ECO-BAC WIPES

Glavna informacija

  • Trgovački naziv:
  • ECO-BAC WIPES
  • Koristi za:
  • Ljudi
  • Vrsta lijekova:
  • Medicinski uređaj

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Lokalizacija

  • Na raspolaganju u:
  • ECO-BAC WIPES
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 112432E
  • 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

Eco-Bac Wipes

Oznaka proizvoda

112432E

Uporaba tvari/pripravka

Dezinficijens

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 dezinfekciju površina. Manualni proces

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

26.07.2017

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari ili smjese

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

Zapaljive tekućine, Klasa 3

H226

Nadražaj očiju, Klasa 2

H319

Specifična toksičnost za ciljne organe/sustavna toksičnost -

jednokratna izloženost, Klasa 3, Središnji živčani sustav

H336

2.2 Elementi označivanja

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

Piktogrami opasnosti

Oznaka opasnosti

Upozorenje

Oznake upozorenja

H319

Uzrokuje jako nadraživanje oka.

H226

Zapaljiva tekućina i para.

H336

Može izazvati pospanost ili vrtoglavicu.

Oznake obavijesti

Sprječavanje:

P210

Čuvati odvojeno od topline, vrućih površina,

iskri, otvorenih plamena i ostalih izvora

paljenja. Ne pušiti.

Opasne tvari koje se moraju navesti na naljepnici:

propan-2-ol

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:

propan-2-ol

67-63-0

200-661-7

01-2119457558-25

Zapaljive tekućine Klasa 2; H225

Nadražaj očiju Klasa 2; H319

Specifična toksičnost za ciljne

organe/sustavna toksičnost -

jednokratna izloženost Klasa 3; H336

>= 30 - < 50

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

trajanju od najmanje 15 minuta. Ukloniti kontaktne leće ako ih

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

liječniku.

U slučaju dodira s kožom

Isprati s mnogo vode.

U slučaju gutanja

Isprati usta. Ako se pojave simptomi, potražiti liječničku pomoć.

U slučaju inhalacije

Premjestiti na svjež zrak. Liječiti simptomatski. Ako se pojave

simptomi, potražiti liječničku pomoć.

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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

Veliki mlaz vode

5.2 Posebne opasnosti koje proizlaze iz tvari ili smjese

Posebne opasnosti tijekom

suzbijanja požara

Opasnost od požara

Držati podalje topline i izvora paljenja.

Moguće je širenje plamena na većoj udaljenosti.

Čuvajte se para čijom akumulacijom mogu nastati eksplozivne

koncentracije. Pare se mogu nakupiti u niskim područjima.

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

: Za rashlađivanje zatvorenih spremnika može se koristiti vodeni

sprej. 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

Savjet za osoblje koje ne

intervenira u hitnim

slučajevima

Ukloniti sve izvore paljenja. Osigurajte da čišcenje obavlja samo

stručno osoblje. Pogledati mjere zaštite navedene u odsjecima 7 i

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.

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6.3 Metode i materijal za sprečavanje širenja i čišćenje

Metodama čišćenja

Uklonite sve izvore paljenja ukoliko to možete učiniti na siguran

način.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

Spriječiti dodir s kožom i očima Ne udisati prašinu/ dim/ plin/

maglu/ pare/ aerosol. Rabiti samo uz odgovarajuću ventilaciju.

Držite podalje od vatre, iskri i ugrijanih površina. Učiniti sve što je

potrebno da bi se izbjeglo oslobađanje statičkog elektriciteta (koji

može prouzročiti zapaljenje organskih para). Nakon uporabe

temeljito oprati ruke Pažljivo otvoriti bačvu budući da je sadržaj

možda pod tlakom.

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.

7.2 Uvijeti sigurnog skladištenja, uzimajući u obzir moguće inkompatibilnosti

Uvjeti skladišnih prostora i

spremnika

Držati podalje topline i izvora paljenja. Čuvati na hladnom, dobro

provjetrenom mjestu. Čuvati odvojeno od oksidacijskih sredstava.

Čuvati izvan dohvata djece. Čuvati u dobro zatvorenom

spremniku. Pohranjujte u primjerenim obilježenim spremnicima.

Temperatura skladištenja

0 °C do 40 °C

7.3 Posebna krajnja uporaba ili uporabe

Posebna uporaba

Sredstvo za dezinfekciju površina. Manualni proces

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

propan-2-ol

67-63-0

400 ppm

999 mg/m3

HR OEL

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Dodatni podaci

Lako zapaljivo

NADRAŽUJUĆE

KGVI

500 ppm

1,250 mg/m3

HR OEL

Dodatni podaci

Lako zapaljivo

NADRAŽUJUĆE

Biološke granične vrijednosti izlaganja na radnom mjestu

Naziv tvari

CAS-br.

Nadzorni parametri

Vrijeme uzorkovanja

Temelj

propan-2-ol

67-63-0

Aceton: 50 mg/l

(Krv)

na kraju radne smjene

HR BEI

Aceton: 50 mg/l

(Urin)

na kraju radne smjene

HR BEI

DNEL

propan-2-ol

Konačna upotreba: Radnici

Načini izloženosti: Kožno

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 888 mg/cm2

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 500 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Kožno

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 319 mg/cm2

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 89 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Gutanje

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 26 ppm

PNEC

propan-2-ol

Slatka voda

Vrijednost: 140.9 mg/l

Morska voda

Vrijednost: 140.9 mg/l

Isprekidano korištenje/otpuštanje

Vrijednost: 140.9 mg/l

Slatka voda

Vrijednost: 552 mg/kg

Talog u moru

Vrijednost: 552 mg/kg

Zemlja

Vrijednost: 28 mg/kg

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Postrojenje za obradu fekalija

Vrijednost: 2251 mg/l

Oralno

Vrijednost: 160 mg/kg

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.

Zaštita očiju/lica (EN 166)

Nije potrebna posebna zaštitna oprema.

Zaštita ruku (EN 374)

Nije potrebna posebna zaštitna oprema.

Zaštita kože i tijela (EN

14605)

Nije potrebna posebna zaštitna oprema.

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

: absorbed liquid (wipes, pads, ...)

Boja

: jasan, svijetlo žut

Miris

: alkoholni

5.0 - 7.0, 100 %

Plamište

23 °C zatvoreni sud, Potpomaže izgaranje

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

Ne može se primijeniti i /ili odrediti iz mješavine

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raspon vrenja

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

0.945 - 0.955

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

52.726 mm2/s (40 °C)

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

Toplina, plamenovi i iskre.

10.5 Inkompatibilni materijali

Nisu poznati.

10.6 Opasni proizvodi raspadanja

Produkti raspadanja mogu uključivati sljedeće materijale:

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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

: Nema raspoloživih podataka o ovom proizvodu.

Akutna toksičnost pri

udisanju

: Nema raspoloživih podataka o ovom proizvodu.

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

: propan-2-ol

LD50 Štakor: 5,840 mg/kg

Sastojci

Akutna toksičnost pri

: propan-2-ol

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udisanju

4 h LC50 Štakor: 30 mg/l

Sastojci

Akutna kožna toksičnost

: propan-2-ol

LD50 Zec: 12,870 mg/kg

Potencijalno djelovanje na zdravlje

Oči

Uzrokuje jako nadraživanje oka.

Koža

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Gutanje

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Inhalacija

Udisanje može prouzrokovati učinke na centralni živčani sustav.

Kronično izlaganje

Zdravstvena oštećenja nisu poznata, niti su za očekivati pri

normalnoj upotrebi.

Iskustvo s izlaganjem ljudi

Dodir s očima

Crvenilo, Bol, Nadraživanje

Dodir s kožom

Nisu poznati ili očekivani nikakvi simptomi.

Gutanje

Nisu poznati ili očekivani nikakvi simptomi.

Inhalacija

Vrtoglavica, Pospanost

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

: propan-2-ol

96 h LC50 Pimephales promelas (Debeloglava gavčica): 9,640

mg/l

Sastojci

Toksično za daphnia i ostale

vodene beskičmenjake.

: propan-2-ol

LC50 Daphnia magna (Vodenbuha): > 10,000 mg/l

12.2 Postojanost i razgradivost

Proizvod

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Biorazgradljivost

: Tenzidi u proizvodu su biorazgradljivi prema zahtjevima iz

regulativa o sredstvima za pranje 648/2004/EC.

Sastojci

Biorazgradljivost

propan-2-ol

Rezultat: Biološki vrlo razgradljivo.

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

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

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

koristi u svim daljnjim postupcima, konačni korisnik mora

redefinirati i dodijeliti najprikladnije Europski kataloški kod za

otpad. To je odgovornost generatora otpada kako bi se utvrdila

toksičnost i fizikalna svojstva materijala generiranog za

određivanje odgovarajuće identifikacije i zbrinjavanja otpada

metode u skladu s važećim europskim (Direktiva EU 2008/98 /

EC) i lokalnim propisima.

ODJELJAK 14. INFORMACIJE O PRIJEVOZU

SIGURNOSNO -TEHNIČKI LIST

Prema Uredbi (EZ) br. 1907/2006

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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

3175

14.2 Pravilno otpremno ime

prema UN-u

KRUTE TVARI KOJE SADRŽE ZAPALJIVE TEKUĆINE, N.D.N.

(izopropanol)

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

3175

14.2 Pravilno otpremno ime

prema UN-u

Solids containing flammable liquid, n.o.s.

(Isopropanol)

14.3 Razred(i) opasnosti pri

prijevozu

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

None

Morski prijevoz (IMDG/IMO)

14.1 UN broj

3175

14.2 Pravilno otpremno ime

prema UN-u

SOLIDS CONTAINING FLAMMABLE LIQUID, N.O.S.

(Isopropanol)

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

Sadrži: Sredstva za dezinfekciju

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,

SIGURNOSNO -TEHNIČKI LIST

Prema Uredbi (EZ) br. 1907/2006

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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

Zapaljive tekućine 3, H226

Na temelju podataka o proizvodima ili procjene

Nadražaj očiju 2, H319

Način izračuna

Specifična toksičnost za ciljne organe/sustavna

toksičnost - jednokratna izloženost 3, H336

Način izračuna

Cjelovit tekst H-izjava

H225

Lako zapaljiva tekućina i para.

H319

Uzrokuje jako nadraživanje oka.

H336

Može izazvati pospanost ili vrtoglavicu.

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 -

SIGURNOSNO -TEHNIČKI LIST

Prema Uredbi (EZ) br. 1907/2006

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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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10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

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

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

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

24-10-2018

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

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

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion 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

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

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

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FDA - U.S. Food and Drug Administration

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

21-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority EFSA Journal

11-9-2018

Risk assessment of white willow (Salix alba) in food

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Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Alcon Announces Voluntary Global Market Withdrawal of CyPass Micro-Stent for Surgical Glaucoma

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FDA - U.S. Food and Drug Administration

29-8-2018

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Strategic partnership with German data providing institutions on data quality (Pilot project) – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 This report describes the framework of collection, management and transmission of food safety data in the Federal Republic of Germany. To adjust optimally the data governance processes to the requirements defined by the EFSA, measures had been agreed upon in order to improve the specified situation. Subsequent methodological system enhancements related to data quality are given as well as structural adjustments and the development and implementation of suppo...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

New recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones

The EU's Pharmacovigilance Risk Assessment Committee (PRAC) has adopted new recommendations for use of Xofigo for treatment of prostate cancer which has spread to the bones (bone metastases). Xofigo should only be used in symptomatic patients who have had two previous treatments for prostate cancer and who cannot be treated with other medicines.

Danish Medicines Agency

23-8-2018

The Manhattan Toy Company recalls Pull-Back Speedy Jets

The Manhattan Toy Company recalls Pull-Back Speedy Jets

The rubber tires can separate from the wheels posing a small parts choking hazard for small children.

Health Canada

23-8-2018

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

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

7-8-2018

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Seaweed consumption: remain vigilant to the risk of excess iodine intake

Over the last few years, seaweed has become increasingly common on our plates. Fresh, dried or as a food supplement, its iodine content varies and can sometimes be high. ANSES assessed the risk of excess iodine intake from the consumption of seaweed-based products. In view of the non-negligible risk of exceeding the upper limit of safe intake for iodine, the Agency advises against the consumption of seaweed and seaweed-based food supplements by certain at-risk populations, and recommends that regular con...

France - Agence Nationale du Médicament Vétérinaire

6-8-2018

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

FDA issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment drugs to treat opioid use disorder.

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

20-7-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

Statement from FDA Commissioner Scott Gottlieb, M.D., on agency’s efforts to encourage the development of and broaden access to generic versions of opioid analgesics that are formulated to deter abuse

FDA posted a new batch of 43 product-specific guidances related to the development of generic drug products that includes three revised product-specific guidances for ADF opioid products. These guidances recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations.

FDA - U.S. Food and Drug Administration

19-7-2018

Assessment of the safety of feminine hygiene products

Assessment of the safety of feminine hygiene products

Today ANSES is publishing its health risk assessment on the safety of feminine hygiene products. Chemicals have been identified in these products at very low concentrations not exceeding health thresholds. The expert appraisal did not reveal any risk associated with these substances. Nevertheless, the Agency recommends that manufacturers improve the quality of these products in order to eliminate or minimise the presence of chemicals. ANSES’s expert appraisal also examined the risk of menstrual toxic sho...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

13-7-2018

Scientific guideline:  Guideline on good pharmacogenomic practice - First version, adopted

Scientific guideline: Guideline on good pharmacogenomic practice - First version, adopted

This guideline provides recommendations for the conduct of genomic studies in relation to medical therapy in order to provide high quality information on the impact of genomic variability on drug response. Primary focus is on the analysis of genomic germline DNA. The analysis of somatic DNA and genomic biomarkers for cancer treatment is not being discussed and might be developed as an Annex or in separate guidance.

Europe - EFSA - European Food Safety Authority EFSA Journal

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

28-6-2018

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

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

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

France - Agence Nationale du Médicament Vétérinaire

8-5-2018

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms

The FDA has received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.

FDA - U.S. Food and Drug Administration

20-3-2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

Medicines Safety Update, Volume 9, Number 1, February-March 2018

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin

Therapeutic Goods Administration - Australia

15-2-2018

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

Be aware of rare but possible risk of liver injury in medical treatment of fibroids

The Danish Medicines Agency recommends doctors not to start any new patients on the medicine Esmya (ulipristal) because of a rare, but possible, risk of developing serious liver injury.

Danish Medicines Agency

14-11-2017

The European Commission has published three recommendations for the clinical trials regulation

The European Commission has published three recommendations for the clinical trials regulation

In cooperation with the clinical trials expert group, the European Commission is updating and issuing new recommendations as a result of the regulation on clinical trials on medicinal products for human use.

Danish Medicines Agency

21-3-2017

New recommendation for phasing out zinc oxide for young pigs

New recommendation for phasing out zinc oxide for young pigs

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has confirmed a previous decision to phase out zinc oxide. Consequently, the CVMP has once more recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

19-12-2016

Zinc oxide for young pigs to be phased out

Zinc oxide for young pigs to be phased out

The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.

Danish Medicines Agency

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

17-10-2014

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Danish Medicines Agency

3-10-2014

Consultation procedure about medicinal products and safety measure requirements not completed yet

Consultation procedure about medicinal products and safety measure requirements not completed yet

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for...

Danish Medicines Agency

25-2-2014

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.

Danish Medicines Agency

5-1-2012

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

Consultation on the Reimbursement Committee's recommendation concerning the reimbursement status of strong painkillers (opioids)

At the Danish Medicines Agency's request, the Reimbursement Committee has reassessed the reimbursement status of medicines in ATC group N02A, opioids, as well as certain medicines in ATC groups N07BC and R05DA.

Danish Medicines Agency

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

11-10-2018

October is #SIDSAwarenessMonth.  Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at  https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobaccopic.twitter.com/i37QX61Bb

October is #SIDSAwarenessMonth. Smoking during pregnancy can lead to complications, premature delivery, low birth weight, stillbirth, and SIDS. Make sure your baby is #safetosleep at https://women.smokefree.gov/  via @FDATobacco pic.twitter.com/i37QX61Bb7

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

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

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

19-9-2018

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin  containing medical devices and device-led combination products to help  reduce the risk of patient injury. To read the guidance, click here:  https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/x

#FDA issues final guidance with recommendations for labeling and safety testing of #heparin containing medical devices and device-led combination products to help reduce the risk of patient injury. To read the guidance, click here: https://go.usa.gov/xP2VB  #MedicalDevice pic.twitter.com/hsdX5ylKPu

FDA - U.S. Food and Drug Administration

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Party with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 26-Sep-2018, To: 26-Sep-2018

This Healthcare Professionals' Working Party (HCPWP) plenary meeting will include discussions on advances in clinical practice and the scientific and regulatory challenges. Members will also be invited to present how they are including regulatory sciences in fellowships and young researchers’ training. Feedback will be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep-2018

This Patients' and Consumers' Working Party (PCWP) plenary meeting will include discussions on patient engagement along the regulatory lifecycle and visibility of patient input throughout scientific procedures. Feedback will also be given from the representatives of the Scientific Committees.

Europe - EMA - European Medicines Agency

21-8-2018

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months!  https://go.usa.gov/xUskq 
#OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCarepic.twitter.com/VRDkVPvMTR

It’s #ContactLensHealthWeek! Remember to wear your contacts no longer than recommended and to replace your contact lens case once every 3 months! https://go.usa.gov/xUskq  #OnePairTakeCare pic.twitter.com/VRDkVPvMTR

FDA - U.S. Food and Drug Administration

15-8-2018

Orbactiv (Rempex London Ltd)

Orbactiv (Rempex London Ltd)

Orbactiv (Active substance: oritavancin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5556 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3785/T/20

Europe -DG Health and Food Safety

14-8-2018

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at  https://go.usa.gov/xUF39   #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kids #MedicalDevice pic.twitter.com/XGwlpgopGn

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

27-7-2018

Withdrawn application:  Raligize, axalimogene filolisbac, Initial authorisation

Withdrawn application: Raligize, axalimogene filolisbac, Initial authorisation

Europe - EMA - European Medicines Agency

18-7-2018

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity:  https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://hea

THREAD: We’re proud to work with the public-private Healthcare Sector Coordinating Council’s Medical Technology & Health IT Task Group to address @HHSgov Cybersecurity Task Force Report recommendations related to medical device cybersecurity: https://healthsectorcouncil.org/health-sector-mobilizes-against-cyber-threats/ …

FDA - U.S. Food and Drug Administration

9-7-2018

Scientific guideline:  Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

Scientific guideline: Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury, draft: consultation open

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.

Europe - EMA - European Medicines Agency

27-6-2018

Orbactiv (The Medicines Company UK Ltd)

Orbactiv (The Medicines Company UK Ltd)

Orbactiv (Active substance: oritavancin) - PSUSA - Modification - Commission Decision (2018)4093 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10368/201709

Europe -DG Health and Food Safety

7-6-2018

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

#FDA announces draft Guidance: “Requests for Feedback and Meetings for #MedicalDevice Submissions: The Q-Submission Program”. Comment period closes in 60 days https://go.usa.gov/xQsCe 

FDA - U.S. Food and Drug Administration

29-5-2018

FDA Open Docket now available for feedback on benefits and risks of software that are not devices-  https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA - U.S. Food and Drug Administration

29-5-2018

FDA issues recommendations to help prevent surgical fires and related patient injury-  https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA issues recommendations to help prevent surgical fires and related patient injury- https://go.usa.gov/xQdwG  #MedicalDevice #Safety

FDA - U.S. Food and Drug Administration