Hoʻoponopono Hoʻokō (EU) 2023/454 o ke Komisina, o 2




ʻO ke Kānāwai Kūkākūkā

hōʻuluʻulu manaʻo

KOMISINA Eulopa,

No ka pili ana i ke Kuikahi no ka hana ana o ka Hui Europa,

E noʻonoʻo ana i ka Regulation (EC) no. 470/2009 o ka European Parliament a me ka Council, o Mei 6, 2009, ka mea e hoʻokumu i nā kaʻina hana kaiāulu no ka hoʻonohonoho ʻana i nā palena koena o nā mea lāʻau pharmacologically active i ka meaʻai o ka holoholona, ​​​​e hoʻopau i ka Regulation (EEC) No. 2377/90 o ka ʻAha a hoʻololi i ka Directive 2001/82/CE o ka European Parliament a me ka Council and Regulation (CE) no. 726/2004 o ka Pāremata ʻEulopa a me ka ʻaha kūkā (1), a me kāna ʻatikala 14, i hui pū me kāna ʻatikala 17,

E noʻonoʻo ana i kēia mau mea:

  • (1) E like me ka Regulation (EC) no. 470/2009, pono e hoʻokumu ke Komisina, ma o ka hoʻoponopono ʻana, ka palena palena ʻoi loa (ma hope aku, MRL) o nā mea lāʻau lapaʻau i manaʻo ʻia no ka hoʻohana ʻana i loko o ka hui i nā lāʻau lapaʻau no nā holoholona hana meaʻai a i ʻole nā ​​biocides i hoʻohana ʻia i ka pēpē. holoholona
  • (2) Ma ka papa 1 o ka annex to Regulation (EU) no. Ua papa inoa ke Komisina 37/2010 (2) i nā mea lāʻau lapaʻau a me kā lākou hoʻokaʻawale ʻana e pili ana i nā MRL i loko o nā meaʻai o nā holoholona.
  • (3) Ua helu mua ʻia ʻo Toltrazuril ma ia papa ma ke ʻano he mea ʻae ʻia no nā ʻano mammalian āpau i manaʻo ʻia no ka hana ʻana i ka meaʻai e pili ana i ka ʻiʻo, ka momona (ka ʻili a me ka momona i nā ʻano maoli no ka puaʻa), ke ake a me ka puʻupaʻa, akā ʻaʻole nā ​​holoholona i hana i ka waiū no ʻai kanaka. Eia kekahi, ua helu ʻia kēia mea ma ke ʻano he mea ʻae ʻia no ka moa no ka ʻiʻo, ka ʻili a me ka momona, ka ate a me ka puʻupaʻa. Eia naʻe, ʻaʻole pono e hoʻohana ʻia ka waiwai i nā holoholona e hana ana i nā hua no ka ʻai kanaka.
  • (4) E like me ka pauku 9, paukū 1, leka b), o ka Regulation (EC) no. 470/2009, i ka lā 29 o Iune, 2021, ua waiho ʻo Netherlands i ka European Medicines Agency (ma hope o ka Agency) i kahi noi e hoʻonui i ke komo ʻana no ka toltrazuril i ka moa i nā hua moa.
  • (5) Ma ka lā 9 Dekemaba 2021, ʻo ka Agency, ma o ka manaʻo o ke Kōmike no nā huahana lāʻau lapaʻau no ka hoʻohana ʻana i nā holoholona, ​​e paipai i ka hoʻokumu ʻana i kahi MRL no toltrazuril i nā hua moa.
  • (6) Ma muli o ka pauku 5 o ka Regulation (EC) no. 470/2009, pono e noʻonoʻo ka ʻOihana i ka hiki ke hoʻohana i nā MRL paʻa no kahi mea lāʻau i hoʻōla ʻia i loko o kahi huahana meaʻai no kekahi huahana meaʻai i loaʻa mai ka ʻano like, kahi i loaʻa ai nā MRL paʻa no kahi mea lāʻau lapaʻau i hoʻokahi a ʻoi aku paha nā ʻano. ʻano ʻano ʻē aʻe.
  • (7) Ua hoʻoholo ka 'Oihana he mea kūpono ke hoʻonui i nā MRL no ka toltrazuril mai nā hua moa i nā hua o nā ʻano moa ʻē aʻe.
  • (8) No ka noʻonoʻo ʻana i ka manaʻo o ka ʻOihana, manaʻo ke Komisina he kūpono ke hoʻokumu ʻana i ka MRL i manaʻo ʻia no ka toltrazuril i nā hua moa.
  • (9) No laila, kūpono ke hoʻololi i ka Regulation (EU) no. 37/2010 e like me ia.
  • (10) ʻO nā hana i hāʻawi ʻia i loko o kēia Hoʻoponopono e like me ka manaʻo o ke Kōmike Kūʻai no nā huahana lāʻau lapaʻau.

Ua hoʻokō i kēia mau kānāwai:

Paukū 1

ʻO ka hoʻohui i ka Regulation (EU) no. Hoʻololi ʻia ʻo 37/2010 e like me nā ʻōlelo o ka hoʻohui i kēia Regulation.

LE0000406195_20220509E hele i ka Affected Normal

Artículo 2

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 Malaki 2, 2023.
No ke Komisina Ka Peresidena
Ursula VON DER LEYEN

MEA MAHIAI

Ma ka papa 1 o ka annex to Regulation (EU) no. 37/2010, ua hoʻololi ʻia ke komo ʻana e pili ana i ka mea toltrazuril e kēia kikokikona:

Pharmacologically active substance Ke koena hōʻailona ʻano holoholona MRL Nā ʻiʻo target Nā mea ʻē aʻe (e like me ka ʻatikala 14.7 o Regulation (EC) No. 470/2009) Hoʻohālikelike Therapeutic Toltrazuril Toltrazuril sulfone ʻO nā ʻano mammalian āpau i manaʻo ʻia no ka hana ʻai.

100 micrograms/kg

150 mg / kg

500 micrograms/kg

250 mg / kg

ʻO ka ʻiʻo momona o ke akepaʻa

No ka puaʻa, ʻo ka MRL i ka momona e pili ana i ka "ʻili a me ka momona i nā ʻāpana kūlohelohe".

ʻAʻole pono e hoʻohana i nā holoholona e hana i ka waiū no ka ʻai kanaka.

Antiparasitic/ Antiprotozoal

100 micrograms/kg

200 micrograms/kg

600 micrograms/kg

400 mg / kg

140 micrograms/kg

ʻIli ʻiʻo a me nā hua momona ate ʻaʻohe mea