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  • Trgovački naziv:
  • P3-ULTRASIL 69 NEW (CLP)
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Lokalizacija

  • Na raspolaganju u:
  • P3-ULTRASIL 69 NEW (CLP)
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 116116E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

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ODJELJAK 1. IDENTIFIKACIJA TVARI/SMJESE I PODACI O TVRTKI/PODUZEĆU

1.1 Identifikacijska oznaka proizvoda

Ime proizvoda

P3-ultrasil 69 NEW

Oznaka proizvoda

116116E

Uporaba tvari/pripravka

Sredstvo za čišćenje

Vrsta tvari

Smjesa

Samo za profesionalne korisnike.

Informacije o razrijeđenom

proizvodu

Nema informacija za razrijeđenje

1.2 Relevantne identificirane uporabe tvari ili smjese i uporabe koje se ne preporučuju

Identificirane uporabe

Sredstvo za čišćenje - CIP postupak

Preporučena ograničenja u

svezi s uporabom

Ograničeno za industrijsku i profesionalnu uporabu.

1.3 Podaci o dobavljaču koji isporučuje sigurnosno-tehnički list

Proizvođač

Ecolab d.o.o.

Zavrtnica 17

10 000, Zagreb Hrvatska 01 632 1600 (radno vrijeme 8-16 h)

dijana.kovacic@ecolab.com

1.4 Broj telefona službe za izvanredna stanja

Broj telefona službe za

izvanredna stanja

+38518000010

+32-(0)3-575-5555 Trans-europski

Broj telefona za medicinske

informacije:

01-23-48-342 (Medicinske Info)

Datum sakupljanja/revizije

21.09.2017

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari ili smjese

Razvrstavanje (prema uredbi (EZ) br. 1272/2008 (CLP))

Nagriz. koža, Klasa 1A

H314

Ozljeda oka, klasa 1

H318

Razvrstavanje ovog proizvoda je bazirano na ekstremnoj pH vrijednosti ( u skladu sa važećom EU

regulativom).

2.2 Elementi označivanja

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Označivanje naljepnicom (prema uredbi (EZ) br. 1272/2008 (CLP))

Piktogrami opasnosti

Oznaka opasnosti

Opasnost

Oznake upozorenja

H314

Uzrokuje teške opekline kože i ozljede oka.

Oznake obavijesti

Sprječavanje:

P280

Nosite zaštitne rukavice/ zaštitu za oči/ zaštitu

za lice.

Postupanje:

P303 + P361 + P353

U SLUČAJU DODIRA S KOŽOM (ili

kosom): odmah skinuti svu zagađenu odjeću.

Isprati kožu vodom/tuširanjem.

P305 + P351 + P338

U SLUČAJU DODIRA S OČIMA: oprezno

ispirati vodom nekoliko minuta. Ukloniti

kontaktne leće ukoliko ih nosite i ako se one

lako uklanjaju. Nastaviti ispiranje.

P310

Odmah nazvati CENTAR ZA KONTROLU

OTROVANJA/liječnika.

Opasne tvari koje se moraju navesti na naljepnici:

Kalijev hidroksid

2.3 Ostale opasnosti

Nisu poznati.

ODJELJAK 3. SASTAV/INFORMACIJE O SASTOJCIMA

3.2 Smjese

Opasni sastojci

Kemijski naziv

CAS-br.

EZ-br.

Br. REACH

Razvrstavanjeprema uredbi (EZ) br.

1272/2008 (CLP)

Koncentracija:

Kalijev karbonat

584-08-7

209-529-3

01-2119532646-36

Akutna toksičnost Klasa 4; H302

Nadražaj očiju Klasa 2; H319

Nadraživanje i nagrizanje kože Klasa 2;

H315

Specifična toksičnost za ciljne

organe/sustavna toksičnost -

jednokratna izloženost Klasa 3; H335

>= 10 - < 20

Kalijev hidroksid

1310-58-3

215-181-3

01-2119487136-33

Akutna toksičnost Klasa 4; H302

Nagriz. koža Klasa 1A; H314

Nagriz .met. klasa 1; H290

>= 2.5 - < 5

Za puni tekst H-izjava navedenih u ovom odjeljku pogledajte odjeljak 16.

ODJELJAK 4. MJERE PRVE POMOĆI

4.1 Opis mjera prve pomoći

U slučaju dodira s očima

Odmah početi ispirati s puno vode, također ispod očnih kapaka, u

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trajanju od najmanje 15 minuta. Ukloniti kontaktne leće ako ih

nosite i ako se one lako uklanjaju. Nastaviti ispiranje. Odmah

pozovite liječnika.

U slučaju dodira s kožom

Odmah ispirati s mnogo vode u trajanju od barem 15 minuta. Ako

je moguće, upotrijebiti blag sapun. Operite kontaminiranu odjeću

prije ponovne rabe. Prije ponovne uporabe, temeljito očistiti

obuću. Odmah pozovite liječnika.

U slučaju gutanja

Isprati usta vodom. NE izazivajte povraćanje. Nikada ne davati

bilo što u usta nesvjesnoj osobi. Odmah pozovite liječnika.

U slučaju inhalacije

Premjestiti na svjež zrak. Liječiti simptomatski. Ako se pojave

simptomi, potražiti liječničku pomoć.

4.2 Najvažniji simptomi i učinci, akutni i odgođeni

Vidjeti odjeljak 11 za detaljnije informacije o utjecajima na zdravlje i mogućim simptomima.

4.3 Navod o slučaju potrebe za hitnom liječničkom pomoći i posebnom obradom

Liječenje

Liječiti simptomatski.

ODJELJAK 5. MJERE GAŠENJA POŽARA

5.1 Sredstva za gašenje

Prikladna sredstva za

gašenje

Upotrijebiti mjere suzbijanja požara koje odgovaraju lokalnim

okolnostima i okolnom ambijentu.

Neprikladna sredstva za

gašenje požara

Nisu poznati.

5.2 Posebne opasnosti koje proizlaze iz tvari ili smjese

Posebne opasnosti tijekom

suzbijanja požara

Nije zapaljivo niti lako zapaljivo.

Opasni proizvodi izgaranja

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljikovi oksidi

Dušikovi oksidi (NOx)

sumporni oksidi

Fosforovi oksidi

5.3 Savjeti za gasitelje požara

Posebna zaštitna oprema za

vatrogasce

: Koristiti osobnu zaštitnu opremu.

Dodatni podaci

: S požarnim ostacima i vodom koja se koristila za gašenje požara

mora se rukovati u skladu s lokalnim uredbama. U slučaju požara

i/ili eksplozije, ne udisati dimove.

ODJELJAK 6. MJERE KOD SLUČAJNOG ISPUŠTANJA

6.1 Osobne mjere opreza, zaštitna oprema i postupci za izvanredna stanja

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Savjet za osoblje koje ne

intervenira u hitnim

slučajevima

Osigurati odgovarajuću ventilaciju. Držati ljude podalje i nasuprot

vjetru u odnosu na prolivenu tekućinu/pukotinu iz koje curi.

Izbjegavati udisanje, gutanje i dodir s kožom te očima. Ukoliko se

radnici susreću s količinama većim od graničnih vrijednosti

izloženosti, moraju koristiti odgovarajuće provjerene respiratore.

Osigurajte da čišcenje obavlja samo stručno osoblje. Pogledati

mjere zaštite navedene u odsjecima 7 i 8.

Savjet za osoblje koje

intervenira u hitnim

slučajevima

Ako je specijalizirana odjeća potrebna za rješavanje izlijevanja,

treba obratiti pažnju na bilo kakve informacije u Odjeljku 8 o

prikladnim i neprikladnim materijalima.

6.2 Mjere zaštite okoliša

Mjere zaštite okoliša

Ne dozvolite dodir s tlom, površinskim ili podzemnim vodama.

6.3 Metode i materijal za sprečavanje širenja i čišćenje

Metodama čišćenja

Ako je sigurno, zaustaviti istjecanje. Zaustavite i počistite

prolivenu tvar negorivim materijalom koji ima dobru moć upijanja

(npr. pijesak, zemlja, dijatomejska zemlja, vermikulit) te stavite u

spremnik za odlaganje prema lokalnim/nacionalnim uredbama

(pogledati odsjek 13).Isperite tragove vodom. Za velike izljeve

omeđiti proliveni materijal ili pokupiti materijal kako bi se osiguralo

da ne dospije u odvod.

6.4 Uputa za druge odjeljke

Vidjeti Odjeljak 1 za konakt za hitne informacije.

Za osobnu zaštitu pogledati odsjek 8.

Vidjeti Odjeljak 13 za dodatne informacije o zbrinjavanju otpada.

ODJELJAK 7. RUKOVANJE I SKLADIŠTENJE

7.1 Mjere opreza za sigurno rukovanje

Savjeti za sigurno rukovanje

Nemojte konzumirati. Spriječiti dodir s očima, kožom ili odjećom.

Ne udisati prašinu/ dim/ plin/ maglu/ pare/ aerosol. Rabiti samo uz

odgovarajuću ventilaciju. Nakon uporabe temeljito oprati ruke

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

sigurnosnom praksom. Skinuti i oprati kontaminiranu odjeću prije

ponovnog korištenja. Nakon rukovanja temeljito oprati lice, ruke i

izloženu kožu. Osigurati odgovarajući prostor za brzo namakanje

ili ispiranje očiju i tijela u slučaju kontakta ili prskanja opasnim

kemikalijama

7.2 Uvijeti sigurnog skladištenja, uzimajući u obzir moguće inkompatibilnosti

Uvjeti skladišnih prostora i

spremnika

Ne skladištiti blizu kiselina. Čuvati izvan dohvata djece. Čuvati u

dobro zatvorenom spremniku. Pohranjujte u primjerenim

obilježenim spremnicima.

Čuvati samo u originalnom spremniku. Pokupite prolivenu tvar

kako bi spriječili oštećenje materijala.

Temperatura skladištenja

0 °C do 40 °C

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Materijal za pakiranje

Prikladni materijal: Plastična tvar, uključujući i ekspandirane

plastične mase

Neprikladni materijal: Čelik dobiven taljenjem, Aluminij

7.3 Posebna krajnja uporaba ili uporabe

Posebna uporaba

Sredstvo za čišćenje - CIP postupak

ODJELJAK 8. NADZOR NAD IZLOŽENOŠĆU/OSOBNA ZAŠTITA

8.1 Nadzorni parametri

Ograničenja kod profesionalnog izlaganja

Sastojci

CAS-br.

Vrsta vrijednosti

(Oblik izloženosti)

Nadzorni parametri

Temelj

Kalijev hidroksid

1310-58-3

KGVI

2 mg/m3

HR OEL

Dodatni podaci

NAGRIZAJUĆE

DNEL

potassium hydroxide

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Vrijednost: 1 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Vrijednost: 1 mg/m3

8.2 Nadzor nad izloženošću

Odgovarajući inženjerski mehanizmi

Tehničke mjere

Djelotvoran odvodno ventilacijski sustav. Održavati vrijednosti

koncentracija u zraku unutar normi za granične vrijednosti

izloženosti na radu.

Individualne mjere zaštite

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

sigurnosnom praksom. Skinuti i oprati kontaminiranu odjeću prije

ponovnog korištenja. Nakon rukovanja temeljito oprati lice, ruke i

izloženu kožu. Osigurati odgovarajući prostor za brzo namakanje

ili ispiranje očiju i tijela u slučaju kontakta ili prskanja opasnim

kemikalijama

Zaštita očiju/lica (EN 166)

Zaštitne naočale

Stitnik za lice

Zaštita ruku (EN 374)

Preporučujemo preventivnu zaštitu kože

Rukavice

Nitrilna guma

Butilna guma

Vrijeme prodiranja: 1-4 sata

Minimalna debljina za butil gumu 0.7 za nitrilnu gumu 0.4 ili

ekvivalent (molimo pogledajte rukavice proizvođač / distributer za

savjet).

U slučaju bilo kakvih znakova razgradnje rukavica ili kemijskog

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prodiranja kroz rukavice treba ih ukloniti i zamijeniti novim.

Zaštita kože i tijela (EN

14605)

Osobna zaštitna oprema sastoji se od: odgovarajućih zaštitnih

rukavica, sigurnosnih naočala i zaštitne odjeće

Zaštita organa za disanje

(EN 143, 14387)

Nije potrebna ako su koncentracije ispod GVI vrijednosti Koristiti

certificiranuzaštitnu opremu za disanje koja prati EU zahtjeve

(89/656/EEZ, 89/686/EEZ) ili slično kada se respiratorni rizici ne

mogu izbjeći ili ograničiti tehničkim mjerama kolektivne zaštite ili

mjerama, metodama i postupcima organizacije rada.

Nadzor nad zaštitom okoliša

Opći savjeti

: Osigurajte okolicu mjesta pohrane.

ODJELJAK 9. FIZIKALNA I KEMIJSKA SVOJSTVA

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Agregatno stanje

: tekućina

Boja

: smeđ

Miris

: blag

12.5 - 13.5, 100 %

Plamište

Nije primjenjivo

Prag osjetljivosti mirisa

Ne može se primijeniti i /ili odrediti iz mješavine

Točka topljenja/Točka

topljenja

Ne može se primijeniti i /ili odrediti iz mješavine

Početna točka vrenja i

raspon vrenja

Ne može se primijeniti i /ili odrediti iz mješavine

Hlapivost

Ne može se primijeniti i /ili odrediti iz mješavine

Zapaljivost (kruta tvar, plin)

Ne može se primijeniti i /ili odrediti iz mješavine

Gornja granica

eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Donja granica eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Tlak pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća

1.31 - 1.35

Topljivost u vodi

topivo

Topivost u drugim

sredstvima za otapanje

Ne može se primijeniti i /ili odrediti iz mješavine

Koeficijent raspodjele n-

oktanol/voda

Ne može se primijeniti i /ili odrediti iz mješavine

Temperatura

samozapaljenja

Ne može se primijeniti i /ili odrediti iz mješavine

Termička razgradnja

Ne može se primijeniti i /ili odrediti iz mješavine

Viskoznost, kinematička

Ne može se primijeniti i /ili odrediti iz mješavine

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Eksplozivna svojstva

Ne može se primijeniti i /ili odrediti iz mješavine

Oksidirajuća svojstva

Tvar ili mješavina nije klasificirana kao oksidirajuća.

9.2 Ostale informacije

Ne može se primijeniti i /ili odrediti iz mješavine

ODJELJAK 10. STABILNOST I REAKTIVNOST

10.1 Reaktivnost

Nisu poznate opasne reakcije u uvjetima uobičajene uporabe.

10.2 Kemijska stabilnost

Stabilno u normalnim uvjetima.

10.3 Mogućnost opasnih reakcija

Nisu poznate opasne reakcije u uvjetima uobičajene uporabe.

10.4 Uvjeti koje treba izbjegavati

Nisu poznati.

10.5 Inkompatibilni materijali

Kiseline

Metali

Organske tvari

Čelik dobiven taljenjem

Aluminij

10.6 Opasni proizvodi raspadanja

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljikovi oksidi

Dušikovi oksidi (NOx)

sumporni oksidi

Fosforovi oksidi

ODJELJAK 11. TOKSIKOLOŠKE INFORMACIJE

11.1 Informacije o toksikološkim učincima

Informacije o vjerojatnim

načinima izlaganja

Inhalacija, Dodir s očima, Dodir s kožom

Proizvod

Akutna oralna toksičnost

: Procjena akutne toksičnosti : > 2,000 mg/kg

Akutna toksičnost pri

udisanju

: Nema raspoloživih podataka o ovom proizvodu.

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Akutna kožna toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Nadraživanje i nagrizanje

kože

: Nema raspoloživih podataka o ovom proizvodu.

Ozbiljno oštećenje

oka/nadraživanje oka

: Nema raspoloživih podataka o ovom proizvodu.

Senzibilizacija kože ili dišnih

puteva

: Nema raspoloživih podataka o ovom proizvodu.

Karcinogenost

: Nema raspoloživih podataka o ovom proizvodu.

Učinci na razmnožavanje

: Nema raspoloživih podataka o ovom proizvodu.

Mutagenost zametnih stanica

: Nema raspoloživih podataka o ovom proizvodu.

Teratogenost

: Nema raspoloživih podataka o ovom proizvodu.

Specifična toksičnost za

ciljne organe/sustavna

toksičnost (jednokratna

izloženost)

: Nema raspoloživih podataka o ovom proizvodu.

Specifična toksičnost za

ciljne organe/sustavna

toksičnost (opetovana

izloženost)

: Nema raspoloživih podataka o ovom proizvodu.

Aspiracijska toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Sastojci

Akutna oralna toksičnost

: Kalijev karbonat

LD50 Štakor: 1,870 mg/kg

Kalijev hidroksid

LD50 Štakor: 333 mg/kg

Sastojci

Akutna toksičnost pri

udisanju

: Kalijev karbonat

4 h LC50 Štakor: 5.26 mg/l

Sastojci

Akutna kožna toksičnost

: Kalijev karbonat

LD50 Zec: 2,000 mg/kg

Potencijalno djelovanje na zdravlje

Oči

Uzrokuje teške ozljede oka.

Koža

Prouzrokuje teške opekline kože.

Gutanje

Prouzrokuje opekline probavnog trakta.

Inhalacija

Može prouzrokovati nadraživanje nosa, grla i pluća.

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Kronično izlaganje

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Iskustvo s izlaganjem ljudi

Dodir s očima

Crvenilo, Bol, Nagrizanje

Dodir s kožom

Crvenilo, Bol, Nagrizanje

Gutanje

Nagrizanje, Bolovi u trbuhu

Inhalacija

Nadraženost dišnih puteva, Kašalj

ODJELJAK 12. EKOLOŠKE INFORMACIJE

12.1 Toksičnost

Utjecaj na okoliš

Proizvod nema poznatih ekotoksičnih posljedica.

Proizvod

Otrovnost za ribe

: Nema raspoloživih podataka

Toksično za daphnia i ostale

vodene beskičmenjake.

: Nema raspoloživih podataka

Otrovnost za alge

: Nema raspoloživih podataka

Sastojci

Otrovnost za ribe

: Kalijev karbonat

96 h LC50 Ribe: 230 mg/l

12.2 Postojanost i razgradivost

Proizvod

Biorazgradljivost

: Tenzidi u proizvodu su biorazgradljivi prema zahtjevima iz

regulativa o sredstvima za pranje 648/2004/EC.

Sastojci

Biorazgradljivost

Kalijev karbonat

Rezultat: Nije primjenjivo - anorganski

Kalijev hidroksid

Rezultat: Nije primjenjivo - anorganski

12.3 Bioakumulacijski potencijal

Nema raspoloživih podataka

12.4 Pokretljivost u tlu

Nema raspoloživih podataka

12.5 Rezultati ocjenjivanja svojstava PBT i vPvB

Proizvod

Ocjena

Ova tvar/smjesa ne sadrži komponente koje se smatraju

postojanim, bioakumulirajućima i toksičnima (PBT), ili jako

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postojanim i jako bioakumulirajućima (VPvB) na razinama od

0.1% ili više.

12.6 Ostali štetni učinci

Nema raspoloživih podataka

ODJELJAK 13. ZBRINJAVANJE

Odlažite u skladu s europskim direktivama o otpadu i opasnom otpadu.Kodove otpada bi trebao

odrediti korisnik, po mogućnosti u dogovoru s nadležnim organima za zbrinjavanje otpada.

13.1 Metode obrade otpada

Proizvod

: Uvijek kada je moguće se preferira recikliranje od odlaganja ili

spaljivanja. Ukoliko se ne može sprovesti recikliranje, odlagati u

skladu s lokalnim uredbama. Otpad odlažite na ovlaštena

odlagališta namijenjena toj svrsi.

Kontaminirana ambalaža

: Odlagati kao neupotrijebljen proizvod. Prazne spremnike treba

dostaviti ovlaštenoj osobi za postupanje s otpadom na recikliranje

ili odlaganje. Prazni spremnici se ne smiju ponovno upotrebljavati.

Odložite u skladu s mjesnim, državnim i federalnim propisima.

Smjernice za izbor koda za

otpad

: Anorganski otpad koji sadrži opasne tvari. Ako se ovaj proizvod

koristi u bilo kojem daljnjem postupku, konačni korisnik mora

redefinirati i dodijeliti najprikladniji kôd kataloga otpada.

Odgovornost generatora otpada je da odredi toksičnost i fizikalna

svojstva materijala koji se generira kako bi se odredile

odgovarajuće metode identifikacije i odlaganja otpada sukladno

važećim europskim (EU Directive 2008/98 / EC) i lokalnim

propisima.

ODJELJAK 14. INFORMACIJE O PRIJEVOZU

Pošiljatelj je odgovoran osigurati da pakiranje, etiketiranje i obilježavanje je u skladu sa odabranim

načinom prijevoza.

Kopneni prijevoz (ADR/ADN/RID)

14.1 UN broj

1814

14.2 Pravilno otpremno ime

prema UN-u

KALIJEV HIDROKSID OTOPINA

14.3 Razred(i) opasnosti pri

prijevozu

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

Zračni prijevoz (IATA)

14.1 UN broj

1814

14.2 Pravilno otpremno ime

prema UN-u

Potassium hydroxide solution

14.3 Razred(i) opasnosti pri

prijevozu

14.4 Skupina pakiranja

SIGURNOSNO -TEHNIČKI LIST

Prema Uredbi (EZ) br. 1907/2006

P3-ultrasil 69 NEW

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14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

None

Morski prijevoz (IMDG/IMO)

14.1 UN broj

1814

14.2 Pravilno otpremno ime

prema UN-u

POTASSIUM HYDROXIDE SOLUTION

14.3 Razred(i) opasnosti pri

prijevozu

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

None

14.7 Prijevoz u razlivenom

stanju u skladu s Prilogom II.

Konvenciji MARPOL i

Kodeksom IBC

Not applicable.

ODJELJAK 15. INFORMACIJE O PROPISIMA

15.1 Propisi u području sigurnosti, zdravlja i okoliša/posebno zakonodavstvo za tvar ili smjesu

sukladno Uredbi o

deterdžentima EZ 648/2004

5% ili više, ali manje od 15%: Fosfonati

Nacionalni propisi

Obratiti pažnju na Direktivu 94/33/EZ o zaštiti mladih ljudi na poslu.

Druge uredbe

Zakon o kemikalijama, Pravilnik o dokumentaciji za ocjenu aktivne

tvari u biocidnim pripravcima, dokumentaciji za ocjenu biocidnih

pripravaka, postupcima ocjenjivanja biocidnih pripravaka i njihove

uporabe te o vrstama biocidnih pripravaka s njihovim opisima i

jedinstvenim načelima za ocjenjivanje biocidnih pripravaka,

Pravilnik o popisu aktivnih tvari u biocidnim pripravcima, Pravilnik

o popisu postojećih aktivnih tvari dopuštenih u biocidnim

pripravcima, Pravilnik o popisu postojećih aktivnih tvari koje nisu

dopuštene u biocidnim pripravcima, Pravilnik o graničnim

vrijednostima izloženosti opasnim tvarima pri radu i o biološkim

graničnim vrijednostima, Zakon o zaštiti na radu, Zakon o

prijevozu opasnih tvari, Pravilnik o deterdžentima.

15.2 Procjena kemijske sigurnosti

Ovaj proizvod sadrži supstance za koje su Procjene sigurnosti kemikalija još uvijek neophodne.

ODJELJAK 16. OSTALE INFORMACIJE

Postupak se koristio za razvrstavanje prema

prema uredbi (EZ) br. 1272/2008 (CLP)

Razvrstavanje

Opravdanje

Nagriz. koža 1A, H314

Na temelju podataka ispitivanja.

Ozljeda oka 1, H318

Na temelju podataka ispitivanja.

Cjelovit tekst H-izjava

H290

Može nagrizati metale.

H302

Štetno ako se proguta.

H314

Uzrokuje teške opekline kože i ozljede oka.

H315

Nadražuje kožu.

SIGURNOSNO -TEHNIČKI LIST

Prema Uredbi (EZ) br. 1907/2006

P3-ultrasil 69 NEW

116116E

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H319

Uzrokuje jako nadraživanje oka.

H335

Može nadražiti dišni sustav.

Cjelovit tekst ostalih skraćenica

ADN - Europskog sporazuma o međunarodnom prijevozu opasnih tvari unutarnjim plovnim

putovima; ADR - Europski sporazum o međunarodnom cestovnom prijevozu opasnih tvari; AICS -

Australijski popis kemijskih tvari; ASTM - Američko društvo za ispitivanje materijala; bw - Tjelesna

masa; CLP - Klasifikacija uredbe o označavanju ambalaže; Uredba (EC) br. 1272/2008; CMR -

Kancerogen,

mutagen

reproduktivni

otrov;

Standard

Njemačkog

instituta

standardizaciju; DSL - Popis domaćih tvari (Kanada); ECHA - Europska agencija za kemikalije;

EC-Number - Broj Europske zajednice; ECx - Koncentracija povezana s x% odgovorom; ELx -

Stopa učitavanja povezana s x% odgovorom; EmS - Hitni raspored; ENCS - Postojeće i nove

kemijske tvari (Japan); ErCx - Koncentracija povezana s x% stopom rasta odgovora; GHS -

Globalno usklađen sustav; GLP - Dobra laboratorijska praksa; IARC - Međunarodna agencija za

istraživanje raka; IATA - Međunarodna udruga za zračni prijevoz; IBC - Međunarodni kodeks za

gradnju i opremanje brodova koji prevoze opasne kemikalije u rasutom stanju; IC50 - Pola

maksimalne koncentracije inhibitora; ICAO - Međunarodna organizacija za civilno zrakoplovstvo;

IECSC - Popis postojećih kemijskih tvari u Kini; IMDG - Međunarodni pomorski pravilnik za

prijevoz opasnih tvari; IMO - Međunarodna pomorska organizacija; ISHL - Zakon o industrijskoj

sigurnosti i zdravlju (Japan); ISO - Međunarodna organizacija za standardizaciju; KECI - Popis

postojećih kemikalija Koreje; LC50 - Smrtonosna koncentracija za 50% testirane populacije; LD50

Smrtonosna

doza

testirane

populacije

(Srednja

smrtonosna

doza);

MARPOL

Međunarodna konvencija o sprječavanju onečišćenja s brodova; n.o.s.

- Koji nije definiran

drugačije;

NO(A)EC

Nije

promatrana

(negativan)

koncentracija

učinka;

NO(A)EL

Nije

promatrano (negativan) razina učinka; NOELR - Nije primjetan učinak stope učitavanja; NZIoC -

Popis kemikalija Novog Zelanda; OECD - Organizacija za ekonomsku suradnju i razvoj; OPPTS -

Ured kemijske sigurnosti i sprječavanja onečišćenja; PBT - Postojana, bioakumulativna i otrovna

tvar; PICCS - Popis kemikalija i kemijskih tvari Filipina; (Q)SAR - (Kvantitativno) Struktura

aktivnosti odnosa; REACH - Uredba (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o

registriranju, ocjenjivanju, odobravanju i ograničavanju kemikalija; RID - Propisi o međunarodnom

prijevozu opasnih tvari željeznicom; SADT - Samoubrzanje temperature raspadanja; SDS -

Sigurnosni podatkovni list; TCSI - Popis kemijskih tvari Tajvana; TRGS - Tehnička pravila za

opasne tvari; TSCA - Zakon o kontroli otrovnih tvari (SAD); UN - Ujedinjene nacije; vPvB - Vrlo

postojani i vrlo bioakumulacijski

Pripremio

Poslovi vezani za zakonske propise

Brojevi navedeni u sigurnosnim listama (MSDS) dani su u obliku: 1,000 ,000 = 1 miljun and 1,000

= 1 tisuća. 0.1 = 1 destinka i 0.001 = 1 tisucinka.

PREPRAVLJENI PODACI: Znatne promjene zdravstvenih podataka za ovu reviziju su obilježene

na lijevoj margini MSDS-a.

Podaci u ovom sigurnosno-tehničkom listu odgovaraju našim saznanjima, informacijama i

uvjerenjima na dan izdavanja istog. Informacije sadržane u njemu, dane su samo kao smjernice

za sigurno rukovanje, upotrebu, postupanje, skladištenje, prijevoz i odlaganje otpada i nisu

garancija ili specifikacija kvalitete. Podaci se odnose isključivo na navedenu tvar/smjesu i nisu

nužno važeći za istu tu tvar/smjesu ukoliko se ista koristi sa bilo kojim drugim tvarima ili u bilo

kojem drugom postupku koji nije specificiran u tekstu.

  • Informativni letak za ovaj proizvod trenutno nije dostupan, možete poslati zahtjev na našu službu za korisnike, a mi ćemo vas obavijestiti čim smo u mogućnosti da ga dobiju.

    Zatražite informativni letak za javnost.



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20-11-2018

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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

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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

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30-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

FDA announces new plan to advance the development of plant and animal biotechnology innovation

FDA - U.S. Food and Drug Administration

30-10-2018

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

Small increased risk of certain types of skin cancer associated with the use of hydrochlorothiazide

There is a small increased risk of developing basal cell carcinoma and squamous cell carcinoma in long-term use of blood pressure medicine containing hydrochlorothiazide. This follows from a review of new studies and available data undertaken by the European Medicines Agency, EMA.

Danish Medicines Agency

30-10-2018

ANSES Newsletter in English - N°49 - October 2018

ANSES Newsletter in English - N°49 - October 2018

France - Agence Nationale du Médicament Vétérinaire

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

Statement from FDA Commissioner Scott Gottlieb, M.D., on how new regulatory authorities will assist the agency in more forcefully addressing opioid crisis; included as part of the newly enacted Substance Use-Disorder Prevention that Promotes Opioid Recove

The SUPPORT Act grants FDA additional authorities to meaningfully advance efforts to combat the crisis of opioid addiction plaguing our nation.

FDA - U.S. Food and Drug Administration

24-10-2018

FDA approves new drug to treat influenza

FDA approves new drug to treat influenza

FDA approved Xofluza (baloxavir marboxil) to treat acute uncomplicated flu in patients 12 years old and older who have been symptomatic for less than 48 hours.

FDA - U.S. Food and Drug Administration

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

23-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to advance new ways to increase the availability of naloxone as one means for reducing opioid overdose deaths

FDA - U.S. Food and Drug Administration

23-10-2018

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

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

19-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, processors more effectively comply with food safety requirements

Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to help produce farmers, fresh-cut produce processors more effectively comply with food safety requirements

FDA - U.S. Food and Drug Administration

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

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

17-10-2018

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy

SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

FDA and DHS announce partnership to address medical device cybersecurity threats

FDA - U.S. Food and Drug Administration

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

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

FDA - U.S. Food and Drug Administration

11-10-2018

FDA approves new DNA-based test to determine blood compatibility

FDA approves new DNA-based test to determine blood compatibility

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

FDA - U.S. Food and Drug Administration

11-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

5-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-10-2018

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

October 1, 2018: AmerisourceBergen Corp. to Pay $625 Million to Settle Civil Fraud Allegations Resulting from Its Repackaging and Sale of Adulterated Drugs and Unapproved New Drugs, Double Billing and Providing Kickbacks

FDA - U.S. Food and Drug Administration

2-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

FDA - U.S. Food and Drug Administration

28-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

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

17-10-2018

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read:  https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF pic.twitter.com/1VPpgHdbic

#FDA issues new draft guidance now open for comment: Content of Premarket Submissions for Management of Cybersecurity in #MedicalDevices. Click to read: https://go.usa.gov/xPRNF  pic.twitter.com/1VPpgHdbic

FDA - U.S. Food and Drug Administration

16-10-2018

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults:  https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH .pic.twitter.com/5mo0xuGCcK

#FDAapproves new drug for the treatment of breast cancer with certain gene mutations for adults: https://go.usa.gov/xPNnH . pic.twitter.com/5mo0xuGCcK

FDA - U.S. Food and Drug Administration

5-10-2018

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release:  https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

Devices flag! The FDA has allowed the marketing a new type of hearing aid, a self-fitted hearing aid controlled by the user. Interested reporters should check out our press release: https://go.usa.gov/xPkuB 

FDA - U.S. Food and Drug Administration

2-10-2018

Xigduo (AstraZeneca AB)

Xigduo (AstraZeneca AB)

Xigduo (Active substance: dapagliflozin/metformin) - Centralised - Renewal - Commission Decision (2018)6462 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2672/R/44

Europe -DG Health and Food Safety

1-10-2018

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients  http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2  pic.twitter.com/8w5m5itceW

FDA - U.S. Food and Drug Administration