title: COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Regulation (EU) No 1301/2014 and Regulation (EU) No 1302/2014 as regards provisions on energy measuring system and data collecting system

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 13.6.2018

               amending Regulation (EU) No 1301/2014 and Regulation (EU) No 1302/2014 as regards provisions on energy measuring system and data collecting system

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union
                  1
               , and in particular Article 5(11) thereof,

               Whereas:

               (1)Article 19 of Regulation (EU) No 2016/796 of the European Parliament and of the Council
                  2
                requires the European Union Agency for Railways (the 'Agency') to address recommendations to the Commission on the technical specifications for interoperability ('TSIs') and their revision, in accordance with Article 5 of Directive (EU) 2016/797, and to ensure that TSIs are adapted to technical progress, market trends and social requirements.

               (2)Article 3(5)(c) of Decision (EU) 2017/1474
                  3
                requires TSIs to be reviewed in order to close the remaining open points.

               (3)On 22 September 2017, the Commission requested the Agency to issue recommendations pursuant to Article 5 paragraph 2 of Directive (EU) 2016/797 for the revision of the TSIs relating to the ‘energy’ subsystem of the rail system in the Union (‘ENE TSI’), and the TSI relating to the ‘rolling stock — locomotives and passenger rolling stock’ subsystem of the rail system in the Union (‘LOC&PAS TSI’).

               (4)The Annex to Regulation (EU) No 1301/2014
                  4
                should be amended in order to close the open point addressing the specification related to interface protocols between energy measuring system ('EMS') and data collecting system and to improve the clarity of the text.

               (5)The Annex to Regulation (EU) No 1302/2014
                  5
                related to EMS should be amended in order to ensure coherence between the two TSIs.

               (6)On 4 October 2017, the Agency issued a recommendation on the amendments to the Regulation (EU) No 1301/2014.

               (7)On 14 November 2017, the Agency issued a recommendation on the amendments to the Regulation (EU) No 1302/2014, covering among others the provisions related to EMS.

               (8)The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 51(1) of Directive (EU) 2016/797,

               HAS ADOPTED THIS REGULATION:

               Article 1

               Commission Regulation (EU) No 1301/2014 is amended as follows:

               (1)the last sentence in recital (6) is deleted;

               (2)Article 3 is deleted;

               (3)in Article 9, paragraph 4 is replaced by the following:

               ‘In addition to the implementation of the on-ground energy data collecting system (DCS) defined in point 7.2.4 of the Annex and without prejudice to provisions of point 4.2.8.2.8 of the Annex of Commission Regulation (EU) No 1302/2014, Member States shall ensure that an on-ground settlement system capable to receive data from a DCS and accept it for billing is implemented by XX XXX [two years after the entering into force of this Regulation]. The on-ground settlement system shall be able to exchange compiled energy billing data (CEBD) with other settlement systems, validate the CEBD and allocate the consumption data to the correct parties. This shall be done by taking into account the relevant legislation concerning the energy market.’;

               (4)the Annex to Regulation (EU) No 1301/2014 is amended in accordance with the Annex I to this Implementing Regulation.

               Article 2

               Commission Regulation (EU) No 1302/2014 is amended as follows: the Annex to Regulation (EU) No 1302/2014 is amended in accordance with the Annex II to this Implementing Regulation.

               Article 3

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

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 13.6.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 138, 26.5.2016, p. 44

                     (2)

                        Regulation (EU) No 2016/796 of the European Parliament and of the Council of 11 May 2016 on the European Union Agency for Railways and repealing Regulation (EC) No 881/2004 (OJ L 138, 26.5.2016, p. 1–43).

                     (3)

                        Commission Delegated Decision (EU) 2017/1474 of 8 June 2017 supplementing Directive (EU) 2016/797 of the European Parliament and of the Council with regard to specific objectives for the drafting, adoption and review of technical specifications for interoperability (OJ L 210, 15.8.2017, p. 5–15).

                     (4)

                        Commission Regulation (EU) No 1301/2014 of 18 November 2014 on the technical specifications for interoperability relating to the ‘energy’ subsystem of the rail system in the Union, (OJ L 356, 12.12.2014, p. 179).

                     (5)

                        Commission Regulation (EU) No 1302/2014 of 18 November 2014 concerning a technical specification for interoperability relating to the ‘rolling stock — locomotives and passenger rolling stock’ subsystem of the rail system in the European Union (OJ L 356, 12.12.2014, p. 228).

    ---documentbreak---

               ANNEXES

                  Annex I

               The Annex to Regulation (EU) 1301/2014 is amended as follows:

               (1)point (3) of point 2.1 is replaced by the following:

               ‘In accordance with Annex II, Section 2.2 of Directive 2008/57/EC, the trackside of the electricity consumption measuring system, referred to in this TSI as on-ground energy data collecting system, is set out in point 4.2.17 of this TSI.’;

               (2)the title of point 4.2.5 replaced by the following:

               ‘Current at standstill (DC systems only)’;

               (3)the first paragraph of point 4.2.13 is replaced by the following:

               ‘The overhead contact line shall be designed for a minimum of two pantographs operating adjacently. The design spacing of the two adjacent pantograph heads, centre line to centre line, shall be equal or lower than values set out in one column ‘A’, ‘B’, or ‘C’ selected from Table 4.2.13:’;

               (4)in point 4.2.13, table 4.2.13, first row, the word “Minimum” in the titles of columns is deleted;

               (5)point 4.2.17 is replaced by the following:

               ‘(1) Point 4.2.8.2.8 of LOC & PAS TSI contains the requirements for on-board Energy Measurement Systems (EMS) intended to produce and transmit the Compiled Energy Billing Data (CEBD) to an on-ground energy data collecting system.

               (2) The on-ground energy data collecting system (DCS) shall receive, store and export CEBD without corrupting it, in accordance with the requirements quoted in clause 4.12 of EN 50463-3:2017.

               (3) The on-ground energy DCS shall support all the data exchange requirements as defined in point 4.2.8.2.8.4 of the LOC&PAS TSI and requirements set out in clauses 4.3.6 and 4.3.7 of EN 50463-4:2017.’;

               (6)the title of point 5.2.1.6 is replaced by the following:

               ‘Current at standstill (DC systems only)’;

               (7)the title of point 6.1.4.2 is replaced by the following:

               ‘Assessment of current at standstill (DC systems only)’;

               (8)point (c) of 6.1.5 is replaced by the following:

               ‘(c) continuous current rating;’;

               (9)point 7.2.4 is replaced by the following:

               ‘By 1 January 2022, Member States shall ensure that an on-ground energy data collecting system capable to exchange compiled energy billing data in accordance with point 4.2.17 of this TSI is implemented.’;

               (10)point (d) of point 7.3.1 is replaced by the following:

               ‘An existing subsystem may allow the circulation of TSI-compliant vehicles whilst meeting the essential requirements of Directive 2008/57/EC. The procedure to be used for the demonstration of the level of compliance with the basic parameters of the TSI shall be in accordance with Commission Recommendation 2014/881/EU ’;

               (11)point 7.3.4 is replaced by the following:

               ‘The procedure to be used for the demonstration of the level of compliance of existing lines with the basic parameters of this TSI shall be in accordance with Commission Recommendation 2014/881/EU.’;

               (12)point 7.4.2.11 is deleted;

               (13)in Appendix D, Figure D.1 Pantograph mechanical gauges is replaced by the following figure:

               (14)in Table E.1 of Appendix E, rows 9 and 10 are added:

                        9

                        EN 50463-3

                        Railway application - Energy measurement on board trains - Part 3: Data handling

                        2017

                        On-ground  energy data collecting system (4.2.17)

                        10

                        EN 50463-4

                        Railway application - Energy measurement on board trains - Part 4: Communication

                        2017

                        On-ground  energy data collecting system (4.2.17)

               (15)the text of Appendix F is replaced by ‘Intentionally deleted’;

               (16)in Table G.1 Glossary of Appendix G, the row “Neutral section insulator” is deleted;

               Annex II

               The Annex to Regulation (EU) 1302/2014 is amended as follows:

               (1)in chapter 4 ‘Characteristics of the rolling stock subsystem’, clause 4.2.8.2.8 ‘On-board energy measurement system’  is replaced by the following clause:

               ‘4.2.8.2.8 On-board energy measurement system

               4.2.8.2.8.1 General

               (1)The on-board energy measurement system (EMS) is the system for measurement of all active and reactive electric energy taken from or returned (during regenerative braking) to the overhead contact line (OCL) by the electric unit.

               (2)The EMS shall include at least the following functions: Energy measurement function (EMF) as set out in clause 4.2.8.2.8.2, data handling system (DHS) as set out in clause 4.2.8.2.8.3.

               (3)A suitable communication system will send the compiled energy billing data sets (CEBD) to an on-ground data collecting system (DCS). The interface protocols and transferred data format between EMS and DCS shall fulfil the requirements set out in point 4.2.8.2.8.4.

               (4)This system is suitable for billing purposes; the data sets defined in point 4.2.8.2.8.3 (4) provided by this system shall be accepted for billing in all Member States.

               (5)The EMS rated current and voltage shall be matched to the electric unit rated current and voltage; it shall continue to function correctly when changing between several traction energy supply systems.

               (6)Data stored in the EMS shall be protected against loss of the power supply and the EMS shall be protected from non-authorised access.

               (7)An on-board location function providing location data originated from an external source to the DHS shall be provided in networks where such function is necessary for billing purposes only. In any case, the EMS system shall be able to accommodate a compatible location function. If the location function is provided, it shall fulfil the requirements set out in specification referenced in Appendix J-1, index 116.

               (8)The fitment of an EMS, its on-board location function, the description of on-board to ground communication and the metrological control including the accuracy class of the EMF shall be recorded in the technical documentation described in clause 4.2.12.2 of this TSI.

               (9)The maintenance documentation described in clause 4.2.12.3 of this TSI shall include any periodic verification procedure to ensure the required accuracy level of the EMS during its lifetime.

               4.2.8.2.8.2 Energy measurement function (EMF)

               (1)The EMF shall ensure the measurement of the voltage and current, calculation of the energy and production of energy data.

               (2)The energy data produced by EMF shall have a time reference period of 5 minutes defined by the Universal Time Coordinated (UTC) clock time at the end of each time reference period; originating from the time stamp 00:00:00; It is permitted to use a shorter measuring period if the data can be aggregated on-board into 5 minutes time reference period.

               (3)The accuracy of EMF for active energy measurement shall comply with clauses 4.2.3.1 to 4.2.3.4 of the specification referenced in Appendix J-1, index 117.

               (4)Each device containing one or more functions of EMF shall indicate: metrological control, and its accuracy class, according to the class designations specified in the specification referenced in clauses 4.3.3.4, 4.3.4.3 and 4.4.4.2 of the specification referenced in Appendix J-1, index 117.

               (5)The conformity assessment of the accuracy is set out in clause 6.2.3.19a.

               4.2.8.2.8.3 Data handling system (DHS)

               (1)The DHS shall ensure the production of compiled energy billing data sets for energy billing purposes, by merging data from the EMF with time data and, when required, geographical position, and storing it ready to be sent to an on-ground data collecting system (DCS) by a communication system.

               (2)The DHS shall compile the data without corrupting them and shall incorporate data storage with a memory capacity sufficient to store the compiled data of at least 60 days continuous operation. The time reference used shall be the same as in the EMF.

               (3)The DHS shall have a capability to be interrogated locally on-board for audit and data recovery purposes.

               (4)The DHS shall produce compiled energy billing data sets, (CEBD), by merging the following data for each time reference period:

               –unique EMS consumption point identification (CPID) as defined in the specification referenced in Appendix J-1, index 118.

               –end time of each period, defined as year, month, day, hour, minute and second;

               –location data at the end of each period;

               –consumed/regenerated active and reactive (if appropriate) energy in each period, in units of Watthour (active energy) and var-hour (reactive energy) or their decimal-multiples.

               (5)The conformity assessment of compilation and handling of data produced by DHS is set out in clause 6.2.3.19a.

               4.2.8.2.8.4 Interface protocols and transferred data format between EMS and DCS

               (1)The data exchange between EMS and DCS shall fulfil the following requirements:

               –The application services (service layer) of the EMS shall comply with clause 4.3.3.1 of the specification referenced in Appendix J-1, index 119.

               –User access rights for these application services shall comply with clause 4.3.3.3 of the specification referenced in Appendix J-1, index 119.

               –The structure (data layer) for these application services shall comply with the XML schema as defined in clause 4.3.4 of the specification referenced in Appendix J-1, index 119.

               –The message mechanism (message layer) for supporting these application services shall comply with the methods and the XML schema in clause 4.3.5 of the specification referenced in Appendix J-1, index 119.

               –The application protocols for supporting the message mechanism shall comply with clause 4.3.6 of the specification referenced in Appendix J-1, index 119.

               –The EMS shall use at least one of the communication architectures in clause 4.3.7 of the specification referenced in Appendix J-1, index 119.”;

               (1)in chapter 4 ‘Characteristics of the rolling stock subsystem’, the point 4.2.12.2 (14) is replaced by the following:

               ‘(14) Fitment of an on-board energy measurement system, and of its on-board location function (optional), as required in clause 4.2.8.2.8. Description of on-board to ground communication and the metrological control including functions related to the accuracy classes of the voltage measurement, current measurement and energy calculation’;

               (2)in chapter 6 ‘Assessment of conformity or suitability for use and ‘EC’ verification’, the following clause is added below the clause 6.2.3.19:

               ‘6.2.3.19a On-board energy measurement system (clause 4.2.8.2.8)

               (1)Energy measurement function (EMF)

               The accuracy of the each device containing one or more functions of EMF shall be assessed by testing each function, under reference conditions, using the relevant method as described in clauses 5.4.3.4.1, 5.4.3.4.2 and 5.4.4.3.1 of the specification referenced in Appendix J-1, index 117. The input quantity and power factor range when testing shall correspond to the values set out in Table 3 of the specification referenced in Appendix J-1, index 117.

               The effects of temperature on accuracy of the each device containing one or more functions of EMF shall be assessed by testing each function, under reference conditions (except for temperature), using the relevant method as described in clauses 5.4.3.4.3.1, and 5.4.4.3.2.1 of the specification referenced in Appendix J-1, index 117.

               The mean temperature coefficient of each device containing one or more functions of EMF shall be assessed by testing each function, under reference conditions (except for temperature), using the relevant method as described in clauses 5.4.3.4.3.2 and 5.4.4.3.2.2 of the specification referenced in Appendix J-1, index 120.

               (2)Data handling system (DHS)

               The compiling and handling of data within the DHS shall be assessed by testing using the method as described in the specification referenced in Appendix J-1, index 121.

               (3)On-board energy measurement system (EMS)

               The EMS shall be assessed by testing as described in the specification referenced in the specification referenced in Appendix J-1, index 122.’;

               (3)in chapter 7 ‘Implementation’, the following clause is added below clause 7.1.1.4:

               7.1.1.4a Transitional measure for on-board energy measurement system requirement

               Requirements set out in 4.2.8.2.8 are not mandatory during a transition period ending on 1 January 2022 for projects which, on XXXX [at the date of publication of this Regulation], are projects at an advanced stage of development, contracts in course of performance and rolling stock of an existing design as set out in point 7.1.1.2 of this TSI.

               When the requirements set out in 4.2.8.2.8.4 are not applied, national rules as regards specification related to interface protocols and transferred data format shall apply and the description of on-board to ground communication shall be provided in the technical documentation. ;

               (4)in the list ‘APPENDICES’ following Chapter 7, the text ‘Appendix D: Energy meter’ is replaced by ‘Appendix D: Intentionally deleted’;

               (5)the text of Appendix D is replaced by ‘Intentionally deleted’;

               (6)in the second table of appendix I ‘Aspects for which the technical specification is not available (open points)’, the following row is deleted:

                        On-board energy measurement

                        system

                        4.2.8.2.8

                        and

                        Appendix D

                        On-board to ground communication: specification related to interface protocols and transferred data format

                        Description of on-board to ground communication shall be provided in the technical documentation.

                        The standard series
                           EN 61375-2-6 should be used.

               (7)in appendix J-1, ‘Standards or normative documents’, the indexes 103, 104 and 105 are replaced by the indexes below:

                        103

                        NOT USED

                        104

                        NOT USED

                        105

                        NOT USED

               (8)in appendix J-1, ‘Standards or normative documents’, the indexes below are added:

                        106

                        NOT USED

                        107

                        NOT USED

                        108

                        NOT USED

                        109

                        NOT USED

                        110

                        NOT USED

                        111

                        NOT USED

                        112

                        NOT USED

                        113

                        NOT USED

                        114

                        NOT USED

                        115

                        NOT USED

                        116

                        On-board location function-Requirements

                        4.2.8.2.8.1

                        EN 50463-3:2017

                        4.4

                        117

                        Accuracy of energy measurement function  for active energy measurement:

                        Requirements

                        Class designations

                        Assessment methodology

                        4.2.8.2.8.2

                        6.2.3.19a

                        EN 50463-2:2017

                        4.2.3.1, 4.2.3.2,  4.2.3.3 and 4.2.3.4

                        4.3.3.4, 4.3.4.3 and 4.4.4.2

                        5.4.3.4.1, 5.4.3.4.2, 5.4.4.3.1, Table 3, 5.4.3.4.3.1 and 5.4.4.3.2.1

                        118

                        Energy measurement function: consumption point identification - Definition

                        4.2.8.2.8.3

                        EN 50463-1:2017

                        4.2.5.2

                        119

                        Interface protocols between on-board energy measurement system (EMS) and on-ground data collection system (DCS) - Requirements

                        4.2.8.2.8.4

                        EN 50463-4:2017

                        4.3.3.1, 4.3.3.3, 4.3.4, 4.3.5, 4.3.6 and 4.3.7

                        120

                        Energy measurement function: mean temperature coefficient of each device - Assessment methodology

                        6.2.3.19a

                        EN 50463-2:2017

                        5.4.3.4.3.2 and 5.4.4.3.2.2

                        121

                        The compiling and handling of data within the data handing system-Assessment methodology

                        6.2.3.19a

                        EN 50463-3:2017

                        5.4.8.3, 5.4.8.5 and 5.4.8.6

                        122

                        On- board energy measurement system-Tests

                        6.2.3.19a

                        EN 50463-5:2017

                        5.3.3 and 5.5.4


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 20.12.2017

               laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods

               (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 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001
                  1
               , and in particular Article 20 and Article 35(3) thereof,

               Whereas:

               (1)Regulation (EU) 2015/2283 lays down rules for the placing on the market and use of novel foods in the Union.

               (2)Pursuant to Article 20 of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down administrative and scientific requirements concerning traditional foods from third countries.

               (3)Without prejudice to Articles 5, 15 and 16 of Regulation (EU) 2015/2283, the Commission should verify whether the notification falls within the scope of that Regulation and the validity of the notification or the application.

               (4)Notifications referred to in Article 14 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable Member States and the Authority to evaluate the history of safe use of the traditional food from a third country.

               (5)Applications referred to in Article 16 of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify the validity and enable the Authority to conduct comprehensive risk assessments.

               (6)Where the applicant submits a notification or an application to add, remove or change the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required for the safety assessment where the applicant provides adequate verifiable justification.

               (7)The exchange of information between the Commission, the Member States and the Authority should allow that duly reasoned safety objections are submitted to the Commission where necessary.

               (8)The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the traditional food from a third country is safe for consumers.

               (9)Pursuant to Article 35(3) of Regulation (EU) 2015/2283 the Commission has to adopt implementing acts laying down the requirements referred to in Article 20 of that Regulation.

               (10)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
               Scope and subject matter

               This Regulation lays down rules for the implementation of Article 20 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements concerning traditional foods from third countries and transitional measures referred to in Article 35(3) of that Regulation.

               It applies to notifications and applications as referred to in Articles 14 and 16 of Regulation (EU) 2015/2283.

               Article 2
               Definitions

               In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002
                  2
                and Regulation (EU) 2015/2283, the following definitions shall apply:

               (a)"notification" means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 14 of Regulation (EU) 2015/2283.

               (b)"application" means a stand-alone dossier containing the information and the scientific data submitted in accordance with Article 16 of Regulation (EU) 2015/2283.

               Article 3
               Structure, content and presentation of a notification

               1.A notification shall be submitted electronically to the Commission and shall consist of the following:

               (a)a cover letter;

               (b)a technical dossier;

               (c)a summary of the dossier.

               2.The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.

               3.The technical dossier referred to in paragraph 1(b) shall contain:

               (a)the administrative data as provided for in Article 5;

               (b)the scientific data as provided for in Article 6.

               4.Where the applicant submits a notification to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing safety assessment.

               5.The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.

               Article 4
               Structure, content and presentation of an application

               1.An application shall be submitted electronically to the Commission and shall consist of the following:

               (a)a cover letter;

               (b)a technical dossier;

               (c)a summary of the dossier;

               (d)duly reasoned safety objections referred to in Article 15(2) of Regulation (EU) 2015/2283;

               (e)the applicant's response to duly reasoned safety objections.

               2.The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.

               3.The technical dossier referred to in paragraph 1(b) shall contain:

               (a)the administrative data as provided for in Article 5;

               (b)the scientific data as provided for in Article 6.

               4.Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.

               5.The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.

               Article 5
               Administrative data to be provided in a notification or an application

               In addition to the information set out in Article 14 of Regulation (EU) 2015/2283, the notifications and the applications shall include the following administrative data:

               (a)the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the Commission;

               (b)the date of submission of the dossier;

               (c)a table of contents of the dossier;

               (d)a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;

               (e)a list of the parts of the dossier to be treated as confidential in accordance with Article 23 of Regulation (EU) 2015/2283 and the rules set out in Annex III to this Regulation.

               Article 6
               Scientific data to be provided in a notification or an application

               1.The dossier submitted in support of a notification or an application for the authorisation of a traditional food from a third country shall enable a history of safe use of the traditional food from a third country to be assessed.

               2.The applicant shall provide a copy of the documentation on the procedure followed when gathering the data.

               3.The applicant shall provide a description of the safety evaluation strategy and shall justify the inclusion and exclusion of specific studies or information.

               4.The applicant shall propose an overall conclusion on the safety of the proposed uses of the traditional food from a third country. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.

               Article 7
               Verification of the validity of a notification

               1.On receipt of a notification of a traditional food from a third country, the Commission shall without delay verify whether the food concerned falls within the scope of Regulation (EU) 2015/2283 and whether the notification fulfils the requirements set out in Articles 3, 5 and 6 of this Regulation.

               2.The Commission may request additional information from the applicant as regards the validity of the notification and inform the applicant of the period within which that information shall be provided.

               3.By way of derogation from paragraph 1 of this Article and without prejudice to Article 14 of Regulation (EU) 2015/2283, a notification may be considered valid even if it does not contain all the elements required under Articles 3, 5 and 6 of this Regulation, provided that the applicant has submitted verifiable justification for each missing element.

               4.The Commission shall inform the applicant, the Member States and the Authority of the reasons why the notification is considered not valid.

               Article 8
               Verification of the validity of an application

               1.On receipt of an application for the authorisation of a traditional food from a third country the Commission shall without delay verify whether the application fulfils the requirements of Articles 4 to 6.

               2.The Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information shall be provided.

               3.By way of derogation from paragraph 1 of this Article and without prejudice to Article 16 of Regulation (EU) 2015/2283, an application may be considered valid even if it does not contain all the elements required under Articles 4 to 6 of this Regulation, provided that the applicant has submitted verifiable justification for each missing element.

               4.The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. If the application is not considered valid, the Commission shall indicate the reasons why it is not valid.

               Article 9
               Duly reasoned safety objections

               1.On receipt of a valid notification, consultation between the Commission, the Member States and the Authority may be carried out in the first three months of the period established in Article 15(2) of Regulation (EU) 2015/2283.

               2.The duly reasoned safety objections submitted by a Member State or the Authority to the Commission in accordance with Article 15(2) of Regulation (EU) 2015/2283 shall include the following information:

               (a)the name and description of the traditional food from a third country;

               (b)a scientific statement indicating why the traditional food from a third country may pose a safety risk to human health.

               Article 10
               Information to be included in the opinion of the Authority

               1.The opinion of the Authority shall include the following information:

               (a)the identity and characterisation of the traditional food from a third country;

               (b)the assessment of the history of safe use in a third country;

               (c)an overall risk assessment establishing if possible the safety of the traditional food from a third country and highlighting uncertainties and limitations where relevant;

               (d)conclusions.

               2.The Commission may ask for additional information in its request for an opinion of the Authority.

               Article 11
               Transitional measures

               The notifications as referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be submitted to the Commission not later than 1 January 2019.

               Article 12
               Entry into force and application

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

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 20.12.2017

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 327, 11.12.2015, p. 1.

                     (2)

                        Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

    ---documentbreak---

               EN

               ANNEX

               ANNEX I

               Template cover letter accompanying a notification for traditional food from a third country following the requirements of Article 14 of Regulation (EU) 2015/2283

               EUROPEAN COMMISSION

               Directorate General

               Directorate

               Unit

               Date: ________

               Subject: Notification for authorisation of a traditional food from a third country in accordance with Regulation (EU) 2015/2283.

               (Please indicate clearly by ticking one of the boxes)

               Notification for an authorisation of a new traditional food.

               Notification for adding, removing or changing the conditions of use of an already authorised traditional food. Please provide a reference to that notification.

               Notification for adding, removing or changing the specifications of an already authorised traditional food. Please provide a reference to that notification.

               Notification for adding, removing or changing additional specific labelling requirements of an already authorised traditional food. Please provide a reference to that notification.

               Notification for adding, removing or changing the post-market monitoring requirements of an already authorised traditional food. Please provide a reference to that notification.

               The Applicant(s) or their Representative(s) in the Union

               (name(s), address(es)….) __________________________________________________________________________

               __________________________________________________________________________

               __________________________________________________________________________

               submit(s) this notification in order to update the Union list on novel foods.

               Identity of the traditional food:

               __________________________________________________________________________

               __________________________________________________________________________

               Confidentiality
                  1
               . Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

               Yes

               No

               Food categories, conditions of use and labelling requirements

                        Food category

                        Specific conditions of use

                        Additional specific labelling requirement

                        -

               Yours sincerely,

               Signature ____________________________________

               Enclosures:

               Complete technical dossier

               Summary of the dossier

               List of the parts of the dossier requested to be treated as confidential and verifiable justification for such claims

               Copy of administrative data of applicant(s)

               ANNEX II

               Template cover letter accompanying an application for traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283

               EUROPEAN COMMISSION

               Directorate General

               Directorate

               Unit

               Date: ________

               Subject: Application for authorisation of a traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283

               The Applicant(s) or their Representative(s) within the European Union

               (name(s), address(es)….) __________________________________________________________________________

               __________________________________________________________________________

               __________________________________________________________________________

               submit(s) this application in order to update the Union list on novel foods.

               Identity of the traditional food:

               __________________________________________________________________________

               __________________________________________________________________________

               Confidentiality
                  2
               . Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

               Yes

               No

               Food categories, conditions of use and labelling requirements

                        Food category

                        Specific conditions of use

                        Additional specific labelling requirement

               Yours sincerely,

               Signature ____________________________________

               Enclosures:

               Complete application

               Summary of the application

               List of the parts of the application requested to be treated as confidential and verifiable justification for such claims

               Documented data relating to the duly reasoned safety objections

               Copy of administrative data of applicant(s)

               ANNEX III

               Justification for confidential information

               This Annex shall be updated during the notification or application procedure each time an applicant submits a request for information to be treated as confidential.

               Where the production process contains confidential data, a non-confidential summary of the production process shall be provided.

                        Information requested to be
                           considered as confidential

                        Justification

                        Section x.y (submitted on YYYY/MM/DD)

                        Annex X (submitted on YYYY/MM/DD)

                        Section x.y. (submitted on YYYY/MM/DD)

                        Annex X (submitted on YYYY/MM/DD)

                     (1)

                        Applicants should use the format established in Annex III to indicate which information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.

                     (2)

                        Applicants should use the format established in Annex III to indicate the information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 22.10.2018

               amending Regulation (EC) No 889/2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91
                  1
               , and in particular Article 22(1) thereof,

               Whereas:

               (1)Article 25l(3)(b) of Commission Regulation (EC) No 889/2008
                  2
                allows to supplement natural feed in the grow-out stage of penaeid shrimps and freshwater prawns (Macrobrachium spp.) as referred to in Section 7 of Annex XIIIa to that Regulation. For those shrimps and prawns in earlier life stages in nurseries and hatcheries supplementation of feed, in particular the need for cholesterol, is essential for their development. It is therefore necessary to extend the supplementation of feed with cholesterol to those shrimps and prawns also in their earlier life stages.

               (2)In accordance with Article 27(1)(f) of Regulation (EC) No 889/2008 minerals (trace elements included), vitamins, amino acids and micronutrients can be used in the processing of organic food only as far as their use is legally required in the foodstuffs in which they are incorporated. According to the judgment of the Court of Justice of the European Union in case C-137/13
                  3
               , the use of these substances in the processing of organic food is legally required only when a provision of Union law or a provision of national law compatible therewith directly requires that that substance be added to a foodstuff in order for that foodstuff to be placed on the market.

               (3)Regulation (EU) 2018/848 of the European Parliament and of the Council
                  4
                will allow the use of minerals (trace elements included), vitamins, amino acids or micronutrients in organic infant formula and follow-on formula and processed organic cereal-based foods and baby food when their use is authorised by the relevant Union legislation. In order to avoid a gap between the current interpretation of the use of these substances in foods for infants and young children and to ensure consistency with the upcoming organic legislation it is appropriate to allow their use in the production of organic baby foods for infants and young children.

               (4)Article 42 of Regulation (EC) No 889/2008 allows, under certain conditions and when organic reared pullets are not available, for non-organically reared pullets for egg production of not more than 18 weeks to be brought into an organic livestock unit until 31 December 2018.

               (5)Production of organically reared pullets for egg production is not sufficiently available, both in terms of quality and quantity, on the Union market to meet the needs of laying hen farmers. In order to allow more time for the production of organically reared pullets for egg production and to establish detailed rules for the production of organically reared pullets, the period of application of the exceptional production rules for non-organically reared pullets for egg production of not more than 18 weeks should be extended until 31 December 2020.

               (6)Article 43 of Regulation (EC) No 889/2008 allows the use of a maximum of 5% of non-organic protein feed for porcine and poultry species per period of 12 months for the calendar year 2018.

               (7)Organic protein supply is not sufficiently available, both in terms of quality and quantity, on the Union market to meet the nutritional requirements of pigs and poultry raised on organic farms. The production of organic protein crops is still lagging behind demand. It is therefore appropriate to extend the period in which it is allowed to use a limited proportion of non-organic protein feed for porcine and poultry species until 31 December 2020.

               (8)Article 30(2) of Regulation (EC) No 834/2007 provides for the communication of information related to irregularities or infringements affecting the organic status of a product. Experience shows that the current tools to communicate information in case a Member State finds irregularities or infringements with regard to a product coming from that Member State need to be improved. To enhance efficiency and effectiveness, such communications should take place via the system referred to in Article 94(1) of Regulation (EC) No 889/2008.

               (9)In accordance with the procedure set out in Article 16(3) of Regulation (EC) No 834/2007, several Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II and VIIIa to Regulation (EC) No 889/2008. Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (EGTOP) and the Commission.

               (10)In its recommendations with regard to fertilisers
                  5
                EGTOP concluded, inter alia, that the substances "industrial lime from sugar production" on the basis of sugar cane and "xylite" comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex I to Regulation (EC) No 889/2008.

               (11)In its recommendations with regard to plant protection products
                  6
                EGTOP concluded, inter alia, that the substances "Allium sativum (garlic extract)", "COS-OGA", "Salix spp. Cortex (aka willow bark extract)" and "sodium hydrogen carbonate" comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex II to Regulation (EC) No 889/2008.

               (12)In its recommendations with regard to products and substances used or added in organic products during certain stages of the production process and as type of treatment in accordance with Annex I A to Commission Regulation (EC) No 606/2009
                  7
                in the wine sector
                  8
                EGTOP concluded, inter alia, that the substances "potato proteins", "yeast protein extracts" and "Chitosan derived from Aspergillus niger" for clarification (point 10 of Annex I A to Regulation (EC) No 606/2009), "inactivated yeast, autolysates of yeast and yeast hulls" for addition (point 15 of that Annex), "yeast mannoproteins", and "Chitosan derived from Aspergillus niger" for use (points 6, 35 and 44 of that Annex) comply with the objectives and principles of organic production. Therefore, those substances should be included in Annex VIIIa to Regulation (EC) No 889/2008.

               (13)In its recommendations with regard to products for cleaning and disinfecting
                  9
               , EGTOP concluded, inter alia, that sodium hydroxide should also be available for organic beekeeping.

               (14)Regulation (EC) No 889/2008 should therefore be amended accordingly.

               (15)The measures provided for in this Regulation are in accordance with the opinion of the Committee on Organic Production,

               HAS ADOPTED THIS REGULATION:

               Article 1

               Regulation (EC) No 889/2008 is amended as follows:

               (1) in Article 25, paragraph 1 is replaced by the following:

               '1. For the purpose of cleaning and disinfection of frames, hives and combs, sodium hydroxide may be used.

               For the purpose of protecting frames, hives and combs, in particular from pests, only rodenticides (to be used only in traps), and appropriate products listed in Annex II, are permitted.';

               (2) in Article 25l(3), point (b) is replaced by the following:

               '(b) the feed ration of penaeid shrimps and freshwater prawns (Macrobrachium spp.) referred to in Section 7 of Annex XIIIa may comprise a maximum of 25 % fishmeal and 10 % fish oil derived from sustainable fisheries. In order to secure the quantitative dietary needs of those shrimps and prawns, organic cholesterol may be used to supplement their diets. Where organic cholesterol is not available, non-organic cholesterol derived from wool, shellfish or other sources may be used. The option to supplement their diet with cholesterol applies both in the grow-out stage and in earlier life stages in nurseries and hatcheries.';

               (3) in Article 27(1), point (f) is replaced by the following:

               '(f) minerals (trace elements included), vitamins, amino acids and micronutrients, provided that:

               (i) their use in food for normal consumption is ‘directly legally required’, in the meaning of being directly required by provisions of Union law or provisions of national law compatible with Union law, with the consequence that the food cannot be placed at all on the market as food for normal consumption if those minerals, vitamins, amino acids or micronutrients are not added; or

               (ii) as regards food placed on the market as having particular characteristics or effects in relation to health or nutrition or in relation to needs of specific groups of consumers:

               - in products referred to in points (a) and (b) of Article 1(1) of Regulation (EU) No 609/2013 of the European Parliament and of the Council*, their use is authorised by that Regulation and acts adopted on the basis of Article 11(1) of that Regulation for the products concerned,

               - in products regulated by Commission Directive 2006/125/EC**, their use is authorised by that Directive, or

               - in products regulated by Commission Directive 2006/141/EC***, their use is authorised by that Directive.

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

               ** Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (OJ L 339, 6.12.2006, p. 16).

               *** Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1). ';

               (4) in Article 42(b), the date '31 December 2018' is replaced by '31 December 2020';

               (5) in Article 43, the second subparagraph is replaced by the following:

               'The maximum percentage of non-organic protein feed authorised per period of 12 months for those species shall be 5% for calendar years 2018, 2019 and 2020.';

               (6) in Article 92a, the following paragraph 1a is inserted:

               '1a Where a Member State finds irregularities or infringements relating to the application of this Regulation with regard to a product coming from that Member State and bearing indications as referred to in Title IV of Regulation (EC) No 834/2007 and in Title III of this Regulation or in Annex XI to this Regulation, and if such irregularities or infringements have implications for one or more other Member States, it shall notify the Member State or States concerned, the other Member States and the Commission without delay via the system referred to in Article 94(1) of this Regulation.';

               (7) Annex I is replaced by the text set out in Annex I to this Regulation;

               (8) Annex II is replaced by the text set out in Annex II to this Regulation;

               (9) Annex VIIIa is replaced by the text set out in Annex III to this Regulation.

               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, 22.10.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 189, 20.7.2007, p. 1.

                     (2)

                        Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control (OJ L 250, 18.9.2008, p. 1).

                     (3)

                        Judgment of the Court of Justice of 5 November 2015, C-137/13, ECLI:EU:C:2014:2335.

                     (4)

                        Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

                     (5)

                        Final Report on Fertilisers (II)
                  https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en
                  .

                     (6)

                        Final report on plant protection (III)
                  https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en
                  .

                     (7)

                        Commission Regulation (EC) No 606/2009 of 10 July 2009 laying down certain detailed rules for implementing Council Regulation (EC) No 479/2008 as regards the categories of grapevine products, oenological practices and the applicable restrictions (OJ L 193, 24.7.2009, p. 1).

                     (8)

                        Final report on Wine
                  https://ec.europa.eu/agriculture/organic/eu-policy/expert-advice/documents/final-reports_en
                  .

                     (9)

                        Final report on cleaning and disinfecting
                  https://ec.europa.eu/agriculture/organic/sites/orgfarming/files/docs/body/final_report_egtop_on_cleaning_disinfection_en.pdf

    ---documentbreak---

               EN

               ANNEX I

               'ANNEX I

               Fertilisers, soil conditioners and nutrients referred to in Article 3(1) and Article 6d(2)

               Note:

               A: authorised under Regulation (EEC) No 2092/91 and carried over by Article 16(3)(c) of Regulation (EC) No 834/2007

               B: authorised under Regulation (EC) No 834/2007

                        Authorisation

                        Name

                        Compound products or products containing only materials listed hereunder:

                        Description, compositional requirements, conditions for use

                        A

                        Farmyard manure

                        Product comprising a mixture of animal excrements and vegetable matter (animal bedding).

                        Factory farming origin forbidden

                        A

                        Dried farmyard manure and dehydrated poultry manure

                        Factory farming origin forbidden

                        A

                        Composted animal excrements, including poultry manure and composted farmyard manure included

                        Factory farming origin forbidden

                        A

                        Liquid animal excrements

                        Use after controlled fermentation and/or appropriate dilution

                        Factory farming origin forbidden

                        B

                        Composted or fermented mixture of household waste

                        Product obtained from source separated household waste, which has been submitted to composting or to anaerobic fermentation for biogas production

                        Only vegetable and animal household waste

                        Only when produced in a closed and monitored collection system, accepted by the Member State

                        Maximum concentrations in mg/kg of dry matter:

                        cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury:

                        0,4; chromium (total): 70; chromium (VI): not detectable

                        A

                        Peat

                        Use limited to horticulture (market gardening, floriculture, arboriculture, nursery)

                        A

                        Mushroom culture wastes

                        The initial composition of the substrate shall be limited to products of this Annex

                        A

                        Dejecta of worms (vermicompost) and insects

                        A

                        Guano

                        A

                        Composted or fermented mixture of vegetable matter

                        Product obtained from mixtures of vegetable matter, which have been submitted to composting or to anaerobic fermentation for biogas production

                        b

                        Biogas digestate containing animal by-products co-digested with material of plant or animal origin as listed in this Annex

                        Animal by-products (including by-products of wild animals) of category 3 and digestive tract content of category 2 (categories 2 and

                        3 as defined in Regulation (EC) No 1069/2009 of the European Parliament and of the Council
                           1
                         must not be from factory farming origin.

                        The Processes have to be in accordance with Commission Regulation (EU) No 142/2011
                           2
                        .

                        Not to be applied to edible parts of the crop

                        B

                        Products or by-products of animal origin as below:

                        Blood meal

                        Hoof meal

                        Horn meal

                        Bone meal or degelatinised bone meal

                        Fish meal

                        Meat meal

                        Feather, hair and “chiquette” meal

                        Wool

                        Fur (1)

                        Hair

                        Dairy products

                        Hydrolysed proteins (2)

                        (1)Maximum concentration in mg/kg of dry matter of chromium (VI): not detectable

                        (2)Not to be applied to edible parts of the crop

                        A

                        Products and by-products of plant origin for fertilisers

                        Examples: oilseed cake meal, cocoa husks, malt culms

                        B

                        Hydrolysed proteins of plant origin

                        A

                        Seaweeds and seaweed products

                        As far as directly obtained by:

                        (I)physical processes including dehydration, freezing and grinding

                        (II)extraction with water or aqueous acid and/or alkaline solution

                        (III)fermentation

                        A

                        Sawdust and wood chips

                        Wood not chemically treated after felling

                        A

                        Composted bark

                        Wood not chemically treated after felling

                        A

                        Wood ash

                        From wood not chemically treated after felling

                        A

                        Soft ground rock phosphate

                        Product as specified in point 7 of Annex IA.2. to Regulation (EC) No 2003/2003 of the European Parliament and of the Council
                           3
                         relating to fertilisers

                        Cadmium content less than or equal to 90 mg/kg of P205

                        A

                        Aluminium-calcium phosphate

                        Product as specified in point 6 of Annex IA.2. of Regulation 2003/2003,

                        Cadmium content less than or equal to 90 mg/kg of P205

                        Use limited to basic soils (pH > 7,5)

                        A

                        Basic slag

                        Products as specified in point 1 of Annex IA.2. of Regulation 2003/2003

                        A

                        Crude potassium salt or kainit

                        Products as specified in point 1 of Annex IA.3. of Regulation 2003/2003

                        A

                        Potassium sulphate, possibly containing magnesium salt

                        Product obtained from crude potassium salt by a physical extraction process, containing possibly also magnesium salts

                        A

                        Stillage and stillage extract

                        Ammonium stillage excluded

                        A

                        Calcium carbonate

                        (chalk, marl, ground limestone, Breton ameliorant, (maerl), phosphate chalk)

                        Only of natural origin

                        A

                        Magnesium and calcium carbonate

                        Only of natural origin

                        e.g. magnesian chalk, ground magnesium, limestone

                        A

                        Magnesium sulphate (kieserite)

                        Only of natural origin

                        A

                        Calcium chloride solution

                        Foliar treatment of apple trees, after identification of deficit of calcium

                        A

                        Calcium sulphate (gypsum)

                        Products as specified in point 1 of Annex ID. of Regulation 2003/2003

                        Only of natural origin

                        A, B

                        Industrial lime from sugar production

                        By-product of sugar production from sugar beet and sugar cane

                        A

                        Industrial lime from vacuum salt production

                        By-product of the vacuum salt production from brine found in mountains

                        A

                        Elemental sulphur

                        Products as specified in Annex ID.3 of Regulation 2003/2003

                        A

                        Trace elements

                        Inorganic micronutrients listed in part E of Annex I to Regulation 2003/2003

                        A

                        Sodium chloride

                        Only mined salt

                        A

                        Stone meal and clays

                        B

                        Leonardite (Raw organic sediment rich in humic acids)

                        Only if obtained as a by-product of mining activities

                        B

                        Xylite

                        Only if obtained as a by-product of mining activities (e.g. by-product of brown coal mining)

                        B

                        Chitin (Polysaccharide obtained from the shell of crustaceans)

                        Only if obtained from sustainable fisheries, as defined in Article 3(e) of Council Regulation (EC) No 2371/2002
                           4
                         or organic aquaculture

                        B

                        Organic rich sediment from fresh water bodies formed
                              under
                              exclusion
                              of oxygen

                        (e.g. sapropel)

                        Only organic sediments that are by-products of fresh water body management or extracted from former freshwater areas

                        When applicable, extraction should be done in a way to cause minimal impact on the aquatic system

                        Only sediments derived from sources free from contaminations of pesticides, persistent organic pollutants and petrol like substances

                        Maximum concentrations in mg/kg of dry matter:

                        cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable

               '

               ANNEX II

               'ANNEX II

               Pesticides — Plant protection products referred to in Article 5(1)

               All the substances listed in this Annex have to comply at least with the conditions for use as specified in the Annex to Implementing Regulation (EU) No 540/2011
                  5
                More restrictive conditions for use for organic production are specified in the second column of each table

               1.
                     Substances of plant or animal origin

                        Name

                        Description, compositional requirement, conditions for use

                        Allium sativum (Garlic extract)

                        Azadirachtin extracted from Azadirachta indica (Neem tree)

                        Basic substances (including: . Lecithins, sucrose, fructose, vinegar, whey, chitosan hydrochloride
                           6
                        , and Equisetum arvense etc )

                        Only those basic substances as defined by Article 23 of Regulation (EC) No 1107/2009
                           7
                         which are food as defined in Article 2 of Regulation (EC) No 178/2002 and have plant or animal origin

                        Substances not to be used as herbicides, but only for the control of pests and diseases.

                        Beeswax

                        Only as pruning agent/wound protectant

                        COS-OGA

                        Hydrolysed proteins excluding gelatine

                        Laminarin

                        Kelp shall be either grown organically in accordance with Article 6d or harvested in a sustainable way in accordance with Article 6c

                        Pheromones

                        Only in traps and dispensers.

                        Plant oils

                        All uses authorised, except herbicide .

                        Pyrethrins extracted from Chrysanthemum cinerariaefolium

                        Pyrethroids (only deltamethrin or lambdacyhalothrin)

                        Only in traps with specific attractants; only against Bactrocera oleae and Ceratitis capitata Wied

                        Quassia extracted from Quassia amara

                        Only as Insecticide, repellent

                        Repellents by smell of animal or plant origin/sheep fat

                        Only on non-edible parts of the crop and where crop material is not ingested by sheep or goats

                        Salix spp. Cortex (aka willow bark extract)

               2.
                     Micro-organisms or substances produced by micro-organisms

                        Name

                        Description, compositional requirement, conditions for use

                        Micro-organisms

                        Not from GMO origin

                        Spinosad

               3.
                     Substances other than those mentioned in Sections 1 and 2

                        Name

                        Description, compositional requirement, conditions or restrictions to use

                        Aluminium silicate (Kaolin)

                        Calcium hydroxide

                        When used as Fungicide, only in fruit trees, including nurseries, to control Nectria galligena

                        Carbon dioxide

                        Copper compounds in the form of: copper hydroxide, copper oxychloride, copper oxide, Bordeaux mixture, and tribasic copper sulphate

                        Up to 6 kg copper per ha per year.

                        For perennial crops, Member States may, by derogation from the previous  paragraph, provide that the 6 kg copper limit can be exceeded in a given year provided that the average quantity actually used over a 5-year period consisting of that year and of the four preceding years does not exceed 6 kg.

                        Diammonium phosphate

                        Only as attractant in traps

                        Ethylene

                        Only indoor uses as plant growth regulator may be authorised. Authorisations shall be limited to professional users.

                        Fatty acids

                        All uses authorised, except herbicide

                        Ferric phosphate (iron (III) orthophosphate)

                        Preparations to be surface-spread between cultivated plants

                        Kieselgur ( diatomaceous earth)

                        Lime sulphur (calcium polysulphide)

                        Paraffin oil

                        Potassium and sodium hydrogen carbonate (aka potassium /sodium bicarbonate)

                        Quartz sand

                        Sulphur

               '

               ANNEX III

               'ANNEX VIIIa

               Products and substances authorised for use or addition in organic products of the wine sector referred to in Article 29c

                        Type of treatment in accordance with Annex I A to Regulation (EC) No 606/2009

                        Name of products or substances

                        Specific conditions, restrictions within the limits and conditions set out in Regulation (EC) No 1234/2007 and Regulation (EC) No 606/2009

                        Point 1: Use for aeration or oxygenation

                        —Air

                        —Gaseous oxygen

                        Point 3: Centrifuging and filtration

                        —Perlite

                        —Cellulose

                        —Diatomeceous earth

                        Use only as an inert filtering agent

                        Point 4: Use in order to create an inert atmosphere and to handle the product shielded from the air

                        —Nitrogen

                        —Carbon dioxide

                        —Argon

                        Points 5, 15 and 21: Use

                        — Yeasts (1)

                        Point 6: Use

                        —Di-ammonium phosphate

                        —Thiamine hydrochloride

                        —Inactivated yeast, autolysates of yeast and yeast hulls

                        Point 7: Use

                        —Sulphur dioxide

                        —Potassium bisulphite or potassium metabisulphite

                        (a)The maximum sulphur dioxide content shall not exceed 100 milligrams per litre for red wines as referred to in point 1(a) of Part A of Annex I B to Regulation (EC) No 606/ 2009 and with a residual sugar level lower than 2 grams per litre;

                        (b)TThe maximum sulphur dioxide content shall not exceed 150 milligrams per litre for white and rosé wines as referred to in point 1(b) of Part A of Annex I B to Regulation (EC) No 606/2009 and with a residual sugar level lower than 2 grams per litre;

                        (c)For all other wines, the maximum sulphur dioxide content applied in accordance with Annex I B to Regulation (EC) No 606/2009 on 1 August 2010, shall be reduced by 30 milligrams per litre.

                        Point 9: Use

                        — Charcoal for oenological use

                        Point 10: Clarification

                        —Edible gelatine (2)

                        —Plant proteins from wheat or peas (2)

                        —Isinglass (2)

                        —Egg white albumin (2)

                        —Tannins (2)

                        —Potato proteins (2)

                        —Yeast protein extracts(2)

                        —Casein

                        —Chitosan derived from Aspergillus niger

                        —Potassium caseinate

                        —Silicon dioxide

                        —Bentonite

                        —Pectolytic enzymes

                        Point 12: Use for acidification purposes

                        —Lactic acid

                        —L(+)Tartaric acid

                        Point 13: Use for deacidification purposes

                        —L(+)Tartaric acid

                        —Calcium carbonate

                        —Neutral potassium tartrate

                        —Potassium bicarbonate

                        Point 14: Addition

                        —— Aleppo pine resin

                        Point 17: Use

                        — Lactic bacteria

                        Point 19: Addition

                        — L-Ascorbic acid

                        Point 22: Use for bubbling

                        — Nitrogen

                        Point 23: Addition

                        — Carbon dioxide

                        Point 24: Addition for wine stabilisation purposes

                        — Citric acid

                        Point 25: Addition

                        — Tannins (2)

                        Point 27: Addition

                        — Meta-tartaric acid

                        Point 28: Use

                        — Acacia gum (2) (= gum arabic)

                        Point 30: Use

                        — Potassium bitartrate

                        Point 31: Use

                        — Cupric citrate

                        Point 31: Use

                        — Copper sulphate

                        Point 35: Use

                        — Yeast mannoproteins

                        Point 38: Use

                        — Oak chips

                        Point 39: Use

                        — Potassium alginate

                        Point 44: Use

                        — Chitosan derived from Aspergillus niger

                        Point 51: Use

                        — Inactivated yeast

                        Type of treatment in accordance with Annex III, point A(2)(b) to Regulation (EC) No 606/2009

                        — Calcium sulphate

                        Only for ‘vino generoso’ or ‘vino generoso de licor’

               (J) For the individual yeast strains: if available, derived from organic raw material. (2) Derived from organic raw material if available.

               '

                     (1)

                        Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1).

                     (2)

                        Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/ 2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).

                     (3)

                        OJ L 304, 21.11.2003, p. 1.

                     (4)

                        Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the Common Fisheries Policy (OJ L 358, 31.12.2002, p. 59).

                     (5)

                        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).

                     (6)

                        Obtained from  sustainable fisheries or organic aquaculture

                     (7)

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