kakaretso
KOMISI EA EUROPE,
Ho latela Tumellano ea Ts'ebetso ea European Union,
Ka lebaka la Regulation (EU) 2015/2283 ea Paramente ea Europe le ea Lekhotla, ea November 25, 2015, mabapi le lijo tse ncha, tse fetolang Regulation (EU) no. 1169/2011 ea Paramente ea Europe le ea Lekhotla le ho hlakola Regulation (EC) No. 258/97 ea Paramente ea Europe le ea Lekhotla le Taolo (CE) n. 1852/2001 ea Komisi (1), ho kenyeletsoa ka ho khetheha ho Article 12,
Nahana ka tse latelang:
- (1) Regulation (EU) 2015/2283 e fana ka hore ke lijo tse ncha feela tse lumelletsoeng le tse kenyellelitsoeng lethathamong la Union tse ka rekisoang Kopanong.
- (2) Ho ea ka Article 8 ea Regulation (EU) 2015/2283, Khomishene Phethahatso Regulation (EU) 2017/2470 (2) e ile ea amoheloa, ho theha lenane la Unit la lijo tse lumelitsoeng novel.
- (3) Ka la 4 Phuptjane 2020, k'hamphani ea Pharmanutra SpA (mokopi) e rometsoe ho Khomishene, ho latela Article 10 (1) ea Regulation (EU) 2015/2283, kopo ea ho rekisa li-acid tse mafura ho Union tse kentsoeng e le lijo tse ncha. Mokopi o boetse a kopa hore li-cetylated fatty acids li sebelisoe lijong, joalo ka ha ho hlalositsoe ho Directive 2002/46/EC ea Paramente ea Europe le ea Lekhotla (3) Kopo e hlalositse hore li-supplement tsa lijo li reretsoe ho sebelisoa ke batho ba baholo. ka tšebeliso e phahameng ea 2,1 g ka letsatsi.
- (4) Mokopi o boetse o kenya kopo ea ts'ireletso ea tlhahisoleseling ho Khomishene mabapi le lintlha tse fapaneng tse rometsoeng ho tšehetsa kopo, e leng tlhahlobo ea phetoho ea phetoho ho libaktheria (4); tlhahlobo ea in vitro micronucleus (5); thuto ea chefo e na le matsatsi a 14 ho likhoto (6); thuto ea chefo e na le libeke tse 13 ho likhoto (7); tafole ea kakaretso ea litebello tsa lipalo-palo lithutong tsa chefo (8); litifikeiti tsa tlhahlobo, liteko tsa batch le mekhoa ea tlhahlobo (9); lintlha tsa botsitso (10).
- (5) Ho latela Article 10 (3) ea Regulation (EU) 2015/2283, ka la 20 Phupu 2020, Komisi e ile ea buisana le European Food Safety Authority (Bolaoli) mme ea e kopa hore e fane ka maikutlo a pele a saense Tlhahlobo ea cetylated fatty acids e le lijo tse ncha.
- (6) Ka la 26 Motšeanong 2021, Bolaoli bo tla amohela maikutlo a bona a mahlale a bitsoang Safety of Cetylated Fatty Acids e le Novel Food ho latela Molao oa (EU) 2015/2283 [Polokeho ea cetylated fatty acids e le lijo tse ncha, jj.] (leshome le motso o mong). Maikutlo ana a lumellana le litlhoko tsa sehlooho sa 11 sa Regulation (EU) 11/2015.
- 7 Boemo bona ba ho noa bo bolokehileng bo tlase ho feta tekanyo e phahameng ea ho noa ea 1.6 g e hlahisitsoeng ke mokopi. Joalo ka ha ho bonts'itsoe ke Bolaoli, tekanyo e phahameng ka ho fetisisa e ithutoang thutong ea chefo e sa foleng e ne e nkuoa e le NoAEL (No Observed Adverse Effect Level). Ho sebelisa boemo bo sa tsitsang le boima ba 'mele bo sa feleng ho batho ba baholo, sena se fella ka ho ja 2,1 g ka letsatsi.
- (8) Ka hona, maikutlo a Bolaoli ke lebaka le lekaneng la ho theha hore mafura a cetylated, a sebelisoang lijong tsa batho ba baholo ba nang le palo e kholo ea 1.6 g ka letsatsi, a finyella litlhoko tsa ho rekisa ho ea ka Article 12, serapa. 1, ea Molawana (EU) 2015/2283.
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- (10) Ho ea ka maikutlo a eona, Lekhotla le boetse le fihletse qeto ea hore tlhahlobo ea phetoho ea phetoho ea libaktheria, tlhahlobo ea in vitro micronucleus, thuto ea chefo ea libeke tse 13 ho likhoto, tafole ea kakaretso ea lipalo-palo tsa lipatlisiso tsa chefo, litifikeiti tsa tlhahlobo, batch. liteko le mekhoa ea tlhahlobo le lintlha tsa botsitso li sebelitse e le motheo oa ho fumana polokeho ea lijo tse ncha. Bolaoli bo boetse bo tiisa hore bo ka be bo sa khona ho fihlela qeto ea bona ntle le lintlha tsena, tseo mokopi a tiisang hore ke thepa ea hae.
- (11) Komisi e ile ea botsa mokopi bakeng sa tlhaloso e eketsehileng mabapi le tokafatso e fanoeng mabapi le tseko ea eona ea ho ba mong'a data ena le ho hlakisa tseko ea eona ea ho ba le tokelo e khethehileng ea ho bua le bona, ho latela Article 26(2) lengolo. b), ea Molawana (EU) 2015/2283.
- (12) Mokopi o bolela hore, ka nako ea tlhahiso ea kopo, e na le litokelo tsa botho le litokelo tse khethehileng tsa ho bua ka lintlha tsena tlas'a molao oa naha le hore, ka hona, ha ho motho oa boraro ea ka li sebelisang kapa ho li fumana kapa ho li fetisetsa ho tsona. .molao
- (13) Komisi e ile ea hlahloba lintlha tsohle tse fanoeng ke mokopi 'me ea nka hore mokopi o bontšitse ka ho lekaneng ho latela litlhoko tse boletsoeng ho Article 26(2) of Regulation (EU) 2015/2283. Kahoo, tlhahlobo ea baktheria reverse mutation assay (12), in vitro micronucleus assay (13), thuto ea chefo ea libeke tse 13 ho likhoto (14), tafole ea kakaretso ea lintlha tsa bohlokoa tsa lipalo lithutong tsa chefo (15), litifikeiti. ea tlhahlobo, liteko tsa sehlopha le mekhoa ea tlhahlobo (16) le lintlha tsa botsitso (17) tse fumanehang faeleng ea mokopi ha lia lokela ho sebelisoa ke Bolaoli molemong oa mokopi ofe kapa ofe ea latelang. ea Molawana ona. Ka hona, nakong eo, tumello ea ho bapatsa bakeng sa cetylated fatty acids Union e lokela ho lekanyetsoa ho mokopi.
- (14) Leha ho le joalo, ho fokotsa tumello ea cetylated fatty acids tšebelisong e khethehileng ea mokopi le tokelo ea ho bua ka ba kenyellelitsoeng tlalehong ea bona ha ho thibele bakopi ba bang ho kenya likopo tsa tumello ea ho bapatsa bakeng sa lijo tse tšoanang tsa novel haeba kopo ea bona e le. e ipapisitse le tlhahisoleseling e fumanoeng ka molao e lokafatsang tumello ho latela Molawana (EU) 2015/2283.
- (15) Ts'ebetso, ka hona, fetola sehlomathiso ho Kenyelletso ea Taolo (EU) 2017/2470 ka nepo.
- (16) Mehato e fanoeng Molaong ona e tsamaellana le maikutlo a Komiti ea Maemo ea Limela, Liphoofolo, Lijo le Phepo;
E AMOHILE MELAO ENA:
Article 1
1. Li- cetylated fatty acids tse boletsoeng sehlomathisong sa Molawana ona li tla kenyeletsoa lethathamong la Yuniti ea lijo tse ngolisitsoeng ka molao tse thehiloeng ho Phethahatso ea Regulation (EU) 2017/2470.
2. Ka nako ea likhoeli tse hlano ho tloha ka letsatsi la ho kena tšebetsong ha Molao ona, ke mokopi oa pele feela:
khampani: Pharmanutra SpA,
Aterese: Via Delle Lenze 216/b, 56122 Pisa, Italy
tumello ea ho rekisa ho Union lijo tse ncha tse boletsoeng serapeng sa 1, ntle le haeba mokopi ea latelang a fumana tumello bakeng sa lijo tsena tse ncha ntle le ho bua ka data e sirelelitsoeng ho latela lipehelo tsa Article 2 ea Molao ona, kapa ka tumellano ea Phamanutra S.p.A
3. Lethathamong la Mokhatlo o boletsoeng serapeng sa 1, ho kena ho tla kenyelletsa maemo a ts'ebeliso le litlhoko tsa ho ngola tse boletsoeng Sehlomathisong sa Molao ona.
Article 2
Lithuto tse ka har'a faele ea kopo eo Bolaoli bo hlahlobileng lijo tse ncha tse boletsoeng sehloohong sa 1, liphuputso tseo mokopi a ipolelang hore ke thepa ea hae, 'me ntle le moo lijo tse ncha li ka beng li sa lumelloa, li ke ke tsa sebelisoa. ea mokopi ea latelang bakeng sa nako ea lilemo tse hlano ho tloha ka letsatsi la ho qala ts'ebetsong ea Melaoana ena ntle le tumellano ea Pharmanutra SpA.
Article 4
Molawana ona o tla kena tshebetsong matsatsi a mashome a mabedi kamora hore o phatlalatswe ho Official Journal of the European Union.
Regulation ena e tla be e tlama likarolo tsohle tsa eona ‘me e sebetsa ka kotloloho Setho se seng le se seng.
E entsoe Brussels, ka la 10 Hlakola 2022.
Bakeng sa Komisi
mopresidente
Ursula VON DER LEYEN
KEKETSO
Sehlomathiso sa Molao oa Phethahatso (EU) 2017/2470 se fetotsoe ka tsela e latelang:
- 1) Ho Lethathamo la 1 (Lijo tsa novel tse lumelitsoeng) ho kenyellelitsoe tse latelang [OP, kenya mofuta oa Sepanishe ka tatellano ea alfabeta]: Lijo tsa novel tse lumelitsoeng Maemo ao ho ona ho ka sebelisoang lijo tsa novel Litlhoko tse ling tse khethehileng tsa ho ngola Litlhoko tse ling Ts'ireletso ea data. li-acids Sehlopha se ikhethileng sa lijo
1.-Lebitso la lijo tse ncha tse ngotsoeng li-supplement tsa lijo tse nang le tsona e tlameha ho ba "cetylated fatty acid preparation".
2.-Ha ho ngoloa li-supplement tsa lijo tse nang le lijo tse ncha, ho tlameha ho kenyelletsoa polelo e hlalosang hore li-supplement tsena tsa lijo ha lia lokela ho sebelisoa ke batho ba ka tlase ho lilemo tse 18.
E lumelletsoe ka la 3 Hlakubele 2022. Kenyelletso ena e ipapisitse le bopaki ba saense le boitsebiso ba saense bo sirelelitsoeng ho latela Article 26 of Regulation (EU) 2015/2283.
Mokopi: Pharmanutra SpA, Via Delle Lenze 216/b, 56122 Pisa, Italy. Nakong ea ts'ireletso ea data, ke Pharmanutra SpA feela e nang le tumello ea ho rekisa lijo tse ncha tsa cetylated fatty acids Setsing, ha feela mokopi ea latelang a fumana tumello bakeng sa lijo tse ncha ntle le bopaki ba mahlale a amanang le litokelo tsa thepa kapa data ea mahlale e sirelelitsoeng. ho latela Article 26 ea Regulation (EU) 2015/2283, kapa ka tumellano ea Pharmanutra SpA
Letsatsi leo tšireletso ea data e qetellang ka lona: La 3 Hlakubele 2027.
Lisebelisoa tsa lijo, joalo ka ha ho hlalositsoe ho Directive 2002/46/EC, e reretsoeng batho ba baholo ba 1,6 g / letsatsi.
- 2) Ho Lethathamo la 2 (Litlhaloso), ho kenyellelitsoe se latelang: Lijo tse ngolisitsoeng tsa novel Specifications cetylated fatty acids
Tlhaloso/Tlhaloso:
Lijo tsa morao-rao li na le motsoako oa cetylated mystic acid le cetylated oleic acid e entsoeng ho tloha ho cetyl alcohol, myrstic acid le oleic acid, 'me, ho isa tekanyong e nyenyane, mafura a mang a cetylated le metsoako e meng ea oli ea mohloaare.
Litšobotsi/sebopeho:
Likahare tsa Ester: 70-80%, tseo: cetyl oleate: 22-30%, cetyl myristate: 41-56%
Li-triglycerides: 22-25%
boleng ba asiti (mg KOH/g): ≤ 5
boleng ba saponification (mg KOH/g): 130-150
Litekanyetso tsa Microbiological:
Kakaretso ea palo ea aerobic microbiological: ≤ 1.000 CFU/g
Litomoso le hlobo: ≤ 100 CFU/g
KOH: potassium hydroxide
CFU: li-unit tse etsang kolone
