EXELERATE ZTF SOFT METAL RTU

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  • EXELERATE ZTF SOFT METAL RTU (914191)
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Lokalizacija

  • Na raspolaganju u:
  • EXELERATE ZTF SOFT METAL RTU (914191)
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 114809E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br.

1907/2006

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

1.1 Identifikacija proizvoda

Ime proizvoda

Exelerate ZTF Soft Metal RTU

Oznaka proizvoda

114809E

Uporaba tvari/pripravka

Sredstvo za čišćenje

Vrsta tvari

Smjesa

Samo za profesionalne korisnike.

Informacije o razrijeđenom

proizvodu

Nema informacija za razrijeđenje

1.2 Važni utvrđeni načini korištenja tvari ili mješavine i načini korištenja koji se ne preporučaju

Identificirane uporabe

Sredstvo za čišćenje - polu zatvoreni postupak čišćenja

Preporučena ograničenja u

svezi s uporabom

Ograničeno za industrijsku i profesionalnu uporabu.

1.3 Podaci o dobavljaču sigurnosno-tehničkog lista

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 službe za izvenredna stanja

Broj službe za izvenredna

stanja

Telefonski broj Centra za

informacije o trovanju

01-23-48-342

Datum sakupljanja/revizije

20.11.2014

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari i smjese

Klasifikacija (UREDBI (EZ) br. 1272/2008)

Izjedanje kože , Klasa 1A

H314

Klasifikacija (67/548/EEZ, 1999/45/EZ)

C; NAGRIZAJUĆE

Razvrstavanje ovog proizvoda je bazirano na ekstremnoj pH

vrijednosti ( u skladu sa važećom EU regulativom).

Za cjelokupan sadržaj R upozorenja spomenutih u ovom odsjeku, pogledati odsjek 16.

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

SIGURNOSNO -TEHNIČKI LIST

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2.2 Elementi oznake

Označivanje naljepnicom (UREDBI (EZ) br. 1272/2008)

Piktogrami rizika

Upozoravajuća riječ

Opasnost

Upozorenja o opasnosti

H314

Uzrokuje teške opekline kože i ozljede oka.

Obavijesti o opasnosti

Sprječavanje:

P280

Nosite zaštitne rukavice/ zaštitu za oči/ zaštitu

za lice.

Intervencija:

P303 + P361 + P353

U SLUČAJU DODIRA S KOŽOM (ili

kosom): odmah ukloniti/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 ili 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

Klasifikacija

(67/548/EEZ)

Klasifikacija

(UREDBI (EZ) br. 1272/2008)

Koncentracija:

Benzyl alcohol

100-51-6

202-859-9

01-2119492630-38

Xn; R20/22

Akutna toksičnostKlasa 4;

H302

Akutna toksičnostKlasa 4;

H332

>= 1 - < 2.5

Kalijev hidroksid

1310-58-3

215-181-3

01-2119487136-33

C; R22-R35

Akutna toksičnostKlasa 4;

H302

Izjedanje kožeKlasa 1A; H314

>= 0.5 - < 1

Za cjelokupan sadržaj R upozorenja spomenutih u ovom odsjeku, pogledati odsjek 16.

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

ODJELJAK 4. MJERE PRVE POMOĆI

SIGURNOSNO -TEHNIČKI LIST

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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. 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 Hitna liječnička pomoć i posebna obrada

Liječenje

Liječiti simptomatski.

ODJELJAK 5. MJERE ZA SUZBIJANJE 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

ugljikovi 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 u slučaju opasnosti

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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. Ne udisati

prašinu/dim/plin/maglu/pare/aerosol. Spriječiti dodir s očima,

kožom ili odjećom. Nakon uporabe temeljito oprati ruke Rabiti

samo uz odgovarajuću ventilaciju.

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.

Temperatura skladištenja

-10 °C do 40 °C

7.3 Posebna krajnja uporaba ili uporabe

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br. 1907/2006

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Posebna uporaba

Sredstvo za čišćenje - polu zatvoreni postupak čišćenja

ODJELJAK 8. NADZOR NAD IZLOŽENOŠĆU/OSOBNA ZAŠTITA

8.1 Nadzorni parametri

Ograničenja kod profesionalnog izlaganja

CAS-br.

Sastojci

Vrsta vrijednosti

(Oblik

izloženosti)

Nadzorni

parametri

Ažurirati

Temelj

1310-58-3

Kalijev

hidroksid

STEL

2 mg/m3

2009-01-30

HR OEL

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)

Nosite sljedeću osobnu zaštitnu opremu:

Nitrilna guma

Butilna guma

Nepropusne rukavice

U slučaju bilo kakvih znakova razgradnje rukavica ili kemijskog

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)

Ukoliko se radnici susreću s količinama većim od graničnih

vrijednosti izloženosti, moraju koristiti odgovarajuće provjerene

respiratore.

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

SIGURNOSNO -TEHNIČKI LIST

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Opće informacije

: gel

Boja

: jasan, svijetlo žut

Miris

: sladak

13.0 - 13.4, 100 %

Plamište

Nije primjenjivo

Prag osjetljivosti mirisa

Nema raspoloživih podataka

Točka topljenja/Točka

topljenja

Nema raspoloživih podataka

Početna točka vrenja i

raspon vrenja

Nema raspoloživih podataka

Hlapivost

Nema raspoloživih podataka

Zapaljivost (kruta tvar, plin)

Nema raspoloživih podataka

Gornja granica

eksplozivnosti

Nema raspoloživih podataka

Donja granica eksplozivnosti

Nema raspoloživih podataka

Tlak pare

Nema raspoloživih podataka

Relativna gustoća pare

Nema raspoloživih podataka

Relativna gustoća

1.011 - 1.029

Topljivost u vodi

topivo

Topivost u drugim

sredstvima za otapanje

Nema raspoloživih podataka

Koeficijent raspodjele n-

oktanol/voda

Nema raspoloživih podataka

Temperatura

samozapaljenja

Nema raspoloživih podataka

Termička razgradnja

Nema raspoloživih podataka

Viskoznost, kinematička

834.834 mm2/s (40 °C)

Eksplozivna svojstva

Nema raspoloživih podataka

Oksidirajuća svojstva

Tvar ili mješavina nije klasificirana kao oksidirajuća.

9.2 Ostali podaci

Nema raspoloživih podataka

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.

SIGURNOSNO -TEHNIČKI LIST

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10.4 Uvjeti koje treba izbjegavati

Nisu poznati.

10.5 Inkompatibilni materijali

Kiseline

Metali

10.6 Opasni proizvodi raspada

ugljikovi oksidi

ODJELJAK 11. TOKSIKOLOŠKE INFORMACIJE

11.1 Informacije o toksikološkim učincima

Informacije o vjerojatnim

načinima izlaganja

Inhalacija, Dodir s očima, Dodir s kožom

Toksičnost

Akutna oralna toksičnost

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

Akutna toksičnost pri

udisanju

: 4 h Procjena akutne toksičnosti : > 20 mg/l

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.

Kancerogenost

: 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.

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Aspiracijska toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Sastojci

Akutna oralna toksičnost

: Benzyl alcohol

LD50 Štakor: 1,620 mg/kg

Sastojci

Akutna kožna toksičnost

: Benzyl alcohol

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.

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 Ekotoksičnost

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

: Benzyl alcohol

96 h LC50 Ribe : > 100 mg/l

Kalijev hidroksid

96 h LC50: 80 mg/l

12.2 Postojanost i razgradivost

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Nema raspoloživih podataka

12.3 Bioakumulacijski potencijal

Nema raspoloživih podataka

12.4 Pokretljivost u tlu

Nema raspoloživih podataka

12.5 Rezultati procjene PBT i vPvB svojstava

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 postupanja s otpadom

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.

Europski katalog otpada

: 200115* - lužine

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

1719

14.2 Točan naziv pošiljke

UN-a

NAGRIZAJUĆA ALKALNA TEKUĆINA, N.D.N.

(Natrij-hidroksid, kalij-hidroksid)

14.3 Klasa(e) opasnosti

prijevoza

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

SIGURNOSNO -TEHNIČKI LIST

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Zračni prijevoz (IATA)

14.1 UN broj

1719

14.2 Točan naziv pošiljke

UN-a

Caustic alkali liquid, n.o.s.

(Natrij-hidroksid, kalij-hidroksid)

14.3 Klasa(e) opasnosti

prijevoza

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

Morski prijevoz (IMDG/IMO)

14.1 UN broj

1719

14.2 Točan naziv pošiljke

UN-a

CAUSTIC ALKALI LIQUID, N.O.S.

(Natrij-hidroksid, kalij-hidroksid)

14.3 Klasa(e) opasnosti

prijevoza

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

14.7 Prijevoz u rasutom

stanju prema aneksu II

konvencije MARPOL 73/78 i

IBC kodu

Nije primjenjivo

ODJELJAK 15. INFORMACIJE O PROPISIMA

15.1 Propisi u području sigurnosti, zdravlja i okoliša/posebni propisi za tvar ili smjesu

Tuzemna odredba

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

Druge uredbe

Zakon o kemikalijama, Pravilnik o razvrstavanju, označavanju,

obilježavanju i pakiranju opasnih kemikalija-rađen prema DSD i

DPD direktivama, Pravilnik o razvrstavanju, označavanju,

obilježavanju i pakiranju opasnih kemikalija-rađen prema CLP-u

Zako

15.2 Procjena sigurnosti kemikalija

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

ODJELJAK 16. OSTALE INFORMACIJE

Cjelovit tekst R-fraza

R20/22

Štetno ako se udiše i ako se proguta

Štetno ako se proguta

Izaziva teške opekotine

Cjelovit tekst H-izjava

H302

Štetno ako se proguta.

H314

Uzrokuje teške opekline kože i ozljede oka.

H332

Štetno ako se udiše

SIGURNOSNO -TEHNIČKI LIST

sukladno Uredbi (EZ) br. 1907/2006

Exelerate ZTF Soft Metal RTU

114809E

11 / 11

Cjelovit tekst ostalih skraćenica

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

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5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

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Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

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1-11-2018

Pest categorisation of Conotrachelus nenuphar

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Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

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30-10-2018

Pest categorisation of Sternochetus mangiferae

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Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

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28-9-2018

EQ3 recalls Arie Chair

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21-9-2018

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

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20-9-2018

Report of the third Joint Meeting of the ECDC's Food‐ and Waterborne Diseases and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network

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12-9-2018

Application of data science in risk assessment and early warning

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11-9-2018

Update of the Xylella spp. host plant database

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11-9-2018

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11-9-2018

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25-5-2018

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2-10-2018

Metalyse (Boehringer Ingelheim International GmbH)

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25-9-2018

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24-9-2018

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18-9-2018

 Third industry stakeholder platform on research and development support, European Medicines Agency, London, UK, From: 18-May-2018, To: 18-May-2018

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17-9-2018

The #FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development and review of their device proposals to prevent and treat opioid u

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FDA - U.S. Food and Drug Administration

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

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Europe - EMA - European Medicines Agency

7-8-2018

Research: Software as a Medical Device and Cyber Security for Medical Devices

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Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance

Therapeutic Goods Administration - Australia

18-7-2018

Knowing what software is included in a device means users and manufacturers can better assess and remediate potential cybersecurity threats that may emerge. #FDA looks forward to participating in the SBOM workstream and engaging broader perspective from t

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FDA - U.S. Food and Drug Administration

18-7-2018

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

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FDA - U.S. Food and Drug Administration

16-7-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9 pic.twitter.

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information http://go.usa.gov/xQvE9  pic.twitter.com/kT7EqyTPxr

FDA - U.S. Food and Drug Administration

16-7-2018

#FDA’s comprehensive plan that places nicotine and the issue of addiction at the center of our tobacco efforts. I’m optimistic about the opportunity to forge a new path for a heathier America. Learn more about the plan and how to submit public comments:

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FDA - U.S. Food and Drug Administration

19-6-2018

New information about #FDAPrecert and opportunity for public input now available-  https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

New information about #FDAPrecert and opportunity for public input now available- https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

New information about #FDAPrecert and opportunity for public input now available- https://go.usa.gov/xQJmG  #DigitalHealth #MedicalDevice #mhealth

FDA - U.S. Food and Drug Administration

30-5-2018

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information  https://go.usa.gov/xQvE9 

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information https://go.usa.gov/xQvE9 

On July 25th, the FDA will host a webinar to provide developers and interested applicants an opportunity to hear from the FDA and answer questions about the #FDAInnovationChallenge. Click the link for more information https://go.usa.gov/xQvE9 

FDA - U.S. Food and Drug Administration

30-5-2018

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use dis

#FDAInnovationChallenge to develop medical devices for #opioid addiction will provide those selected with the opportunity to work directly with the agency to accelerate the development & review of their device proposals to prevent and treat opioid use disorder. #FDA MedicalDevice

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

3-5-2018

Perjeta (Roche Registration GmbH)

Perjeta (Roche Registration GmbH)

Perjeta (Active substance: pertuzumab) - Centralised - 2-Monthly update - Commission Decision (2018)2771 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2547/II/35

Europe -DG Health and Food Safety

27-4-2018

Pending EC decision:  Perjeta, pertuzumab, Opinion date: 26-Apr-2018

Pending EC decision: Perjeta, pertuzumab, Opinion date: 26-Apr-2018

Europe - EMA - European Medicines Agency