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    Hrvatska
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Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 102233E
  • 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 Identifikacijska oznaka proizvoda

Ime proizvoda

OZONIT

Oznaka proizvoda

102233E

Uporaba tvari/pripravka

Biocid

Vrsta tvari

Smjesa

Samo za profesionalne korisnike.

Informacije o razrijeđenom

proizvodu

Nema informacija za razrijeđenje

1.2 Odgovarajuće identificirane namjene tvari ili smjese i namjene koje se ne preporučuju

Identificirane uporabe

Pomoćna sredstva za pranje rublja ( uparavanjem). Automatsko

nanošenje.

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

Broj telefona za medicinske

informacije:

01-23-48-342 (Medicinske Info)

Datum sakupljanja/revizije

04.11.2016

Verzija

ODJELJAK 2. IDENTIFIKACIJA OPASNOSTI

2.1 Razvrstavanje tvari i smjese

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

Oksidirajuće tekućine, Klasa 2

H272

Nagriz .met., klasa 1

H290

Akutna toksičnost, Klasa 4

H302

Akutna toksičnost, Klasa 4

H332

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Nagriz. koža, Klasa 1A

H314

Ozljeda oka, klasa 1

H318

Specifična toksičnost za ciljne organe/sustavna toksičnost -

jednokratna izloženost, Klasa 3, Dišni sustav

H335

Kronična toksičnost u vodenom okolišu, klasa 1

H410

2.2 Elementi označivanja prema Direktivi 1999/45/EZ ili Uredbi (EZ) br. 1272/2008 (CLP)

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

Piktogrami opasnosti

Oznaka opasnosti

Opasnost

Oznake upozorenja

H272

Može pojačati požar; oksidans.

H290

Može nagrizati metale.

H302 + H332

Štetno ako se proguta ili ako se udiše.

H314

Uzrokuje teške opekline kože i ozljede oka.

H335

Može nadražiti dišni sustav.

H410

Vrlo otrovno za vodeni okoliš, s dugotrajnim

učincima.

Oznake obavijesti

Sprječavanje:

P210

Čuvati odvojeno od topline, vrućih površina,

iskri, otvorenih plamena i ostalih izvora

paljenja. Ne pušiti.

P221

Poduzmite sve mjere opreza kako bi izbjegli

miješanje sa zapaljivim tvarima.

P273

Izbjegavati ispuštanje u okoliš.

P280

Nosite zaštitne rukavice/ zaštitu za oči/ zaštitu

za lice.

Postupanje:

P303 + P361 + P353

U SLUČAJU DODIRA S KOŽOM (ili

kosom): odmah skinuti svu zagađenu odjeću.

Isprati kožu vodom/tuširanjem.

P305 + P351 + P338

U SLUČAJU DODIRA S OČIMA: oprezno

ispirati vodom nekoliko minuta. Ukloniti

kontaktne leće ukoliko ih nosite i ako se one

lako uklanjaju. Nastaviti ispiranje.

P310

Odmah nazvati CENTAR ZA KONTROLU

OTROVANJA/liječnika.

Opasne tvari koje se moraju navesti na naljepnici:

Hydrogen peroxide

Octena kiselina

Peroksioctena kiselina

2.3 Ostale opasnosti

Ne miješati sa izbjeljivačima i ostalim kloriranim proizvodima - nastati će plinoviti klor.

ODJELJAK 3. SASTAV/INFORMACIJE O SASTOJCIMA

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3.2 Smjese

Opasni sastojci

Kemijski naziv

CAS-br.

EZ-br.

Br. REACH

Razvrstavanjeprema uredbi (EZ) br.

1272/2008 (CLP)

Koncentracija:

Hydrogen peroxide

7722-84-1

231-765-0

01-2119485845-22

Note B Oksidirajuće tekućine klasa 1;

H271

Akutna toksičnost Klasa 4; H302

Akutna toksičnost Klasa 4; H332

Nagriz. koža Klasa 1A; H314

>= 25 - < 30

Octena kiselina

64-19-7

200-580-7

01-2119475328-30

Note B Zapaljive tekućine Klasa 3; H226

Nagriz. koža Klasa 1A; H314

>= 5 - < 10

Peroksioctena kiselina

79-21-0

201-186-8

Zapaljive tekućine Klasa 3; H226

Organski peroksidi Vrsta D; H242

Akutna toksičnost Klasa 4; H302

Akutna toksičnost Klasa 4; H332

Akutna toksičnost Klasa 4; H312

Nagriz. koža Klasa 1A; H314

Ak.toks.vod.okol. klasa 1; H400

Specifična toksičnost za ciljne

organe/sustavna toksičnost -

jednokratna izloženost Klasa 3; H335

Kronična toksičnost u vodenom okolišu

klasa 1; H410

>= 2.5 - < 5

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

ODJELJAK 4. MJERE PRVE POMOĆI

4.1 Opis mjera prve pomoći

U slučaju dodira s očima

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

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. Pođite liječniku.

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.

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ODJELJAK 5. MJERE GAŠENJA POŽARA

5.1 Sredstva za gašenje

Prikladna sredstva za

gašenje

Upotrijebiti mjere suzbijanja požara koje odgovaraju lokalnim

okolnostima i okolnom ambijentu.

Neprikladna sredstva za

gašenje požara

Nisu poznati.

5.2 Posebne opasnosti koje proizlaze iz tvari ili smjese

Posebne opasnosti tijekom

suzbijanja požara

Posebna zaštitna oprema za vatrogasce

Oksidans. U dodiru s drugim materijalom može uzrokovati požar.

Oksidans; tvar je oksidans koji može reagirati s drugim tvarima,

posebno nakon zagrijavanja.

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

: U slucaju vatre, nosite aparat za disanje s pozitivnim tlakom s

maskom za lice i zaštitno odijelo.

Dodatni podaci

: Odvojeno sakupiti otpadnu vodu korištenu za gašenje požara. Ne

ispuštati u odvodni sustav. 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

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.Za upijanje prolivenih kiselina i

lužina nikad ne koristiti piljevinu, drveno iverje i slične materijale.

Izolirati otpad ne dopustiti da dođe u kontakt s nekompatibilnim

materijalima. Za mala izlijevanja pokupiti pijeskom ili vermikulitom

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i razrijediti pokupljeni proizvod najmanje 10 puta s vodom.

Prenijeti na otvoreni vrh spremnika i ukloniti na sigurno mjesto za

neutralizaciju * / odlaganje..Kod velikih izlijevanja sadržaj prosuti i

evakuirati područje, ostaviti da sve reakcije splasnu, onda skupiti

za odlaganje. Dobiti suglasnost od lokalne tvrtke za vode / vlasti,

s obzirom na ispuštanje u kanalizaciju. * Neutralizaciia: jednom

razrijedi, neutralizirati s prikladnom lužinom, kao što je natrijev

bikarbonat

6.4 Uputa za druge odjeljke

Vidjeti Odjeljak 1 za konakt za hitne informacije.

Za osobnu zaštitu pogledati odsjek 8.

Vidjeti Odjeljak 13 za dodatne informacije o zbrinjavanju otpada.

ODJELJAK 7. RUKOVANJE I SKLADIŠTENJE

7.1 Mjere opreza za sigurno rukovanje

Savjeti za sigurno rukovanje

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

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

odgovarajuću ventilaciju. Nakon uporabe temeljito oprati ruke Ne

miješati sa izbjeljivačima i ostalim kloriranim proizvodima - nastati

će plinoviti klor.

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

Čuvati na hladnom, dobro provjetrenom mjestu. Čuvati odvojeno

od redukcijskih sredstava. Čuvati odvojeno od jakih baza. Čuvati

odvojeno od zapaljivog materijala Čuvati izvan dohvata djece.

Čuvati u dobro zatvorenom spremniku. Pohranjujte u primjerenim

obilježenim spremnicima. Pucanja zbog povišenog tlaka mogu se

javiti zbog stvaranja plina ako spremnik nije dobro provjetren.

Čuvati samo u originalnom spremniku. Pokupite prolivenu tvar

kako bi spriječili oštećenje materijala.

Temperatura skladištenja

-20 °C do 30 °C

Materijal za pakiranje

Prikladni materijal: Plastična tvar, uključujući i ekspandirane

plastične mase

Neprikladni materijal: Aluminij, Čelik dobiven taljenjem

7.3 Posebna krajnja uporaba ili uporabe

Posebna uporaba

Pomoćna sredstva za pranje rublja ( uparavanjem). Automatsko

nanošenje.

ODJELJAK 8. NADZOR NAD IZLOŽENOŠĆU/OSOBNA ZAŠTITA

8.1 Nadzorni parametri

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Ograničenja kod profesionalnog izlaganja

Sastojci

CAS-br.

Vrsta vrijednosti

(Oblik izloženosti)

Nadzorni parametri

Temelj

Hydrogen peroxide

7722-84-1

KGVI

2 ppm

2.8 mg/m3

HR OEL

Dodatni podaci

NAGRIZAJUĆE

OKSIDIRAJUCE

1 ppm

1.4 mg/m3

HR OEL

Dodatni podaci

NAGRIZAJUĆE

OKSIDIRAJUCE

Octena kiselina

64-19-7

10 ppm

25 mg/m3

HR OEL

Dodatni podaci

Naznaka da se radi o tvarima za koje su utvrđene indikativne granične

vrijednosti izloženosti prema Direktivi 91/322/ EEC

NAGRIZAJUĆE

DNEL

Hydrogen peroxide

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: ratkotrajno - lokalno

Vrijednost: 3 mg/m3

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 1.4 mg/m3

acetic acid

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: ratkotrajno - lokalno

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

peracetic acid

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Akutni sustavni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Radnici

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Akutni lokalni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Radnici

Načini izloženosti: Dodir s kožom

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Potencijalni učinci na zdravlje: Akutni lokalni učinci

Vrijednost: 0.12

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni sustavni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Akutni sustavni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Dugoročni lokalni učinci

Vrijednost: 0.6 mg/m3

Konačna upotreba: Potrošači

Načini izloženosti: Inhalacija

Potencijalni učinci na zdravlje: Akutni lokalni učinci

Vrijednost: 0.3 mg/m3

PNEC

acetic acid

Slatka voda

Vrijednost: 3.058 mg/l

Morska voda

Vrijednost: 0.3058 mg/l

Isprekidano korištenje/otpuštanje

Vrijednost: 30.58 mg/l

Postrojenje za obradu fekalija

Vrijednost: 85 mg/l

Talog

Vrijednost: 11.36 mg/kg

Zemlja

Vrijednost: 0.47 mg/kg

peracetic acid

Slatka voda

Vrijednost: 0.000224 mg/l

Talog u slatkoj vodi

Vrijednost: 0.00018 mg/kg

Voda

Vrijednost: 0.051 mg/l

Zemlja

Vrijednost: 0.32 mg/kg

8.2 Nadzor nad izloženošću

Odgovarajući inženjerski mehanizmi

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Tehničke mjere

Djelotvoran odvodno ventilacijski sustav. Održavati vrijednosti

koncentracija u zraku unutar normi za granične vrijednosti

izloženosti na radu.

Individualne mjere zaštite

Higijenske mjere

Rukovati u skladu s važećom industrijskom higijenom i

sigurnosnom praksom. Skinuti i oprati kontaminiranu odjeću prije

ponovnog korištenja. Nakon rukovanja temeljito oprati lice, ruke i

izloženu kožu. Osigurati odgovarajući prostor za brzo namakanje

ili ispiranje očiju i tijela u slučaju kontakta ili prskanja opasnim

kemikalijama

Zaštita očiju/lica (EN 166)

Zaštitne naočale

Stitnik za lice

Zaštita ruku (EN 374)

Preporučujemo preventivnu zaštitu kože

Rukavice

Nitrilna guma

Butilna guma

Vrijeme prodiranja: 1-4 sata

Minimalna debljina za butil gumu 0.7 za nitrilnu gumu 0.4 ili

ekvivalent (molimo pogledajte rukavice proizvođač / distributer za

savjet).

U slučaju bilo kakvih znakova razgradnje rukavica ili kemijskog

prodiranja kroz rukavice treba ih ukloniti i zamijeniti novim.

Zaštita kože i tijela (EN

14605)

Osobna zaštitna oprema sastoji se od: odgovarajućih zaštitnih

rukavica, sigurnosnih naočala i zaštitne odjeće

Zaštita organa za disanje

(EN 143, 14387)

Nije potrebna ako su koncentracije ispod GVI vrijednosti Koristiti

certificiranuzaštitnu opremu za disanje koja prati EU zahtjeve

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

mogu izbjeći ili ograničiti tehničkim mjerama kolektivne zaštite ili

mjerama, metodama i postupcima organizacije rada.

Nadzor nad zaštitom okoliša

Opći savjeti

: Osigurajte okolicu mjesta pohrane.

ODJELJAK 9. FIZIKALNA I KEMIJSKA SVOJSTVA

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Agregatno stanje

: tekućina

Boja

: jasan, Bezbojno

Miris

: poput octa

1.0, 100 %

Plamište

Nije primjenjivo

Prag osjetljivosti mirisa

Ne može se primijeniti i /ili odrediti iz mješavine

Točka topljenja/Točka

Ne može se primijeniti i /ili odrediti iz mješavine

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topljenja

Početna točka vrenja i

raspon vrenja

Ne može se primijeniti i /ili odrediti iz mješavine

Hlapivost

Ne može se primijeniti i /ili odrediti iz mješavine

Zapaljivost (kruta tvar, plin)

Ne može se primijeniti i /ili odrediti iz mješavine

Gornja granica

eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Donja granica eksplozivnosti

Ne može se primijeniti i /ili odrediti iz mješavine

Tlak pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća pare

Ne može se primijeniti i /ili odrediti iz mješavine

Relativna gustoća

1.12

Topljivost u vodi

topivo

Topivost u drugim

sredstvima za otapanje

Ne može se primijeniti i /ili odrediti iz mješavine

Koeficijent raspodjele n-

oktanol/voda

Ne može se primijeniti i /ili odrediti iz mješavine

Temperatura

samozapaljenja

Ne može se primijeniti i /ili odrediti iz mješavine

Termička razgradnja

Ne može se primijeniti i /ili odrediti iz mješavine

Viskoznost, kinematička

Ne može se primijeniti i /ili odrediti iz mješavine

Eksplozivna svojstva

Ne može se primijeniti i /ili odrediti iz mješavine

Oksidirajuća svojstva

DaTvar ili mješavina klasificira se kao oksidirajuća s kategorijom

9.2 Ostali podaci

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

Ne miješati sa izbjeljivačima i ostalim kloriranim proizvodima - nastati će plinoviti klor.

10.4 Uvjeti koje treba izbjegavati

Direktni izvori topline.

Izlaganje sunčevoj svjetlosti.

10.5 Inkompatibilni materijali

Baze

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Metali

Organske tvari

Aluminij

Čelik dobiven taljenjem

10.6 Opasni proizvodi raspadanja

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljikovi oksidi

Dušikovi oksidi (NOx)

sumporni oksidi

Fosforovi oksidi

ODJELJAK 11. TOKSIKOLOŠKE INFORMACIJE

11.1 Informacije o toksikološkim učincima

Informacije o vjerojatnim

načinima izlaganja

Inhalacija, Dodir s očima, Dodir s kožom

Proizvod

Akutna oralna toksičnost

: Procjena akutne toksičnosti : 1,565 mg/kg

Akutna toksičnost pri

udisanju

: 4 h Procjena akutne toksičnosti : 4.81 mg/l

Akutna kožna toksičnost

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

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.

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Aspiracijska toksičnost

: Nema raspoloživih podataka o ovom proizvodu.

Sastojci

Akutna oralna toksičnost

: Hydrogen peroxide

LD50 Štakor: 486 mg/kg

Octena kiselina

LD50 Štakor: 3,310 mg/kg

Sastojci

Akutna toksičnost pri

udisanju

: Octena kiselina

4 h LC50 Štakor: > 40 mg/l

Peroksioctena kiselina

4 h LC50 Štakor: 1.5 mg/l

Potencijalno djelovanje na zdravlje

Oči

Uzrokuje teške ozljede oka.

Koža

Prouzrokuje teške opekline kože.

Gutanje

Prouzrokuje opekline probavnog trakta.

Inhalacija

Može prouzrokovati nadraživanje dišnog trakta. 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

Vrlo otrovno za vodeni okoliš, s dugotrajnim učincima.

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

: Octena kiselina

96 h LC50: 75 mg/l

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96 h LC50 Oncorhynchus mykiss (Kalifornijska pastrva): 1,000

mg/l

Peroksioctena kiselina

96 h LC50: 0.8 mg/l

Sastojci

Toksično za daphnia i ostale

vodene beskičmenjake.

: Octena kiselina

48 h EC50 Daphnia magna (Vodenbuha): 1,000 mg/l

Peroksioctena kiselina

48 h EC50: 0.73 mg/l

Sastojci

Otrovnost za alge

: Hydrogen peroxide

72 h EC50: 1.38 mg/l

Octena kiselina

72 h EC50 Skeletonema costatum (morska dijatomeja): 1,000

mg/l

Peroksioctena kiselina

72 h EC50: 0.7 mg/l

12.2 Postojanost i razgradivost

Proizvod

Biorazgradljivost

: Tenzidi u proizvodu su biorazgradljivi prema zahtjevima iz

regulativa o sredstvima za pranje 648/2004/EC.

Sastojci

Biorazgradljivost

Hydrogen peroxide

Rezultat: Nije primjenjivo - anorganski

Octena kiselina

Rezultat: Biološki vrlo razgradljivo.

Peroksioctena kiselina

Rezultat: Biološki vrlo razgradljivo.

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.

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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

: Proizvod ne smije ući u odvodne kanale, izvore vode ili tlo. 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

: Inorganic wastes containing dangerous substances. If this product

is used in any further processes, the final user must redefine and

assign the most appropriate European Waste Catalogue Code. It

is the responsibility of the waste generator to determine the

toxicity and physical properties of the material generated to

determine the proper waste identification and disposal methods in

compliance with applicable European (EU Directive 2008/98/EC)

and local regulations.

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

3149

14.2 Pravilno otpremno ime

prema UN-u

VODIKOV PEROKSID I PEROKSIOCTENA KISELINA, SMJESA,

STABILIZIRANA

14.3 Razred(i) opasnosti pri

prijevozu

5.1 (8)

14.4 Skupina pakiranja

14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

Zračni prijevoz (IATA)

14.1 UN broj

3149

14.2 Pravilno otpremno ime

prema UN-u

Hydrogen peroxide and peroxyacetic acid mixture stabilized

14.3 Razred(i) opasnosti pri

prijevozu

5.1 (8)

14.4 Skupina pakiranja

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14.5 Opasnosti za okoliš

14.6 Posebne mjere opreza

za korisnike

Nijedan

Morski prijevoz (IMDG/IMO)

14.1 UN broj

3149

14.2 Pravilno otpremno ime

prema UN-u

HYDROGEN PEROXIDE AND PEROXYACETIC ACID

MIXTURE, STABILIZED

14.3 Razred(i) opasnosti pri

prijevozu

5.1 (8)

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/posebno zakonodavstvo za tvar ili smjesu

sukladno Uredbi o

deterdžentima EZ 648/2004

15% ili više, ali manje od 30%: Sredstva za izbjeljivanje bazirana

na kisiku

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,

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 sigurnosti kemikalija

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

Oksidirajuće tekućine 2, H272

Na temelju podataka ispitivanja.

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Nagriz .met. 1, H290

Na temelju podataka ispitivanja.

Akutna toksičnost 4, H302

Način izračuna

Akutna toksičnost 4, H332

Način izračuna

Nagriz. koža 1A, H314

Na temelju podataka ispitivanja.

Ozljeda oka 1, H318

Na temelju podataka ispitivanja.

Specifična toksičnost za ciljne organe/sustavna

toksičnost - jednokratna izloženost 3, H335

Način izračuna

Kronična toksičnost u vodenom okolišu 1, H410

Način izračuna

Cjelovit tekst H-izjava

H226

Zapaljiva tekućina i para.

H242

Zagrijavanje može uzrokovati požar.

H271

Može uzrokovati požar ili eksploziju; jaki oksidans.

H302

Štetno ako se proguta.

H312

Štetno u dodiru s kožom.

H314

Uzrokuje teške opekline kože i ozljede oka.

H332

Štetno ako se udiše.

H335

Može nadražiti dišni sustav.

H400

Vrlo otrovno za vodeni okoliš.

H410

Vrlo otrovno za vodeni okoliš, s dugotrajnim učincima.

Cjelovit tekst ostalih skraćenica

ADN - Europskog sporazuma o međunarodnom prijevozu opasnih tvari unutarnjim plovnim

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

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

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

Kancerogen,

mutagen

reproduktivni

otrov;

Standard

Njemačkog

instituta

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

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

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

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

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

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

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

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

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

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

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

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

Smrtonosna

doza

testirane

populacije

(Srednja

smrtonosna

doza);

MARPOL

Međunarodna konvencija o sprječavanju onečišćenja s brodova; n.o.s. - Koji nije definiran

drugačije;

NO(A)EC

Nije

promatrana

(negativan)

koncentracija

učinka;

NO(A)EL

Nije

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

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

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

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

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

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

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

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

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

postojani i vrlo bioakumulacijski

Pripremio

Poslovi vezani za zakonske propise

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

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

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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.

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Setting of import tolerances for teflubenzuron in grapefruits, mandarins and broccoli

Published on: Mon, 12 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro BV submitted a request to the competent national authority in the United Kingdom to set import tolerances for the active substance teflubenzuron in grapefruits and mandarins imported from Brazil and for broccoli imported from Paraguay. The data submitted were found to be sufficient to derive maximum residue level (MRL) proposals for grapefruits and broccoli. The MRL derived ...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

12-11-2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

European Antibiotic Awareness Day 2018

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

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

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

9-11-2018

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Safety assessment of the active substance polyacrylic acid, sodium salt, cross‐linked, for use in active food contact materials

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of polyacrylic acid, sodium salt, cross‐linked, FCM substance No 1015, which is intended to be used as a liquid absorber in the packaging of fresh or frozen foods such as meat, poultry and seafood as well as fresh fruits and vegetables. Specific migration tests were not performed due to the high absorption of liquids by the substance. The Panel noted that if polya...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

8-11-2018

Theme event on big data and medicine

Theme event on big data and medicine

The U.S. Food and Drug Administration, FDA, The European Medicines Agency, EMA, and Novo Nordisk are among the speakers when The Danish Medicines Agency on 20 November 2018 puts focus on big data and medicine under the event heading “From Big Data to Real World Evidence”.

Danish Medicines Agency

8-11-2018

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Hazard analysis approaches for certain small retail establishments and food donations: second scientific opinion

Published on: Wed, 07 Nov 2018 00:00:00 +0100 In 2017, EFSA published a ‘simplified’ food safety management system (FSMS) for certain small retail establishments (butcher, grocer, baker, fish and ice cream shop) based on the application of prerequisite programme (PRP) criteria. The aim of this opinion was to develop similar FSMSs for other small retail enterprises including retail distribution centres, supermarkets, restaurants (including pubs and other catering activities) and food donation. The latter...

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

6-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

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

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

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 ...

France - Agence Nationale du Médicament Vétérinaire

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

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...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Acrobasis pirivorella

Pest categorisation of Acrobasis pirivorella

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Acrobasis pirivorella (Lepidoptera: Pyralidae), a monophagous moth whose larvae exclusively feed on developing buds, flowers, and fruits of cultivated and wild Pyrus spp. A. pirivorella is a species with reliable methods available for identification. A. pirivorellaoccurs in north‐east Asia only, causing significant damage in cultivated pears. It is regulated in the EU by Council Direc...

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

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Outcome of a public consultation on the draft guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft guidance on the scientific requirements for health claims related to muscle function and physical performance, prepared by the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), supported by the Working Group on Claims. The draft guidance was endorsed by the Panel for public consultation ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA 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 a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

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

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

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

Danish Medicines Agency

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

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...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

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

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

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

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

6-11-2018

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Vertex Pharmaceuticals (Europe) Limited)

Symkevi (Active substance: tezacaftor/ivacaftor) - Centralised - Authorisation - Commission Decision (2018)7415 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4682

Europe -DG Health and Food Safety

6-11-2018

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (GlaxoSmithKline Trading Services Limited)

Trelegy Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7416 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4363/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (GlaxoSmithKline Trading Services Limited)

Elebrato Ellipta (Active substance: fluticasone furoate/umeclidinium/vilanterol) - Centralised - 2-Monthly update - Commission Decision (2018)7417 of Tue, 06 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4781/WS/1369

Europe -DG Health and Food Safety

6-11-2018

Neulasta (Amgen Europe B.V.)

Neulasta (Amgen Europe B.V.)

Neulasta (Active substance: Pegfilgrastim) - Centralised - Yearly update - Commission Decision (2018)7420 of Tue, 06 Nov 2018

Europe -DG Health and Food Safety

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

1-11-2018

Zolvix (Elanco GmbH)

Zolvix (Elanco GmbH)

Zolvix (Active substance: monepantel) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7383 of Thu, 01 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/000154/T/0024

Europe -DG Health and Food Safety

31-10-2018

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (GlaxoSmithKline (Ireland) Limited)

Integrilin (Active substance: Eptifibatide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7340 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/230/T/79

Europe -DG Health and Food Safety

31-10-2018

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (GlaxoSmithKline (Ireland) Limited)

Volibris (Active substance: Ambrisentan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7339 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/839/T/56

Europe -DG Health and Food Safety

31-10-2018

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Amgen Europe B.V.)

AMGEVITA (Active substance: adalimumab) - Centralised - Yearly update - Commission Decision (2018)7341 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

31-10-2018

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Samsung Bioepis NL B.V.)

Imraldi (Active substance: adalimumab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7344 of Wed, 31 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/T/15

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety