QC 50 ULTRA CONCENTRATED GLASS CLEANER

Informasi Utama

  • Nama dagang:
  • QC 50 ULTRA CONCENTRATED GLASS CLEANER
  • 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:
  • QC 50 ULTRA CONCENTRATED GLASS CLEANER
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 914990-06
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

QC 50 ULTRA CONCENTRATED GLASS CLEANER

Pembersih Kaca

LEMBAR DATA KEAMANAN

Nama produk

Penggunaan dan

pembatasan yang

direkomendasikan

Nomor telepon darurat

:

:

Informasi pemasok

:

QC 50 ULTRA CONCENTRATED GLASS CLEANER

Gunakan hanya untuk tujuan pada label produk.

:

Bagian 1. Identifikasi produk kimia dan perusahaan

Nama-nama lain

:

Tidak ada.

Informasi pengenceran

produk

:

Up to 4 oz/gal or 31 mL/L in water

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

IRITASI/ KERUSAKAN PARAH PADA MATA -

Klasifikasi GHS

(Globally

Harmonised System

~ Sistim Harmonisasi

Global)

:

Kata sinyal

:

Peringatan

Pernyataan bahaya

:

Menyebabkan iritasi serius pada mata.

Piktogram

:

Pernyataan kehati-hatian

Pencegahan

:

Kenakan pelindung mata atau wajah. Cuci

tangan dengan bersih setelah penanganan.

Tanggapan

:

JIKA TERKENA MATA: Bilas secara hati-hati

dengan air selama beberapa menit. Lepaskan

lensa kontak jika memakainya dan mudah

dilakukan. Lanjutkan membilas. Jika iritasi

mata berlanjut: Dapatkan nasihat medis.

Penyimpanan

:

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Pembuangan

:

Tidak berlaku.

Bahaya lain

:

Tidak diketahui.

2. Identifikasi Bahaya

Elemen label GHS

Produk TERJUAL

Penggunaan produk dicairkan

Tidak diklasifikasikan.

Tanpa Kata Sinyal

Tidak diketahui efek signifikan atau bahaya

kritis.

Cuci sepenuhnya sesudah penanganan.

Tidak berlaku.

Tidak teridentifikasi adanya tindakan khusus

lainnya.

Tidak berlaku.

Tidak diketahui.

914990-06

Halaman: 1/6

QC 50 ULTRA CONCENTRATED GLASS CLEANER

Campuran

3. Komposisi/ Informasi tentang Bahan Penyusun Senyawa tunggal

Zat/sediaan

:

d-glukopiranosa, oligomer, desil oktil glikosida

10 - 30

68515-73-1

Alanin, n,n-bis(karboksimetil)-garam trinatrium

1 - 10

164462-16-2

oils, lavandin

<1.0

8022-15-9

Komponen-komponen yang berbahaya

Nomor CAS

Rentang konsentrasi (%)

Produk TERJUAL

Penggunaan produk dicairkan

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

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

bagian ini.

Dapatkan pertolongan medis jika terjadi gejala.

Bilas secara hati-hati dengan air selama

beberapa menit. Lepaskan lensa kontak jika

memakainya dan mudah dilakukan. Lanjutkan

membilas. Dapatkan bantuan medis jika terjadi

iritasi.

Efek setelah terkena kulit tidak diketahui. Bilas

dengan air selama beberapa menit.

Tidak perlu tindakan khusus. Obati berdasarkan

gejala.

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

Efek setelah terkena mata tidak diketahui.

Bilas dengan air selama beberapa menit.

Efek setelah terkena kulit tidak diketahui.

Bilas dengan air selama beberapa menit.

Tidak perlu tindakan khusus. Obati

berdasarkan gejala.

Dapatkan pertolongan medis jika terjadi

gejala.

Jika ada kebakaran segera isolasi tempat kejadian dengan menjauhkan semua

orang dari lokasi kebakaran. Tidak boleh melakukan tindakan yang menyangkut

risiko pribadi atau tanpa pelatihan yang sesuai.

Produk dekomposisi termal

berbahaya

Bahaya spesifik yang

diakibatkan bahan kimia

tersebut

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

hayati:

karbon dioksida

karbon monoksida

oksida nitrogen

oksida logam/oksida

Dalam kebakaran atau jika dipanaskan, peningkatan tekanan akan terjadi dan

wadah bisa meledak.

Petugas pemadam kebakaran harus memakai perlengkapan pelindung yang

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

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

Alat pelindung khusus

untuk petugas pemadam

kebakaran

Gunakan semprotan air, kabut atau busa.

:

:

:

Media yang sesuai untuk

pemadaman kebakaran

:

:

5. Tindakan Pemadaman Kebakaran

Produk TERJUAL

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QC 50 ULTRA CONCENTRATED GLASS CLEANER

Langkah-langkah

pencegahan bagi

lingkungan

Tindakan

pencegahan pribadi

:

:

Gunakan alat pelindung diri sesuai kebutuhan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran air di

permukaan tanah.

Gunakan air bilas untuk pembersihan akhir.

Metode untuk

membersihan

:

6. Tindakan Penanggulangan jika terjadi Kebocoran

Produk TERJUAL

Penggunaan produk dicairkan

Gunakan alat pelindung diri sesuai

kebutuhan.

Jaga agar tumpahan bahan dalam jumlah

banyak tidak mengalir ke tanah dan saluran

air di permukaan tanah.

Gunakan air bilas untuk pembersihan akhir.

Menangani/

Penanganan

Penyimpanan

Cuci sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak. Pastikan

wadah tertutup rapat.

:

:

7. Penanganan dan Penyimpanan

Produk TERJUAL

Penggunaan produk dicairkan

Cuci sepenuhnya sesudah penanganan.

Jauhkan dari jangkauan anak-anak.

Simpan dalam suhu antara: 10 dan 50°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.

Gunakan pelindung mata.

Perlindungam mata

Perlindungan

pernapasan

:

:

:

Perlindungan kulit

Tidak ada peralatan pelindung yang dibutuhkan

dalam kondisi pemakaian normal.

:

Pengendalian teknik

yang sesuai

:

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap kadar kontaminasi yang terbawa-udara.

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

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

digunakan untuk melepaskan/membuang pakaian berpotensi terkontaminasi. Cuci pakaian

yang terkontaminasi sebelum dipakai kembali.

Tindakan higienis

:

Parameter pengendalian

Perlindungan perorangan

8. Kontrol Paparan/Perlindungan Diri

Produk TERJUAL

Penggunaan produk dicairkan

Ventilasi umum yang baik semestinya cukup

untuk mengendalikan pemaparan pekerja

terhadap kadar kontaminasi yang terbawa-

udara.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

Tidak diperlukan respirator dalam kondisi

normal dan kondisi yang ditentukan untuk

penggunaan produk.

Tidak ada.

Nama bahan

Batas pemaparan

Tidak ada peralatan pelindung yang

dibutuhkan dalam kondisi pemakaian normal.

914990-06

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QC 50 ULTRA CONCENTRATED GLASS CLEANER

Bentuk fisik

Titik lebur

Tekanan uap

Kerapatan relatif

Rapat uap

Kelarutan

Cairan.

Tidak tersedia.

1.002 sampai dengan 1.072 (Air = 1)

Tidak tersedia.

Tidak tersedia.

Dengan mudah dapat larut pada bahan-bahan

berikut: air dingin dan air panas.

Mirip-wewangian

Bau

pH

Biru.

Warna

Laju penguapan

(butil asetat = 1)

Tidak tersedia.

Suhu dapat

membakar sendiri

(auto-ignition)

Titik nyala

Tidak tersedia.

> 100°C

Produk tidak mendukung pembakaran

Tidak tersedia.

10.4 sampai dengan 11.4 (100%)

Kekentalan

Kinematik (temperatur ruang): 0 cm

/s (0 cSt)

Koefisien partisi (n-

oktanol/air)

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Titik didih

:

>100°C (>212°F)

Flamabilitas

(padatan, gas)

:

Tidak tersedia.

Batas ledakan

:

Tidak tersedia.

9. Sifat Fisika dan Kimia

Produk TERJUAL

Penggunaan produk dicairkan

Cairan.

Biru.

Mirip-wewangian

9.2 sampai dengan 10

> 100°C

Suhu penguraian

Ambang bau

:

:

Tidak tersedia.

Tidak tersedia.

Hasil peruraian yang

berbahaya

Kondisi untuk dihindarkan

Tidak ada data khusus.

Pada kondisi penyimpanan dan penggunaan yang normal, produk-produk

penguraian-hayati yang berbahaya seharusnya tidak terproduksi.

Produk ini stabil.

Stabilitas

Tidak tersedia.

:

:

:

Bahan untuk dihindari

:

Kemungkinan reaksi yang

berbahaya

:

Dibawah kondisi penyimpanan dan penggunaan yang normal, reaksi yang

berbahaya tidak akan terjadi.

10. Stabilitas dan Reaktifitas

Produk TERJUAL

Rute Paparan

:

Kontak kulit, Kontak mata, Penghirupan, Tertelan

11. Informasi Toksikologi

Gejala

Kontak kulit

Penghirupan

Tidak ada data khusus.

Tidak ada data khusus.

:

:

Kontak mata

:

Gejala-gejala gangguan kesehatan mungkin

akan meliputi:

pedih atau iritasi

berair

kemerahan

Produk TERJUAL

Penggunaan produk dicairkan

Tidak ada data khusus.

Tidak ada data khusus.

Tidak ada data khusus.

914990-06

Halaman: 4/6

QC 50 ULTRA CONCENTRATED GLASS CLEANER

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

:

Tidak diketahui efek signifikan atau bahaya kritis.

Tidak diketahui efek signifikan atau bahaya kritis.

:

Tertelan

Kontak kulit

:

Tidak diketahui efek signifikan atau bahaya kritis.

Menyebabkan iritasi serius pada mata.

:

Kontak mata

Tertelan

Tidak ada data khusus.

:

Tidak ada data khusus.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

Tidak diketahui efek signifikan atau bahaya

kritis.

d-glukopiranosa, oligomer, desil oktil

glikosida

LD50 Kulit

Kelinci

>2000 mg/kg

LD50 Mulut

Tikus besar

>5000 mg/kg

Alanin, n,n-bis(karboksimetil)-garam

trinatrium

LD50 Kulit

Tikus besar

>4000 mg/kg

LD50 Mulut

Tikus besar

>2000 mg/kg

oils, lavandin

LD50 Kulit

Kelinci

>5000 mg/kg

LD50 Mulut

Tikus besar

>5000 mg/kg

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

d-glukopiranosa, oligomer, desil oktil glikosida

Akut EC50 18 mg/l

Tanaman-

tanaman air

72 jam

Alanin, n,n-bis(karboksimetil)-garam trinatrium

Akut LC50 >200 mg/l

Ikan

96 jam

oils, lavandin

Akut LC50 17.622 mg/l

Ikan

96 jam

Tidak tersedia.

Produk diencerkan dapat disalurkan ke saluran

pembuangan sanitasi Buang kemasan kosong di

tempat sampah

:

Metode

pembuangan

13. Pertimbangan Pembuangan/Pemusnahan

Produk TERJUAL

Penggunaan produk dicairkan

Produk diencerkan dapat disalurkan ke

saluran pembuangan sanitasi Buang

kemasan kosong di tempat sampah

914990-06

Halaman: 5/6

QC 50 ULTRA CONCENTRATED GLASS CLEANER

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 tersedia.

Tidak

tersedia.

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).

Sejauh diketahui tidak ada peraturan

nasional atau kedaerahan spesifik yang

berlaku untuk produk ini (termasuk bahan-

bahan produk tersebut).

Sejarah / Riwayat

Tanggal terbitan

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

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

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

KELENGKAPAN ATAU AKURASI LANJUTAN DARI INFORMASI INI.

Pemberitahuan kepada pembaca

Tanggal terbitan

sebelumnya

:

:

16. Informasi Lain

Referensi

Disiapkan oleh

:

Urusan peraturan

Tidak tersedia.

21 Jan 2014

19 Des 2013

914990-06

Halaman: 6/6

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Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, Llc Issues Allergy Alert on Undeclared Almond and Cashew Tree-Nut in 10 Oz. Nutty Choco Pop Found in Chocolate Popcorn Gift Box, Holiday Crowd Pleaser and Crowd Pleaser Gifts

Funky Chunky, LLC of Eden Prairie, MN is recalling 10 oz Nutty Choco Pop Gift Box, 50 oz. Holiday Crowd Pleaser and 50 oz. Crowd Pleaser, because it may contain undeclared Almond and Cashew Tree Nut. People who have an allergy or severe sensitivity to Almonds and Cashews run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

21-12-2018

Avian influenza overview August – November 2018

Avian influenza overview August – November 2018

Published on: Thu, 20 Dec 2018 Between 16 August and 15 November 2018, 14 highly pathogenic avian influenza (HPAI) A(H5N8) outbreaks in poultry establishments in Bulgaria and seven HPAI A(H5N6) outbreaks, one in captive birds in Germany and six in wild birds in Denmark and the Netherlands were reported in the European Union (EU). No human infection due to HPAI A(H5N8) and A(H5N6) viruses have been reported in Europe so far. Seroconversion of people exposed during outbreaks in Russia has been reported in...

Europe - EFSA - European Food Safety Authority EFSA Journal

19-12-2018

Nature's Ultimate recalls Nature's Ultimate - Concentrated Cleaner 1.9L (64 fl. oz)

Nature's Ultimate recalls Nature's Ultimate - Concentrated Cleaner 1.9L (64 fl. oz)

The child-resistant cap on some units of the product may not function as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

13-12-2018

Expanded Recall: TJX Canada recalls Various Casa Décor Brand Glass Knobs

Expanded Recall: TJX Canada recalls Various Casa Décor Brand Glass Knobs

The drawer knobs can shatter when pulled, posing a laceration hazard.

Health Canada

12-12-2018

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Nettoyants Lemieux recalls Concentrated Dishwasher Powder

Health Canada has determined that the recalled product does not comply with Canadian packaging and labeling regulations.

Health Canada

11-12-2018

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

International Lubricants, Inc. recalls Kool-It Evaporator & Heater Foam Cleaner

The recalled product does not have proper consumer chemical hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

5-12-2018

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

Chukar Cherries Expands Recall of Ultra Dark Chocolate Product Due to Undeclared Milk

Chukar Cherries of Prosser, WA expands a recall on Ultra Dark Chocolate product because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

29-11-2018

ANSES Newsletter in English - N°50 - November 2018

ANSES Newsletter in English - N°50 - November 2018

France - Agence Nationale du Médicament Vétérinaire

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 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 the safety and efficacy of Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

19-11-2018

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

Certain Option and Personelle sunscreens voluntarily recalled because of bacterial contamination

One lot each of Option Family Sunscreen Lotion SPF 50 and Personnelle Sport Sunscreen Lotion SPF 50 have been voluntarily recalled by Empack Spraytech Inc. because of bacterial contamination.

Health Canada

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

CB2 recalls Colby Lacquered Wood and Glass Ceiling Pendant Light

CB2 recalls Colby Lacquered Wood and Glass Ceiling Pendant Light

The insulation on the electrical wiring may come loose, posing a fire and shock hazard.

Health Canada

19-10-2018

Crate and Barrel Canada, Inc. recalls Josephine Floor Mirrors

Crate and Barrel Canada, Inc. recalls Josephine Floor Mirrors

The mirror's glass can separate from the wooden backing and fall, posing a laceration hazard.

Health Canada

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

IKEA Canada recalls CALYPSO Ceiling Lamps

IKEA Canada recalls CALYPSO Ceiling Lamps

The glass shade affixed to the ceiling lamp fixture may fall, posing an injury hazard to consumers.

Health Canada

19-9-2018

TJX Canada recalls Casa Décor Brand Mercury Glass Crackling Knobs

TJX Canada recalls Casa Décor Brand Mercury Glass Crackling Knobs

The drawer knobs can shatter when pulled, posing a laceration hazard.

Health Canada

11-9-2018

Emerson Electric Canada Limited recalls RIDGID NXT 6 Gallon and 9 Gallon Wet/Dry Vacuum Cleaners

Emerson Electric Canada Limited recalls RIDGID NXT 6 Gallon and 9 Gallon Wet/Dry Vacuum Cleaners

The on/off switch can be dislodged or pulled out from the vacuum motor cover. Doing so while the vacuum is plugged in could expose the user to energised wiring connectors and pose a potential shock hazard.

Health Canada

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

10-9-2018

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

Jay Trends Inc. recalls Tempered Glass of the Sunbeam Linear Fire Table

In some circumstances the tempered glass pane may break or shatter unexpectedly into small pieces and may pose laceration injuries to consumers.

Health Canada

7-9-2018

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Montelukast Tablets USP, 10mg 30Ct. due to Product/Label Mix-Up

Camber Pharmaceuticals, Inc. is voluntarily recalling one single lot of Montelukast Sodium Tablets, USP 10mg, to the consumer level. This recall of one batch of Montelukast Sodium Tablets, USP 10mg, lot# MON17384 Exp. 12/31/2019, was prompted because a complaint of a sealed bottle labeled as Montelukast 10mg 30 ct found to contain 90 tablets of Losartan Potassium Tablets, USP 50mg

FDA - U.S. Food and Drug Administration

17-8-2018

Empack Spraytech Inc. recalls Emzone Brake & Parts Cleaner

Empack Spraytech Inc. recalls Emzone Brake & Parts Cleaner

The products were designed and labelled for professional/trade (GHS) requirements and should have only been sold to industrial clients. However, these products were sold to industrial and retail clients. The professional grade product, which lacks consumer labelling information, including appropriate warnings, may lead to serious injury or property damage.

Health Canada

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance, adopted

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

31-7-2018

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

AuroMedics Pharma LLC Issues Voluntary Nationwide Recall of Piperacillin and Tazobactam for Injection 3.375 grams per vial, Due to Presence of Particulates Identified as Glass and Silicone Material

East Windsor, New Jersey, AuroMedics Pharma LLC is voluntarily recalling two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. One vial from lot# PP0317012-A was found to contain particulate matter, identified as glass within the vial and another vial from lot# PP0317059-A was fo...

FDA - U.S. Food and Drug Administration

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

17-7-2018

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

July 17, 2018: Former President of Cumberland Distribution, Inc. Sentenced to 15 Years in Federal Prison for $50 Million Drug Diversion Scheme

FDA - U.S. Food and Drug Administration

28-6-2018

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

Ambient air quality: ANSES recommends the surveillance of 1,3-butadiene and the enhanced monitoring of ultrafine particles (UFPs) and carbon black

The European monitoring strategy for air quality relies heavily on quality standards for a number of pollutants. Advances in knowledge on the toxicity of substances and their emissions in the atmosphere have shown that certain pollutants that may have an impact on human health are not currently taken into account in regulatory monitoring. ANSES therefore received a formal request from the Ministries of Ecology and Health to propose a list of new priority pollutants for this air quality monitoring to supp...

France - Agence Nationale du Médicament Vétérinaire

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

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

Health Canada

13-6-2018

Carmen Jewellery Inc. recalls Kenneth Cole-branded men's watches

Carmen Jewellery Inc. recalls Kenneth Cole-branded men's watches

The clear domed crystal glass on the watch face may detach or shatter, posing a physical or laceration hazard.

Health Canada

5-6-2018

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA issued warning letters to the parties responsible for liquidcaffeine.com and Dual Health Body and Mind for illegally selling certain highly concentrated caffeine products.

FDA - U.S. Food and Drug Administration

31-5-2018

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles

The glass particles could block the actuator and impact the functionality of the pump and expose patients to the glass particles.

FDA - U.S. Food and Drug Administration

31-5-2018

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. Issues Voluntary Nationwide Recall of Fluticasone Propionate Nasal Spray USP 50 mcg Per Spray 120 Metered Sprays Due to Potential for Small Glass Particles

Apotex Corp. is voluntarily recalling one (1) lot of Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, 120 Metered Sprays, to the consumer level. The Fluticasone Propionate Nasal Spray USP 50 mcg per spray 120 Metered Sprays has been found to contain small glass particles. The glass particles could block the actuator and impact the functionality of the pump. The issue was discovered through a customer complaint.

FDA - U.S. Food and Drug Administration

25-5-2018

H-E-B Voluntarily Issues a Precautionary Recall H-E-B Ode to Olives Sliced Salad Olives Being Recalled for Potential Glass in The Product

H-E-B Voluntarily Issues a Precautionary Recall H-E-B Ode to Olives Sliced Salad Olives Being Recalled for Potential Glass in The Product

Committed to the quality of its products, H-E-B is voluntarily issuing an all-store precautionary recall for H-E-B Ode to Olives Sliced Salad Olives in 10-ounce glass jars with a best by date of Nov. 3, 2019 due to the possible presence of glass in the product.

FDA - U.S. Food and Drug Administration

14-2-2019

EU/3/15/1525 (Ultragenyx Netherlands B.V.)

EU/3/15/1525 (Ultragenyx Netherlands B.V.)

EU/3/15/1525 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1368 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003845

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1524 (Ultragenyx Netherlands B.V.)

EU/3/15/1524 (Ultragenyx Netherlands B.V.)

EU/3/15/1524 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1367 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003772

Europe -DG Health and Food Safety

14-2-2019

EU/3/15/1508 (Ultragenyx Netherlands B.V.)

EU/3/15/1508 (Ultragenyx Netherlands B.V.)

EU/3/15/1508 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2019)1366 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003846

Europe -DG Health and Food Safety

12-12-2018


Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Scientific recommendation on classification of advanced therapy medicinal products: Autologous concentrated bone marrow

Europe - EMA - European Medicines Agency

26-11-2018

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009.  https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https

Today, #FDA’s device center also posted performance report highlighting measures taken to increase predictability, transparency of 510(k) review process, incl. 50 final guidance documents on important medical device policy issues issued since 2009. https://go.usa.gov/xPHdn 

FDA - U.S. Food and Drug Administration

22-10-2018

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Ultragenyx Netherlands B.V.)

EU/3/15/1495 (Active substance: Triheptanoin) - Transfer of orphan designation - Commission Decision (2018)6992 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/007/15/T/02

Europe -DG Health and Food Safety

19-9-2018

Targretin (Eisai GmbH)

Targretin (Eisai GmbH)

Targretin (Active substance: bexarotene) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6098 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/326/T/50

Europe -DG Health and Food Safety

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

27-8-2018

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Ultragenyx Germany GmbH)

Mepsevii (Active substance: vestronidase alfa) - Centralised - Authorisation - Commission Decision (2018)5714 of Mon, 27 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4438

Europe -DG Health and Food Safety

4-6-2018

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Bristol-Myers Squibb/Pfizer EEIG)

Eliquis (Active substance: apixaban) - Centralised - 2-Monthly update - Commission Decision (2018)3616 of Mon, 04 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2148/II/50

Europe -DG Health and Food Safety

25-5-2018

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media:  https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7  pic.twitter.com/hKJbKLnwni

FDA - U.S. Food and Drug Administration