hōʻuluʻulu manaʻo
KOMISINA Eulopa,
No ka pili ana i ke Kuikahi no ka hana ana o ka Hui Europa,
I ka manaʻo o Regulation (EU) 2015/2283 o ka European Parliament a me ka Council, o Nowemapa 25, 2015, e pili ana i nā meaʻai hou, e hoʻololi ana i ka Regulation (EU) no. 1169/2011 o ka Pāremata ʻEulopa a me ka ʻaha kūkā a hoʻopau i ka Regulation (EC) no. 258/97 o ka European Parliament a me ka Council and Regulation (CE) n. 1852/2001 o ke Komisina (1), e pili ana i ka pauku 12,
E noʻonoʻo ana i kēia mau mea:
- (1) ʻO Regulation (EU) 2015/2283 e hāʻawi i nā meaʻai hou wale nō i ʻae ʻia a hoʻokomo ʻia i loko o ka papa inoa ʻo Union ke kūʻai ʻia ma ka Union.
- (2) Ma muli o ka Paukū 8 o Regulation (EU) 2015/2283, ua ʻae ʻia ka Commission Implementing Regulation (EU) 2017/2470 (2), e hoʻokumu ana i ka papa inoa o nā meaʻai novel i ʻae ʻia.
- (3) Ma Iune 4, 2020, ua waiho ʻia ka hui ʻo Pharmanutra SpA (mea noi) i ke Komisina, e like me ka Paukū 10 (1) o Regulation (EU) 2015/2283, kahi noi e kūʻai aku i nā momona momona i ka Union cetylated e like me ka meaʻai hou. . Ua noi hou ka mea noi e hoʻohana ʻia nā ʻakika momona cetylated i nā meaʻai, e like me ka wehewehe ʻana ma Directive 2002/46/EC o ka European Parliament a me ka Council (3) Ua ʻōlelo ʻia ka palapala noi e hoʻohana ʻia nā meaʻai e ka poʻe mākua. me ka pae hoʻohana kiʻekiʻe loa o 2,1 g i kēlā me kēia lā.
- (4) Hoʻouna pū ka mea noi i kahi palapala noi mālama ʻike ponoʻī i ke Komisina e pili ana i nā ʻikepili like ʻole i waiho ʻia no ke kākoʻo ʻana i ka noi, ʻo ia hoʻi ka hoʻololi ʻana i ka mutation assay in bacteria (4); in vitro micronucleus hoao (5); He 14 mau lā ma ka ʻiole (6); He 13 mau pule ma ka iole (7); papaʻaina hōʻuluʻulu o nā ʻike koʻikoʻi i nā haʻawina ʻona (8); nā palapala hōʻoia o ka nānā ʻana, nā hōʻike pūʻulu a me nā ʻano o ka nānā ʻana (9); ʻikepili kūpaʻa (10).
- (5) Ma muli o ka Paukū 10(3) o Regulation (EU) 2015/2283, ma 20 Iulai 2020 ua kūkākūkā ke Komisina i ka European Food Safety Authority (Authority) a noi iā ia e hoʻopuka i kahi manaʻo ʻepekema ma mua o ka loiloi ʻana i nā waikawa momona cetylated ma ke ʻano he meaʻai hou.
- (6) Ma Mei 26, 2021, e ʻae ka Mana i kāna manaʻo ʻepekema i kapa ʻia ʻo Safety of Cetylated Fatty Acids as a Novel Food e like me ka Regulation (EU) 2015/2283 [Safety of cetylated fatty acids as a novel food, etc. ] (umikumākahi) . Kūlike kēia manaʻo me nā koi o ka ʻatikala 11 o Regulation (EU) 11/2015.
- (7) Ma kāna mau ʻōlelo ponoʻī, hoʻoholo ka Mana i ka palekana o ka meaʻai hou, cetylated fatty acids, ma kahi pae ʻai o 1.6 g i kēlā me kēia lā no ka heluna kanaka makua. ʻOi aku ka haʻahaʻa o kēia pae intake palekana ma mua o ka pae kiʻekiʻe loa o 2,1 g i noi ʻia e ka mea noi. E like me ka mea i hōʻike ʻia e ka Mana, ʻo ka helu kiʻekiʻe loa i aʻo ʻia i loko o kahi haʻawina subchronic toxicity i manaʻo ʻia ʻo ia ka No Observed Adverse Effect Level (NOAEL). Ke hoʻohana nei i ka helu paʻa ʻole a me ke kaumaha o ke kino paʻamau no ka heluna kanaka makua, ʻo ia ka hopena o ka lawe ʻana o 1,6 g i kēlā me kēia lā.
- (8) No laila, ʻo ka manaʻo o ka Mana he kumu kūpono e hoʻokumu ai i nā ʻakika momona cetylated, i hoʻohana ʻia i nā meaʻai meaʻai no ka heluna kanaka makua me ka nui o 1.6 g i kēlā me kēia lā, e hoʻokō i nā koi no ke kūʻai aku e like me ka Paukū 12, paukū. 1, o ka Hooponopono (EU) 2015/2283.
- (9) ʻAʻole pono e hoʻopau ʻia nā meaʻai i loaʻa i nā waikawa momona cetylated e ka poʻe ma lalo o ka ʻumikūmāwalu makahiki o ka makahiki, no laila pono e hoʻokumu ʻia kahi koi e hoʻopaʻa inoa e hoʻomaopopo pono i nā mea kūʻai aku ma kēia ʻano.
- (10) Ma kona manaʻo, ua hoʻoholo ka Mana i ka ho'āʻo hoʻololi hoʻololi i loko o ka bacteria, ka in vitro micronucleus ho'āʻo, ka 13-week toxicity study i nāʻiole, ka papa hōʻuluʻulu o nāʻikeʻike nui ma nā haʻawina toxicity, nā palapala hōʻoia o ka nānāʻana, ka hui. nā ho'āʻo a me nā ʻano analytical a me ka ʻikepili kūpaʻa i lilo i kumu no ka hoʻoholo ʻana i ka palekana o ka meaʻai hou. Hoʻopaʻa pū ka Mana i ka hiki ʻole ke hoʻokō i kāna hopena me ka ʻole o kēia mau ʻikepili, a ka mea noi i hōʻoia ai ʻo ia kāna waiwai.
- (11) Ua noi ke Komisina i ka mea noi no ka ho'ākāka hou aku e pili ana i ka ʻāpono i hāʻawi ʻia e pili ana i kāna koi no ka mea nona kēia mau ʻikepili a e wehewehe i kāna koi no ka loaʻa ʻana o ke kuleana kūʻokoʻa iā lākou, e like me ka Paukū 26(2), leka. b), o ka Hooponopono (EU) 2015/2283.
- (12) Ua haʻi ka mea noi, i ka manawa o ka hoʻouna ʻana i ka noi, aia iā ia nā kuleana kuleana a me nā kuleana kūʻokoʻa e nānā i kēia mau ʻikepili ma lalo o ke kānāwai aupuni a no laila, ʻaʻole hiki i kekahi ʻaoʻao ke hoʻohana iā lākou a i ʻole ke komo a kuhikuhi iā lākou. . kānāwai
- (13) Ua loiloi ke Komisina i nā ʻike a pau i hāʻawi ʻia e ka mea noi a noʻonoʻo ua hōʻike pono ka mea noi i ka hoʻokō ʻana i nā koi i hōʻike ʻia ma ka Paukū 26(2) o Regulation (EU) 2015/2283. No laila, ʻo ka bacterial reverse mutation assay (12), ka in vitro micronucleus assay (13), ka 13-week toxicity study i nā ʻiole (14), ka papa hōʻuluʻulu o nā ʻike koʻikoʻi nui i nā haʻawina o ka ʻona (15), nā palapala hōʻoia. ʻAʻole pono e hoʻohana ʻia e ka Mana Mana no ka pono o kekahi mea noi ma hope o ka manawa o ʻelima mau makahiki mai ka lā i komo ai i ka mana. o keia Hooponopono. No laila, i loko o ia manawa, pono e kaupalena ʻia ka ʻae kūʻai aku no nā waikawa momona cetylated i ka Union i ka mea noi.
- (14) Eia naʻe, ʻo ka kaupalena ʻana i ka ʻae ʻia o nā waikawa momona cetylated i ka hoʻohana wale ʻana o ka mea noi a me ke kuleana e kuhikuhi i nā mea i komo i loko o kā lākou dossier, ʻaʻole ia e pale i nā mea noi ʻē aʻe mai ka hoʻouna ʻana i nā noi no ka ʻae kūʻai ʻana no ka meaʻai hou like inā ʻo kā lākou noi. ma muli o ka ʻike i loaʻa ma ke kānāwai e hōʻoia i ka ʻae e like me ka Regulation (EU) 2015/2283.
- (15) No laila, ke kaʻina hana, e hoʻololi i ka hoʻohui i ka Implementing Regulation (EU) 2017/2470 e like me ia.
- (16) ʻO nā ana i hāʻawi ʻia i loko o kēia Hoʻoponopono e like me ka manaʻo o ke Komite Kū i nā mea kanu, nā holoholona, nā meaʻai a me nā meaʻai,
Ua hoʻokō i kēia mau kānāwai:
Paukū 1
1. ʻO nā ʻakika momona cetylated i kuhikuhi ʻia ma ka hoʻohui i kēia Regulation e hoʻokomo ʻia i loko o ka papa inoa o ka Unit o nā meaʻai hou i ʻae ʻia i hoʻokumu ʻia ma ka Implementing Regulation (EU) 2017/2470.
2. No ʻelima mahina mai ka lā i hoʻokomo ʻia ai kēia Hoʻoponopono, ʻo ka mea noi mua wale nō:
hui: Pharmanutra SpA,
Wahi: Via Delle Lenze 216/b, 56122 Pisa, Italia
ʻae ʻia e waiho i ka meaʻai hou i ʻōlelo ʻia ma ka paukū 1 ma ka mākeke ma ka Union, ke ʻole ka mea noi ma hope e loaʻa ka ʻae no kēia meaʻai hou me ka ʻole o ka ʻike ʻana i ka ʻikepili i pale ʻia e like me nā ʻōlelo o ka Paukū 2 o kēia Regulation, a i ʻole me ka ʻaelike o Pharmanutra SpA
3. Ma ka papa inoa o ka Union i kuhikuhi ʻia ma ka paukū 1, e komo i loko o ke komo ʻana i nā kūlana o ka hoʻohana ʻana a me nā koi e hoʻopaʻa inoa ʻia i loko o ka Annex to this Regulation.
Artículo 2
ʻO nā haʻawina i loaʻa i loko o ka faila noi kahi i loiloi ai ka Mana i ka meaʻai hou i ʻōlelo ʻia ma ka ʻatikala 1, nā noiʻi e ʻōlelo ana ka mea noi i kāna waiwai a inā ʻaʻole hiki ke ʻae ʻia ka meaʻai hou, ʻaʻole e hoʻohana ʻia. o ka mea noi ma hope no ka manawa o ʻelima mau makahiki mai ka lā i hoʻokomo ʻia ai kēia mau Hoʻoponopono me ka ʻole o ka ʻae ʻana o Pharmanutra SpA.
Artículo 4
E hoʻomaka ana kēia Hoʻoponopono i nā lā he iwakālua ma hope o kona paʻi ʻia ʻana ma ka Official Journal of the European Union.
E hoʻopaʻa ʻia kēia Hoʻoponopono i nā mea āpau a pili pono i kēlā me kēia Moku'āina lālā.
Hana ʻia ma Brussels, ma Pepeluali 10, 2022.
No ke Komisina
ka peresidena
Ursula VON DER LEYEN
MEA MAHIAI
Hoʻololi ʻia ka Annex of the Execution Regulation (EU) 2017/2470 penei:
- 1) Ma ka Papa 1 (Nā meaʻai noʻonoʻo ʻae ʻia) ua hoʻokomo ʻia ka helu ma lalo nei [OP, e hoʻokomo i ka ʻōlelo Paniolo ma ke ʻano pīʻāpā]: Meaʻai puke ʻae ʻia Nā kūlana e hiki ai ke hoʻohana ʻia ka meaʻai noʻonoʻo. acids Māhele kikoʻī o ka meaʻai ʻO ka ʻike nui loa
1.-ʻO ka inoa o ka meaʻai hou ma ka lepili o nā meaʻai hoʻohui i loko o ia mea pono e "hoʻomākaukau ʻia mai nā waikawa momona cetylated".
2.-Ma ka hōʻailona ʻana i nā meaʻai i loaʻa i ka meaʻai hou, pono e hoʻokomo ʻia kahi ʻōlelo e hōʻike ana ʻaʻole pono e ʻai ʻia kēia mau meaʻai e ka poʻe ma lalo o 18 makahiki.
ʻAe ʻia ma Malaki 3, 2022. Hoʻokumu ʻia kēia hoʻokomo ʻana ma luna o nā hōʻike ʻepekema ponoʻī a me nā ʻikepili ʻepekema i pale ʻia e like me ka Paukū 26 o Regulation (EU) 2015/2283.
Mea noi: Pharmanutra SpA, Via Delle Lenze 216/b, 56122 Pisa, Italia. I loko o ka wā mālama ʻikepili, ʻo Pharmanutra SpA wale nō ka mea i ʻae ʻia e kūʻai aku i nā meaʻai cetylated fatty acids hou i loko o ka Unit, inā loaʻa i kahi mea noi ma hope e loaʻa ka mana no ka meaʻai hou me ka ʻole o ka pili ʻana i ka hōʻike ʻepekema pili i nā kuleana proprietary a i ʻole ka ʻike ʻepekema i pale ʻia ma. e like me ka ʻatikala 26 o Regulation (EU) 2015/2283, a i ʻole me ka ʻaelike o Pharmanutra SpA
Ka lā i pau ai ka pale ʻikepili: Malaki 3, 2027.
Nā mea hoʻohui meaʻai, e like me ka wehewehe ʻana ma Directive 2002/46/EC, i manaʻo ʻia no ka heluna kanaka makua 1,6 g/lā
- 2) Ma ka Papa 2 (Specifications), ua hoʻokomo ʻia kēia helu ma lalo nei: Nā meaʻai hou ʻae ʻia Nā kikoʻī kikoʻī cetylated fatty acids
Wehewehe/Wehewehe:
ʻO ka meaʻai noʻonoʻo ka nui o ka hui ʻana o ka waikawa mystic cetylated a me ka waikawa oleic cetylated i hoʻohui ʻia mai ka cetyl alcohol, myrstic acid a me ka oleic acid, a ma kahi liʻiliʻi, nā ʻakika momona cetylated a me nā pūhui aila ʻoliva ʻē aʻe.
Nā hiʻohiʻona/hui:
Ester maʻiʻo: 70-80%, nona: cetyl oleate: 22-30%, cetyl myristate: 41-56%
Triglycerides: 22-25%
waiwai ʻakika (mg KOH/g): ≤ 5
waiwai saponification (mg KOH/g): 130-150
Nā pae hoʻohālike microbiological:
Huina helu microbiological aerobic: ≤ 1.000 CFU/g
ʻO nā mea hu a me nā poʻi: ≤ 100 CFU / g
KOH: potassium hydroxide
CFU: nā ʻāpana hana koloni
