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  • 12-03-2018

Glavnih Značilnosti Zdravila

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ODDELEK 1: Identifikacija snovi/zmesi in družbe/podjetja

1.1 Identifikator izdelka

Ime proizvoda

Xense Rain

Koda proizvoda

111127E

Uporaba snovi/zmesi

Osvežilec zraka

Vrsta snovi

Zmes

Samo za poklicne uporabnike.

Podatki o redčenju izdelka

Podatkov o redčenju ni na voljo.

1.2 Pomembne identificirane uporabe snovi ali zmesi in odsvetovane uporabe

Identifikacija uporabe

Uporaba: proizvodi za osveževanje zraka

Priporočene omejitve

uporabe

Samo za industrijsko in profesionalno uporabo.

1.3 Podrobnosti o dobavitelju varnostnega lista

Družba

Ecolab d.o.o.

Vajngerlova ulica 4

2000, Maribor Slovenija 02 429 3100 (Delavnik: 8:00 - 16:00)

narocila@ecolab.com

1.4 Telefonska številka za nujne primere

Telefonska številka za nujne

primere

02 429 3100 (Delavnik: 8:00 - 16:00)

Telefonska številka Centra

za zastrupitve

Datum sestavitve/Revizije

17.03.2017

Verzija

ODDELEK 2: Ugotovitev nevarnosti

2.1 Razvrstitev snovi ali zmesi

Razvrstitev (UREDBA (ES) št. 1272/2008)

Vnetljive tekočine, Kategorija 2

H225

2.2 Elementi etikete

Etiketiranje (UREDBA (ES) št. 1272/2008)

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Piktogrami za nevarnost

Opozorilna beseda

Nevarno

Opozorila o nevarnosti

H225

Lahko vnetljiva tekočina in hlapi.

Obvestila o nevarnosti

Preprečevanje:

P210

Hraniti ločeno od vročine, vročih površin, isker,

odprtega ognja in drugih virov vžiga. Kajenje

prepovedano.

2.3 Druge nevarnosti

Nobena znana.

ODDELEK 3: Sestava/podatki o sestavinah

3.2 Zmesi

Nevarne sestavine

Kemijsko ime

Št. CAS

ES-št.

Št. REACH

RazvrstitevUREDBA (ES) št. 1272/2008

Koncentracija:

etanol

64-17-5

200-578-6

01-2119457610-43

Vnetljive tekočine Kategorija 2; H225

>= 50 - <= 100

butanone

78-93-3

201-159-0

01-2119457290-43

Vnetljive tekočine Kategorija 2; H225

Draženje oči Kategorija 2; H319

Specifična strupenost za ciljne organe

(STOT) - enkratna izpostavljenost

Kategorija 3; H336

>= 1 - < 2.5

Za celotno besedilo H-stavkov, omenjenih v tem Oddelku, glej Oddelek 16.

ODDELEK 4: Ukrepi za prvo pomoč

4.1 Opis ukrepov za prvo pomoč

Pri stiku z očmi

Izprati z obilo vode.

Pri stiku s kožo

Izprati z obilo vode.

Pri zaužitju

Splaknite usta. Če se pojavijo simptomi, poiskati zdravniško

pomoč.

Pri vdihavanju

Če se pojavijo simptomi, poiskati zdravniško pomoč.

4.2 Najpomembnejši simptomi in učinki, akutni in zapozneli

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

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4.3 Navedba kakršne koli takojšnje medicinske oskrbe in posebnega zdravljenja

Zdravljenje

Simptomatsko zdravljenje.

ODDELEK 5: Protipožarni ukrepi

5.1 Sredstva za gašenje

Ustrezna sredstva za

gašenje:

Uporabljajte gasilne ukrepe, ki so primerni lokalnim okoliščinam in

bližnjemu okolju.

Neustrezna sredstva za

gašenje

Zelo voluminozen vodni curek

5.2 Posebne nevarnosti v zvezi s snovjo ali zmesjo

Specifične nevarnosti med

gašenjem

Tveganje požara

Hranite ločeno od vročine in virov vžiga.

Možno je, da plamen bruhne nazaj v znatni razdalji.

Pazite se kopičenja hlapov, ki tvorijo eksplozivne koncentracije.

Hlapi se lahko nakopičijo na nizkih področjih.

Nevarni proizvodi izgorevanja

Razkrojni produkti lahko vsebujejo naslednje snovi:

ogljikova oksida

Dušikovi oksidi (NOx)

Žveplovi oksidi

Fosforjevi oksidi

5.3 Nasvet za gasilce

Posebna zaščitna oprema za

gasilce

: Uporabljajte osebno varovalno opremo.

Dodatne informacije

: Vodni pršec se lahko uporablja za hlajenje neodprtih vsebnikov.

Ostanke po požaru in kontaminirano vodo za gašenje požara je

treba varno odstraniti v skladu z lokalnimi predpisi. Pri požaru

in/ali eksploziji ne vdihavajte dima.

ODDELEK 6: Ukrepi ob nenamernih izpustih

6.1 Osebni varnostni ukrepi, zaščitna oprema in postopki v sili

Nasvet za neizučeno osebje

Odstranite vse vire vžiga. Glej zaščitne ukrepe, navedene v

Oddelkih 7 in 8.

Nasvet za reševalce

Če so pri rokovanju z razlitjem zahtevana specialna oblačila,

upoštevati podatke o primernih in neprimernih materialih v

Oddelku 8.

6.2 Okoljevarstveni ukrepi

Okoljevarstveni ukrepi

Preprečiti, da pride v stik z zemljo, površinsko vodo ali podtalnico.

6.3 Metode in materiali za zadrževanje in čiščenje

Metode čiščenja

Odstraniti vse vire vžiga, če je varno.Zaustaviti puščanje, če je

varno. Zajeziti in zadržati izlitje z negorljivim absorpcijskim

materialom (npr. peskom, zemljo, diatomejsko zemljo,

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vermikulitom) in prenesti v vsebnik za odstranjevanje skladno z

lokalnimi/nacionalnimi predpisi (glej Oddelek 13).Splakniti sledi z

vodo. Pri večjih razlitjih zajeziti ali drugače zadržati razlito snov in

s tem zagotoviti, da ne doseže vodotokov.

6.4 Sklicevanje na druge oddelke

Glej Oddelek 1 za podatke o kontaktu za nujne primere.

Za osebno zaščito glejte oddelek 8.

Glej Oddelek 13 za podatke o dodatni obdelavi odpadkov.

ODDELEK 7: Ravnanje in skladiščenje

7.1 Varnostni ukrepi za varno ravnanje

Navodilo za varno rokovanje

Uporabljati samo ob ustreznem prezračevanju. Hrante proč od

ognja, isker in razžarjenih površin. Ukrenite vse potrebno za

preprečitev statičnega naelektrenja (ki bi lahko povzročilo vžig

organskih hlapov). Po uporabi temeljito umiti roke. Sod previdno

odprite, ker je vsebina lahko pod tlakom.

Higienski ukrepi

Ravnajte v skladu z dobro proizvodno in varnostno prakso.

Odstranite in operite kontaminirana oblačila pred ponovno

uporabo. Po uporabi temeljito umiti obraz, roke in izpostavljeno

kožo.

7.2 Pogoji za varno skladiščenje, vključno z nezdružljivostjo

Zahteve glede skladiščnih

prostorov in vsebnikov

Hranite ločeno od vročine in virov vžiga. Hranite na hladnem in

dobro prezračevanem mestu. Hraniti ločeno od oksidantov. Hraniti

zunaj dosega otrok. Hraniti v tesno zaprti posodi. Hraniti v

posodah z ustreznimi nalepkami.

Temperatura pri skladiščenju

0 °C do 25 °C

7.3 Posebne končne uporabe

Posebni način(-i) uporabe

Uporaba: proizvodi za osveževanje zraka

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

8.1 Parametri nadzora

Mejne vrednosti za poklicno izpostavljenost

Sestavine

Št. CAS

Tip vrednosti

(Oblika

izpostavljanja)

Parametri nadzora

Osnova

etanol

64-17-5

1,000 ppm

1,900 mg/m3

SI OEL

Dodatne informacije

Snovi, pri katerih ni nevarnosti za zarodek ob upoštevanju mejnih vrednosti in

BAT vrednosti.

butanone

78-93-3

200 ppm

600 mg/m3

SI OEL

Dodatne informacije

Mejna vrednost, določena z Direktivo Komisije 2000/39/ES z dne 8. junija

2000 o določitvi prvega seznama indikativnih mejnih vrednosti za poklicno

izpostavljenost pri izvajanju Direktive Sveta 98/24/ES o varovanju zdravja in

zagotavljanju varnosti delavcev pred tveganjem zaradi izpostavljenosti

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kemičnim dejavnikom pri delu (UL L, št. 142, z dne 16. junija 2000, str. 47).

Biološka mejna vrednost - določena je biološka mejna vrednost, ki pomeni

opozorilno raven nevarne kemične snovi in njenih metabolitov v tkivih,

telesnih tekočinah ali izdihanem zraku, ne glede na to, ali je nevarna kemična

snov vnesena v organizem z vdihavanjem, zaužitjem ali skozi kožo.

Biološke mejne vrednosti izpostavljenosti na delovnem mestu

Ime snovi

Št. CAS

Parametri nadzora

Čas vzorčenja

Osnova

butanone

78-93-3

metil etil keton: 4.08

mmol/mol kreatinina

(Urin)

Ob koncu delovne izmene

SI BAT

metil etil keton: 2.6 mg/g

kreatinina

(Urin)

Ob koncu delovne izmene

SI BAT

8.2 Nadzor izpostavljenosti

Ustrezni inženirski mehanizmi

Tehnični ukrepi

Učinkovit izpušni prezračevalni sistem. Ohranjati vrednosti

koncentracij v zraku znotraj standardov za poklicno

izpostavljenost.

Individualni zaščitni ukrepi

Higienski ukrepi

Ravnajte v skladu z dobro proizvodno in varnostno prakso.

Odstranite in operite kontaminirana oblačila pred ponovno

uporabo. Po uporabi temeljito umiti obraz, roke in izpostavljeno

kožo.

Zaščita za oči / obraz (EN

166)

Ni potrebna posebna varovalna oprema.

Zaščita rok (EN 374)

Ni potrebna posebna varovalna oprema.

Zaščita kože (EN 14605)

Ni potrebna posebna varovalna oprema.

Zaščita dihal (EN 143,

14387)

Ni potrebna, če se koncentracija nevarnih snovi v zraku ohrani

pod mejnimi vrednostmi, navedenimi v podatkih o mejnih

vrednostih izpostavitve. Uporabiti certificirano dihalno napravo,

skladno z zahtevami Direktiv 89/656/EGS in 89/686/EGS ali

enakovredno, kadar se tveganju za dihala ni mogoče izogniti s

tehničnimi varovalnimi sredstvi in ukrepi, metodami ali postopki

organizacije dela.

Nadzor izpostavljenosti okolja

Splošna navodila

: Razmislite o ukrepih glede zadrževanja okoli posod za

skladiščenje.

ODDELEK 9: Fizikalne in kemijske lastnosti

9.1 Podatki o osnovnih fizikalnih in kemijskih lastnostih

Videz

: tekočina

Barva

: svetlo modra

Vonj

: Parfumi, dišave

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6.8 - 7.2, 100 %

Plamenišče

21 °C odprta čaša

Mejne vrednosti vonja

Ni primerno in/ali ni določeno za zmesi

Tališče/ledišče

Ni primerno in/ali ni določeno za zmesi

Začetno vrelišče in območje

vrelišča

Ni primerno in/ali ni določeno za zmesi

Hitrost izparevanja

Ni primerno in/ali ni določeno za zmesi

Vnetljivost (trdno, plinasto)

Ni primerno in/ali ni določeno za zmesi

Zgornja meja eksplozivnosti

Ni primerno in/ali ni določeno za zmesi

Spodnja meja eksplozivnosti

Ni primerno in/ali ni določeno za zmesi

Parni tlak

Ni primerno in/ali ni določeno za zmesi

Relativna gostota par/hlapov

Ni primerno in/ali ni določeno za zmesi

Relativna gostota

0.898 - 0.903

Topnost v vodi

topno

Topnost v drugih topilih

Ni primerno in/ali ni določeno za zmesi

Porazdelitveni koeficient: n-

oktanol/voda

Ni primerno in/ali ni določeno za zmesi

Temperatura samovžiga

Ni primerno in/ali ni določeno za zmesi

Toplotni razpad/razgradnja

Ni primerno in/ali ni določeno za zmesi

Viskoznost, kinematična

Ni primerno in/ali ni določeno za zmesi

Eksplozivne lastnosti

Ni primerno in/ali ni določeno za zmesi

Oksidativne lastnosti

Snov ali zmes ni razvrščena kot oksidativna.

9.2 Drugi podatki

Ni primerno in/ali ni določeno za zmesi

ODDELEK 10: Obstojnost in reaktivnost

10.1 Reaktivnost

Nevarne reakcije pri normalni uporabi niso znane.

10.2 Kemijska stabilnost

Stabilno pri normalnih pogojih.

10.3 Možnost poteka nevarnih reakcij

Nevarne reakcije pri normalni uporabi niso znane.

10.4 Pogoji, ki se jim je treba izogniti

Toplota/vročina, plameni in iskre.

10.5 Nezdružljivi materiali

Nobena znana.

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10.6 Nevarni produkti razgradnje

Razkrojni produkti lahko vsebujejo naslednje snovi:

ogljikova oksida

Dušikovi oksidi (NOx)

Žveplovi oksidi

Fosforjevi oksidi

ODDELEK 11: Toksikološki podatki

11.1 Podatki o toksikoloških učinkih

Podatki o možnih načinih

izpostavljenosti

Vdihavanje, Stik z očmi, Stik s kožo

Proizvod

Akutna oralna strupenost

: Za ta proizvod ni na voljo podatkov.

Akutna toksičnost pri

vdihavanju

: Za ta proizvod ni na voljo podatkov.

Akutna dermalna strupenost

: Za ta proizvod ni na voljo podatkov.

Jedkost za kožo/draženje

kože

: Za ta proizvod ni na voljo podatkov.

Resne okvare oči/draženje

: Za ta proizvod ni na voljo podatkov.

Preobčutljivost pri vdihavanju

in preobčutljivost kože

: Za ta proizvod ni na voljo podatkov.

Rakotvornost

: Za ta proizvod ni na voljo podatkov.

Učinki na razplojevanje

: Za ta proizvod ni na voljo podatkov.

Mutagenost za zarodne

celice

: Za ta proizvod ni na voljo podatkov.

Teratogenost

: Za ta proizvod ni na voljo podatkov.

STOT - enkratna

izpostavljenost

: Za ta proizvod ni na voljo podatkov.

STOT - ponavljajoča se

izpostavljenost

: Za ta proizvod ni na voljo podatkov.

Toksičnost pri vdihavanju

: Za ta proizvod ni na voljo podatkov.

Sestavine

Akutna oralna strupenost

: etanol

LD50 Podgana: 10,470 mg/kg

Sestavine

Akutna toksičnost pri

: etanol

4 h LC50 Podgana: 117 mg/l

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vdihavanju

Sestavine

Akutna dermalna strupenost

: etanol

LD50 Kunec: > 15,800 mg/kg

Možni učinki na zdravje

Oči

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Koža

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Zaužitje

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Vdihavanje

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Kronična izpostavljenost

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Izkušnje z izpostavljenostjo človeka

Stik z očmi

Ni znanih ali pričakovanih simptomov.

Stik s kožo

Ni znanih ali pričakovanih simptomov.

Zaužitje

Ni znanih ali pričakovanih simptomov.

Vdihavanje

Ni znanih ali pričakovanih simptomov.

ODDELEK 12: Ekološki podatki

12.1 Ekotoksičnost

Učinki na okolje

Ta proizvod nima znanih strupenih učinkov na okolje.

Proizvod

Strupenost za ribe

: Ni razpoložljivih podatkov

Strupenost za vodno bolho in

druge vodne vretenčarje.

: Ni razpoložljivih podatkov

Strupenost za alge

: Ni razpoložljivih podatkov

Sestavine

Strupenost za ribe

: etanol

96 h LC50 Pimephales promelas (Črnoglavi pisanec): > 100 mg/l

12.2 Obstojnost in razgradljivost

Proizvod

Biorazgradljivost

: V proizvodu vsebovane površinsko aktivne snovi so

biorazgradljive v skladu z Uredbo o detergentih 648/2004/EC.

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Sestavine

Biorazgradljivost

etanol

Rezultat: Zlahka biorazgradljivo.

butanone

Rezultat: Zlahka biorazgradljivo.

12.3 Zmožnost kopičenja v organizmih

Ni razpoložljivih podatkov

12.4 Mobilnost v tleh

Ni razpoložljivih podatkov

12.5 Rezultati ocene PBT in vPvB

Proizvod

Ocena

Snov/zmes ne vsebuje komponent, ki so obstojne,

bioakumulacijske in strupene (PBT) ali izredno obstojne in zelo

bioakumulacijske (vPvB) v koncentracijah 0,1% ali več.

12.6 Drugi škodljivi učinki

Ni razpoložljivih podatkov

ODDELEK 13: Odstranjevanje

Odložiti v skladu z evropskimi direktivami o odpadkih in nevarnih odpadkih.Odpadkom naj bi kode

pripisal uporabnik, prednostno po posvetu z organi, ki so pristojni za odstranjevanje odpadkov.

13.1 Metode ravnanja z odpadki

Proizvod

: Kjer je mogoče, ima recikliranje prednost pred odlaganjem ali

sežiganjem. Če recikliranje ni izvedljivo, odstraniti skladno z

lokalnimi predpisi. Odpad odlagajte v odobrenih objektih za

odlaganje odpada.

Kontaminirana

embalaža/pakiranje

: Odstranite kot nerabljen proizvod. Prazne posode je treba

dostaviti pooblaščeni osebi za ravnanje z odpadki na recikliranje

ali odlaganje. Prazni vsebniki niso za ponovno uporabo. Odstraniti

skladno z lokalnimi, državnimi in zveznimi predpisi.

Napotki za izbiro kode

odpadka

: Organski odpadki, ki vsebujejo nevarne snovi. Če se ta proizvod

uporablja v katerih koli nadaljnjih postopkih, mora končni

uporabnik opredeliti in določiti najprimernejšo kodo odpadka glede

na Evropski seznam odpadkov. Odgovornost povzročitelja

odpadkov je, da določi strupenost in fizikalne lastnosti nastalega

materiala ter določi ustrezne metode identifikacije in

odstranjevanje odpadkov, skladno z veljavnimi evropskimi (EU

Direktiva 2008/98/ES) in lokalnimi predpisi.

ODDELEK 14: Podatki o prevozu

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Špediter/pošiljatelj/dobavitelj je odgovoren zagotoviti, da so embalaža, oznake in nalepke za

označevanje nevarnosti skladni z izbranim načinom prevoza.

Transport po kopnem (ADR/ADN/RID)

14.1 Številka ZN

1170

14.2 Uradno ime blaga ZN

ETANOL, RAZTOPINA

14.3 Razredi nevarnosti

prevoza

14.4 Embalažna skupina

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Noben

Zračni transport (IATA)

14.1 Številka ZN

1170

14.2 Uradno ime blaga ZN

Ethanol solution

14.3 Razredi nevarnosti

prevoza

14.4 Embalažna skupina

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Noben

Pomorski transport

(IMDG/IMO)

14.1 Številka ZN

1170

14.2 Uradno ime blaga ZN

ETHANOL SOLUTION

14.3 Razredi nevarnosti

prevoza

14.4 Embalažna skupina

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Noben

14.7 Prevoz v razsutem

stanju v skladu s Prilogo II k

MARPOL 73/78 in Kodeksom

IBC

Se ne upošteva.

ODDELEK 15: Zakonsko predpisani podatki

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

v skladu z Uredbo o

detergentih ES 648/2004

manj kot 5 %: Neionske površinsko aktivne snovi

Druge sestavine: Parfumi

Alergeni:

linalool

d-Limonen

Eugenol

Citronelol

Benzil alkohol

citral

Nacionalni predpis

Upoštevajte direktivo 94/33/ES o varstvo mladih ljudi pri delu.

Razred skladiščenja

VARNOSTNI LIST

v skladu z Uredbo (ES) št. 1907/2006

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Drugi predpisi

Zakon o kemikalijah

Pravilnik o tehničnih in organizacijskih ukrepih za skladiščenje

nevarnih kemikalij

Pravilnik o varovanju delavcev pred tveganji zaradi

izpostavljenosti kemičnim snovem pri delu (Uradni list RS, št.

100/01, 39/05, 53/07, 102/10, 43/11 -- ZVZD-1, 38/15)

Pravilnik o varovanju delavcev pred tveganji zaradi

izpostavljenosti rakotvornim ali mutagenim snovem

Pravilnik o osebni varovalni opremi, ki jo delavci uporabljajo pri

delu

Pravilnik o varovanju zdravja pri delu otrok, mladostnikov in

mladih oseb

Pravilnik o varovanju zdravja pri delu nosečih delavk, delavk, ki so

pred kratkim rodile ter doječih delavk

Zakon o varstvu okolja

Uredba o odpadkih

Uredba o ravnanju z embalažo in odpadno embalažo

Zakon o prevozu nevarnega blaga

15.2 Ocena kemijske varnosti

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

ODDELEK 16: Drugi podatki

Način, na katerega je bila določena razvrstitev

UREDBA (ES) št. 1272/2008

Razvrstitev

Utemeljitev

Vnetljive tekočine 2, H225

Na osnovi podatkov o izdelku ali ocene

Celotno besedilo H-stavkov

H225

Lahko vnetljiva tekočina in hlapi.

H319

Povzroča hudo draženje oči.

H336

Lahko povzroči zaspanost ali omotico.

Celotno besedilo drugih okrajšav

ADN - Evropski sporazum o mednarodnem prevozu nevarnih snovi po celinskih vodah; ADR -

Evropski sporazum o mednarodnem prevozu nevarnih snovi po cesti; AICS - Avstralski popis

kemičnih snovi; ASTM - Ameriško združenje za testiranje materialov; bw - Telesna teža; CLP -

Uredba o razvrščanju, označevanju in pakiranju; Uredba (ES) št. 1272/2008; CMR - Karcinogena,

mutagena strupena snov ali snov, strupena za razmnoževanje; DIN

- Standard nemškega

inštituta za standardizacijo; DSL - Seznam domačih snovi (Kanada); ECHA - Evropska agencija

za kemikalije; EC-Number - Evropska številka Skupnosti; ECx - Koncentracija, povezana z x%

odzivom; ELx - Stopnja obremenitve, povezana z x% odzivom; EmS - Načrt v sili; ENCS -

Obstoječe in nove kemične snovi (Japonska); ErCx - Koncentracija, povezana z x% odzivom

stopnje rasti; GHS - Globalno usklajeni sistem; GLP - Dobra laboratorijska praksa; IARC -

Mednarodna agencija za raziskave raka; IATA - Mednarodno združenje letalskih prevoznikov;

IBC - Mednarodni kodeks za gradnjo in opremo ladij, ki prevažajo nevarne kemikalije v razsutem

stanju; IC50 - Polovična največja inhibitorna koncentracija; ICAO - Mednarodna organizacija

civilnega letalstva; IECSC - Kitajski seznam obstoječih kemičnih snovi; IMDG - Mednarodni

kodeks za prevoz nevarnih snovi po morju; IMO - Mednarodna pomorska organizacija; ISHL -

Zakon

varnosti

zdravju

delu

(Japonska);

Mednarodna

organizacija

VARNOSTNI LIST

v skladu z Uredbo (ES) št. 1907/2006

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standardizacijo; KECI - Korejski seznam obstoječih kemikalij; LC50 - Smrtna koncentracija za

50% testirane populacije; LD50 - Smrtni odmerek za 50% testirane populacije (srednji smrtni

odmerek); MARPOL - Mednarodna konvencija o preprečevanju onesnaževanja morja z ladij;

n.o.s. - Nikjer drugje navedeno; NO(A)EC - Koncentracija brez opaznega (škodljivega) učinka;

NO(A)EL - Raven brez opaznega (škodljivega) učinka; NOELR - Stopnja obremenitve brez

opaznega učinka; NZIoC - Novozelandski popis kemikalij; OECD - Organizacija za gospodarsko

sodelovanje in razvoj; OPPTS - Urad za kemijsko varnost in preprečevanje onesnaževanja; PBT -

Snov, ki je obstojna, se kopiči v organizmih in je strupena; PICCS - Filipinski seznam kemikalij in

kemičnih snovi; (Q)SAR - (Kvantitativno) razmerje med strukturo in aktivnostjo; REACH - Uredba

(ES) št. 1907/2006 Evropskega parlamenta in Sveta o registriranju, vrednotenju, potrjevanju in

omejevanju kemikalij; RID - Pravilniki o mednarodnem železniškem prevozu nevarnega blaga;

SADT - Samopospešujoča temperatura razgradnje; SDS - Varnostni list; TCSI - Tajvanski popis

kemičnih snovi; TRGS - Tehnično pravilo za nevarne snovi; TSCA - Zakon o nadzoru strupenih

snovi (ZDA); UN - Združeni narodi; vPvB - Zelo obstojno in se zelo lahko kopiči v organizmih

Pripravil

Regulatory Affairs

Številke, navedene v varnostnem listu, so podane v obliki: 1,000,000=1 milijon in 1,000=1 tisoč.

0.1 = 1 desetina in 0.001 = 1 tisočina.

SPREMEMBE PODATKOV: Pomembne spremembe podatkov o predpisih in zdravju pri tej

popravljeni izdaji so nakazane s črto ob levem robu varnostnega lista.

Informacija v tem Varnostnem listu je pravilna po našem najboljšem znanju, informacijah in

prepričanju na dan njegove objave. Informacija je zasnovana samo kot napotilo za varno

rokovanje, uporabo, obdelavo/predelavo, shranjevanje/skladiščenje, transport, odstranjevanje in

izpust in ne sme biti interpretirana kot specifikacija jamstev in kakovosti. Informacija se nanaša

samo na označeni specifični material in morda ne bo veljavna za tak material, če bo uporabljen v

kombinaciji s kakšnim drugim materialom ali postopkom, razen če to ni posebej navedeno v

tekstu.

PRILOGA: SCENARIJI IZPOSTAVLJENOSTI

Snovi po DPD+:

:

Naslednje snovi so glavne sestavine, ki prispevajo k scenariju izpostavljenosti za zmesi, skladno z

metodologijo DPD+:

Pot

Snov

Št. CAS

Št. EINECS

Zaužitje

Ni snovi v sledeh

Vdihavanje

butanone

78-93-3

201-159-0

Kožno

butanone

78-93-3

201-159-0

Oči

butanone

78-93-3

201-159-0

vodno okolje

Ni snovi v sledeh

Fizikalne lastnosti snovi po DPD+:

Snov

Parni tlak

Topnost v vodi

Pow

Molska masa

VARNOSTNI LIST

v skladu z Uredbo (ES) št. 1907/2006

Xense Rain

111127E

13 / 13

butanone

104 hPa

1.995

Za preračun, ali so vaši nadaljnji pogoji obratovanja in ukrepi za obvladovanje tveganja varni,

prosimo, izračunajte faktor tveganja na spodaj navedeni spletni strani:

www.ecetoc.org/tra

Kratek naslov scenarija

izpostavljenosti

Uporaba: proizvodi za osveževanje zraka

Deskriptorji uporabe

Glavne skupine uporabnikov

Poklicne uporabe: javna uporaba (uprava, izobraževanje,

razvedrilo, storitve, obrt)

Sektorji končne uporabe

SU22: Poklicne uporabe: javna uporaba (uprava, izobraževanje,

razvedrilo, storitve, obrt)

Skupine postopkov

PROC11: Neindustrijsko brizganje

Kategorije izdelka

PC35: Izdelki za pranje in čiščenje (vključno z izdelki na osnovi

topil)

Kategorije sproščanja v

okolje

ERC8a: Močno razpršena notranja uporaba procesnih

pripomočkov v odprtih sistemih

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐OC)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐a‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐OC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels recommended, dietary exposure to the food enzyme–...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Safety evaluation of the food enzyme maltogenic amylase from a genetically modified Bacillus subtilis (strain NZYM‐SO)

Published on: Wed, 14 Nov 2018 The food enzyme maltogenic amylase (glucan 1,4‐α‐maltohydrolase; EC 3.2.1.133) is produced with a genetically modified Bacillus subtilis strain NZYM‐SO by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production microorganism and recombinant DNA. This maltogenic amylase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme–total organi...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

1-11-2018

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Safety evaluation of the food enzyme glucan 1,4‐α‐glucosidase from a genetically modified Aspergillus niger (strain NZYM‐BW)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucan 1,4‐α‐glucosidase (EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM‐BW by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucan 1,4‐α‐glucosidase food enzyme is intended to be used in distilled alcohol production and starch processing for the production of glucose syrups. Residu...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Safety of the food enzyme glucoamylase from a genetically modified Aspergillus niger (strain NZYM‐BF)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme glucoamylase (glucan 1,4‐α‐glucosidase; EC 3.2.1.3) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This glucoamylase is intended to be used in brewing processes and in starch processing for glucose syrups production. Residual amounts of total organic s...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Safety evaluation of the food enzyme α‐amylase from a genetically modified Aspergillus niger (strain NZYM‐MC)

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The food enzyme alpha‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified strain of Aspergillus niger by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This α‐amylase is intended to be used in starch processing for glucose syrups production, beverage alcohol (distilling) processes and baking proces...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

26-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of Stagonosporopsis andigena, the causal agent of black blight of potato, for the EU. The pest is a well‐defined fungal species and reliable methods exist for its detection and identification. S. andigena is present in Bolivia and Peru. The pest is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC as Phoma andina, meaning its introduction into the EU is prohibited. The ma...

Europe - EFSA - European Food Safety Authority Publications

9-10-2018

TerraTrike recalls Rambler x16, Rambler All Terrain and Rambler E.V.O. Adult Tricycles

TerraTrike recalls Rambler x16, Rambler All Terrain and Rambler E.V.O. Adult Tricycles

The right hand wheel hub mount can bend or break and cause the rider to lose control, posing serious crash and injury hazards.

Health Canada

28-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

19-9-2018

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

National dietary survey in 2012‐2016 on the general population aged 1‐79 years in the Netherlands

Published on: Tue, 18 Sep 2018 00:00:00 +0200 During the years 2012‐2016, the Dutch National Food Consumption survey was conducted in the Netherlands. For the survey, a random sample was drawn from consumer panels stratified by age and gender and maintained representative to the population with regard to region, address density and educational level. Complete results were obtained for 4,313 persons (response rate 65%); including toddlers, children, adolescents, adults and elderly. Pregnant or lactating ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Risk assessment of antimicrobial resistance along the food chain through culture‐independent methodologies

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Antimicrobial resistance (AMR) represents a major challenge for Public Health and the scientific community, and requires immediate and drastic solutions. Acquired resistance to certain antimicrobials is already widespread to such an extent that their efficacy in the treatment of certain life‐threatening infections is already compromised. To date, the emergence and spread of AMR has been attributed to the use, misuse or indiscriminate use of antibiotics as th...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

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

17-8-2018

Jimmy Hack Golf, LLC recalls Orange Whip Trainer

Jimmy Hack Golf, LLC recalls Orange Whip Trainer

The orange ball can detach from the trainer while in use, posing an injury hazard to the user and bystanders.

Health Canada

31-7-2018

Heat wave: Retailers may refrain from selling non-prescription drugs

Heat wave: Retailers may refrain from selling non-prescription drugs

Due to the summer heat, the Danish Medicines Agency has given Danish retailers dispensation from the requirement to stock a basic selection of medicines if they are having trouble keeping the temperature in their store cool enough for proper storage of the drugs. This dispensation applies until 1 September.

Danish Medicines Agency

29-6-2018

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® Voluntarily Recalls Sparkling Ice® Cherry Limeade in Response to Customer Complaints

Talking Rain® (the Company) is voluntarily recalling specific lot codes of bottles of its Sparkling Ice® Cherry Limeade beverage in response to a small number of customer complaints that reported an off-taste and off-odor of the affected product. The Company made the decision to recall the product out of an abundance of caution.

FDA - U.S. Food and Drug Administration

6-6-2018

Manufacturers Assistance and Technical Training Branch (MATTB)

Manufacturers Assistance and Technical Training Branch (MATTB)

CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide timely, accurate and useful information to stakeholders.

FDA - U.S. Food and Drug Administration

23-5-2018

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Ten Thousand Villages Canada recalls Choo-Choo Train & Blocks Set

Health Canada's sampling and evaluation program has determined that the recalled toy does not meet the Canadian safety requirements for toys. The numbered blocks are small parts and the toy may further break apart exposing more small parts, posing a choking hazard for young children.

Health Canada

17-5-2018

Dollarama L.P. recalls Oball Rollin' Rainstick and Oball 2-IN-1 Roller

Dollarama L.P. recalls Oball Rollin' Rainstick and Oball 2-IN-1 Roller

If the ball structure were to be damaged, pieces of the ball could be pulled off therefore posing a choking hazard to young children. As of May 14, 2018, the company has received two incidents with no injuries in Canada.

Health Canada

26-5-2017

Malta and Iceland strengthen cooperation on medicines regulation

Malta and Iceland strengthen cooperation on medicines regulation

The Malta Medicines Authority made a cooperation agreement with the Icelandic Medicines Agency in an effort to strengthen capacity for medicines authorisations through joint assessment.  The agreement will facilitate mutual training for experts and explore the feasibility of conducting joint inspections.

IMA - Icelandic Medicines Agency

21-10-2018

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9

FDA - U.S. Food and Drug Administration

17-10-2018

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review.

Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD.  https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https:

Interact with experts from CDER, CBER & CDRH to learn what’s important when conducting clinical trials & preparing submissions for FDA review. Register for FDA #CDERSBIA Clinical Investigator Training Course – November 13-15 in Silver Spring, MD. https://go.usa.gov/xPqku  pic.twitter.com/EYNZANlgr9

FDA - U.S. Food and Drug Administration

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

25-9-2018

Conducting clinical trials & preparing a submission for #FDA review?

Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more!  https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.

Conducting clinical trials & preparing a submission for #FDA review? Register for #CDERSBIA’s Clinical Investigator Training Course: November 13-15 to learn about FDA regulations, scientific principles for conducting clinical trials, & more! https://go.usa.gov/xPqku . pic.twitter.com/Ktqq9Slx0y

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

22-8-2018

BTVPUR (Merial)

BTVPUR (Merial)

BTVPUR (Active substance: Bluetongue virus vaccine (inactivated) (multistrain: 1-2 strains out of a set of 4)) - Centralised - 2-Monthly update - Commission Decision (2018)5630 of Wed, 22 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2231/II/10

Europe -DG Health and Food Safety

22-7-2018

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

We'll consider regulatory options to speed up requiring companies to mitigate safety problems identified postmarket. Currently, mitigations such as new user training or new labeling can require rulemaking, which takes time and resources

FDA - U.S. Food and Drug Administration

11-7-2018

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Laboratorios Hipra, S.A.)

ERYSENG (Active substance: Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018)4523 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

11-7-2018

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Laboratorios Hipra, S.A.)

Hiprabovis IBR Marker Live (Active substance: Live gE- tk- double-gene deleted Bovine Herpes Virus type 1 (BoHV-1), strain CEDDEL) - Centralised - Yearly update - Commission Decision (2018)4520 of Wed, 11 Jul 2018

Europe -DG Health and Food Safety

4-7-2018

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Laboratorios Hipra, S.A.)

ERYSENG PARVO (Active substance: Inactivated porcine parvovirus, strain NADL-2 / Inactivated Erysipelothrix rhusiopathiae, strain R32E11) - Centralised - Yearly update - Commission Decision (2018) 4354 of Wed, 04 Jul 2018

Europe -DG Health and Food Safety

19-6-2018

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Merial)

Aftovaxpur Doe (Active substance: purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir, SAT2 Saudi Arabia) - Centralised - Renewal - Commission Decision (2018)3891 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2292/R/8

Europe -DG Health and Food Safety

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, November 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency

13-6-2018

Agenda:  Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

Agenda: Agenda and registration form - eXtended EudraVigilance medicinal product dictionary face-to-face training course, London, September 2018

The training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

Europe - EMA - European Medicines Agency