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Glavnih Značilnosti Zdravila

ECO-MAT

VARNOSTNI LIST

Ime proizvoda

ECO-MAT

V skladu z Uredbo (ES) št. 1907/2006 (REACH), Priloga II (453/2010) - Evropa

:

1.1 Identifikator izdelka

1.3 Podrobnosti o dobavitelju varnostnega lista

1.2 Pomembne identificirane uporabe snovi ali zmesi in odsvetovane uporabe

Navedene uporabe

ODDELEK 1: Identifikacija snovi/zmesi in družbe/podjetja

Šifra proizvoda

:

Odsvetujejo se načini uporabe

1.4 Telefonska številka za nujne primere

Nacionalno posvetovalno telo/Center za zastrupitve

Detergent za pranje perila. Avtomatski postopek

Detergent za pranje perila. Polavtomatski postopek

Ni znano.

Ecolab d.o.o.

Vajngerlova 4

SI-2000 Maribor

Slovenija

Tel.: +386 (0)2 42 93 100

Št. faksa: +386 (0)2 42 93 152

office.maribor@ecolab.com

:

Proizvajalec/ Distributer/

Uvoznik

112225E

Uporaba proizvoda

:

Sredstvo za pranje perila

Proizvod je samo za profesionalno uporabo.

Proizvajalec/ Distributer/ Uvoznik

:

Številka telefona

Navodilo v primeru zdravstvene ogroženosti: nemudoma se posvetovati z osebnim

ali dežurnim zdravnikom, le v primeru življenjske ogroženosti poklicati 112.

:

Številka telefona

Tel.: +386 (0)2 42 93 100 (Uradne ure ob delavnikih: 8:00 – 15:00)

Verzija

: 2

Razvrstitev

Xi; R36

Razvrstitev proizvoda temelji na toksikološki oceni.

:

:

Nevarnosti za človeka

Draži oči.

Glej Oddelek 11 za podrobnejše podatke o učinkih na zdravje in simptomih.

Razvrstitev skladno z Uredbo (ES) 1272/2008 [CLP/GHS]

ODDELEK 2: Ugotovitev nevarnosti

2.1 Razvrstitev snovi ali zmesi

Opredelitev izdelka

:

Zmes

Glej Oddelek 16 za celotno besedilo zgoraj navedenih stavkov R ali H.

Razvrstitev v skladu z Direktivo 1999/45/ES [DSD]

Proizvod je razvrščen kot nevaren v skladu z Direktivo 1999/45/ES in njenimi dopolnitvami.

2.2 Elementi etikete

Piktogrami za nevarnosti

:

Eye Irrit. 2, H319

Datum izdaje/Datum

revidirane izdaje

:

1/13

2 Januar 2014

ECO-MAT

ODDELEK 2: Ugotovitev nevarnosti

:

Ostale nevarnosti, ki

nimajo vpliva na

razvrstitev

Pri rokovanju in/ali predelavi te snovi lahko nastaja prah, ki lahko povzroči

mehansko draženje oči, kože, nosu in grla.

Opozorilna beseda

:

Stavki o nevarnosti

:

Preprečevanje

:

Previdnostni stavki

Pozor

P280 - Nositi zaščito za oči.

2.3 Druge nevarnosti

Vsebuje

:

natrijev perkarbonat

H319

Povzroča hudo draženje oči.

Proizvod ne vsebuje dodatnih sestavin, ki bi bile, glede na trenutno znane podatke, ki so na voljo dobavitelju in v

primernih koncentracijah, razvrščene kot zdravju ali okolju nevarne in ki bi jih bilo potrebno navajati v tem oddelku.

ODDELEK 3: Sestava/podatki o sestavinah

Identifikatorji

67/548/EGS

Ime ali trgovsko ime

izdelka/snovi

Glej Oddelek 16 za

celotno besedilo

zgoraj navedenih R

stavkov

%

Tip

Uredba (ES) št.

1272/2008 [CLP]

Razvrstitev

Glej Oddelek 16 za

celotno besedilo

zgoraj navedenih

stavkov o nevarnosti

H.

Natrijev karbonat

(soda)

REACH #:

01-2119485498-19

EC: 207-838-8

CAS: 497-19-8

Indeks: 011-005-00-2

25 -

<35

Xi; R36

Eye Irrit. 2, H319

natrijev perkarbonat

REACH #:

01-2119457268-30

EC: 239-707-6

CAS: 15630-89-4

7 - <10

O; R8

Xn; R22

Xi; R41

Ox. Liq. 1, H271

Acute Tox. 4, H302

Eye Dam. 1, H318

Benzensulfonska

kislina, C10-13-alkil

derivati, natrijeve soli

REACH #:

01-2119489428-22

EC: 270-115-0

CAS: 68411-30-3

3 - <5

Xn; R22

Xi; R41, R38

Acute Tox. 4, H302

Skin Irrit. 2, H315

Eye Dam. 1, H318

Natrijev silikat

REACH #:

01-2119448725-31

EC: 215-687-4

CAS: 1344-09-8

1 - <5

Xi; R36/37/38

Skin Irrit. 2, H315

Eye Irrit. 2, H319

STOT SE 3, H335

Etoksilati alkohola

REACH #:

01-2119548515-35

CAS: 68951-67-7

1 - <3

Xn; R22

Xi; R41

Acute Tox. 4, H302

Eye Dam. 1, H318

Etoksilati alkohola

EC: 500-182-6

CAS: 68002-97-1

0.1 - <1

Xn; R22

Xi; R41, R38

N; R50

Acute Tox. 4, H302

Skin Irrit. 2, H315

Eye Dam. 1, H318

Aquatic Acute 1, H400

Zmesi

3.2

Datum izdaje/Datum

revidirane izdaje

:

2/13

2 Januar 2014

ECO-MAT

ODDELEK 3: Sestava/podatki o sestavinah

Mejne vrednosti izpostavitve pri delu, če so na voljo, so navedene v oddelku 8.

[1] Snov razvrščena kot nevarna za zdravje ali okolje

[2] Snov za katero obstajajo mejne vrednosti za poklicno izpostavljenost

[3] Snov izpolnjuje merila za PBT skladno z Uredbo (ES) št. 1907/2006, priloga XIII.

[4] Snov izpolnjuje merila za vPvB skladno z Uredbo (ES) št. 1907/2006, priloga XIII.

[5] Snov, ki vzbuja enakovredno zaskrbljenost

Usta sprati z vodo. Če ima ponesrečenec zobno protezo, jo je potrebno odstraniti.

Če je snov bila zaužita in je ponerečenec pri zavesti, dajati manjše količine vode za

pitje. Prenehati, če se ponesrečeni počuti slabo, ker je bruhanje nevarno. Ne

sprožiti bruhanja, razen po navodilih zdravniškega osebja. Ob bruhanju držite

glavo v nizkem položaju, da izbljuvek ne vstopi v pljuča. Nikoli ničesar dajati v usta

nezavestni osebi. Nezavestnega spraviti v bočni položaj in nemudoma poklicati

zdravniško pomoč. Vzdrževati proste dihalne poti. Zrahljati oblačila npr. ovratnik,

kravato ali pas. Prenesti ponesrečenca na svež zrak in ga pustiti počivati v položaju,

ki olajša dihanje. Poklicati zdravniško pomoč, če stranski učinki ne prenehajo oz. so

resni.

Stik s kožo

Oči takoj izpirati z obilo vode, občasno dvigniti zgornjo in spodnjo veko. Preveriti, ali

ima ponesrečenec kontaktne leče in jih odstraniti . Spirati vsaj 15 minut. Če se

pojavi draženje, poiskati zdravniško pomoč.

Onesnažen predel kože izprati z obilo vode. Odstraniti onesnažena oblačila in

obutev. Oprati oblačila pred ponovno uporabo. Temeljito očistiti čevlje pred

ponovno uporabo. Če se pojavijo simptomi, poiskati zdravniško pomoč.

4.1 Opis ukrepov za prvo pomoč

Prenesti ponesrečenca na svež zrak in ga pustiti počivati v položaju, ki olajša

dihanje. Če ponesrečenec ne diha, če diha neredno, ali če je prišlo do ustavitve

dihanja, naj mu usposobljena oseba daje umetno dihanje ali kisik. Nezavestnega

spraviti v bočni položaj in nemudoma poklicati zdravniško pomoč. Vzdrževati proste

dihalne poti. Zrahljati oblačila npr. ovratnik, kravato ali pas. Poklicati zdravniško

pomoč, če stranski učinki ne prenehajo oz. so resni.

Zaužitje

Vdihavanje

Stik z očmi

:

:

:

:

Zaščita osebja za prvo

pomoč

:

ODDELEK 4: Ukrepi za prvo pomoč

4.2 Najpomembnejši simptomi in učinki, akutni in zapozneli

Potencialno akutni vplivi na zdravje

Vdihavanje

:

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje nosa, grla in pljuč.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

:

Zaužitje

Stik s kožo

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Povzroča hudo draženje oči.

:

Stik z očmi

Znaki/simptomi prekomerne izpostavljenosti

Stik s kožo

Zaužitje

Vdihavanje

Škodljivi simptomi lahko vključujejo naslednje:

draženje dihalnih poti

kašljanje

Ni specifičnih podatkov.

Ni specifičnih podatkov.

:

:

:

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

bolečina ali draženje

solzenje

pordelost

Do ukrepanja ne bo prišlo, če ima za posledico osebno tveganje ali osebje ni

predhodno ustrezno šolano.

Datum izdaje/Datum

revidirane izdaje

:

3/13

2 Januar 2014

ECO-MAT

ODDELEK 4: Ukrepi za prvo pomoč

Opombe za zdravnika

Zdraviti simptomatično. Pri zaužitju ali vdihavanju večjih količin, takoj poklicati

specialista za ravnanje v primeru zastrupitev.

:

Posebno ravnanje

4.3 Navedba kakršne koli takojšnje medicinske oskrbe in posebnega zdravljenja

Ni specifičnega zdravljenja.

:

V primeru požara, evakuirati območje. Do ukrepanja ne bo prišlo, če ima za

posledico osebno tveganje ali osebje ni predhodno ustrezno šolano. Odstraniti

embalažo iz območja gorenja, če je to možno storiti brez tveganja. Uporabite vodno

prho, da ohranite embalažo, ki je izpostavljena ognju, hladno.

Nevarni produkti

izgorevanja

Nevarnosti zaradi snovi ali

zmesi.

Razkrojni produkti lahko vsebujejo naslednje snovi:

ogljikov dioksid

ogljikov monoksid

žveplovi oksidi

kovinski oksid/oksidi

Oblaki drobnega prahu lahko tvorijo eksplozivne mešanice z zrakom.

Gasilci morajo nositi primerno zaščitno opremo in samostojni dihalni aparat (SCBA)

z masko, ki pokriva celoten obraz in ima pozitiven tlak.

Navedba posebne

varovalne opreme za

gasilce

V primeru požara uporabiti razpršeno vodo (meglica), peno, suha gasilna sredstva

ali CO2.

5.1 Sredstva za gašenje

:

:

:

Ni znano.

Ustrezna sredstva za

gašenje

:

Neustrezna sredstva za

gašenje

:

ODDELEK 5: Protipožarni ukrepi

5.2 Posebne nevarnosti v zvezi s snovjo ali zmesjo

5.3 Nasvet za gasilce

Posebni previdnostni

ukrepi za gasilce

:

6.2 Okoljevarstveni ukrepi

Preprečiti, da bi se razlit oz. razsut tovor razširil; preprečiti stik s tlemi, vodotoki,

cestno kanalizacijo in odplakami. Če je prišlo do onesnaženja okolja (kanalizacije,

vodotokov, tal ali zraka), obvestiti pristojne službe.

Odmakniti embalažo z mesta razlitja. Posesati ali pomesti material in ga preložiti v

primerno označeno embalažo za odpadke.

Majhno razlitje

:

6.3 Metode in materiali za zadrževanje in čiščenje

ODDELEK 6: Ukrepi ob nenamernih izpustih

6.1 Osebni varnostni ukrepi, zaščitna oprema in postopki v sili

Za osebje. ki ni nujno

:

Za reševalce

:

Do ukrepanja ne bo prišlo, če ima za posledico osebno tveganje ali osebje ni

predhodno ustrezno šolano. Preprečiti dostop odvečnim in nezaščitenim osebam.

Poskusite se izogniti stiku ali hoji preko razlitega materiala. Izključiti vse vire vžiga.

V območju nevarnosti je prepovedano svetiti z odprtim ognjem, zažigati in kaditi.

Preprečiti vdihovanje prahu. Zagotoviti zadostno prezračevanje. Če je

prezračevanje nezadostno, nositi ustrezno opremo za dihanje. Nositi ustrezno

osebno zaščitno opremo.

Če so pri rokovanju z razlitjem zahtevana specialna oblačila, upoštevati podatke o

primernih in neprimernih materialih v Oddelku 8. Glej tudi informacije pod "Za

neizučeno osebje".

:

Datum izdaje/Datum

revidirane izdaje

:

4/13

2 Januar 2014

ECO-MAT

ODDELEK 6: Ukrepi ob nenamernih izpustih

Odmakniti embalažo z mesta razlitja. Bližnji izpust v obratni smeri vetra. Preprečiti

iztekanje v kanalizacijo, vodotoke, kleti ali zaprte prostore. Posesati ali pomesti

material in ga preložiti v primerno označeno embalažo za odpadke. Preprečiti

nastanek prahu in preprečiti širjenje z vetrom.

Obsežno razlitje

:

6.4 Sklicevanje na druge

oddelke

Glej Oddelek 1 za podatke o kontaktu za nujne primere.

Glej Oddelek 8 za podatke o ustrezni zaščitni opremi.

Glej Oddelek 13 za podatke o dodatni obdelavi odpadkov.

:

Skladiščiti med sledečima temperaturama: 5 do 40°C (41 do 104°F). Skladiščiti

skladno z lokalno zakonodajo. Hraniti na ločenem in odobrenem mestu. Skladiščiti

v originalni embalaži, zaščiteno pred direktno sončno svetlobo v suhem, hladnem in

dobro prezračevanem prostoru, ločeno od nezdružljivih snovi (glej Oddelek 10) ter

hrane in pijače. Odstraniti vse vire vžiga. Hraniti ločeno od oksidativnih snovi. Do

uporabe hraniti posodo tesno zaprto in zatesnjeno. Odprto embalažo previdno

zatesniti in držati v pokončnem položaju, da se prepreči iztekanje. Ne hraniti v

neoznačeni embalaži. S primernim ravnanjem preprečiti onesnaževanje okolja.

ODDELEK 7: Ravnanje in skladiščenje

Informacije v tem oddelku vsebujejo splošne nasvete in napotke. Glede specifične uporabe je za podatke, ki so na

voljo v scenariju(ih) izpostavljenosti, potrebno upoštevati seznam identificiranih uporab v Oddelku 1.

7.1 Varnostni ukrepi za varno ravnanje

Zaščitni ukrepi

:

Nasvet glede splošne

poklicne higiene

:

7.2 Pogoji za varno

skladiščenje, vključno z

nezdružljivostjo

7.3 Posebne končne uporabe

Nositi ustrezno osebno zaščitno opremo. (Glej Oddelek 8) Ne zaužiti. Preprečiti

stik z očmi, kožo in oblačili. Preprečiti vdihovanje prahu. Pri rokovanju preprečiti

nastajanje prahu in kakršnokoli izpostavljenost virom vžiga (iskra ali ogenj).

Preprečiti kopičenje prahu. Uporabljati le ob primernem prezračevanju. Če je

prezračevanje nezadostno, nositi ustrezno opremo za dihanje. Hraniti v originalni

embalaži ali odobrenem nadomestilu iz ustreznega materiala; kadar se ne uporablja,

mora biti tesno zaprto.

Pred jedjo, pitjem ali kajenjem si je potrebno umiti roke in obraz. Glej Oddelek 8 za

dodatne podatke glede higienskih ukrepov.

:

Razred skladiščenja

:

Rešitve, specifične za

industrijsko panogo

:

Ni primerno dokler ni na razpolago scenarijev izpostavljenosti za surovine.

Ni primerno dokler ni na razpolago scenarijev izpostavljenosti za surovine.

8.2 Nadzor izpostavljenosti

Za zmesi ni na razpolago DNEL vrednosti.

Predvidena koncentracija brez učinka (PNEC)

Za zmesi ni na razpolago PNEC vrednosti.

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

8.1 Parametri nadzora

Izpeljana raven učinka (DNEL)

Ime ali trgovsko ime izdelka/snovi

Mejne vrednosti izpostavljenosti

Mejne vrednosti izpostavitve pri delu

Mejna vrednost za izpostavljenost ni znana.

Datum izdaje/Datum

revidirane izdaje

:

5/13

2 Januar 2014

ECO-MAT

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

Varovanje rok

(EN 374)

Če se na osnovi ocene tveganja ugotovi, je potrebno uporabljati ustrezno

nameščen respirator s prečiščevanjem zraka ali respirator z dovodom zraka, ki je

skladen z odobrenim standardom. Izbira respiratorja naj temelji na znanih in

pričakovanih nivojih izpostavitve, nevarnosti proizvoda in delovnih omejitvah

respiratorja.

Ni posebnih priporočil.

Priporočljivo : Zaščitna očala.

Zaščitoza oči/obraz

(EN 166)

Zaščita dihal

(EN 143, 14387)

:

:

:

Varovanje kože

Osebno zaščitno opremo za telo je potrebno izbrati na podlagi vrste dela, ki se

izvaja, in tveganj, ki so prisotna. To opremo mora pred ravnanjem s tem

proizvodom odobriti strokovnjak.

:

Nadzor izpostavljenosti

okolja

:

Emisije iz prezračevanja ali delovne procesne opreme je potrebno preveriti, da se

zagotovi skladnost z zahtevami zakonodaje o varovanju okolja. V nekaterih

primerih bodo za znižanje emisij na sprejemljivo raven potrebne naprave za

čiščenje hlapov, filtri ali inženirske modifikacije na procesni opremi.

Ustrezen tehnično-

tehnološki nadzor

:

Uporabljati le ob primernem prezračevanju. Če pri delu s proizvodom nastaja prah,

dim, plin, hlapi ali meglica, je potrebno delovni proces fizično omejiti, zagotoviti

lokalno prezračevanje ali kako drugače zagotoviti, da so izpostavitve delavcev

nečistočam v zraku pod katerimikoli priporočenimi ali predpisanimi mejnimi

vrednostmi. Tehnične kontrolne merilne naprave morajo ohranjati koncentracije

plina, par ali prahu pod katerokoli spodnjo mejo eksplozivnosti. Uporabite

eksplozijsko varno ventilacijsko opremo.

Po ravnanju s kemikalijami ter pred jedjo, kajenjem, uporabo stranišča in ob koncu

delovnega cikla, si temeljito umiti roke, podlakti in obraz. Primerno tehniko je

potrebno uporabiti za odstranitev potencialno onesnaženih oblačil. Oprati

onesnažena oblačila pred ponovno uporabo. Zagotoviti primerno bližino priprave

za izpiranje oči in prhe za nujne primere.

Higienski ukrepi

:

Osebni zaščitni ukrepi

Zaščita telesa

(EN 14605)

:

Druga zaščita za kožo

Toplotno nevarnostjo

:

Pred postopkom se mora na podlagi dela, ki se ga opravlja in z njim povezanih

tveganj, izbrati primerno obutev in morebitne dodatne ukrepe za zaščito kože, ki jih

odobri strokovnjak.

Ni primerno.

ODDELEK 9: Fizikalne in kemijske lastnosti

Fizikalno stanje

Tališče/ledišče

Začetno vrelišče in območje vrelišča

Prašek.

Po parfumu.

Vonj

pH

bela s pisanimi zrnci

Barva

Hitrost izparevanja

Plamenišče

> 100°C

10.3 do 11.3 [Konc. (%w/w): 1%]

Prag vonja

:

:

:

:

:

:

:

:

:

9.1 Podatki o osnovnih fizikalnih in kemijskih lastnostih

Izgled

Čas gorenja

Stopnja gorenja

:

:

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Vnetljivost (trdno, plinasto)

:

Ni primerno in/ali ni določeno za zmesi.

Datum izdaje/Datum

revidirane izdaje

:

6/13

2 Januar 2014

ECO-MAT

ODDELEK 9: Fizikalne in kemijske lastnosti

Parni tlak

Relativna gostota

Parna gostota

Topnost

0.53 do 0.61

Lahko topno v naslednjih snoveh: hladni vodi in vroči vodi.

Temperatura samovžiga

Porazdelitveni koeficient: n-

oktanol/voda

Eksplozivne lastnosti

:

:

:

:

:

:

:

Brez.

Oksidativne lastnosti

:

9.2 Drugi podatki

Temperatura razkroja

:

Ni dodatnih podatkov.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno.

Ni primerno in/ali ni določeno za zmesi.

Viskoznost

:

Zgornje/

spodnje meje vnetljivosti ali eksplozivnosti

:

Ni primerno in/ali ni določeno za zmesi.

10.6 Nevarni produkti

razgradnje

10.4 Pogoji, ki se jim je

treba izogniti

Pri rokovanju preprečiti nastajanje prahu in kakršnokoli izpostavljenost virom vžiga

(iskra ali ogenj). Preprečiti elektrostatično razelektritev. Da se izognemo požaru ali

eksploziji med transportom, pred prenosom izničimo statično elektriko z ozemljitvijo

in povezavo sodov ter opreme. Preprečiti kopičenje prahu.

Pri normalnih pogojih skladiščenja in uporabe ne bi smelo prihajati do nevarnih

razkrojnih produktov.

Proizvod je stabilen.

10.2 Kemijska stabilnost

:

:

:

10.5 Nezdružljivi materiali

:

10.3 Možnost poteka

nevarnih reakcij

:

Pri normalnih pogojih skladiščenja in uporabe do nevarnih reakcij ne bo prihajalo.

ODDELEK 10: Obstojnost in reaktivnost

10.1 Reaktivnost

:

Konkretnih podatkov o preskusih v zvezi z reaktivnostjo tega izdelka ali njegovih

sestavin ni na razpolago.

Reaktivno ali nezdružljivo z naslednjimi snovmi: kislinami.

Rahlo reaktivno ali nezdružljivo z naslednjimi snovmi: kovine.

Nereaktivno ali združljivo z naslednjimi snovmi: organskimi snovmi, alkalijami in

vlaga.

Akutna strupenost

ODDELEK 11: Toksikološki podatki

11.1 Podatki o toksikoloških učinkih

Datum izdaje/Datum

revidirane izdaje

:

7/13

2 Januar 2014

ECO-MAT

ODDELEK 11: Toksikološki podatki

Potencialno akutni vplivi na zdravje

Natrijev karbonat (soda)

LC50 Vdihavanje Prah in

meglice

Podgana

1.15 mg/L

4 ur

LD50 Dermalno

Kunec

>2000 mg/kg

LD50 Oralno

Podgana

2800 mg/kg

natrijev perkarbonat

LD50 Dermalno

Kunec

>2000 mg/kg

LD50 Oralno

Podgana

1034 mg/kg

Benzensulfonska kislina,

C10-13-alkil derivati,

natrijeve soli

LD50 Dermalno

Podgana

>2000 mg/kg

LD50 Oralno

Podgana

1080 mg/kg

Natrijev silikat

LD50 Oralno

Podgana

>2000 mg/kg

Etoksilati alkohola

LD50 Dermalno

Kunec

5000 mg/kg

LD50 Oralno

Podgana

1000 mg/kg

Etoksilati alkohola

LC50 Vdihavanje Prah in

meglice

Podgana

>50 mg/L

4 ur

LD50 Dermalno

Podgana

>2000 mg/kg

LD50 Oralno

Podgana

>1000 mg/kg

Ime ali trgovsko ime

izdelka/snovi

Rezultat

Vrste

Odmerek

Izpostavljenost

Rakotvornost

Mutagenost

Teratogenost

Strupenost za razmnoževanje

Dražilnost/Jedkost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Povzroča preobčutljivost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ocene akutne strupenosti

Oralno

7694.3 mg/kg

Pot

Vrednost ATE

SPECIFIČNA STRUPENOST ZA CILJNE ORGANE (STOT) – ENKRATNA IZPOSTAVLJENOST

STOT – ponavljajoča se izpostavljenost

Ime ali trgovsko ime izdelka/snovi

Kategorija

Nevarnost pri vdihavanju

Način

izpostavljenosti

Ciljni organi

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Natrijev silikat

Kategorija 3

Ni primerno.

Draženje dihalnih

poti

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Podatki o možnih načinih

izpostavljenosti

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Datum izdaje/Datum

revidirane izdaje

:

8/13

2 Januar 2014

ECO-MAT

ODDELEK 11: Toksikološki podatki

Potencialno kronični vplivi na zdravje

Vdihavanje

:

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje nosa, grla in pljuč.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

:

Zaužitje

Stik s kožo

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Povzroča hudo draženje oči.

:

Stik z očmi

Ponavljajoče ali dolgotrajno vdihovanje prahu lahko privede kroničnega draženja

dihal.

Splošno

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Rakotvornost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Mutagenost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Teratogenost

:

Učinek na razvoj

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Učinki na plodnost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Simptomi, ki izvirajo iz fizikalnih, kemičnih in toksikoloških značilnosti

Stik s kožo

Zaužitje

Vdihavanje

Škodljivi simptomi lahko vključujejo naslednje:

draženje dihalnih poti

kašljanje

Ni specifičnih podatkov.

Ni specifičnih podatkov.

:

:

:

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

bolečina ali draženje

solzenje

pordelost

Zapozneli in takojšnji učinki ter kronični učinki po kratkodobni in dolgodobni izpostavljenosti

Kratkotrajna izpostavljenost

Dolgotrajna izpostavljenost

Možni neposredni učinki

:

Možni zapozneli učinki

:

Možni neposredni učinki

:

Možni zapozneli učinki

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Drugi podatki

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

ODDELEK 12: Ekološki podatki

12.1 Strupenost

Natrijev karbonat (soda)

Akutni EC50 200 mg/L

Vodne bolhe

48 ur

natrijev perkarbonat

Akutni EC50 4.9 mg/L

Vodne bolhe

48 ur

Benzensulfonska kislina,

C10-13-alkil derivati,

natrijeve soli

Akutni LC50 1.04 mg/L

Ribe

96 ur

Natrijev silikat

Akutni LC50 210 mg/L

Ribe

96 ur

Etoksilati alkohola

Akutni EC50 1.5 mg/L

Vodne bolhe

48 ur

Akutni LC50 5.33 mg/L

Raki

48 ur

Akutni LC50 0.7 mg/L

Ribe

96 ur

Etoksilati alkohola

Akutni EC50 >0.1 mg/L

Vodne bolhe

48 ur

Ime ali trgovsko ime

izdelka/snovi

Vrste

Rezultat

Izpostavljenost

Datum izdaje/Datum

revidirane izdaje

:

9/13

2 Januar 2014

ECO-MAT

ODDELEK 12: Ekološki podatki

LogP

ow

BCF

Potencialno

12.3 Zmožnost kopičenja v organizmih

12.6 Drugi škodljivi učinki

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ime ali trgovsko ime

izdelka/snovi

Benzensulfonska kislina,

C10-13-alkil derivati,

natrijeve soli

3.32

nizko

12.2 Obstojnost in razgradljivost

Zaključek/Povzetek

:

V proizvodu vsebovane površinsko aktivne snovi so biorazgradljive v skladu z

Uredbo o detergentih 648/2004/EC.

PBT

:

Ni primerno.

vPvB

:

Ni primerno.

12.4 Mobilnost v tleh

12.5 Rezultati ocene PBT in vPvB

:

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Porazdelitveni koeficient

prst/voda (K

OC

)

:

Ni določeno za zmesi.

Mobilnost

:

Ni določeno za zmesi.

Evropski katalog odpadkov (EWC)

Nevarni odpadki

:

Kjerkoli je možno, se je potrebno izogniti nastajanju odpadkov, oziroma jih zmanjšati

na najmanjšo možno raven. Prazne posode ali podloge lahko zadržijo ostanke

proizvoda. Vsebina in embalaža morata biti varno odstranjeni. Znatnih količin

odpadnih ostankov proizvoda se ne sme spuščati v kanalizacijo, ampak jih je

potrebno obdelati v ustreznih čistilnih napravah. Preostanke in proizvode, ki se jih

ne da reciklirati, odstrani pooblaščeno podjetje za odstranjevanje odpadkov.

Odstranjevanje tega proizvoda, raztopin in kakršnih koli stranskih proizvodov mora

vedno potekati v skladu z zahtevami predpisov o zaščiti okolja in odstranjevanju

odpadkov oz. katerih koli drugih predpisov. Preprečiti, da bi se razlit oz. razsut tovor

razširil; preprečiti stik s tlemi, vodotoki, cestno kanalizacijo in odplakami.

:

Metode odstranjevanja

ODDELEK 13: Odstranjevanje

Informacije v tem oddelku vsebujejo splošne nasvete in napotke. Glede specifične uporabe je za podatke, ki so na

voljo v scenariju(ih) izpostavljenosti, potrebno upoštevati seznam identificiranih uporab v Oddelku 1.

13.1 Metode ravnanja z odpadki

Proizvod

Pakiranje

Šifra odpadka

Oznaka odpadka

Metode odstranjevanja

:

20 01 29*

čistila, ki vsebujejo nevarne snovi

Kjerkoli je možno, se je potrebno izogniti nastajanju odpadkov, oziroma jih zmanjšati

na najmanjšo možno raven. Odpadno embalažo je potrebno reciklirati.

Datum izdaje/Datum

revidirane izdaje

:

10/13

2 Januar 2014

ECO-MAT

ODDELEK 13: Odstranjevanje

Posebni previdnostni

ukrepi

:

Vsebina in embalaža morata biti varno odstranjeni. Z izpraznjeno posodo, ki ni bila

očiščena ali splaknjena, je potrebno previdno ravnati. Prazne posode ali podloge

lahko zadržijo ostanke proizvoda. Preprečiti, da bi se razlit oz. razsut tovor razširil;

preprečiti stik s tlemi, vodotoki, cestno kanalizacijo in odplakami.

Not regulated.

Ni predmet predpisov.

Ni predmet predpisov.

Not regulated.

ODDELEK 14: Podatki o prevozu

ADR/RID

IMDG

IATA

14.1 UN številka

14.2 UN Uradno

ime blaga

14.3 Razredi

nevarnosti

prevoza

14.4 Embalažna

skupina

ADN/ADNR

14.5 Okolju

nevarno

14.6 Posebni

previdnostni

ukrepi za

uporabnika

14.7 Prevoz v razsutem

stanju v skladu s Prilogo II

k MARPOL 73/78 in

Kodeksom IBC

:

Ni primerno.

Brez.

Brez.

None.

None.

Drugi predpisi EU

Ni primerno.

Priloga XVII - Omejitve

proizvodnje, dajanja v

promet in uporabe

nekaterih nevarnih snovi,

pripravkov in izdelkov

:

ODDELEK 15: Zakonsko predpisani podatki

15.1 Predpisi/zakonodaja o zdravju, varnosti in okolju, specifični za snov ali zmes

Uredba ES (ES) št 1907/2006 (REACH)

Priloga XIV - Seznam snovi, ki so predmet avtorizacije

Snovi, ki vzbujajo zelo veliko zaskrbljenost

Nobene od sestavin ni na seznamu.

Datum izdaje/Datum

revidirane izdaje

:

11/13

2 Januar 2014

ECO-MAT

ODDELEK 15: Zakonsko predpisani podatki

Državni predpisi

15.2 Ocena kemijske

varnosti

Izdelek vsebuje snovi, za katere se še vedno zahtevajo ocene kemijske varnosti.

:

≥5 - <15% zeoliti, belilno sredstvo na osnovi aktivnega kisika

<5% anionski tenzidi, neionski tenzidi, milo, polikarboksilati

vsebuje encime

Vsebuje optični belilec

Vsebuje dišave: (Butylphenyl Methylpropional)

Navedba sestavin v skladu z Uredbo o detergentih 648/2004/EC:

Slovenija

Razred skladiščenja

:

Prikazuje informacijo, ki se je spremenila od prejšnje izdaje.

ODDELEK 16: Drugi podatki

Okrajšave in akronimi

:

ADN = Evropski sporazum o mednarodnem prevozu nevarnih snovi po celinskih

vodah/po Renu

ADR = Evropski sporazum o mednarodnem cestnem prevozu nevarnega blaga

ATE = ocena akutne strupenosti

BCF = biokoncentracijski faktor

CLP = Uredba (ES) št. 1272/2008 o razvrščanju, označevanju in pakiranju snovi ter

zmesi

DNEL = Izpeljana raven brez učinka

DPD = Direktiva Sveta EU [1999/45/EC] o razvrščanju, pakiranju in označevanju

nevarnih pripravkov

EC = evropska komisija

EUH = CLP - specifičen stavek nevarnosti

IATA = Mednarodno združenje letalskih prevoznikov

IBC = vsebnik IBC

IMDG = Mednarodni kodeks o prevozu nevarnega blaga po morju

LogPow = logaritem porazdelitvenega koeficienta oktanol/voda

MARPOL 73/78 = Mednarodna konvencija o preprečevanju onesnaževanja morja z

ladij, 1973, in njen Protokol iz leta 1978

OEL = mejna vrednost za poklicno izpostavljenost

PBT = Obstojen, bioakumulativen in strupen

PNEC = predvidena koncentracija brez učinka

REACH = Registracija, Evalvacija, Avtorizacija in omejevanje Kemikalij [Uredba (ES)

št. 1907/2006]

RID = Pravilnik o mednarodnem železniškem prevozu nevarnega blaga

REACH # = Registracijska številka REACH

vPvB = zelo obstojen in zelo bioakumulativen

Postopek, po katerem se je določilo razvrstitev po uredbi (ES) št. 1272/2008 [CLP/GHS]

Razvrstitev

Utemeljitev

Eye Irrit. 2, H319

Računska metoda

Datum izdaje/Datum

revidirane izdaje

:

12/13

2 Januar 2014

ECO-MAT

ODDELEK 16: Drugi podatki

2 Januar 2014

Datum tiskanja

Datum izdaje/ Datum

revidirane izdaje

Verzija

Za posredovane podatke verjamemo, da so pravilni glede na formulacijo uporabljeno za proizvodnjo izdelka v

državi porekla. V primeru, da se podatki, standardi ali zakonodaja spremenijo, kakor tudi pogoji uporabe ter

rokovanja, ki so izven našega nadzora, NE DAJEMO NOBENEGA JAMSTVA, IZRAŽENEGA ALI NAZNAČENEGA,

GLEDE CELOVITOSTI ALI NEOKRNJENE TOČNOSTI NAVEDENIH PODAKOV.

Obvestilo bralcu

Datum prejšnje izdaje

:

:

:

:

Celotno besedilo okrajšanih

stavkov R

:

R8- V stiku z vnetljivim materialom lahko povzroči požar.

R22- Zdravju škodljivo pri zaužitju.

R41- Nevarnost hudih poškodb oči.

R36- Draži oči.

R38- Draži kožo.

R36/37/38- Draži oči, dihala in kožo.

R50- Zelo strupeno za vodne organizme.

O - Oksidativno

Xn - Zdravju škodljivo

Xi - Dražilno

N - Okolju nevarno

:

Celotno besedilo razvrstitev

[DSD/DPD]

2 Januar 2014

Ni prejšnje validacije

Celotno besedilo okrajšanih

stavkov H

:

Celotno besedilo razvrstitev

[CLP/GHS]

:

H271

Lahko povzroči požar ali eksplozijo; močna oksidativna

snov.

H302

Zdravju škodljivo pri zaužitju.

H315

Povzroča draženje kože.

H318

Povzroča hude poškodbe oči.

H319

Povzroča hudo draženje oči.

H335

Lahko povzroči draženje dihalnih poti.

H400

Strupeno za vodne organizme.

Acute Tox. 4, H302

AKUTNA STRUPENOST: ORALNO - Kategorija 4

Aquatic Acute 1, H400

NEVARNO ZA VODNO OKOLJE (AKUTNO) - Kategorija

Eye Dam. 1, H318

HUDA POŠKODBA OČI/DRAŽENJE OČI - Kategorija 1

Eye Irrit. 2, H319

HUDA POŠKODBA OČI/DRAŽENJE OČI - Kategorija 2

Ox. Liq. 1, H271

OKSIDATIVNE TEKOČINE - Kategorija 1

Skin Irrit. 2, H315

JEDKOST ZA KOŽO/DRAŽENJE KOŽE - Kategorija 2

STOT SE 3, H335

SPECIFIČNA STRUPENOST ZA CILJNE ORGANE

(STOT) – ENKRATNA IZPOSTAVLJENOST [Draženje

dihalnih poti] - Kategorija 3

Datum izdaje/Datum

revidirane izdaje

:

13/13

2 Januar 2014

17-11-2018

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Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Review of the existing maximum residue levels for tau‐fluvalinate according to Article 12 of Regulation (EC) No 396/2005

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17-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for picolinafen

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Europe - EFSA - European Food Safety Authority Publications

16-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for pyraclostrobin

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Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues

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15-11-2018

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Safety evaluation of the food enzyme acetolactate decarboxylase from a genetically modified Bacillus licheniformis (strain NZYM‐JB)

Published on: Wed, 14 Nov 2018 The food enzyme acetolactate decarboxylase (α‐acetolactate decarboxylase; EC 4.1.1.5) is produced with a genetically modified Bacillus licheniformis strain NZYM‐JB by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This acetolactate decarboxylase is intended to be used in distilled alcohol production and brewing processes. Residual amounts of total organi...

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Evaluation of confirmatory data following the Article 12 MRL review for cyazofamid

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

FDA Publishes Design Recommendations for Residue Studies in Honey

FDA Publishes Design Recommendations for Residue Studies in Honey

FDA published draft guidance for industry #243 “Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods.”

FDA - U.S. Food and Drug Administration

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative uses of napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

Published on: Mon, 12 Nov 2018 00:00:00 +0100 This joint ECDC‐EFSA report assesses whether vector count data (abundance) and the way these change throughout the year (seasonality) can provide useful information about vector‐borne diseases epidemiological processes of interest, and therefore, whether resources should be devoted to collecting such data. The document also summarises what measures of abundance and seasonality can be collected for each vector group (mosquitoes, sandflies, midges and ticks), ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Bacillus subtilis (strain LMG S‐24584)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme endo‐1,4‐β‐xylanase (EC 3.2.1.8) is produced with the genetically modified Bacillus subtilis strain LMG S‐24584 by Puratos N. V. The genetic modifications do not give rise to safety concerns. The Panel noted that, although the production strain was not detected in the food enzyme, recombinant DNA was present in all batches of the food enzyme tested. The food enzyme is intended to be used in baking processes. Based on the maximum use levels re...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance dimethoate

Peer review of the pesticide risk assessment of the active substance dimethoate

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate 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 dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

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

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Peer review of the pesticide risk assessment of the active substance methiocarb

Peer review of the pesticide risk assessment of the active substance methiocarb

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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 use...

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

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Nutrition Facts Label Reboot: A Tale of Two Labels

Nutrition Facts Label Reboot: A Tale of Two Labels

The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize...

FDA - U.S. Food and Drug Administration

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

Information Update - Staying Safe on Halloween

Information Update - Staying Safe on Halloween

Costume and decoration safety

Health Canada

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

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Evaluation of confirmatory data following the Article 12 MRL review for dimethomorph

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

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

4-10-2018

Peer review of the pesticide risk assessment of the active substance ethoprophos

Peer review of the pesticide risk assessment of the active substance ethoprophos

Published on: Wed, 03 Oct 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 Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

Health Canada

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

FDA - U.S. Food and Drug Administration

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on  http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealth pic.twitter.com/1DCieYB33v

FDA - U.S. Food and Drug Administration

13-11-2018

Health information for those affected by #WoolseyFire is available on our website at:  http://publichealth.lacounty.gov/media/FireSafety …
- Food safety
- Ash clean-up
- Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air quality pic.twitter.com/8HC7NoLaXB

FDA - U.S. Food and Drug Administration

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

2-11-2018

Check out @US_FDA's information on Direct-to-Consumer Tests:  https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

30-10-2018

#DYK: Mammograms are still the best tool for breast cancer screening.  Check out @US_FDA’s information on the importance of choosing a certified mammography facility:  https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH

FDA - U.S. Food and Drug Administration

26-10-2018

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options:  https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1

FDA - U.S. Food and Drug Administration

21-10-2018

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting  ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting ht

We’re now moving to update/modernize our oversight to capitalize on a # of important advances, including the increased use of digital imaging, revised screening recommendations from the @CDCgov and need for uniform nation-wide breast density reporting https://go.usa.gov/xPnyd .

FDA - U.S. Food and Drug Administration

21-10-2018

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects https://go.usa.gov/xPnVQ . pic.twitter.com/MyoBPe0IGg

FDA - U.S. Food and Drug Administration

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

9-10-2018

#ICYMI - FDA issues recommendations to help prevent surgical fires and      related patient injury. Click the link to read the recommendations:  https://go.usa.gov/xQdwG   #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

#ICYMI - FDA issues recommendations to help prevent surgical fires and related patient injury. Click the link to read the recommendations: https://go.usa.gov/xQdwG  #FirePreventionWeek #MedicalDevice

FDA - U.S. Food and Drug Administration

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

Click the link for a handy list of #FDA’s recommendations for using and  caring for your medical devices during a #hurricane.   https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

Click the link for a handy list of #FDA’s recommendations for using and caring for your medical devices during a #hurricane. https://go.usa.gov/xPbgc  #MedicalDevice

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency