mwachidule
COMMISSION YA ULAYA,
Poganizira za Pangano la Ntchito ya European Union,
Malinga ndi Regulation (EU) 2015/2283 ya Nyumba Yamalamulo yaku Europe ndi Council, ya Novembara 25, 2015, ponena za zakudya zatsopano, zomwe zimasintha Lamulo (EU) No. 1169/2011 ya Nyumba Yamalamulo ku Europe ndi Council and Repeals Regulation (EC) No. 258/97 ya Nyumba Yamalamulo ku Europe ndi Council and Regulation (CE) n. 1852/2001 ya Commission (1), kuphatikiza makamaka ndime 12,
Poganizira izi:
- (1) Regulation (EU) 2015/2283 imapereka kuti zakudya zatsopano zokha zololedwa ndikuphatikizidwa pamndandanda wa Union zitha kugulitsidwa ku Union.
- (2) Malinga ndi Article 8 ya Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) idakhazikitsidwa, ndikukhazikitsa mndandanda wazakudya zovomerezeka za Unit.
- (3) Pa 4 June 2020, kampani ya Pharmanutra SpA (wofunsira) idapereka ku Commission, motsatira Article 10 (1) ya Regulation (EU) 2015/2283, pempho logulitsa mafuta acids ku Union cetylated ngati chakudya chatsopano. Wopemphayo adapemphanso kuti ma cetylated fatty acids agwiritsidwe ntchito muzakudya, monga momwe Directive 2002/46/EC ya European Parliament and of the Council (3) idaneneratu kuti zakudya zowonjezera ziyenera kugwiritsidwa ntchito ndi anthu akuluakulu. Kugwiritsa ntchito kwambiri 2,1 g patsiku.
- (4) Wopemphayo amatumizanso pempho la chitetezo chachinsinsi ku Commission mogwirizana ndi deta zosiyanasiyana zomwe zaperekedwa kuti zigwirizane ndi ntchitoyo, zomwe ndi reverse mutation assay mu mabakiteriya (4); mu vitro micronucleus test (5); kafukufuku wapoizoni ali ndi masiku 14 mu makoswe (6); kafukufuku wapoizoni ali ndi masabata a 13 mu makoswe (7); tebulo lachidule la zowonera mozama mu maphunziro a kawopsedwe (8); ziphaso zowunikira, mayeso a batch ndi njira zowunikira (9); deta yokhazikika (10).
- (5) Motsatira Article 10 (3) ya Regulation (EU) 2015/2283, pa 20 Julayi 2020 Commission idakambirana ndi European Food Safety Authority (Authority) ndikuipempha kuti ipereke lingaliro lasayansi lakale Kuwunika kwamafuta acid monga chakudya chatsopano.
- (6) Pa Meyi 26, 2021, Ulamuliro udzatengera malingaliro ake asayansi otchedwa Safety of Cetylated Fatty Acids monga Chakudya Chatsopano molingana ndi Regulation (EU) 2015/2283 [Chitetezo chamafuta a cetylated ngati chakudya chatsopano, ndi zina zambiri. (khumi ndi chimodzi). Lingaliro ili likugwirizana ndi zofunikira za Article 11 of Regulation (EU) 11/2015.
- (7) M'mawu akeake, Boma likumaliza kuti chakudya chatsopano, mafuta a cetylated, ndi otetezeka pamlingo wa 1.6 g patsiku kwa anthu akuluakulu. Mulingo wotetezedwawu ndiwotsika kuposa kuchuluka kwa 2,1 g komwe wofunsira akufuna. Monga zawonetseredwa ndi Ulamuliro, mlingo wapamwamba kwambiri womwe unaphunziridwa mu kafukufuku wapoizoni wosakhazikika unkaganiziridwa kuti ndi No Observed Adverse Effect Level (NOAEL). Pogwiritsira ntchito chinthu chosatsimikizika komanso kulemera kwa thupi kwa anthu akuluakulu, izi zimapangitsa kuti adye 1,6 g patsiku.
- (8) Choncho, maganizo a Authority ndi chifukwa chokwanira kukhazikitsa kuti cetylated mafuta zidulo, ntchito zowonjezera chakudya kwa anthu akuluakulu ndi okhutira pazipita 1.6 g patsiku, kukwaniritsa zofunika malonda malinga ndi Article 12, ndime. 1, ya Malamulo (EU) 2015/2283.
- (9) Zakudya zowonjezera zakudya zomwe zili ndi cetylated fatty acids siziyenera kudyedwa ndi anthu osapitirira zaka khumi ndi zisanu ndi zitatu, choncho chofunika cholembera chiyenera kukhazikitsidwa kuti chidziwitse ogula mokwanira pankhaniyi.
- (10) M'malingaliro ake, a Authority adatsimikizanso kuti kuyesa kosinthika kwa mabakiteriya, kuyesa kwa in vitro micronucleus, kafukufuku wapoizoni wamasabata a 13 mu makoswe, tebulo lachidule lazowunikira pamaphunziro a kawopsedwe, satifiketi yakusanthula, batch. mayeso ndi njira zowunikira ndi deta yokhazikika idagwiritsidwa ntchito ngati maziko otsimikizira chitetezo cha chakudya chatsopano. Ulamuliro umatsimikiziranso kuti sichikanatha kufikira mapeto ake popanda deta iyi, yomwe wopemphayo akutsimikizira kuti ndi katundu wake.
- (11) Commission inapempha wopemphayo kuti afotokoze zambiri pa zifukwa zomwe zimaperekedwa pokhudzana ndi zomwe akunena kuti ndi umwini wa detayi ndi kufotokozera zomwe akunena kuti ali ndi ufulu wodzipatula kwa iwo, malinga ndi Article 26 (2) , kalata. b), ya Malamulo (EU) 2015/2283.
- (12) Wopemphayo akulengeza kuti, pa nthawi yoperekedwa kwa pempho, ali ndi ufulu waumwini ndi ufulu wodzipatula kuti atchule deta izi pansi pa malamulo a dziko ndipo kotero, palibe gulu lachitatu lomwe lingawagwiritse ntchito kapena kuwapeza kapena kuwatchula. .zalamulo
- (13) Commission idawunika zonse zomwe wopemphayo adapereka ndipo idawona kuti wopemphayo adawonetsa mokwanira kutsatira zomwe zili mu Article 26 (2) ya Regulation (EU) 2015/2283. Chifukwa chake, mabakiteriya reverse mutation assay (12), in vitro micronucleus assay (13), kafukufuku wapoizoni wamasabata 13 mu makoswe (14), tebulo lachidule lazowunikira mozama pamaphunziro a kawopsedwe (15), satifiketi. kusanthula, kuyesa kwamagulu ndi njira zowunikira (16) ndi deta yokhazikika (17) yomwe ili mufayilo ya wopemphayo sayenera kugwiritsidwa ntchito ndi Boma kuti apindule aliyense wotsatira. za Regulation iyi. Chifukwa chake, panthawiyo, chilolezo chotsatsa zamafuta a cetylated mu Union chikuyenera kuperekedwa kwa wopemphayo.
- (14) Komabe, kuchepetsa chilolezo cha cetylated mafuta acids kuti agwiritse ntchito wopemphayo yekha komanso ufulu wolozera kwa omwe akuphatikizidwa muzolemba zawo sikulepheretsa ofunsira ena kuti atumize mafomu ofunsira chilolezo chogulitsa chakudya cham'buku lomwelo ngati ntchito yawo ili. kutengera zomwe zapezedwa mwalamulo zomwe zimavomereza chilolezo molingana ndi Regulation (EU) 2015/2283.
- (15) Njira, motero, sinthani chowonjezera ku Implementing Regulation (EU) 2017/2470 molingana.
- (16) Miyezo yoperekedwa mu Lamuloli ikugwirizana ndi malingaliro a Komiti Yoyimilira ya Zomera, Zinyama, Chakudya ndi Chakudya,
WAKAMBA MALAMULO AWA:
Ndime 1
1. Ma cetylated mafuta acid omwe afotokozedwa m'zowonjezera za Lamuloli adzaphatikizidwa pamndandanda wa Zakudya Zam'buku zovomerezeka zomwe zakhazikitsidwa mu Implementing Regulation (EU) 2017/2470.
2. Kwa nthawi ya miyezi isanu kuyambira tsiku lomwe Lamuloli linayamba kugwira ntchito, wofunsira woyamba yekha:
kampani: Pharmanutra SpA,
Address: Via Delle Lenze 216/b, 56122 Pisa, Italy
kuloledwa kugulitsa mu Union zakudya zatsopano zomwe zatchulidwa m'ndime 1, pokhapokha ngati wopemphayo adzalandira chilolezo cha chakudya chatsopanochi popanda kunena za deta yotetezedwa molingana ndi zomwe zili mu Article 2 ya lamulo ili, kapena ndi mgwirizano wa Malingaliro a kampani Pharmanutra S.p.A
3. Pamndandanda wa Mgwirizano womwe watchulidwa mu ndime 1, kulowamo kudzaphatikizapo zikhalidwe zogwiritsira ntchito ndi zofunikira zolembera zomwe zafotokozedwa mu Annex ku Lamuloli.
Nkhani 2
Maphunziro omwe ali mufayilo yofunsira omwe Ulamuliro wawunika chakudya chatsopano chomwe chatchulidwa m'ndime 1, maphunziro omwe wopemphayo amati ndi katundu wake ndipo popanda zomwe chakudya chatsopano sichikanaloledwa, sichidzagwiritsidwa ntchito. kwa wofunsira wotsatira kwa zaka zisanu kuyambira tsiku lomwe Malamulowa adayamba kugwira ntchito popanda mgwirizano wa Pharmanutra SpA.
Nkhani 4
Lamuloli liyamba kugwira ntchito patatha masiku makumi awiri kuchokera pomwe lidasindikizidwa mu Official Journal of the European Union.
Lamuloli likhala lomanga muzinthu zake zonse ndikugwira ntchito mwachindunji m'boma lililonse.
Zachitika ku Brussels, pa February 10, 2022.
Kwa Commission
pulezidenti
Ursula VON DER LEYEN
Zowonjezera
Zowonjezera za Execution Regulation (EU) 2017/2470 zasinthidwa motere:
- 1) Patebulo 1 (zazakudya zovomerezeka za m'buku) zotsatirazi zayikidwa [OP, ikani m'Chisipanishi motsatira zilembo]: Chakudya chovomerezeka chovomerezeka Mikhalidwe yomwe chakudya cham'bukuli chingagwiritsidwe ntchito Zina zofunikira zolembera Zofunikira Zina Zofunikira pakutetezedwa kwa data cetylated zidulo Enieni gulu la chakudya Pazipita okhutira
1.-Dzina la chakudya chatsopano cholembedwa pazakudya zopatsa thanzi zomwe zilimo ziyenera "kukonzedwa kuchokera ku cetylated fatty acids".
2.-Polemba zakudya zomwe zili ndi chakudya chatsopanocho, payenera kuphatikizidwa mawu omwe amafotokoza kuti zakudya izi siziyenera kudyedwa ndi anthu osakwanitsa zaka 18.
Adavomerezedwa pa Marichi 3, 2022. Kuphatikizikaku kuzikidwa paumboni wokhudzana ndi sayansi ndi data yasayansi yotetezedwa molingana ndi Article 26 of Regulation (EU) 2015/2283.
Wofunsira: Pharmanutra SpA, Via Delle Lenze 216/b, 56122 Pisa, Italy. Panthawi yoteteza deta, Pharmanutra SpA yekha ndi amene amaloledwa kugulitsa zakudya zatsopano za cetylated mafuta acids mu Unit, malinga ngati wopemphayo adzalandira chilolezo cha chakudya chatsopanocho popanda umboni wa sayansi womwe uli ndi ufulu waumwini kapena deta yasayansi yotetezedwa. molingana ndi Article 26 ya Regulation (EU) 2015/2283, kapena ndi chilolezo cha Pharmanutra SpA
Tsiku lomwe chitetezo cha data chimatha: Marichi 3, 2027.
Zakudya zowonjezera, monga tafotokozera mu Directive 2002/46/EC, zopangira anthu akuluakulu 1,6 g / tsiku.
- 2) Mu Table 2 (Zofotokozera), zolembera zotsatirazi zayikidwa: Zakudya zovomerezeka za novel Specifications cetylated fatty acids
Kufotokozera/Tanthauzo:
Chakudya cham'bukuli chimakhala ndi kusakaniza kwa cetylated mystic acid ndi cetylated oleic acid opangidwa kuchokera ku cetyl mowa, myrstic acid ndi oleic acid, komanso, pang'ono, ma cetylated mafuta acid ndi mafuta ena a azitona.
Makhalidwe/kapangidwe:
Zomwe zili mu Ester: 70-80%, zomwe: cetyl oleate: 22-30%, cetyl myristate: 41-56%
Triglycerides: 22-25%
asidi (mg KOH/g): ≤ 5
mtengo wa saponification (mg KOH/g): 130-150
Miyezo ya Microbiological:
Chiwerengero chonse cha aerobic microbiological: ≤ 1.000 CFU/g
Yisiti ndi nkhungu: ≤ 100 CFU/g
KOH: potaziyamu hydroxide
CFU: zigawo zopanga koloni
