Marketguard Quat Sanitizer

Informasi Utama

  • Nama dagang:
  • Marketguard Quat Sanitizer
  • 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:
  • Marketguard Quat Sanitizer
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 926808-08
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

Marketguard Quat Sanitizer

desinfektan

LEMBAR DATA KEAMANAN

Nama produk

Penggunaan dan

pembatasan yang

direkomendasikan

Nomor telepon darurat

:

:

Informasi pemasok

:

Marketguard Quat Sanitizer

Gunakan hanya untuk tujuan pada label produk.

:

Bagian 1. Identifikasi produk kimia dan perusahaan

Nama-nama lain

:

Tidak ada.

Informasi pengenceran

produk

:

0.20

PT. Ecolab Indonesia

Jl. Jababeka XII Kav V-37

Kawasan Industri jababeka, Cikarang

Indonesia 17350

Tel : (62-21) 5707557 Fax : (62-21) 5707682

+1 651-222-5352

KOROSI/IRITASI KULIT - 1B

IRITASI/ KERUSAKAN PARAH PADA MATA -

BAHAYA TOKSISITAS AKUT PADA

LINGKUNGAN AKUATIK - 2

Klasifikasi GHS

(Globally

Harmonised System

~ Sistim Harmonisasi

Global)

:

Kata sinyal

:

Berbahaya

Pernyataan bahaya

:

Menyebabkan luka bakar yang parah pada kulit

dan kerusakan mata.

Beracun terhadap kehidupan akutik.

Piktogram

:

Pernyataan kehati-hatian

Pencegahan

:

Kenakan sarung tangan pelindung. Kenakan

pelindung mata atau wajah. Kenakan pakaian

pelindung. Hindari pelepasan ke lingkungan.

Cuci tangan dengan bersih setelah

penanganan.

Tanggapan

:

JIKA TERHIRUP: Pindahkan korban ke udara

segar dan menjaga nyaman untuk bernafas.

Segera hubungi Pusat Penanggulangan

Keracunan atau tenaga medis. JIKA

TERTELAN: Segera hubungi Pusat

Penanggulangan Keracunan atau tenaga

medis. Kumur. JANGAN merangsang muntah.

JIKA TERKENA KULIT (atau rambut): Segera

tanggalkan semua pakaian yang

2. Identifikasi Bahaya

Elemen label GHS

Produk TERJUAL

Penggunaan produk dicairkan

Tidak diklasifikasikan.

Tanpa Kata Sinyal

Tidak diketahui efek signifikan atau bahaya

kritis.

Cuci sepenuhnya sesudah penanganan.

Tidak berlaku.

926808-08

Halaman: 1/7

Marketguard Quat Sanitizer

2. Identifikasi Bahaya

terkontaminasi. Cuci kult dengan air atau

pancuran. Cuci pakaian yang terkontaminasi

sebelum dipakai kembali. Segera hubungi

Pusat Penanggulangan Keracunan atau tenaga

medis. JIKA TERKENA MATA: Bilas secara

hati-hati dengan air selama beberapa menit.

Lepaskan lensa kontak jika memakainya dan

mudah dilakukan. Lanjutkan membilas. Segera

hubungi Pusat Penanggulangan Keracunan

atau tenaga medis.

Penyimpanan

:

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Pembuangan

:

Buang isi dan wadah sesuai dengan peraturan

lokal, regional, nasional dan internasional.

Bahaya lain

:

Tidak diketahui.

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Tidak berlaku.

Tidak diketahui.

Campuran

3. Komposisi/ Informasi tentang Bahan Penyusun Senyawa tunggal

Zat/sediaan

:

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

10 - 30

68424-85-1

ETIL ALKOHOL

1 - 10

64-17-5

Komponen-komponen yang berbahaya

Nomor CAS

Rentang konsentrasi (%)

Produk TERJUAL

Penggunaan produk dicairkan

Tidak terdapat bahan yang, sejauh pengetahuan pemasok saat ini dan pada konsentrasi yang berlaku,

diklasifikasikan sebagai berbahaya pada kesehatan atau lingkungan dan karenanya diperlukan pelaporan dalam

bagian ini.

Segera dapatkan pertolongan medis. Kumur.

Jangan memaksa muntah.

Bilas secara hati-hati dengan air selama

beberapa menit. Lepaskan lensa kontak jika

memakainya dan mudah dilakukan. Lanjutkan

membilas. Segera dapatkan pertolongan medis.

Segera tanggalkan semua pakaian yang

terkontaminasi. Cuci kult dengan air atau

pancuran. Segera dapatkan pertolongan medis.

Cuci pakaian sebelum dikenakan lagi. Bersihkan

sepatu secara menyeluruh sebelum digunakan

kembali.

Pindahkan korban ke udara segar dan

istirahatkan pada posisi yang nyaman untuk

bernafas. Segera dapatkan pertolongan medis.

Kontak mata

Kontak kulit

Penghirupan

Tertelan

:

:

:

:

Perlindungan bagi

penolong pertama

:

Tidak boleh melakukan tindakan yang menyangkut risiko pribadi atau tanpa pelatihan yang

sesuai. Mungkin dapat membahayakan bagi orang yang memberikan pertolongan resusitasi dari

mulut-ke-mulut. Cuci pakaian yang terkontaminasi dengan air sampai bersih sebelum

melepaskannya, atau memakai sarung tangan.

Catatan untuk

dokter

:

Obati berdasarkan gejala. Segera menghubungi ahli perawatan racun jika jumlah besar

termakan atau terhirup.

Lihat informasi toksikologi (bagian 11)

4. Tindakan Pertolongan Pertama

Produk TERJUAL

Penggunaan produk dicairkan

Efek setelah terkena mata tidak diketahui.

Bilas dengan air selama beberapa menit.

Efek setelah terkena kulit tidak diketahui.

Bilas dengan air selama beberapa menit.

Tidak perlu tindakan khusus. Obati

berdasarkan gejala.

Dapatkan pertolongan medis jika terjadi

gejala.

926808-08

Halaman: 2/7

Marketguard Quat Sanitizer

Jika ada kebakaran segera isolasi tempat kejadian dengan menjauhkan semua

orang dari lokasi kebakaran. Tidak boleh melakukan tindakan yang menyangkut

risiko pribadi atau tanpa pelatihan yang sesuai.

Produk dekomposisi termal

berbahaya

Bahaya spesifik yang

diakibatkan bahan kimia

tersebut

Bahan-bahan berikut ini mungkin dapat termasuk golongan produk penguraian-

hayati:

karbon dioksida

karbon monoksida

Dalam kebakaran atau jika dipanaskan, peningkatan tekanan akan terjadi dan

wadah bisa meledak. Bahan ini toksik bagi kehidupan air. Air bekas memadamkan

kebakaran yang tercemar dengan bahan ini harus dibendung dan dicegah agar

tidak mengalir masuk/dibuang ke saluran air, parit, atau selokan.

Petugas pemadam kebakaran harus memakai perlengkapan pelindung yang

memadai dan alat bantu pernapasan (Self-Contained Breathing Apparatus - SCBA)

yang berpelindung-wajah penuh dan yang beroperasi dalam mode tekanan positif.

Alat pelindung khusus

untuk petugas pemadam

kebakaran

Gunakan semprotan air, kabut atau busa.

:

:

:

Media yang sesuai untuk

pemadaman kebakaran

:

:

5. Tindakan Pemadaman Kebakaran

Produk TERJUAL

Langkah-langkah

pencegahan bagi

lingkungan

Tindakan

pencegahan pribadi

:

:

Segera laksanakan prosedur perusahaan untuk

menanggulangi tumpahan. Jauhkan orang-orang

dari tepat tumpahan. Kenakan perlengkapan

pelindung pribadi yang layak (lihat bagian 8).

Jangan menyentuh atau berjalan kaki melintasi

tumpahan bahan.

Mencegah pengaliran tumpahan bahan ke tanah

dan ke saluran air yang terbuka.

Patuhi prosedur perusahaan mengenai

tumpahan. Jauhkan orang-orang dari tumpahan.

Kenakan perlengkapan pelindung pribadi yang

layak (lihat bagian 8). Serap/netralisasi bahan

cairan. Gunakan alat untuk menyekop padatan

atau bahan yang terserap dan masukkan ke

dalam wadah berlabel yang layak. Gunakan alat

untuk menyekop padatan atau bahan yang

terserap lalu masukkan ke dalam wadah limbah

berlabel yang layak. Gunakan air bilas untuk

pembersihan akhir.

Metode untuk

membersihan

:

6. Tindakan Penanggulangan jika terjadi Kebocoran

Produk TERJUAL

Penggunaan produk dicairkan

Gunakan alat pelindung diri sesuai

kebutuhan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran

air di permukaan tanah.

Gunakan air bilas untuk pembersihan akhir.

Menangani/

Penanganan

Penyimpanan

Jangan terkena mata atau kulit atau pakaian.

Jangan menghirup uap atau kabut. Gunakan

hanya dengan ventilasi yang memadai. Cuci

sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak. Pastikan

wadah tertutup rapat.

:

:

7. Penanganan dan Penyimpanan

Produk TERJUAL

Penggunaan produk dicairkan

Cuci sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak.

Simpan dalam suhu antara: 0 dan 50°C

926808-08

Halaman: 3/7

Marketguard Quat Sanitizer

Perlindungan

tangan

Tidak diperlukan respirator dalam kondisi normal

dan kondisi yang ditentukan untuk penggunaan

produk.

Gunakan sarung tangan yang kuat, tahan-kimia.

Gunakan kacamata pelindung. Selanjutnya

gunakan pelindung wajah.

Perlindungam mata

Perlindungan

pernapasan

:

:

:

Perlindungan kulit

Gunakan celemek sintetis, peralatan pelindung

lainnya yang diperlukan untuk mencegah kontak

kulit.

:

Pengendalian teknik

yang sesuai

:

Gunakan hanya dengan ventilasi yang memadai.

Jika pengoperasian pemakai menimbulkan debu,

asap, gas, uap atau kabut, gunakan daerah kerja

terkurung, ventilasi pembuangan lokal atau

kontrol teknis lainnya untuk menjaga agar

pekerja tidak terbuka terhadap kontaminan

terbawa-udara di atas batas yang

direkomendasikan atau ketentuan hukum.

Menyediakan fasilitas untuk cepat membasahi

atau pembilasan pada mata dan tubuh pada

kasus kontak atau bahaya lain.

Cuci tangan, lengan dan wajah sampai bersih setelah menangani produk kimia, sebelum

makan, merokok dan menggunakan WC dan seusai waktu kerja. Teknik yang sesuai harus

digunakan untuk melepaskan/membuang pakaian berpotensi terkontaminasi. Cuci pakaian

yang terkontaminasi sebelum dipakai kembali.

Tindakan higienis

:

Parameter pengendalian

Perlindungan perorangan

8. Kontrol Paparan/Perlindungan Diri

Produk TERJUAL

Penggunaan produk dicairkan

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap kadar kontaminasi yang terbawa-

udara.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak diperlukan respirator dalam kondisi

normal dan kondisi yang ditentukan untuk

penggunaan produk.

ETIL ALKOHOL

Departemen Tenaga Kerja (Indonesia,

2/2005).

NAB: 1880 mg/m³ 8 jam.

NAB: 1000 BDS 8 jam.

Nama bahan

Batas pemaparan

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Bentuk fisik

Titik lebur

Tekanan uap

Rapat uap

Cairan.

Tidak tersedia.

Tidak tersedia.

Tidak tersedia.

Rasa manis

Bau

pH

Merah

Warna

Laju penguapan

(butil asetat = 1)

Tidak tersedia.

Titik nyala

> 100°C

7.5 (100%)

:

:

:

:

:

:

:

:

:

Titik didih

:

Tidak tersedia.

Flamabilitas

(padatan, gas)

:

Tidak tersedia.

Batas ledakan

:

Tidak tersedia.

9. Sifat Fisika dan Kimia

Produk TERJUAL

Penggunaan produk dicairkan

Cairan.

Merah

Tidak berbau

7 sampai dengan 8

> 100°C

926808-08

Halaman: 4/7

Marketguard Quat Sanitizer

9. Sifat Fisika dan Kimia

Kerapatan relatif

Kelarutan

0.995 (Air = 1)

Tidak tersedia.

Suhu dapat

membakar sendiri

(auto-ignition)

Tidak tersedia.

Tidak tersedia.

Kekentalan

Tidak tersedia.

Koefisien partisi (n-

oktanol/air)

:

:

:

:

:

Suhu penguraian

Ambang bau

:

:

Tidak tersedia.

Tidak tersedia.

Hasil peruraian yang

berbahaya

Kondisi untuk dihindarkan

Tidak ada data khusus.

Pada kondisi penyimpanan dan penggunaan yang normal, produk-produk

penguraian-hayati yang berbahaya seharusnya tidak terproduksi.

Produk ini stabil.

Stabilitas

Tidak tersedia.

:

:

:

Bahan untuk dihindari

:

Kemungkinan reaksi yang

berbahaya

:

Dibawah kondisi penyimpanan dan penggunaan yang normal, reaksi yang

berbahaya tidak akan terjadi.

10. Stabilitas dan Reaktifitas

Produk TERJUAL

Rute Paparan

:

Kontak kulit, Kontak mata, Penghirupan, Tertelan

Toksisitas akut

Penghirupan

:

Dapat menyebabkan iritasi pernafasan.

Dapat menyebabkan luka bakar pada mulut,

tenggorokan dan perut.

:

Tertelan

Kontak kulit

:

Menyebabkan luka bakar parah.

Menyebabkan kerusakan serius pada mata.

:

Kontak mata

11. Informasi Toksikologi

Gejala

Kontak kulit

Tertelan

Penghirupan

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

batuk

Iritasi saluran pernapasan

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

sakit perut

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

pedih atau iritasi

kemerahan

kelepuhan bisa terjadi

:

:

:

Kontak mata

:

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

sakit/nyeri

berair

kemerahan

Produk TERJUAL

Penggunaan produk dicairkan

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

926808-08

Halaman: 5/7

Marketguard Quat Sanitizer

11. Informasi Toksikologi

Data toksisitas

Nama produk/bahan

Hasil

Spesies

Dosis

Tidak diketahui efek signifikan atau bahaya kritis.

Karsinogenisitas

:

Tidak diketahui efek signifikan atau bahaya kritis.

Mutagenisitas

:

Tidak diketahui efek signifikan atau bahaya kritis.

Teratogenisitas

:

Efek-efek perkembangan

selama masa pertumbuhan

:

Tidak diketahui efek signifikan atau bahaya kritis.

Efek-efek kesuburan

:

Tidak diketahui efek signifikan atau bahaya kritis.

Toksisitas kronis

BENZIL-(C12-C16 ALKIL)-DIMETIL-

AMONIUM KLORIDA

LD50 Kulit

Kelinci

3340 mg/kg

LD50 Mulut

Tikus besar

344 mg/kg

ETIL ALKOHOL

LC50 Penghirupan Uap

Tikus besar

117 mg/l

LD50 Kulit

Kelinci

15800 mg/kg

LD50 Mulut

Tikus besar

10470 mg/kg

Mobilitas dalam tanah

Tidak tersedia.

:

LogP

ow

BCF

Potensial

Potensi bioakumulasi

Efek merugikan lainnya

:

Tidak diketahui efek signifikan atau bahaya kritis.

Nama produk/bahan

Efek keracunan pada organisme air dan darat

Nama produk/bahan

Spesies

Hasil

Pemaparan

Persistensi dan kemudahan terurai

Nama produk/bahan

Uji

Dosis

Hasil

Zat inokulasi

Ekotoksisitas

:

Bahan ini toksik bagi kehidupan air.

12. Informasi Ekologi

Produk TERJUAL

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

KLORIDA

Akut LC50 0.515 mg/l

Ikan

96 jam

ETIL ALKOHOL

Akut LC50 11000 mg/l

Ikan

96 jam

Tidak tersedia.

ETIL ALKOHOL

-0.31

rendah

Hindari pembuangan. Upayakan untuk

menggunakan produk seluruhnya sesuai dengan

maksud penggunaannya. Pembuangan harus

sesuai dengan hukum dan peraturan yang

berlaku di tingkat regional, nasional dan lokal.

:

Metode

pembuangan

13. Pertimbangan Pembuangan/Pemusnahan

Produk TERJUAL

Penggunaan produk dicairkan

Produk diencerkan dapat disalurkan ke

saluran pembuangan sanitasi Buang

kemasan kosong di tempat sampah

14. Informasi Transportasi

Produk TERJUAL

926808-08

Halaman: 6/7

Marketguard Quat Sanitizer

14. Informasi Transportasi

Nomor PBB Nama pengapalan yang sesuai

Penggolongan

Informasi

pengaturan

PG*

Informasi tambahan

PG* : Kelompok pengemasan

Lihat dokumen pengapalan untuk informasi transportasi tertentu.

Penggunaan produk dicairkan

Tidak dimaksudkan untuk

transportasi.

Kelas ADR/RID

UN3082

ENVIRONMENTALLY

HAZARDOUS SUBSTANCE,

LIQUID, N.O.S. (BENZIL-

(C12-C16 ALKIL)-DIMETIL-

AMONIUM KLORIDA)

Nomor identifikasi

bahaya

Jumlah yang terbatas

Ketentuan khusus

274, 335, 601

Kode terowongan

Kelas IMDG

UN3082

ENVIRONMENTALLY

HAZARDOUS SUBSTANCE,

LIQUID, N.O.S. (BENZIL-

(C12-C16 ALKIL)-DIMETIL-

AMONIUM KLORIDA). Polutan

bahari

Jadwal darurat (EmS)

F-A, S-F

15. Informasi yang berkaitan dengan Regulasi

Regulasi tentang

lingkungan, kesehatan

dan keamanan untuk

produk tersebut

:

Produk TERJUAL

Penggunaan produk dicairkan

Sejauh diketahui tidak ada peraturan nasional

atau kedaerahan spesifik yang berlaku untuk

produk ini (termasuk bahan-bahan produk

tersebut).

Sejauh diketahui tidak ada peraturan

nasional atau kedaerahan spesifik yang

berlaku untuk produk ini (termasuk bahan-

bahan produk tersebut).

Sejarah / Riwayat

Tanggal terbitan

Informasi di atas diyakini benar sehubungan dengan formula yang digunakan untuk memproduksi produk di

negara asal. Sebagai data, standar, dan perubahan peraturan, dan ketentuan penggunaan dan penanganan

berada di luar kendali kami, TIDAK ADA GARANSI, TERSURAT MAUPUN TERSIRAT, DIBUAT SEBAGAI

KELENGKAPAN ATAU AKURASI LANJUTAN DARI INFORMASI INI.

Pemberitahuan kepada pembaca

Tanggal terbitan

sebelumnya

:

:

16. Informasi Lain

Referensi

Disiapkan oleh

:

Urusan peraturan

Tidak tersedia.

17 Apr 2013

Tidak ada validasi sebelumnya

926808-08

Halaman: 7/7

15-2-2019

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

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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...

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

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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 ...

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Modification of the existing maximum residue level for trifloxystrobin in broccoli

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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

6-6-2018

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA seeks permanent injunction against company selling unapproved hand sanitizers that claim to prevent infections from numerous pathogens

FDA - U.S. Food and Drug Administration

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