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Lokalizacija

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  • PRE STABIMIX 1231
    Hrvatska
  • Jezik:
  • hrvatski

Druge informacije

Status

  • Izvor:
  • Ecolab
  • Broj odobrenja:
  • 109108E
  • Zadnje ažuriranje:
  • 12-03-2018

Sažetak Opisa Svojstava

PREMIX Stabimix 1231

SIGURNOSNO- TEHNIČKI LIST

Ime proizvoda

PREMIX Stabimix 1231

Odgovara Regulativi (EC) br. 1907/2006 (REACH), Annex II (453/2010) - Europa

:

1.1 Identifikator proizvoda

1.3 Detalji dobavljača sigurnosno tehničkog lista

1.2 Važne identificirane uporabe tvari ili smjese i uporabe protiv kojih se savjetuje

Identificirane uporabe

ODJELJAK 1: Identifikacija supstance/smjese i kompanije/poduzeća

Kod proizvoda

:

Ne preporučive uporabe

1.4 Telefon zа hitne slučajeve

Nacionalno savjetodavno tijelo/Centar za trovanja

Sredstvo za čišćenje u prehrambenoj industriji. CIP proces.

Nisu poznati.

Ecolab d.o.o.

Zavrtnica 17

10 000 Zagreb

tel: +385 1 6321 600

fax: +385 1 6321 633

email:iva.nola@ecolab.com

:

Proizvođač/ Distributer/

Uvoznik

:

Broj telefona

Hrvatska: 1 476 6464, 06-80-201-199

Bosna i Hercegovina: 112

109108E

Uporaba proizvoda

:

Ecolabov poluproizvod

Samo za profesionalnu uporabu

Proizvođač/ Distributer/ Uvoznik

:

Broj telefona

112 (medicinske informacije na broj +385 (0)1 2348 342)

Izdanje

: 1

Klasifikacija

C; R35

:

:

Opasnosti za ljudsko

zdravlje

Izaziva teške opekotine.

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

Klasifikacija prema Regulativi (EC) 1272/2008 [CLP/GHS]

ODJELJAK 2: Identifikacija opasnosti

2.1 Klasifikacija supstance ili mješavine

Definicija proizvoda

:

Mješavina

Vidjeti Odjeljak 16 za cijeli tekst R fraza i H iskaza gore priopćenog.

Klasifikacija prema Uredbi 1999/45/EC [DPD]

Proizvod je klasificiran kao opasno sredstvo prema odredbi 1999/45/EC i njenim dopunama.

2.2 Elementi označavanja

Piktogrami opasnosti

:

Signalna riječ

:

Opasnost

Skin Corr. 1A, H314

Datum izdanja/Datum revizije

:

1/13

27 Ožujka 2012

HZT, klasa

:

Nema.

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ODJELJAK 2: Identifikacija opasnosti

:

Druge opasnosti koje ne

rezultiraju u klasifikaciji

Izjava opasnosti

:

Prevencija

:

Izjava opreza

Odgovor

:

P280 - Nositi zaštitne rukavice i zaštitu za oči/lice.

P303 + P361 + P353 - U SLUČAJU DODIRA S KOŽOM (ili kosom): Odmah skinuti

svu zagađenu odjeću. Isprati kožu s vodom ili tušem.

P305 + P351 + P338 - U SLUČAJU DODIRA S OČIMA: Ispirati oprezno vodom

nekoliko minuta. Odstraniti kontaktne leće, ako je moguće. Nastaviti ispirati.

P310 - Odmah nazvati CENTAR ZA KONTROLU OTROVANJA ili liječnika.

2.3 Druge opasnosti

Sadrži

:

Nije primjenljiv.

alkoksilat masnog alkohola

Natrijev hidroksid

H314

Uzrokuje teške opekline kože i ozljede oka.

Nadzor nad izloženošću, ako je dostupno navedeno je u odjeljku 8.

Ne postoje dodatni sastojci koji su, u okviru sadašnjeg znanja dobavljača i u primjenljivim koncentracijama, klasificirani

opasnim po zdravlje ili okoliš i stoga zahtijevaju podnošenje izvještaja u ovom odjeljku.

ODJELJAK 3: Sastav/informacije o sastojcima

[1] Supstance koje su klasificirane kao opasne za zdravlje ili okolinu

[2] Supstance koje imaju zadanu granicu izlaganja na radnom mjestu

[3] Tvar ispunjava kriterije za OBT prema Propisu (EC) Br 1907/2006, Aneks XIII

[4] Tvar ispunjava kriterije za vPvB prema Propisu (EC) Br 1907/2006, Aneks XIII

Indentifikatori

67/548/EEC

Naziv

proizvoda/sastojka

%

Tip

Pravilo (EC) Br.

1272/2008 [CLP]

Klasifikacija

Vidjeti odjeljak 16 za

cijeli tekst R-fraza

gore deklariranih

Vidjeti Odjeljak 16 za

cijeli tekst H iskaza

gore priopćenog.

alkoksilat masnog

alkohola

Xi; R38

N; R50

Skin Irrit. 2, H315

Aquatic Acute 1, H400

alkilpoliglikozidi

REACH #: 01-

2119488530-36

EC: 500-220-1

CAS (Služba kemijskih

abstrakata): 68515-73-1

Xi; R41

Eye Dam. 1, H318

Natrijev hidroksid

REACH #: 01-

2119457892-27

EC: 215-185-5

CAS (Služba kemijskih

abstrakata): 1310-73-2

Indeks: 011-002-00-6

C; R35

Skin Corr. 1A, H314

[1] [2]

Mješavine

3.2

Datum izdanja/Datum revizije

:

2/13

27 Ožujka 2012

HZT, klasa

:

Nema.

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Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Isprati usta vodom. Ukloniti umjetno zubalo ako postoji. Ukoliko je tvar progutana i

izložena osoba je pri svijesti, dati popiti male količine vode. Prestati ukoliko izložena

osoba osjeća mučninu jer povraćanje može biti opasno. Ne izazivati povraćanje

osim ako to nije naloženo od strane medicinskog osoblja. Ukoliko dođe do

povraćanja, glavu treba držati spuštenom tako da izbljuvak ne uđe u pluća. Lliječnik

mora smjesta tretirati kemijske opekline. Osobi bez svijesti nikad ništa ne davati na

usta. Ukoliko je osoba bez svijesti, postaviti je u bočni položaj i smjesta osigurati

liječničku pomoć. Održavati slobodan protok zraka. Popustiti usku odjeću poput

okovratnika, kravate, pojasa ili remena. Premjestiti unesrećenog na svježi zrak,

umiriti ga i postaviti u položaj koji olakšava disanje.

Kontakt s kožom

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Odmah isprati oči s velikom količinom vode, te povremeno podići gornje i donje

kapke. Provjeriti postojanje leća te iste ukloniti. Nastaviti ispirati najmanje 10

minuta. Lliječnik mora smjesta tretirati kemijske opekline.

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Isprati kontaminiranu kožu s puno vode. Skinuti kontaminiranu odjeću i cipele.

Oprati kontaminiranu odjeću prije ponovne upotrebe. Nastaviti ispirati najmanje 10

minuta. Lliječnik mora smjesta tretirati kemijske opekline. Temeljito očistiti cipele

prije ponovne upotrebe.

4.1 Opis mjera prve pomoći

Smjesta tražiti liječničku pomoć. Pozvati centar za kontrolu trovanja ili liječnika.

Premjestiti unesrećenog na svježi zrak, umiriti ga i postaviti u položaj koji olakšava

disanje. Ukoliko se sumnja da su zagušljiva isparenja i dalje prisutna, spasilac treba

nositi odgovarajuću masku ili samostalni dišni aparat. Ukoliko nema disanja, ukoliko

je disanje neregularno ili ukoliko dođe do zastoja u disanju, trenirano osoblje treba

obezbijediti umjetno disanje ili kisik. Oživljavanje usta na usta može biti opasno po

pružaoca pomoći. Ukoliko je osoba bez svijesti, postaviti je u bočni položaj i smjesta

osigurati liječničku pomoć. Održavati slobodan protok zraka. Popustiti usku odjeću

poput okovratnika, kravate, pojasa ili remena.

Gutanje

Udisanje

Kontakt očima

:

:

:

:

Zaštita pružalaca prve

pomoći

:

ODJELJAK 4: Mjere prve pomoći

4.2 Najvažniji simptomi i efekti, i akutni i odloženi

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Može ispuštati plinove ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Može izazvati opekline usta, grla i trbuha.

:

Gutanje

Kontakt s kožom

:

Izaziva teške opekotine.

Uzrokuje teške ozljede oka.

:

Kontakt očima

Znaci/simptomi pretjeranog izlaganja

Kontakt s kožom

Udisanje

Štetni simptomi mogu uključivati slijedeće:

nadražaj dišnog sustava

kašljanje

Štetni simptomi mogu uključivati slijedeće:

bol ili nadraživanje

crvenilo

može se dogoditi stvaranje mjehura

:

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti aktivnost za koju

osoba nije prošla odgovarajuću obuku. Ukoliko se sumnja da su zagušljiva isparenja

i dalje prisutna, spasilac treba nositi odgovarajuću masku ili samostalni dišni aparat.

Oživljavanje usta na usta može biti opasno po pružaoca pomoći. Temeljito vodom

oprati kontaminiranu odjeću prije skidanja, ili nositi rukavice.

Datum izdanja/Datum revizije

:

3/13

27 Ožujka 2012

HZT, klasa

:

Nema.

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ODJELJAK 4: Mjere prve pomoći

Obavijesti liječniku

Tretirati po simptomima. Kontaktirati liječnika specijalistu za otrove odmah ukoliko je

osoba progutala ili udisala velike količine.

:

Dodatna upozorenja

Gutanje

Štetni simptomi mogu uključivati slijedeće:

bolovi u trbuhu

:

4.3 Indikacija potrebe za liječničkom pomoći bez odgode i specijalnim liječenjem

Nema specifičnog liječenja.

:

U slučaju požara odmah izolirati mjesto događaja uklanjanjem svih osoba koje se

nalaze u blizini. Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti

aktivnost za koju osoba nije prošla odgovarajuću obuku.

Opasni samozapaljivi

proizvodi

Opasnosti od tvari ili

smjese

Produkti raspadanja mogu uključivati sljedeće materijale:

ugljik dioksid

ugljik monoksid

oksidi fosfora

metalni oksid/oksidi

U požaru ili ako grijano, dogodit će se porast tlaka i kontejner može prsnuti.

Vatrogasci bi trebali nositi odgovarajuću zaštitnu opremu i samostalni aparat za

disanje koji pokriva čitavo lice i koji je pod pozitivnim tlakom.

Posebna oprema za zaštitu

vatrogasaca

5.1 Sredstva za gašenje požara

:

:

:

Nisu poznati.

Odgovarajuća sredstva za

gašenje

:

Neodgovarajuća sredstva

za gašenje

:

ODJELJAK 5: Vatrogasne mjere

5.2 Specijalne opasnosti koje proističu od tvari ili smjese

5.3 Savjet za vatrogasce

Specijalna mjere

predostrožnosti za

vatrogasce

:

6.2 Mjere zaštite okoliša

Izbjegavati rasipanje prosutog materijala i otjecanje ili kontakt sa tlom, vodotocima,

odvodima i kanalizacijom. Obavijestiti odgovarajuće vlasti ukoliko je proizvod

prouzročio zagađenje okoliša (kanalizacije, vodotokova, tla ili zraka).

6.3 Metode i materijali za zadržavanje i čišćenje

ODJELJAK 6: Mjere za slučajna ispuštanja

6.1 Osobne mjere predostrožnosti, zaštitna oprema i postupci u slučaju hitnih slučajeva

Za ne-interventno osoblje

:

Za pružaoce hitne pomoći

:

Ne poduzimati ni jednu aktivnost koja uključuje osobni rizik niti aktivnost za koju

osoba nije prošla odgovarajuću obuku. Spriječiti ulazak nepotrebnog i nezaštićenog

osoblja. Izbjegavati diranje i hodanje po prolivenom materijalu. Ne udisati pare ili

maglu. Osigurati odgovarajuću ventilaciju. Nosite prikladni respirator kad je

ventilacija neadekvatna. Staviti prikladnu osobnu zaštitnu opremu.

Ako je specijalizirana odjeća potrebna za rješavanje izlijevanja, treba obratiti pažnju

na bilo kakve informacije u Odjeljku 8 o prikladnim i neprikladnim materijalima.

Pogledati također informacije u "Za ne-interventno osoblje".

:

Datum izdanja/Datum revizije

:

4/13

27 Ožujka 2012

HZT, klasa

:

Nema.

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ODJELJAK 6: Mjere za slučajna ispuštanja

Zaustaviti propuštanje ako ne postoji rizik. Ukloniti spremnike s mjesta izlijevanja.

Prići izlivenom sadržaju iz smjera puhanja vjetra. Spriječiti prilaz kanalizaciji,

vodotocima, podrumima ili zatvorenim prostorima. Isprati izljevanja u postrojenje za

prečišćavanje otpadnih voda ili postupiti po slijedećem. Zadržati i pokupiti izljev

negorivim, apsorbirajućim materijalom na pr. pijeskom, zemljom, vermikulitom,

diatomejskom zemljom i smjestiti u kontejner za odlaganje u skladu s lokalnim

pravilima. Kontaminirani apsorbirajući materijal može predstavljati istu opasnost

poput prolivenog proizvoda.

Veliko izljevanje

:

Zaustaviti propuštanje ako ne postoji rizik. Ukloniti spremnike s mjesta izlijevanja.

Razrijediti vodom i prebrisati ako je topivo u vodi. Alternativno, ili ako nije topivo u

vodi, absorbirati sa inertnim suhim materijalom i odložiti u odgovarajući kontejner za

odlaganje otpada.

Malo izljevanje

:

6.4 Upućivanje na druge

odjeljke

Vidjeti Odjeljak 1 za hitne konakt informacije.

Vidjeti Odjeljak 8 za informacije o prikladnoj osobnoj zaštitnoj opremi.

Vidjeti Odjeljak 13 za dodatne informacije o obradi otpada.

:

Skladištiti na temperaturi između: -5 do 40°C (23 do 104°F). Skladištiti u skladu sa

lokalnim uredbama. Skladištiti u originalnom spremniku zaštićeno od izravnog

sunčevog svjetla, u suhom, hladnom i dobro ventiliranom prostoru, daleko od

nekompatiblinih materijala (vidjeti odjeljak 10), te hrane i pića. Odijeliti od kiselina.

Držati spremnik čvrsto zatvoren i zapečaćen dok nije spreman za uporabu. Posude

koje su otvorene moraju biti pažljivo nanovo zabrtvljene i držane uspravno radi

spriječavanja odljevanja. Ne skladištiti u neobilježenim kontejnerima. Koristiti

odgovarajuću ambalažu kako bi se spriječilo zagađivanje okoliša.

ODJELJAK 7: Rukovanje i skladištenje

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Lista identificiranih uporaba u Odjeljku 1 treba biti

konzultirana za bilo koju dostupnu uporabno specifičnu informaciju datu u Scenariju(ima) izloženosti.

7.1 Mjere predostrožnosti za sigurno rukovanje

Sigurnosne mjere

:

Savjet o općoj

profesionalnoj higijeni

:

7.2 Uvjeti za sigurno

skladištenje, uključujući bilo

koje nekompatibilnosti

7.3 Specifični krajnji korisnik(ci)

Staviti odgovarajuću osobnu zaštitnu opremu (vidjeti odjeljak 8). Ne smije dospjeti u

oči ili na kožu ili odjeću. Ne udisati pare ili maglu. Ne gutati. Ukoliko tijekom

normalne uporabe materijal prestavlja opasnost po disanje, koristiti samo uz

odgovarajuću ventilaciju ili nositi odgovarajući respirator. Čuvati u u originalnom

kontejneru ili odobrenom alternativnom napravljenom od kompatibilnog materijala,

držanog čvrsto zatvorenim kad nije u upotrebi. Držati se podalje od kiselina. Prazni

spremnici sadrže ostatke proizvoda i mogu biti opasni.

Radnici trebaju oprati ruke i lice prije jedenja, pijenja i pušenja. Vidjeti također

Odjeljak 8 za dodatne informacije o higijenskim mjerama.

:

Preporuke

:

Specifične otopine za

industrijski sektor

:

Nije primjenljiv.

Nije primjenljiv.

ODJELJAK 8: Kontrole izlaganja/osobna zaštita

8.1 Kontrolni parametri

Limit profesionalnog izlaganja

Datum izdanja/Datum revizije

:

5/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 8: Kontrole izlaganja/osobna zaštita

Zaštita ruku

(EN 374)

Upotrijebiti ispravno postavljen, respirator koji pročišćava zrak ili koji koristi već

očišćeni zrak, koji je u skladu sa odobrenim standardom, ukoliko analiza rizika

ukazuje na neophodnost. Odabir respiratora se mora zasnivati na poznatim ili

očekivanim nivoima izloženosti, štetnostima tvari i granicama sigurnog djelovanja

odabranog respiratora. Ukoliko su radnici izloženi koncentracijama iznad

dozvoljenih granica izlaganja, moraju koristiti odgovarajuće, certificirane respiratore.

(P2)

Preporuča se : Rukavice - butil-guma , nitril-guma ( Vrijeme prodiranja: 1 - 4 sati ) .

Preporuča se : Sigurnosne naočale. Naočale, Zaštita za lice ili ostala sredstva za

potpunu zaštitu lica.

Zaštita оčiju/lica

(EN 166)

Zaštita dišnih puteva

(EN 143, 14387)

:

:

:

Zaštita kože

Osobna zaštitna oprema za tijelo treba biti odabrana na osnovu posla koji se obavlja

i rizika uključenih i treba biti odobrena od strane specijaliste prije obrade ovog

proizvoda.

:

Kontrole izlaganja zaštite

okoliša

:

Emisije iz ventilacije ili opreme radnog procesa trebaju biti prekontrolirane radi

osiguranja da udovoljavaju zahtjevima zakonskih propisa o ekološkoj zaštiti. U

nekim slučajevima, čistači plina, filteri ili inženjerske preinake procesne opreme biti

će neophodne za redukciju emisija na prihvatljive nivoe.

Odgovarajuće inženjerske

kontrole

:

Ukoliko se pri rukovanju stvara prašina, plinovi, para ili magla, upotrebiti procesne

zatvorene prostore, lokalnu ventilaciju ispušnih plinova ili druge mehaničke

upravljačke uređaje radi očuvanja izlaganja radnika kontaminantima u zraku ispod

preporučenih ili zakonskih limita.

Temeljito oprati ruke, podlaktice i lice nakon rukovanja kemijskim proizvodima, prije

jela, pušenja ili korištenja toaleta te po svršetku radnog vremena. Odgovarajuće

tehnike trebaju biti korištene pri uklanjanju potencijalno kontaminirane odjeće.

Oprati kontaminiranu odjeću prije ponovne upotrebe. Osigurati da su mjesta za

ispiranje očiju i tuševi blizu radnih mjesta.

8.2 Tehničke mjere za smanjenje izloženosti

Higijenske mjere

:

Nema dostupnih Izvedene razine učinka.

Predviđen učinak koncentracija

Nema dostupnih Predviđen učinak koncentracija.

Izvedene razine učinka

Individualne mjere zaštite

Zaštita tijela

(EN 14605)

:

Druga zaštita kože

Termičke opasnosti

:

Odgovarajuća obuća i sve dodatne mjere zaštite kože trebaju biti odabrani na

temelju zadatka koji se obavlja kao i rizika koji su uključeni i trebaju biti odobreni od

strane stručnjaka prije rukovanja s ovim proizvodom.

Nije primjenljiv.

Naziv proizvoda/sastojka

Granične vrijednosti izlaganja

Nije poznata vrijednost granice izlaganja.

Datum izdanja/Datum revizije

:

6/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 9: Fizikalna i kemijska svojstva

Fizikalno stanje

Točka taljenja/točka

smrzavanja

Inicijalna točka vrelišta i opseg

vrenja

Tlak pare

Relativna gustoča

Gustoća pare

Tekućina.

1.14 do 1.18

Slab miris.

Miris

pH

Smeđ. [Svijetla boja]

Boja

Brzina isparavanja

Temperatura samozapaljena

Temperatura zapaljenja

> 100°C

12.5 do 13.5 [Konc. (% t/t): 100%]

Prag mirisa:

Oktanol/voda koeficijent

raspodjele

Svojstva eksploziva

:

:

:

:

:

:

:

:

:

:

:

:

:

:

:

Niti jedan.

Oksidirajuća svojstva

:

9.1 Informacije o osnovnim fizikalnim i kemijskim svojstvima

Izgled

9.2 Ostale informacije

Vrijeme izgaranja

Brzina izgaranja

:

:

Temperatura dekompozicije

:

Nema dodatnih informacija.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Ne može se primijeniti i /ili odrediti iz mješavine.

Nije primjenljiv.

Ne može se primijeniti i /ili odrediti iz mješavine.

Viskozitet

:

Gornje/donje granice

zapaljivosti ili eksplozivnosti

:

Ne može se primijeniti i /ili odrediti iz mješavine.

Zapaljivost (krutina, plin)

:

Ne može se primijeniti i /ili odrediti iz mješavine.

Topljivost(i)

:

Ne može se primijeniti i /ili odrediti iz mješavine.

10.4 Uvjeti koje treba

izbjegavati

Nema specifičnih podataka.

Proizvod je stabilan.

10.2 Kemijska stabilnost

:

:

10.5 Nekompatibilni

materijali

:

10.3 Mogućnost opasnih

reakcija

:

Pod normalnim uvjetima skladištenja i uporabe, opasne reakcije se neće dogoditi.

ODJELJAK 10: Stabilnost i reaktivnost

10.1 Reaktivnost

:

Na raspolaganju nema specifičnih test podataka vezanih za reaktivnost za ovaj

proizvod ili njegove sastojke.

Ekstremno reaktivan ili nekompatibilan sa sljedećim materijalima: organski materijali

i kiseline.

Datum izdanja/Datum revizije

:

7/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 10: Stabilnost i reaktivnost

10.6 Opasni proizvodi

raspadanja

Pod normalnim uvjetima skladištenja i uporabe, opasni proizvodi raspadanja ne bi

smjeli biti proizvedeni.

:

akutno trovanje

alkoksilat masnog alkohola

LD50 Oralno

Štakor

>2000 mg/kg

Natrijev hidroksid

LD50 Kožni

Kunić

1350 mg/kg

LD50 Kožni

Kunić

>2000 mg/kg

LD50 Oralno

Kunić

500 mg/kg

LD50 Oralno

Štakor

300 do 500

mg/kg

Naziv proizvoda/sastojka

Rezultat

Vrste

Doza

Izlaganje

Karcinogenost

Mutagenost

Teratogenost

Reproduktivna toksičnost

Iritacija/korozija

Natrijev hidroksid

Oči - Blago nadražujuće

sredstvo

Kunić

Micrograms

Oči - jako nadražuje

Kunić

24 sati 50

Micrograms

Oči - jako nadražuje

Kunić

1 Percent

Oči - jako nadražuje

Kunić

0.5 minute 1

milligrams

Koža - Blago nadražujuće

sredstvo

Ljudski

24 sati 2

Percent

Koža - jako nadražuje

Kunić

24 sati 500

milligrams

Naziv proizvoda/sastojka

Rezultat

Rezultat

Izlaganje

Promatranje

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Sensitajzer

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Vrste

ODJELJAK 11: Toksikološke informacije

11.1 Informacije o toksikološkim učincima

Akutne procjene toksičnosti

Nema podataka za proizvod.

Toksičnost specifično određenih organa (samo jedno izlaganje)

Toksičnost specifično određenih organa (ponovljeno izlaganje)

Opasnost od aspiracije

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Datum izdanja/Datum revizije

:

8/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 11: Toksikološke informacije

Potencijalne kronične zdravstvene posljedice

Potencijalne akutne zdravstvene posljedice

Udisanje

:

Može ispuštati plinove ili pare koji su vrlo nadražujući i nagrizajući za dišni sustav.

Može izazvati opekline usta, grla i trbuha.

:

Gutanje

Kontakt s kožom

:

Izaziva teške opekotine.

Uzrokuje teške ozljede oka.

:

Kontakt očima

Značajne posljedice ili kritične opasnosti nisu poznate.

Opća

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Karcinogenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Mutagenost

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Teratogenost

:

Razvojni efekti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Efekti fertilnosti

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Simptomi u svezi s fizičkim, kemijskim i toksikološkim karakteristikama

Kontakt s kožom

Gutanje

Udisanje

Nema specifičnih podataka.

Štetni simptomi mogu uključivati slijedeće:

bolovi u trbuhu

Štetni simptomi mogu uključivati slijedeće:

bol ili nadraživanje

crvenilo

može se dogoditi stvaranje mjehura

:

:

:

Kontakt očima

:

Štetni simptomi mogu uključivati slijedeće:

suzenje

crvenilo

Efekti sa i bez odgode te također kronični efekti od kratkotrajnog i dugotrajnog izlaganja

Kratkotrajno izlaganje

Dugotrajno izlaganje

Informacije o vjerojatnim

putevima izlaganja

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Potencijalni neposredni

učinci

:

Potencijalni odgođeni

učinci

:

Potencijalni neposredni

učinci

:

Potencijalni odgođeni

učinci

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Značajne posljedice ili kritične opasnosti nisu poznate.

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Ostale informacije

:

Značajne posljedice ili kritične opasnosti nisu poznate.

ODJELJAK 12: Ekološke informacije

12.1 Otrovnost

alkoksilat masnog alkohola

Akutni EC50 0.1 do 1 mg/l

Vodene biljke

72 sati

Akutni EC50 1 mg/l

Vodenbuha

48 sati

Akutni LC50 1 do 10 mg/l

Riba - Leuciscus idus

96 sati

Natrijev hidroksid

Akutni EC50 40 mg/L

Vodenbuha

48 sati

Akutni LC50 72 mg/L

Riba

96 sati

Naziv proizvoda/sastojka

Vrste

Rezultat

Izlaganje

Zaključak/Sažetak

:

Značajne posljedice ili kritične opasnosti nisu poznate.

Datum izdanja/Datum revizije

:

9/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 12: Ekološke informacije

12.3 Bioakumulativni potencijal

12.6 Drugi štetni efekti

Značajne posljedice ili kritične opasnosti nisu poznate.

12.2 Postojanost i razgradivost

Zaključak/Sažetak

:

Tenzidi u proizvodu su biorazgradljivi prema zahtjevima iz regulativa o sredstvima za

pranje 648/2004/EC.

PBT

:

Nije primjenljiv.

vPvB

:

Nije primjenljiv.

12.4 Pokretljivost kroz tlo

12.5 Rezultati OBT i vPvB procjene

:

Tlo/voda koeficijent

raspodjele (K

OC

)

:

Nema podataka za proizvod.

Pokretljivost

:

Nema podataka za proizvod.

Zaključak/Sažetak

:

Nema podataka za proizvod.

Katalog Europskog otpada (EWC)

Opasni otpad

:

Stvaranje otpada treba izbjegavati ili umanjiti gdje god je to moguće. Prazni

kontejneri ili obloge mogu zadržati nešto ostatka proizvoda. Ostaci tvari i spremnici

moraju biti odloženi na siguran način. Značajne količine otpadnog ostatka proizvoda

ne bi trebale biti odložene putem prljave kanalizacije, nego procesirane u

odgovarajućem pogonu za obradu otpadne vode. Ukloniti suvišak i ne-reciklirajuće

proizvode preko ovlaštene osobe za odlaganje otpada. Odlaganje ovog proizvoda,

otopine i bilo kojeg nus proizvoda mora uvijek biti u skladu sa zahtjevima zaštite

okoliša i zakonima o odlaganju otpada i bilo kojim regionalnim zahtjevima lokalne

uprave. Izbjegavati rasipanje prosutog materijala i otjecanje ili kontakt sa tlom,

vodotocima, odvodima i kanalizacijom.

:

Metode odlaganja

ODJELJAK 13: Okolnosti odlaganja

Informacije u ovom odjeljku sadrže opće savjete i smjernice. Lista identificiranih uporaba u Odjeljku 1 treba biti

konzultirana za bilo koju dostupnu uporabno specifičnu informaciju datu u Scenariju(ima) izloženosti.

13.1 Metode prerade otpada

Proizvod

Pakiranje

Kod otpada

Oznaka otpada

Metode odlaganja

:

Specijalne mjere

predostrožnosti

:

20 01 15*

lužine

Stvaranje otpada treba izbjegavati ili umanjiti gdje god je to moguće. Ambalažni

otpad treba biti recikliran.

Ostaci tvari i spremnici moraju biti odloženi na siguran način. Treba paziti pri

rukovanju praznim spremnicima koji nisu bili očišćeni ili isprani. Prazni kontejneri ili

obloge mogu zadržati nešto ostatka proizvoda. Izbjegavati rasipanje prosutog

materijala i otjecanje ili kontakt sa tlom, vodotocima, odvodima i kanalizacijom.

Datum izdanja/Datum revizije

:

10/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

NATRIJEV

HIDROKSID

OTOPINA

SODIUM HYDROXIDE

SOLUTION

Sodium hydroxide

solution

UN1824

NATRIJEV

HIDROKSID

OTOPINA

UN1824

UN1824

UN1824

ODJELJAK 14: Informacije o transportu

ADR/RID

IMDG

IATA

14.1 UN broj

14.2 UN ispravni

otpremni naziv

14.3 Klasa(e)

opasnosti pri

transportu

14.4 Ambalažna

skupina

ADN/ADNR

14.5 Opasnosti za

okoliš

14.6 Specijalna

mjere

predostrožnosti za

korisnika

14.7 Transport u

nezapakiranom stanju

prema Aneks II MARPOL

73/78 i IBC Kodu

:

Nije primjenljiv.

Niti jedan.

Niti jedan.

None.

None.

Nacionalna pravila

Ostala EU pravila

Nije primjenljiv.

Aneks XVII – Restrikcija

na proizvodnju, stavljanje

na tržište i uporabu

određenih opasnih tvari,

smjesa i artikala

:

Hrvatska

ODJELJAK 15: Regulatorne informacije

15.1 Pravila/zakonski propisi o sigurnosti, zdravlju i zaštiti okoliša, specifični za tvar ili smjesu

EU Pravilo (EC) Br 1907/2006 (REACH)

Aneks XIV – Lista tvari podvrgnutih odobrenju

Supstance vrlo visoke zabrinutosti

Ni jedna komponenta nije izlistana.

≥5 - <15% neionski tenzidi, fosfonati

<5% anionski tenzidi

Deklaracija o sastojcima prema regulativi o deterdžentima 648/2004/EC:

Važeći lokalni propisi: Zakon o otpadu, Pravilnik o vrstama otpada , Pravilnik o postupanju s ambalažnim otpadom ,

Uredba za postupanje s opasnim otpadom.

Važeći lokalni propisi: Zakon o kemikalijama, Pravilnik o označavanju i obilježavanju otrova koji se stavljaju u promet,

Pravilnik o mjerilima za razvrstavanje otrova u skupine, Pravilnik o maksimalno dopustivim koncentracijama štetnih

tvari u atmosferi radnih prostorija i prostor MDK i o biološkim graničnim vrijednostima BGV.

Datum izdanja/Datum revizije

:

11/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 15: Regulatorne informacije

15.2 Procjena sigurnosti

kemikalije

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

neophodne.

:

Dodatni propisi: Zakon o prijevozu opasnih tvari (NN 97/93, 34/95 i 151/03)

Provedeno ocjenjivanje kemijske sigurnosti: NE

27 Ožujka 2012

Datum tiskanja

Datum izdanja/ Datum

revizije

:

:

Naznačuje informacije koje su se promijenile od prethodne izdane verzije.

27 Ožujka 2012

ODJELJAK 16: Ostale informacije

Kratice i akronimi

:

ADN/ADNR = European Provisions concerning the International Carriage of

Dangerous Goods by Inland Waterway

ADR = Europski sporazum u vezi s internacionalnim prijevozom opasne robe cestom

ATE- Procijenjene vrijednosti akutne toksičnosti.

BKF = Biokoncentracijski faktor

CLP- Uredba o razvrstavanju, označavanju i pakiranju kemijskih tvari i mješavina

(regulativa (EU) br. 1272/2008

DNEL - Izvedena razina izloženosti bez učinka

DPD = Direktiva o opasnim pripravcima [1999/45/EZ]

EC = Europska Komisija

EUH izjava - CLP Ddopunske oznake upozorenja

IATA = Internacionalno udruženje zračnog transporta

IBC = Kontejner srednjeg obujma

IMDG = Internacionalne pomorski opasne tvari

LogPow = logaritam koeficijenta razdjeljenja između oktanola i vode

MARPOL 73/78 = Internacionalna konvencija za prevenciju zagađivanja od brodova,

1973 modificirano protokolom iz 1978. ("Marpol" = zagađenje mora)

OEL = Profesionalna granica izloženosti

PBT = Postojan, bioakumulativni i toksični

PNEC - Predviđena koncentracija bez učinka

REACH = Registracija, Evaluacija, Autorizacija i Restrikcija Kemijskih Regulativa

[Uredba (EZ) Br. 1907/2006]

RID = Uredba u vezi internacionalnog prijevoza opasnih tvari željezničkim putem

REACH #- Broj REACH registracije

vPvB = Vrlo otporno i vrlo bioakumulativno

Procedura koja se koristi za dobivanje klasifikacije prema Propisu (EC) Br 1272/2008 [CLP/GHS]

Klasifikacija

Obrazloženje

Skin Corr. 1A, H314

Na temelju test podataka

Cijeli tekst skraćenih R fraza

:

R 35 Izaziva teške opekotine

R 41 Opasnost od teških ozljeda očiju

R38- Nadražuje kožu.

R 50 Vrlo otrovno za organizme koji žive u vodi

:

Cijeli tekst klasifikacija

[DSD/DPD]

Cijeli tekst skraćenih H

iskaza

:

Cijeli tekst klasifikacija

[CLP/GHS]

:

H314

Uzrokuje teške opekline kože i ozljede oka.

H315

Nadražuje kožu.

H318

Uzrokuje teške ozljede oka.

H400

Vrlo otrovno za vodeni okoliš.

Aquatic Acute 1, H400

VODENA TOKSIČNOST (AKUTNO) - Kategorija 1

Eye Dam. 1, H318

ozbiljne ozljede očiju/NADRAŽUJE OČI - Kategorija 1

Skin Corr. 1A, H314

nagrizanje kože/nadražaj - Kategorija 1A

Skin Irrit. 2, H315

nagrizanje kože/nadražaj - Kategorija 2

C - Nagrizajuće

Xi - Nadražajuće

N - Opasno za okoliš

Datum izdanja/Datum revizije

:

12/13

27 Ožujka 2012

HZT, klasa

:

Nema.

PREMIX Stabimix 1231

ODJELJAK 16: Ostale informacije

Izdanje

Informacije navedene u ovom dokumentu smatraju se vjerodostojnima s obzirom na formulu korištenu u

proizvodnji sredstva u zemlji porijekla. Kako su promjene podataka, standarda, normi i propisa, kao i uvjeti

korištenja i rukovanja izvan naše kontrole, NE DAJE SE NIKAKVO JAMSTVO, NI IZRIČITO NITI IMPLICITNO, ZA

POTPUNOST ILI TRAJNU VALJANOST TIH INFORMACIJA."

Napomena

Datum prethodnog izdanja

:

:

Nema prethodnih validacija

Datum izdanja/Datum revizije

:

13/13

27 Ožujka 2012

HZT, klasa

:

Nema.

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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

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

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

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

9-10-2018

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Peer review of the pesticide risk assessment for the active substance flumioxazin in light of negligible exposure data submitted

Published on: Mon, 08 Oct 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Czech Republic, for the pesticide active substance flumioxazin are reported. The European Commission requested EFSA to conduct a peer review and provide its conclusions on whether exposure of humans to flumioxazin can be considered negligible, taking into account the European Commission's draft guidance on th...

Europe - EFSA - European Food Safety Authority Publications

6-10-2018

Modification of the existing maximum residue level for epoxiconazole in beetroots

Modification of the existing maximum residue level for epoxiconazole in beetroots

Published on: Fri, 05 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Agriculture & Horticulture Development Board submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue level (MRL) for the active substance epoxiconazole in beetroots. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for beetroots. Adequate analytical methods for enforcement are...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 2018 00:00:00 +0200 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 Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

EQ3 recalls Arie Chair

EQ3 recalls Arie Chair

The weld of the metal mounting plate can fail, resulting in the chair's stem breaking off and the chair falling, which presents a fall hazard to consumers.

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

27-9-2018

Outcome of the consultation on confirmatory data used in risk assessment for the active substance  copper (I), copper (II) variants

Outcome of the consultation on confirmatory data used in risk assessment for the active substance copper (I), copper (II) variants

Published on: Wed, 26 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following the first approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Me...

Europe - EFSA - European Food Safety Authority Publications

24-9-2018

FDA Announces Availability of Resources for Animal Drug Sponsors

FDA Announces Availability of Resources for Animal Drug Sponsors

The FDA is making available two pre-recorded webinars and a slide presentation to help drug sponsors understand recent changes to the submission process for new animal drug applications and related submissions. The changes take effect 10/1/2018.

FDA - U.S. Food and Drug Administration

21-9-2018

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Outcome of the consultation with Member States, the applicant and EFSA on the pesticide risk assessment for sulfoxaflor in light of confirmatory data

Published on: Thu, 20 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the risk assessment for an active substance in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009. In this context EFSA's scientific views on the specific points raised during the commenting phase conducted with Member State...

Europe - EFSA - European Food Safety Authority Publications

20-9-2018

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

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

Published on: Wed, 19 Sep 2018 00:00:00 +0200 The third Joint Meeting of the ECDC's Food‐ and Waterborne Disease and Zoonoses Network and of the EFSA's Zoonoses Monitoring Data Network was held on 16 and 17 October 2017 in Parma. The meeting was constructed around the principle of ‘One health approach to collaborative response to foodborne disease outbreaks in EU/EEA’ and served as an opportunity for public health authorities and food safety/veterinary authorities to meet and exchange information on the...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 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 Austria for the pesticide active substance sodium hydrogen carbonate 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 use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin 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 b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin 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 additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Use of the convection oven fan during pre-heating or broiling can cause accumulated gas to ignite, posing a burn hazard to consumers when oven door is opened.

Health Canada

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin 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...

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

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 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 milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

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

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

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin 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 cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Anthrax

Anthrax

Anthrax is a zoonosis (i.e. a disease common to humans and animals) that primarily affects herbivores. It is caused by Bacillus anthracis, a bacterium that is unusual in that it persists in soil for decades as spores. ANSES is the National Reference Laboratory for this disease. Here we provide a presentation of the disease and the role played by ANSES.

France - Agence Nationale du Médicament Vétérinaire

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Slovakia and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Presented document is the final report of the project GA/EFSA/DATA/2017/01: “Strategic Partnership with Slovakia on Data Quality (Pilot project)”. The report describes national processes and tools in order to implement internal validation and quality control of collected data according to EFSA requirements. A description of the data transmission processes from the National Databases to the EFSA databases, terminology, data mapping and data transformations fo...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone 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

18-6-2018

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

Ouderen willen het liefst in hun eigen vertrouwde omgeving zelfstandig oud worden en een fijn en zinvol leven leiden. Om dat beter mogelijk te maken presenteert minister De Jonge (VWS) vandaag het programma Langer Thuis. Het Kabinet investeert daar de komende jaren ruim 340 miljoen euro in. Het programma is vandaag door minister De Jonge en minister Ollongren (BZK) naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-6-2018

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Lagere maximumprijzen, scherper inkopen en beter kijken welke geneesmiddelen tegen welke prijs vergoed worden.  Dat zijn drie belangrijke onderwerpen in een nieuw pakket aan maatregelen van minister Bruno Bruins voor Medische Zorg. Doel is de uitgavengroei aan geneesmiddelen te beheersen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

6-6-2018

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

At the 35th French occupational medicine and health congress (CNMST) held in Marseille from 5 to 8 June 2018, ANSES presented for the very first time data on cancers of occupational origin collected by the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) coordinated by the Agency. These data are used to build up a comprehensive picture of the cancers associated with occupational exposure situations, in order toidentify the industry sectors and situations most at risk, with ...

France - Agence Nationale du Médicament Vétérinaire

25-4-2018

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immun...

FDA - U.S. Food and Drug Administration

10-8-2017

Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

Danish Medicines Agency

3-2-2015

New director at the DHMA

New director at the DHMA

On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

Danish Medicines Agency

4-11-2011

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

Danish Medicines Agency

10-9-2018

 Pre-authorisation guidance

Pre-authorisation guidance

Europe - EMA - European Medicines Agency

27-8-2018

Discontinuing pre-market evaluation of Herbal Component Names: Frequently asked questions (FAQs)

Discontinuing pre-market evaluation of Herbal Component Names: Frequently asked questions (FAQs)

Frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs

Therapeutic Goods Administration - Australia

27-8-2018

Submissions received: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

Submissions received: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

Submissions received on the Discontinuing pre-market evaluation of Herbal Component Names (HCNs) consultation have been published

Therapeutic Goods Administration - Australia

23-8-2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

MMDR implementation, SME Assist, GMP reforms, medicinal cannabis and international cooperation

Therapeutic Goods Administration - Australia

14-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

Europe - EMA - European Medicines Agency

12-7-2018

TGA presentations: The new Code - where are we at? 12 &amp; 13 June 2018

TGA presentations: The new Code - where are we at? 12 &amp; 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

6-7-2018

TGA presentation: National Medicines Symposium, 30 May 2018

TGA presentation: National Medicines Symposium, 30 May 2018

This presentation covers the revised requirements for advertisements for medicines containing Schedule 3 substances

Therapeutic Goods Administration - Australia

29-6-2018

TGA presentation: ARCS  webinar, 22 June 2018

TGA presentation: ARCS webinar, 22 June 2018

An overview of the expectations and best practices for structuring and formatting data in module 1.3 for submissions in the eCTD format using the Australian specifications version 3.1

Therapeutic Goods Administration - Australia

14-6-2018

Evaluation Plan Estimators

Evaluation Plan Estimators

Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example...

Therapeutic Goods Administration - Australia

1-6-2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

Presentations for the medical devices health consumer workshop on consumer information for implantable medical devices.

Therapeutic Goods Administration - Australia

24-5-2018

TGA presentation: Update on the therapeutic goods advertising reforms

TGA presentation: Update on the therapeutic goods advertising reforms

Some important changes are being implemented

Therapeutic Goods Administration - Australia

2-5-2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

Update on TGA activities from the Scientific Evaluation Branch

Therapeutic Goods Administration - Australia