title: Commission Implementing Regulation (EU) 2018/408 of 15 March 2018 amending Implementing Regulation (EU) 2017/1758 laying down form and content of the accounting information to be submitted to the Commission for the purpose of the clearance of the accounts of the EAGF and the EAFRD as well as for monitoring and forecasting purposes

text:
               16.3.2018

               EN

               Official Journal of the European Union

               L 74/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/408
   of 15 March 2018
   amending Implementing Regulation (EU) 2017/1758 laying down form and content of the accounting information to be submitted to the Commission for the purpose of the clearance of the accounts of the EAGF and the EAFRD as well as for monitoring and forecasting purposes
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular Article 104 thereof,
   Whereas:

               (1)

               Annex IV to Commission Implementing Regulation (EU) 2017/1758 (2) sets out the structure of the European Agricultural Fund for Rural Development (‘the EAFRD’) budget codes for the programming period 2014 to 2020.

               (2)

               Regulation (EU) 2017/2393 (3) of the European Parliament and of the Council has amended several provisions of Regulation (EU) No 1305/2013 of the European Parliament and of the Council (4), including those concerning an additional allocation and a new category of derogation of the EAFRD contribution rate. Therefore, Implementing Regulation (EU) 2017/1758 should reflect the amendments to the relevant provisions of Regulation (EU) No 1305/2013.

               (3)

               Implementing Regulation (EU) 2017/1758 should therefore be amended accordingly.

               (4)

               This Regulation should apply from the same day as Regulation (EU) 2017/2393.

               (5)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The third table, under point 1.2 ‘budget code structure’, defining the second digit of the combination of articles used to establish the maximum EAFRD contribution rate ‘RRR’ in Annex IV to Implementing Regulation (EU) 2017/1758, is amended as follows:

               (1)

               the line for code 6 is replaced by the following:

                           ‘6

                           59(4)(f)

                           Additional allocation for Ireland, Portugal and Cyprus’

               (2)

               the following line is added:

                           ‘8

                           59(4)(h)

                           Contribution rate referred to in Article 39a(13) of Regulation (EU) No 1303/2013 for the financial instrument referred to in point (c) of Article 38(1) of that Regulation’

         Article 2
   This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 January 2018.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 15 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 347, 20.12.2013, p. 549.

      (2)  Commission Implementing Regulation (EU) 2017/1758 of 27 September 2017 laying down form and content of the accounting information to be submitted to the Commission for the purpose of the clearance of the accounts of the EAGF and the EAFRD as well as for monitoring and forecasting purposes (OJ L 250, 28.9.2017, p. 1).

      (3)  Regulation (EU) 2017/2393 of the European Parliament and of the Council of 13 December 2017 amending Regulations (EU) No 1305/2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD), (EU) No 1306/2013 on the financing, management and monitoring of the common agricultural policy, (EU) No 1307/2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy, (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products and (EU) No 652/2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material (OJ L 350, 29.12.2017, p. 15).

      (4)  Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (OJ L 347, 20.12.2013, p. 487).


title: Commission Implementing Regulation (EU) 2018/406 of 2 March 2018 entering a name in the register of protected designations of origin and protected geographical indications (‘Amêndoa Coberta de Moncorvo’ (PGI))

text:
               16.3.2018

               EN

               Official Journal of the European Union

               L 74/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/406
   of 2 March 2018
   entering a name in the register of protected designations of origin and protected geographical indications (‘Amêndoa Coberta de Moncorvo’ (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Portugal's application to register the name ‘Amêndoa Coberta de Moncorvo’ was published in the Official Journal of the European Union
                   (2).

               (2)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Amêndoa Coberta de Moncorvo’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Amêndoa Coberta de Moncorvo’ (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 2.3. — bread, pastry, cakes, confectionery, biscuits and other baker's wares, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   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 March 2018.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  OJ C 391, 18.11.2017, p. 11.

      (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2018/407 of 14 March 2018 concerning the classification of certain goods in the Combined Nomenclature

text:
               16.3.2018

               EN

               Official Journal of the European Union

               L 74/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/407
   of 14 March 2018
   concerning the classification of certain goods in the Combined Nomenclature
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
   Whereas:

               (1)

               In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

               (2)

               Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

               (3)

               Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

               (4)

               It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

               (5)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.
   Article 2
   Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 14 March 2018.

            For the Commission,

            On behalf of the President,

         Stephen QUEST

            Director-General

            Directorate-General for Taxation and Customs Union

      (1)  OJ L 269, 10.10.2013, p. 1.

      (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

      ANNEX

                  Description of goods

                  Classification (CN Code)

                  Reasons

                  (1)

                  (2)

                  (3)

                  A product named ‘brown fused alumina slag’ which is a by-product obtained during the production of ordinary electro-corundum in electric furnaces.
                  The product is composed of the following ingredients (% by weight):

                  7202 29 90

                  Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, Note 3(a) to Chapter 26, Note 1(c) to Chapter 72, Subheading note 2 to Chapter 72 and by the wording of CN codes 7202 , 7202 29  and 7202 29 90 .
                  Classification under heading 2620  is excluded because the product does not fulfil the requirements of Note 3(a) to Chapter 26.
                  The chemical composition of this product fulfils the requirements of note 1(c) to Chapter 72, defining ferro-alloys, and of subheading note 2 to Chapter 72, defining ferro-alloys of heading 7202 .
                  The two essential characteristics of this product, which are in line with description of ferro-alloys, are that this product is used in gravimetric separation of metal ores and is prepared in electric furnaces (see also the Harmonized System Explanatory Notes to heading 7202 , the fourth and sixth paragraphs).
                  Because of the chemical composition of the product which allows its use in the gravimetric separation of metal ores by selective flotation, the product is to be classified under heading 7202  as a ferro-alloy.
                  The product is therefore to be classified in CN code 7202 29 90  as other ferro-silicon alloy.

                              —

                              iron

                  75

                              —

                              silicon

                  15

                              —

                              titanium

                  5

                              —

                              aluminium

                  3

                              —

                              other metals

                  2

                  The product is used for concentrating metal ores by selective flotation in the gravimetric separation process.


title: Council Implementing Regulation (EU) 2018/420 of 19 March 2018 implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria

text:
               19.3.2018

               EN

               Official Journal of the European Union

               LI 75/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/420
   of 19 March 2018
   implementing Regulation (EU) No 36/2012 concerning restrictive measures in view of the situation in Syria
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 36/2012 of 18 January 2012 concerning restrictive measures in view of the situation in Syria and repealing Regulation (EU) No 442/2011 (1), and in particular Article 32(1) thereof,
   Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 18 January 2012, the Council adopted Regulation (EU) No 36/2012.

               (2)

               In view of the gravity of the situation in Syria, in particular the use by the Syrian regime of chemical weapons and its involvement in chemical weapons proliferation, four persons should be added to the list of natural and legal persons, entities or bodies subject to restrictive measures in Annex II to Regulation (EU) No 36/2012.

               (3)

               Annex II to Regulation (EU) No 36/2012 should therefore be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex II to Regulation (EU) No 36/2012 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 March 2018.

            For the Council

            The President

         F. MOGHERINI

      (1)  OJ L 16, 19.1.2012, p. 1.

      ANNEX
      The following persons are added to the list set out in Section A (Persons) of Annex II to Regulation (EU) No 36/2012:

                     Name

                     Identifying information

                     Reasons

                     Date of listing

                     ‘260.

                     Yusuf Ajeeb
                     (a.k.a:; Yousef; Ajib)

                     Brigadier General; Doctor; Head of Security Office, Scientific Studies and Research Centre (SSRC)
                     Address: Scientific Studies and Research Centre (SSRC), Barzeh Street, P.O. Box 4470, Damascus

                     Holds the rank of Brigadier General, a senior officer in the Syrian Armed Forces, in post after May 2011. Since 2012, he has been Head of Security for the Scientific Studies and Research Centre (SSRC) which is involved in the chemical weapons proliferation sector. As a result of his senior position as Head of Security for SSRC, he is associated with the designated entity SSRC.

                     19.3.2018

                     261.

                     Maher Sulaiman
                     (a.k.a:; Mahir; Suleiman)

                     Doctor; Director of the Higher Institute for Applied Sciences and Technology
                     Address: Higher Institute for Applied Sciences and Technology (HIAST), P.O. Box 31983, Damascus

                     Director of the Higher Institute for Applied Sciences and Technology (HIAST), which provides training and support as part of the Syrian chemical weapons proliferation sector. Due to his senior position at the HIAST, which is an affiliate and subsidiary of the Scientific Studies and Research Centre (SSRC), he is associated with the HIAST and SSRC, both of which are designated entities.

                     19.3.2018

                     262.

                     Salam Tohme
                     (a.k.a:; Salim; Taame, Ta'mah, Toumah)

                     Doctor: Deputy Director General, Scientific Studies and Research Centre (SSRC)
                     Address: Scientific Studies and Research Centre (SSRC), Barzeh Street, P.O. Box 4470, Damascus

                     Deputy Director General of the Scientific Studies and Research Centre (SSRC) which is responsible for the development and production of non-conventional weapons, including chemical weapons, and the missiles to deliver them. Due to his senior position at SSRC, he is associated with designated entity SSRC.

                     19.3.2018

                     263.

                     Zuhair Fadhlun
                     (a.k.a:; Zoher; Fadloun, Fadhloun)

                     Head of Institute 3000 (a.k.a. Institute 5000), Scientific Studies and Research Centre (SSRC)
                     Address: Scientific Studies and Research Centre (SSRC), Barzeh Street, P.O. Box 4470, Damascus

                     Director of the branch of the Scientific Studies and Research Centre (SSRC) that is known as Institute 3000 (a.k.a. Institute 5000). In this role, he is responsible for chemical weapons projects, including production of chemical agents and munitions. Due to his senior position at SSRC, he is associated with designated entity SSRC.

                     19.3.2018’


title: Commission Implementing Regulation (EU) 2018/456 of 19 March 2018 on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )

text:
                  20.3.2018

                  EN

                  Official Journal of the European Union

                  L 77/6

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/456
      of 19 March 2018
      on the procedural steps of the consultation process for determination of novel food status in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council 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 4 thereof,
      Whereas:

                  (1)

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

                  (2)

                  Article 4 of Regulation (EU) 2015/2283 lays down basic principles on the procedure for the determination of novel food status. Paragraph 1 of that Article requires food business operators to verify whether or not the food which they intend to place on the Union market falls within the scope of that Regulation.

                  (3)

                  In order to determine the novel food status of a particular food, a consultation request should be submitted. The Member States should verify the validity of such requests. Therefore, it is necessary to establish rules for the verification process.

                  (4)

                  Rules should be established in order to ensure that the consultation request for determination of novel food status provides all the information necessary for the evaluation by the Member States.

                  (5)

                  In order to ensure that food business operators and the public are informed of the novel food status, the information on the novel food status should be made publicly available.

                  (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
      Scope and subject matter
      This Regulation lays down rules for the implementation of Article 4 of Regulation (EU) 2015/2283 as regards the procedural steps of the consultation process to determine whether or not a food falls within the scope of that Regulation.
      Article 2
      Definitions
      In addition to the definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council (2) and Regulation (EU) 2015/2283, the following definitions shall apply:

                  (a)

                  ‘consultation request’ means a request from a food business operator to a recipient Member State to determine the novel food status of a particular food;

                  (b)

                  ‘recipient Member State’ means a Member State where the food business operator intends to place on the market a particular food for the first time.

            Article 3
      Submission of a consultation request
      1.   The food business operator shall consult the recipient Member State as provided for in Article 4(2) of Regulation (EU) 2015/2283 by submitting a consultation request to that Member State.
      2.   Where the food business operator intends to place the food on the market simultaneously in several Member States, the food business operator shall submit the consultation request only to one of those Member States.
      Article 4
      Content and presentation of a consultation request
      1.   The consultation request shall be submitted electronically to the recipient Member State and shall consist of the following:

                  (a)

                  a cover letter;

                  (b)

                  a technical dossier;

                  (c)

                  supporting documentation;

                  (d)

                  an explanatory note clarifying the purpose and relevance of the submitted documentation.

            2.   The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
      3.   The technical dossier referred to in paragraph 1(b) shall contain the information necessary to enable the recipient Member State to conclude on the novel food status and shall be drafted in accordance with the template provided in Annex II.
      4.   By way of derogation from paragraph 3, an applicant is not required to provide all the elements referred to in Annex II, provided that the applicant has submitted verifiable justification for the absence of each missing element.
      Article 5
      Procedures for verifying the validity of a consultation request
      1.   The recipient Member State shall without delay verify whether the consultation request complies with the requirements of Article 4.
      2.   Where the food business operator submits insufficient information in the consultation request, the recipient Member State shall request the food business operator to provide additional information or make the relevant updates to the consultation request within the time period specified by the recipient Member State.
      3.   The consultation request shall be considered not valid where:

                  (a)

                  the food business operator does not provide requested additional information or updated consultation request within the period specified by the recipient Member State;

                  (b)

                  the submitted additional information is insufficient to conclude that the consultation request is valid.

            4.   The recipient Member State shall decide on the validity of the consultation request and without delay inform the food business operator, the other Member States and the Commission of the decision. Where the consultation request is considered not valid, the recipient Member State shall provide the reasons for that conclusion.
      Article 6
      Procedures for evaluating a valid consultation request
      1.   The recipient Member State shall conclude on the novel food status of a food within 4 months from the date on which it decided on the validity of the consultation request.
      2.   Where the recipient Member State identifies that it does not have sufficient evidence to decide on the novel food status of a food, it may request the food business operator to provide additional information. The period of that request shall be determined together with the food business operator.
      The recipient Member State may consult the other Member States and the Commission.
      3.   Without prejudice to paragraph 4, a request for additional information referred to in paragraph 2 shall not extend the time period referred to in paragraph 1.
      4.   In duly justified cases, the recipient Member State may extend the time period referred to in paragraph 1 by a maximum of 4 months. The recipient Member State shall inform the food business operator, the other Member States and the Commission of their decision and shall provide justification.
      5.   On concluding on the novel food status of a food, the recipient Member State shall without delay notify the food business operator, the other Member States and the Commission of the decision and shall provide justification in accordance with Article 7 of this Regulation.
      Article 7
      Information on the novel food status and publication
      1.   The notification referred to in Article 6(5) of this Regulation shall include the following:

                  (a)

                  the name and description of the food concerned;

                  (b)

                  a statement indicating whether the food concerned is novel, not novel or not novel only in food supplements;

                  (c)

                  reasons justifying the statement referred to in point (b);

                  (d)

                  where the food is novel food, the most appropriate food category under which it falls in accordance with Article 3(2) of Regulation (EU) 2015/2283.

            2.   The Commission shall without delay make the information on the novel food status publicly available on the Commission's website.
      Article 8
      Competent authorities of the Member States
      Member States shall provide the Commission with the contact details of the national competent authorities and the contact details of the respective contact points designated for the purposes of this Regulation by 1 March 2018.
      The Commission shall publish those contact details on the Commission's website by 1 May 2018.
      Article 9
      Confidentiality
      1.   Food business operators may request the recipient Member State to agree that the disclosure of certain information submitted as part of the consultation request needs to benefit from confidential treatment where disclosure of such information may harm their competitive position.
      2.   For the purpose of paragraph 1, food business operators shall indicate to the recipient Member State the parts of the information provided that they wish to be treated as confidential and provide all the necessary details to substantiate their request for confidentiality.
      3.   The recipient Member State shall inform the food business operator of its views on which parts of the information are to remain confidential.
      However, confidentiality shall not apply to the following information:

                  (a)

                  the name and address of the applicant;

                  (b)

                  the name and description of the food;

                  (c)

                  a summary of the studies submitted by the applicant;

                  (d)

                  where appropriate, the analysis method(s).

            4.   In case of the consultation of other Member States pursuant to Article 6(2), second subparagraph, the recipient Member State shall inform the Commission and the Member States about its views on confidentiality of the consultation request.
      5.   After being informed pursuant to paragraph 3, the food business operator may withdraw its consultation request within 3 weeks during which the confidentiality of the information provided shall be observed.
      6.   The Commission and the Member States shall take necessary measures to ensure appropriate confidentiality of the information referred to in paragraphs 3 and received by them under this Regulation, except for information which is required to be made public in order to protect human health.
      7.   Where a food business operator withdraws or has withdrawn its consultation request in accordance with paragraph 5, neither the Commission nor the Member States shall disclose information for which confidentiality was requested by the food business operator pursuant to paragraph 1.
      8.   The application of paragraphs 1 to 7 shall not affect the exchange of information between the Commission and the Member States necessary to consider the consultation requests submitted under this Regulation.
      Article 10
      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, 19 March 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         ANNEX I

            TEMPLATE COVER LETTER ACCOMPANYING A CONSULTATION REQUEST FOR DETERMINATION OF THE NOVEL FOOD STATUS

            Competent authority of the Member State

         Date: …
         Subject: Consultation request for determination of the novel food status of …
         …
         The Food business operator(s)/consulting party:
         Company: …
         Address: …
         Telephone: …
         Email: …
         Contact person: …
         submit(s) the present consultation request in order to determine the novel food status of …
         Yours sincerely,
         Signature …
         Enclosures:

                     ☐

                     Technical dossier

                     ☐

                     Documents in support of the consultation request

                     ☐

                     Explanatory note

         ANNEX II

            TEMPLATE TECHNICAL DOSSIER

         The connection between the different pieces of information shall be explained in an explanatory note. In particular, as regards the evidence presented to support a human consumption to a significant degree within the Union before 15 May 1997, where documents from a range of sources must be considered to be able to reach a conclusion.
         Where only parts of the documents are relevant for the determination of the novel food status, those parts shall be highlighted.
         For all foods, Section 1 must be completed.
         For extracts, in addition to Section 1, Section 2 must be completed.
         For foods resulting from a production process not used for food production within the Union before 15 May 1997, Section 1 (points 1 to 3, and point 7) and Section 3 must be completed.

            Section 1: All foods (for foods resulting from a production process not used for food production within the Union before 15 May 1997 only points 1 to 3 and point 7)

                                    1.

                                 Description of the food

                                 1.1

                                 Name of the food

                                 1.2

                                 Detailed description of the food, including information whether the food consists of engineered nanomaterials as referred to in points (a)(viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283 (1)

                                 1.3

                                 Proposed category of the novel food in accordance with Article 3(2)(a) of Regulation (EU) 2015/2283, where applicable

                                    2.

                                 Further characterisation of the food and/or source of the food (where relevant)

               A.   Organisms (microorganisms, fungi, algae, plants, animals)

                                 2.1

                                 Taxonomic name (full Latin name with author name)

                                 2.2

                                 Synonyms, other names, where applicable

                                 2.3

                                 Specification of which part of the organism the use for human consumption before 15 May 1997 within the Union refers to, where applicable

                                 2.4

                                 Specification about purity/concentration

               B.   Chemical substances

                                 2.5

                                 CAS number(s) (if this has been attributed)

                                 2.6

                                 Chemical name(s) according to IUPAC nomenclature rules

                                 2.7

                                 Synonyms, trade name, common name, where applicable

                                 2.8

                                 Molecular and structural formulae

                                 2.9

                                 Specification about purity/concentration

                                    3.

                                 Conditions of use

                                 3.1

                                 How is the food intended to be used?

                                 3.2

                                 Type of product(s) in which the food is intended to be used

                                 3.3

                                 Level/concentration (or range of levels) in the product(s) in which the food is intended to be used

                                    4.

                                 Production process

                                 4.1

                                 Detailed description of the production process. Include a flow process chart to describe the production process.

                                    5.

                                 History of human consumption of the food within the Union before 15 May 1997

                                 5.1

                                 To what extent was the food consumed to a significant degree throughout the Union before 15 May 1997? Details shall be provided.

                                 5.2

                                 To what extent was the food consumed to a significant degree in one Member State before 15 May 1997? Details shall be provided.

                                 5.3

                                 Was the food consumed only regionally/on a small local scale in the Union before 15 May 1997? Details shall be provided.

                                 5.4

                                 Was the food available before 15 May 1997 in the Union as an ingredient designed for specific target population (e.g. food for a special medical purpose)? Details shall be provided.

                                    6.

                                 Consultations on availability in the Union
                                 Where food business operators are unsure whether the information in their possession is sufficient to prove that the food concerned has been used for human consumption to a significant degree within the Union before 15 May 1997, they may consult other food business operators or food business operator federations in order to gather sufficient information.

                                 6.1

                                 Have other food business operators or food business operator federations been consulted? Details should be provided.

                                 6.2

                                 Is the food currently available on the market within the Union? Details should be provided.

                                    7.

                                 Additional information

                                 7.1

                                 Is there any information that the product concerned is used within the Union as medicinal product in accordance with Directive 2001/83/EC (2)?

                                 7.2

                                 Is there any other information which would assist in determining the novel food status? Any information which is relevant even if not specifically requested shall be submitted.

            Section 2: Extracts

                                    8.

                                 Extracts

                                 8.1

                                 Any further details of the source material for the extract, if not provided in Section 1. Details shall be provided.

                                 8.2

                                 Specification of the extract. Details shall be provided.

                                 8.3

                                 If extracted from a food source, will the intake of any extract components in the food be higher than the intake of these components in the food source? Details shall be provided.

            Section 3: Foods resulting from a production process not used for food production within the Union before 15 May 1997

                                    9.

                                 Production process

                                 9.1

                                 Detailed description of the production process. Include a flow process chart to describe the production process.

                                 9.2

                                 Is the structure or composition of the food affecting its nutritional value, metabolism or level of undesirable substances because of the process by which the food has been prepared? Details shall be provided.

                                 9.3

                                 Is the food produced from a source that in itself is not normally consumed as part of the diet? Details shall be provided.

                     (1)

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

                     (2)

                     Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).


title: Commission Implementing Regulation (EU) 2018/460 of 20 March 2018 authorising the placing on the market of Ecklonia cava phlorotannins 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:
               21.3.2018

               EN

               Official Journal of the European Union

               L 78/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/460
   of 20 March 2018
   authorising the placing on the market of Ecklonia cava phlorotannins 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) was adopted, which establishes a Union list of authorised novel foods.

               (3)

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

               (4)

               Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) and for which the final decision has not been taken before 1 January 2018, shall be treated as an application submitted under Regulation (EU) 2015/2283.

               (5)

               On 14 May 2015, the company Botamedi Inc. made a request to the competent authority of Ireland to place phlorotannins extracted from the edible marine alga Ecklonia cava (‘Ecklonia cava phlorotannins’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97. The application requests for Ecklonia cava phlorotannins to be used in food supplements for the general population, excluding children below 12 years of age.

               (6)

               While the request for placing Ecklonia cava phlorotannins as a novel food on the Union market was submitted in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

               (7)

               On 29 March 2016, the competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that an additional assessment is required for Ecklonia cava phlorotannins in accordance with Article 6(3) of Regulation (EC) No 258/97.

               (8)

               On 10 May 2016, the Commission forwarded the initial assessment report to the other Member States. The Member States, within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97, agreed with the initial assessment report of Ireland.

               (9)

               In view of the initial assessment report issued by Ireland, to which the other Member States agreed, on 22 July 2016, the Commission consulted the European Food Safety Authority (EFSA), asking it to carry out an additional assessment for Ecklonia cava phlorotannins as a novel food ingredient in accordance with Regulation (EC) No 258/97.

               (10)

               On 20 September 2017, EFSA adopted ‘Scientific Opinion on the safety of Ecklonia cava phlorotannins as a novel food pursuant to Regulation (EC) No 258/97’ (4). This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97, is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

               (11)

               The EFSA opinion underlined that iodine intake from food supplements containing Ecklonia cava phlorotannins may be of concern for people at risk of thyroid disease, and that, if people who are not at risk of thyroid disease take food supplements containing Ecklonia cava phlorotannins in addition to other food supplements containing iodine, their overall iodine intake may exceed the upper limit established for iodine (5). Food supplements containing Ecklonia cava phlorotannins should therefore be appropriately labelled.

               (12)

               Moreover, taking into account the intended use and the fact that the request for authorisation excludes children under the age of 12 years, food supplements containing Ecklonia cava phlorotannins should also be appropriately labelled in this regard.

               (13)

               It follows, that the EFSA opinion gives sufficient grounds to establish that Ecklonia cava phlorotannins in the proposed uses and use levels when used as an ingredient in food supplements, complies with the criteria laid down in Article 12(1) of Regulation (EU) 2015/2283

               (14)

               Directive 2002/46/EC of the European Parliament and of the Council (6) lays down requirements on food supplements. The use of Ecklonia cava phlorotannins should be authorised without prejudice to that Directive.

               (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.   Ecklonia cava phlorotannins as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.
   2.   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 to this Regulation.
   3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
   Article 2
   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OL 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 foods ingredients (OJ L 43, 14.2.1997, p. 1).

      (4)  EFSA Journal 2017;15(10):5003.

      (5)  Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Iodine, 7.10.2002.

      (6)  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).

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

                  (1)

                  The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

                              Authorised novel food

                              Conditions under which the novel food may be used

                              Additional specific labelling requirements

                              Other requirements

                              ‘
                                    Ecklonia cava phlorotannins

                                 Specified food category

                                 Maximum levels

                              The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Ecklonia cava Phlorotannins’.
                              Food supplements containing Ecklonia cava phlorotannins shall bear the following statement:

                                          (a)

                                          This food supplement should not be consumed by children/adolescents under the age of twelve/fourteen/eighteen (*) years.

                                          (b)

                                          This food supplement should not be consumed by persons with thyroid disease or by persons who are aware of or have been identified as being at risk of developing thyroid disease.

                                          (c)

                                          This food supplement should not be consumed if other food supplements containing iodine are also consumed.

                                          (*)

                                          Depending on the age group the food supplement is intended for.’

                              Food Supplements as defined in Directive 2002/46/EC intended for the general population, excluding children under the age of 12 years

                              163 mg/day for adolescents from 12 to 14 years of age;
                              230 mg/day for adolescents above 14 years of age;
                              263 mg/day for adults.

                  (2)

                  The following entry is inserted in Table 2 (Specifications) in alphabetical order:

                              Authorised Novel Food

                              Specification

                              ‘
                                    Ecklonia cava phlorotannins

                                 Description/Definition:

                                 Ecklonia cava phlorotannins are obtained via alcohol extraction from the edible marine alga Ecklonia cava. The extract is a dark brown powder, rich in phlorotannins, polyphenolic compounds found as secondary metabolites in certain brown algae species.

                                 Characteristics/Composition

                              Phlorotannin content: 90 ± 5 %
                              Antioxidant activity: > 85 %
                              Moisture: < 5 %
                              Ash: < 5 %

                                 Microbiological criteria:

                              Total viable cell count: < 3 000  CFU/g
                              Mould/yeast: < 300 CFU/g
                              Coliforms: Negative to test

                                 Salmonella spp.: Negative to test

                                 Staphylococcus aureus: Negative to test

                                 Heavy metals and Halogens:

                              Lead: < 3,0 mg/kg
                              Mercury: < 0,1 mg/kg
                              Cadmium: < 3,0 mg/kg
                              Arsenic: < 25,0 mg/kg
                              Inorganic Arsenic: < 0,5 mg/kg
                              Iodine: 150,0-650,0 mg/kg
                              CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2018/462 of 20 March 2018 authorising an extension of use of L-ergothioneine 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:
               21.3.2018

               EN

               Official Journal of the European Union

               L 78/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/462
   of 20 March 2018
   authorising an extension of use of L-ergothioneine 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) was adopted, which establishes a Union list of authorised novel foods.

               (3)

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

               (4)

               On 25 July 2013, the company Tetrahedron made a request to the competent authority of France to place synthetic L-ergothioneine (‘L-ergothioneine’) on the Union market as a novel food ingredient within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 (3). The application requested for L-ergothioneine to be used in food supplements for the general population excluding pregnant and lactating women and for children older than three years, and in non-alcoholic beverages, fresh milk products, milk based drinks, cereal bars and chocolate for the general population excluding pregnant and lactating women, infants and young children.

               (5)

               On 26 October 2016, EFSA adopted a ‘Scientific Opinion on the safety of L-ergothioneine as a novel food pursuant to Regulation (EC) No 258/97’ (4). In its opinion it concluded that L-ergothioneine is safe for the proposed uses and use levels.

               (6)

               Commission Implementing Decision (EU) 2017/1281 (5) authorised, in accordance with Regulation (EC) No 258/97, the placing on the market of L-ergothioneine as a novel food ingredient to be used in food supplements intended for the general population, excluding infants and young children, pregnant and lactating women.

               (7)

               This Implementing Regulation addresses the remainder of the uses and use levels for which authorisation was sought by the applicant. The Commission initiated a further evaluation before taking a final decision on the full scope of the application, in order to ensure that L-ergothioneine is also safe when consumed in other forms than in food supplements by infants, young children, pregnant and lactating women.

               (8)

               On 26 April 2017, the applicant was informed of and agreed with the Commission's additional request to EFSA.

               (9)

               On 19 May 2017, the Commission consulted EFSA asking it to carry out a supplementary safety assessment for L-ergothioneine in non-alcoholic beverages, fresh milk products, milk-based drinks, cereal bars and chocolate for pregnant and lactating women, infants and young children.

               (10)

               Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

               (11)

               On 25 October 2017, EFSA adopted a ‘Scientific Opinion on the safety of L-ergothioneine’ (6). This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

               (12)

               The opinion gives sufficient grounds to establish that L-ergothioneine when used as an ingredient in non-alcoholic beverages, fresh milk products, milk-based drinks, cereal bars and chocolate confectionery taking into account all population groups, complies with Article 12(1) of Regulation (EU) 2015/2283.

               (13)

               Regulation (EU) No 1308/2013 of the European Parliament and of the Council establishing a common organisation of the markets in agricultural products (7) lays down requirements for milk and milk products which apply to L-ergothioneine when used as an ingredient in milk products. Pursuant to its point 2 of Part III of Annex VII L-ergothioneine cannot be used in milk products to replace, in whole or in part, any milk constituent. The use of L-ergothioneine as a novel food in milk products therefore has to be limited accordingly.

               (14)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   The entry in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283 referring to the substance L-ergothioneine shall be amended as specified in the Annex to this Regulation
   2.   The entry in the Union list referred to in the first paragraph shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.
   Article 2
   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

      (3)  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)  EFSA Journal 2016; 14(11):4629

      (5)  Commission Implementing Decision (EU) 2017/1281 of 13 July 2017 authorising the placing on the market of L-ergothioneine as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 184, 15.7.2017, p. 65).

      (6)  EFSA Journal 2017; 15(11):5060.

      (7)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, p. 671).

      ANNEX
      The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:
      The entry for ‘L-ergothioneine’ in Table 1 (Authorised novel foods) is replaced by the following:

                     Authorised novel food

                     Conditions under which the novel food may be used

                     Additional specific labelling requirements

                     Other requirements

                     ‘L-ergothioneine

                        Specified food category

                        Maximum levels

                     The designation of the novel food on the labelling of the foodstuffs containing it shall be “L-ergothioneine”’

                     Alcohol-free beverages

                     0,025 g/kg

                     Milk-based drinks

                     0,025 g/kg

                     ‘Fresh’ milk products (*)

                     0,040 g/kg

                     Cereal bars

                     0,2 g/kg

                     Chocolate confectionery

                     0,25 g/kg

                     Food supplements as defined in Directive 2002/46/EC

                     30 mg/day for general population (excluding pregnant and lactating women)
                     20 mg/day for children older than 3 years

                                 (*)

                                 When used in milk products L-ergothioneine may not replace in whole or in part, any milk constituent


title: Council Implementing Regulation (EU) 2018/465 of 21 March 2018 implementing Regulation (EU) No 270/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt

text:
               21.3.2018

               EN

               Official Journal of the European Union

               LI 78/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/465
   of 21 March 2018
   implementing Regulation (EU) No 270/2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 270/2011 of 21 March 2011 concerning restrictive measures directed against certain persons, entities and bodies in view of the situation in Egypt (1), and in particular Article 12(4) thereof,
   Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 21 March 2011, the Council adopted Regulation (EU) No 270/2011.

               (2)

               The statement of reasons for four persons listed in Annex I to Regulation (EU) No 270/2011 should be amended.

               (3)

               Six persons should be removed from the list of natural and legal persons, entities and bodies set out in Annex I to Regulation (EU) No 270/2011.

               (4)

               Annex I to Regulation (EU) No 270/2011 should therefore be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EU) No 270/2011 is amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the 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, 21 March 2018.

            For the Council

            The President

         E. ZAHARIEVA

      (1)  OJ L 76, 22.3.2011, p. 4.

      ANNEX

                  1.

                  In Annex I to Regulation (EU) No 270/2011, the entries concerning the persons below are replaced by the following entries:

                              Name (and any aliases)

                              Identifying information

                              Grounds for designation

                              2.

                              ‘Suzanne Saleh Thabet

                              Spouse of Mr Mohamed Hosni Elsayed Mubarak, former President of the Arab Republic of Egypt
                              Date of birth: 28.2.1941
                              Female

                              Associated with Mohamed Hosni Elsayed Mubarak, who is subject to judicial proceedings or an asset recovery process by the Egyptian authorities following a final court ruling in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption.

                              4.

                              Heidy Mahmoud Magdy Hussein Rasekh

                              Spouse of Mr Alaa Mohamed Elsayed Mubarak, son of former President of the Arab Republic of Egypt
                              Date of birth: 5.10.1971
                              Female

                              Person subject to judicial proceedings or an asset recovery process by the Egyptian authorities following a final court ruling in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption, and associated with Alaa Mohamed Hosni Elsayed Mubarak.

                              6.

                              Khadiga Mahmoud El Gammal

                              Spouse of Mr Gamal Mahamed Hosni Elsayed Mubarak, son of former President of the Arab Republic of Egypt
                              Date of birth: 13.10.1982
                              Female

                              Person subject to judicial proceedings or an asset recovery process by the Egyptian authorities following a final court ruling in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption, and associated with Gamal Mohamed Hosni Elsayed Mubarak.

                              19.

                              Elham Sayed Salem Sharshar

                              Spouse of Mr Habib Ibrahim Eladli
                              Date of birth: 23.1.1963
                              Female

                              Person subject to judicial proceedings in respect of the misappropriation of State Funds on the basis of the United Nations Convention against corruption, and associated with Habib Ibrahim Eladli.’

                  2.

                  In Annex I to Regulation (EU) No 270/2011, the entries concerning the following persons are deleted:

                              7.

                              Ahmed Abdelaziz Ezz,

                              8.

                              Abla Mohamed Fawzi Ali Ahmed Salama,

                              9.

                              Khadiga Ahmed Ahmed Kamel Yassin,

                              10.

                              Shahinaz Abdel Aziz Abdel Wahab Al Naggar,

                              11.

                              Ahmed Alaeldin Amin Abdemaksoud Elmaghraby,

                              12.

                              Naglaa Abdallah El Gazaerly.


title: Commission Implementing Regulation (EU) 2018/469 of 21 March 2018 authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) 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:
               22.3.2018

               EN

               Official Journal of the European Union

               L 79/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/469
   of 21 March 2018
   authorising the placing on the market of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) 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) was adopted, which establishes a Union list of authorised novel foods.

               (3)

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

               (4)

               Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3) and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

               (5)

               On 13 March 2014, the company Naturalendo Tech Co., Ltd made a request to the competent authority of Ireland to place an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) on the market as a novel food ingredient within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97. The application requests for the novel food to be used in food supplements intended for post-menopausal women.

               (6)

               While the request for placing an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

               (7)

               On 29 July 2014, the competent authority of Ireland issued its initial assessment report. In that report it came to the conclusion that an extract of mixture of the three herbal roots meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97.

               (8)

               On 15 September 2014, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97.

               (9)

               In view of the objections raised by the other Member States, the Commission consulted the European Food Safety Authority (EFSA) on 20 April 2015, asking it to carry out an additional assessment for an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as novel food ingredient in accordance with Regulation (EC) No 258/97.

               (10)

               On 21 September 2016, EFSA adopted ‘Scientific opinion on the safety of an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as a novel food’ (4). This opinion, although elaborated and adopted by EFSA under Regulation (EC) No 258/97 is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

               (11)

               In its opinion, EFSA did not establish the safety of the extract of mixture of the three herbal roots used in food supplements intended for adults at the maximum intake level of 514 mg/day as proposed by the applicant because the intake would exceed the level which is considered safe (2,5 mg/kg bw). However, EFSA concluded that the extract of mixture of the three herbal roots is safe for adults when added to food supplements at a maximum daily dose of 175 mg which corresponds to the safe level of intake for an adult person with a default body weight of 70 kg.

               (12)

               In view of the EFSA opinion, the applicant provided additional information to alleviate the safety concerns. On 12 January 2017, the Commission consulted EFSA to review the additional information in relation to the scientific opinion on the safety of the extract of mixture of the three herbal roots. On 4 April 2017, EFSA in its reviewed opinion on the safety of the extract of mixture of the three herbal roots (5), concluded that the scientific opinion initially adopted on 21 September 2016 did not need to be revised and thus, EFSA reconfirmed that the extract of mixture of the three herbal roots is safe for adults when added to food supplements at a maximum daily dose of 175 mg.

               (13)

               In its initial opinion, EFSA considers that the risk of allergic reaction to Angelica gigas Nakai is not dissimilar to that associated with celery as both plants belong to the same botanical family (i.e. Apiaceae). As celery is a food required to be labelled as an allergen under Regulation (EU) No 1169/2011 of the European Parliament and of the Council (6), it is necessary that the novel food ingredient should be appropriately labelled.

               (14)

               Both opinions give sufficient grounds to establish that the extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) at the proposed uses and use levels when used as an ingredient in food supplements, complies with Article 12(1) of Regulation (EU) 2015/2283.

               (15)

               Taking into account the intended use and the fact that the request for authorisation is only intended for adults, food supplements containing an extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) should be appropriately labelled.

               (16)

               Directive 2002/46/EC of the European Parliament and of the Council (7) lays down requirements on food supplements. The use of the extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) should be authorised without prejudice to that Directive.

               (17)

               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.   An extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai) as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods as provided for in Article 8 of Regulation (EU) 2015/2283.
   2.   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 to this Regulation.
   3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.
   Article 2
   The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 21 March 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

      (3)  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)  EFSA Journal 2016;14(10): 4589.

      (5)  EFSA Journal 2017;15(5): 4778.

      (6)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18).

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

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

                  (1)

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

                              Authorised novel food

                              Conditions under which the novel food may be used

                              Additional specific labelling requirements

                              Other requirements

                              ‘Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

                                 Specified food category

                                 Maximum levels

                              The designation of the novel food on the labelling of the foodstuffs containing it shall be “extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)”.
                              The labelling of food supplements containing the extract of mixture of the three herbal roots shall bear a statement in close proximity to the list of ingredients indicating that it should not be consumed by individuals with known celery allergy.’

                              Food Supplements as defined in Directive 2002/46/EC for adult population

                              175 mg/day

                  (2)

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

                              Authorised Novel Food

                              Specification

                              ‘Extract of three herbal roots (Cynanchum wilfordii Hemsley, Phlomis umbrosa Turcz. and Angelica gigas Nakai)

                                 Description/Definition:

                              The mixture of the three herbal roots is yellowish brown fine powder produced by hot-water extraction, concentration by evaporation, and spray drying

                                 Composition of the extract of mixture of the 3 herbal roots:

                                 Cynanchum wilfordii root: 32,5 % (w/w)

                                 Phlomis umbrosa root: 32,5 % (w/w)

                                 Angelica gigas root: 35,0 % (w/w)

                                 Specifications:

                              Loss on drying: NMT 100 mg/g

                                 Assay:

                              Cinnamic acid: 0,012 – 0,039 mg/g
                              Shanzhiside methyl ester: 0,20 – 1,55 mg/g
                              Nodakenin: 3,35 – 10,61 mg/g
                              Methoxsalen: < 3 mg/g
                              Phenols: 13,0 – 40,0 mg/g
                              Coumarins: 13,0 – 40,0 mg/g
                              Iridoids: 13,0 – 39,0 mg/g
                              Saponins: 5,0 – 15,5 mg/g

                                 Nutritive components:

                              Carbohydrates: 600 – 880 mg/g
                              Proteins: 70 – 170 mg/g
                              Fats: < 4 mg/g

                                 Microbiological parameters:

                              Total viable plate count: < 5 000  CFU/g
                              Total mould and yeast: < 100 CFU/g
                              Coliform bacteria: < 10 CFU/g

                                 Salmonella: Negative/25 g

                                 Escherichia coli: Negative/25 g

                                 Staphylococcus aureus: Negative/25 g

                                 Heavy metals:

                              Lead: < 0,65 mg/kg
                              Arsenic: < 3,0 mg/kg
                              Mercury: < 0,1 mg/kg
                              Cadmium: < 1,0 mg/kg
                              CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2018/481 of 21 March 2018 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
               23.3.2018

               EN

               Official Journal of the European Union

               L 81/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/481
   of 21 March 2018
   amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,
   Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

               (2)

               Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

               (3)

               Regulation (EC) No 1484/95 should therefore be amended accordingly.

               (4)

               Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 21 March 2018.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (2)  OJ L 150, 20.5.2014, p. 1.

      (3)  Commission Regulation (EC) No 1484/95 of 28 June 1995 laying down detailed rules for implementing the system of additional import duties and fixing representative prices in the poultrymeat and egg sectors and for egg albumin, and repealing Regulation No 163/67/EEC (OJ L 145, 29.6.1995, p. 47).

      ANNEX
      ‘
            ANNEX I

                        CN code

                        Description

                        Representative price
                        (EUR/100 kg)

                        Security under Article 3
                        (EUR/100 kg)

                        Origin (1)

                        0207 12 10

                        Fowls of the species Gallus domesticus, not cut in pieces, presented as “70 % chickens”, frozen

                        103,6

                        0

                        AR

                        0207 12 90

                        Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen

                        127,4

                        0

                        AR

                        154,1

                        0

                        BR

                        0207 14 10

                        Fowls of the species Gallus domesticus, boneless cuts, frozen

                        244,2

                        17

                        AR

                        225,0

                        23

                        BR

                        320,2

                        0

                        CL

                        233,5

                        20

                        TH

                        0207 27 10

                        Turkeys, boneless cuts, frozen

                        327,6

                        0

                        BR

                        303,4

                        0

                        CL

                        0408 91 80

                        Eggs, not in shell, dried

                        368,4

                        0

                        AR

                        1602 32 11

                        Preparations of fowls of the species Gallus domesticus, uncooked

                        240,9

                        14

                        BR

                  ’

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


title: Commission Implementing Regulation (EU) 2018/482 of 22 March 2018 on the maximum buying-in price for skimmed milk powder for the first individual invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2018/154

text:
               23.3.2018

               EN

               Official Journal of the European Union

               L 81/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/482
   of 22 March 2018
   on the maximum buying-in price for skimmed milk powder for the first individual invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2018/154
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 1370/2013 of 16 December 2013 determining measures on fixing certain aids and refunds related to the common organisation of the markets in agricultural products (1), and in particular Article 3 thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) 2018/154 (2) has opened buying-in of skimmed milk powder by a tendering procedure for the public intervention period from 1 March to 30 September 2018, in accordance with the conditions provided for in Commission Implementing Regulation (EU) 2016/1240 (3).

               (2)

               In accordance with Article 14(1) of Implementing Regulation (EU) 2016/1240, on the basis of the tenders received in response to individual invitations to tender, the Commission has to fix a maximum buying-in price or to decide not to fix a maximum buying-in price.

               (3)

               In the light of the tenders received for the first individual invitation to tender, a maximum buying-in price should not be fixed.

               (4)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   For the first individual invitation to tender for the buying-in of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2018/154, in respect of which the time limit for the submission of tenders expired on 20 March 2018, no maximum buying-in price shall be fixed.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 March 2018.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

      (1)  OJ L 346, 20.12.2013, p. 12.

      (2)  Commission Implementing Regulation (EU) 2018/154 of 30 January 2018 opening a tendering procedure for buying-in skimmed milk powder during the public intervention period from 1 March to 30 September 2018 (OJ L 29, 1.2.2018, p. 6).

      (3)  Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (OJ L 206, 30.7.2016, p. 71).


title: Commission Implementing Regulation (EU) 2018/497 of 21 March 2018 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Marrone del Mugello’ (PGI))

text:
               26.3.2018

               EN

               Official Journal of the European Union

               L 82/2

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/497
   of 21 March 2018
   approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Marrone del Mugello’ (PGI))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
   Whereas:

               (1)

               By virtue of the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy's application for the approval of amendments to the specification for the protected geographical indication ‘Marrone del Mugello’, registered under Commission Regulation (EC) No 1263/96 (2).

               (2)

               Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union
                   (3) as required by Article 50(2)(a) of that Regulation.

               (3)

               As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Marrone del Mugello’ (PGI) are hereby approved.
   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, 21 March 2018.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

      (1)  OJ L 343, 14.12.2012, p. 1.

      (2)  Commission Regulation (EC) No 1263/96 of 1 July 1996 supplementing the Annex to Regulation (EC) No 1107/96 on the registration of geographical indications and designations of origin under the procedure laid down in Article 17 of Regulation (EEC) No 2081/92 (OJ L 163, 2.7.1996, p. 19).

      (3)  OJ C 413, 5.12.2017, p. 14.


title: Commission Implementing Regulation (EU) 2018/838 of 31 May 2018 concerning the classification of certain goods in the Combined Nomenclature

text:
               7.6.2018

               EN

               Official Journal of the European Union

               L 141/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/838
   of 31 May 2018
   concerning the classification of certain goods in the Combined Nomenclature
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
   Whereas:

               (1)

               In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

               (2)

               Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

               (3)

               Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

               (4)

               It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

               (5)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.
   Article 2
   Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.
   Article 3
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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

            For the Commission,

            On behalf of the President,

         Stephen QUEST

            Director-General

            Directorate-General for Taxation and Customs Union

      (1)  OJ L 269, 10.10.2013, p. 1.

      (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

      ANNEX

                  Description of goods

                  Classification (CN code)

                  Reasons

                  (1)

                  (2)

                  (3)

                  A product consisting of a disposable liner, to be used in conjunction with a child's potty, composed of a plastic bag to which a multilayer absorbent pad made from paper and a superabsorbent polymer of polyacrylate in the form of granules is attached at the bottom of the bag.
                  These superabsorbent polyacrylate granules are transformed into a gel when they come in contact with urine.

                  3924 90 00

                  Classification is determined by general rules 1, 3(b) and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 3924  and 3924 90 00 .
                  Classification under heading 4818  is excluded because the essential character of the product is not given by its paper components but by the superabsorbent polymer of polyacrylate.
                  Classification under heading 9619  is excluded because the product is not shaped so that it fits to the human body (see also the Harmonised System Explanatory Notes (HSEN) to heading 9619 ).
                  The product is a combination of plastics and other materials. A product which combines plastics and other materials is classified in chapter 39 provided that it retains the essential character of articles of plastics (see also the HSEN, General Notes to Chapter 39).
                  The essential character of the product is provided by superabsorbent polymer; the paper is solely considered to have a carrier or packaging function.
                  The product is therefore to be classified in CN code 3924 90 00  as other household articles and hygienic or toilet articles, of plastics.