title: Commission Implementing Regulation (EU) 2019/1686 of 8 October 2019 authorising the extension of use of bovine milk basic whey protein isolate 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:
                  9.10.2019

                  EN

                  Official Journal of the European Union

                  L 258/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1686
         of 8 October 2019
         authorising the extension of use of bovine milk basic whey protein isolate 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)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     Commission Implementing Regulation (EU) 2018/1632 (3) authorised the placing on the market of bovine milk basic whey protein isolate as a novel food under Regulation (EU) 2015/2283 and amended the Union list of authorised novel foods.

                     (5)

                     On 10 October 2018 the company Armor Protéines S.A.S made a request to the Commission for the extension of use of the bovine milk basic whey protein isolate within the meaning of Article 10(1) of Regulation (EU) 2015/2283. The requested changes concern the use of the bovine milk basic whey protein isolate in foods for special medical purposes as defined in Regulation (EU) No 609/2013 of the European Parliament and of the Council (4) and in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5) for infants up to 12 months.

                     (6)

                     On 24 January 2019, the Commission consulted the European Food Safety Authority (‘the Authority’), asking it to carry out an additional assessment for the extension of use of the bovine milk basic whey protein isolate as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.

                     (7)

                     On 14 March 2019, the Authority adopted its scientific opinion ‘Safety of whey basic protein isolate for extended uses in foods for special medical purposes and food supplements for infants pursuant to Regulation (EU) 2015/2283’ (6). That scientific opinion is in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (8)

                     That scientific opinion gave sufficient grounds to establish that bovine milk basic whey protein isolate, in the proposed extended uses and use levels in foods for special medical purposes, and in food supplements for infants up to 12 months, complies with Article 12(1) of Regulation (EU) 2015/2283. The Authority in that opinion concluded that the extended uses would not increase the potential intake of the novel food compared to that assessed in its 2018 Opinion (7). It is therefore appropriate to amend the Union list of authorised novel foods to include this extension of uses in the authorised uses of the bovine milk basic whey protein isolate.

                     (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

               1.   The entry in the Union list of authorised novel foods, established under Implementing Regulation (EU) 2017/2470, referring to the substance bovine milk basic whey protein isolate 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.

               3.   The authorisation provided for in this Article shall be without prejudice to the provisions of Regulation (EU) No 609/2013 and of Directive 2002/46/EC.

            Article 2
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 8 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  Commission Implementing Regulation (EU) 2018/1632 of 30 October 2018 authorising the placing on the market of bovine milk basic whey protein isolate 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 (OJ L 272, 31.10.2018, p. 23).

            (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)  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).

            (6)  EFSA Journal 2019; 17(4):5659.

            (7)  EFSA Journal 2018; 16(7):5360.

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

                        (1)

                        In Table 1 (Authorised novel foods), the entry on ‘Bovine milk basic whey protein isolate’ is replaced by the following:

                                    ‘Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       Data Protection

                                    Bovine milk basic whey protein isolate

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “Milk whey protein isolate”.
                                    Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:
                                    “This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years”
                                    (*) Depending on the age group the food supplement is intended for.

                                    Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283. Applicant: Armor Protéines S.A.S., 19 bis, rue de la Libération 35460 Saint-Brice-en- Coglès, France. During the period of data protection the novel food bovine milk basic whey protein isolate is authorised for placing on the market within the Union only by Armor Protéines S.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 Armor Protéines S.A.S. End date of the data protection: 20 November 2023.’

                                    Infant formulae as defined in Regulation (EU) No 609/2013
                                    Follow-on formulae as defined in Regulation (EU) No 609/2013
                                    Total diet replacement foods for weight control as defined by Regulation (EU) No 609/2013
                                    Foods for special medical purposes as defined in Regulation (EU) No 609/2013
                                    Food Supplements as defined in Directive 2002/46/EC

                                    30 mg/100 g (powder)
                                    3,9 mg/100 mL (reconstituted)
                                    30 mg/100 g (powder)
                                    4,2 mg/100 mL (reconstituted)
                                    300 mg/day
                                    30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)
                                    3,9 mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)
                                    30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)
                                    4,2 mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)
                                    58 mg/day for young children
                                    380 mg/day for children and adolescents from 3 to 18 years of age
                                    610 mg/day for adults
                                    25 mg/day for infants
                                    58 mg/day for young children
                                    250 mg/day for children and adolescents from 3 to 18 years of age
                                    610 mg/day for adults

                        (2)

                        in Table 2 (Specifications), the entry on ‘Bovine milk basic whey protein isolate’ is replaced by the following:

                                    ‘Authorised Novel Food

                                       Specification

                                    Bovine milk basic whey protein isolate

                                       Description

                                    Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.

                                       Characteristics/Composition

                                    Total protein (w/weight of product): ≥ 90 %
                                    Lactoferrin (w/weight of product): 25-75 %
                                    Lactoperoxidase (w/weight of product): 10-40 %
                                    Other proteins (w/weight of product): ≤ 30 %
                                    TGF-β2: 12-18 mg/100 g
                                    Moisture: ≤ 6,0 %
                                    pH (5 % solution w/v): 5,5 – 7,6
                                    Lactose: ≤ 3,0 %
                                    Fat: ≤ 4,5 %
                                    Ash: ≤ 3,5 %
                                    Iron: ≤ 25 mg/100 g

                                       Heavy Metals

                                    Lead: < 0,1 mg/kg
                                    Cadmium: < 0,2 mg/kg
                                    Mercury: < 0,6 mg/kg
                                    Arsenic: < 0,1 mg/kg

                                       Microbiological criteria:

                                    Aerobic mesophilic count: ≤ 10 000  CFU/g

                                       Enterobacteriaceae: ≤ 10 CFU/g

                                       Escherichia coli: Negative/g
                                    Coagulase positive Staphylococci: Negative/g

                                       Salmonella: Negative/25 g

                                       Listeria: Negative/25 g

                                       Cronobacter spp.: Negative/25 g
                                    Moulds: ≤ 50 CFU/g
                                    Yeasts: ≤ 50 CFU/g

                                    CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2019/1687 of 8 October 2019 amending Annex 1 to Implementing Regulation (EU) 2017/2179 imposing a definitive anti-dumping duty on imports of ceramic tiles originating in the People’s Republic of China

text:
                  9.10.2019

                  EN

                  Official Journal of the European Union

                  L 258/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1687
         of 8 October 2019
         amending Annex 1 to Implementing Regulation (EU) 2017/2179 imposing a definitive anti-dumping duty on imports of ceramic tiles originating in the People’s Republic of China
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1),
         Having regard to Commission Implementing Regulation (EU) 2017/2179 of 22 November 2017 imposing a definitive anti-dumping duty on imports of ceramic tiles originating in the People’s Republic of China following an expiry review pursuant to Article 11(2) of Regulation (EU) 2016/1036 of the European Parliament and of the Council (2), and in particular Article 2 thereof,
         Whereas:
         A.   MEASURES IN FORCE

                     (1)

                     On 12 September 2011 the Council imposed, by means of Implementing Regulation (EU) No 917/2011 (3) (‘the original investigation’), a definitive anti-dumping duty on imports of ceramic tiles (the ‘product concerned ’) originating in the People’s Republic of China (‘the PRC’). Given the large number of cooperating exporting producers in China during the original investigation, a sample of Chinese exporting producers was selected and individual ad-valorem duty rates ranging from 13,9 % (4) to 36,5 % were imposed on the companies included in the sample, while other cooperating companies not included in the sample were attributed a duty rate of 30,6 %. The residual duty imposed on non-cooperating Chinese exporting producers amounted to 69,7 %.

                     (2)

                     On 22 November 2017, following an expiry review, the Commission decided, by means of Implementing Regulation (EU) 2017/2179, to maintain the anti-dumping duties in force.

                     (3)

                     Pursuant to Article 2 of Implementing Regulation (EU) 2017/2179, the Commission may amend Annex I of that Regulation by granting a new exporting producer the duty rate applicable to the cooperating companies not sampled or not granted individual treatment, namely the weighted average duty rate of 30,6 %, where any new exporting producer in the PRC provides sufficient evidence to the Commission.

               B.   REQUEST FOR NEW EXPORTING PRODUCER TREATMENT

                     (4)

                     In October 2018, the company Zhuhai Xuri Ceramics Co., Ltd (‘the applicant’) came forward, after the publication of the Implementing Regulation (EU) 2017/2179 and submitted a request to be granted new exporting producer treatment and hence be subject to the duty rate applicable to the cooperating companies in the PRC not included in the sample or not granted individual treatment, namely 30,6 %. The applicant claimed that it met all three criteria set out in Article 2 of Implementing Regulation (EU) 2017/2179.

                     (5)

                     In order to determine whether the applicant fulfilled those criteria the Commission asked the applicant to complete a questionnaire. Following the analysis of the questionnaire response, the Commission considered that the applicant had provided sufficient information and did not request further supporting evidence.

                     (6)

                     The Commission notified the Union industry about the request for new exporting producer treatment and gave it the opportunity to comment. The Commission did not receive any comments.

               C.   ANALYSIS OF THE REQUEST

                     (7)

                     With regard to the condition set out in point (a) of Article 2 of Implementing Regulation (EU) 2017/2179, the first criterion, the Commission thoroughly examined the applicant’s sales ledger covering the investigation period. The ledger reflected only domestic sales.

                     (8)

                     Upon further verification of other sales data, EU customs statistics and documentation no evidence was found suggesting that the applicant exported the product concerned to the Union prior or during the investigation period. Therefore, in light of the available information, the Commission concluded that the applicant met the first criterion.

                     (9)

                     With regard to the condition set out in point (b) of Article 2 of Implementing Regulation (EU) 2017/2179, the second criterion, the Commission noted that the corporate structure of the applicant comprises ten related companies. Two of those related companies were involved in the manufacturing of the product concerned during the investigation period but operated only domestically. Based on the evidence provided no further commercial or operational links with exporters or producers from the PRC subject to the anti-dumping measures in force were identified. Five of those related companies were founded after the investigation period and the remaining three were not involved in any commercial activity concerning the product concerned. Thus, the Commission concluded that the applicant met the second criterion.

                     (10)

                     Regarding the condition set out in point (c) of Article 2 of Implementing Regulation (EU) 2017/2179, the third criterion, based on the documentary evidence provided, the Commission established that the applicant had not exported the product concerned to the Union following the investigation period. Failing that, the applicant provided evidence of irrevocable contractual agreements of sales of significant quantities of the product concerned to the Union. Therefore, the Commission concluded that the applicant met the third criterion.

                     (11)

                     The Union industry did not provide any evidence/information indicating that any of the three criteria were not met by the applicant.

               D.   CONCLUSION

                     (12)

                     The Commission concluded that the applicant fulfilled the three criteria required in order to be granted new exporting producer treatment. Therefore, the applicant’s name should be added to the list of cooperating producers not sampled or not granted individual treatment listed in Annex I of Implementing Regulation (EU) 2017/2179.

               E.   DISCLOSURE

                     (13)

                     The applicant and the Union industry were informed of the essential facts and considerations on the basis of which it was considered appropriate to grant the anti-dumping duty rate applicable to the non-sampled cooperating Chinese exporting producers to Zhuhai Xuri Ceramics Co., Ltd.

                     (14)

                     The parties were granted the possibility to submit comment which were duly taken into consideration where warranted.

                     (15)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 15(1) of the basic Regulation,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The following company is added to the list of Chinese cooperating producers not sampled or not granted individual treatment in Annex I of Implementing Regulation (EU) 2017/2179:

                        Name

                        TARIC additional code

                        Zhuhai Xuri Ceramics Co., Ltd

                        C505

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 8 October 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  OJ L 307, 23.11.2017, p. 25.

            (3)  Council Implementing Regulation (EU) No 917/2011 of 12 September 2011 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of ceramic tiles originating in the People’s Republic of China (OJ L 238, 15.9.2011, p. 1).

            (4)  Implementing Regulation (EU) No 917/2011 was subsequently amended by Commission Implementing Regulation (EU) 2015/409 of 11 March 2015.