title: Commission Implementing Regulation (EU) 2021/898 of 28 May 2021 entering a name in the register of protected designations of origin and protected geographical indications (‘Salată cu icre de știucă de Tulcea’ (PGI))

text:
                  4.6.2021

                  EN

                  Official Journal of the European Union

                  L 197/67

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/898
         of 28 May 2021
         entering a name in the register of protected designations of origin and protected geographical indications (‘Salată cu icre de știucă de Tulcea’ (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Romania’s application to register the name ‘Salată cu icre de știucă de Tulcea’ was published in the Official Journal of the European Union (2).

                     (2)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Salată cu icre de știucă de Tulcea’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.7. – Fresh fish, molluscs and crustaceans and products derived therefrom, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

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

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

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

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

            (2)  OJ C 39, 4.2.2021, p. 26.

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


title: Commission Implementing Regulation (EU) 2021/900 of 3 June 2021 authorising a change of the conditions of use of the novel food ‘galacto-oligosaccharide’ 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:
                  4.6.2021

                  EN

                  Official Journal of the European Union

                  L 197/71

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/900
         of 3 June 2021
         authorising a change of the conditions of use of the novel food ‘galacto-oligosaccharide’ 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 20 January 2014, the company Yakult Pharmaceutical Industry Co., Ltd. informed the Commission, pursuant to Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council (3), of its intention to place on the market ‘galacto-oligosaccharide’ as a novel food to be used in a number of foods, including infant formula and follow-on formula as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4). Therefore, galacto-oligosaccharide was included in the Union list of novel foods.

                     (4)

                     On 3 March 2020, the company Yakult Pharmaceutical Industry Co., Ltd. (‘the applicant’) submitted an application to the Commission pursuant to Article 10(1) of Regulation (EU) 2015/2283 to change the conditions of use of the novel food ‘galacto-oligosaccharide’. The applicant requested to increase the maximum use level of the novel food galacto-oligosaccharide in food supplements from 0,333 kg GOS/kg food supplement (33,3 %) to 0,450 kg GOS/kg food supplement (45,0 %) for the general population. During the application process, the applicant agreed to exclude infants and young children from the request.

                     (5)

                     In accordance with Article 10(3) of Regulation (EU) 2015/2283, the Commission consulted the European Food Safety Authority (‘the Authority’) on 18 June 2020, requesting it to provide a scientific opinion by carrying out an assessment for the change of the conditions of use of galacto-oligosaccharide as a novel food.

                     (6)

                     On 17 December 2020, the Authority adopted its scientific opinions on the ‘Safety of a change in the conditions of use of galacto-oligosaccharides as a novel food ingredient in food supplements pursuant to Regulation (EU) 2015/2283’ (5). This opinion is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (7)

                     In its opinion, the Authority concluded that the proposed increase in the maximum use level of galacto-oligosaccharide as a novel food in food supplements is safe under the proposed changes of the conditions of use.

                     (8)

                     The opinion of the Authority gives sufficient grounds to establish that galacto-oligosaccharide under the proposed conditions of use for the general population, excluding infants and young children, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (9)

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

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   The entry in the Union list of authorised novel foods as provided for in Article 6 of Regulation (EU) 2015/2283 and included in the Annex to Implementing Regulation (EU) 2017/2470, referring to the novel food galacto-oligosaccharide, shall be amended as specified in the Annex to this Regulation.

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

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

            (4)  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).

            (5)  EFSA Journal 2021;19(1):6384.

            ANNEX
            In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for the novel food ‘Galacto-oligosaccharide’ is replaced by the following:

                              Authorised novel food

                              Conditions under which the novel food may be used

                              Additional specific labelling requirements

                              Other requirements

                           ‘Galacto-oligosaccharide

                                 Specified food category

                                 Maximum levels (expressed as ratio kg galacto-oligosaccharide/kg final food)

                           Food Supplements as defined in Directive 2002/46/EC

                           0,333

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

                           0,450 (corresponding to 5,4 g galacto-oligosaccharide/serving; maximum 3 servings/day up to a maximum of 16,2 g/day)

                           Milk

                           0,020

                           Milk drinks

                           0,030

                           Meal replacement for weight control (as drinks)

                           0,020

                           Dairy analogue drinks

                           0,020

                           Yoghurt

                           0,033

                           Dairy based desserts

                           0,043

                           Frozen dairy desserts

                           0,043

                           Fruit drinks and energy drinks

                           0,021

                           Infant meal replacement drinks

                           0,012

                           Baby juice

                           0,025

                           Baby yogurt drink

                           0,024

                           Baby dessert

                           0,027

                           Baby snack

                           0,143

                           Baby cereals

                           0,027

                           Drinks intended to meet the expenditure of intense muscular effort especially for sportsmen

                           0,013

                           Juice

                           0,021

                           Fruit pie filling

                           0,059

                           Fruit preparations

                           0,125

                           Bars

                           0,125

                           Cereals

                           0,125

                           Infant formula and follow-on formula as defined in Regulation (EU) No 609/2013

                           0,008’


title: Commission Implementing Regulation (EU) 2021/901 of 3 June 2021 correcting the Swedish language version of Implementing Regulation (EU) 2019/2072 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament of the Council, as regards protective measures against pests of plants

text:
                  4.6.2021

                  EN

                  Official Journal of the European Union

                  L 197/75

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/901
         of 3 June 2021
         correcting the Swedish language version of Implementing Regulation (EU) 2019/2072 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament of the Council, as regards protective measures against pests of plants
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 41(2) and Article 72(1) thereof,
         Whereas:

                     (1)

                     The Swedish language version of Commission Implementing Regulation (EU) 2019/2072 (2) contains errors in points 65 and 68 of Annex VII as regards conditions that have to be fulfilled for introducing certain plants or plant products in the Union and in point 12 of Part A of Annex XI as regards the indication of a plant.

                     (2)

                     The Swedish language version of Implementing Regulation (EU) 2019/2072 should therefore be corrected accordingly. The other language versions are not affected.

                     (3)

                     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

               (does not concern the English language)

            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, 3 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 317, 23.11.2016, p. 4.

            (2)  Commission Implementing Regulation (EU) 2019/2072 of 28 November 2019 establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants, and repealing Commission Regulation (EC) No 690/2008 and amending Commission Implementing Regulation (EU) 2018/2019 (OJ L 319, 10.12.2019, p. 1).