title: Commission Implementing Regulation (EU) No 1373/2013 of 19 December 2013 laying down detailed rules for implementing the system of export licences in the pigmeat sector

text:
               20.12.2013

               EN

               Official Journal of the European Union

               L 346/29

         COMMISSION IMPLEMENTING REGULATION (EU) No 1373/2013
   of 19 December 2013
   laying down detailed rules for implementing the system of export licences in the pigmeat sector
   (codification)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 161(3), the first paragraph of Article 170 and Article 192(2), in conjunction with Article 4 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1518/2003 of 28 August 2003 laying down detailed rules for implementing the system of export licences in the pigmeat sector (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Regulation should be codified.

               (2)

               Specific implementing rules should be laid down for export licences in the pigmeat sector which should in particular include provisions for the submission of applications and the information which is to appear on the applications and licences, in addition to those contained in Commission Regulation (EC) No 376/2008 of 23 April 2008 laying down common detailed rules for the application of the system of import and export licences and advance fixing certificates for agricultural products (4).

               (3)

               In order to assure the proper administration of the system of export licences, the rate of the security for export licences under that system should be fixed. In view of the risk of speculation inherent in the system in the pigmeat sector, export licences should not be transferable and precise conditions governing access by operators to the said system should be laid down.

               (4)

               In accordance with Article 169 of Regulation (EC) No 1234/2007 compliance with the obligations arising from agreements concluded under Article 218 of the Treaty regarding the export volume is to be ensured on the basis of the export licences. Therefore, a detailed schedule for the lodging of applications and for the issuing of licences should be laid down.

               (5)

               In addition, the decision regarding applications for export licences should be notified only after a period of consideration. This period should allow the Commission to assess the quantities applied for as well as the expenditure involved and, if appropriate, to take special measures applicable in particular to the applications which are pending. It is in the interest of operators to allow the licence application to be withdrawn after the acceptance coefficient has been fixed.

               (6)

               The Commission should have precise information concerning applications for licences and the use of licences issued, in order to be able to manage the licence system. In the interests of efficient administration, Member States should use the information systems in accordance with Commission Regulation (EC) No 792/2009 of 31 August 2009 laying down detailed rules for the Member States’ notification to the Commission of information and documents in implementation of the common organisation of the markets, the direct payments’ regime, the promotion of agricultural products and the regimes applicable to the outermost regions and the smaller Aegean islands (5).

               (7)

               In the case of applications concerning quantities equal to or less than 25 tonnes, the export licence should be issued immediately if the operators requests it. In this case, the licences should not be subject to any special measures taken by the Commission.

               (8)

               In order to ensure an exact follow up of the quantities to be exported, a derogation from the rules regarding the tolerances laid down in Regulation (EC) No 376/2008 should be laid down.

               (9)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   All exports of products in the pigmeat sector for which an export refund is requested, shall be subject to the presentation of an export licence with advance fixing of the refund.
   Article 2
   1.   Export licences shall be valid for 90 days from their actual day of issue within the meaning of Article 22(2) of Regulation (EC) No 376/2008.
   2.   Applications for licences and licences shall bear, in Section 15, the description of the product and, in Section 16, the 12-digit product code of the agricultural product nomenclature for export refunds.
   3.   The categories of products referred to in the second subparagraph of Article 13(1) of Regulation (EC) No 376/2008, as well as the rate of the security for export licences, are set out in Annex I to this Regulation.
   4.   Applications for licences and licences shall bear, in Section 20, at least one of the entries listed in Annex II.
   Article 3
   1.   Applications for export licences may be lodged with the competent authorities from Monday to Friday of each week.
   2.   Applicants for export licences shall be natural or legal persons who, at the time the applications are submitted, are able to prove to the satisfaction of the competent authorities in the Member States that they have been engaged in trade in the pigmeat sector for at least 12 months. However, retail establishments or restaurants selling their products to end consumers may not lodge applications.
   3.   Export licences shall be issued on the Wednesday following the period referred to in paragraph 1, provided that none of the special measures referred to in paragraph 4 have since been taken by the Commission.
   4.   Where the issue of export licences would or might result in the available budgetary amounts being exceeded or in the maximum quantities which may be exported with a refund being exhausted during the period concerned, in view of the limits referred to in Article 169 of Regulation (EC) No 1234/2007, or where the issue of export licences would not allow exports to continue during the remainder of the period, the Commission may:

               (a)

               set a single percentage of acceptance for the quantities applied for;

               (b)

               reject applications for which licences have not yet been granted;

               (c)

               suspend the lodging of licence applications for a maximum period of five working days, extendable by the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007.

         In the circumstances referred to in point (c) of the first subparagraph, licence applications made during the suspension period shall be invalid.
   The measures provided for in the first subparagraph may be implemented or modulated by category of product and by destination.
   5.   The measures provided for in paragraph 4 may also be adopted where export licence applications relate to quantities which exceed or might exceed the normal disposable quantities for one destination and issuing the licences requested would entail a risk of speculation, distortion of competition between operators, or disturbance of the trade concerned or the internal market.
   6.   Where the quantities applied for are rejected or reduced, the security shall be released immediately for all quantities for which an application was not satisfied.
   7.   Notwithstanding paragraph 3, where a single percentage of acceptance less than 80 % is set, the licence shall be issued at the latest by the 11th working day following publication of that percentage in the Official Journal of the European Union. During the 10 working days following its publication, the operator may:

               (a)

               either withdraw his application, in which case the security shall be released immediately; or

               (b)

               request the immediate issuing of the licence, in which case the competent authority shall issue it without delay but no sooner than the normal issue date for the relevant week.

         8.   By way of derogation from paragraph 3, the Commission may set a day other than Wednesday for the issuing of export licences when it is not possible to respect this day.
   Article 4
   1.   On application by the operator, licence applications for up to 25 tonnes of products shall not be subject to any special measures as referred to in Article 3(4) and the licences applied for shall be issued immediately.
   In such cases, notwithstanding Article 2(1), the term of validity of the licences shall be limited to five working days from their actual day of issue within the meaning of Article 22(2) of Regulation (EC) No 376/2008 and Section 20 of licence applications and of licences shall show one of the entries listed in Annex III.
   2.   The Commission may, where necessary, suspend the application of this Article.
   Article 5
   Export licences shall not be transferable.
   Article 6
   1.   The quantity exported within the tolerance referred to in Article 7(4) of Regulation (EC) No 376/2008 shall not give entitlement to payment of the refund.
   2.   In Section 22 of the licence, at least one of the entries listed in Annex IV shall be indicated.
   Article 7
   1.   By Friday each week, Member States shall notify the Commission of the following information:

               (a)

               the applications for export licences as referred to in Article 1 lodged from Monday to Friday of the same week, stating whether or not they fall within the scope of Article 4;

               (b)

               the quantities covered by export licences issued on the preceding Wednesday, not including those issued immediately under Article 4;

               (c)

               the quantities covered by export licence applications withdrawn pursuant to Article 3(7) during the preceding week.

         2.   The notification of the applications referred to in point (a) of paragraph 1 shall specify:

               (a)

               the quantity in product weight for each category referred to in Article 2(3);

               (b)

               the breakdown by destination of the quantity for each category in the case where the rate of refund varies according to the destination;

               (c)

               the rate of refund applicable;

               (d)

               the total amount of refund fixed in advance in euro per category.

         3.   Member States shall notify to the Commission on a monthly basis, following the expiry of the validity of the export licences, the unused quantity of export licences.
   4.   The notifications referred to in this Regulation, including ‘nil’ notifications, shall be made in accordance with Regulation (EC) No 792/2009.
   Article 8
   Regulation (EC) No 1518/2003 is repealed.
   References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI.
   Article 9
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 December 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 217, 29.8.2003, p. 35.

      (3)  See Annex V.

      (4)  OJ L 114, 26.4.2008, p. 3.

      (5)  OJ L 228, 1.9.2009, p. 3.

      ANNEX I

                  Product code of the agricultural product nomenclature for export refunds (1)

                  Category

                  Rate of the security (EUR/100 kg) Net weight

                  0203 11 10 9000
                  0203 21 10 9000

                  1

                  10

                  0203 12 11 9100
                  0203 12 19 9100
                  0203 19 11 9100
                  0203 19 13 9100
                  0203 19 55 9110
                  0203 22 11 9100
                  0203 22 19 9100
                  0203 29 11 9100
                  0203 29 13 9100
                  0203 29 55 9110

                  2

                  10

                  0203 19 15 9100
                  0203 19 55 9310
                  0203 29 15 9100

                  3

                  6

                  0210 11 31 9110
                  0210 11 31 9910

                  4

                  14

                  0210 12 19 9100

                  5

                  0

                  0210 19 81 9100

                  6

                  14

                  0210 19 81 9300

                  7

                  14

                  1601 00 91 9120

                  8

                  5

                  1601 00 99 9110

                  9

                  4

                  1602 41 10 9110

                  10

                  8

                  1602 42 10 9110

                  11

                  6

                  1602 41 10 9130
                  1602 42 10 9130
                  1602 49 19 9130

                  12

                  5

         (1)  Commission Regulation (EEC) No 3846/87 Sector 6 (OJ L 366, 24.12.1987, p. 1).

      ANNEX II

         Entries referred to in Article 2(4)

                  —

                  :

                  In Bulgarian

                  :

                  Регламент за изпълнение (ЕC) № […]

                  —

                  :

                  In Spanish

                  :

                  Reglamento de Ejecución (UE) no […]

                  —

                  :

                  In Czech

                  :

                  Prováděcí nařízení (EU) č. […]

                  —

                  :

                  In Danish

                  :

                  Gennemførelsesforordning (EU) nr. […]

                  —

                  :

                  In German

                  :

                  Durchführungsverordnung (EU) Nr. […]

                  —

                  :

                  In Estonian

                  :

                  Rakendusmäärus (EL) nr […]

                  —

                  :

                  In Greek

                  :

                  Εκτελεστικός κανονισμός (ΕΕ) αριθ. […]

                  —

                  :

                  In English

                  :

                  Implementing Regulation (EU) No […]

                  —

                  :

                  In French

                  :

                  Règlement d’exécution (UE) no […]

                  —

                  :

                  In Croatian

                  :

                  Provedbena uredba (EU) br. […]

                  —

                  :

                  In Italian

                  :

                  Regolamento di esecuzione (UE) n. […]

                  —

                  :

                  In Latvian

                  :

                  Īstenošanas regula (ES) Nr. […]

                  —

                  :

                  In Lithuanian

                  :

                  Įgyvendinimo reglamentas (ES) Nr. […]

                  —

                  :

                  In Hungarian

                  :

                  …/…/EU végrehajtási rendelet

                  —

                  :

                  In Maltese

                  :

                  Regolament ta’ Implimentazzjoni (UE) Nru […]

                  —

                  :

                  In Dutch

                  :

                  Uitvoeringsverordening (EU) nr. […]

                  —

                  :

                  In Polish

                  :

                  Rozporządzenie wykonawcze (UE) nr […]

                  —

                  :

                  In Portuguese

                  :

                  Regulamento de Execução (UE) n.o […]

                  —

                  :

                  In Romanian

                  :

                  Regulamentul de punere în aplicare (UE) nr. […]

                  —

                  :

                  In Slovak

                  :

                  Vykonávacie nariadenie (EÚ) č. […]

                  —

                  :

                  In Slovenian

                  :

                  Izvedbena uredba (EU) št. […]

                  —

                  :

                  In Finnish

                  :

                  Täytäntöönpanoasetus (EU) N:o […]

                  —

                  :

                  In Swedish

                  :

                  Genomförandeförordning (EU) nr […]

      ANNEX III

         Entries referred to in the second subparagraph of Article 4(1)

                  —

                  :

                  In Bulgarian

                  :

                  Лицензия, валидна пет работни дни

                  —

                  :

                  In Spanish

                  :

                  Certificado válido durante cinco días hábiles

                  —

                  :

                  In Czech

                  :

                  Licence platná pět pracovních dní

                  —

                  :

                  In Danish

                  :

                  Licens, der er gyldig i fem arbejdsdage

                  —

                  :

                  In German

                  :

                  Fünf Arbeitstage gültige Lizenz

                  —

                  :

                  In Estonian

                  :

                  Litsents kehtib viis tööpäeva

                  —

                  :

                  In Greek

                  :

                  Πιστοποιητικό που ισχύει για πέντε εργάσιμες ημέρες

                  —

                  :

                  In English

                  :

                  Licence valid for five working days

                  —

                  :

                  In French

                  :

                  Certificat valable cinq jours ouvrables

                  —

                  :

                  In Croatian

                  :

                  Dozvola vrijedi pet radnih dana

                  —

                  :

                  In Italian

                  :

                  Titolo valido cinque giorni lavorativi

                  —

                  :

                  In Latvian

                  :

                  Licences derīguma termiņš ir piecas darbdienas

                  —

                  :

                  In Lithuanian

                  :

                  Licencijos galioja penkias darbo dienas

                  —

                  :

                  In Hungarian

                  :

                  Öt munkanapig érvényes tanúsítvány

                  —

                  :

                  In Maltese

                  :

                  Liċenza valida għal ħamest ijiem tax-xogħol

                  —

                  :

                  In Dutch

                  :

                  Certificaat met een geldigheidsduur van vijf werkdagen

                  —

                  :

                  In Polish

                  :

                  Pozwolenie ważne pięć dni roboczych

                  —

                  :

                  In Portuguese

                  :

                  Certificado de exportação válido durante cinco dias úteis

                  —

                  :

                  In Romanian

                  :

                  Licență valabilă timp de cinci zile lucrătoare

                  —

                  :

                  In Slovak

                  :

                  Licencia platí päť pracovných dní

                  —

                  :

                  In Slovenian

                  :

                  Dovoljenje velja 5 delovnih dni

                  —

                  :

                  In Finnish

                  :

                  Todistus on voimassa viisi työpäivää

                  —

                  :

                  In Swedish

                  :

                  Licensen är giltig fem arbetsdagar

      ANNEX IV

         Entries referred to in Article 6(2)

                  —

                  :

                  In Bulgarian

                  :

                  Възстановяване, валидно за […] тона (количество, за което е издадена лицензията).

                  —

                  :

                  In Spanish

                  :

                  Restitución válida por […] toneladas (cantidad por la que se expida el certificado).

                  —

                  :

                  In Czech

                  :

                  Náhrada platná pro […] tun (množství, pro které je licence vydána).

                  —

                  :

                  In Danish

                  :

                  Restitutionen omfatter […] t (den mængde, licensen vedrører).

                  —

                  :

                  In German

                  :

                  Erstattung gültig für […] Tonnen (Menge, für welche die Lizenz ausgestellt wurde).

                  —

                  :

                  In Estonian

                  :

                  Eksporditoetus kehtib […] tonni kohta (kogus, millele on antud ekspordilitsents).

                  —

                  :

                  In Greek

                  :

                  Επιστροφή ισχύουσα για […] τόνους (ποσότητα για την οποία έχει εκδοθεί το πιστοποιητικό).

                  —

                  :

                  In English

                  :

                  Refund valid for […] tonnes (quantity for which the licence is issued).

                  —

                  :

                  In French

                  :

                  Restitution valable pour […] tonnes (quantité pour laquelle le certificat est délivré).

                  —

                  :

                  In Croatian

                  :

                  Subvencija vrijedi za […] tona (količina za koju je izdana dozvola).

                  —

                  :

                  In Italian

                  :

                  Restituzione valida per […] t (quantitativo per il quale il titolo è rilasciato).

                  —

                  :

                  In Latvian

                  :

                  Kompensācija ir spēkā attiecībā uz […] tonnām (daudzums, par kuru ir izsniegta licence).

                  —

                  :

                  In Lithuanian

                  :

                  Grąžinamoji išmoka galioja […] tonoms (kiekis, kuriam išduota licencija).

                  —

                  :

                  In Hungarian

                  :

                  A visszatérítés […] tonnára érvényes (azt a mennyiséget kell feltüntetni, amelyre az engedélyt kiadták).

                  —

                  :

                  In Maltese

                  :

                  Rifużjoni valida għal […] tunnellati (kwantità li għaliha tinħareġ il-liċenza).

                  —

                  :

                  In Dutch

                  :

                  Restitutie geldig voor […] ton (hoeveelheid waarvoor het certificaat wordt afgegeven).

                  —

                  :

                  In Polish

                  :

                  Refundacja ważna dla […] ton (ilość, dla której zostało wydane pozwolenie).

                  —

                  :

                  In Portuguese

                  :

                  Restituição válida para […] toneladas (quantidade relativamente à qual é emitido o certificado).

                  —

                  :

                  In Romanian

                  :

                  Restituire valabilă pentru […] tone (cantitatea pentru care a fost eliberată licența).

                  —

                  :

                  In Slovak

                  :

                  Náhrada je platná pre […] ton (množstvo, pre ktoré bola vydaná licencia).

                  —

                  :

                  In Slovenian

                  :

                  Nadomestilo velja za […] ton (količina, za katero je bilo dovoljenje izdano).

                  —

                  :

                  In Finnish

                  :

                  Tuki on voimassa […] tonnille (määrä, jolle todistus on myönnetty).

                  —

                  :

                  In Swedish

                  :

                  Ger rätt till exportbidrag för […] ton (den kvantitet för vilken licensen utfärdats).

      ANNEX V

         Repealed Regulation with list of its successive amendments

                  Commission Regulation (EC) No 1518/2003
                  (OJ L 217, 29.8.2003, p. 35).

                  Commission Regulation (EC) No 130/2004
                  (OJ L 19, 27.1.2004, p. 14).

                  Commission Regulation (EC) No 1361/2004
                  (OJ L 253, 29.7.2004, p. 9).

                  Commission Regulation (EC) No 1713/2006
                  (OJ L 321, 21.11.2006, p. 11).

                  Article 12 only

                  Commission Regulation (EU) No 557/2010
                  (OJ L 159, 25.6.2010, p. 13).

                  Article 1 only

                  Commission Regulation (EU) No 519/2013
                  (OJ L 158, 10.6.2013, p. 74).

                  Point 6.G(2) of Annex only

      ANNEX VI

         Correlation Table

                  Regulation (EC) No 1518/2003

                  This Regulation

                  Article 1

                  Article 1

                  Article 2(1) first subparagraph

                  Article 2(1)

                  Article 2(1) second subparagraph

                  —

                  Article 2(2) and (3)

                  Article 2(2) and (3)

                  Article 2(4), introductory wording

                  Article 2(4)

                  Article 2(4), first to eleventh indents

                  Annex II

                  Article 3(1) to (4)

                  Article 3(1) to (4)

                  Article 3(4a)

                  Article 3(5)

                  Article 3(5)

                  Article 3(6)

                  Article 3(6)

                  Article 3(7)

                  Article 3(7)

                  Article 3(8)

                  Articles 4 and 5

                  Articles 4 and 5

                  Article 6(1)

                  Article 6(1)

                  Article 6(2), introductory wording

                  Article 6(2)

                  Article 6(2), first to eleventh indents

                  Annex IV

                  Article 7

                  Article 7

                  Article 8

                  —

                  —

                  Article 8

                  Article 9

                  Article 9

                  Annex I

                  Annex I

                  Annex Ia

                  Annex III

                  Annex III

                  —

                  Annex IV

                  —

                  —

                  Annex V

                  —

                  Annex VI


title: Commission Implementing Regulation (EU) No 739/2011 of 27 July 2011 amending Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption  Text with EEA relevance

text:
               28.7.2011

               EN

               Official Journal of the European Union

               L 196/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 739/2011
   of 27 July 2011
   amending Annex I to Regulation (EC) No 854/2004 of the European Parliament and of the Council laying down specific rules for the organisation of officials controls on products of animal origin intended for human consumption
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 854/2004 of 29 April 2004 of the European Parliament and the Council laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption (1), and in particular Article 17(1) thereof,
   Whereas:

               (1)

               Regulation (EC) No 854/2004 lays down specific rules for the organisation of official controls on products of animal origin intended for human consumption. In particular, a number of provisions relating to meat inspections in Parts B, D and F of Chapter II of Section I, and in Chapters I and V of Section II as well as in Chapter II of Section III of Annex I to that Regulation refer to, diseases on Lists A or B of the World Organisation for Animal Health (OIE).

               (2)

               The OIE system categorising and listing of diseases has changed. A single OIE list replaces Lists A and B. In addition, Union legislation is now in line with OIE recommendations. As a result, most references to those lists are superfluous. It is therefore appropriate to amend the relevant provisions in Sections I, II and III of Annex I to that Regulation and instead refer to animal diseases covered by Union legislation when carrying out ante-mortem or post-mortem inspection or any other inspection activity, unless reference is made to currently unknown diseases originating in third countries.

               (3)

               Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (2) provides that products of animal origin are to be obtained from animals which do not come from a holding, establishment, territory or part of territory subject to relevant animal health restrictions. Annex I of that Directive lists Union legislation containing control measures for certain animal diseases of relevance to trade in products of animal origin. For reasons of consistency, the trade in products of animal origin should only be restricted for animal health reasons based on Union legislation listed in the Annex I.

               (4)

               In accordance with Part E of Annex II to Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and other specified food-borne zoonotic agents (3), salmonella is to be absent in 25 grams of fresh poultry meat to be placed on the market for human consumption. However, pursuant to that Part, that criterion does not apply to fresh poultry meat destined for industrial heat treatment or other treatment to eliminate salmonella. Point 2 of Chapter V of Section II of Annex I to Regulation (EC) No 854/2004 provides that the official veterinarian may impose requirements concerning the use of certain meat. In order to allow the official veterinarian to impose industrial heat treatment or other treatment to eliminate salmonella, Section II, chapter V point 2 should be amended.

               (5)

               Annex I to Regulation (EC) No 854/2004 should be amended accordingly.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 854/2004 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day following 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, 27 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 139, 30.4.2004, p. 206.

      (2)  OJ L 18, 23.1.2003, p. 11.

      (3)  OJ L 325, 12.12.2003, p. 1.

      ANNEX
      Annex I to Regulation (EC) No 854/2004 is amended as follows:

                  (1)

                  in Section I, Chapter II is amended as follows:

                              (a)

                              In Part B(2), point (b) is replaced by the following:

                                          ‘(b)

                                          of any condition which might adversely affect human or animal health, paying particular attention to the detection of zoonotic diseases and animal diseases for which animal health rules are laid down in Union legislation.’;

                              (b)

                              in Part D, point 1 is replaced by the following:

                                          ‘1.

                                          Carcases and accompanying offal must be subjected without delay after slaughter to post-mortem inspection. All external surfaces must be viewed. Minimal handling of the carcases and offal or special technical facilities may be required for that purpose. Particular attention must be paid to the detection of zoonotic diseases and animal diseases for which animal health rules are laid down in Union legislation. The speed of the slaughter line and the number of inspection staff present must be such as to allow for proper inspection.’;

                              (c)

                              in Part F(1), point (d) is replaced by the following:

                                          ‘(d)

                                          the detection of animal diseases for which animal health rules are laid down in Union legislation.’;

                  (2)

                  Section II is amended as follows:

                              (a)

                              in Chapter I, point 4 is replaced by the following:

                                          ‘4.

                                          When the official veterinarian, while carrying out ante-mortem or post-mortem inspection or any other inspection activity, suspects the presence of an infectious agent of animal diseases for which animal health rules are laid down in Union legislation, the official veterinarian must notify as appropriate the competent authority and both must take all necessary measures and precautions to prevent the possible spread of the infectious agent in accordance with applicable Union legislation.’;

                              (b)

                              Chapter V is amended as follows:

                                          (i)

                                          point 1(e) is replaced by the following:

                                                      ‘(e)

                                                      derives from animals affected by animal diseases for which animal health rules are laid down in the Union legislation listed in Annex I to Council Directive 2002/99/EC (1), except if it is obtained in conformity with the specific requirements provided for in that legislation, unless otherwise provided for in Section IV;

                                          (ii)

                                          point 2 is replaced by the following:

                                                      ‘2.

                                                      The official veterinarian may impose requirements concerning the use of meat derived from animals:

                                                                  (a)

                                                                  having undergone emergency slaughter outside the slaughterhouse; or

                                                                  (b)

                                                                  if derived from flocks where a treatment of the meat will be applied in accordance with Part (E) of Annex II to Regulation (EC) No 2160/2003 before placing the meat on the market.’;

                  (3)

                  in Section III, Chapter II.3, points (e) and (f) are replaced by the following:

                              ‘(e)

                              in the case of an outbreak of animal diseases for which animal health rules are laid down in Union legislation. This concerns animals susceptible to the particular disease in question that come from the particular region as defined in Article 2 of Council Directive 64/432/EEC (2);

                              (f)

                              when stricter controls are necessary to take account of emerging diseases or particular OIE listed diseases.

         (1)  OJ L 18, 23.1.2003, p. 11.’;

         (2)  OJ 121, 29.7.1964, p. 1977/64.’.


title: Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings  Text with EEA relevance

text:
               11.3.2011

               EN

               Official Journal of the European Union

               L 64/15

         COMMISSION REGULATION (EU) No 234/2011
   of 10 March 2011
   implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (1), and in particular Article 9(1) thereof,
   After consulting the European Food Safety Authority pursuant to Article 9(2) of Regulation (EC) No 1331/2008,
   Whereas:

               (1)

               Regulation (EC) No 1331/2008 lays down procedural arrangements for updating the lists of substances the marketing of which is authorised in the Union pursuant to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (2), Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes (3) and Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods (4) (hereinafter referred to as ‘the sectoral food laws’).

               (2)

               Pursuant to Article 9 of Regulation (EC) No 1331/2008 it is for the Commission to adopt the implementing measure as regards the content, drafting and presentation of applications to update the Union lists under each sectoral food law, arrangements for checking the validity of applications and the type of information that should be included in the opinion of the European Food Safety Authority (hereinafter referred to as ‘the Authority’).

               (3)

               In order to update the lists it is necessary to verify that the use of the substance complies with the general and specific conditions of use as provided for in the respective sectoral food laws.

               (4)

               The Authority adopted a scientific opinion on 9 July 2009 on data requirements for the evaluation of food additive applications (5). This data should be provided when an application for the use of a new food additive is submitted. In case of an application for a modification of the conditions of use of an already authorised food additive or for a modification of the specifications of an already authorised food additive, the data required for risk assessment may not be required, as long as this is justified by the applicant.

               (5)

               The Authority adopted a scientific opinion on 23 July 2009 on data requirements for the evaluation of food enzyme applications (6). This data should be provided when an application for the use of a new food enzyme is submitted. In case of an application for a modification of the conditions of use of an already authorised food enzyme or for a modification of the specifications of an already authorised food enzyme, the data required for risk assessment may not be required, as long as this is justified by the applicant.

               (6)

               The Authority adopted a scientific opinion on 19 May 2010 on data requirements for the risk assessment of flavourings to be used in or on foods (7). This data should be provided when an application for the use of a new flavouring is submitted. In case of an application for a modification of the conditions of use of an already authorised flavouring or for a modification of the specifications of an already authorised flavouring, the data required for risk assessment may not be required, as long as this is justified by the applicant.

               (7)

               It is important that toxicological tests are performed to a certain standard. Therefore 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 (8) should be followed. Where such tests are carried out outside the territory of the Union, they should follow ‘the OECD Principles of Good Laboratory Practice’ (GLP) (OECD, 1998) (9).

               (8)

               The use of food additives and food enzymes should always be technologically justified. Applicants should also explain in case of a food additive why the technological effect cannot be achieved by any other economically and technologically practicable means.

               (9)

               The use of a substance should be authorised if it does not mislead the consumer. Applicants should explain that the requested uses do not mislead the consumer. The advantages and benefits for the consumer should also be explained in case of a food additive.

               (10)

               Without prejudice to Article 9 of Regulation (EC) No 1332/2008, Article 19 of Regulation (EC) No 1333/2008 and Article 13 of Regulation (EC) No 1334/2008, the Commission should verify the validity of the application and whether it falls within the scope of the respective sectoral food law. An advice from the Authority should be taken into account, where appropriate, on the suitability of the submitted data for risk assessment. Such verification should not delay the assessment of an application.

               (11)

               The information provided in the opinion of the Authority should be sufficient to ascertain whether the authorisation of the proposed use of the substance is safe for consumers. This includes conclusions on the toxicity of the substance, where appropriate, and possible establishment of an acceptable daily intake (ADI) expressed in a numerical form with details of a dietary exposure assessment for all food categories, including exposure of vulnerable consumer groups.

               (12)

               The applicant should also take into account detailed guidance concerning the data required for risk assessment established by the Authority (The EFSA Journal (10)).

               (13)

               This Regulation takes into account current scientific and technical knowledge. The Commission may revise this Regulation in the light of any developments in this field and the publication of any revised or additional scientific guidance by the Authority.

               (14)

               Practical arrangements related to an application for the authorisation of food additives, food enzymes and flavourings, such as addresses, persons to contact, transmission of documents, etc., should be made available in a separate communication of the Commission and/or the Authority.

               (15)

               It is necessary to provide for a time period in order to allow the applicants to comply with the provisions of this Regulation.

               (16)

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

         HAS ADOPTED THIS REGULATION:
   CHAPTER I

      GENERAL PROVISIONS

   Article 1
   Scope
   This Regulation shall apply to applications as referred to in Article 3(1) of Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
   CHAPTER II

      CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

   Article 2
   Content of an application
   1.   The application referred to in Article 1 shall consist of the following:

               (a)

               a letter;

               (b)

               a technical dossier;

               (c)

               a summary of the dossier.

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

               (a)

               the administrative data as provided for in Article 4;

               (b)

               the data required for risk assessment as provided for in Articles 5, 6, 8 and 10; and

               (c)

               the data required for risk management as provided for in Articles 7, 9 and 11.

         4.   In case of an application for a modification of the conditions of use of an already authorised food additive, food enzyme or flavouring all the data mentioned in Articles 5 to 11 may not be required. The applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.
   5.   In case of an application for a modification of the specifications of an already authorised food additive, food enzyme or flavouring:

               (a)

               the data may be limited to the justification of the request and the changes in the specification;

               (b)

               the applicant shall submit a verifiable justification why the proposed changes do not affect the results of the existing risk assessment.

         6.   The summary of the dossier referred to in paragraph 1(c) shall include a reasoned statement that the use of the product complies with the conditions laid down in:

               (a)

               Article 6 of Regulation (EC) No 1332/2008; or

               (b)

               Articles 6, 7 and 8 of Regulation (EC) No 1333/2008; or

               (c)

               Article 4 of Regulation (EC) No 1334/2008.

         Article 3
   Drafting and presentation
   1.   Applications shall be sent to the Commission. The applicant shall take into account the practical guidance on the submission of applications made available by the Commission (Directorate General for Health and Consumers’ (11) website).
   2.   For the establishment of the Union list of food enzymes as referred to in Article 17 of Regulation (EC) No 1332/2008, the deadline for submitting applications shall be 24 months after the date of application of the implementing measures established by this Regulation.
   Article 4
   Administrative data
   The administrative data as referred to in Article 2(3)(a) shall include:

               (a)

               name of the applicant (company, organisation, etc.), address and contact details;

               (b)

               name of the manufacturer(s) of the substance, if different than the applicant’s, address and contact details;

               (c)

               name of the person responsible for the dossier, address and contact details;

               (d)

               date of submission of the dossier;

               (e)

               type of the application, i.e. concerning a food additive, a food enzyme, or a flavouring;

               (f)

               where applicable, chemical name according to IUPAC nomenclature;

               (g)

               where applicable, E-number of the additive as defined in the Union legislation on food additives;

               (h)

               where applicable, a reference to similar authorised food enzymes;

               (i)

               where applicable, the FL-number of a flavouring substance as defined in the Union legislation on flavourings;

               (j)

               where applicable, the information on authorisations falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (12);

               (k)

               table of content of the dossier;

               (l)

               list of documents and other particulars; the applicant shall identify the number and titles of volumes of documentation submitted in support of the application; a detailed index with a reference to volumes and pages shall be included;

               (m)

               list of the parts of the dossier to be treated as confidential; applicants shall indicate what they wish to be treated as confidential and give verifiable justification in accordance with Article 12 of Regulation (EC) No 1331/2008.

         Article 5
   General provisions on data required for risk assessment
   1.   The dossier submitted in support of an application for the safety evaluation of a substance shall enable a comprehensive risk assessment of the substance and shall permit verification that the substance does not pose a safety concern to consumers within the meaning of Article 6(a) of Regulation (EC) No 1332/2008, Article 6(1)(a) of Regulation (EC) No 1333/2008 and Article 4(a) of Regulation (EC) No 1334/2008.
   2.   The application dossier shall include all the available data relevant for the purpose of the risk assessment (i.e. full published papers of all references cited or full copies of the original unpublished studies).
   3.   The applicant shall take into account the latest guidance documents adopted or endorsed by the Authority available at the time of the submission of the application (The EFSA Journal).
   4.   The documentation on the procedure followed when gathering the data shall be provided, including the literature search strategies (assumptions made, key words used, databases used, time period covered, limitation criteria, etc.) and a comprehensive outcome of such search.
   5.   The safety evaluation strategy and the corresponding testing strategy shall be described and justified with rationales for inclusion and exclusion of specific studies and/or information.
   6.   The individual raw data of the unpublished studies and, where possible, of the published studies as well as the individual results of examinations shall be made available on request from the Authority.
   7.   For each biological or toxicological study, it shall be clarified 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 substance under consideration.
   Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC of the European Parliament and of the Council or, if they are carried out outside the territory of the Union, they shall follow ‘the OECD Principles of Good Laboratory Practice’ (GLP). The applicant shall provide evidence to demonstrate that those requirements are complied with. For studies not conducted according to standard protocols, data interpretation, as well as a justification on their appropriateness for the risk assessment, shall be provided.
   8.   The applicant shall propose an overall conclusion on the safety of the proposed uses of the substance. The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
   Article 6
   Specific data required for risk assessment of food additives
   1.   In addition to data to be provided pursuant to Article 5, information shall be provided on:

               (a)

               the identity and characterisation of the additive, including the proposed specifications and analytical data;

               (b)

               where applicable, the particle size, particle size distribution and other physicochemical characteristics;

               (c)

               the manufacturing process;

               (d)

               presence of impurities;

               (e)

               the stability, reaction and fate in foods to which the additive is added;

               (f)

               where applicable, the existing authorisations and risk assessments;

               (g)

               proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;

               (h)

               a dietary exposure assessment;

               (i)

               the biological and toxicological data.

         2.   As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered:

               (a)

               toxicokinetics;

               (b)

               subchronic toxicity;

               (c)

               genotoxicity;

               (d)

               chronic toxicity/carcinogenicity;

               (e)

               reproductive and developmental toxicity.

         Article 7
   Data required for risk management of food additives
   1.   The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6(1) of Regulation (EC) No 1333/2008.
   2.   In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:

               (a)

               the identity of the food additive, including reference to the existing specifications;

               (b)

               the function and technological need for the level proposed in each of the food categories or products for which authorisation is requested and an explanation that this can not be reasonably achieved by other economically and technologically practical means;

               (c)

               the investigations on the efficacy of the food additive for the intended effect at the use level proposed;

               (d)

               advantages and benefit for the consumer. The applicant shall take into account the requirements laid down in Article 6(2) of Regulation (EC) No 1333/2008;

               (e)

               why the use would not mislead the consumer;

               (f)

               proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;

               (g)

               the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned;

               (h)

               the amount of the food additive present in the final food as consumed by the consumer;

               (i)

               analytical methods allowing the identification and quantification of the additive or its residues in food;

               (j)

               where applicable, the compliance with the specific conditions for sweeteners and for colours as laid down in Articles 7 and 8 of Regulation (EC) No 1333/2008.

         Article 8
   Specific data required for risk assessment of food enzymes
   1.   In addition to data to be provided pursuant to Article 5, information shall be provided on:

               (a)

               name(s), synonyms, abbreviations and classification(s);

               (b)

               Enzyme Commission Number;

               (c)

               the proposed specifications, including the origin;

               (d)

               the properties;

               (e)

               the reference to any similar food enzyme;

               (f)

               the source material;

               (g)

               the manufacturing process;

               (h)

               the stability, reaction and fate in foods in which the food enzyme is used;

               (i)

               where applicable the existing authorisations and evaluations;

               (j)

               the proposed uses in food and, where applicable, the proposed normal and maximum use levels;

               (k)

               the dietary exposure assessment;

               (l)

               the biological and toxicological data.

         2.   As regards to the biological and toxicological data, referred to in point (1) of paragraph 1, the following core areas shall be covered:

               (a)

               subchronic toxicity;

               (b)

               genotoxicity.

         Article 9
   Data required for risk management of food enzymes
   1.   The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6 of Regulation (EC) No 1332/2008.
   2.   In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:

               (a)

               the identity of the food enzyme, including reference to the specifications;

               (b)

               the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied;

               (c)

               the effect of the food enzyme on the final food;

               (d)

               why the use would not mislead the consumer;

               (e)

               the proposed normal and maximum use levels where applicable;

               (f)

               the dietary exposure assessment, as described in the Authority’s guidance document on food enzymes (13).

         Article 10
   Specific data required for risk assessment of flavourings
   1.   In addition to data to be provided pursuant to Article 5, information shall be provided on:

               (a)

               the manufacturing process;

               (b)

               specifications;

               (c)

               where applicable, information on particle size, particle size distribution and other physicochemical characteristics;

               (d)

               where applicable the existing authorisations and evaluations;

               (e)

               the proposed uses in food and proposed normal and maximum use levels in the categories according to the Union list or in a more specified type of product within the categories;

               (f)

               the data on dietary sources;

               (g)

               the dietary exposure assessment;

               (h)

               the biological and toxicological data.

         2.   As regards to the biological and toxicological data, referred to in point (h) of paragraph 1, the following core areas shall be covered:

               (a)

               examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE);

               (b)

               genotoxicity;

               (c)

               subchronic toxicity, where applicable;

               (d)

               developmental toxicity, where applicable;

               (e)

               chronic toxicity and carcinogenicity data, where applicable.

         Article 11
   Data required for risk management of flavourings
   The dossier submitted in support of an application shall include the following information:

               (a)

               the identity of the flavouring, including reference to the existing specifications;

               (b)

               organoleptic properties of the substance;

               (c)

               the proposed normal and maximum use levels in the food categories or in a more specific food belonging to one of these categories;

               (d)

               the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned.

         CHAPTER III

      ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN APPLICATION

   Article 12
   Procedures
   1.   On receipt of an application the Commission shall without delay verify whether the food additive, food enzyme or flavouring falls within the scope of the appropriate sectoral food law and whether the application contains all the elements required under Chapter II.
   2.   Where the application contains all the elements required under Chapter II, the Commission shall, where necessary, request the Authority to verify the suitability of the data for risk assessment in accordance with the scientific opinions on data requirements for the evaluation of substance applications and to prepare, if appropriate, an opinion.
   3.   Within 30 working days following the receipt of the Commission’s request, the Authority shall inform the Commission by letter about the suitability of the data for risk assessment. If the data is considered suitable for risk assessment, the evaluation period referred to in Article 5(1) of Regulation (EC) No 1331/2008 shall begin from the date when the Authority’s letter is received by the Commission.
   However, in accordance with point (a) of the second subparagraph of Article 17(4) of Regulation (EC) No 1332/2008, in the case of establishment of the Union list of food enzymes, Article 5(1) of Regulation (EC) No 1331/2008 shall not apply.
   4.   In case of an application to update the Union list of food additives, food enzymes or flavourings, 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. In the case of applications submitted in compliance with Article 17(2) of Regulation (EC) No 1332/2008, the Commission shall determine that period together with the applicant.
   5.   When the application does not fall within the appropriate sectoral food law or when it does not contain all the elements required under Chapter II or when the Authority considers that the data for risk assessment are not suitable, the application shall be considered as not valid. In such a case the Commission shall inform the applicant, the Member States and the Authority indicating the reasons why the application is considered not valid.
   6.   By way of derogation from paragraph 5, an application may be considered as valid even if it does not contain all the elements required under Chapter II, provided that the applicant has submitted verifiable justification for each missing element.
   CHAPTER IV

      OPINION OF THE AUTHORITY

   Article 13
   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 food additive, food enzyme or flavouring;

               (b)

               the assessment of the biological and toxicological data;

               (c)

               a dietary exposure assessment for the European population taking into account other possible sources of dietary exposure;

               (d)

               an overall risk assessment establishing if possible and relevant a health-based guidance value, and highlighting uncertainties and limitations where relevant;

               (e)

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

               (f)

               conclusions.

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

      FINAL PROVISIONS

   Article 14
   Entry into force and application
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 11 September 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 10 March 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 354, 31.12.2008, p. 1.

      (2)  OJ L 354, 31.12.2008, p. 16.

      (3)  OJ L 354, 31.12.2008, p. 7.

      (4)  OJ L 354, 31.12.2008, p. 34.

      (5)  http://www.efsa.europa.eu/en/scdocs/doc/1188.pdf

      (6)  http://www.efsa.europa.eu/en/scdocs/doc/1305.pdf

      (7)  http://www.efsa.europa.eu/en/scdocs/doc/1623.pdf

      (8)  OJ L 50, 20.2.2004, p. 44.

      (9)  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.

      (10)  http://www.efsa.europa.eu/en/efsajournal.htm

      (11)  http://ec.europa.eu/dgs/health_consumer/index_en.htm

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

      (13)  Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes. The EFSA Journal (2009) 1305, p. 1.

      ANNEX

         MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ADDITIVES

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Application for authorisation of food additive in accordance with Regulation (EC) No 1331/2008.

                  

                  Application for an authorisation of a new food additive

                  

                  Application for a modification of the conditions of use of an already authorised food additive

                  

                  Application for a modification of the specifications of an already authorised food additive

            (Please indicate clearly by ticking one of the boxes).
      The Applicant(s) and/or his/their Representative(s) in the European Union.
      (name, address, …)
      …
      …
      …
      submit(s) the present application in order to update the EU list on food additives.
      Food additive name:
      …
      ELINCS or EINECS number (if attributed)
      CAS No (if applicable)
      Functional class(es) of food additives (1):
      (list)
      …
      Food categories and required levels:

                  Food category

                  Normal use level

                  Maximum proposed use level

            Yours sincerely,
      Signature: …
      Enclosures:

                  

                  Complete dossier

                  

                  Public summary of the dossier

                  

                  Detailed summary of the dossier

                  

                  List of the parts of the dossier requested to be treated as confidential

                  

                  Copy of administrative data of applicant(s)

         MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ENZYMES

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Application for authorisation of food enzyme in accordance with Regulation (EC) No 1331/2008.

                  

                  Application for an authorisation of a new food enzyme

                  

                  Application for a modification of the conditions of use of an already authorised food enzyme

                  

                  Application for a modification of the specifications of an already authorised food enzyme

            (Please indicate clearly by ticking one of the boxes)
      The Applicant(s) and/or his/their Representative(s) in the European Union
      (name, address, …)
      …
      …
      submit(s) the present application in order to update the EU list on food enzymes.
      Food enzyme name:
      …
      Enzyme Classification Number of Enzyme Commission of the IUBMB
      Source material
      …
      …

                  Name

                  Specifications

                  Foods

                  Conditions of use

                  Restrictions on the sale of the food enzyme to the final consumer

                  Specific requirement in respect of labelling of food

            Yours sincerely,
      Signature: …
      Enclosures:

                  

                  Complete dossier

                  

                  Public summary of the dossier

                  

                  Detailed summary of the dossier

                  

                  List of the parts of the dossier requested to be treated as confidential

                  

                  Copy of administrative data of applicant(s)

         MODEL LETTER ACCOMPANYING AN APPLICATION FOR FLAVOURINGS

      EUROPEAN COMMISSION
      Directorate General
      Directorate
      Unit
      Date: …
      Subject: Application for authorisation of food flavouring in accordance with Regulation (EC) No 1331/2008.

                  

                  Application for an authorisation of a new flavouring substance

                  

                  Application for an authorisation of a new flavouring preparation

                  

                  Application for an authorisation of a new flavour precursor

                  

                  Application for an authorisation of a new thermal process flavouring

                  

                  Application for an authorisation of a new other flavouring

                  

                  Application for an authorisation of a new source material

                  

                  Application for a modification of the conditions of use of an already authorised food flavouring

                  

                  Application for a modification of the specifications of an already authorised food flavouring

            (Please indicate clearly by ticking one of the boxes)
      The Applicant(s) and/or his/their Representative(s) in the European Union
      (name, address, …)
      …
      …
      submit(s) the present application in order to update the EU list on food flavourings.
      Name of the flavouring or source material:
      …
      FL-, CAS-, JECFA-, CoE-number (if attributed)
      Organoleptic properties of the flavouring
      …
      Food categories and required levels:

                  Food category

                  Normal use level

                  Maximum proposed use level

            Yours sincerely,
      Signature: …
      Enclosures:

                  

                  Complete dossier

                  

                  Public summary of the dossier

                  

                  Detailed summary of the dossier

                  

                  List of the parts of the dossier requested to be treated as confidential

                  

                  Copy of administrative data of applicant(s)

         (1)  The functional classes of food additives in foods and of food additives in food additives and food enzymes are listed in Annex I to Regulation (EC) No 1333/2008. If the additive does not belong to one of the mentioned classes, a new functional class name and definition can be proposed.


title: Commission Implementing Regulation (EU) No 726/2014 of 30 June 2014 amending Council Regulation (EC) No 992/95 as regards a new Union tariff quota for prepared herring originating in Norway

text:
               1.7.2014

               EN

               Official Journal of the European Union

               L 192/41

         COMMISSION IMPLEMENTING REGULATION (EU) No 726/2014
   of 30 June 2014
   amending Council Regulation (EC) No 992/95 as regards a new Union tariff quota for prepared herring originating in Norway
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 992/95 of 10 April 1995 opening and providing for the administration of Community tariff quotas for certain agricultural and fishery products originating in Norway (1), and in particular Article 5(1)(b) thereof,
   Whereas:

               (1)

               By Council Decision 2014/343/EU (2), the signing and the provisional application of an Additional Protocol to the Agreement between the European Economic Community and the Kingdom of Norway consequent to the accession of the Republic of Croatia to the European Union have been approved.

               (2)

               The Additional Protocol provides for a new tariff quota for release for free circulation in the European Union of certain prepared herring originating in Norway.

               (3)

               It is necessary to amend Regulation (EC) No 992/95 in order to implement the new tariff quota.

               (4)

               The new tariff quota should apply for a period of 12 months. In accordance with Decision 2014/343/EU, it is to apply from the day of the provisional application of the Additional Protocol. This Regulation should therefore apply from the same date.

               (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 following row is added to the Annex to Regulation (EC) No 992/95:

                  ‘09.0859

                  ex 1604 12 91
                  ex 1604 12 99

                  10
                  11
                  19

                  Herring, spiced and/or vinegar cured, in brine

                  From 1.8.2014 to 31.7.2015

                  1 400 tonnes net drained weight

                  0’

   Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 August 2014.

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

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 101, 4.5.1995, p. 1.

      (2)  OJ L 170, 11.6.2014, p. 3.


title: Commission Implementing Regulation (EU) No 1222/2013 of 29 November 2013 concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for ruminants, pigs and poultry  Text with EEA relevance

text:
               30.11.2013

               EN

               Official Journal of the European Union

               L 320/16

         COMMISSION IMPLEMENTING REGULATION (EU) No 1222/2013
   of 29 November 2013
   concerning the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for ruminants, pigs and poultry
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
   Whereas:

               (1)

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

               (2)

               In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of propionic acid, sodium propionate and ammonium propionate. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               That application concerns the authorisation of propionic acid, sodium propionate and ammonium propionate as feed additives for all animal species to be classified in the additive category ‘technological additives’, functional group ‘silage additives’. The application includes also other uses of the same substances for which no decision has yet been taken.

               (4)

               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 November 2011 (2) that, under the proposed conditions of use, propionic acid, sodium propionate and ammonium propionate do not have an adverse effect on animal health, human health or the environment. It was also concluded that the substances improve the aerobic stability of easy to ensile materials. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (5)

               The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised as specified in the Annex to this Regulation.

               (6)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The substances specified in the Annex belonging to the additive category ‘technological additives’ and to the functional group ‘silage additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 29 November 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  EFSA Journal 2011; 9(12):2446.

      ANNEX

                  Identification number of the additive

                  Name of the holder of authorisation

                  Additive

                  Composition, chemical formula, description, analytical method

                  Species or category of animal

                  Maximum age

                  Minimum content

                  Maximum content

                  Other provisions

                  End of period of authorisation

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

                     Category of technological additives. Functional group: silage additives

                  1k280

                  —

                  Propionic acid

                                 Additive composition

                              Propionic acid ≥ 99,5 %

                                 Characterisation of the active substance

                                          Propionic acid ≥ 99,5 %

                                          C3H6O2 CAS No: 79-09-4

                                          Non-volatile residue ≤ 0,01 % when dried at 140 °C to constant weight

                                          Aldehydes ≤ 0,1 % expressed as formaldehyde

                                          Produced by chemical synthesis

                                 Method of Analysis
                                  (1)

                              Quantification of propionic acid as total propionic acid in feed additive, premixtures, feedingstuffs: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)

                  Ruminants

                  —

                  —

                  —

                              1.

                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.

                              2.

                              The additive shall be used in easy to ensile material (2).

                              3.

                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.

                              4.

                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.

                  20 December 2023

                  Pigs

                  —

                  30 000

                  Poultry

                  —

                  10 000

                  1k281

                  —

                  Sodium propionate

                                 Additive composition

                              Sodium propionate ≥ 98,5 %

                                 Characterisation of the active substance

                                          Sodium propronate ≥ 98,5 %

                                          C3H5O2Na

                                          CAS No: 137-40-6

                                          Loss on drying ≤ 4 % determined by drying for two hours at 105 °C

                                          Water insolubles ≤ 0,1 %

                                          Produced by chemical synthesis

                                 Method of Analysis
                                  (1)

                              Quantification of sodium propionate in feed additive:

                                          (1)

                                          ion exclusion High Performance Liquid Chromatography with refractive index detection (HPLC-RI) – for the determination of total propionate; and

                                          (2)

                                          atomic absorption spectrometry, AAS (EN ISO 6869) – for the determination of total sodium.

                                    Quantification of sodium propionate as total propionic acid in premixtures, feedingstuffs: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)

                  Ruminants

                  —

                  —

                  —

                              1.

                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.

                              2.

                              The additive shall be used in easy to ensile materials (2).

                              3.

                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.

                              4.

                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.

                  20 December 2023

                  Pigs

                  —

                  30 000 (3)

                  Poultry

                  —

                  10 000 (3)

                  1k284

                  —

                  Ammonium propionate

                                 Additive composition

                              Preparation of ammonium propionate ≥ 19,0 %, propionic acid ≤ 80,0 % and water ≤ 30 %

                                 Characterisation of the active substance

                                          Ammonium propionate: C3H9O2N

                                          CAS No: 17496-08-1

                                          Produced by chemical synthesis

                                 Method of Analysis
                                  (1)

                              Quantification of the ammonium propionate in feed additive:

                                          (1)

                                          ion exclusion High Performance Liquid Chromatography with refractive index detection (HPLC-RI) – for the determination of total propionate; and

                                          (2)

                                          titration with sulphuric acid and sodium hydroxide for the determination of ammonia.

                                    Quantification of ammonium propionate as total propionic acid in premixtures, feedingstuffs:
                              ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)

                  Ruminants

                  —

                  —

                  —

                              1.

                              The simultaneous use of other organic acids at the maximum permitted doses is contraindicated.

                              2.

                              The additive shall be used in easy to ensile materials (2).

                              3.

                              Simultaneous use with other sources of the active substance shall not exceed the authorised maximum content.

                              4.

                              For safety: breathing protection, eye protection, gloves and protective clothing shall be used during handling.

                  20 December 2023

                  Pigs

                  —

                  30 000 (3)

                  Poultry

                  —

                  10 000 (3)

         (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx

         (2)  Easy to ensile forage: > 3 % soluble carbohydrates in fresh material (e.g. whole plant maize, ryegrass, brome grass or sugar beet pulp). Commission Regulation (EC) No 429/2008 (OJ L 133, 22.5.2008, p. 1).

         (3)  As propionic acid.


title: Commission Implementing Regulation (EU) 2015/1921 of 26 October 2015 amending Council Regulation (EC) No 314/2004 concerning certain restrictive measures in respect of Zimbabwe

text:
               27.10.2015

               EN

               Official Journal of the European Union

               L 281/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1921
   of 26 October 2015
   amending Council Regulation (EC) No 314/2004 concerning certain restrictive measures in respect of Zimbabwe
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 314/2004 of 19 February 2004 concerning certain restrictive measures in respect of Zimbabwe (1), and in particular Article 11(b) thereof,
   Whereas:

               (1)

               Annex III to Regulation (EC) No 314/2004 lists the persons and entities covered by the freezing of funds and economic resources under that Regulation.

               (2)

               Council Decision 2011/101/CFSP (2) identifies the natural and legal persons to whom restrictions are to apply as provided for in Article 5 of that Decision, and Regulation (EC) No 314/2004 gives effect to that Decision to the extent that action at Union level is required.

               (3)

               On 26 October 2015, the Council decided to remove the name of one deceased person to whom the restrictions should apply. Annex III to Regulation (EC) No 314/2004 should therefore be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex III to Regulation (EC) No 314/2004 is amended in accordance with 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, 26 October 2015.

            For the Commission,

            On behalf of the President,

            Head of the Service for Foreign Policy Instruments

      (1)  OJ L 55, 24.2.2004, p. 1.

      (2)  Council Decision 2011/101/CFSP of 15 February 2011 concerning restrictive measures against Zimbabwe (OJ L 42, 16.2.2011, p. 6).

      ANNEX
      In Annex III to Regulation (EC) No 314/2004 the following natural persons shall be deleted from the section ‘I. Persons’:
      I.   Persons

         ‘Amos Bernard MIDZI (Mugenva). Date of birth: 4.7.1952. other information: (a) Former Minister of Mines and Mining Development; (b) former Minister of Energy and Power Development; (c) ZANU-PF party Chairman in Harare, (d) Former member of the Government associated with ZANU-PF faction of government (e) Organised convoy of ZANU-PF supporters and soldiers who assaulted people and destroyed homes in June 2008. (f) Linked with violence in Epworth, supporting militia bases in 2008 and again in 2011.’