Document ID: 02019R1686-20230129
Language: ENG

02019R1686 — EN — 29.01.2023 — 001.001
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<table><col/><col/><tr><td><p><a>&#9658;B</a></p></td><td><p>                        COMMISSION IMPLEMENTING REGULATION (EU) 2019/1686</p><p>of 8 October 2019</p><p>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</p><p><a>(Text with EEA relevance)</a></p><p>(OJ L 258 9.10.2019, p. 13)</p></td></tr></table>
Amended by:
<table><col/><col/><col/><col/><col/><tr><td><p>&#160;</p></td><td><p>&#160;</p></td><td><p>Official Journal</p></td></tr><tr><td><p>&#160;&#160;No</p></td><td><p>page</p></td><td><p>date</p></td></tr><tr><td><p><a>&#9658;M1</a></p></td><td><p><a>                              COMMISSION IMPLEMENTING REGULATION (EU) 2023/65&#160;of 6&#160;January 2023</a></p></td><td><p>&#160;&#160;L&#160;6</p></td><td><p>1</p></td><td><p>9.1.2023</p></td></tr></table>
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)
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.
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:
<table><col/><col/><col/><col/><col/><col/><tbody><tr><td><p>&#8216;<span>Authorised novel food</span></p></td><td><p><span>Conditions under which the novel food may be used</span></p></td><td><p><span>Additional specific labelling requirements</span></p></td><td><p><span>Other requirements</span></p></td><td><p><span>Data Protection</span></p></td></tr><tr><td><p><a>&#9660;M1</a></p></td></tr><tr><td><p><span>Bovine milk basic whey protein isolate</span></p></td><td><p><span>Specified food category</span></p></td><td><p><span>Maximum levels</span></p></td><td><p>The designation of the novel food on the labelling of the foodstuffs containing it shall be &#8220;Milk whey protein isolate&#8221;.</p><p>Food supplements containing bovine milk basic whey protein isolate shall bear the following statement:</p><p>&#8220;This food supplement should not be consumed by infants/children/adolescents under the age of one/three/eighteen (*) years&#8221;</p><p>(*)&#160;&#160;Depending on the age group the food supplement is intended for.</p></td><td><p>&#160;</p><div/></td><td><p>Authorised on 20&#160;November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article&#160;26 of Regulation (EU) 2015/2283. Applicant: Armor Prot&#233;ines S.A.S., 19 bis, rue de la Lib&#233;ration 35460 Saint-Brice-en-Cogl&#232;s, 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 Prot&#233;ines 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&#160;26 of Regulation (EU) 2015/2283 or with the agreement of Armor Prot&#233;ines S.A.S. End date of the data protection: 20&#160;November 2023.&#8217;</p></td></tr><tr><td><p>Infant formulae as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder)</p></td></tr><tr><td><p>3,9&#160;mg/100 mL (reconstituted)</p></td></tr><tr><td><p>Follow-on formulae as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder)</p></td></tr><tr><td><p>4,2&#160;mg/100 mL (reconstituted)</p></td></tr><tr><td><p>Total diet replacement foods for weight control as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>300 mg/day</p></td></tr><tr><td><p>Foods for special medical purposes as defined in Regulation (EU) No&#160;609/2013</p></td><td><p>30 mg/100 g (powder formula for infants during the first months of life until the introduction of appropriate complementary feeding)</p></td></tr><tr><td><p>3,9&#160;mg/100 mL (reconstituted formula for infants during the first months of life until the introduction of appropriate complementary feeding)</p></td></tr><tr><td><p>30 mg/100 g (powder formula for infants when appropriate complementary feeding is introduced)</p></td></tr><tr><td><p>4,2&#160;mg/100 mL (reconstituted formula for infants when appropriate complementary feeding is introduced)</p></td></tr><tr><td><p>58 mg/day for young children</p></td></tr><tr><td><p>380 mg/day for children and adolescents from 3 to 18 years of age</p></td></tr><tr><td><p>610 mg/day for adults</p></td></tr><tr><td><p>Food supplements as defined in Directive 2002/46/EC</p></td><td><p>25 mg/day for infants</p></td></tr><tr><td><p>58 mg/day for young children</p></td></tr><tr><td><p>250 mg/day for children and adolescents from 3 to 18 years of age</p></td></tr><tr><td><p>610 mg/day for adults</p></td></tr><tr><td><p><a>&#9660;B</a></p></td></tr></tbody></table>
(2) in Table 2 (Specifications), the entry on ‘Bovine milk basic whey protein isolate’ is replaced by the following:
<table><col/><col/><tbody><tr><td><p>&#8216;<span>Authorised Novel Food</span></p></td><td><p><span>Specification</span></p></td></tr><tr><td><p>Bovine milk basic whey protein isolate</p></td><td><p><span>Description</span></p><p>Bovine milk basic whey protein isolate is a yellowish grey powder obtained from bovine skimmed milk via a series of isolation and purification steps.</p><p><span>Characteristics/Composition</span></p><p>Total protein (w/weight of product): &#8805; 90 %</p><p>Lactoferrin (w/weight of product): 25-75 %</p><p>Lactoperoxidase (w/weight of product): 10-40 %</p><p>Other proteins (w/weight of product): &#8804; 30 %</p><p>TGF-&#946;2: 12-18 mg/100 g</p><p>Moisture: &#8804; 6,0 %</p><p>pH (5 % solution w/v): 5,5 &#8211; 7,6</p><p>Lactose: &#8804; 3,0 %</p><p>Fat: &#8804; 4,5 %</p><p>Ash: &#8804; 3,5 %</p><p>Iron: &#8804; 25 mg/100 g</p><p><span>Heavy Metals</span></p><p>Lead: &lt; 0,1 mg/kg</p><p>Cadmium: &lt; 0,2 mg/kg</p><p>Mercury: &lt; 0,6 mg/kg</p><p>Arsenic: &lt; 0,1 mg/kg</p><p><span>Microbiological criteria:</span></p><p>Aerobic mesophilic count: &#8804; 10&#160;000  CFU/g</p><p><span>Enterobacteriaceae</span>: &#8804; 10 CFU/g</p><p><span>Escherichia coli</span>: Negative/g</p><p>Coagulase positive<span>Staphylococci:</span> Negative/g</p><p><span>Salmonella</span>: Negative/25 g</p><p><span>Listeria</span>: Negative/25 g</p><p><span>Cronobacter</span> spp.: Negative/25 g</p><p>Moulds: &#8804; 50 CFU/g</p><p>Yeasts: &#8804; 50 CFU/g</p></td></tr><tr><td><p>CFU: Colony Forming Units&#8217;</p></td></tr></tbody></table>