FIRST IMPRESSION

Informasi Utama

  • Nama dagang:
  • FIRST IMPRESSION
  • 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:
  • FIRST IMPRESSION
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 912477
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

FIRST IMPRESSION

Pelapis logam

LEMBAR DATA KEAMANAN

Nama produk

Penggunaan dan

pembatasan yang

direkomendasikan

Nomor telepon darurat

:

:

Informasi pemasok

:

FIRST IMPRESSION

Gunakan hanya untuk tujuan pada label produk.

:

Bagian 1. Identifikasi produk kimia dan perusahaan

Nama-nama lain

:

Tidak ada.

Informasi pengenceran

produk

:

Tidak berlaku

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

CAIRAN MUDAH MENYALA - 4

TOKSISITAS AKUT: ORAL - 5

KOROSI/IRITASI KULIT - 3

TOSISITAS SISTEMIK PADA ORGAN

TARGET SPESIFIK KARENA PAPARAN

TUNGGAL [Iritasi saluran pernapasan] - 3

Klasifikasi GHS

(Globally

Harmonised System

~ Sistim Harmonisasi

Global)

:

Kata sinyal

:

Peringatan

Pernyataan bahaya

:

Cairan yang dapat menyala (bila terjadi kontak

singkat dengan sumber nyala).

Mungkin berbahaya bila tertelan.

Menyebabkan iritasi kulit ringan.

Dapat menyebabkan iritasi pernafasan.

Piktogram

:

Pernyataan kehati-hatian

Pencegahan

:

Jauhkan dari nyala api dan permukaan yang

panas - dilarang merokok. Gunakan hanya di

udara terbuka atau di area dengan ventilasi

yang baik. Hindari menghirup uap.

2. Identifikasi Bahaya

Elemen label GHS

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

912477

Halaman: 1/7

FIRST IMPRESSION

2. Identifikasi Bahaya

Tanggapan

:

JIKA TERHIRUP: Pindahkan korban ke udara

segar dan menjaga nyaman untuk bernafas.

Hubungi Pusat Penanggulangan Keracunan

atau tenaga medis jika anda merasa kurang

sehat. JIKA TERTELAN: Hubungi Pusat

Penanggulangan Keracunan atau tenaga

medis jika anda merasa kurang sehat. Jika

terjadi iritasi kulit: Dapatkan nasihat medis.

Penyimpanan

:

Simpan di tempat berventilasi baik. Simpan

ditempat sejuk.

Pembuangan

:

Buang isi dan wadah sesuai dengan peraturan

lokal, regional, nasional dan internasional.

Bahaya lain

:

Tidak diketahui.

Campuran

3. Komposisi/ Informasi tentang Bahan Penyusun Senyawa tunggal

Zat/sediaan

:

KUARSA KRISTALIN

10 - 30

14808-60-7

Ammonia oleat

1 - 10

544-60-5

Garam amonium

1 - 10

3012-65-5

Komponen-komponen yang berbahaya

Nomor CAS

Rentang konsentrasi (%)

Produk dijual siap pakai.

Komponen-komponen yang berbahaya

Nomor CAS

Rentang konsentrasi (%)

Produk TERJUAL

Penggunaan produk dicairkan

Dapatkan pertolongan medis jika terjadi gejala.

Efek setelah terkena mata tidak diketahui. Bilas

dengan air selama beberapa menit.

Bilas dengan air beberapa menit. Jika terjadi

iritasi kulit: Dapatkan pertolongan medis.

Pindahkan korban ke udara segar dan

istirahatkan pada posisi yang nyaman untuk

bernafas. Dapatkan nasihat medis jika anda

merasa kurang sehat.

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.

Catatan untuk

dokter

:

Jika terhirup produk uraian dalam kebakaran, gejalanya mungkin tertunda. Orang yang terkena

mungkin harus terus berada dalam pengamatan medis selama 48 jam.

Lihat informasi toksikologi (bagian 11)

4. Tindakan Pertolongan Pertama

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

912477

Halaman: 2/7

FIRST IMPRESSION

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. Pindahkan wadah dari kebakaran

jika ini dapat dilakukan tanpa risiko. Gunakan semprotan air untuk menjaga agar

wadah yang terkena panasnya api tetap dingin.

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

oksida nitrogen

oksida logam/oksida

Cairan yang dapat menyala (bila terjadi kontak singkat dengan sumber nyala).

Dalam kebakaran atau jika memanas, peningkatan tekanan akan terjadi dan wadah

bisa meledak pecah, dengan risiko ledakan susulan. Aliran ke selokan dapat

menimbulkan kebakaran atau bahaya ledakan.

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 bahan kimia kering,

CO₂,

semprotan air atau busa.

:

:

:

Media yang sesuai untuk

pemadaman kebakaran

:

:

5. Tindakan Pemadaman Kebakaran

Produk TERJUAL

Langkah-langkah

pencegahan bagi

lingkungan

Tindakan

pencegahan pribadi

:

:

Menghilangkan semua sumber penyulut.

Gunakan alat pelindung diri sesuai kebutuhan.

Jangan menyentuh atau berjalan kaki melintasi

tumpahan bahan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran air di

permukaan tanah.

Jika petugas keadaan darurat tidak ada,

bendung dan kumpulkan tumpahan kecil dengan

bahan penyerap yang tidak mudah-menyala,

misalnya, pasir, tanah atau bahan lain yang

sesuai dan masukkan ke dalam wadah yang

layak untuk pembuangan. Gunakan air bilas

untuk pembersihan akhir.

Metode untuk

membersihan

:

6. Tindakan Penanggulangan jika terjadi Kebocoran

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

Menangani/

Penanganan

Jangan dimakan/diminum. Jangan terkena mata

atau kulit atau pakaian. Jangan menghirup uap

atau kabut. Jauhkan dari panas, percikan dan

nyala-api. Untuk menghindarkan kebakaran,

hilangkan sumber penyulut. Gunakan hanya

dengan ventilasi yang memadai. Cuci

sepenuhnya sesudah penanganan.

:

7. Penanganan dan Penyimpanan

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

912477

Halaman: 3/7

FIRST IMPRESSION

7. Penanganan dan Penyimpanan

Penyimpanan

Jauhkan dari jangkauan anak-anak. Pastikan

wadah tertutup rapat. Jaga agar wadah tertutup

rapat dan tersegel sampai siap untuk digunakan.

Simpan wadah di tempat yang sejuk dan

berventilasi baik. Hindari semua sumber yang

memungkinkan penyulutan (percikan api atau

nyala api). Simpan di tempat terpisah dan yang

diakui.

:

Simpan dalam suhu antara: 5 dan 45°C

Perlindungan

tangan

Tidak diperlukan respirator dalam kondisi normal

dan kondisi yang ditentukan untuk penggunaan

produk.

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

Perlindungam mata

Perlindungan

pernapasan

:

:

:

Perlindungan kulit

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

:

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.

Pengendalian teknis pun harus menjaga agar

konsentrasi gas, uap atau debu di bawah batas

ledakan terendah yang ada.

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

Produk dijual siap pakai.

KUARSA KRISTALIN

Departemen Tenaga Kerja (Indonesia,

2/2005).

NAB: 0.1 mg/m³ 8 jam. Berbentuk/bentuk:

partikel respirabel

Nama bahan

Batas pemaparan

Produk dijual siap pakai.

9. Sifat Fisika dan Kimia

912477

Halaman: 4/7

FIRST IMPRESSION

9. Sifat Fisika dan Kimia

Bentuk fisik

Titik lebur

Tekanan uap

Kerapatan relatif

Rapat uap

Kelarutan

Cairan.

Tidak tersedia.

1.14 sampai dengan 1.18 (Air = 1)

Tidak tersedia.

Tidak tersedia.

Tidak tersedia.

sitrus

Bau

pH

Buram / Tidak tembus cahaya

Warna

Laju penguapan

(butil asetat = 1)

Tidak tersedia.

Suhu dapat

membakar sendiri

(auto-ignition)

Titik nyala

Tidak tersedia.

74 °C (Cawan tertutup)

Produk tidak mendukung pembakaran

Tidak tersedia.

9.9 sampai dengan 10.4 (100%)

Kekentalan

Tidak tersedia.

Koefisien partisi (n-

oktanol/air)

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Titik didih

:

100°C (212°F)

Flamabilitas

(padatan, gas)

:

Tidak tersedia.

Batas ledakan

:

Tidak tersedia.

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

Suhu penguraian

Ambang bau

:

:

Tidak tersedia.

Tidak tersedia.

Hasil peruraian yang

berbahaya

Kondisi untuk dihindarkan

Hindari semua sumber yang memungkinkan penyulutan (percikan api atau nyala

api). Jangan diberi tekanan ,dipotong,dilas, disolder,dibor,digerinda atau wadah

dibiarkan dekat panas atau sumber pengapian.

Pada kondisi penyimpanan dan penggunaan yang normal, produk-produk

penguraian-hayati yang berbahaya seharusnya tidak terproduksi.

Produk ini stabil.

Stabilitas

Reaktif atau inkompabilitas dengan bahan-bahan berikut: bahan-bahan yang

mengoksidasi.

:

:

:

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

11. Informasi Toksikologi

912477

Halaman: 5/7

FIRST IMPRESSION

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

Toksisitas akut

Penghirupan

:

Dapat menyebabkan iritasi pernafasan.

Mungkin berbahaya bila tertelan.

:

Tertelan

Kontak kulit

:

Menyebabkan iritasi kulit ringan.

Dapat menyebabkan iritasi ringan pada mata.

:

Kontak mata

Gejala

Kontak kulit

Tertelan

Penghirupan

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

batuk

Iritasi saluran pernapasan

Tidak ada data khusus.

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

iritasi

kemerahan

:

:

:

Kontak mata

:

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

iritasi

berair

kemerahan

Produk TERJUAL

Penggunaan produk dicairkan

Produk dijual siap pakai.

Tidak tersedia.

Mobilitas dalam tanah

Tidak tersedia.

:

Efek merugikan lainnya

:

Tidak diketahui efek signifikan atau bahaya kritis.

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

:

Tidak diketahui efek signifikan atau bahaya kritis.

12. Informasi Ekologi

Produk TERJUAL

Tidak tersedia.

Tidak tersedia.

912477

Halaman: 6/7

FIRST IMPRESSION

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 dijual siap pakai.

Nomor PBB Nama pengapalan yang sesuai

Penggolongan

Informasi

pengaturan

PG*

Informasi tambahan

PG* : Kelompok pengemasan

Lihat dokumen pengapalan untuk informasi transportasi tertentu.

14. Informasi Transportasi

Produk TERJUAL

Penggunaan produk dicairkan

Tidak dimaksudkan untuk

transportasi.

Kelas ADR/RID

Tidak diatur.

Kelas IMDG

regulated.

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).

Produk dijual siap pakai.

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.

14 Mar 2013

Tidak ada validasi sebelumnya

912477

Halaman: 7/7

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Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Annual report of the Scientific Network on Microbiological Risk Assessment 2018

Published on: Fri, 14 Dec 2018 Among the tasks of EFSA, according to its founding regulation (Regulation (EC) No 178/2002), there is the establishment of a system of Networks of organisations operating in the fields within EFSA's mission, the objective being to facilitate a scientific cooperation framework by the coordination of activities, the exchange of information, the development and implementation of joint projects, the exchange of expertise and best practices. Additionally, the EFSA Science Strat...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Contaminants update: first of two opinions on PFAS in food

Contaminants update: first of two opinions on PFAS in food

Contaminants update: first of two opinions on PFAS in food

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

12-12-2018

White-Rodgers recalls First-Generation Emerson branded Sensi Wi-Fi Thermostats

White-Rodgers recalls First-Generation Emerson branded Sensi Wi-Fi Thermostats

The thermostat can be damaged by household line voltage (120 volts or 240 volts) during service or replacement of a heating or cooling system, posing a fire hazard.

Health Canada

30-11-2018

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

FDA - U.S. Food and Drug Administration

30-11-2018

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

The European Union summary report on surveillance for the presence of transmissible spongiform encephalopathies (TSEs) in 2017

Published on: Thu, 29 Nov 2018 This report presents the results of surveillance on transmissible spongiform encephalopathies (TSEs) in bovine animals, sheep, goats, cervids and other animal species, as well as genotyping in sheep, carried out in 2017 in the European Union (EU) according to Regulation (EC) 999/2001, and in Iceland, Norway and Switzerland. In total, 1,312,714 cattle were tested by the 28 EU Member States (MSs) which is a decrease of 3% compared with 2016; 18,526 were tested by the three n...

Europe - EFSA - European Food Safety Authority Publications

29-11-2018

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

FDA approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder. This is the first FDA approval of a treatment for LEMS.

FDA - U.S. Food and Drug Administration

28-11-2018

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The FDA approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy.

FDA - U.S. Food and Drug Administration

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 1: Compendium of Representative Processing Techniques investigated in regulatory studies for pesticides

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray

First Source of Tonawanda, NY, is voluntarily recalling Chocolate and Nut Tray because it contains undeclared tree nuts, pecan and cashew. People who have an allergy or sensitivity to tree nuts (Pecan & Cashew) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

20-11-2018

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The FDA approved Gamifant (emapalumab-lzsg) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH.

FDA - U.S. Food and Drug Administration

20-11-2018

Pest categorisation of non‐EU Monochamus spp.

Pest categorisation of non‐EU Monochamus spp.

Published on: Mon, 19 Nov 2018 The Panel on Plant Health performed a pest categorisation of non‐EU Monochamus spp., a well‐defined insect genus in the family Cerambycidae (Insecta: Coleoptera). Species can be identified using taxonomic keys at national and regional level, and DNA barcoding. Two online world catalogues exist for the genus. The genus includes about one hundred species and many subspecies colonising conifers and non‐conifer trees in many areas in the world. The non‐EU species are listed in...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

16-11-2018

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The FDA expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

FDA - U.S. Food and Drug Administration

9-11-2018

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

31-10-2018

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility.Test is first of this type approved to report genotypes as final results

FDA - U.S. Food and Drug Administration

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

5-10-2018

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of first self-fitting hearing aid controlled by the user

FDA allows marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables the user to fit, program and control the hearing aid on his or her own, without assistance from a health care provider.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation

The FDA approved the first antibacterial drug under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). LPAD was created by Congress to spur development of drugs targeting serious infections in limited patient populations with unmet need.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves first treatment for advanced form of the second most common skin cancer

FDA approves Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

FDA - U.S. Food and Drug Administration

28-9-2018

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma

FDA - U.S. Food and Drug Administration

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-9-2018

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Marvelon 28 birth control pills: Packages do not contain day-of-the-week stickers

Health Canada is informing Canadians that packages of certain lots of Marvelon 28 do not include day-of-the-week stickers. The stickers are meant to be applied on the blister pack containing the pills. The stickers indicate the first day of the week when the medication is started, and the weekdays that the pills should be taken. The stickers may be used by women to help them remember if they took their daily pill on a given day. Without these stickers, there may be an increased chance of missing a dose.

Health Canada

11-9-2018

Risk ranking of chemical and microbiological hazards in food

Risk ranking of chemical and microbiological hazards in food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Risk ranking is a versatile tool used to prioritise activities performed by public health regulatory bodies. It also allows efficient communication between all stakeholders in the process of risk analysis. However, risk ranking methods are still not optimal. Because of the different approaches employed in the risk assessment of microbiological agents and chemicals, it is difficult to rank them together using the same metrics. In our work, we first discuss di...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

On September 19, 2018, the FDA will host the third of a three-part eSubmitter webinar series. This session will provide a platform to answer any remaining questions participants may have after attending or viewing the first two webinars on the use of CVM’s electronic submission tool, eSubmitter.

FDA - U.S. Food and Drug Administration

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

22-8-2018

FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA approves first drug for neurotrophic keratitis, a rare eye disease

FDA approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye).

FDA - U.S. Food and Drug Administration

16-8-2018

FDA approves first generic version of EpiPen

FDA approves first generic version of EpiPen

FDA approves the first generic version of EpiPen and EpiPen Jr for the emergency treatment of allergic reactions in adults and pediatric patients who weigh more than 33 pounds.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA approves new treatment for a rare genetic disorder, Fabry disease

FDA approved Galafold (migalastat), the first oral medication for the treatment of adults with Fabry disease.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease

FDA approves new drug for treatment of polyneuropathy caused by hereditary transthyretin-mediated amyloidosis (hATTR). This is the first FDA-approved treatment for this rare, debilitating and often fatal genetic disease and the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.

FDA - U.S. Food and Drug Administration

1-2-2019


First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

First oral add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Europe - EMA - European Medicines Agency

29-1-2019

On January 23rd, @US_FDA permitted the marketing of first test to aid in  the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here:  https://go.usa.gov/xEkt3  #FDA #MedicalDevice

On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3  #FDA #MedicalDevice

On January 23rd, @US_FDA permitted the marketing of first test to aid in the diagnosis of a sexually-transmitted infection known as Mycoplasma genitalium. For more information, read the press release here: https://go.usa.gov/xEkt3  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

25-1-2019

The first six months: embedding the TGA advertising reforms

The first six months: embedding the TGA advertising reforms

A recap of the important developments in therapeutic goods advertising regulation and what we will focus on next

Therapeutic Goods Administration - Australia

22-1-2019

Therapeutic Goods Advertising Consultative Committee (TGACC)

Therapeutic Goods Advertising Consultative Committee (TGACC)

Information about the TGACC, including a communique from its first meeting, is now available

Therapeutic Goods Administration - Australia

21-1-2019

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

St John Ambulance Tiny Tots First Aid Kit - electronic thermometer

Recall - potential risk of harm for children who access the button battery

Therapeutic Goods Administration - Australia

26-11-2018

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Actio

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Actio

We believe in merits of 510(k) process, but also believe it must be modernized to reflect advances in technology, safety, capabilities of newer devices. It’s time to fundamentally modernize an approach first adopted in 1976 c/w Medical Device Safety Action we issued in April 2018

FDA - U.S. Food and Drug Administration

20-11-2018

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients.  https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7 pic.twitter.com/IATHeEUgHe

#FDA has set important new goal when it comes to device safety: ensuring that we’re consistently first in the world to identify and act upon device safety signals to protect patients. https://go.usa.gov/xPAf7  pic.twitter.com/IATHeEUgHe

FDA - U.S. Food and Drug Administration

2-11-2018

#DYK the @US_FDA recently authorized the first direct-to-consumer test   for detecting genetic variants that may be associated with medication   metabolism? Learn more about the authorization:  https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

#DYK the @US_FDA recently authorized the first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism? Learn more about the authorization: https://go.usa.gov/xPVUt  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

1-11-2018

Comparable Overseas Reports (COR-A) pathway - First registration decision

Comparable Overseas Reports (COR-A) pathway - First registration decision

Cabozantinib (CABOMETYX) is the first medicine to be registered via the new COR-A pathway

Therapeutic Goods Administration - Australia

10-8-2018

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy  https://go.usa.gov/xUHC6 

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6 

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy https://go.usa.gov/xUHC6 

FDA - U.S. Food and Drug Administration