title: Commission Implementing Regulation (EU) 2021/1751 of 1 October 2021 laying down implementing technical standards for the application of Directive 2014/59/EU of the European Parliament and of the Council with regard to uniform formats and templates for notifications of determination of the impracticability of including contractual recognition of write down and conversion powers (Text with EEA relevance)

text:
                  4.10.2021

                  EN

                  Official Journal of the European Union

                  L 349/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1751
         of 1 October 2021
         laying down implementing technical standards for the application of Directive 2014/59/EU of the European Parliament and of the Council with regard to uniform formats and templates for notifications of determination of the impracticability of including contractual recognition of write down and conversion powers
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 establishing a framework for the recovery and resolution of credit institutions and investment firms and amending Council Directive 82/891/EEC, and Directives 2001/24/EC, 2002/47/EC, 2004/25/EC, 2005/56/EC, 2007/36/EC, 2011/35/EU, 2012/30/EU and 2013/36/EU, and Regulations (EU) No 1093/2010 and (EU) No 648/2012, of the European Parliament and of the Council (1), and in particular Article 55(8), third subparagraph, thereof,
         Whereas:

                     (1)

                     Article 55(1) of Directive 2014/59/EU provides that under certain conditions Member States are to require institutions and entities referred to in Article 1(1), points (b), (c) and (d), of that Directive to include a contractual term by which the counterparty to an agreement or instrument creating the liability recognises that that liability may be subject to the write down and conversion powers.

                     (2)

                     Article 55(2), first subparagraph, of Directive 2014/59/EU requires Member States to ensure that where such an institution or entity reaches the determination that it is legally or otherwise impracticable to include such a term (‘determination of impracticability of contractual recognition’), that institution or entity is to notify its determination to the resolution authority.

                     (3)

                     The Commission is to adopt implementing technical standards to specify uniform formats and templates for such notification to resolution authorities.

                     (4)

                     Uniform formats and templates for the notification of determination of impracticability of contractual recognition should be designed in such a way that they ensure a meaningful and uniform assessment of such determination by resolution authorities across the Union.

                     (5)

                     To enhance the data quality and ensure comparability, the data items set out in the notification templates should comply with the single data point model. Use of the single data point model is a widespread practice in supervisory reporting. The single data point model should consist of a structural representation of the data items, and identify all relevant business concepts for uniform notification of the determination of impracticability of contractual recognition.

                     (6)

                     In order to safeguard the quality, consistency and accuracy of data items notified, the data items should be subject to common validation rules.

                     (7)

                     Due to their very nature, validation rules and data point definitions are updated regularly in order to ensure they comply, at all times, with applicable regulatory, analytical and information technology requirements. Stringent qualitative criteria should be established for the detailed single data point model and the detailed common validation rules which will be published electronically by the European Banking Authority on its website.

                     (8)

                     This Regulation is based on the draft implementing technical standards submitted to the Commission by the European Banking Authority.

                     (9)

                     The European Banking Authority has conducted open public consultations on the draft implementing standards on which this Regulation is based, analysed the potential related costs and benefits and requested the advice of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (2),

               HAS ADOPTED THIS REGULATION:

            Article 1
            Information to be provided in a notification of determination of impracticability
            For the purposes of making a notification in accordance with Article 55(2), first subparagraph, of Directive 2014/59/EU, the institution or entity referred to in Article 1(1), points (b), (c) or (d), of that Directive shall submit to the resolution authority the information specified in the templates set out in Annex I. Those templates shall be completed in accordance with the instructions set out in Annex II.

            Article 2
            Format for the submission of information

               1.   The institutions and the entities referred to in Article 1(1), points (b), (c) or (d), of Directive 2014/59/EU shall submit the information referred to in Article 1 of this Regulation in the data exchange formats and representations specified by the relevant resolution authority.

               2.   When submitting information referred to in Article 1 of this Regulation, institutions and entities referred to in Article 1(1), points (b), (c) or (d), of Directive 2014/59/EU shall respect the data point definitions included in the single data point model referred to in Annex III and the validation rules referred to in Annex IV.

            Article 3
            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, 1 October 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 173, 12.6.2014, p. 190.

            (2)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

            ANNEXE I

                           N 00.01 - Notification Identification

                           Columns

                        Identification

                        0010

                           Rows

                        Notification ID

                        0010

                        Notification date

                        0020

                        Notification type

                        0030

                        Reference date for templates N01.01 and N01.02

                        0040

                        Reference date for template N02.00

                        0050

                        Applicable currency

                        0060

                        Institution or entity name

                        0070

                        Code

                        0080

                        Type of code

                        0090

                        Contact person

                        0100

                        Email

                        0110

                        Telephone

                        0120

                           N 01.01 - Impracticability of contractual recognition of bail-in by contract/instrument

                           Type of notification

                           LIABILITY ID

                           MATERIAL AMENDMENT?

                           FINAL MATURITY DATE

                           RENEWABLE?

                           RENEWAL FREQUENCY

                           CONTRACT / INSTRUMENT

                           IMPRACTICABILITY

                           COUNTERPARTY

                           DESCRIPTION

                           LIABILITY TYPE

                           GOVERNING LAW

                           INSOLVENCY RANKING UNDER THIRD-COUNTRY LAW

                           INSOLVENCY RANKING IN THE MEMBER STATE OF INCORPORATION

                           NOMINAL AMOUNT IN THE MAIN ORIGINAL CURRENCY

                           MAIN ORIGINAL CURRENCY

                           NOMINAL AMOUNT IN LOCAL CURRENCY

                           CONDITIONS

                           CATEGORY

                           REASONS FOR MEETING THE CONDITIONS

                           LEGAL OPINION?

                           NAME

                           CODE

                           TYPE OF CODE

                           NATIONAL CODE

                        0010

                        0020

                        0030

                        0040

                        0050

                        0060

                        0070

                        0080

                        0090

                        0100

                        0110

                        0120

                        0130

                        0140

                        0150

                        0160

                        0170

                        0180

                        0190

                        0200

                        0210

                           N 01.02 -Impracticability of contractual recognition of bail-in by category

                           CATEGORY

                           TOTAL VALUE OF LIABILITIES IN LOCAL CURRENCY IN CATEGORY

                           REASONS FOR MEETING THE CATEGORIES / CONDITIONS

                           INSOLVENCY RANKING

                           NUMBER OF UNDERLYING LIABILITIES

                        0010

                        0020

                        0030

                        0040

                        0050

                           N 02.00 - Liability Insolvency Classes

                           INSOLVENCY RANKING

                           NOMINAL AMOUNT OF TOTAL LIABILITIES CURRENTLY NOTIFIED TO THE RESOLUTION AUTHORITY

                           OUTSTANDING AMOUNT OF TOTAL LIABILITIES IN RANKING

                           OF WHICH: EXCLUDED FROM BAIL-IN

                           OF WHICH: LIABILITIES GOVERNED BY THE LAW OF A THIRD COUNTRY

                           OF WHICH: NOT INCLUDING CONTRACTUAL RECOGNITION

                           OF WHICH: CURRENTLY NOTIFIED TO THE RESOLUTION AUTHORITY

                        0010

                        0020

                        0030

                        0040

                        0050

                        0060

                        0070

            ANNEX II
            Instructions for filling in the notification of determination of impracticability of contractual recognition of write down and conversion powers
            PART I: GENERAL INSTRUCTIONS
            This Annex provides instructions for the notification by an institution or entity of determination of the impracticability of contractual recognition of write down and conversion powers.
            Each notification can refer to several contracts/instruments and/or several categories of liabilities (if applicable), which meet the conditions of impracticability of contractual recognition of bail-in, as laid down in Article 55(2), first subparagraph, of Directive 2014/59/EU.
            An institution or an entity can provide additional supporting documentation, including a legal opinion or a copy of the contract, where it is considered appropriate. The relevant resolution authority shall decide how such additional documentation is to be provided.
            Where an information field listed in this Annex is not applicable to a certain type of contract and the institution or entity demonstrates this to the resolution authority, the institution or entity does not need to provide the information listed in that field .
            1.   Structure of the notification

            The information in the notification shall be provided by completing the following templates set out in Annex I:

                        (a)

                        ‘Notification Identification’(N00.01), which is to be used for providing information to identify the notification itself and the institution or entity that is notifying the resolution authority;

                        (b)

                        ‘Impracticability of contractual recognition of bail-in by contract/instrument’ (N01.01), which is to be used to provide the information on liabilities that meet the conditions of impracticability of contractual recognition of bail-in, as laid down in Article 55(2), first subparagraph, of Directive 2014/59/EU;

                        (c)

                        ‘Impracticability of contractual recognition of bail-in by category’ (N01.02), which is to be used to provide information on categories of liabilities that meet the conditions of impracticability of contractual recognition of bail-in, , if the relevant resolution authority deems it necessary to specify the categories of liabilities as provided for in Article 55(7) of Directive 2014/59/EU;

                        (d)

                        ‘Liability insolvency classes’ (N02.00), which is to be used to provide information on the ranking of liabilities according to national insolvency law for the purposes of Article 55(2), fifth subparagraph, of Directive 2014/59/EU.

                  2.   Scope of consolidation

            The notification shall be sent by institutions and entities on an individual basis.
            PART II: TEMPLATE-SPECIFIC INSTRUCTIONS
            3.   N00.01 – Notification identification

            3.1   Instructions concerning specific rows

                        Rows

                        Instructions

                        0010

                           Notification ID

                        Each notification shall have a unique ID provided by the notifying institution or entity.
                        The notification ID is per notification [submission], not per liability or category. A notification allows the inclusion of any number of liabilities or categories, as relevant at the time of the notification.
                        The institution or entity shall provide the notification ID, which shall be unique for each notification.

                        0020

                           Notification date

                        Institutions and entities shall indicate the date when the notification was sent to the resolution authority.

                        0030

                           Notification type
                            (1)

                        Institutions and entities shall indicate the type of items being notified in the submission in question, as follows:

                                    (a)

                                    only contracts/instruments (only template N01.01 is to be used);

                                    (b)

                                    only categories of liabilities (only template N01.02 is to be used);

                                    (c)

                                    both contracts/instruments and categories of liabilities (both templates N01.01 and N01.02 are to be used for the same notification).

                        0040

                           Reference date for templates N01.01 and N01.02

                        Institutions and entities shall indicate the reference date for the information in template N01.01 and template N01.02 notifications.

                        0050

                           Reference date for template N02.00

                        Institutions and entities shall indicate the reference date for the information in the template N02.00.

                        0060

                           Applicable currency

                        Institutions and entities shall indicate the reference currency for the amounts in template N01.01, column 0130; template N01.02, column 0020; and template N02.00.
                        This value refers to the official currency in the Member State where the notifying institution is incorporated. The value shall be in line with the alphabetical ISO 4217 code.

                        0070

                           Institution or entity name

                        Name of the notifying institution or entity.

                        0080

                           Code

                        Code of the notifying institution or entity. For institutions, the code shall be the 20-digit, alphanumerical Legal Entity Identifier (LEI) code. For other entities, the code shall be the 20-digit, alphanumerical LEI code or, if not available, a code under a uniform codification applicable in the Union or, if not available, a national code.
                        The code shall be consistent with the code reported for the same institution or entity under Commission Implementing Regulation (EU) 2018/1624 (2). The code field shall always have a value.

                        0090

                           Type of code

                        The institution or entity shall specify the type of code indicated in column 0080 as an ‘LEI code’ or ‘Non-LEI code’. The type of code shall always have one of the two values.

                        0100

                           Contact person

                        Institutions and entities shall indicate the name of a person to be contacted if the resolution authority needs clarification regarding the notification.

                        0110

                           Email

                        Institutions and entities shall indicate the email address of the person referred to in row 0100, ‘Contact person’.

                        0120

                           Telephone

                        Institutions and entities shall indicate the telephone number of the person referred to in row 0100, ‘Contact person’.

                  4.   N01.01 – Impracticability of contractual recognition of bail-in by contract/instrument

            4.1   General remarks

            Template N01.01 shall be used for submissions concerning notifications of contracts on an individual basis. Template N01.01 allows a submission to include multiple contracts in the same notification. This template shall be used for the notification of the following:

                        (a)

                        contracts/instruments creating new liabilities: contracts/instruments that have not been notified previously to the resolution authority;

                        (b)

                        contracts /instruments amending existing liabilities: if the contract or instrument for the existing liability has been previously notified to the resolution authority and has been assessed as meeting a condition of impracticability, the amending contracts or instruments shall have the same liability ID (column 0010) as previously notified, and the remaining columns shall be filled in only if subject to changes. In particular, column 0020, ‘Material amendment?’ shall be completed, if relevant, only for contracts amending existing liabilities;

                        (c)

                        off-balance sheet items: institutions and entities shall provide the insolvency ranking of the liability that would materialise upon activation of off-balance sheet item.

                  If data are not available or not applicable, institutions and entities should not fill in the following columns: 0020, 0030, 0050, 0090, 0130, 0150 and 0210.
            4.2   Instructions concerning specific columns

                        Columns

                        Legal references and instructions

                        0010

                        LIABILITY ID
                        The liability ID is a unique identifier generated by the notifying institution or entity that shall be used in all notifications to identify each liability. The institution or entity may use the internal code of the liability.

                        0020

                        MATERIAL AMENDMENT?
                        This field is to be filled in only for contracts/instruments amending existing liabilities. The institution or entity making the notification shall indicate if the amendments to the existing liability are considered material.
                        Institutions and entities shall use one of the following values:

                                    —

                                    Yes

                                    —

                                    No

                        0030

                        FINAL MATURITY DATE
                        The date upon which all principal and interest of the liability must be repaid (based on the transaction contractual documentation).
                        The day, month and year of the final maturity date shall be provided. The exact day shall be provided where that information is available, otherwise the first day of the month shall be used.

                        0040

                        RENEWABLE?
                        Institutions and entities shall use one of the following values:

                                    —

                                    Yes

                                    —

                                    No

                              This column shall be filled in with ‘Yes’ if the contract includes an explicit provision regarding its renewability.

                        0050

                        RENEWAL FREQUENCY
                        If column 0040 is filled in with ‘Yes’, institutions and entities shall specify the frequency of the maturity renewal in months.

                        0060–0130

                        CONTRACT/INSTRUMENT

                        0060

                        DESCRIPTION
                        Institutions and entities shall provide a contract/instrument description of no more than 300 characters. This field shall contain the main characteristics of the contract/instrument not captured in the other fields of this notification (such as. the purpose/essence of the liability, whether the instrument is bail-in-able under the governing third-country law).

                        0070

                        LIABILITY TYPE
                        Institutions and entities shall identify the contract/instrument as being one of the following types:

                                    (a)

                                    interbank deposits

                                    (b)

                                    deposits with non-banking clients

                                    (c)

                                    derivatives

                                    (d)

                                    borrowing/funding

                                    (e)

                                    trade finance

                                    (f)

                                    operational services that are not critical to the functioning of the entity

                                    (g)

                                    other

                              If more than one type is applicable, the one that best describes the purpose of the contract /instrument shall be selected.

                        0080

                        GOVERNING LAW
                        Institutions and entities shall provide the ISO 3166-1 three-letter alphabetical code of the country the law of which governs the contract/instrument.

                        0090

                        INSOLVENCY RANKING UNDER THIRD-COUNTRY LAW
                        The institution or entity shall fill in the value corresponding to the liability’s ranking on a scale from 1 to x, with 1 being the most subordinated and x the most senior class, as defined by the relevant applicable third-country law governing the liability.
                        The institution shall try to obtain said ranking from the relevant third-country resolution authority or, in the absence of such an official ranking, shall determine on its own the value (on a scale from 1 to x) based on the liability ranking according to the relevant third-country law.

                        0100

                        INSOLVENCY RANKING IN THE MEMBER STATE OF INCORPORATION
                        Institutions and entities shall fill in the value corresponding to the liability’s ranking on a scale from 1 to x, with 1 the most subordinated and x the most senior class, as defined by the relevant law applicable in the Member State where the notifying institution or entity is incorporated.

                        0110

                        NOMINAL AMOUNT IN THE MAIN ORIGINAL CURRENCY
                        Institutions and entities shall provide the nominal amount of the liability as laid down in the contract/instrument.
                        For framework agreements, the institution or entity should indicate the maximum amount it expects to be reached under that framework agreement or the maximum amount permitted under the framework agreement.
                        If the contract/instrument has more than one currency, institutions and entities shall report the nominal amount in the prevailing currency in the contract.

                        0120

                        MAIN ORIGINAL CURRENCY
                        Institutions and entities shall assign a currency ISO code corresponding to the denomination of the liability under the contract. The three-letter currency unit code according to ISO 4217 shall be used.
                        If the contract has more than one currency, institutions and entities shall report the prevailing currency in the contract.

                        0130

                        NOMINAL AMOUNT IN LOCAL CURRENCY
                        Institutions and entities shall fill in this column if the currency used in column 0110 is not the local currency where the institution or entity is incorporated. Institutions and entities shall use the foreign exchange rate applicable at the date of notification.

                        0140–0190

                        IMPRACTICABILITY

                        0140

                        CONDITIONS
                        Institutions and entities shall identify the condition(s) under which they consider it is legally or otherwise impracticable to include the contractual term, as specified in Commission Delegated Regulation (EU) 2021/1527 (3).
                        Institutions and entities shall provide the combination of applicable conditions (they can identify only one or as many as all five):

                                    (a)

                                    Condition (a) - the inclusion of the contractual term would constitute a breach of the laws, regulations or administrative provisions of the third country governing the liability;

                                    (b)

                                    Condition (b) - the inclusion of the contractual term would be contrary to an explicit and binding instruction from a third country authority;

                                    (c)

                                    Condition (c) - the liability arises from instruments or agreements concluded in accordance with international standardised terms or protocols that the institution or entity is unable to amend;

                                    (d)

                                    Condition (d) - the liability is governed by contractual terms that the institution or entity has to accept in order to be able to participate in or to utilise the services of a non-Union body, and which the institution or entity is unable to amend;

                                    (e)

                                    Condition (e) - the liability is owed to a commercial or trade creditor and relates to provision of goods or services that, while not critical, are used for daily operational functioning of the institution or entity and the institution or entity is unable to amend the terms of the agreement.

                           All conditions that are applicable shall be notified.

                        0150

                        CATEGORY
                        Institutions and entities shall indicate the categories of liabilities specified by the relevant resolution authority under Article 55(7) of Directive 2014/59/EU, if applicable.

                        0160

                        REASONS FOR MEETING THE CONDITIONS
                        Institutions and entities shall describe clearly their reasons for determining impracticability arising from the conditions reported in column 0140.
                        The information entered in this field is relevant for determining whether the notified contract/instrument meets the conditions of impracticability and shall therefore constitute the basis for the resolution authority’s assessment of the institution’s determination.
                        Institutions and entities shall avoid overly brief justifications such as ‘Product cannot be used’ or ‘Loss of competitiveness’ and shall present more in-depth justifications in order to enable the resolution authority to take an informed decision.

                        0170

                        LEGAL OPINION?
                        Institutions and entities shall inform the resolution authority if there is a legal opinion concerning the notified impracticability of this liability.
                        Institutions and entities shall indicate one of the following:

                                    —

                                    Yes

                                    —

                                    No

                              If institutions or entities indicate ‘Yes’, they shall transmit the legal opinion to the resolution authority by the means specified by the resolution authority.

                        0180–0210

                        COUNTERPARTY
                        Institutions and entities shall indicate the identity of the counterparty of this liability.

                        0180

                        NAME
                        The name indicated shall be of the individual counterparty.
                        In the case of multi-party contracts, the institution shall either indicate the main counterparty or use the value ‘multi-party contract’.

                        0190

                        CODE
                        The code as part of a row identifier must be unique for each notifying entity. For institutions, the code shall be the LEI code. For other entities, the code shall be the LEI code or, if not available, a national code. The code shall be unique and used consistently across the templates and over time. The code field shall always have a value.

                        0200

                        TYPE OF CODE
                        The institutions or entities shall identify the type of code filled in column 0190 as ‘LEI code’ or ‘National code’.

                        0210

                        NATIONAL CODE
                        Institutions or entities may also provide a national code if they use the LEI code as the identifier in the ‘Code’ column 0190.

                  5.   N01.02 – Impracticability of contractual recognition of bail-in by category

            5.1   General remarks

            Template N01.02 shall be used for submissions concerning notification of categories of liabilities when the relevant resolution authority deems it necessary, in accordance with Article 55(7) of Directive 2014/59/EU, to specify categories of liabilities for which a determination of impracticability of including the contractual recognition term can be reached.
            5.2   Instructions concerning specific columns

                        Columns

                        Legal references and instructions

                        0010

                        CATEGORY
                        Institutions and entities shall indicate the category of liabilities, as specified by the relevant resolution authority in accordance with Article 55(7) of Directive 2014/59/EU, for which it submits the notification.
                        A notification using template N01.02 can include as many categories of liabilities as necessary.

                        0020

                        TOTAL VALUE OF LIABILITIES IN LOCAL CURRENCY IN CATEGORY
                        Institutions and entities shall indicate the expected total amount of liabilities for each of the notified categories indicated in column 0010.
                        The amount shall be an estimated maximum amount to be reached under the specified category for a period of 6 months from the date of notification.
                        The amount shall be expressed in the currency of the Member State where the institution or entity is incorporated.
                        If during the 6-month period following the notification, the institution or entity determines that the value of the liabilities in the category has increased by more than 10% of the notified amount, it shall submit another notification to the resolution authority.

                        0030

                        REASONS FOR MEETING THE CATEGORIES/CONDITIONS
                        Institutions and entities shall explain why the category of liabilities has been notified.
                        The reasoning will constitute the basis for the resolution authority to make an assessment of the notification of impracticability.

                        0040

                        INSOLVENCY RANKING
                        Institutions and entities shall fill in the values corresponding to the ranking of the liabilities in each category in column 0010, on a scale from 1 to x, with 1 being the most subordinated and x the most senior class, as defined by the relevant law applicable in the Member State where the notifying institution or entity is incorporated.

                        0050

                        NUMBER OF UNDERLYING LIABILITIES
                        Institutions and entities shall indicate the estimated maximum number of contracts/instruments to be held under the respective category of liabilities for a period of 6 months from the date of notification.

                  6.   N02.00 – Liability insolvency classes

            6.1   General remarks

            The institutions or entities shall complete template N02.00 with reference to the last quarter for which data are available (4), except for the values in column 0070.
            By default, amounts notified in this template shall be outstanding values, except for column 0070. The outstanding amount of a claim or instrument is the sum of the principal amount of and the accrued interest on the claim or instrument. The outstanding amount due is equal to the value of the claim that the creditor could file under insolvency proceedings. Values in column 0070 should reflect the total amount notified in templates N01.01 and N01.02 and therefore should be the maximum expected value to be reached under the currently notified contracts/instruments and/or categories.
            For off-balance sheet items, institutions and entities shall provide the insolvency ranking of the liability that would materialise upon activation of that off-balance sheet item.
            All values in this template shall be provided in the local currency of the Member State where the institution or entity is incorporated.
            6.2   Instructions concerning specific columns

                        Columns

                        Legal references and instructions

                        0010

                        INSOLVENCY RANKING
                        The institution or entity shall fill in the value corresponding to the liability’s ranking on a scale from 1 to x, with 1 being the most subordinated and x the most senior class, as defined by the national law applicable in the Member State where the institution or entity is incorporated.
                        Template N02.00 shall include a line for each insolvency ranking indicated in template N01.01, column 0100, and in template N01.02, column 0040.

                        0020

                        OUTSTANDING AMOUNT OF TOTAL LIABILITIES IN RANKING
                        The total outstanding amount of all liabilities for the insolvency ranking provided in column 0010.

                        0030

                        OF WHICH: LIABILITIES GOVERNED BY THE LAW OF A THIRD COUNTRY
                        This column shall include the outstanding amount of liabilities governed by the law of a third country.

                        0040

                        OF WHICH: NOT INCLUDING CONTRACTUAL RECOGNITION
                        This column shall include the outstanding amount of all liabilities governed by the law of a third-country that do not include the contractual recognition of bail-in clause as required by Article 55(1) of Directive 2014/59/EU. The value will be the outstanding amount.
                        The value will be computed as the sum of all liabilities that fulfil the following conditions:

                                    (a)

                                    the liabilities still exist;

                                    (b)

                                    the liabilities are governed by the law of a third country;

                                    (c)

                                    the liabilities do not include the contractual recognition term as required by Article 55(1) of Directive 2014/59/EU;

                                    (d)

                                    the liabilities are not excluded from bail-in;

                                    (e)

                                    the liabilities are not deposits as referred to in Article 108, point (a), of Directive 2014/59/EU.

                        0050

                        OF WHICH: CURRENTLY NOTIFIED TO THE RESOLUTION AUTHORITY
                        This column shall include the outstanding amounts of all liabilities and/or categories of liabilities notified in templates N01.01 and N01.02 of this notification.

                        0060

                        OF WHICH: EXCLUDED FROM BAIL-IN
                        This column shall include liabilities that are excluded from the application of the bail-in tool in accordance with Article 44(2) of Directive 2014/59/EU or that could fall under any condition in Article 44(3) of that Directive.

                        0070

                        NOMINAL AMOUNT OF TOTAL LIABILITIES CURRENTLY NOTIFIED TO THE RESOLUTION AUTHORITY
                        This column shall reflect the total (sum) of the nominal and/or maximum expected amounts of the liabilities and/or categories of liabilities notified in templates N01.01 and N01.02 of this notification.

               (1)  Template N02.00 is to be submitted in all cases described in points (a), (b) and (c).

               (2)  Commission Implementing Regulation (EU) 2018/1624 of 23 October 2018 laying down implementing technical standards with regard to procedures and standard forms and templates for the provision of information for the purposes of resolution plans for credit institutions and investment firms pursuant to Directive 2014/59/EU of the European Parliament and of the Council, and repealing Commission Implementing Regulation (EU) 2016/1066 (OJ L 277, 7.11.2018, p. 1).

               (3)  Commission Delegated Regulation (EU) 2021/1527 of 31 May 2021 supplementing Directive 2014/59/EU of the European Parliament and of the Council with regard to regulatory technical standards for the contractual recognition of write down and conversion powers (OJ L 329, 17.9.2021, p. 2).

               (4)  The last quarter for which data are available shall be in line with the remittance dates for quarterly reporting: 12 May (for reference date 31 March), 11 August (for reference date 30 June), 11 November (for reference date 30 September) and 11 February (for reference date 31December).

            ANNEX III
            Single data point model
            All data items set out in the Annexes to this Regulation shall be transformed into a single data point model which is the basis for uniform IT systems of institutions and resolution authorities?.
            The single data point model shall meet the following criteria:

                        (a)

                        provide a structured representation of all data items set out in the Annexes to this Regulation;

                        (b)

                        identify all the business concepts set out in the Annexes to this Regulation;

                        (c)

                        provide a data dictionary identifying table labels, ordinate labels, axis labels, domain labels, dimension labels and member labels;

                        (d)

                        provide metrics which define the property or amount of data points;

                        (e)

                        provide data point definitions that are expressed as a composition of characteristics that univocally identify the financial concept;

                        (f)

                        contain all the relevant technical specifications necessary for developing IT reporting solutions producing uniform resolution data.

            ANNEX IV
            Validation rules
            The data items set out in Annex I shall be subject to validation rules ensuring data quality and consistency. The validation rules shall meet the following criteria:

                        (a)

                        define the logical relationships between relevant data points;

                        (b)

                        include filters and preconditions that define a set of data to which a validation rule applies;

                        (c)

                        check the consistency of the transmitted data;

                        (d)

                        check the accuracy of the transmitted data;

                        (e)

                        set default values which shall be applied where the relevant information has not been transmitted.


title: Commission Implementing Regulation (EU) 2022/672 of 22 April 2022 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food trans-resveratrol (from microbial source) (Text with EEA relevance)

text:
                  25.4.2022

                  EN

                  Official Journal of the European Union

                  L 122/24

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/672
         of 22 April 2022
         amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food trans-resveratrol (from microbial source)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes trans-resveratrol from synthetic and microbial sources as an authorised novel food.

                     (4)

                     The novel food trans-resveratrol from a microbial source has been authorised as a novel food ingredient under pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) to be used in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4), in capsule or tablet form, for the adult population on the basis of its substantial equivalence to resveratrol with a history of consumption before 15 May 1997 extracted from the Japanese knotweed (Fallopia japonica).

                     (5)

                     Commission Implementing Decision (EU) 2016/1190 (5) authorised the placing on the Union market of synthetic trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97, also to be used in food supplements as defined in Directive 2002/46/EC in capsule or tablet form, for the adult population.

                     (6)

                     Commission Implementing Regulation (EU) 2021/51 (6) amended the conditions of use of trans-resveratrol. In particular, the restrictions on the delivery formats of food supplements containing the novel food have been lifted.

                     (7)

                     On 29 July 2021, the company Evolva AG (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of trans-resveratrol from a microbial source. The applicant requested to remove the requirement that 100 % of the particles of the novel food produced by S. cerevisiae should be of a size less than 62,23 micrometres (< 62,23 μm).

                     (8)

                     The applicant justifies the request by indicating that the change is necessary in order to take account of the variation in the particle sizes of trans-resveratrol from a microbial source in the course of its production process and processing for use in food supplements. In support of the request, the applicant provided analytical data demonstrating that the particle size profile of trans-resveratrol from a microbial source is comparable to the particle size profile of the chemically synthesised trans-resveratrol that was evaluated by the European Food Safety Authority (‘the Authority’) (7), and for which no particle size requirements are included in the Union list of novel foods.

                     (9)

                     The Commission considers that the requested update of the Union list is not liable to have an effect on human health and that a safety evaluation by the Authority in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary as the requested removal of the particle size requirement for trans-resveratrol from a microbial source does not alter its safety profile because the analytical evidence submitted by the applicant demonstrates that its particle size distribution profile is comparable to that of the chemically synthesised trans-resveratrol which was evaluated by the Authority.

                     (10)

                     The information provided in the application gives sufficient grounds to establish that the requested changes to the specifications of trans-resveratrol are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.

                     (11)

                     The Annex to Implementing Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (12)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex 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 April 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

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

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

            (5)  Commission Implementing Decision (EU) 2016/1190 of 19 July 2016 authorising the placing on the market of trans-resveratrol as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 196, 21.7.2016, p. 53).

            (6)  Commission Implementing Regulation (EU) 2021/51 of 22 January 2021 authorising a change of the conditions of use of the novel food ‘trans-resveratrol’ under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (OJ, L 23, 25.1.2021, p. 10).

            (7)  EFSA Journal 2016;14(1):4368.

            ANNEX
            In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470 the entry for trans-resveratrol is replaced by the following:

                           Authorised Novel Food

                           Specifications

                           ‘Trans-resveratrol

                              Description/Definition:

                              Synthetic: Trans-resveratrol is off-white to beige crystals.
                           Chemical name: 5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol
                           Chemical formula: C14H12O3

                           Molecular weight: 228,25 Da
                           CAS No: 501-36-0

                              Purity:

                           Trans-resveratrol: ≥ 98 %-99 %
                           Total by-products (related substances): ≤ 0,5 %
                           Any single related substance: ≤ 0,1 %
                           Sulphated ash: ≤ 0,1 %
                           Loss on drying: ≤ 0,5 %

                              Heavy metals:

                           Lead: ≤ 1,0 ppm
                           Mercury: ≤ 0,1 ppm
                           Arsenic: ≤ 1,0 ppm

                              Impurities:

                           Diisopropylamine: ≤ 50 mg/kg

                              Microbial source: A genetically modified strain of Saccharomyces cerevisiae
                           Appearance: Off-white to slight yellow powder
                           Trans-resveratrol content: Min. 98 % w/w (dry weight basis)
                           Ash: Max. 0,5 % w/w
                           Moisture: Max. 3 % w/w’


title: Commission Implementing Regulation (EU) 2022/673 of 22 April 2022 authorising the placing on the market of mung bean (Vigna radiata) protein as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  25.4.2022

                  EN

                  Official Journal of the European Union

                  L 122/27

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/673
         of 22 April 2022
         authorising the placing on the market of mung bean (Vigna radiata) protein as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     On 10 March 2020, the company Eat Just, Inc. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place mung bean protein on the Union market as a novel food. The applicant requested for mung bean protein, extracted from seeds of the plant Vigna radiata, to be used in protein products, excluding dairy analogues and beverage whiteners, intended for the general population. The category protein products refer to protein analogues or substitutes for standard products, such as meat, fish, or egg.

                     (4)

                     On 10 March 2020, the applicant also made a request to the Commission for the protection of proprietary data for a number of data submitted in support of their application, namely analytical data on phytic acid, lectins, trypsin inhibitors, cyanogenic glycosides and tannins (3).

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 5 August 2020, with a request to provide a scientific opinion by carrying out an assessment for the suitability of mung bean protein as a novel food.

                     (6)

                     On 14 September 2021, the Authority adopted its scientific opinion ‘Safety of mung bean protein as a novel food pursuant to Regulation (EU) 2015/2283’ (4), in accordance with Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority concluded that mung bean protein, is safe under the proposed in the application conditions of use. Therefore, the Authority’s opinion gives sufficient grounds to establish that mung bean protein, when used as a food ingredient added to protein products, excluding dairy analogues and beverage whiteners, within the general population, complies with requirements set in Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     In its opinion the Authority concluded on the basis of limited published evidence on food allergy related to the consumption of mung bean proteins and on the basis of evidence demonstrating that mung bean proteins contain a number of potentially allergenic proteins that consumption of this novel food may trigger sensitisation. Considering that to date, evidence directly linking the consumption of mung bean protein to cases of primary sensitisation is equivocal, the Commission considers that no specific labelling requirements concerning the potential of mung bean proteins to cause primary sensitisation should be included in the Union list of authorised novel foods.

                     (9)

                     By using a weight of evidence approach on the basis of limited studies and one protein sequence homology analysis performed by the applicant between mung bean protein and those of soybean, peanut and lupin, the Authority in its opinion considered that the consumption of mung bean protein has the potential capacity to induce allergic reactions in persons that are allergic to soybean, peanut, lupin and birch pollen. However, additional in vivo experimental or epidemiological evidence normally needed to confirm or exclude the likelihood that the identified potential cross-reactivity may manifest itself in the population, is lacking. Taking the lack of such evidence, the Commission considers that at present the potential of mung bean proteins to cause cross-reactivity to soybean, peanut, lupin and birch pollen is unlikely to manifest itself in the population and consequently no specific labelling requirement should be included in the Union list of authorised novel foods in this regard.

                     (10)

                     In their opinion, the Authority considered that it could not have reached their conclusions on the safety of the mung bean protein without the proprietary analytical data on phytic acid, lectins, trypsin inhibitors, cyanogenic glycosides and tannins submitted by the applicant.

                     (11)

                     The applicant declared that, at the time of the submission of the application, they held proprietary and exclusive rights of reference to the scientific evidence provided at the time they submitted the application. Therefore, third parties cannot lawfully access or use those data or refer to those data.

                     (12)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of mung bean protein, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of mung bean protein should be restricted to the applicant for that period.

                     (13)

                     However, restricting the authorisation of mung bean protein and of the reference to the data contained in the applicant’s file to the sole use by the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

                     (14)

                     The Annex to Regulation (EU) 2017/2470 should therefore be amended accordingly.

                     (15)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   Mung bean protein as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of 5 years from the date of entry into force of this Regulation only the initial applicant:
               Company: Eat Just, Inc.;
               Address: 2000 Folsom Street San Francisco, CA 94110 USA,
               is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of the applicant.

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

            Article 2
            The data contained in the application file on the basis of which mung bean protein has been assessed by the Authority, claimed by the applicant as proprietary and without which the novel food could not have been authorised, therefore fulfil the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, and shall not be used for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation without the agreement of the applicant.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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 April 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  Analytical results Cyanogenic Glycosides (unpublished)
         Sayre_2021 cyanogenic glycosde exec sum (unpublished)
         Analytical results lectins (unpublished)
         CoAs Phytic acid MB flour 5 batches (unpublished)
         CoAs Phytic acid MBP 5 batches (unpublished)
         Analytical results tannins (unpublished)
         CoAs Trypsin Inhibitors MB flour 5 batches (unpublished)
         CoAs Trypsin Inhibitors MBP 5 batches (unpublished).

            (4)  EFSA Journal 2021;19(10):6846.

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

                        (1)

                        in Table 1 (Authorised novel foods), the following entry is inserted:

                                    Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    ‘Mung bean (Vigna radiata) protein

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “mung bean protein from Vigna radiata”.

                                    Authorised on 15 May 2022. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Eat Just, Inc., 2000 Folsom Street San Francisco, CA 94110 USA. During the period of data protection, the novel mung bean protein is authorised for placing on the market within the Union only by Eat Just, Inc., unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Eat Just, Inc.
                                    End date of the date protection: 15 May 2027.’

                                    Protein products

                                    20 g/100 g

                        (2)

                        in Table 2 (Specifications), the following entry is inserted:

                                    Authorised Novel Food

                                    Specification

                                    ‘Mung bean (Vigna radiata) protein

                                       Description/Definition:

                                    The novel food is mung bean protein powder extracted from seeds of the plant Vigna radiata by several processing steps followed by pasteurization and spray drying.

                                       Characteristics/composition:

                                    Moisture: ≤ 6 %
                                    Protein (w/w)(a): ≥ 84 %
                                    Ash (w/w): ≤ 6,0 %
                                    Fat (w/w): ≤ 5,5 %
                                    Carbohydrate (w/w): ≤ 5,0 by calculation

                                       Microbiological criteria:

                                    Aerobic plate count: < 5 000  CFU/g (b)

                                    Yeasts and moulds: < 100 CFU/g
                                    Coliforms: < 100 CFU/g

                                       Escherichia coli: < 10 CFU/g

                                       Listeria monocytogenes: Not detected in 25 g

                                       Salmonella spp.: Not detected in 25 g

                                                (a)

                                                w/w: weight per weight.

                                                (b)

                                                CFU: colony forming units.’


title: Commission Implementing Regulation (EU) 2022/674 of 22 April 2022 correcting Implementing Regulation (EU) 2022/95 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council

text:
                  25.4.2022

                  EN

                  Official Journal of the European Union

                  L 122/31

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/674
         of 22 April 2022
         correcting Implementing Regulation (EU) 2022/95 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (the basic Regulation), and in particular Article 11(2) thereof,
         Whereas:

                     (1)

                     By Commission Implementing Regulation (EU) 2022/95 (2), the Commission imposed a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China (‘PRC’), as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not.

                     (2)

                     By Article 1 of Council Regulation (EC) No 763/2000 (3), three Taiwanese producers, Chup Hsin Enterprise Co. Ltd, Niang Hong Pipe Fittings Co. Ltd, and Rigid Industries Co. Ltd were exempted from the extension of the duty, as it was found that the said companies did not circumvent the measures.

                     (3)

                     However, the exemption from the extension of the duty to imports of the fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100) was repealed by Council Regulation (EC) No 803/2009 (4).

                     (4)

                     Article 2(1) of Implementing Regulation (EU) 2022/95 erroneously states that imports of fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and by Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100) continue to be exempted from the application of the anti-dumping duties.

                     (5)

                     Therefore, the Commission has decided to correct Article 2(1) of Implementing Regulation (EU) 2022/95 in order to rectify the error mentioned in recital (4). This rectification should take effect as from the entry into force of Implementing Regulation (EU) 2022/95, namely 26 January 2022.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Article 2(1) of Implementing Regulation (EU) 2022/95 is replaced by the following:

                  ‘1.   The definitive anti-dumping duty imposed by Article 1 on imports originating in the People’s Republic of China is hereby extended to imports of the same fittings (currently classified under TARIC codes: 7307931191; 7307931991; 7307998092) consigned from Taiwan (TARIC additional code A999), whether declared as originating in Taiwan or not, with the exception of those produced by Rigid Industries Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A099).’.

            Article 2
            Members States’ customs authorities shall correct the customs declarations accepted from 26 January 2022 impacted by Article 1 of this Regulation and retroactively collect the anti-dumping duties on imports of the fittings produced by Chup Hsin Enterprise Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A098) and Niang Hong Pipe Fittings Co. Ltd, Kaohsiung (Taiwan) (TARIC additional code A100).

            Article 3
            This Regulation shall enter into force with retroactive effect as from 26 January 2022.
            This Regulation shall be binding in its entirety and directly applicable in all Member States.

            Done at Brussels, 22 April 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) 2022/95 of 24 January 2022 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China, as extended to imports of certain tube and pipe fittings, of iron or steel consigned from Taiwan, Indonesia, Sri Lanka and the Philippines, whether declared as originating in these countries or not, following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (OJ L 16, 25.1.2022, p. 36).

            (3)  Council Regulation (EC) No 763/2000 of 10 April 2000 extending the definitive anti-dumping duty, imposed by Regulation (EC) No 584/96 on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China to imports of certain tube and pipe fittings, of iron or steel, consigned from Taiwan, whether declared as originating in Taiwan or not, and terminating the investigation in respect of imports from three Taiwanese exporters (OJ L 94, 14.4.2000, p. 1).

            (4)  Council Regulation (EC) No 803/2009 of 27 August 2009 imposing a definitive anti-dumping duty on imports of certain tube and pipe fittings, of iron or steel, originating in the People’s Republic of China and Thailand, and those consigned from Taiwan, whether declared as originating in Taiwan, or not, and repealing the exemption granted to Chup Hsin Enterprise Co. Ltd and Nian Hong Pipe Fittings Co. Ltd (OJ L 233, 4.9.2009, p. 1).


title: Commission Implementing Regulation (EU) 2019/1313 of 2 August 2019 concerning the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening (holder of authorisation Cargill Incorporated, represented by Provimi Holding BV) (Text with EEA relevance.)

text:
                  5.8.2019

                  EN

                  Official Journal of the European Union

                  L 205/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1313
         of 2 August 2019
         concerning the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening (holder of authorisation Cargill Incorporated, represented by Provimi Holding BV)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

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

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     That application concerns the authorisation of a preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 as a feed additive for pigs for fattening and minor porcine species for fattening, to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 February 2019 (2) that, under the proposed conditions of use, the preparation Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 does not have an adverse effect on animal health or the environment. It also concluded that the additive is considered as a potential respiratory sensitiser, even if with a low dusting potential, and that no conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive has a potential to be efficacious in feed to gain ratio in pigs for fattening at the recommended dose and that this conclusion can be extended to minor porcine species for fattening. 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 the preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is authorised as an additive in animal nutrition as set out 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, 2 August 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2019;17(3):5647.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1893

                        Cargill Incorporated, represented by Provimi Holding BV

                           Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and

                           Bacillus subtilis NRRL B-50510

                           Additive composition:

                        Preparation of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510 containing a minimum of: Bacillus spp. 2,5 × 109 CFU/g (ratio 1:1:1)
                        Powder form

                           Characterisation of the active substance:

                        Viable spore of Bacillus amyloliquefaciens NRRL B-50508, Bacillus amyloliquefaciens NRRL B-50509 and Bacillus subtilis NRRL B-50510

                           Analytical method
                            (1)

                        For the identification: Pulsed Field Gel Electrophoresis (PFGE)
                        For enumeration in the feed additive, premixtures and feedingstuffs: Spread plate method on tryptone soya agar (EN 15784)

                        Pigs for fattening
                        Minor porcine species for fattening

                        —

                        1,5 × 108

                        —

                                    1.

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

                                    2.

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

                        25 August 2029

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


title: Commission Implementing Regulation (EU) 2019/1314 of 2 August 2019 authorising the change of the specifications of the novel food Lacto-N-neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  5.8.2019

                  EN

                  Official Journal of the European Union

                  L 205/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1314
         of 2 August 2019
         authorising the change of the specifications of the novel food Lacto-N-neotetraose produced with Escherichia coli K-12 under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

                     Commission Implementing Decision (EU) 2016/375 (3) authorised, in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council (4), the placing on the market of chemically synthesized Lacto-N-neotetraose as a novel food ingredient.

                     (5)

                     Pursuant to Article 5 of Regulation (EC) No 258/97, on 1 September 2016, the company Glycom A/S (‘the Applicant’), informed the Commission of its intention to place on the market Lacto-N-neotetraose of microbial source produced with Escherichia coli strain K-12 as a novel food ingredient.

                     (6)

                     In the notification to the Commission, the Applicant also submitted a report issued by the competent authority of Ireland pursuant to Article 3(4) of Regulation (EC) No 258/97, which, on the basis of the scientific evidence submitted by the Applicant, had concluded that Lacto-N-neotetraose produced with Escherichia coli strain K-12 is substantially equivalent to the synthetic Lacto-N-neotetraose authorised by Commission Implementing Decision (EU) 2016/375. Therefore, Lacto-N-neotetraose of microbial origin was included in the Union list of novel foods.

                     (7)

                     On 18 December 2018, the Applicant pursuant to Article 10(1) of Regulation (EU) 2015/2283, requested a change in the specifications of the Lacto-N-neotetraose with Escherichia coli strain K-12 in order to reduce the energy and environmental load of the Lacto-N-neotetraose manufacturing process and reduce the cost per unit produced. The changes concern a decrease in the levels of the Lacto-N-neotetraose from equal or greater than 92 % to equal or greater than 80 %, and increases in the levels of the minor saccharides present in the novel food, namely an increase in the levels of D-Lactose from up to 3,0 % to up to 10,0 %, and an increase in the levels of para-Lacto-N-neohexaose from up to 3,0 % to up to 5,0 %.

                     (8)

                     To ensure that the overall purity of the novel food after the requested changes are introduced in its specifications remains as high as the currently authorised Lacto-N-neotetraose, the Applicant also proposes that the sum of the levels of Lacto-N-neotetraose and of the minor saccharides (D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, and Lacto-N-neotetraose fructose isomer) in the novel food is equal or greater than 92,0 %.

                     (9)

                     The requested changes in the specifications of the novel food are due to the modifications in its manufacturing process that entail the replacement of the crystallisation purification step with a spray drying step which is currently used in the production of Lacto-N-neotetraose by Escherichia coli strain K-12. The applicant therefore requested to amend the entry of Lacto-N-neotetraose of microbial origin in the Union list of authorised novel foods in order to reflect that change in the purification step of the manufacturing process.

                     (10)

                     The Commission considered that the requested modifications involving saccharides of the authorised novel food which are also components of the human milk while maintaining an overall high sum of those and the other minor saccharides present in the novel food, do not alter the safety considerations that supported the authorisation of the synthetic Lacto-N-neotetraose and the Lacto-N-neotetraose produced with Escherichia coli strain K-12, and therefore do not necessitate a consultation of the European Food Safety Authority.

                     (11)

                     Taking into account the above considerations, the requested changes comply with Article 12(1) of Regulation (EU) 2015/2283. Therefore, it is appropriate to amend the specifications of the novel food Lacto-N-neotetraose of microbial origin produced with Escherichia coli strain K-12 at the proposed levels of Lacto-N-neotetraose, of D-Lactose, and of para-Lacto-N-neohexaose, and of the overall levels of Lacto-N-neotetraose together with minor saccharides (D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, and Lacto-N-neotetraose fructose isomer).

                     (12)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 referring to the substance Lacto-N-neotetraose produced with Escherichia coli strain K-12 shall be amended as specified in the Annex 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, 2 August 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  Commission Implementing Decision (EU) 2016/375 of 11 March 2016 authorising the placing on the market of Lacto-N-neotetraose as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (
               OJ L 70, 16.3.2016, p. 22).

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

            ANNEX
            In Table 2 (Specifications) of Implementing Regulation (EU) 2017/2470, the entry for ‘Lacto-N-neotetraose (microbial source)’ is replaced by the following:

                           ‘Lacto-
                                 N
                              -neotetraose

                              (microbial source)

                              Definition:

                           Chemical name: β-D-Galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose
                           Chemical formula: C26H45NO21

                           CAS No: 13007-32-4
                           Molecular weight: 707,63 g/mol

                              Source:

                           Genetically modified strain of Escherichia coli K-12

                              Description:

                           Lacto-N-neotetraose is a white to off-white powder that is produced by a microbiological process.

                              Purity:

                           Assay (water free): ≥ 80 %
                           D-Lactose: ≤ 10,0 %
                           Lacto-N-triose II: ≤ 3,0 %

                              para-Lacto-N-neohexaose: ≤ 5,0 %
                           Lacto-N-neotetraose fructose isomer: ≤ 1,0 %
                           Sum of saccharides (Lacto-N-neotetraose, D-Lactose, Lacto-N-triose II, para-Lacto-N-neohexaose, Lacto-N-neotetraose fructose isomer): ≥ 92 %
                           pH (20 C, 5 % solution): 4,0-7,0
                           Water: ≤ 9,0 %
                           Ash, sulphated: ≤ 0,4 %
                           Residual solvents (methanol): ≤ 100 mg/kg
                           Residual proteins: ≤ 0,01 %

                              Microbiological criteria:

                           Aerobic mesophilic bacteria total count: ≤ 500 CFU/g
                           Yeasts: ≤ 10 CFU/g
                           Moulds: ≤ 10 CFU/g
                           Residual endotoxins: ≤ 10 EU/mg

                           CFU: Colony Forming Units; EU: Endotoxin Units’