title: Commission Implementing Regulation (EU) 2019/1132 of 2 July 2019 providing temporary exceptional adjustment aid to farmers in the beef and veal sector in Ireland

text:
                  3.7.2019

                  EN

                  Official Journal of the European Union

                  L 179/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1132
         of 2 July 2019
         providing temporary exceptional adjustment aid to farmers in the beef and veal sector in Ireland
         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 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 221(1) thereof,
         Whereas:

                     (1)

                     The beef and veal sector has traditionally been the most fragile agri-food sector due to a number of factors, in particular restricted market access to third-country markets and falling domestic consumption. Additional new challenges emerge from concerns over the sector's contribution to greenhouse gas emissions

                     (2)

                     The structure of the beef and veal industry makes it vulnerable, mainly due to its long life-cycle and high costs linked to extensive production. These factors have been aggravated by the prospect of the United Kingdom leaving the Union and uncertainties linked to the future United Kingdom's customs tariff once it withdraws from the Union. The United Kingdom is a premium market for beef and veal that is critical for the sustainability of the entire Union beef and veal sector. In parallel, the sector is confronted with demands of trade partners for increased market access to the Union.

                     (3)

                     Those problems are more acute in the case of the Irish beef and veal sector. The latter is concentrated in small-scale holdings in the poorer regions of the country where alternative types of production are limited. After years of stagnating beef prices in Ireland, gross margins have fallen in the past year by 11 to 19 %, with suckler cow farms suffering the biggest losses.

                     (4)

                     Ireland's beef and veal sector is both large and hugely dependent on exports. Five of every 6 tonnes of beef produced is exported and almost 50 % of these exports are to the United Kingdom. Uncertainty around the withdrawal of the United Kingdom is putting downward pressure on prices, deteriorating further the situation of beef producers in Ireland. This actually happened in the months preceding earlier announced dates for the withdrawal of the United Kingdom.

                     (5)

                     Market adjustment is particularly slow in Ireland's extensive beef production system where animals are typically slaughtered at a later age, between 18 and 30 months of age. This particular production system is suited to the requirements of the United Kingdom's beef market. Efforts to open new markets continue to be hampered by third-country restrictions related to outdated animal health requirements in particular.

                     (6)

                     In the light of the abovementioned specific problems faced by Irish producers, it is in the interest of the market stability of the Union beef and veal sector to adopt measures that reinforce the resilience of Irish beef. In conjunction with the need to avoid that downward price pressure on Irish beef spills over to other Member States, those problems constitute specific problems within the meaning of Article 221 of Regulation (EU) No 1308/2013. Those specific problems cannot be addressed by measures taken pursuant to Article 219 or 220 of that Regulation. On the one hand, they are not specifically linked to a significant market disturbance or threat thereof. On the other hand, the measures provided for in this Regulation are not taken in a context of combatting the spread of a disease.

                     (7)

                     In addition, available instruments under the common agricultural policy such as public intervention and private storage aid are not adequate measures to address the needs of the Irish beef and veal sector. It is therefore appropriate to provide Ireland with a financial grant to support farmers in that sector engaging in actions enhancing their resilience and sustainability, including the adjustment of production to markets with requirements other than the United Kingdom.

                     (8)

                     The Union aid made available to Ireland should take into account the main features of its beef and veal sector, including its share of specialised beef farmers and its vulnerability to disruption of exports.

                     (9)

                     Ireland should design measures aimed at production reduction and restructuring of its beef and veal sector to protect its long-term viability, based on one or more of the following activities: fostering environmental and economic sustainability, developing new markets and enhancing beef and veal quality.

                     (10)

                     Ireland should distribute the aid through measures on the basis of objective and non-discriminatory criteria, while ensuring that farmers in the beef and veal sector are the ultimate beneficiaries of the aid, and avoiding any market and competition distortion.

                     (11)

                     As the amount allocated to Ireland would compensate only a part of the actual cost for farmers in the beef and veal sector, Ireland should be allowed to grant additional support to those farmers, under the same conditions of objectiveness, non-discrimination and non-distortion of competition.

                     (12)

                     In order to give Ireland the flexibility to distribute the aid as circumstances require, Ireland should be allowed to cumulate it with other support financed by the European Agricultural Guarantee Fund and the European Agricultural Fund for Rural Development.

                     (13)

                     In accordance with Article 221 of Regulation (EU) No 1308/2013, this Regulation should be limited to a period of maximum 12 months starting from its date of entry into force. Payments made by Ireland to the beneficiaries after that period should not be eligible for Union financing.

                     (14)

                     In order to ensure transparency, monitoring and proper administration of the amounts available, Ireland should provide the Commission with certain information, including, in particular, information on the concrete measures to be taken, the criteria used to distribute the aid and the measures taken to avoid distortion of competition in the market concerned.

                     (15)

                     In order to ensure that farmers receive aid as soon as possible, Ireland should be enabled to implement this Regulation without delay. Therefore, this Regulation should apply from the day following that of its publication.

                     (16)

                     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

               1.   Union aid of a total amount of EUR 50 000 000 shall be available to Ireland to provide exceptional adjustment aid to farmers in the beef and veal sector subject to the conditions set out in paragraphs 2 to 5.

               2.   Ireland shall use the amount available for measures referred to in paragraph 3. The measures shall be taken on the basis of objective and non-discriminatory criteria, provided that the resulting payments do not cause distortion of competition.

               3.   The measures taken by Ireland shall be aimed at reducing production or restructuring the beef and veal sector and one or more of the following objectives:

                           (a)

                           implementation of quality schemes in the beef and veal sector or projects aiming at promoting quality and value added;

                           (b)

                           boosting market diversification;

                           (c)

                           protecting and improving the farmers' environmental, climate and economic sustainability.

               4.   Ireland shall ensure that, if farmers in the beef and veal sector are not the direct beneficiaries of the payments of the Union aid, the economic benefit of the Union aid is passed on to them in full.

               5.   Ireland's expenditure in relation to the payments for the measures referred to in paragraph 3 shall only be eligible for Union aid if those payments have been made by 31 May 2020 at the latest.

               6.   Measures under this Regulation may be cumulated with other support financed by the European Agricultural Guarantee Fund and the European Agricultural Fund for Rural Development.

            Article 2
            Ireland may grant additional national support for the measures taken under Article 1 up to a maximum of 100 % of the amount set out in Article 1, on the basis of objective and non-discriminatory criteria, provided that the resulting payments do not cause distortion of competition.
            Ireland shall pay the additional support by 31 May 2020 at the latest.

            Article 3
            Ireland shall notify the Commission of the following:

                        (a)

                        without delay and no later than 31 July 2019:

                                    (i)

                                    a description of the measures to be taken;

                                    (ii)

                                    the criteria used to determine the methods for granting the aid;

                                    (iii)

                                    the intended impact of the measures;

                                    (iv)

                                    the actions taken to check that the intended impact is reached;

                                    (v)

                                    the actions taken to avoid distortion of competition;

                                    (vi)

                                    the level of additional support granted pursuant to Article 2;

                        (b)

                        no later than 31 July 2020, the total amounts paid per measure (when applicable, broken down by Union aid and additional support), and the number and type of beneficiaries and the assessment of the effectiveness of the measure.

            Article 4
            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, 2 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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


title: Commission Implementing Regulation (EU) 2017/2468 of 20 December 2017 laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )

text:
               30.12.2017

               EN

               Official Journal of the European Union

               L 351/55

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2468
   of 20 December 2017
   laying down administrative and scientific requirements concerning traditional foods from third countries in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council 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 20 and Article 35(3) thereof,
   Whereas:

               (1)

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

               (2)

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

               (3)

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

               (4)

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

               (5)

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

               (6)

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

               (7)

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

               (8)

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

               (9)

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

               (10)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Scope and subject matter
   This Regulation lays down rules for the implementation of Article 20 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements concerning traditional foods from third countries and transitional measures referred to in Article 35(3) of that Regulation.
   It applies to notifications and applications as referred to in Articles 14 and 16 of Regulation (EU) 2015/2283.
   Article 2
   Definitions
   In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (2) and Regulation (EU) 2015/2283, the following definitions shall apply:

               (a)

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

               (b)

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

         Article 3
   Structure, content and presentation of a notification
   1.   A notification shall be submitted electronically to the Commission and shall consist of the following:

               (a)

               a cover letter;

               (b)

               a technical dossier;

               (c)

               a summary of the dossier.

         2.   The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
   3.   The technical dossier referred to in paragraph 1(b) shall contain:

               (a)

               the administrative data as provided for in Article 5;

               (b)

               the scientific data as provided for in Article 6.

         4.   Where the applicant submits a notification to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing safety assessment.
   5.   The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
   Article 4
   Structure, content and presentation of an application
   1.   An application shall be submitted electronically to the Commission and shall consist of the following:

               (a)

               a cover letter;

               (b)

               a technical dossier;

               (c)

               a summary of the dossier;

               (d)

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

               (e)

               the applicant's response to duly reasoned safety objections.

         2.   The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex II.
   3.   The technical dossier referred to in paragraph 1(b) shall contain:

               (a)

               the administrative data as provided for in Article 5;

               (b)

               the scientific data as provided for in Article 6.

         4.   Where the applicant submits an application to modify the conditions of use, the specifications, specific labelling requirements or post-market monitoring requirements of an authorised traditional food from a third country, it may not be necessary for the applicant to provide all the data required under Article 6 where the applicant provides verifiable justification explaining that the proposed changes not affect the results of the existing safety assessment.
   5.   The summary of the dossier referred to in paragraph 1(c) shall provide evidence that the use of a traditional food from a third country complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
   Article 5
   Administrative data to be provided in a notification or an application
   In addition to the information set out in Article 14 of Regulation (EU) 2015/2283, the notifications and the applications shall include the following administrative data:

               (a)

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

               (b)

               the date of submission of the dossier;

               (c)

               a table of contents of the dossier;

               (d)

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

               (e)

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

         Article 6
   Scientific data to be provided in a notification or an application
   1.   The dossier submitted in support of a notification or an application for the authorisation of a traditional food from a third country shall enable a history of safe use of the traditional food from a third country to be assessed.
   2.   The applicant shall provide a copy of the documentation on the procedure followed when gathering the data.
   3.   The applicant shall provide a description of the safety evaluation strategy and shall justify the inclusion and exclusion of specific studies or information.
   4.   The applicant shall propose an overall conclusion on the safety of the proposed uses of the traditional food from a third country. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
   Article 7
   Verification of the validity of a notification
   1.   On receipt of a notification of a traditional food from a third country, the Commission shall without delay verify whether the food concerned falls within the scope of Regulation (EU) 2015/2283 and whether the notification fulfils the requirements set out in Articles 3, 5 and 6 of this Regulation.
   2.   The Commission may request additional information from the applicant as regards the validity of the notification and inform the applicant of the period within which that information shall be provided.
   3.   By way of derogation from paragraph 1 of this Article and without prejudice to Article 14 of Regulation (EU) 2015/2283, a notification may be considered valid even if it does not contain all the elements required under Articles 3, 5 and 6 of this Regulation, provided that the applicant has submitted verifiable justification for each missing element.
   4.   The Commission shall inform the applicant, the Member States and the Authority of the reasons why the notification is considered not valid.
   Article 8
   Verification of the validity of an application
   1.   On receipt of an application for the authorisation of a traditional food from a third country the Commission shall without delay verify whether the application fulfils the requirements of Articles 4 to 6.
   2.   The Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information shall be provided.
   3.   By way of derogation from paragraph 1 of this Article and without prejudice to Article 16 of Regulation (EU) 2015/2283, an application may be considered valid even if it does not contain all the elements required under Articles 4 to 6 of this Regulation, provided that the applicant has submitted verifiable justification for each missing element.
   4.   The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. If the application is not considered valid, the Commission shall indicate the reasons why it is not valid.
   Article 9
   Duly reasoned safety objections
   1.   On receipt of a valid notification, consultation between the Commission, the Member States and the Authority may be carried out in the first three months of the period established in Article 15(2) of Regulation (EU) 2015/2283.
   2.   The duly reasoned safety objections submitted by a Member State or the Authority to the Commission in accordance with Article 15(2) of Regulation (EU) 2015/2283 shall include the following information:

               (a)

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

               (b)

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

         Article 10
   Information to be included in the opinion of the Authority
   1.   The opinion of the Authority shall include the following information:

               (a)

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

               (b)

               the assessment of the history of safe use in a third country;

               (c)

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

               (d)

               conclusions.

         2.   The Commission may ask for additional information in its request for an opinion of the Authority.
   Article 11
   Transitional measures
   The notifications as referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be submitted to the Commission not later than 1 January 2019.
   Article 12
   Entry into force and application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

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

      ANNEX I

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

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Notification for authorisation of a traditional food from a third country in accordance with Regulation (EU) 2015/2283.
      (Please indicate clearly by ticking one of the boxes)

                  ☐

                  Notification for an authorisation of a new traditional food.

                  ☐

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

                  ☐

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

                  ☐

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

                  ☐

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

            The Applicant(s) or their Representative(s) in the Union
      (name(s), address(es)…)
      …
      …
      …
      submit(s) this notification in order to update the Union list on novel foods.
      Identity of the traditional food:
      …
      …
      Confidentiality (1). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

                  ☐

                  Yes

                  ☐

                  No

            Food categories, conditions of use and labelling requirements

                  Food category

                  Specific conditions of use

                  Additional specific labelling requirement

                  —

            Yours sincerely,
      Signature …
      Enclosures:

                  ☐

                  Complete technical dossier

                  ☐

                  Summary of the dossier

                  ☐

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

                  ☐

                  Copy of administrative data of applicant(s)

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

      ANNEX II

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

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Application for authorisation of a traditional food from a third country following the requirements of Article 16 of Regulation (EU) 2015/2283
      The Applicant(s) or their Representative(s) within the European Union
      (name(s), address(es)…)
      …
      …
      …
      submit(s) this application in order to update the Union list on novel foods.
      Identity of the traditional food:
      …
      …
      Confidentiality (1). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

                  ☐

                  Yes

                  ☐

                  No

            Food categories, conditions of use and labelling requirements

                  Food category

                  Specific conditions of use

                  Additional specific labelling requirement

            Yours sincerely,
      Signature …
      Enclosures:

                  ☐

                  Complete application

                  ☐

                  Summary of the application

                  ☐

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

                  ☐

                  Documented data relating to the duly reasoned safety objections

                  ☐

                  Copy of administrative data of applicant(s)

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

      ANNEX III

         Justification for confidential information

      This Annex shall be updated during the notification or application procedure each time an applicant submits a request for information to be treated as confidential.
      Where the production process contains confidential data, a non-confidential summary of the production process shall be provided.

                     Information requested to be considered as confidential

                     Justification

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

                     Annex X (submitted on YYYY/MM/DD)

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

                     Annex X (submitted on YYYY/MM/DD)


title: Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Text with EEA relevance. )

text:
               30.12.2017

               EN

               Official Journal of the European Union

               L 351/64

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2469
   of 20 December 2017
   laying down administrative and scientific requirements for applications referred to in Article 10 of 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 13 and Article 35(3) thereof,
   Whereas:

               (1)

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

               (2)

               Pursuant to Article 13 of Regulation (EU) 2015/2283, the Commission has to adopt implementing acts laying down administrative and scientific data requirements for applications referred to in Article 10(1) of that Regulation.

               (3)

               Without prejudice to Articles 5 and 10 of Regulation (EU) 2015/2283, the Commission should verify whether the application falls within the scope of that Regulation and its validity.

               (4)

               Applications referred to in Article 10(1) of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify their validity and enable the European Food Safety Authority (the Authority) to conduct comprehensive risk assessments of the novel foods.

               (5)

               The applications should include detailed descriptions of the safety evaluation strategy, the raw data, information on the relevance of the test material used in the toxicological studies, and detection and characterisation test methods for the engineered nanomaterials.

               (6)

               Experience has shown that in certain cases a novel food intended for a particular group of the population may also reasonably be expected to be consumed by other groups of the population and that risk management measures may be necessary to mitigate potential health risks to those other population groups. Therefore, sufficient information should be provided in the application to enable the risks to those population groups to be assessed.

               (7)

               Where the applicant submits an application to add, remove or change the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required for the risk assessment, where the applicant provides verifiable justification.

               (8)

               In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council (2). Where those tests are carried out outside the territory of the Union, they should follow the OECD Principles of Good Laboratory Practice (3).

               (9)

               The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the novel food is safe for consumers.

               (10)

               In order to benefit from data protection, as laid down in Article 26 of Regulation (EU) 2015/2283, requests for protection of proprietary data should be justified and all data concerned should be kept in a separate part of the application.

               (11)

               Pursuant to Article 35 of Regulation (EU) 2015/2283, it is necessary to lay down transitional measures for the entry into force of that Regulation.

               (12)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Scope and subject matter
   This Regulation lays down rules for the implementation of Article 13 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements for applications referred to in Article 10(1) and the transitional measures referred to in Article 35(3) of that Regulation.
   Article 2
   Definitions
   In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4) and Regulation (EU) 2015/2283, the following definition shall apply:

               ‘application’ means a stand-alone dossier containing the information and the scientific data submitted for the authorisation of a novel food pursuant to Article 10(1) of Regulation (EU) 2015/2283.

         Article 3
   Structure, content and presentation of an application
   1.   An application shall be submitted electronically to the Commission and shall consist of the following:

               (a)

               a cover letter;

               (b)

               a technical dossier;

               (c)

               a summary of the dossier.

         2.   The cover letter referred to in paragraph 1(a) shall be drafted in accordance with the template provided in Annex I.
   3.   The technical dossier referred to in paragraph 1(b) shall contain:

               (a)

               the administrative data as provided for in Article 4;

               (b)

               the scientific data as provided for in Article 5.

         4.   Where the applicant submits an application to modify the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required under Article 5 of this Regulation where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing risk assessment.
   5.   In addition to the information referred to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/2283, the summary of the dossier referred to in paragraph 1(c) of this Article shall set out the reasons why the use of the novel food complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
   Article 4
   Administrative data requirements
   In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:

               (a)

               the name(s) of the manufacturer(s) of the novel food, if different than the applicant's, address and contact details;

               (b)

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

               (c)

               the date of submission of the dossier;

               (d)

               a table of contents of the dossier;

               (e)

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

               (f)

               a list of the parts of the dossier to be treated as confidential and verifiable justification in accordance with Article 23 of Regulation (EU) 2015/2283 and the rules set out in Annex II to this Regulation. Where the production process contains confidential data, a non-confidential summary of the production process shall be provided;

               (g)

               information and explanations substantiating the existence of the applicant's right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283. That information shall be included in a separate folder.

         Article 5
   Scientific data requirements
   1.   The dossier submitted in support of an application for the authorisation of a novel food shall enable a comprehensive risk assessment of the novel food.
   2.   Where the application for the authorisation of a novel food involves the use of engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283, the applicant shall provide detection and characterisation test methods in compliance with the requirements of Article 10(4) of that Regulation.
   3.   The applicant shall provide a copy of the documentation on the procedure and strategy followed when gathering the data.
   4.   The applicant shall provide a description of the safety evaluation strategy and the corresponding toxicological testing strategy and shall justify the inclusion or exclusion of specific studies or information.
   5.   The applicant shall provide on request the raw data for the individual studies, published and unpublished, undertaken by the applicant, or on their behalf, to support their application. This information includes data used to generate the conclusions of the individual studies and results of examinations.
   6.   Where it cannot be excluded that a novel food intended for a particular group of the population would be also consumed by other groups of the population the safety data provided shall also cover those groups.
   7.   For each biological or toxicological study, the applicant shall clarify whether the test material conforms to the proposed or existing specification. Where the test material differs from that specification, the applicant shall demonstrate the relevance of those data to the novel food under consideration.
   Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC or, if they are carried out outside the territory of the Union, they shall follow the OECD Principles of Good Laboratory Practice. The applicant shall provide evidence of compliance with those requirements and shall justify any deviation from the standard protocols.
   8.   The applicant shall propose an overall conclusion on the safety of the proposed uses of the novel food. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
   Article 6
   Verification of the validity of an application
   1.   On receipt of an application the Commission shall without delay verify whether the application falls within the scope of Regulation (EU) 2015/2283 and whether the application fulfils the requirements set out in Article 10(2) of that Regulation.
   2.   The Commission may consult the Authority. The Authority shall provide the Commission with its views on whether the application fulfils the relevant requirements set out in Article 10(2) of Regulation (EU) 2015/2283 within a period of 30 working days.
   3.   The Commission may request additional information from the applicant as regards the validity of the application and agree with the applicant of the period within which that information shall be provided.
   4.   By way of derogation from paragraph 1 of this Article, and without prejudice to Article 10(2) of Regulation (EU) 2015/2283, an application may be considered as valid even if it does not contain all the elements required under Articles 3 to 5 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.
   5.   The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not. If the application is not considered valid, the Commission shall indicate the reasons why it is not valid.
   Article 7
   Information to be included in the opinion of the Authority
   1.   The opinion of the Authority shall include the following information:

               (a)

               the identity of the novel food;

               (b)

               the assessment of the production process;

               (c)

               compositional data;

               (d)

               specifications;

               (e)

               the history of use of the novel food and/or its source;

               (f)

               the proposed uses and use levels and anticipated intake;

               (g)

               absorption, distribution, metabolism and excretion (ADME);

               (h)

               nutritional information;

               (i)

               toxicological information;

               (j)

               allergenicity;

               (k)

               an overall risk assessment for the novel food under the proposed uses and use levels and highlighting uncertainties and limitations where relevant;

               (l)

               when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the novel food shall be detailed, providing the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;

               (m)

               conclusions.

         2.   The Commission may ask for additional information in its request for an opinion of the Authority.
   Article 8
   Transitional measures
   1.   By 1 January 2018 the Member States shall notify to the Commission the lists of requests referred to in Article 35(1) of Regulation (EU) 2015/2283.
   2.   The Members States shall make available all the information they have received on each request referred to in paragraph 1 to the Commission.
   3.   Any request referred to in paragraph 1 of this Article shall be updated by the applicant in order to comply with the requirements set out in Article 10(2) of Regulation (EU) 2015/2283 and in this Regulation.
   4.   By way of derogation, paragraphs 1 and 2 shall not apply to requests referred to in paragraph 1 of this Article for which an initial assessment report has been forwarded to the Commission pursuant to Article 6(4) of Regulation (EC) No 258/97 of the European Parliament and of the Council (5) by 1 January 2018, and for which no reasoned objections have been made to the marketing of the novel food concerned within the period established in Article 6(4) of that Regulation.
   5.   The deadline for the submission of the applications referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be 1 January 2019.
   Article 9
   Entry into force and application
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 20 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p. 44).

      (3)  OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring. Number 1. OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.

      (4)  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).

      (5)  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).

      ANNEX I

         Template cover letter accompanying an application for novel food

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 2015/2283.
      (Please indicate clearly by ticking one of the boxes)

                  ☐

                  Application for an authorisation of a new novel food.

                  ☐

                  Application for adding, removing or changing the conditions of use of an already authorised novel food. Please provide a reference to that authorisation.

                  ☐

                  Application for adding, removing or changing the specifications of an already authorised novel food. Please provide a reference to that authorisation.

                  ☐

                  Application for adding, removing or changing additional specific labelling requirements of an already authorised novel food. Please provide a reference to that authorisation.

                  ☐

                  Application for adding, removing or changing post market monitoring requirements of an already authorised novel food. Please provide a reference to that authorisation.

            The Applicant(s) or their Representative(s) in the Union
      (name(s), address(es)…)
      …
      …
      …
      submit(s) this application in order to update the Union list on novel foods.
      Identity of the novel food (information on the identity of the novel food should be provided, depending on the category(ies) under which the novel food falls):
      …
      …
      Confidentiality (1). Where appropriate, state whether the application includes confidential data in accordance with Article 23 of Regulation (EU) 2015/2283

                  ☐

                  Yes

                  ☐

                  No

            Data Protection (2). Where appropriate, state whether the application includes a request for the protection of proprietary data according to Article 26 of Regulation (EU) 2015/2283:

                  ☐

                  Yes

                  ☐

                  No

            Food categories, conditions of use and labelling requirements

                  Food category

                  Specific conditions of use

                  Additional specific labelling requirement

            Yours sincerely,
      Signature …
      Enclosures:

                  ☐

                  Complete dossier

                  ☐

                  Summary of the dossier

                  ☐

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

                  ☐

                  Information supporting the protection of proprietary data relating to the novel food application

                  ☐

                  Copy of administrative data of applicant(s)

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

         (2)  Applicant should specify the part(s) of the application which include(s) proprietary data for which protection is requested, clearly stating section(s) and page number(s). Applicant should provide verifiable justification /declaration for the proprietary claim.

      ANNEX II

         Justification for confidential information

      This Annex shall be updated during the application procedure each time an applicant submits a request for information to be treated as confidential.
      Where the production process contains confidential data, a non-confidential summary of the production process shall be provided.

                     Information requested to be considered as confidential

                     Justification

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

                     Annex X (submitted on YYYY/MM/DD)

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

                     Annex X (submitted on YYYY/MM/DD)