title: Commission Implementing Regulation (EU) 2020/1256 of 7 September 2020 amending Annex I to Implementing Regulation (EU) 2018/659 as regards the entry into the Union of live equidae and of semen, ova and embryos of equidae from Malaysia (Text with EEA relevance)

text:
                  8.9.2020

                  EN

                  Official Journal of the European Union

                  L 293/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1256
         of 7 September 2020
         amending Annex I to Implementing Regulation (EU) 2018/659 as regards the entry into the Union of live equidae and of semen, ova and embryos of equidae from Malaysia
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A (I) to Directive 90/425/EEC (1), and in particular Article 17(3) thereof,
         Having regard to Council Directive 2009/156/EC of 30 November 2009 on animal health conditions governing the movement and importation from third countries of equidae (2), and in particular point (i) of Article 2, Article 12(1), (4) and (5), Article 13(2), Articles 15 and 16 and points (a) and (b) of Article 19 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2018/659 (3) establishes the list of third countries and parts of the territory of third countries from which the entry into the Union of equidae and of their semen, ova and embryos is authorised. It also lays down the animal health and veterinary certification requirements applicable to those consignments.

                     (2)

                     Directive 2009/156/EC lays down the animal health requirements governing imports of equidae into the Union. It provides that equidae imported into the Union must come from a third country that is free from African horse sickness.

                     (3)

                     Directive 92/65/EEC lays down the animal health requirements governing imports of semen, ova and embryos of equidae into the Union. It provides that only those commodities that come from a third country or part of the territory of a third country on a list of third countries drawn up in accordance with that Directive, may be imported into the Union.

                     (4)

                     The specific rules for official controls of consignments of animals and germinal products in transit through the Union, including equidae and their germinal products, are laid down in Commission Delegated Regulation (EU) 2019/2124 (4).

                     (5)

                     On 1 September 2020 the Department of Veterinary Services of Malaysia confirmed positive results in a test for the detection of genome of the African horse sickness virus carried out on samples taken from horses in the State of Terrenganu, in the north-east of the Malaysian peninsula, at least 60 km from the border with Thailand. The Department of Veterinary Services of Malaysia has duly declared movement controls on horses throughout that third country and informed the World Organisation for Animal Health (OIE).

                     (6)

                     The entry into the Union of equidae and of germinal products of equidae from the Malaysian peninsula should no longer be authorised. Accordingly, the entry for Malaysia in Annex I to Implementing Regulation (EU) 2018/659 should be amended, so that the entry into the Union of equidae and germinal products of equidae from the Malaysian peninsula is no longer authorised.

                     (7)

                     Implementing Regulation (EU) 2018/659 should therefore be amended accordingly.

                     (8)

                     Given the risks to animal health, the amendment to the entry for Malaysia in Annex I to Implementing Regulation (EU) 2018/659 should take effect as soon as possible.

                     (9)

                     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
            In Annex I to Implementing Regulation (EU) 2018/659, the entry for Malaysia is replaced by the following:

                           ‘MY

                           Malaysia

                           MY-0

                           Whole country

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           MY-1

                           Peninsula

                           G

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —

                           —’

            Article 2
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 7 September 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 268, 14.9.1992, p. 54.

            (2)  OJ L 192, 23.7.2010, p. 1.

            (3)  Commission Implementing Regulation (EU) 2018/659 of 12 April 2018 on the conditions for the entry into the Union of live equidae and of semen, ova and embryos of equidae (OJ L 110, 30.4.2018, p. 1).

            (4)  Commission Delegated Regulation (EU) 2019/2124 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for official controls of consignments of animals and goods in transit, transhipment and onward transportation through the Union, and amending Commission Regulations (EC) No 798/2008, (EC) No 1251/2008, (EC) No 119/2009, (EU) No 206/2010, (EU) No 605/2010, (EU) No 142/2011, (EU) No 28/2012, Commission Implementing Regulation (EU) 2016/759 and Commission Decision 2007/777/EC (OJ L 321, 12.12.2019, p. 73)


title: Commission Implementing Regulation (EU) 2021/94 of 27 January 2021 amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin

text:
                  29.1.2021

                  EN

                  Official Journal of the European Union

                  L 31/196

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/94
         of 27 January 2021
         amending Regulation (EC) No 1484/95 as regards fixing representative prices in the poultrymeat and egg sectors and for egg albumin
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 183(b) thereof,
         Having regard to Regulation (EU) No 510/2014 of the European Parliament and of the Council of 16 April 2014 laying down the trade arrangements applicable to certain goods resulting from the processing of agricultural products and repealing Council Regulations (EC) No 1216/2009 and (EC) No 614/2009 (2), and in particular Article 5(6)(a) thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 January 2021.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 150 20.5.2014, p. 1.

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

            ANNEX

                     ‘ANNEX I

                                 CN code

                                 Description of goods

                                 Representative price
                                 (EUR/100 kg)

                                 Security under Article 3
                                 (EUR/100 kg)

                                 Origin (1)

                                 0207 14 10

                                 Fowls of the species Gallus domesticus, boneless cuts, frozen

                                 184,7
                                 139,9
                                 197,6

                                 38
                                 60
                                 31

                                 AR
                                 BR
                                 TH

                                 1602 32 11

                                 Preparations of fowls of the species Gallus domesticus, uncooked

                                 151,5

                                 49

                                 BR

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


title: Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

text:
                  29.1.2021

                  EN

                  Official Journal of the European Union

                  L 31/201

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/96
         of 28 January 2021
         authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     On 28 February 2019, the company Glycom A/S (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3'-sialyllactose (‘3'-SL’) sodium salt, obtained by microbial fermentation with a genetically modified strain of Escherichia coli, strain K12 DH1, on the Union market as a novel food. The applicant requested for 3'-SL sodium salt to be used as a novel food in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (3), milk-based drinks and similar products intended for young children, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (4) intended for the general population, excluding infants and young children. The applicant also proposed that food supplements containing 3'-SL sodium salt should not be used if other foods with added 3'-SL sodium salt, are consumed on the same day.

                     (4)

                     On 28 February 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk (5); the detailed characterisation data on the production bacterial strains (6) and their certificates (7); the specifications for the raw materials and processing aids (8); the certificates of analyses of the various 3'-SL sodium salt batches (9); the analytical methods and validation reports (10); the 3'-SL sodium salt stability reports (11); the detailed description of the production process (12); the laboratory accreditation certificates (13); the 3'-SL intake assessment reports (14); an in vitro mammalian cell micronucleus test with 3'-SL sodium salt (15); an in vitro mammalian cell micronucleus test with the related compound 6'-sialyllactose (‘6'-SL’) sodium salt (16); a bacterial reverse mutation test with 3'-SL sodium salt (17); a bacterial reverse mutation test with 6'-SL sodium salt (18); a 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt (19); a 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt including the summary table of the statistically significant observations (20), a 14-day oral toxicity study in the neonatal rat with 6'-SL sodium salt (21), and a 90-day oral toxicity study in the neonatal rat with 6'-SL sodium salt, including the summary table of the statistically significant observations (22).

                     (5)

                     On 12 June 2019, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3'-SL sodium salt as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (6)

                     On 25 March 2020, the Authority adopted its scientific opinion ‘Safety of 3'-Sialyllactose (3'-SL) sodium salt as a novel food pursuant to Regulation (EU) 2015/2283’ (23).

                     (7)

                     In its scientific opinion, the Authority concluded that 3'-SL sodium salt is safe under the proposed conditions of use for the proposed target populations. Therefore, that scientific opinion gives sufficient grounds to establish that 3'-SL sodium salt, when used in unflavoured pasteurised and unflavoured sterilised milk products, flavoured and unflavoured fermented milk based products including heat-treated products, beverages (flavoured drinks excluding drinks with a pH less than 5), cereal bars, infant formula and follow-on formula, processed cereal-based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013, milk-based drinks and similar products intended for young children, total diet replacement foods for weight control as defined in Regulation (EU) No 609/2013, foods for special medical purposes as defined in Regulation (EU) No 609/2013, and in food supplements as defined in Directive 2002/46/EC, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (8)

                     In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3'-SL sodium salt without the data from the proprietary analytical reports on the structure comparison via NMR of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids, the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations.

                     (9)

                     Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

                     (10)

                     The applicant declared that, at the time the application was made, they held proprietary and exclusive rights of reference to the studies under national law and that therefore third parties could not lawfully access or use those studies.

                     (11)

                     The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283. Therefore, the data contained in the applicant’s file which served as a basis for the Authority to establish the safety of the novel food and to reach its conclusions on the safety of 3'-SL sodium salt, and without which the novel food could not have been assessed by the Authority, should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation. Accordingly, the placing on the market within the Union of 3'-SL sodium salt should be restricted to the applicant for that period.

                     (12)

                     However, restricting the authorisation of 3'-SL sodium salt and of the reference to the data contained in the applicant’s file for the sole use by the applicant, does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such authorisation under Regulation (EU) 2015/2283.

                     (13)

                     In line with the conditions of use of food supplements containing 3'-SL sodium salt as proposed by the applicant and assessed by the Authority, it is necessary to inform consumers with an appropriate label that food supplements containing 3'-SL sodium salt should not be consumed the same day if other foods with added 3'-SL sodium salt are consumed on the same day.

                     (14)

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

                     (15)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   3'-Sialyllactose (3'-SL) sodium salt as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of five years from the date of entry into force of this Regulation only the initial applicant:
               Company: Glycom A/S;
               Address: Kogle Allé 4, DK-2970 Hørsholm, Denmark,
               is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for that novel food without reference to the data protected pursuant to Article 2 or with the agreement of the applicant.

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

            Article 2
            The data contained in the application file on the basis of which 3'-sialyllactose sodium salt has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283, shall not be used for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of the applicant.

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

            Article 4
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).

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

            (5)  Glykos Finland LTD 2019 (unpublished).

            (6)  Glycom 2019 (unpublished).

            (7)  Glycom/DSMZ 2018 (unpublished).

            (8)  Glycom 2019 (unpublished).

            (9)  Glycom 2019 (unpublished).

            (10)  Glycom 2019 (unpublished).

            (11)  Glycom 2019 (unpublished).

            (12)  Glycom 2018 (unpublished).

            (13)  Glycom 2019 (unpublished).

            (14)  Glycom 2019 (unpublished).

            (15)  Gilby 2019 (unpublished).

            (16)  Gilby 2018 (unpublished).

            (17)  Šoltésová, 2019 (unpublished).

            (18)  Šoltésová, 2018 (unpublished)

            (19)  Stannard 2019a (unpublished).

            (20)  Stannard 2019b (unpublished).

            (21)  Flaxmer 2018a (unpublished).

            (22)  Flaxmer 2018b (unpublished).

            (23)  EFSA Journal 2020;18(5):6098

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

                        (1)

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

                                    ‘Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data Protection

                                       3'-Sialyllactose (3'-SL) sodium salt

                                       (microbial source)

                                          Specified food category

                                          Maximum levels (expressed as 3'- Sialyllactose)

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “3'-Sialyllactose sodium salt”.
                                    The labelling of food supplements containing 3'-Sialyllactose sodium salt shall bear a statement that they should not be consumed:

                                                a)

                                                if foods containing added 3'-Sialyllactose sodium salt are consumed the same day.

                                                b)

                                                by infants and young children

                                    Authorised on 18 February 2021. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Glycom A/S, Kogle Allé 4, DK-2970 Hørsholm, Denmark. During the period of data protection, the novel food 3'-sialyllactose sodium salt is authorised for placing on the market within the Union only by Glycom A/S, unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Glycom A/S.
                                    End date of the data protection: 18 February 2026.’

                                    Unflavoured pasteurised and unflavoured sterilised (including UHT) milk products

                                    0,25 g/L

                                    Flavoured fermented milk-based products including heat-treated products

                                    0,25 g/L (beverages)

                                    0,5 g/kg (products other than beverages)

                                    Unflavoured fermented milk-based products

                                    0,25 g/L (beverages)

                                    2,5 g/kg (products other than beverages)

                                    Beverages (flavoured drinks, excluding drinks with a pH less than 5)

                                    0,25 g/L

                                    Cereal bars

                                    2,5 g/kg

                                    Infant formula as defined under Regulation (EU) No 609/2013

                                    0,2 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Follow-on formula as defined under Regulation (EU) No 609/2013

                                    0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Processed cereal-based food and baby food for infants and young children as defined under Regulation (EU) No 609/2013

                                    0,15 g/L (beverages) in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    1,25 g/kg for products other than beverages

                                    Milk-based drinks and similar products intended for young children

                                    0,15 g/L in the final product ready for use, marketed as such or reconstituted as instructed by the manufacturer

                                    Total diet replacement foods for weight control as defined under Regulation (EU) No 609/2013

                                    0,5 g/L (beverages)

                                    5 g/kg (products other than beverages)

                                    Food for special medical purposes as defined under Regulation (EU) No 609/2013

                                    In accordance with the particular nutritional requirements of the persons for whom the products are intended

                                    Food Supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children

                                    0,5 g/day

                        (2)

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

                                    ‘Authorised Novel Food

                                       Specification

                                       3'-Sialyllactose (3'-SL) sodium salt

                                       (microbial source)

                                       Description:

                                    3'-Sialyllactose (3'-SL) sodium salt is a purified, white to off-white powder or agglomerate that is produced by a microbial process and contains limited levels of lactose, 3'-sialyl-lactulose, and sialic acid

                                       Source: Genetically modified strain of Escherichia coli K-12 DH1

                                       Definition:

                                    Chemical formula: C23H38NO19Na
                                    Chemical name: N-Acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt
                                    Molecular mass: 655,53 Da
                                    CAS No 128596-80-5

                                       Characteristics/Composition:

                                    Appearance: White to off-white powder or agglomerate
                                    Sum of 3'-Sialyllactose sodium salt, D-Lactose, and Sialic acid (% of dry matter): ≥ 90,0 % (w/w)
                                    3'-Sialyllactose sodium salt (% of dry matter): ≥ 88,0 % (w/w)
                                    D-Lactose: ≤ 5,0 % (w/w)
                                    Sialic acid: ≤ 1,5 % (w/w)
                                    3'-Sialyl-lactulose: ≤ 5,0 % (w/w)
                                    Sum of other carbohydrates: ≤ 3,0 % (w/w)
                                    Moisture: ≤ 8,0 % (w/w)
                                    Sodium: 2,5 – 4,5 % (w/w)
                                    Chloride: ≤ 1,0 % (w/w)
                                    pH (20 °C, 5 % solution): 4,5 -6,0
                                    Residual protein: ≤ 0,01 % (w/w)

                                       Microbiological criteria:

                                    Aerobic mesophilic bacteria total plate count: ≤ 1000 CFU/g

                                       Enterobacteriaceae: ≤ 10 CFU/g

                                       Salmonella sp.: Absence in 25 g
                                    Yeast: ≤ 100 CFU/g
                                    Mould: ≤ 100 CFU/g
                                    Residual endotoxins: ≤ 10 EU/mg

                              CFU: Colony Forming Units; EU: Endotoxin Units’


title: Commission Implementing Regulation (EU) 2021/97 of 28 January 2021 amending and correcting Regulation (EU) 2015/640 as regards the introduction of new additional airworthiness requirements

text:
                  29.1.2021

                  EN

                  Official Journal of the European Union

                  L 31/208

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/97
         of 28 January 2021
         amending and correcting Regulation (EU) 2015/640 as regards the introduction of new additional airworthiness requirements
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (1), and in particular Article 17(1), point (h) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 76(3) of Regulation (EU) 2018/1139, the European Union Aviation Safety Agency (the ‘Agency’) issues certification specifications (‘CS’) and regularly updates them in order to ensure that CS remain fit for purpose. However, an aircraft the design of which has already been certified is not required to comply with the updated version of CS when it is produced or while in service. Therefore, in order to support continuing airworthiness and safety improvements, compliance of such aircraft with additional airworthiness requirements that were not included in the initial CS at the time of certification of design should be introduced. Commission Regulation (EU) 2015/640 (2) sets out such additional airworthiness requirements.

                     (2)

                     Commission Implementing Regulation (EU) 2019/133 (3) introduced in point 26.60 of Annex I to Regulation (EU) 2015/640 additional airworthiness requirements for the dynamic conditions of passenger and cabin crew seats of large aeroplanes newly produced on the basis of a design which has already been certified by the Agency. Large aeroplanes for which the individual certificate of airworthiness is first issued on or after 18 February 2021 have to comply with point 26.60. Because of delays in aeroplanes production caused by the Covid-19 pandemic, some aeroplanes, which were planned to be issued with a certificate of airworthiness before 18 February 2021, will be issued with that certificate after that date. In order to avoid imposing additional burden on the industry because of the need to requalify the seats in those aeroplanes to the dynamic conditions, aeroplanes whose production has been delayed by the Covid-19 pandemic should therefore be exempted from compliance with point 26.60.

                     (3)

                     For this reason, the issue date of the first individual certificate of airworthiness referred to in point 26.60 of Annex I to Regulation (EU) 2015/640, which is currently set for 18 February 2021 should be aligned with the application date of the list of aeroplanes models which are not subject to certain provisions of Annex I to Regulation (EU) 2015/640 set out in Appendix I to Commission Implementing Regulation (EU) 2020/1159 (4), this is 26 February 2021. Considering that the time difference is minimal, there would be no significant impact on aviation safety. Regulation (EU) 2015/640 should therefore be amended accordingly.

                     (4)

                     Implementing Regulation (EU) 2020/1159 introduced new requirements on ageing aircraft. In particular, point 26.334 of Annex I to Regulation (EU) 2015/640 implies that all holders of supplemental type-certificate issued before 1 September 2003 will have to develop the damage tolerance data whether or not this data is actually required by operators. To ensure a proportionate burden on industry, it has always been intended that this data should only be developed if required by operators and only upon their request. Regulation (EU) 2015/640 should therefore be corrected accordingly.

                     (5)

                     The measures provided for in this Regulation refer to the amendments introduced by Implementing Regulation (EU) 2020/1159 which apply from 26 February 2021. For reasons of consistency, this Regulation should therefore also be applicable as of 26 February.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127 of Regulation (EU) 2018/1139,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) 2015/640 is amended in accordance with Annex I to this Regulation.

            Article 2
            Annex I to Regulation (EU) 2015/640 is corrected in accordance with Annex II to this Regulation.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 26 February 2021, except point (1) of Annex I, which shall apply from 16 February 2021.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 28 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 212, 22.8.2018, p. 1.

            (2)  Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).

            (3)  Commission Implementing Regulation (EU) 2019/133 of 28 January 2019 amending Regulation (EU) 2015/640 as regards the introduction of new additional airworthiness specifications (OJ L 25, 29.1.2019, p. 14).

            (4)  Commission Implementing Regulation (EU) 2020/1159 of 5 August 2020 amending Regulations (EU) No 1321/2014 and (EU) No 2015/640 as regards the introduction of new additional airworthiness requirements (OJ L 257, 6.8.2020, p. 14).

            ANNEX I
            Annex I to Regulation (EU) 2015/640 is amended as follows:

                        (1)

                        point 26.60 is replaced by the following:
                        ‘26.60   Emergency landing – dynamic conditions

                        Operators of large aeroplanes used in commercial air transport of passengers, type-certified on or after 1 January 1958, and for which the individual certificate of airworthiness is first issued on or after 26 February 2021 shall demonstrate for each seat type design approved for occupancy during taxiing, take-off or landing that the occupant is protected when exposed to loads resulting from emergency landing conditions. The demonstration shall be made by one of the following means:

                                    (a)

                                    successfully completed dynamic tests;

                                    (b)

                                    rational analysis providing equivalent safety, based on dynamic tests of a similar seat type design.

                              The obligation set out in the first paragraph shall not apply to the following seats:

                                    (a)

                                    flight deck crew seats;

                                    (b)

                                    seats in low-occupancy aeroplanes involved only in on-demand non-scheduled commercial air transport operations;

                                    (c)

                                    seats in an aeroplane model listed in Table A.1 of Appendix 1 and carrying a manufacturer serial number listed in that Table.’;

                        (2)

                        Appendix 1 is replaced by the following:

                              ‘Appendix 1

                                 List of aeroplane models not subject to certain provisions of Annex I (Part-26)

                                 Table A.1

                                          TC Holder

                                          Type

                                          Models

                                          Manufacturer serial number

                                          Provisions of Annex I (Part-26) that do NOT apply

                                          The Boeing Company

                                          707

                                          All

                                          26.301 to 26.334

                                          The Boeing Company

                                          720

                                          All

                                          26.301 to 26.334

                                          The Boeing Company

                                          DC-10

                                          DC-10-10
                                          DC-10-30
                                          DC-10-30F

                                          All

                                          26.301 to 26.334

                                          The Boeing Company

                                          DC-8

                                          All

                                          26.301 to 26.334

                                          The Boeing Company

                                          DC-9

                                          DC-9-11, DC-9-12, DC-9-13, DC-9-14,DC-9-15, DC-9-15F, DC-9-21, DC-9-31,DC-9-32, DC-9-32 (VC-9C), DC-9-32F,DC-9-32F (C-9A, C-9B), DC-9-33F, DC-9-34, DC-9-34F, DC-9-41, DC-9-51

                                          All

                                          26.301 to 26.334

                                          The Boeing Company

                                          MD-90

                                          MD-90-30

                                          All

                                          26.301 to 26.334

                                          FOKKER SERVICES B.V.

                                          F27

                                          Mark 100, 200, 300, 400, 500, 600, 700

                                          All

                                          26.301 to 26.334

                                          FOKKER SERVICES B.V.

                                          F28

                                          Mark 1000, 1000C, 2000, 3000, 3000C, 3000R, 3000RC, 4000

                                          All

                                          26.301 to 26.334

                                          GULFSTREAM AEROSPACE CORP.

                                          G-159

                                          G-159 (Gulfstream I)

                                          All

                                          26.301 to 26.334

                                          GULFSTREAM AEROSPACE CORP.

                                          G-II_III_IV_V

                                          G-1159A (GIII)
                                          G-1159B (GIIB)
                                          G-1159 (GII)

                                          All

                                          26.301 to 26.334

                                          KELOWNA FLIGHTCRAFT LTD.

                                          CONVAIR 340/440

                                          440

                                          All

                                          26.301 to 26.334

                                          LEARJET INC.

                                          Learjet 24/25/31/36/35/55/60

                                          24,24 A,24B,24B-A,24D, 24D-A,24F,24F-A,25,25B,25C,25D,25F

                                          All

                                          26.301 to 26.334

                                          LOCKHEED MARTIN CORPORATION

                                          1329

                                          All

                                          26.301 to 26.334

                                          LOCKHEED MARTIN CORPORATION

                                          188

                                          All

                                          26.301 to 26.334

                                          LOCKHEED MARTIN CORPORATION

                                          382

                                          382, 382B, 382E, 382F, 382G

                                          All

                                          26.301 to 26.334

                                          LOCKHEED MARTIN CORPORATION

                                          L-1011

                                          All

                                          26.301 to 26.334

                                          PT. DIRGANTARA INDONESIA

                                          CN-235

                                          All

                                          26.301 to 26.334

                                          SABRELINER CORPORATION

                                          NA-265

                                          NA-265-65

                                          All

                                          26.301 to 26.334

                                          VIKING AIR LIMITED

                                          SD3

                                          SD3-30
                                          Sherpa
                                          SD3 Sherpa

                                          All

                                          26.301 to 26.334

                                          VIKING AIR LIMITED

                                          DHC-7

                                          All

                                          26.301 to 26.334

                                          VIKING AIR LIMITED

                                          CL-215

                                          CL-215-6B11

                                          All

                                          26.301 to 26.334

                                          TUPOLEV PUBLIC STOCK COMPANY

                                          TU-204

                                          204-120CE

                                          All

                                          26.301 to 26.334

                                          AIRBUS

                                          A320 series

                                          A320-251N, A320-271N

                                          10033, 10242, 10281 and 10360

                                          26.60

                                          AIRBUS

                                          A321 series

                                          A321-271NX, A321-251NX

                                          10071, 10257, 10371 and 10391

                                          26.60.

                                          AIRBUS

                                          A330 series

                                          A330-243, A330-941

                                          1844, 1861, 1956, 1978, 1982, 1984, 1987, 1989, 1998, 2007, 2008, 2011, and 2012

                                          26.60

                                          ATR-GIE Avions de Transport Régional

                                          ATR 72 series

                                          ATR72-212A

                                          1565, 1598, 1620, 1629, 1632, 1637, 1640, 1642, 1649, 1657, 1660, 1661

                                          26.60

                                          The Boeing Company

                                          737 series

                                          737-8 and 737-9

                                          43299, 43304, 43305, 43310, 43321, 43322, 43332, 43334, 43344, 43348, 43391, 43579, 43797, 43798 43799, 43917, 43918, 43919, 43921, 43925, 43927, 43928, 43957, 43973, 43974, 43975, 43976, 44867, 44868, 44873, 60009, 60010, 60040, 60042, 60056, 60057, 60058, 60059, 60060, 60061, 60063, 60064, 60065, 60066, 60068, 60194, 60195, 60389, 60434, 60444, 60455, 61857, 61859, 61862, 61864, 62451, 62452, 62453, 62454, 62533, 63358, 63359, 63360, 64610, 64611, 64612, 62613, 64614, 65899, 66147, 66148, 66150

                                          26.60

                        ’

            ANNEX II
            In point 26.334 of Annex I, points (a) and (b) are replaced by the following:

                        ‘(a)

                        Upon request of an operator required to comply with point 26.370(a)(ii), a holder of a change approval that was issued before 1 September 2003 shall:

                                    (i)

                                    for changes and published repairs identified in accordance with paragraph (a)(i) of point 26.332 and paragraph (a)(iii) of point 26.332, perform a damage tolerance evaluation;

                                    (ii)

                                    establish and document the associated damage tolerance inspection, unless it has already been done.

                        (b)

                        The holder of a change approval shall submit the damage tolerance data resulting from the evaluation performed in accordance with paragraph (a)(i) to the Agency:

                                    (i)

                                    within 24 months from receipt of a request, for requests received prior to 26 February 2023, for approval; or

                                    (ii)

                                    before 26 February 2025 or within 12 months from receipt of a request, whichever occurs later, for requests received on or after 26 February 2023, for approval.’


title: Commission Implementing Regulation (EU) 2021/111 of 29 January 2021 making the exportation of certain products subject to the production of an export authorisation

text:
                  30.1.2021

                  EN

                  Official Journal of the European Union

                  LI 31/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/111
         of 29 January 2021
         making the exportation of certain products subject to the production of an export authorisation
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports (1), and in particular Article 5 thereof,
         Whereas:

                     (1)

                     The COVID-19 virus continues to spread rapidly within the Union, with severe consequences in terms of public health – in particular with a dramatic number of fatal outcomes – as well as economic and societal disruption. A permanent solution to this crisis depends on the deployment of an effective and safe vaccine against the virus.

                     (2)

                     Under its vaccines strategy, the Commission has financed and secured the production of a sufficient quantity of vaccines in the Union and forged agreements with individual vaccine manufacturers on behalf of Union Member States in order to ensure affordable and timely access to COVID-19 vaccines for all Member States and their population, while leading the global solidarity effort. It is essential that these supplies are effectively delivered by the manufacturers, as production of vaccines in the Union takes place only in a limited number of Member States.

                     (3)

                     Despite the fact that financial support has been given to increase production, certain vaccine manufacturers have already announced that they would not be in a position to supply the quantities of vaccine destined to the Union that they had pledged, in potential breach of their contractual commitments. Furthermore, there is a risk that vaccines produced in the Union are exported from the Union, in particular to non-vulnerable countries. Such a potential breach of contractual commitments made by the pharmaceutical industries, carries the risk of shortages and therefore delays within the Union. Such delays severely disrupt the Union’s plan to inoculate its population.

                     (4)

                     In the current situation that is marked by the fact that the production and delivery of vaccines is still in the building-up phase and the ensuing temporary global shortage, it is important to ensure the necessary level of transparency about the quantities of vaccines covered by this Regulation produced and the quantities delivered in order to further support the orderly implementation of the vaccination campaigns in the Member States but also elsewhere in countries that depend on Union produced COVID-19 vaccines produced in the Union.

                     (5)

                     In order to remedy a critical situation and to ensure transparency, it is in the Union interest to take immediate action for a limited duration to ensure that exports of COVID-19 vaccine covered by Advanced Purchased Agreements (APA) with the Union are subject to a prior authorisation so that they are adequate supplies in the Union to meet the vital demand, but without impacting on the Union’s international commitments in this respect. The Commission is also mindful of APAs contracted by third countries, and will endeavour that the expectations of these countries to obtain their deliveries will be met as much as possible.

                     (6)

                     In order to avoid the risk that measures are circumvented, vaccines should be covered by this regulation irrespective of their packaging and active substances including master and working cell banks used for the manufacture of such vaccines.

                     (7)

                     Export authorisation should be granted by the Member States where products covered by this regulation are manufactured to the extent that the volume of exports is not such that it poses a threat to the continuous supply of the vaccines necessary for the execution of the APAs between the Union and vaccines manufacturers. In order to ensure an adequate coordinated decision at Union level, the Member States should seek in advance the opinion of the Commission and decide in accordance with that opinion

                     (8)

                     The administrative modalities for these authorisations should be left to the discretion of the Member States during the time of this temporary system.

                     (9)

                     It is not the intention of the Union to restrict exports any more than absolutely necessary, and the Union remains fully committed to international solidarity and strongly supports the principle that any measures deemed necessary to prevent or relieve critical shortages are implemented in a manner that is targeted, transparent, proportionate, temporary and consistent with WTO obligations.

                     (10)

                     Based on the principle of international solidarity, exports to enable the provisions of supplies in the context of humanitarian emergency response, exports to the COVAX facilities, and in particular to low and middle-lower income countries given their vulnerability and limited access to vaccines, exports of COVID-19 vaccines purchased and/or delivered through COVAX, UNICEF and PAHO with destination to any other COVAX participating country and exports of COVID vaccine purchased by Member States under the Union’s APAs and resold or donated to a third country should be excluded from the export authorisation requirement.

                     (11)

                     The single market for medical products is closely integrated beyond the boundaries of the Union, and so are its production value chains and distribution networks. This is particularly the case with regard to the neighbouring countries and economies, the member States of the European Free Trade Area, and the Western Balkans which are engaged in a process of deep integration with the Union. Subjecting exports of COVID-19 vaccines to these countries to an export authorisation requirement would be counterproductive due to their proximity and dependency on Union supplies of vaccines (most of them do not have their own production capacity for the vaccines in question in adequate quantities) and the fact that vaccines are an essential product necessary to prevent the further spreading of the pandemic. It is therefore appropriate to exclude such countries from the scope of application of this Regulation.

                     (12)

                     It is likewise appropriate to exclude from the export authorisation requirement the overseas countries and territories listed in Annex II to the Treaty, as well as the Faeroe Islands, Andorra, San Marino and the Vatican City since they have a particular dependency on the metropolitan supply chains of the Member States to which they are attached or on the supply chains of neighbouring Member States, respectively.

                     (13)

                     This Regulation should apply to exports of Union goods from the customs territory of the Union. Therefore countries that form part of that customs territory need not be exempted in order to receive unrestricted shipments from within the Union. This is the case notably for the Principality of Monaco (2). Conversely, territories of Member States specifically excluded from the customs territory of the Union should not fall under the requirement of export authorisation and should therefore be exempted as well. This concerns the territories of Büsingen, Helgoland, Livigno, Ceuta and Melilla. Likewise, exports to the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to United Nations Convention on the Law of the Sea (UNCLOS) should be exempted from the application of this regulation. All these territories, likewise, have a particular dependency on the supply chains of the Member States which they are part of or of neighbouring Member States, respectively

                     (14)

                     To assess the situation in regular intervals, and in order to ensure transparency and consistency Member States should report their decisions to grant or reject requests for export authorisations to the Commission. The Commission should make such information publicly available on a regular basis, due account being taken of their confidential nature.

                     (15)

                     In order to ensure an effective monitoring of the situation and to assess whether the objectives of this regulation are met when the export authorisations are requested, the manufactures that have concluded APAs with the Union should provide to the Member States and to the Commission relevant data concerning their exports in the last three months. This information should include the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products. The absence of such information may lead to refusals of export authorisation.

                     (16)

                     Due to the urgency of the situation, justified by the fast spreading of the COVID-19 pandemic, the measures provided for in this Regulation should be taken in accordance with Article 3(3) of Regulation (EU) 2015/479.

                     (17)

                     It is considered that measures should remain in force until 31 March 2021, when full production capacity for COVID-19 vaccines in the EU has been installed and the risk of shortages and diversion of supplies will be reduced.

                     (18)

                     This Regulation should enter into force on the day following that of its publication. Having regard to Article 5(5) of Regulation (EU) 2015/479, the initial measures should have a duration of six weeks. In order to cover the period until 31 March 2021, the Commission intends to propose an extension of these measures pursuant to Article 6 of Regulation (EU) 2015/479,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Export authorisation

               1.   An export authorisation established in accordance with the form set out in Annex I shall be required for the export of the following Union goods in the meaning of Article 5(23) of Regulation (EU) No 952/2013 of the European Parliament and of the Council (3):
               vaccines against SARS-related coronaviruses (SARS-CoV species) falling under CN code 3002 20 10, irrespective of their packaging. It will also cover active substances including master and working cell banks used for the manufacture of such vaccines.
               It shall be granted by the competent authorities of the Member State where products covered by this regulation are manufactured and shall be issued in writing or by electronic means.

               2.   The export authorisation shall be produced when the goods are declared for export and at the latest at the moment of the release of the goods.

               3.   Without the production of a valid export authorisation, the exportation of such goods is prohibited.

               4.   The competent authority shall deliver an export authorisation only where the volume of exports is not such that it poses a threat to the execution of Union APAs concluded with vaccines manufacturers.

               5.   Based on the principle of solidarity, the following exports shall not be subject to the measures set out in paragraphs 1 and 2:

                           —

                           exports to Republic of Albania, Andorra, Bosnia and Herzegovina, the Faeroe Islands, the Republic of Iceland, Kosovo (4), the Principality of Liechtenstein, Montenegro, the Kingdom of Norway, the Republic of North Macedonia, the Republic of San Marino, Serbia, the Swiss confederation, Vatican City State, the overseas countries, territories listed in Annex II of the Treaty of the Functioning of the European Union, and exports to Büsingen, Helgoland, Livigno, Ceuta and Melilla, Algeria, Egypt, Jordan, Lebanon, Libya, Morocco, Palestine (5), Syria, Tunisia, Armenia, Azerbaijan, Belarus, Georgia, Israel, Moldova and Ukraine.

                           —

                           exports to low and middle income countries in the COVAX AMC list (6)

                           —

                           exports of goods purchased and/or delivered through COVAX, UNICEF and PAHO with destination to any other COVAX participating country

                           —

                           exports of goods purchased by EU Member States under the EU APAs and donated or resold to a third country.

                           —

                           exports in the context of a humanitarian emergency response.

                           —

                           exports to facilities located on the continental shelf of a Member State or the exclusive economic zone declared by a Member State pursuant to UNCLOS. For such exports, the declaration shall provide the information about the continental shelf or exclusive economic zone of the Member State to which the goods under this regulation) are to be brought by using the relevant additional reference code as defined in data element 2/3 in point 2 of Title II of Annex B of Commission Implementing Regulation (EU) 2015/2447 (7).

            Article 2
            Procedure

               1.   The request for export authorisation shall be made to the competent authorities of the Member States where products covered by this regulation are manufactured and shall contain the information set out in Annex I and the applicable TARIC additional codes in Annex II. In addition it shall also contain information on the number of vaccine doses of goods covered by this Regulation distributed in the Union since 1st December 2020 broken down by Member States as well as information on the number of vaccine doses of goods covered by this Regulation distributed in Northern Ireland since the entry into force of the Regulation.

               2.   The competent authorities of Member States shall process the applications for export authorisations as soon as possible, and shall issue a draft decision no later than two working days from the date on which all required information has been provided to the competent authorities. Under exceptional circumstances and for duly justified reasons, that period may be extended by a further period of two working days.

               3.   Member States shall immediately notify the applications to the Commission at the following email address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu

               4.   The competent authority shall notify its draft decision to the European Commission to the same email address.

               5.   In case of disagreement with the draft decision made by a Member State, the Commission shall issue an opinion to the competent authority within one working day from the receipt of the notification of the draft decision of the Member State. The Commission shall evaluate the impact of exports for which an authorisation is requested on the execution of the relevant APAs with the Union. The Member State shall decide on the request for authorisation in accordance with the Commission’s opinion.

               6.   The vaccine manufacturers that have concluded APAs shall provide electronically to the the Commission (at the following address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu) and to the competent Member State’s authorities the relevant data concerning their exports in the last three months prior to the entry into force of this Regulation together with the first request for authorisation. This information shall include the volume of exports of COVID-19 vaccines, the final destination and final recipients and a precise description of the products. The absence of such information may lead to refusal of export authorisations.

               7.   The competent authorities of the Member States may decide to make use of electronic documents for the purpose of processing the applications for export authorisation.

               8.   The competent Member States authorities may verify the information submitted pursuant to paragraph 6 on premises of the applicant, even after authorisation.

            Article 3
            Notifications

               1.   Member States shall immediately notify the Commission of authorisations granted and those refused.

               2.   These notifications shall contain the following information:

                           (a)

                           name and contact details of the competent Authority,

                           (b)

                           identity of the exporter,

                           (c)

                           destination country,

                           (d)

                           final recipient,

                           (e)

                           acceptance or refusal to grant the export authorisation,

                           (f)

                           commodity code,

                           (g)

                           quantity expressed in number of vaccine doses,

                           (h)

                           units and description of the goods,

                           (i)

                           information on the number of vaccine doses of goods covered by this Regulation distributed in the Union since 1st December 2020 broken down by Member States.

                     The notification shall be submitted electronically at the following address: SANTE-PHARMACEUTICALS-B4@ec.europa.eu

               3.   The Commission shall make the information on the authorisations granted and those refused publicly available, due account being taken of the confidentiality of the data submitted.

            Article 4
            Final provisions
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 83, 27.3.2015, p. 34.

            (2)  See Article 4(2)(a) of Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

            (3)  See for excluded transactions Article 269(2) of Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269 10.10.2013, p. 1)

            (4)  This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.

            (5)  This designation shall not be construed as recognition of a State of Palestine and is without prejudice to the individual positions of the Member States on this issue.

            (6)  https://www.gavi.org/news/media-room/92-low-middle-income-economies-eligible-access-covid-19-vaccines-gavi-covax-amc

            (7)  Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).

            ANNEX I

               Model for export authorisation forms referred to in Article 1

            Member States shall ensure the visibility of the nature of the authorisation on the form issued. The export authorisation shall be valid in all Member States of the European Union until its expiry date.

                        EUROPEAN UNION

                        Export of Covid19 vaccines (Regulation (EU) 2021/111)

                                    1.

                                    Exporter

                                       (EORI number if applicable) and TARIC additional code

                                    2.

                                    Authorisation number

                                    3.

                                    Expiry date

                                    4.

                                    Issuing authority

                                    5.

                                    Destination country

                                    6.

                                    Final recipient

                                    7.

                                    Commodity code

                                    8.

                                    Quantity

                                    9.

                                    Unit

                                    10.

                                    Description of the goods

                                    11.

                                    Location

                                    7.

                                    Commodity code

                                    8.

                                    Quantity

                                    9.

                                    Unit

                                    10.

                                    Description of the goods

                                    11.

                                    Location

                                    7.

                                    Commodity code

                                    8.

                                    Quantity

                                    9.

                                    Unit

                                    10.

                                    Description of the goods

                                    11.

                                    Location

                                    7.

                                    Commodity code

                                    8.

                                    Quantity

                                    9.

                                    Unit

                                    10.

                                    Description of the goods

                                    11.

                                    Location

                                    12.

                                    Signature, place and date, stamp

               Explanatory notes to the export authorisation form

            The completion of all the boxes is mandatory except when stated otherwise.
            Boxes 7 to 11 are repeated 4 times to allow requesting an authorisation for 4 different products.

                        Box 1

                        Exporter

                        Full name and address of the exporter for whom the authorisation is issued + EORI number if applicable.
                        TARIC additional code as defined in Annex II.

                        Box 2

                        Authorisation number

                        The authorisation number is completed by the authority issuing the export authorisation and has the following format: XXyyyy999999, where XX is the 2-letter geonomenclature code (1)of the issuing Member State, yyyy is the 4-digit year of issuance of the authorisation, 999999 is a 6-digit number unique within XXyyyy and attributed by the issuing authority.

                        Box 3

                        Expiry date

                        The issuing authority can define an expiry date for the authorisation. This expiry date cannot be later than 6 weeks after the entry into force of this regulation.
                        If no expiry date is defined by the issuing authority, the authorisation expires at the latest 6 weeks after the entry into force of this regulation.

                        Box 4

                        Issuing authority

                        Full name and address of the Member State authority that issued the export authorisation.

                        Box 5

                        Destination country

                        2-letter geonomenclature code of the country of destination of the goods for which the authorisation is issued.

                        Box 6

                        Final recipient

                        Full name and address of the final recipient of the goods, if known at the time of issuance + EORI number if applicable. If the final recipient is not known at the time of issuance, the field is left empty.

                        Box 7

                        Commodity code

                        The numerical code from the Harmonised System or the Combined Nomenclature (2) under which the goods to export are classified when the authorisation is issued.

                        Box 8

                        Quantity

                        The quantity of goods measured in the unit declared in box 9.

                        Box 9

                        Unit

                        The measurement unit in which the quantity declared in box 8 is expressed. The units to use are number of vaccines doses.

                        Box 10

                        Description of the goods

                        Plain language description precise enough to allow identification the goods.

                        Box 11

                        Location

                        The geonomenclature code of the Member State where the goods are located. If the goods are located in the Member State of the issuing authority, this box must be left empty.

                        Box 12

                        Signature, stamp, place and date,

                        The signature and stamp of the issuing authority. The place and the date of issuance of the authorisation.

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

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

            ANNEX II
            Taric additional codes

                        Company

                        Taric additional code

                        Astra Zeneca AB

                        4500

                        Pfizer / BioNTech

                        4501

                        Moderna Switzerland / Moderna Inc

                        4502

                        Janssen Pharmaceutica NV

                        4503

                        CureVac AG

                        4504

                        Sanofi Pasteur / Glaxosmithkline Biologicals S.A

                        4505

                        Novavax

                        4506

                        Other

                        4999