title: Commission Implementing Regulation (EU) No 1249/2012 of 19 December 2012 laying down implementing technical standards with regard to the format of the records to be maintained by central counterparties according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories  Text with EEA relevance

text:
               21.12.2012

               EN

               Official Journal of the European Union

               L 352/32

         COMMISSION IMPLEMENTING REGULATION (EU) No 1249/2012
   of 19 December 2012
   laying down implementing technical standards with regard to the format of the records to be maintained by central counterparties according to Regulation (EU) No 648/2012 of the European Parliament and of the Council on OTC derivatives, central counterparties and trade repositories
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to the opinion of the European Central Bank (1),
   Having regard to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (2), and in particular Article 29(5) thereof,
   Whereas:

               (1)

               In accordance with Article 29(4) of Regulation (EU) No 648/2012, Articles 13, 14 and 15 of the delegated act with regard to regulatory technical standards specifying the details of the records and information to be kept by central counterparties (CCPs) adopted pursuant to Article 29(4) of Regulation (EU) No 648/2012, rules should also be laid down to specify the format of the record and information kept in accordance those Articles.

               (2)

               To carry out their duties effectively and consistently, the relevant authorities should be provided with data that are comparable among CCPs. The use of common formats also facilitates the reconciliation of data between CCPs.

               (3)

               A CCP should be required to retain data for record keeping purposes in a format compatible with the format in which data is retained by trade repositories, taking into account that in certain circumstances CCPs and trade repositories are required to maintain or report the same information. The use of a common format across different financial market infrastructures facilitates the greater use of these formats by a wide variety of market participants, thus promoting standardisation.

               (4)

               To facilitate straight through processing and reduction of costs to market participants, it is important to use standardised procedures and data formats across CCPs as much as possible.

               (5)

               The underlying should be identified by using a single identifier, however there is currently no market wide standardised code to identify the underlyings within a basket. CCPs should therefore indicate at least that the underlying is a basket and use International Securities Identification numbers (ISINs) for standardised indices where possible.

               (6)

               This Regulation is based on the draft implementing technical standards submitted by the European Securities and Markets Authority (ESMA) to the Commission.

               (7)

               In accordance with Article 15 of Regulation (EU) No 1095/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Securities and Markets Authority) (3), ESMA has conducted an open public consultation before submitting the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Securities and Markets Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1095/2010,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Formats of records
   1.   A CCP shall retain the records specified in Article 20 of the delegated act with regard to regulatory technical standards on requirements specifying the details of the records and information to be kept by central counterparties (CCPs) adopted pursuant to Article 29(4) of Regulation (EU) No 648/2012 for each contract processed in the format set out in Table 1 in the Annex.
   2.   A CCP shall retain the records specified in Article 21 of the delegated act with regard to regulatory technical standards on requirements specifying the details of the records and information to be kept by central counterparties (CCPs) adopted pursuant to Article 29(4) of Regulation (EU) No 648/2012 for each position in the format set out in Table 2 in the Annex.
   3.   A CCP shall retain the records specified in Article 22 of the delegated act with regard to regulatory technical standards on requirements specifying the details of the records and information to be kept by central counterparties (CCPs) adopted pursuant to Article 29(4) of Regulation (EU) No 648/2012 for activities related to its business and internal organisation in the format set out in Table 3 in the Annex.
   4.   A CCP shall provide the competent authority the records and information under paragraphs 1, 2 and 3 in a format that allows a direct data feed between the CCP and the competent authority. A CCP shall establish such data feed within six months after the request of the competent authority.
   Article 2
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 December 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  Not yet published in the Official Journal.

      (2)  OJ L 201. 27.7.2012, p. 1.

      (3)  OJ L 331, 15.12.2010, p. 84.

      ANNEX

         Tables of fields to be recorded as referred to in Article 1

         Table 1

         Records of transactions processed

                  Field

                  Format

                  Description

                  1

                  Reporting timestamp

                     ISO 8601 date format / UTC time format.

                  Date and time of reporting.

                  2

                  Price/rate

                     Up to 20 numerical digits in the format xxxx,yyyyy.

                  The price per security or derivative contract excluding commission and (where relevant) accrued interest. In the case of a debt instrument, the price may be expressed either in terms of currency or as a percentage.

                  2a

                  Price notation

                     E.g. ISO 4217 Currency Code, 3 alphabetical digits, percentage.

                  The manner in which the price is expressed.

                  3

                  Notional Currency

                     ISO 4217 Currency Code, 3 alphabetical digits.

                  The currency in which the price is expressed. If, in the case of a bond or other form of securitised debt, the price is expressed as a percentage, that percentage shall be included.

                  3a

                  Deliverable currency

                     ISO 4217 Currency Code, 3 alphabetical digits.

                  The currency to be delivered.

                  4

                  Quantity

                     Up to 10 numerical digits.

                  The number of units of the financial instruments, the nominal value of bonds, or the number of derivative contracts included in the transaction.

                  5

                  Quantity notation

                     Up to 10 numerical digits.

                  An indication as to whether the quantity is the number of units of financial instruments, the nominal value of bonds or the number of derivative contracts.

                  6

                  CCP side

                     B=Buyer / S=Seller.

                  7

                  Product ID

                     Interim taxonomy in accordance with the information in Article 4 of Regulation (EC) xx/2012 [draft ITS on format and frequency of trade reports to trade repositories], ISIN or a unique product identifier (UPI).

                  The contract shall be identified by using a product identifier, where available.

                  8

                  Clearing member ID

                     Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), BIC (11 alphanumerical digits) or client code (50 alphanumerical digits).

                  In case the reporting counterparty is not a clearing member, its clearing member shall be identified in this field by a unique code. In case of an individual, a client code, as assigned by the CCP, shall be used.

                  9

                  Beneficiary ID

                     Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), BIC (11 alphanumerical digits) or client code (50 alphanumerical digits).

                  If the beneficiary of the contract is not a C/P to this contract it has to be identified by a unique code or, in case of individuals, by a client code as assigned by the legal entity used by the individual.

                  10

                  Party that transferred the contract (in case of give-up)

                     Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), BIC (11 alphanumerical digits) or client code (50 alphanumerical digits).

                  11

                  Venue of execution

                     ISO 10383 Market Identifier Code (MIC) where relevant, XOFF for listed derivatives that are traded off-exchange or XXXX for OTC derivatives.

                  Identification of the venue where the transaction was executed. In case of a contract concluded OTC, it has to be identified whether the respective instrument is admitted to trading but traded OTC or not admitted to trading and traded OTC.

                  12

                  Date of interposition

                     ISO 8601 date format.

                  The day on which the interposition of the CCP in the contract was executed.

                  13

                  Time of interposition

                     UTC time format.

                  The time at which the interposition of the CCP in the contract was executed, reported in the local time of the competent authority to which the transaction will be reported, and the basis in which the transaction is reported expressed as Coordinated Universal Time (UTC) +/- hours.

                  14

                  Date of termination of the contract

                     ISO 8601 date format.

                  The day on which the termination of the contract occurred.

                  15

                  Time of termination of the contract

                     UTC time format.

                  The time at which the termination of the contract occurred, reported in the local time of the competent authority to which the transaction will be reported, and the basis in which the transaction is reported expressed as Coordinated Universal Time (UTC) +/- hours.

                  16

                  Delivery type

                     C = cash, P = physical, O = optional for counterparty.

                  Whether the contract is settled physically or in cash.

                  17

                  Settlement date

                     ISO 8601 date format.

                  The day on which the settlement or the buy-in of the contract is executed. If more than one, further fields may be identified.

                  18

                  Time of settlement or of buy-in in the contract

                     UTC time format.

                  The time at which the settlement or the buy-in of the contract is executed, reported in the local time of the competent authority to which the transaction will be reported, and the basis in which the transaction is reported expressed as Coordinated Universal Time (UTC) +/- hours.

                  Details on the original terms of the contracts cleared, to be provided to the extent they are applicable

                  19

                  Date

                     ISO 8601 date format.

                  The day on which the contract was originally concluded.

                  20

                  Time

                     UTC time format.

                  The time at which the original contract was originally concluded, reported in the local time of the competent authority to which the transaction will be reported, and the basis in which the transaction is reported expressed as Coordinated Universal Time (UTC) +/- hours.

                  21

                  Product ID

                     Interim taxonomy in accordance with the information in Article 4 of Regulation (EC) xx/2012 [draft ITS on format and frequency of trade reports to trade repositories], ISIN or a unique product identifier (UPI).

                  The contract shall be identified by using a unique product identifier where available.

                  22

                  Underlying

                     A unique product identifier, ISIN (12 alphanumerical digits and CFI (6 alphanumerical digits). Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), B= Basket, or I=Index.

                  The instrument identification applicable to the security that is the underlying asset in a derivative contract as well as the transferable security falling within Article 4(1)(18)(c) of Directive 2004/39/EC.

                  23

                  Derivative type (in case of derivative contract)

                  The harmonised description of the derivative type should be done according to one of the top level categories as provided by a uniform internationally accepted standard for financial instrument classification.

                  24

                  Inclusion of the instrument in the ESMA register of contracts subject to the clearing obligation (in case of derivative contract)

                     Y=Yes / N=No.

                  Other information to be provided to the extent they are applicable

                  25

                  Identification of the interoperable CCP clearing one leg of the transaction

                     Legal Entity Identifier (LEI) (20 alphanumerical digits), interim entity identifier (20 alphanumerical digits), BIC (11 alphanumerical digits) or client code (50 alphanumerical digits).

         Table 2

         Position records

                  Field

                  Format

                  1

                  Clearing member ID

                     Legal Entity Identifier (LEI), interim entity identifier or BIC

                  2

                  Beneficiary ID

                     Legal Entity Identifier (LEI), interim entity identifier, BIC or Client Code

                  3

                  Interoperable CCP maintaining the position

                     Legal Entity Identifier (LEI), interim entity identifier, BIC or Client Code

                  4

                  Sign of the position

                     B=Buyer / S=Seller

                  5

                  Value of the position

                     Up to 10 numerical digits (xxxx,yy).

                  6

                  Price at which the contracts are valued

                     Up to 10 numerical digits (xxxx,yy).

                  7

                  Currency

                     ISO Currency Code.

                  8

                  Other relevant information

                     Free Text

                  9

                  Amount of margins called by the CCP

                     Up to 10 numerical digits (xxxx,yy).

                  10

                  Amount of default fund contributions called by the CCP

                     Up to 10 numerical digits (xxxx,yy).

                  11

                  Amount of other financial resources called by the CCP

                     Up to 10 numerical digits (xxxx,yy).

                  12A

                  Amount of margins posted by the Clearing Member with reference to client account A

                     Up to 10 numerical digits (xxxx,yy).

                  13A

                  Amount of default fund contributions posted by the Clearing Member with reference to client account A

                     Up to 10 numerical digits (xxxx,yy).

                  14A

                  Amount of other financial resources posted by the Clearing Member with reference to client account A

                     Up to 10 numerical digits (xxxx,yy).

                  15B

                  Amount of margins posted by the Clearing Member with reference to client account B

                     Up to 10 numerical digits (xxxx,yy).

                  16B

                  Amount of default fund contributions posted by the Clearing Member with reference to client account B

                     Up to 10 numerical digits (xxxx,yy).

                  17B

                  Amount of other financial resources posted by the Clearing Member with reference to client account B

                     Up to 10 numerical digits (xxxx,yy).

         Table 3

         Business records

                  Field

                  Format

                  Description

                  1

                  Organisational charts

                     Free text

                  Board and relevant committees, clearing unit, risk management unit, and all other relevant units or divisions.

                  Shareholders or members that have qualifying holdings (fields to be added for each of the relevant shareholder/member)

                  2

                  Type

                     S=Shareholder / M=member.

                  3

                  Type of qualified holding

                     D=direct / I=indirect.

                  4

                  Type of entity

                     N=natural person / L=legal person.

                  5

                  Amount of the holding

                     Up to 10 numerical digits (xxxx,yyyyy).

                  Other documents

                  6

                  Policies, procedures, processes required under organisational requirements

                     Documents

                  7

                  Minutes of Board meetings, meeting of sub-committees (if applicable) and of Senior Management Committees (if applicable)

                     Documents

                  8

                  Minutes of meetings of the risk committee

                     Documents

                  9

                  Minutes of consultation group with clearing members and clients (if any)

                     Documents

                  10

                  Reports of internal and external audit, risk management, compliance and consultant

                     Documents

                  11

                  Business continuity policy and disaster recovery plan

                     Documents

                  12

                  Liquidity plan and daily liquidity reports

                     Documents

                  13

                  Documents reflecting all assets and liabilities and capital accounts

                     Documents

                  14

                  Complaints received

                     Free text

                  For each complaint: information on complaint’s name, address and account number; date of receiving the complaint; names of all persons identified in the complaint; description of the nature of the complaint; disposition of the complaint; date at which the complaint was resolved.

                  15

                  Information on interruption of services or dysfunction

                     Free text

                  Information on any interruption of services or dysfunction, including a detailed report on the timing, effects and remedial actions.

                  16

                  Results of back and stress test performed

                     Free text

                  17

                  Written communications with competent Authorities, ESMA and the relevant members of the ESCB

                     Documents

                  18

                  Legal opinions received in accordance with organisational requirements

                     Documents

                  19

                  Interoperability arrangements with other CCPs (where applicable)

                     Documents

                  20

                  List of all clearing members (Article 17 of Regulation (EU) No XXX/2012)

                     Free text / Document

                  List in accordance with Article 17 of Regulation (EU) No XXX/2012.

                  21

                  Information required by Article 17 of Regulation (EU) No XXX/2012

                     Free text / Documents

                  Law and Rules governing (i) the access to the CCP, (ii) the contracts concluded by the CCP with clearing members and, where practicable, clients, (iii) the contracts that the CCP accepts for clearing, (iv) any interoperability arrangements, (v) the use of collateral and default fund contributions, including the liquidation of positions and collateral and the extent to which collateral is protected against third party claims (level of segregation).

                  22

                  Development on new initiative processes

                     Free text

                  In case of the provision of new services.


title: Commission Implementing Regulation (EU) No 828/2014 of 30 July 2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food  Text with EEA relevance

text:
               31.7.2014

               EN

               Official Journal of the European Union

               L 228/5

         COMMISSION IMPLEMENTING REGULATION (EU) No 828/2014
   of 30 July 2014
   on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (1), and in particular Article 36(3)(d) thereof,
   Whereas:

               (1)

               People with coeliac disease suffer from a permanent intolerance to gluten. Wheat (i.e. all Triticum species, such as durum wheat, spelt, and khorasan wheat), rye and barley have been identified as grains that are scientifically reported to contain gluten. The gluten present in those grains can cause adverse health effects to people intolerant to gluten and therefore its consumption should be avoided by such people.

               (2)

               Information on the absence or reduced presence of gluten in food should help people intolerant to gluten to identify and choose a varied diet when eating inside or outside the home.

               (3)

               Commission Regulation (EC) No 41/2009 (2) sets out harmonised rules on the information provided to consumers on the absence (‘gluten-free’) or reduced presence of gluten (‘very low gluten’) in food. The rules of that Regulation are based on scientific data and guarantee that consumers are not misled or confused by information provided on a divergent basis on the absence or reduced presence of gluten in food.

               (4)

               In the context of the revision of the legislation on foodstuffs intended for particular nutritional uses Regulation (EU) No 609/2013 of the European Parliament and of the Council (3) repeals Regulation (EC) No 41/2009 from 20 July 2016. It should be ensured that, after that date, the provision of information on the absence or reduced presence of gluten in food continues to be based on the relevant scientific data and is not provided on a divergent basis which could mislead or confuse the consumers, in accordance with the requirements laid down in Article 36(2) of Regulation (EU) No 1169/2011. It is therefore necessary that uniform conditions for the application of these requirements to food information provided by food business operators on the absence or reduced presence of gluten in food are maintained in the Union and these conditions should be based on Regulation (EC) No 41/2009.

               (5)

               Certain foods have been specially produced, prepared and/or processed to reduce the gluten content of one or more gluten-containing ingredients or to substitute the gluten-containing ingredients with other ingredients naturally free of gluten. Other foods are made exclusively from ingredients that are naturally free of gluten.

               (6)

               The removal of gluten from gluten-containing grains presents considerable technical difficulties and economic constraints and therefore the manufacture of totally gluten-free food when using such grains is difficult. Consequently, many foods especially processed to reduce the gluten content of one or more gluten-containing ingredients on the market may contain low residual amounts of gluten.

               (7)

               Most people with intolerance to gluten can include oats in their diet without adverse effect on their health. This is an issue of ongoing study and investigation by the scientific community. However, a major concern is the contamination of oats with wheat, rye or barley that can occur during grain harvesting, transport, storage and processing. Therefore, the risk of gluten contamination in products containing oats should be taken into consideration with regard to the relevant information provided on those food products by food business operators.

               (8)

               Different people with intolerance to gluten may tolerate variable small amounts of gluten within a restricted range. In order to enable individuals to find on the market a variety of foodstuffs appropriate for their needs and for their level of sensitivity, a choice of products should be possible with different low levels of gluten within such a restricted range. It is important, however, that the different products are properly labelled in order to ensure their correct use by people intolerant to gluten with the support of information campaigns fostered in the Member States.

               (9)

               It should be possible for a food which is specially produced, prepared and/or processed to reduce the gluten content of one or more gluten-containing ingredients or to substitute the gluten-containing ingredients with other ingredients naturally free of gluten to bear terms indicating either the absence (‘gluten-free’) or reduced presence (‘very low gluten’) of gluten in accordance with the provisions laid down in this Regulation. It should also be possible for this food to bear a statement informing consumers that it is specifically formulated for people intolerant to gluten.

               (10)

               It should also be possible for a food containing ingredients naturally free of gluten to bear terms indicating the absence of gluten, in accordance with the provisions laid down in this Regulation and provided that the general conditions on fair information practices set out in Regulation (EU) No 1169/2011 are complied with. In particular, food information should not be misleading by suggesting that the food possesses special characteristics when in fact all similar foods possess such characteristics.

               (11)

               Commission Directive 2006/141/EC (4) prohibits the use of ingredients containing gluten in the manufacture of infant formulae and follow-on formulae. Therefore, the use of the statements ‘very low gluten’ or ‘gluten-free’ when providing information on such products should be prohibited given that pursuant to the present Regulation, these statements are used for indicating respectively a content of gluten not exceeding 100 mg/kg and 20 mg/kg.

               (12)

               The Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten (5) should be taken appropriately into consideration for the purposes of this Regulation.

               (13)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Scope and subject matter
   This Regulation applies to the provision of information to consumers on the absence or reduced presence of gluten in food.
   Article 2
   Definitions
   For the purposes of this Regulation, the following definitions shall apply:

               (a)

               ‘gluten’ means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives thereof, to which some persons are intolerant and which is insoluble in water and 0,5 M sodium chloride solution;

               (b)

               ‘wheat’ means any Triticum species.

         Article 3
   Information to consumers
   1.   Where statements are used to provide information to consumers on the absence or reduced presence of gluten in food, such information shall be given only through the statements and in accordance with the conditions set out in the Annex.
   2.   The food information referred to in paragraph 1 may be accompanied by the statements ‘suitable for people intolerant to gluten’ or ‘suitable for coeliacs’.
   3.   The food information referred to in paragraph 1 may be accompanied by the statements ‘specifically formulated for people intolerant to gluten’ or ‘specifically formulated for coeliacs’ if the food is specially produced, prepared and/or processed to:

               (a)

               reduce the gluten content of one or more gluten-containing ingredients; or

               (b)

               substitute the gluten-containing ingredients with other ingredients naturally free of gluten.

         Article 4
   Infant formulae and follow-on formulae
   The provision of food information on the absence or reduced presence of gluten in infant formulae and follow-on formulae as defined in Directive 2006/141/EC shall be prohibited.
   Article 5
   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.
   It shall apply from 20 July 2016.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 30 July 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 304, 22.11.2011, p. 18.

      (2)  Commission Regulation (EC) No 41/2009 of 20 January 2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten (OJ L 16, 21.1.2009, p. 3).

      (3)  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).

      (4)  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).

      (5)  CODEX STAN 118-1979.

      ANNEX
      Statements on the absence or reduced presence of gluten in food that are allowed to be made and conditions thereof
      A.   General requirements

      GLUTEN-FREE
      The statement ‘gluten-free’ may only be made where the food as sold to the final consumer contains no more than 20 mg/kg of gluten.
      VERY LOW GLUTEN
      The statement ‘very low gluten’ may only be made where the food, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, contains no more than 100 mg/kg of gluten in the food as sold to the final consumer.
      B.   Additional requirements for food containing oats

      Oats contained in a food presented as gluten-free or very low gluten must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats cannot exceed 20 mg/kg.


title: Commission Implementing Regulation (EU) No 197/2013 of 7 March 2013 amending Implementing Regulation (EU) No 80/2012 establishing the list of biological or chemical substances provided for in Article 53(1)(b) of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from custom duty

text:
               8.3.2013

               EN

               Official Journal of the European Union

               L 65/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 197/2013
   of 7 March 2013
   amending Implementing Regulation (EU) No 80/2012 establishing the list of biological or chemical substances provided for in Article 53(1)(b) of Council Regulation (EC) No 1186/2009 setting up a Community system of reliefs from custom duty
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1186/2009 of 16 November 2009 setting up a Community system of reliefs from customs duty (1), and in particular Article 53(1)(b) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 80/2012 (2) sets out the list of biological or chemical substances provided for in Article 53(1)(b) of Regulation (EC) No 1186/2009.

               (2)

               Implementing Regulation (EU) No 80/2012 should be amended in order to include in the list two substances for which there is at present no equivalent production within the customs territory of the Union.

               (3)

               Moreover, it is no longer necessary to maintain in the list a substance which is currently listed in Annex 3 to Part Three of Annex I to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (3) concerning the pharmaceutical substances which are free of duty.

               (4)

               Implementing Regulation (EU) No 80/2012 should therefore be amended accordingly.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Implementing Regulation (EU) No 80/2012 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 7 March 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 324, 10.12.2009, p. 23.

      (2)  OJ L 29, 1.2.2012, p. 33.

      (3)  OJ L 256, 7.9.1987, p. 1.

      ANNEX
      Annex I to Implementing Regulation (EU) No 80/2012 is amended as follows:

                  (1)

                  the following row is inserted after the row containing the CN code ex 2845 90 90 for (Oxygen-18) Water:

                              ‘ex 2849 90 90

                              Titanium silicon carbide powder of a purity by weight of 99 % or more’

                  (2)

                  the following row is inserted after the row containing the CN code ex 2926 90 95 for 2-Naphtonitrile:

                              ‘ex 2934 99 90

                              Morpholino phosphorodiamidate oligomers (morpholino oligonucleotides)’

                  (3)

                  the following row is deleted:

                              ‘0014364-6

                              ex 2923 90 00

                              Decamethonium bromide (INN)’


title: Commission Implementing Regulation (EU) No 3/2012 of 4 January 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               5.1.2012

               EN

               Official Journal of the European Union

               L 2/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 3/2012
   of 4 January 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed 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.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 January 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  MA

                  52,6

                  TR

                  101,5

                  ZZ

                  77,1

                  0707 00 05

                  TR

                  155,2

                  ZZ

                  155,2

                  0709 93 10

                  MA

                  37,8

                  TR

                  84,6

                  ZZ

                  61,2

                  0805 10 20

                  CL

                  33,0

                  MA

                  58,8

                  TR

                  69,8

                  ZZ

                  53,9

                  0805 20 10

                  MA

                  80,9

                  ZZ

                  80,9

                  0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

                  IL

                  75,3

                  TR

                  91,3

                  ZZ

                  83,3

                  0805 50 10

                  AR

                  53,1

                  MA

                  126,4

                  TR

                  45,3

                  ZZ

                  74,9

                  0808 10 80

                  CA

                  115,9

                  US

                  111,5

                  ZA

                  128,3

                  ZZ

                  118,6

                  0808 30 90

                  CN

                  69,3

                  ZZ

                  69,3

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2016/1078 of 4 July 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               5.7.2016

               EN

               Official Journal of the European Union

               L 179/29

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1078
   of 4 July 2016
   establishing the standard import values for determining the entry price of 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),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed 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.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 4 July 2016.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX

         Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  MA

                  154,3

                  ZZ

                  154,3

                  0709 93 10

                  TR

                  138,3

                  ZZ

                  138,3

                  0805 50 10

                  AR

                  179,9

                  CL

                  198,5

                  MA

                  174,9

                  UY

                  188,9

                  ZA

                  181,9

                  ZZ

                  184,8

                  0808 10 80

                  AR

                  113,8

                  BR

                  100,6

                  CL

                  133,2

                  CN

                  133,6

                  NZ

                  142,5

                  US

                  161,9

                  UY

                  74,9

                  ZA

                  111,9

                  ZZ

                  121,6

                  0809 10 00

                  TR

                  225,5

                  ZZ

                  225,5

                  0809 29 00

                  TR

                  350,1

                  ZZ

                  350,1

                  0809 30 10 , 0809 30 90

                  TR

                  124,7

                  ZZ

                  124,7

                  0809 40 05

                  TR

                  160,5

                  ZZ

                  160,5

         (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2017/439 of 13 March 2017 concerning the authorisation of L-lysine sulphate produced by Escherichia coli as a feed additive for all animal species (Text with EEA relevance. )

text:
                  14.3.2017

                  EN

                  Official Journal of the European Union

                  L 67/70

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/439
      of 13 March 2017
      concerning the authorisation of L-lysine sulphate produced by Escherichia coli 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-lysine sulphate as a feed additive. 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 L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 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 opinions of 16 June 2015 (2) and 26 January 2017 (3) that, under the proposed conditions of use, L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705 does not have an adverse effect on animal health, human health or the environment and that it is an effective source of the amino acid lysine for all animal species. It also concluded that for the supplemental L-lysine sulphate to be fully efficacious in ruminants, it 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 that substance 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 substance 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, 13 March 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

         (2)  EFSA Journal 2015; 13(7):4155.

         (3)  EFSA Journal 2017; 15(2):4714.

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

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

                     3c323

                     L-lysine sulphate

                        Additive composition

                     Granulate with a minimum L-lysine content of 55 % and a maximum content of

                                 —

                                 4 % moisture and

                                 —

                                 22 % sulphate.

                        Characterisation of the active substance

                     L-lysine sulphate produced by fermentation with Escherichia coli CGMCC 3705
                     Chemical formula: C12H28N4O4 · H2SO4/[NH2-(CH2)4-CH(NH2)-COOH]2SO4

                     CAS number: 60343-69-3

                        Analytical methods
                         (1)

                     For the quantification of L-lysine in the feed additive:

                                 —

                                 ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) — EN ISO 17180

                           For the identification of sulphate in the feed additive:

                                 —

                                 European Pharmacopoeia Monograph 20301

                           For the quantification of L-lysine in compound feed and feed materials:

                                 —

                                 ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV) — Commission Regulation (EC) No 152/2009 (2)

                     All species

                     —

                     —

                     10 000

                                 1.

                                 The L-lysine content shall be indicated on the labelling of the additive.

                                 2.

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

                                 3.

                                 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 level by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.

                     2 April 2027

            (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)  Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1).