MIKRO QUAT

Informasi Utama

  • Nama dagang:
  • MIKRO QUAT
  • Digunakan untuk:
  • manusia
  • Jenis Obat:
  • Perangkat medis

Dokumen

  • untuk masyarakat umum:
  • Informasi leaflet untuk produk ini saat ini tidak tersedia, Anda dapat mengirim permintaan untuk layanan pelanggan kami dan kami akan memberitahu Anda segera setelah kami mampu mendapatkannya.


    Meminta selebaran informasi untuk masyarakat umum.

Lokalisasi

  • Tersedia di:
  • MIKRO QUAT
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 930818
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

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BAGIAN 1. IDENTIFIKASI PRODUK DAN PERUSAHAAN

Nama produk

MIKRO QUAT

Cara identifikasi lainnya

Tidak berlaku.

Penggunaan yang dianjurkan

Pembersih dan desinfektan

Informasi pengenceran

produk

0.2 % - 0.8 %

Perusahaan

PT. Ecolab International Indonesia

Jl. Jababeka XII.B Kav V-37

Kawasan Industri Jababeka, Cikarang Indonesia 17530

(62-21) 8983 4891

Nomor telepon darurat

+1-651-222-5352 (Amerika Syarikat)

Tanggal penerbitan pertama

15.12.2016

BAGIAN 2. IDENTIFIKASI BAHAYA

Klasifikasi GHS

Produk TERJUAL

Korosi/iritasi kulit

Kategori 1B

Kerusakan mata serius/iritasi

pada mata

Kategori 1

Toksisitas akuatik akut

Kategori 1

Toksisitas akuatik kronis

Kategori 2

Penggunaan produk dicairkan

Bukan merupakan zat atau campuran yang berbahaya.

Elemen label GHS

Produk TERJUAL

Piktogram bahaya

Kata sinyal

Bahaya

Pernyataan Berbahaya

Menyebabkan kulit terbakar yang parah dan kerusakan mata.

Sangat toksik pada kehidupan perairan.

Toksik pada kehidupan perairan dengan efek jangka panjang.

Pernyataan Hati-hati

Pencegahan:

Cuci kulit dengan seksama setelah menangani. Hindarkan pelepasan

ke lingkungan. Pakai sarung tangan pelindung /pakaian pelindung

/pelindung mata/pelindung wajah.

Respons:

JIKA TERTELAN : Basuh mulut. JANGAN merangsang muntah. JIKA

TERKENA KULIT (atau rambut): Tanggalkan segera semua pakaian

yang terkontaminasi. Bilas kulit dengan air/pancuran. JIKA

TERHIRUP: Pindahkan korban ke udara segar dan posisikan yang

nyaman untuk bernapas. Segera hubungi SENTRA INFORMASI

KERACUNAN atau dokter/tenaga medis. JIKA TERKENA MATA:

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Bilas secara hati-hati dengan air selama beberapa menit. Lepas lensa

kontak, jika digunakan dan mudah melakukannya. Lanjutkan

membilas. Segera telponlah PUSAT RACUN atau dokter. Cucilah

pakaian yang terkontaminasi sebelum digunakan kembali. Kumpulkan

tumpahan.

Penyimpanan:

Simpan di tempat terkunci.

Pembuangan:

Buang isi / wadah ke tempat pembuangan limbah yang disetujui.

Penggunaan produk dicairkan

Pernyataan Hati-hati

Pencegahan:

Cucilah tangan bersih-bersih setelah menangani.

Respons:

Dapatkan nasehat/perhatian medis jika kamu merasa tidak sehat.

Penyimpanan:

Simpan sesuai dengan peraturan setempat.

Produk TERJUAL

Bahaya lain

Tidak ada yang diketahui.

BAGIAN 3. KOMPOSISI/INFORMASI TENTANG BAHAN PENYUSUN

Produk TERJUAL

Bahan/preparasi murni

Campuran

Nama kimia

No-CAS

Konsentrasi (%)

BENZIL-(C12-C16 ALKIL)-DIMETIL-AMONIUM

KLORIDA

68424-85-1

5 - 10

monoethanolamine

141-43-5

1 - 5

Penggunaan produk dicairkan

Tidak ada zat berbahaya

BAGIAN 4. TINDAKAN PERTOLONGAN PERTAMA PADA KECELAKAAN

Produk TERJUAL

Jika kontak dengan mata

Basuhlah segera dengan banyak air, dan berikan air sebanyak-

banyaknya di bawah kelopak mata, sekurangnya selama 15 menit.

Lepas lensa kontak, jika digunakan dan mudah melakukannya.

Lanjutkan membilas. Segera panggil dokter.

Jika kontak dengan kulit

Segera cuci bersih dengan banyak air sedikitnya selama 15 menit.

Gunakan sabun lunak bila tersedia. Cuci pakaian yang tercemar

sebelum dipakai lagi. Cucilah sebersih mungkin sepatu sebelum

dipakai lagi. Segera panggil dokter.

Jika tertelan

Berkumurlah dengan air. JANGAN pancing supaya muntah. Jangan

sekali-kali memberikan apa pun lewat mulut kepada orang yang tidak

sadar. Segera panggil dokter.

Jika terhirup

Pindahkan ke tempat berudara segar. Tangani menurut gejala.

Segera panggil dokter.

Perlindungan aiders pertama

Bila ada bahaya kontaminasi lihat bab 8 tentang perlengkapan

melindungi diri.

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Instruksi kepada dokter

Tangani menurut gejala.

Gejala dan efek yang paling

penting, baik yang akut

maupun yang tertunda

Lihat bagian 11 untuk informasi yang lebih terperinci mengenai

berbagai efek dan gejala pada kesehatan.

Penggunaan produk dicairkan

Jika kontak dengan mata

Bilas dengan banyak air.

Jika kontak dengan kulit

Bilas dengan banyak air.

Jika tertelan

Bilas mulut. Tangani secara medis jika muncul gejala.

Jika terhirup

Tangani secara medis jika muncul gejala.

BAGIAN 5. TINDAKAN PEMADAMAN KEBAKARAN

Produk TERJUAL

Media pemadam yang sesuai

Gunakan tindakan pemadaman kebakaran yang sesuai untuk situasi

lokal dan lingkungan sekitar.

Zat pemadam kebakaran

yang tidak sesuai

Tidak ada yang diketahui.

Bahaya spesifik yang

diakibatkan bahan kimia

tersebut

Eksposur terhadap produk-produk dekomposisi dapat berbahaya bagi

kesehatan.

Produk pembakaran

berbahaya

Hasil penguraian mungkin termasuk bahan-bahan berikut:

Karbon oksida

Nitrogen oksida (NOx)

Alat pelindung khusus bagi

petugas pemadam

kebakaran

Gunakan alat pelindung diri.

Metode pemadaman khusus

Kumpulkan air bekas pemadam kebakaran yang tercemar secara

terpisah. Air ini tidak boleh dibuang ke saluran pembuangan. Residu

kebakaran dan air bekas pemadam kebakaran yang tercemar harus

dibuang sesuai dengan peraturan lokal. Jika terjadi kebakaran

dan/atau ledakan, jangan menghirup asap.

BAGIAN 6. TINDAKAN PENANGGULANGAN JIKA TERJADI TUMPAHAN DAN KEBOCORAN

Produk TERJUAL

Tindakan pencegahan

pribadi, peralatan pelindung

dan prosedur darurat

Pastikan ventilasi memadai. Jauhkan orang dari tumpahan/bocoran ke

arah yang berlawanan dengan arah angin. Hindari penghirupan,

penelanan dan kontak langsung dengan kulit dan mata. Jika karyawan

menghadapi konsentrasi yang melebihi ambang batas pajanan,

mereka harus memakai alat bantu pernapasan yang memenuhi

standar. Pastikan agar pembersihan dilakukan hanya oleh petugas

terlatih. Mengaculah pada langkah-langkah perlindungan yang

dicantumkan dalam seksi 7 dan 8.

Tindakan pencegahan untuk

melindungi lingkungan

Jangan sampai mengenai tanah, air permukaan atau air tanah.

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Metode dan bahan untuk

penyimpanan dan

pembersihan

Hentikan kebocoran jika aman untuk melakukannya. Tahan dan

kumpulkan tumpahan dengan bahan penyerap yang tidak mudah

terbakar (misalnya pasir, tanah, tanah diatomaceus, vermiculite) dan

tempatkan dalam kontener untuk dibuang berdasarkan peraturan

lokal/nasional (lihat seksi 13). Untuk tumpahan dalam jumlah banyak,

bendung tumpahan bahan atau tumpahan yang mengandung bahan

materi untuk memastikan agar tidak mengalir menuju saluran air.

Penggunaan produk dicairkan

Tindakan pencegahan

pribadi, peralatan pelindung

dan prosedur darurat

Pastikan agar pembersihan dilakukan hanya oleh petugas terlatih.

Mengaculah pada langkah-langkah perlindungan yang dicantumkan

dalam seksi 7 dan 8.

Tindakan pencegahan untuk

melindungi lingkungan

Jangan sampai mengenai tanah, air permukaan atau air tanah.

Metode dan bahan untuk

penyimpanan dan

pembersihan

Hentikan kebocoran jika aman untuk melakukannya. Tahan dan

kumpulkan tumpahan dengan bahan penyerap yang tidak mudah

terbakar (misalnya pasir, tanah, tanah diatomaceus, vermiculite) dan

tempatkan dalam kontener untuk dibuang berdasarkan peraturan

lokal/nasional (lihat seksi 13). Untuk tumpahan dalam jumlah banyak,

bendung tumpahan bahan atau tumpahan yang mengandung bahan

materi untuk memastikan agar tidak mengalir menuju saluran air.

BAGIAN 7. PENANGANAN DAN PENYIMPANAN

Produk TERJUAL

saran penanganan yang

aman

Jangan dimakan. Jangan sampai kena kulit dan mata. Jangan

menghirup debu/ asap/ gas/ kabut/ uap/ semburan. Gunakan hanya

dengan ventilasi yang cukup. Cucilah tangan bersih-bersih setelah

menangani. Jangan terkena mata, kulit atau pakaian.

Kondisi untuk penyimpanan

yang aman

Jauhkan dari jangkauan anak-anak. Jaga wadah tertutup rapat.

Simpan dalam wadah yang berlabel sesuai.

Suhu penyimpanan

0 °C ke 50 °C

Penggunaan produk dicairkan

saran penanganan yang

aman

Cucilah tangan bersih-bersih setelah menangani.

Kondisi untuk penyimpanan

yang aman

Jauhkan dari jangkauan anak-anak. Jaga wadah tertutup rapat.

Simpan dalam wadah yang berlabel sesuai.

BAGIAN 8. KONTROL PAPARAN/ PERLINDUNGAN DIRI

Produk TERJUAL

Komponen dengan parameter pengendalian di tempat kerja

Komponen

No-CAS

Bentuk

eksposur

Konsentrasi yang

diizinkan

Basis

monoethanolamine

141-43-5

3 ppm

ID OEL

6 ppm

ID OEL

Pengendalian teknik yang

Sistem ventilasi pembuangan yang efektif. Jaga konsentrasi udara di

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sesuai

bawah standar paparan okupasional.

Alat Pelindung Diri

Perlindungan mata

Katamata pelindung keamanan

Topeng-wajah

Perlindungan tangan

Kenakan perlengkapan perlindungan pribadi berikut ini:

Jenis sarung tangan standar.

lapisan film tipis

Karet alami

Nitril

Sarung tangan harus dibuang atau diganti apabila terdapat indikasi

mengalami degradasi atau kebocoran kimia.

Perlindungan kulit

Peralatan pelindung personal terdiri atas: sarung tangan pelindung,

kacamata keselamatan kerja dan baju pelindung

Perlindungan pernapasan

Jika karyawan menghadapi konsentrasi yang melebihi ambang batas

pajanan, mereka harus memakai alat bantu pernapasan yang

memenuhi standar.

Tindakan higienis

Tangani sesuai dengan praktik kebersihan dan keselamatan industri

yang baik. Lepaskan dan cuci pakaian yang tercemar sebelum dipakai

lagi. Cuci muka, tangan dan kulit yang terpapar dengan seksama

setelah menangani. Menyediakan fasilitas untuk cepat membasahi

atau pembilasan pada mata dan tubuh pada kasus kontak atau

bahaya lain.

Penggunaan produk dicairkan

Pengendalian teknik yang

sesuai

Ventilasi umum yang baik semestinya cukup untuk mengendalikan

pemaparan pekerja terhadap kadar kontaminasi yang terbawa-udara.

Alat Pelindung Diri

Perlindungan mata

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan tangan

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan kulit

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan pernapasan

Biasanya tidak diperlukan alat bantu pelindung pernapasan pribadi.

BAGIAN 9. SIFAT FISIKA DAN KIMIA

Produk TERJUAL

Penggunaan produk dicairkan

Tampilan

: cair

cair

Warna

: merah tua

merah muda

: sitrus

Disinfektan

11.35, 100 %

10.0 - 10.5

Titik nyala

Tidak berlaku.

Ambang Bau

Data tidak tersedia

Titik lebur/titik beku

Data tidak tersedia

Titik didih awal/rentang didih

Data tidak tersedia

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Laju penguapan

Data tidak tersedia

Flamabilitas (padatan, gas)

Data tidak tersedia

Tertinggi batas ledakan

Data tidak tersedia

Terendah batas ledakan

Data tidak tersedia

Tekanan uap

Data tidak tersedia

Kerapatan (densitas) uap

relatif

Data tidak tersedia

Berat jenis relatif

1.01

Kelarutan dalam air

Data tidak tersedia

Kelarutan dalam pelarut lain

Data tidak tersedia

Koefisien partisi (n-

oktanol/air)

Data tidak tersedia

Suhu dapat membakar

sendiri (auto-ignition

temperature)

Data tidak tersedia

Dekomposisi termal

Data tidak tersedia

Viskositas, kinematis

Data tidak tersedia

Sifat peledak

Data tidak tersedia

Sifat oksidator

Data tidak tersedia

Berat Molekul

Data tidak tersedia

Data tidak tersedia

BAGIAN 10. STABILITAS DAN REAKTIFITAS

Produk TERJUAL

Stabilitas kimia

Stabil pada kondisi normal.

Kemungkinan reaksi

berbahaya

Tidak ada reaksi berbahaya yang diketahui dalam kondisi

penggunaan normal.

Kondisi yang harus dihindari

Tidak ada yang diketahui.

Bahan non-kompatibel

Asam

Produk berbahaya hasil

peruraian

Hasil penguraian mungkin termasuk bahan-bahan berikut:

Karbon oksida

Nitrogen oksida (NOx)

BAGIAN 11. INFORMASI TOKSIKOLOGI

Informasi tentang rute

paparan

Penghirupan, Kena mata, Kena kulit

Kemungkinan Dampak Kesehatan

Produk TERJUAL

Mata

Menyebabkan kerusakan mata yang serius.

Kulit

Menimbulkan sensasi terbakar yang parah pada kulit.

Tertelan

Menyebabkan sensasi terbakar pada saluran pencernaan.

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Penghirupan

Dapat menyebabkan iritasi pada hidung, tenggorokan, dan paru-paru.

Eksposur Kronis

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Penggunaan produk dicairkan

Mata

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Kulit

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Tertelan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Penghirupan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Eksposur Kronis

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Pengalaman dengan paparan pada manusia

Produk TERJUAL

Kena mata

Kemerahan, Nyeri, Korosi

Kena kulit

Kemerahan, Nyeri, Korosi

Tertelan

Korosi, Sakit perut

Penghirupan

Iritasi alat pernafasan, Batuk

Penggunaan produk dicairkan

Kena mata

Tidak ada gejala yang diketahui atau diperkirakan.

Kena kulit

Tidak ada gejala yang diketahui atau diperkirakan.

Tertelan

Tidak ada gejala yang diketahui atau diperkirakan.

Penghirupan

Tidak ada gejala yang diketahui atau diperkirakan.

Toksisitas

Produk TERJUAL

Produk

Toksisitas oral akut

: Perkiraan toksisitas akut : 3,398 mg/kg

Toksisitas inhalasi akut

: 4 h Perkiraan toksisitas akut : 1.63 mg/l

4 h Perkiraan toksisitas akut : > 10 mg/l

Toksisitas kulit akut

: Perkiraan toksisitas akut : > 5,000 mg/kg

Kerusakan/gangguan kulit

Data tidak tersedia

Gangguan mata/kerusakan

mata serius

Data tidak tersedia

Sensitisasi sistem

pernafasan atau kulit

Data tidak tersedia

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Karsinogenisitas

Data tidak tersedia

Pengaruh pada alat

reproduksi

Data tidak tersedia

Mutagenitas sel germinal

Data tidak tersedia

Teratogenisitas

Data tidak tersedia

STOT - paparan tunggal

Data tidak tersedia

STOT - paparan berulang

Data tidak tersedia

Derajat keracunan melalui

pernapasan

Data tidak tersedia

BAGIAN 12. INFORMASI EKOLOGI

Produk TERJUAL

Derajat racun bagi lingkungan (ekotoksisitas)

Dampak lingkungan

Sangat toksik pada kehidupan perairan. Toksik pada kehidupan

perairan dengan efek jangka panjang.

Produk

Keracunan untuk ikan

: Data tidak tersedia

Derajat racun bagi daphnia

dan binatang tak bertulang

belakang lainnya yang hidup

dalam air.

: Data tidak tersedia

Keracunan untuk ganggang

: Data tidak tersedia

Komponen

Derajat racun bagi daphnia

dan binatang tak bertulang

belakang lainnya yang hidup

dalam air.

: BENZIL-(C12-C16 ALKIL)-DIMETIL-AMONIUM KLORIDA

48 h EC50 Daphnia magna (Kutu air): 0.016 mg/l

monoethanolamine

48 h EC50 Daphnia (Kutu air): 65 mg/l

Ketahanan dan tingkat penguraian

Produk TERJUAL

Biodegradabel

Penggunaan produk dicairkan

Biodegradabel

Potensi penumpukan biologis

Data tidak tersedia

Mobilitas di dalam tanah

Data tidak tersedia

Dampak merugikan lainnya

Data tidak tersedia

BAGIAN 13. PERTIMBANGAN PEMBUANGAN/ PEMUSNAHAN

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Produk TERJUAL

Metode pembuangan

Jika mungkin, pendauran-ulang lebih disukai daripada pembuangan

atau pembakaran. Jika proses daur-ulang tidak praktis, buang sesuai

dengan peraturan lokal. Buanglah sampah dalam fasilitas

pembuangan sampah yang disetujui.

Produk tidak boleh sampai memasuki saluran pembuangan, sungai,

danau dsb. atau tanah.

Pembuangan limbah

Buang sebagai produk yang tidak digunakan. Wadah kosong harus

dibawa ke tempat penanganan limbah yang telah disetujui untuk

didaur-ulang atau dibuang. Dilarang menggunakan kembali

kemasan/wadah yang sudah kosong. Buanglah sesuai dengan

peraturan lokal, negara bagian, dan federal.

Penggunaan produk dicairkan

Metode pembuangan

Jika mungkin, pendauran-ulang lebih disukai daripada pembuangan

atau pembakaran. Jika proses daur-ulang tidak praktis, buang sesuai

dengan peraturan lokal. Buanglah sampah dalam fasilitas

pembuangan sampah yang disetujui.

Produk tidak boleh sampai memasuki saluran pembuangan, sungai,

danau dsb. atau tanah.

Pembuangan limbah

Buang sebagai produk yang tidak digunakan. Wadah kosong harus

dibawa ke tempat penanganan limbah yang telah disetujui untuk

didaur-ulang atau dibuang. Dilarang menggunakan kembali

kemasan/wadah yang sudah kosong. Buanglah sesuai dengan

peraturan lokal, negara bagian, dan federal.

BAGIAN 14. INFORMASI PENGANGKUTAN

Produk TERJUAL

Pengangkut/ pengirim barang/ pengirim bertanggung jawab untuk memastikan kemasan, label, dan

penandaan yang sesuai dengan jenis transportasi yang digunakan.

Transpor jalan

Nomor UN

3082

deskripsi barang

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.

Kelas

Kelompok pengemasan

Kode Hazchem

Berbahaya bagi lingkungan

Transpor laut (IMDG/IMO)

Nomor UN

3082

deskripsi barang

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID, N.O.S.

Kelas

Kelompok pengemasan

Bahan pencemar laut

BAGIAN 15. INFORMASI YANG BERKAITAN DENGAN REGULASI

Regulasi domestik

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Sistem Harmonisasi Global Klasifikasi dan Label Pada Bahan Kimia (87/M-IND/PER/9/2009)

Komponen-komponen produk ini dilaporkan dalam inventorisasi berikut:

1907/2006 (Uni Eropa) :

belum ditentukan

Inventaris TSCA Amerika Serikat :

Pada Inventaris TSCA

Daftar Senyawa Domestik Kanada :

Seluruh komponen produk ini terdapat pada daftar DSL Kanada

Australia. Undang-undang (Pengkajian dan Pemberitahuan) Kimia Industri :

Sesuai dengan inventaris

Selandia Baru. Inventaris Bahan Kimia (NZIoC), seperti yang diterbitkan oleh ERMA Selandia

Baru :

belum ditentukan

Jepang. ENCS - Inventaris Senyawa Kimia Yang Sudah Ada Dan Yang Baru :

belum ditentukan

Korea. Inventaris Bahan Kimia Yang Sudah Ada (KECI) :

belum ditentukan

Inventaris Bahan Kimia dan Senyawa Kimia Filipina (PICCS) :

belum ditentukan

Cina. Inventaris Senyawa Kimia yang Sudah Ada :

Sesuai dengan inventaris

Daftar Senyawa Kimia Taiwan :

belum ditentukan

BAGIAN 16. INFORMASI LAIN

Tanggal penerbitan pertama

15.12.2016

Versi

Disiapkan oleh

Urusan peraturan

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15-2-2019

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition

FDA announces new draft guidance titled, Competitive Generic Therapies, to help provide even greater clarity to industry about the CGT pathway.

FDA - U.S. Food and Drug Administration

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Modification of the existing maximum residue levels for sulfoxaflor in various crops

Published on: Thu, 31 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Ireland to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in various crops, including limes imported from Australia. The data submitted in support of the request were found to be sufficient to derive MRL proposals for limes, cauliflowers, Brussels sprouts, kales, spinaches and similar ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Modification of the existing maximum residue levels for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Isagro S.p.A submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tetraconazole in various crops and animal commodities. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tetraconazole in kaki/Japanese persimmon, linseeds and poppy seeds. Adequate analytical me...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Modification of the existing maximum residue levels for aminopyralid in certain cereals

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Denmark submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance aminopyralid in cereals. The data submitted in support of the request were found to be sufficient to derive MRL proposals for barley, rye, sorghum, millet and oats. A modification of the existing MRL of aminopyralid in wh...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Modification of the existing maximum residue levels for spirotetramat in various crops

Modification of the existing maximum residue levels for spirotetramat in various crops

Published on: Fri, 18 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the competent national authority in Belgium prepared a request to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in Florence fennels and rhubarbs. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing MRLs for spirotetramat in the group of ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Safety for the environment of vitamin D3 for salmonids

Safety for the environment of vitamin D3 for salmonids

Published on: Thu, 17 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of EFSA assessed the safety for the target species and the consumer of the use of a maximum total level of 1.5 mg vitamin D3/kg feed in fish nutrition (2017). The assessment was based on data that had been provided by the Norwegian Food Safety Authority (NFSA). Since the data set provided by the NFSA did not include any new information concerning the safety for the user and the environment...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Setting of an import tolerance for spiromesifen in coffee beans

Setting of an import tolerance for spiromesifen in coffee beans

Published on: Mon, 14 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience submitted a request to the competent national authority in Greece to set an import tolerance for the active substance spiromesifen in coffee beans. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for coffee beans. Adequate analytical methods for enforcement are available to control the residues of spiromesife...

Europe - EFSA - European Food Safety Authority EFSA Journal

4-1-2019

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Modification of the existing maximum residue levels for lambda‐cyhalothrin in celeries, fennel and rice

Published on: Thu, 03 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda‐cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in hops

Modification of the existing maximum residue level for captan in hops

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV on behalf of ADAMA Makhteshim Ltd. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level for the active substance captan in hops. The data submitted in support of the request were found to be insufficient to conclude whether the existing residue definitions are appropriate for hops. Although the number of residue ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-12-2018

Modification of the existing maximum residue level for captan in cranberries

Modification of the existing maximum residue level for captan in cranberries

Published on: Fri, 21 Dec 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the Belgian Federal Public Service (FPS) for Health, Food chain safety and Environment, submitted an application as the competent national authority in Belgium to modify the existing maximum residue level (MRL) for the active substance captan in cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposal for cranberries. Adequate analytical methods for enforcement ...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

One lot of Equate brand Lens Care System and Multi-Purpose Solution voluntarily recalled because of a labelling error

Teva Canada is voluntarily recalling one lot (Lot 150261) of two products because of a labelling error. While the outer carton of Equate brand Lens Care System is correctly labelled, the bottle within the carton is mislabelled as Equate brand Multi-Purpose Solution. Because of the labelling error, the company is recalling both products labelled with Lot 150261. Bottles labelled as Equate Multi-Purpose Solution should contain a 0.0001% w/v polyhexanide based disinfecting solution for rinsing. The mislabel...

Health Canada

19-12-2018

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Safety and efficacy of vitamin B2 (riboflavin 5′‐phosphate ester monosodium salt) for all animal species when used in water for drinking

Published on: Tue, 18 Dec 2018 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on vitamin B2 in the form of riboflavin 5′‐phosphate ester monosodium salt as an additive for all animal species for use in water for drinking. The additive under assessment is obtained from ■■■■■ a source of riboflavin produced by Ashbya gossypii. No information was provided on the identity and character...

Europe - EFSA - European Food Safety Authority EFSA Journal

6-12-2018

Bee health: ANSES reviews the latest scientific developments

Bee health: ANSES reviews the latest scientific developments

ANSES is holding its annual scientific conference on bee health. This event is an opportunity for the Agency to review the latest major developments in research and surveillance in this field. For this seventh edition, ANSES is inviting the various stakeholders involved in the issue to discuss the latest scientific advances, technological innovations and international and local initiatives contributing to adequate prevention and protection of the health of pollinating insects.

France - Agence Nationale du Médicament Vétérinaire

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

ÖHLINS RACING AB recalls Front Air Suspension Bicycle Forks

ÖHLINS RACING AB recalls Front Air Suspension Bicycle Forks

The right-side top cap on some forks may not be adequately torqued which in some cases may lead to the top cap working itself free through riding. When this happens, the air cartridge may abruptly spring out of the stanchion tube causing a risk of injury to the rider.

Health Canada

21-11-2018

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Implementation and verification of PBPK modelling codes of TCDD in rats and humans into Berkeley Madonna

Published on: Tue, 20 Nov 2018 The goal of the current work was to implement and verify previously published rat and human PBPK modelling codes for TCDD into Berkeley Madonna. The US‐EPA has used these PBPK models in the reassessment of TCDD. A procurement contract has been set up to explore the possibilities to adequately run the models and reproduce previously published results. The implementation of the available codes in Berkeley Madonna was carried out at RIKILT‐WUR under the framework agreement wi...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Setting of an import tolerance for mandipropamid in cocoa beans

Setting of an import tolerance for mandipropamid in cocoa beans

Published on: Tue, 20 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Agro GmbH submitted a request to the competent national authority in Austria to set a maximum residue level (MRL) for the active substance mandipropamid in cocoa beans imported from Nigeria and Cameroon. The data submitted in support of the request were found to be sufficient to derive a MRL proposal of 0.06 mg/kg. Adequate analytical methods for enforcement are available to control the res...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Modification of the existing maximum residue levels for pyraclostrobin in soyabean

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue level (MRL) for the active substance pyraclostrobin in soyabean. The data submitted in support of the request were found to be sufficient to derive MRL proposals for soyabean. The applicant provided a new validated analytical method to control residues of pyraclostrobin on the commodity u...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Spiraledge Inc. recalls Backless Yoga Chair

Spiraledge Inc. recalls Backless Yoga Chair

The chairs may have missing screws or washers, loose screws or inadequate spot welding, resulting in potential collapse of the chair and injury to the user.

Health Canada

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Modification of the existing maximum residue level for flonicamid in various crops

Modification of the existing maximum residue level for flonicamid in various crops

Published on: Tue, 25 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Ne...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Modification of the existing maximum residue level for clothianidin in potatoes

Modification of the existing maximum residue level for clothianidin in potatoes

Published on: Thu, 20 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer CropScience AG submitted a request to the competent national authority in Germany to modify the existing maximum residue level (MRL) for the active substance clothianidin to accommodate the use on potatoes imported from Canada. The data submitted in support of the request were found to be sufficient to derive a MRL proposal. Adequate analytical methods for enforcement are availa...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Modification of the existing maximum residue levels for potassium phosphonates in certain berries and small fruits

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant LTZ Augustenberg submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in raspberries, blackberries, currants, blueberries, gooseberries and elderberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all crops under c...

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

Modification of the existing maximum residue levels for flonicamid in various root crops

Modification of the existing maximum residue levels for flonicamid in various root crops

Published on: Tue, 18 Sep 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Council submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance flonicamid in beetroots, carrots, celeriacs/turnip rooted celeries, horseradishes, Jerusalem artichokes, parsnips, parsley roots/Hamburg roots parsley, radishes, salsifies, swedes/rutabagas, tu...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Setting of import tolerances for mandestrobin in strawberries and table and wine grapes

Published on: Thu, 16 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe SAS submitted a request to the competent national authority in Austria to set an import tolerance for the active substance mandestrobin in strawberries, table grapes and wine grapes. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for the crops under consideration. Adequate analytica...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

8-8-2018

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

FDA approves first generic drug under Competitive Generic Therapy (CGT) designation for products with inadequate generic competition

FDA - U.S. Food and Drug Administration

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Testing by the CSA Group has shown that glasses distributed between October 2017 and April 2018 do not comply with the side impact requirements of the safety standard for eye and face protectors. The affected safety glasses may not provide adequate protection against side impact, posing a risk of eye injury.

Health Canada

14-6-2018

ANSES consolidates its presence in Boulogne-sur-Mer!

ANSES consolidates its presence in Boulogne-sur-Mer!

Centrally located in the port of Boulogne-sur-Mer, the Laboratory for Food Safety's site specialising in fishery and aquaculture products is expanding! This extension, financed jointly by the Hauts-de-France Region and the local community, underlines ANSES's scientific investment in Boulogne-sur-Mer and is fully consistent with regional research dynamics for the quality and safety of aquatic products.

France - Agence Nationale du Médicament Vétérinaire

21-5-2018

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls

Manufacturing products without proper process controls increases the probability that products will vary in strength, quality and purity

FDA - U.S. Food and Drug Administration

18-5-2018

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. Issues Voluntary Nationwide Recall of Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir Due to a Lack of Process Controls

MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls.

FDA - U.S. Food and Drug Administration

30-11-2018

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer  Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack  of Adequate Validation and Controls to Ensure Product Cleanliness. Read  more about the recall:  https://go.us

.@US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.us

. @US_FDA issues class I recall, the most serious type pf recall: Zimmer Biomet, Inc. Recalls Spinal Fusion & Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness. Read more about the recall: https://go.usa.gov/xPMEK  #MedicalDevice pic.twitter.com/M55ddC98wW

FDA - U.S. Food and Drug Administration

21-10-2018

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Cli

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Cli

Fortunately, while women were underrepresented, the trials were large enough w/adequate #’s of women to determine safety and effectiveness. #FDA continues taking steps to encourage greater inclusion of women in trials, including OWH’s Diverse Women in Clinical Trials Initiative. pic.twitter.com/20d9Sg2vqn

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

13-9-2018

 European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

European Medicines Agency stakeholder interaction on the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH), European Medicines Agency, London, UK, From: 03-Dec-2018, To: 03-Dec-2018

This workshop on the development of medicines for chronic non-infectious liver diseases, including primary biliary cholangitis, primary sclerosing cholangitis and nonalcoholic steatohepatitis, provides a platform for discussion on appropriate endpoints including validation of surrogate endpoints/biomarkers, suitable study populations, potentially adequate trial designs and the specific challenges with paediatric medicine development. The workshop will support the drafting of a reflection paper on regul...

Europe - EMA - European Medicines Agency

5-9-2018

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical dev

Patients may not have access to an #FDA approved or cleared device in the absence of adequate coverage. That’s why we’re expanding our work with private payors to help narrow the time it takes for payors to make a coverage determination on new medical devices

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

Scientific guideline: Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies, draft: consultation open

The guideline aims to address the use of undetectable minimal residual disease (MRD) as an intermediate efficacy endpoint in controlled randomised clinical studies in patients with multiple myeloma (MM), adequately designed to demonstrate efficacy by relevant hard endpoints. MRD as an endpoint in this context would allow earlier approval of new drugs pending final confirmatory data.

Europe - EMA - European Medicines Agency