SMARTPOWER RINSE ADDITIVE ALL PURPOSE

Informasi Utama

  • Nama dagang:
  • SMARTPOWER RINSE ADDITIVE ALL PURPOSE
  • 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:
  • SMARTPOWER RINSE ADDITIVE ALL PURPOSE
    Indonesia
  • Bahasa:
  • Bahasa Indonesia

Informasi lainnya

Status

  • Sumber:
  • Ecolab
  • Nomor Otorisasi:
  • 916870-01
  • Pembaharuan Terakhir:
  • 12-03-2018

Ringkasan karakteristik Produk: dosis, interaksi, efek samping

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BAGIAN 1. IDENTIFIKASI PRODUK DAN PERUSAHAAN

Nama produk

SMARTPOWER RINSE ADDITIVE ALL PURPOSE

Cara identifikasi lainnya

Tidak berlaku.

Penggunaan yang dianjurkan

Bilas bahan tambahan

Informasi pengenceran

produk

0.0018 % - 0.0044 %

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

22.09.2016

BAGIAN 2. IDENTIFIKASI BAHAYA

Klasifikasi GHS

Produk TERJUAL

Kerusakan mata serius/iritasi

pada mata

Kategori 2A

Penggunaan produk dicairkan

Bukan merupakan zat atau campuran yang berbahaya.

Elemen label GHS

Produk TERJUAL

Piktogram bahaya

Kata sinyal

Awas

Pernyataan Berbahaya

Menyebabkan iritasi mata yang serius.

Pernyataan Hati-hati

Pencegahan:

Cuci kulit dengan seksama setelah menangani. Pakai perlindungan

mata/ perlindungan muka.

Respons:

JIKA TERKENA MATA : Bilas dengan seksama dengan air untuk

beberapa menit. Lepaskan lensa kontak jika memakainya dan mudah

melakukannya.Lanjutkan membilas. Jika iritasi mata tidak segera

sembuh: Cari pertolongan medis.

Penggunaan produk dicairkan

Pernyataan Hati-hati

Pencegahan:

Cucilah tangan bersih-bersih setelah menangani.

Respons:

Dapatkan nasehat/perhatian medis jika kamu merasa tidak sehat.

Penyimpanan:

Simpan sesuai dengan peraturan setempat.

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Produk TERJUAL

Bahaya lain

Tidak ada yang diketahui.

BAGIAN 3. KOMPOSISI/INFORMASI TENTANG BAHAN PENYUSUN

Produk TERJUAL

Bahan/preparasi murni

Campuran

Nama kimia

No-CAS

Konsentrasi (%)

Urea

57-13-6

30 - 60

ALKOHOL, C10-16, TERETOKSILASI

68002-97-1

10 - 30

Penggunaan produk dicairkan

Tidak ada zat berbahaya

BAGIAN 4. TINDAKAN PERTOLONGAN PERTAMA PADA KECELAKAAN

Produk TERJUAL

Jika kontak dengan mata

Basuhlah segera dengan banyak air, dan berikan air sebanyak-

banyaknya di bawah kelopak mata, sekurangnya selama 15 menit.

Lepas lensa kontak, jika digunakan dan mudah melakukannya.

Lanjutkan membilas. Cari dan dapatkan bantuan medis.

Jika kontak dengan kulit

Bilas dengan banyak air.

Jika tertelan

Bilas mulut. Tangani secara medis jika muncul gejala.

Jika terhirup

Tangani secara medis jika muncul gejala.

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.

Penggunaan produk dicairkan

Jika kontak dengan mata

Bilas dengan banyak air.

Jika kontak dengan kulit

Bilas dengan banyak air.

Jika tertelan

Bilas mulut. Tangani secara medis jika muncul gejala.

Jika terhirup

Tangani secara medis jika muncul gejala.

BAGIAN 5. TINDAKAN PEMADAMAN KEBAKARAN

Produk TERJUAL

Media pemadam yang sesuai

Gunakan tindakan pemadaman kebakaran yang sesuai untuk situasi

lokal dan lingkungan sekitar.

Zat pemadam kebakaran

Tidak ada yang diketahui.

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yang tidak sesuai

Bahaya spesifik yang

diakibatkan bahan kimia

tersebut

Tidak mudah-menyala atau terbakar.

Produk pembakaran

berbahaya

Hasil penguraian mungkin termasuk bahan-bahan berikut:

Karbon oksida

Nitrogen oksida (NOx)

Alat pelindung khusus bagi

petugas pemadam

kebakaran

Gunakan alat pelindung diri.

Metode pemadaman khusus

Residu kebakaran dan air bekas pemadam kebakaran yang tercemar

harus dibuang sesuai dengan peraturan lokal. Jika terjadi kebakaran

dan/atau ledakan, jangan menghirup asap.

BAGIAN 6. TINDAKAN PENANGGULANGAN JIKA TERJADI TUMPAHAN DAN KEBOCORAN

Produk TERJUAL

Tindakan pencegahan

pribadi, peralatan pelindung

dan prosedur darurat

Pastikan 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

Sapulah dan sekoplah ke dalam wadah yang sesuai untuk dibuang.

Penggunaan produk dicairkan

Tindakan pencegahan

pribadi, peralatan pelindung

dan prosedur darurat

Mengaculah pada langkah-langkah perlindungan yang dicantumkan

dalam seksi 7 dan 8.

Tindakan pencegahan untuk

melindungi lingkungan

Tidak diperlukan tindakan pencegahan khusus untuk melindungi

lingkungan.

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

Produk TERJUAL

saran penanganan yang

aman

Jangan sampai kena kulit dan mata. Cucilah tangan bersih-bersih

setelah menangani.

Kondisi untuk penyimpanan

yang aman

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

Simpan dalam wadah yang berlabel sesuai.

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Suhu penyimpanan

0 °C ke 40 °C

Penggunaan produk dicairkan

saran penanganan yang

aman

Cucilah tangan setelah menangani. Untuk perlindungan pribadi lihat

seksi 8.

Kondisi untuk penyimpanan

yang aman

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

Simpan dalam wadah yang berlabel sesuai.

BAGIAN 8. KONTROL PAPARAN/ PERLINDUNGAN DIRI

Produk TERJUAL

Komponen dengan parameter pengendalian di tempat kerja

Pengendalian teknik yang

sesuai

Ventilasi umum yang baik semestinya cukup untuk mengendalikan

pemaparan pekerja terhadap kadar kontaminasi yang terbawa-udara.

Alat Pelindung Diri

Perlindungan mata

Karena bentuk dan kemasan produk, tidak ada peralatan pelindung

yang dibutuhkan dalam kondisi pemakaian normal.

Perlindungan tangan

Karena bentuk dan kemasan produk, tidak ada peralatan pelindung

yang dibutuhkan dalam kondisi pemakaian normal.

Perlindungan kulit

Karena bentuk dan kemasan produk, tidak ada peralatan pelindung

yang dibutuhkan dalam kondisi pemakaian normal.

Perlindungan pernapasan

Karena bentuk dan kemasan produk, tidak ada peralatan pelindung

yang dibutuhkan dalam kondisi pemakaian normal.

Tindakan higienis

Tangani sesuai dengan praktik kebersihan dan keselamatan industri

yang baik. Cuci muka, tangan dan kulit yang terpapar dengan

seksama setelah menangani.

Penggunaan produk dicairkan

Pengendalian teknik yang

sesuai

Ventilasi umum yang baik semestinya cukup untuk mengendalikan

pemaparan pekerja terhadap kadar kontaminasi yang terbawa-udara.

Alat Pelindung Diri

Perlindungan mata

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan tangan

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan kulit

Tidak diperlukan peralatan perlindungan khusus.

Perlindungan pernapasan

Biasanya tidak diperlukan alat bantu pelindung pernapasan pribadi.

BAGIAN 9. SIFAT FISIKA DAN KIMIA

Produk TERJUAL

Penggunaan produk dicairkan

Tampilan

: Padatan yang dibentuk

cair

Warna

: bening, hijau tua

Tanpa-warna

: Tak berbau

Tak berbau

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2.5 - 4.0, 1 %

6.5 - 8.5

Titik nyala

Tidak berlaku.

Ambang Bau

Data tidak tersedia

Titik lebur/titik beku

Data tidak tersedia

Titik didih awal/rentang didih

Data tidak tersedia

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

1.0 - 1.2

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.

Berat Molekul

Data tidak tersedia

Data tidak tersedia

BAGIAN 10. STABILITAS DAN REAKTIFITAS

Produk TERJUAL

Stabilitas kimia

Stabil pada kondisi normal.

Kemungkinan reaksi

berbahaya

Tidak ada reaksi berbahaya yang diketahui dalam kondisi

penggunaan normal.

Kondisi yang harus dihindari

Tidak ada yang diketahui.

Bahan non-kompatibel

Tidak ada yang diketahui.

Produk berbahaya hasil

peruraian

Hasil penguraian mungkin termasuk bahan-bahan berikut:

Karbon oksida

Nitrogen oksida (NOx)

BAGIAN 11. INFORMASI TOKSIKOLOGI

Informasi tentang rute

paparan

Kena mata, Kena kulit

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Kemungkinan Dampak Kesehatan

Produk TERJUAL

Mata

Menyebabkan iritasi mata yang serius.

Kulit

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Tertelan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Penghirupan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Eksposur Kronis

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Penggunaan produk dicairkan

Mata

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Kulit

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Tertelan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Penghirupan

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Eksposur Kronis

Gangguan kesehatan tidak diketahui atau tidak diperkirakan jika

penggunaannya normal.

Pengalaman dengan paparan pada manusia

Produk TERJUAL

Kena mata

Kemerahan, Nyeri, Iritasi

Kena kulit

Tidak ada gejala yang diketahui atau diperkirakan.

Tertelan

Tidak ada gejala yang diketahui atau diperkirakan.

Penghirupan

Tidak ada gejala yang diketahui atau diperkirakan.

Penggunaan produk dicairkan

Kena mata

Tidak ada gejala yang diketahui atau diperkirakan.

Kena kulit

Tidak ada gejala yang diketahui atau diperkirakan.

Tertelan

Tidak ada gejala yang diketahui atau diperkirakan.

Penghirupan

Tidak ada gejala yang diketahui atau diperkirakan.

Toksisitas

Produk TERJUAL

Produk

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Toksisitas oral akut

: Perkiraan toksisitas akut : 3,401 mg/kg

Perkiraan toksisitas akut : > 2,000 mg/kg

Toksisitas inhalasi akut

: Data tidak tersedia

Toksisitas kulit akut

: Data tidak tersedia

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

Komponen

Toksisitas inhalasi akut

: Urea

4 h LC50 Tikus: > 2.71 mg/l

ALKOHOL, C10-16, TERETOKSILASI

4 h LC50 Tikus: > 50 mg/l

Komponen

Toksisitas kulit akut

: Urea

LD50 Tikus: 8,200 mg/kg

BAGIAN 12. INFORMASI EKOLOGI

Produk TERJUAL

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

: Urea

96 h LC50 Ikan: 127.9 mg/l

Komponen

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Derajat racun bagi daphnia

dan binatang tak bertulang

belakang lainnya yang hidup

dalam air.

: ALKOHOL, C10-16, TERETOKSILASI

48 h EC50: > 0.1 mg/l

Ketahanan dan tingkat penguraian

Produk TERJUAL

Biodegradabel

Potensi penumpukan biologis

Data tidak tersedia

Mobilitas di dalam tanah

Data tidak tersedia

Dampak merugikan lainnya

Data tidak tersedia

BAGIAN 13. PERTIMBANGAN PEMBUANGAN/ PEMUSNAHAN

Produk TERJUAL

Metode pembuangan

Jika mungkin, pendauran-ulang lebih disukai daripada pembuangan

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

dengan peraturan lokal. Buanglah sampah dalam fasilitas

pembuangan sampah yang disetujui.

Pembuangan limbah

Buang sebagai produk yang tidak digunakan. Wadah kosong harus

dibawa ke tempat penanganan limbah yang telah disetujui untuk

didaur-ulang atau dibuang. Dilarang menggunakan kembali

kemasan/wadah yang sudah kosong. Buanglah sesuai dengan

peraturan lokal, negara bagian, dan federal.

Penggunaan produk dicairkan

Metode pembuangan

Produk diencerkan dapat disalurkan ke saluran pembuangan sanitasi

Pembuangan limbah

Buanglah sesuai dengan peraturan lokal, negara bagian, dan federal.

BAGIAN 14. INFORMASI PENGANGKUTAN

Produk TERJUAL

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

penandaan yang sesuai dengan jenis transportasi yang digunakan.

Transpor jalan

Bukan barang berbahaya

Transpor laut (IMDG/IMO)

Bukan barang berbahaya

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 :

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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

Jepang. ISHL - Inventaris Senyawa Kimia (METI) :

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

BAGIAN 16. INFORMASI LAIN

Tanggal penerbitan pertama

22.09.2016

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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31-1-2019

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Data dictionaries‐guidelines for reporting 2018 data on zoonoses, antimicrobial resistance and food‐borne outbreaks

Published on: Wed, 30 Jan 2019 This technical report of the European Food Safety Authority (EFSA) presents guidance to reporting European Union (EU) Member States and non‐Member States in data submission using extensible markup language (XML) data transfer covering the reporting of isolate‐based quantitative antimicrobial resistance data, as well as reporting of prevalence data on zoonoses and food‐borne contaminants, food‐borne outbreak data, animal population data and disease status data. For data col...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

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

22-1-2019

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

SIGMA Animal Disease Data Model: A comprehensive approach for the collection of standardised data on animal diseases

Published on: Mon, 21 Jan 2019 The European Commission is routinely asking EFSA for scientific and technical support in the epidemiological analysis of animal disease outbreaks (i.e. African swine fever, lumpy skin disease and avian influenza) and to report or assess surveillance data (i.e. Echinococcus multilocularis and avian influenza). For this purpose, EFSA has over the last years carried out several data collections and gathered specific information on outbreaks, surveillance activities and concer...

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

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

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Safety and efficacy of 8‐mercapto‐p‐menthan‐3‐one and p‐menth‐1‐ene‐8‐thiol belonging to chemical group 20 when used as flavourings for all animal species

Published on: Wed, 16 Jan 2019 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 two compounds belonging to chemical group 20 (aliphatic and aromatic mono‐ and di‐thiols and mono‐, di‐, tri‐, and polysulfides with or without additional oxygenated functional groups). 8‐Mercapto‐p‐menthan‐3‐one [12.038] and p‐menth‐1‐ene‐8‐thiol [12.085] are currently ...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

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

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β‐unsaturation in ring/side‐chain and precursors from chemical subgroup 2.2 of FGE.19

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

Safety and efficacy of Lactobacillus reuteri NBF‐2 (DSM 32264) as a feed additive for cats

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 Lactobacillus reuteri NBF‐2 when used in feed for cats at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32264. This species is considered by EFSA to be suitable for the qualified presum...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

Safety and efficacy of Lactobacillus reuteri NBF‐1 (DSM 32203) as a feed additive for dogs

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 Lactobacillus reuteri NBF‐1 when used in feed for dogs at a minimum dose of 6 × 109 colony forming units (CFU) per animal and day. The additive is a preparation of viable cells of L. reuteri DSM 32203. This species is considered by the European Food Safety Authority to be sui...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from Bacillus subtilis (strain XAS)

Published on: Fri, 11 Jan 2019 The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p‐mentha‐1,8‐dien‐7‐al [FL‐no: 05.117], which was found to be genotoxic in vivo. The Panel conclu...

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

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

21-12-2018

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

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

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

Health Canada

20-12-2018

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Scientific assistance to assess the detoxification process for dioxins and PCBs in sunflower cake by hexane extraction

Published on: Wed, 19 Dec 2018 EFSA was requested to provide scientific assistance to the European Commission on a detoxification process for dioxins and PCBs from sunflower cake by hexane extraction in an emergency situation, as specified in Article 7 of Commission Regulation (EU) 2015/786. The process entails hexane extraction of sunflower oil from the cake to remove dioxins (PCDDs and PCDFs) as well as DL- and NDL-PCBs. The data provided by the applicant were assessed with respect to the efficacy of ...

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

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

7-12-2018

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Re‐evaluation of propane‐1,2‐diol esters of fatty acids (E 477) as a food additive

Published on: Thu, 06 Dec 2018 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of propane‐1,2‐diol esters of fatty acids (E 477) when used as a food additive. The Scientific Committee on Food (SCF) in 1978 endorsed the acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day, expressed as propane‐1,2‐diol, established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974. No adverse effects were observed in short‐t...

Europe - EFSA - European Food Safety Authority Publications

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

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

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 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 sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

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

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

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

8-10-2018

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

Public consultation: Guidance on feed additives and the environment

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

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

18-9-2018

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Les Distributions Orca Lite Inc. recalls FLEXI LIGHT multi-purpose utility lighters

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically, the child-resistant mechanism may not work properly.

Health Canada

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

Scientific guideline:  Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

Scientific guideline: Procedure for the review and revision of European Union herbal monographs and European Union list entries - Revision 2, adopted

The purpose of this procedure is to enable a consistent and proportionate process in reviewing and revising all European Union herbal monographs and European Union list entries adopted by the HMPC. The aim of this document is to describe how to identify the criteria/reasons that trigger the revision of European Union herbal monographs and list entries and the associated procedure and timelines for both the review and the revision.

Europe - EFSA - European Food Safety Authority EFSA Journal

19-7-2018

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

Food additive re-evaluation: EFSA workshop in November focuses on foods for infants below 16 weeks of age

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

26-6-2018

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Home Hardware Stores Ltd. recalls Home Flexible Multi-Purpose Lighter

Health Canada's sampling and evaluation program has determined that these lighters do not meet the Lighters Regulations in Canada and may pose a fire or burn hazard. Specifically the lighters:

Health Canada

1-6-2018

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

Expanded Recall: Medline Canada, Corp. recalls Various Medline Cosmetic Products

The recalled products may be contaminated with the bacteria Burkolderia cepacia. Burkolderia cepacia can pose a risk of infections to consumers, especially those with weakened immune systems. Contamination of the bacteria has only been confirmed for the Remedy Essentials Cleanser No Rinse Foam that was includedin the previous recall.

Health Canada

19-5-2018

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Unauthorized Botox and other health products seized from Arshia Hair Salon and Spa in Toronto May Pose Serious Health Risks

Health Canada is advising Canadians that it has seized an unauthorized “Botox” product and other unauthorized health products from Arshia Hair Salon and Spa (6062A Yonge Street) in Toronto, ON, because they may pose serious health risks. These products may have been administered as injectable treatments for cosmetic purposes.

Health Canada

10-5-2018

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

FDA - U.S. Food and Drug Administration

9-5-2018

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

FDA - U.S. Food and Drug Administration

2-5-2018

Danish-Japanese collaboration on better use of health data

Danish-Japanese collaboration on better use of health data

The Danish Medicines Agency met today with leading representatives from the Japanese Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency at the Danish Medicines Agency in Copenhagen. The purpose of the meeting was to exchange knowledge and experience regarding regulatory work in the pharmaceutical area, and to begin a broader collaboration between the agencies.

Danish Medicines Agency

5-10-2017

Collection of scientific experience for medicinal cannabis pilot programme

Collection of scientific experience for medicinal cannabis pilot programme

One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.

Danish Medicines Agency

3-7-2018

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices  https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://

The Pediatric Medical Device Development public meeting is August 13-14 at #FDA White Oak Campus. Do you know how the FDA defines “pediatrics” for medical device purposes? Click the link for the answer and more info on #Pediatric #MedicalDevices https://go.usa.gov/xU2e8 

FDA - U.S. Food and Drug Administration

25-5-2018

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

Therapeutic Goods (Medicines-Listing) Approval of Application Forms and Specification of Office to which Application Must be Delivered

I, Larry Kelly, Acting Deputy Secretary, Health Products Regulation Group, a delegate of the Secretary of the Department of Health for the purposes of section 23C of the Therapeutic Goods Act 1989, make the following instrument under paragraphs 23C(2)(a...

Therapeutic Goods Administration - Australia