 shall include the establishment and maintenance of policies on:

               (a)

               the conducting of a planned sequence of observations or measurements to assess whether network and information systems are operating as intended;

               (b)

               inspection and verification to check whether a standard or set of guidelines is being followed, records are accurate, and efficiency and effectiveness targets are being met;

               (c)

               a process intended to reveal flaws in the security mechanisms of a network and information system that protect data and maintain functionality as intended. Such process shall include technical processes and personnel involved in the operation flow.

         5.   International standards referred to in point (e) of Article 16(1) of Directive (EU) 2016/1148 mean standards that are adopted by an international standardisation body as referred to in point (a) of Article 2(1) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council (2). Pursuant to Article 19 of Directive (EU) 2016/1148, European or internationally accepted standards and specifications relevant to the security of network and information systems, including existing national standards, may also be used.
   6.   Digital service providers shall ensure that they have adequate documentation available to enable the competent authority to verify compliance with the security elements set out in paragraphs 1, 2, 3, 4 and 5.
   Article 3
   Parameters to be taken into account to determine whether the impact of an incident is substantial
   1.   With regard to the number of users affected by an incident, in particular users relying on the service for the provision of their own services referred to in point (a) of Article 16(4) of Directive (EU) 2016/1148, the digital service provider shall be in a position to estimate either of the following:

               (a)

               the number of affected natural and legal persons with whom a contract for the provision of the service has been concluded; or

               (b)

               the number of affected users having used the service based in particular on previous traffic data.

         2.   The duration of an incident referred to in point (b) of Article 16(4) means the time period from the disruption of the proper provision of the service in terms of availability, authenticity, integrity or confidentiality until the time of recovery.
   3.   As far as the geographical spread with regard to the area affected by the incident referred to in point (c) of Article 16(4) of Directive (EU) 2016/1148 is concerned, the digital service provider shall be in a position to identify whether the incident affects the provision of its services in specific Member States.
   4.   The extent of disruption of the functioning of the service referred to in point (d) of Article 16(4) of Directive (EU) 2016/1148 shall be measured as regards one or more of the following characteristics impaired by an incident: the availability, authenticity, integrity or confidentiality of data or related services.
   5.   With regard to the extent of the impact on economic and societal activities referred to in point (e) of Article 16(4) of Directive (EU) 2016/1148, the digital service provider shall be able to conclude, based on indications such as the nature of his contractual relations with the customer or, where appropriate, the potential number of affected users, whether the incident has caused significant material or non-material losses for the users such as in relation to health, safety or damage to property.
   6.   For the purpose of paragraph 1, 2, 3, 4 and 5, the digital service providers shall not be required to collect additional information to which they do not have access.
   Article 4
   Substantial impact of an incident
   1.   An incident shall be considered as having a substantial impact where at least one of the following situations has taken place:

               (a)

               the service provided by a digital service provider was unavailable for more than 5 000 000 user-hours whereby the term user-hour refers to the number of affected users in the Union for a duration of 60 minutes;

               (b)

               the incident has resulted in a loss of integrity, authenticity or confidentiality of stored or transmitted or processed data or the related services offered by, or accessible via a network and information system of the digital service provider affecting more than 100 000 users in the Union;

               (c)

               the incident has created a risk to public safety, public security or of loss of life;

               (d)

               the incident has caused material damage to at least one user in the Union where the damage caused to that user exceeds EUR 1 000 000.

         2.   Drawing on the best practice collected by the Cooperation Group in the exercise of its tasks under Article 11(3) of Directive (EU) 2016/1148 and on the discussions under point (m) of Article 11(3) thereof, the Commission may review the thresholds laid down in paragraph 1.
   Article 5
   Entry into force
   1.   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   2.   It shall apply from 10 May 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 30 January 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 194, 19.7.2016, p. 1.

      (2)  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).