ECO-STAR SOUR PLUS

Informasi Utama

  • Nama dagang:
  • ECO-STAR SOUR PLUS
  • 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:
  • ECO-STAR SOUR PLUS
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 919286
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

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BAGIAN 1. IDENTIFIKASI PRODUK DAN PERUSAHAAN

Nama produk

ECO-STAR SOUR PLUS

Cara identifikasi lainnya

Tidak berlaku.

Penggunaan yang dianjurkan

Produk binatu

Pembatasan penggunaan

Disediakan untuk penggunaan industrial dan profesional.

Informasi pengenceran

produk

Produk dijual siap pakai.

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

03.05.2017

BAGIAN 2. IDENTIFIKASI BAHAYA

Klasifikasi GHS

Korosi/iritasi kulit

Kategori 1

Kerusakan mata serius/iritasi

pada mata

Kategori 1

Elemen label GHS

Piktogram bahaya

Kata sinyal

Bahaya

Pernyataan Berbahaya

Menyebabkan kulit terbakar yang parah dan kerusakan mata.

Pernyataan Hati-hati

Pencegahan:

Cuci kulit dengan seksama setelah menangani. 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:

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.

Penyimpanan:

Simpan di tempat terkunci.

Pembuangan:

Buang isi / wadah ke tempat pembuangan limbah yang disetujui.

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Bahaya lain

Jangan dicampur dengan pemutih atau produk lain yang mengandung

klor - akan menyebabkan gas klorin.

BAGIAN 3. KOMPOSISI/INFORMASI TENTANG BAHAN PENYUSUN

Bahan/preparasi murni

Campuran

Nama kimia

No-CAS

Konsentrasi (%)

Asam fluorosilikat

16961-83-4

10 - 30

BAGIAN 4. TINDAKAN PERTOLONGAN PERTAMA PADA KECELAKAAN

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.

Tangani secara medis jika muncul gejala.

Perlindungan aiders pertama

Bila ada bahaya kontaminasi lihat bab 8 tentang perlengkapan

melindungi diri.

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.

BAGIAN 5. TINDAKAN PEMADAMAN KEBAKARAN

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

Alat pelindung khusus bagi

petugas pemadam

kebakaran

Gunakan alat pelindung diri.

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Metode pemadaman khusus

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

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.

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).Siramlah sisa-sisa dengan air. 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

saran penanganan yang

aman

Jangan dimakan. 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. Jangan dicampur dengan pemutih atau produk lain

yang mengandung klor - akan menyebabkan gas klorin.

Kondisi untuk penyimpanan

yang aman

Jauhkan dari zat-zat basa kuat. Jauhkan dari jangkauan anak-anak.

Jaga wadah tertutup rapat. Simpan dalam wadah yang berlabel

sesuai.

Suhu penyimpanan

-5 °C ke 45 °C

BAGIAN 8. KONTROL PAPARAN/ PERLINDUNGAN DIRI

Komponen dengan parameter pengendalian di tempat kerja

Tidak mengandung bahan-bahan yang mempunyai nilai batas eksposur pekerjaan.

Pengendalian teknik yang

sesuai

Sistem ventilasi pembuangan yang efektif. Jaga konsentrasi udara di

bawah standar paparan okupasional.

Alat Pelindung Diri

Perlindungan mata

Katamata pelindung keamanan

Topeng-wajah

Perlindungan tangan

Kenakan perlengkapan perlindungan pribadi berikut ini:

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Jenis sarung tangan standar.

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.

BAGIAN 9. SIFAT FISIKA DAN KIMIA

Tampilan

: cair

Warna

: bening, Tanpa-warna

: Lemah

0.5 - 2.0, (100 %)

Titik nyala

Tidak berlaku.

Ambang Bau

Data tidak tersedia

Titik lebur/titik beku

Data tidak tersedia

Titik didih awal/rentang didih

> 100 °C

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

1.19 - 1.25

Kelarutan dalam air

larut

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

Bahan atau campuran ini tidak diklasifikasikan sebagai pengoksidasi.

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Berat Molekul

Data tidak tersedia

Data tidak tersedia

BAGIAN 10. STABILITAS DAN REAKTIFITAS

Stabilitas kimia

Stabil pada kondisi normal.

Kemungkinan reaksi

berbahaya

Jangan dicampur dengan pemutih atau produk lain yang mengandung

klor - akan menyebabkan gas klorin.

Kondisi yang harus dihindari

Tidak ada yang diketahui.

Bahan non-kompatibel

Agen pemutih berbasis klorin

Basa

Tembaga

Bahan organik

Produk berbahaya hasil

peruraian

Hasil penguraian mungkin termasuk bahan-bahan berikut:

Karbon oksida

BAGIAN 11. INFORMASI TOKSIKOLOGI

Informasi tentang rute

paparan

Penghirupan, Kena mata, Kena kulit

Kemungkinan Dampak Kesehatan

Mata

Menyebabkan kerusakan mata yang serius.

Kulit

Menimbulkan sensasi terbakar yang parah pada kulit.

Tertelan

Menyebabkan sensasi terbakar pada saluran pencernaan.

Penghirupan

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

Eksposur Kronis

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Pengalaman dengan paparan pada manusia

Kena mata

Kemerahan, Nyeri, Korosi

Kena kulit

Kemerahan, Nyeri, Korosi

Tertelan

Korosi, Sakit perut

Penghirupan

Iritasi alat pernafasan, Batuk

Toksisitas

Produk

Toksisitas oral akut

: Perkiraan toksisitas akut : 2,024 mg/kg

Perkiraan toksisitas akut : > 2,000 mg/kg

Toksisitas inhalasi akut

: Data tidak tersedia

Toksisitas kulit akut

: Data tidak tersedia

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Kerusakan/gangguan kulit

Data tidak tersedia

Gangguan mata/kerusakan

mata serius

Data tidak tersedia

Sensitisasi sistem

pernafasan atau kulit

Data tidak tersedia

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

Derajat racun bagi lingkungan (ekotoksisitas)

Dampak lingkungan

Produk ini tidak mempunyai dampak racun lingkungan yang diketahui.

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

Keracunan untuk ikan

: Asam fluorosilikat

96 h LC50 Ikan: 50 mg/l

Ketahanan dan tingkat penguraian

Mudah terurai secara hayati.

Potensi penumpukan biologis

Data tidak tersedia

Mobilitas di dalam tanah

Data tidak tersedia

Dampak merugikan lainnya

Data tidak tersedia

BAGIAN 13. PERTIMBANGAN PEMBUANGAN/ PEMUSNAHAN

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.

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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

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

penandaan yang sesuai dengan jenis transportasi yang digunakan.

Transpor jalan

Nomor UN

1778

deskripsi barang

FLUOROSILICICACID

Kelas

Kelompok pengemasan

Berbahaya bagi lingkungan

Tidak

Transpor laut (IMDG/IMO)

Nomor UN

1778

deskripsi barang

FLUOROSILICIC ACID

Kelas

Kelompok pengemasan

Bahan pencemar laut

Tidak

BAGIAN 15. INFORMASI YANG BERKAITAN DENGAN REGULASI

Regulasi domestik

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

Komponen-komponen produk ini dilaporkan dalam inventorisasi berikut:

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 :

Sesuai dengan inventaris

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

Sesuai dengan inventaris

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

Sesuai dengan inventaris

Inventaris Bahan Kimia dan Senyawa Kimia Filipina (PICCS) :

Sesuai dengan inventaris

Cina. Inventaris Senyawa Kimia yang Sudah Ada :

Sesuai dengan inventaris

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Daftar Senyawa Kimia Taiwan :

Sesuai dengan inventaris

BAGIAN 16. INFORMASI LAIN

Tanggal penerbitan pertama

03.05.2017

Versi

Disiapkan oleh

Urusan peraturan

Perbahan-perubahan peraturan atau informasi kesehatan yang signifikan dalam revisi ini ditunjukkan

oleh batang di bagian sisi kiri MSDS.

Informasi yang diberikan dalam Lembar Data Keselamatan ini benar menurut pengetahuan, informasi,

dan keyakinan kami pada tanggal penerbitan. Informasi yang diberikan dimaksudkan hanya sebagai

pedoman untuk penanganan, penggunaan, pemprosesan, penyimpanan, pengangkutan,

pembuangan, dan pembebasan yang aman dan tidak boleh dianggap sebagai jaminan atau

spesifikasi mutu. Informasi hanya menyangkut bahan spesifik yang telah ditentukan dan dapat tidak

berlaku jika bahan tersebut digunakan sebagai campuran dengan bahan lain atau dalam proses lain

kecuali jika dinyatakan secara spesifik dalam tulisan.

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Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

31-1-2019

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information derived from the year 2018

Manual for reporting on zoonoses and zoonotic agents, within the framework of Directive 2003/99/EC, and on some other pathogenic microbiological agents for information derived from the year 2018

Published on: Wed, 30 Jan 2019 This reporting manual provides guidance to Member States (MSs) for reporting on zoonoses and zoonotic agents in animals, food and feed under the framework of Directive 2003/99/EC and also on the reporting of other pathogenic microbiological agents in food. The objective of this manual is to harmonise and streamline reporting by MSs to ensure that the data collected are relevant and comparable for analysis at the European Union (EU) level. This manual covers all the zoonose...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-1-2019

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 9: suitability of taxonomic units notified to EFSA until September 2018

Published on: Thu, 24 Jan 2019 The qualified presumption of safety (QPS) procedure was developed to provide a harmonised generic pre‐evaluation to support safety risk assessments of biological agents performed by EFSA's Scientific Panels. The taxonomic identity, body of knowledge, safety concerns and antimicrobial resistance were assessed. Safety concerns identified for a taxonomic unit are, where possible and reasonable in number, reflected by ‘qualifications’ which should be assessed at the strain lev...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

ANSES recommends improving baby diaper safety

ANSES recommends improving baby diaper safety

Today, ANSES published its assessment of the risks of chemicals found in baby diapers. Based on tests conducted on disposable diapers and their use, the Agency’s assessment highlighted several chemicals for which safety threshold values were exceeded. With regard to the possible risks of these chemicals to baby health, ANSES recommends eliminating these latter or reducing their levels as much as possible in disposable diapers.

France - Agence Nationale du Médicament Vétérinaire

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

Data sources on animal diseases: Country Card of Ireland

Data sources on animal diseases: Country Card of Ireland

Published on: Mon, 21 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 ;project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Poland

Data sources on animal diseases: Country Card of Poland

Published on: Fri, 18 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Belgium

Data sources on animal diseases: Country Card of Belgium

Published on: Fri, 18 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Portugal

Data sources on animal diseases: Country Card of Portugal

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Lithuania

Data sources on animal diseases: Country Card of Lithuania

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Spain

Data sources on animal diseases: Country Card of Spain

Published on: Thu, 17 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-1-2019

Data sources on animal diseases: Country Card of Latvia

Data sources on animal diseases: Country Card of Latvia

Published on: Thu, 17 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

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

18-1-2019

Data sources on animal diseases: Country Card of Greece

Data sources on animal diseases: Country Card of Greece

Published on: Wed, 16 Jan 2019 Mapping ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresponding ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Austria

Data sources on animal diseases: Country Card of Austria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the corresp...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Cyprus

Data sources on animal diseases: Country Card of Cyprus

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State is one of the activities of EFSA's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspond...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-1-2019

Data sources on animal diseases: Country Card of Bulgaria

Data sources on animal diseases: Country Card of Bulgaria

Published on: Wed, 16 Jan 2019 Mapping the ‘data sources’ on animal diseases in each European Union (EU) Member State, is one of the activities of EFSA 's SIGMA1,2 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which EFSA is currently working): African swine fever, avian influenza and lumpy skin disease; and on the correspo...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Genotoxicity assessment of chemical mixtures

Genotoxicity assessment of chemical mixtures

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Guidance on Communication of Uncertainty in Scientific Assessments

Guidance on Communication of Uncertainty in Scientific Assessments

Published on: Wed, 16 Jan 2019 This document provides guidance for communicators on how to communicate the various expressions of uncertainty described in EFSA's document: ‘Guidance on uncertainty analysis in scientific assessments’. It also contains specific guidance for assessors on how best to report the various expressions of uncertainty. The document provides a template for identifying expressions of uncertainty in scientific assessments and locating the specific guidance for each expression. The g...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) as a feed additive for turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised for laying

Published on: Mon, 14 Jan 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of B‐Act® when used in feed for turkeys for fattening, reared for breeding and minor poultry species for fattening or raised for laying. B‐Act® is a preparation containing viable spores of a Bacillus licheniformis strain. This species is considered by EFSA to be suitable for the qua...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Software for Benchmark Dose Modelling

Software for Benchmark Dose Modelling

Published on: Mon, 14 Jan 2019 In specific contract No 7 issued under the framework agreement OC/EFSA/AMU/2015/02, EFSA requested Open Analytics to extend the Web application for Benchmark Dose Modelling built under specific contracts No 3 and No 4. The Web application is further developed in R with focus on creating a graphical module to evaluate model fit and to modify specific plot settings, as specified in the Technical Annex to Specific Contract No 7. The web application includes the latest develop...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Safety and efficacy of HOSTAZYM® X (endo‐1,4‐beta‐xylanase) as a feed additive for rabbits for fattening

Published on: Fri, 11 Jan 2019 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 the safety and efficacy of HOSTAZYM® X as a feed additive for rabbits for fattening. HOSTAZYM® X contains endo‐1,4‐beta‐xylanase produced by a strain of Trichoderma citrinoviride and is available in liquid and solid formulations. It is authorised as a feed additive for chickens for fattening, turkeys f...

Europe - EFSA - European Food Safety Authority EFSA Journal

10-1-2019

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Safety evaluation of the food enzyme alpha‐amylase from a genetically modified Trichoderma reesei (strain DP‐Nzb48)

Published on: Wed, 09 Jan 2019 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with a genetically modified strain of Trichoderma reesei by Danisco US Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organic solids (TOS) are removed by distill...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-1-2019

Monitoring sales of veterinary antimicrobials

Monitoring sales of veterinary antimicrobials

Veterinary antimicrobial sales have been monitored annually by the Agency since 1999. This monitoring is based on the recommendations in Chapter 6.8 of the OIE's 2016 Terrestrial Animal Health Code "Monitoring of the quantities and usage patterns of antimicrobial agents used in food-producing animals".

France - Agence Nationale du Médicament Vétérinaire

8-1-2019

Resapath

Resapath

The development of antimicrobial resistance in animal and human bacteria is a major public health issue requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to combat antimicrobial resistance, in particular by coordinating the French Surveillance Network for Antimicrobial Resistance in Pathogenic Bacteria of Animal Origin (Resapath), which is devoted to monitoring resistance in bact...

France - Agence Nationale du Médicament Vétérinaire

8-1-2019

Antimicrobial resistance

Antimicrobial resistance

Antimicrobial resistance is a major international human and animal health issue, because the emergence and spread of drug-resistant strains of bacteria call into question the efficacy of these treatments in humans and animals alike. Preserving the effectiveness of antibiotics is therefore a genuine public health challenge requiring an integrated approach across all types of medicine, according to the "One Health" concept covering both humans and animals. ANSES has mobilised significant resources to addr...

France - Agence Nationale du Médicament Vétérinaire

4-1-2019

Bee health

Bee health

For several years now, a phenomenon resulting in the weakening and mortality of bee colonies has been seen in many countries. In this context, the impact of various factors that may act alone or in combination on the health of bee colonies (infectious and parasitic diseases, stress related to changes in food resources, plant protection products, climate conditions, etc.) has regularly been demonstrated through different scientific studies. Below is an update on this issue and details of the Agency's work.

France - Agence Nationale du Médicament Vétérinaire

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

20-12-2018

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Data sources on animal diseases: Methodology on mapping the data sources on animal diseases in European Union Member States

Published on: Wed, 19 Dec 2018 Mapping the ‘data sources’ on animal diseases, in each European Union (EU) Member State, is one of the activities of EFSA's SIGMA1 project. The aim of this activity is to identify the central competent authorities responsible for managing the data on animal diseases and animal populations in each Member State. Initially EFSA is focusing on three diseases (on which Animal Health and Plant Health Unit is currently working): African swine fever, avian influenza and lumpy skin...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

6-2-2019

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations:  https://go.usa.gov/xENj4  #MedicalDevicepic.twitter.com/szwLQ8FvxA

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4  #MedicalDevicepic.twitter.com/szwLQ8FvxA

Today, the @US_FDA issued a Letter to Healthcare Providers about diagnosing and treating BIA-ALCL. Click to read more about the #FDA's recommendations: https://go.usa.gov/xENj4  #MedicalDevice pic.twitter.com/szwLQ8FvxA

FDA - U.S. Food and Drug Administration

31-1-2019

Today @US_FDA issued a safety communication to providers and patients  about the risks of air-in-line when using infusion pumps, rapid  infusers, and fluid warmers. Find out more about the risks and #FDA  recommendations:  https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  ##Medi

Today @US_FDA issued a safety communication to providers and patients about the risks of air-in-line when using infusion pumps, rapid infusers, and fluid warmers. Find out more about the risks and #FDA recommendations: https://go.usa.gov/xE9g7  # #MedicalDevice pic.twitter.com/lLIyoG6680

FDA - U.S. Food and Drug Administration

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Scientific recommendation on classification of advanced therapy medicinal products: Codon-optimized mRNA that will be translated to functional human cystic fibrosis transmembrane conductance regulator protein after cellular uptake

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Scientific recommendation on classification of advanced therapy medicines: Allogeneic Epstein-Barr Virus specific cytotoxic T lymphocytes

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Scientific recommendation on classification of advanced therapy medicines: In vitro cultured autologous mesenchymal stem cells isolated from bone marrow

Europe - EMA - European Medicines Agency

7-1-2019


Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Scientific recommendation on classification of advanced therapy medicinal products: Recombinant adeno-associated virus serotype 9 vector encoding the soluble lysosomal enzyme TPP1

Europe - EMA - European Medicines Agency

4-1-2019


New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

New product information wording: extracts from PRAC recommendations on signals adopted at the 26-29 November 2018 PRAC

Europe - EMA - European Medicines Agency

2-1-2019

Medicine shortages guidance and resources

Medicine shortages guidance and resources

Medicine Shortages Information Initiative - Critical medicine shortages and other information

Therapeutic Goods Administration - Australia

19-12-2018


Recommendations on eligibility to PRIME scheme -  Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 10-13 December 2018

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Mesenchymal stem cells isolated from autologous bone marrow

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous melanocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous muscle-derived stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Scientific recommendation on classification of advanced therapy medicinal products: Human autologous keratinocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Scientific recommendation on classification of advanced therapy medicinal products: Viable human autologous skin fibroblasts

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Scientific recommendation on classification of advanced therapy medicinal products: In vitro cultured autologous chondrocytes

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Scientific recommendation on classification of advanced therapy medicinal products: Autologous cultured adipose derived mesenchymal stem cells

Europe - EMA - European Medicines Agency

18-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Scientific recommendation on classification of advanced therapy medicinal products: Extracellular matrix isolated from adipose tissue

Europe - EMA - European Medicines Agency