PRE. STABIMIX WR

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Glavnih Značilnosti Zdravila

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VARNOSTNI LIST

Ime proizvoda

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V skladu z Uredbo (ES) št. 1907/2006 (REACH), Priloga II (453/2010) - Evropa

:

1.1 Identifikator izdelka

1.3 Podrobnosti o dobavitelju varnostnega lista

1.2 Pomembne identificirane uporabe snovi ali zmesi in odsvetovane uporabe

Navedene uporabe

ODDELEK 1: Identifikacija snovi/zmesi in družbe/podjetja

Šifra proizvoda

:

Odsvetujejo se načini uporabe

1.4 Telefonska številka za nujne primere

Nacionalno posvetovalno telo/Center za zastrupitve

Procesno čiščenje; Cleaning In place (CIP) postopek

Ni znano.

Ecolab d.o.o.

Vajngerlova 4

SI-2000 Maribor

Slovenija

Tel.: +386 (0)2 42 93 100

Št. faksa: +386 (0)2 42 93 152

office.maribor@ecolab.com

:

Proizvajalec/ Distributer/

Uvoznik

113894E

Uporaba proizvoda

:

Sredstvo za nego tal.

Proizvod je samo za profesionalno uporabo.

Proizvajalec/ Distributer/ Uvoznik

:

Številka telefona

Navodilo v primeru zdravstvene ogroženosti: nemudoma se posvetovati z osebnim

ali dežurnim zdravnikom, le v primeru življenjske ogroženosti poklicati 112.

:

Številka telefona

Tel.: +386 (0)2 42 93 100 (Uradne ure ob delavnikih: 8:00 – 15:00)

Verzija

: 1

Razvrstitev

C; R35Razvrstitev temelji izključno na pH vrednosti proizvoda (skladno z veljavno

evropsko zakonodajo).

:

:

Nevarnosti za človeka

Povzroča hude opekline.

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

Razvrstitev skladno z Uredbo (ES) 1272/2008 [CLP/GHS]

ODDELEK 2: Ugotovitev nevarnosti

2.1 Razvrstitev snovi ali zmesi

Opredelitev izdelka

:

Zmes

Glej Oddelek 16 za celotno besedilo zgoraj navedenih stavkov R ali H.

Razvrstitev v skladu z Direktivo 1999/45/ES [DSD]

Proizvod je razvrščen kot nevaren v skladu z Direktivo 1999/45/ES in njenimi dopolnitvami.

2.2 Elementi etikete

Piktogrami za nevarnosti

:

Skin Corr. 1A, H314

Razvrstitev temelji izključno na pH vrednosti proizvoda (skladno z veljavno evropsko zakonodajo).

Datum izdaje/Datum

revidirane izdaje

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ODDELEK 2: Ugotovitev nevarnosti

:

Ostale nevarnosti, ki

nimajo vpliva na

razvrstitev

Opozorilna beseda

:

Stavki o nevarnosti

:

Preprečevanje

:

Previdnostni stavki

Odziv

:

Nevarno

P280 - Nositi zaščitne rokavice in zaščito za oči/obraz.

P303 + P361 + P353 - PRI STIKU S KOŽO (ali lasmi): Takoj sleči vso onesnaženo

obleko. Kožo sprati z vodo ali prho.

P305 + P351 + P338 - PRI STIKU Z OČMI: Previdno izpirati z vodo nekaj minut.

Odstranite kontaktne leče, če jih imate in če to lahko storite brez težav. Nadaljujte z

izpiranjem.

P310 - Takoj pokličite CENTER ZA ZASTRUPITVE ali zdravnika.

2.3 Druge nevarnosti

Vsebuje

:

Ni primerno.

Etoksilati alkohola

Alkilpoliglikozidi

Kisline

ATMP: nitrilotrimetilentris(fosfonska kislina) ali njena sol

HEDP: (1-hidroksietiliden)bifosfonska kislina ali njena sol

H314

Povzroča hude opekline kože in poškodbe oči.

Proizvod ne vsebuje dodatnih sestavin, ki bi bile, glede na trenutno znane podatke, ki so na voljo dobavitelju in v

primernih koncentracijah, razvrščene kot zdravju ali okolju nevarne in ki bi jih bilo potrebno navajati v tem oddelku.

ODDELEK 3: Sestava/podatki o sestavinah

Identifikatorji

67/548/EGS

Ime ali trgovsko ime

izdelka/snovi

Glej Oddelek 16 za

celotno besedilo

zgoraj navedenih R

stavkov

%

Tip

Uredba (ES) št.

1272/2008 [CLP]

Razvrstitev

Glej Oddelek 16 za

celotno besedilo

zgoraj navedenih

stavkov o nevarnosti

H.

Etoksilati alkohola

CAS: 111905-53-4

10-20

Xi; R36/38

Skin Irrit. 2, H315

Eye Irrit. 2, H319

Alkilpoliglikozidi

REACH #: 01-

2119488530-36

EC: 500-220-1

CAS: 68515-73-1

5-10

Xi; R41

Skin Irrit. 2, H315

Eye Dam. 1, H318

Kisline

REACH #: 01-

2119436643-39

EC: 253-733-5

CAS: 37971-36-1

5-10

Ni razvrščeno.

Met. Corr. 1, H290

Eye Irrit. 2, H319

ATMP:

nitrilotrimetilentris(fosfonska

kislina) ali njena sol

REACH #: 01-

2119487988-08

EC: 229-146-5

CAS: 6419-19-8

Xi; R36

Eye Irrit. 2, H319

HEDP: (1-

hidroksietiliden)bifosfonska

kislina ali njena sol

REACH #: 01-

2119510391-53

EC: 220-552-8

CAS: 2809-21-4

Xi; R41

Eye Dam. 1, H318

Zmesi

3.2

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ODDELEK 3: Sestava/podatki o sestavinah

Mejne vrednosti izpostavitve pri delu, če so na voljo, so navedene v oddelku 8.

[1] Snov razvrščena kot nevarna za zdravje ali okolje

[2] Snov za katero obstajajo mejne vrednosti za poklicno izpostavljenost

[3] Snov izpolnjuje merila za PBT skladno z Uredbo (ES) št. 1907/2006, priloga XIII.

[4] Snov izpolnjuje merila za vPvB skladno z Uredbo (ES) št. 1907/2006, priloga XIII.

Usta sprati z vodo. Če ima ponesrečenec zobno protezo, jo je potrebno odstraniti.

Če je snov bila zaužita in je ponerečenec pri zavesti, dajati manjše količine vode za

pitje. Prenehati, če se ponesrečeni počuti slabo, ker je bruhanje nevarno. Ne

sprožiti bruhanja, razen po navodilih zdravniškega osebja. Ob bruhanju držite glavo

v nizkem položaju, da izbljuvek ne vstopi v pljuča. Opekline zaradi kemikalij mora

nemudoma oskrbeti zdravnik. Nikoli ničesar dajati v usta nezavestni osebi.

Nezavestnega spraviti v bočni položaj in nemudoma poklicati zdravniško pomoč.

Vzdrževati proste dihalne poti. Zrahljati oblačila npr. ovratnik, kravato ali pas.

Prenesti ponesrečenca na svež zrak in ga pustiti počivati v položaju, ki olajša

dihanje. Takoj poiskati zdravniško pomoč. Pokličite center za zastrupitve ali

zdravnika.

Stik s kožo

Oči takoj izpirati z obilo vode, občasno dvigniti zgornjo in spodnjo veko. Preveriti, ali

ima ponesrečenec kontaktne leče in jih odstraniti . Spirati vsaj 15 minut. Opekline

zaradi kemikalij mora nemudoma oskrbeti zdravnik. Takoj poiskati zdravniško

pomoč. Pokličite center za zastrupitve ali zdravnika.

Umiti onesnaženo kožo z milom in vodo. Odstraniti onesnažena oblačila in obutev.

Spirati vsaj 15 minut. Opekline zaradi kemikalij mora nemudoma oskrbeti zdravnik.

Oprati onesnažena oblačila pred ponovno uporabo. Temeljito očistiti čevlje pred

ponovno uporabo. Takoj poiskati zdravniško pomoč. Pokličite center za zastrupitve

ali zdravnika.

4.1 Opis ukrepov za prvo pomoč

Prenesti ponesrečenca na svež zrak in ga pustiti počivati v položaju, ki olajša

dihanje. Če ponesrečenec ne diha, če diha neredno, ali če je prišlo do ustavitve

dihanja, naj mu usposobljena oseba daje umetno dihanje ali kisik. Nezavestnega

spraviti v bočni položaj in nemudoma poklicati zdravniško pomoč. Vzdrževati proste

dihalne poti. Zrahljati oblačila npr. ovratnik, kravato ali pas. Pri vdihavanju

produktov razkroja v požaru so lahko simptomi zakasnjeni. Takoj poiskati

zdravniško pomoč. Pokličite center za zastrupitve ali zdravnika.

Zaužitje

Vdihavanje

Stik z očmi

:

:

:

:

Zaščita osebja za prvo

pomoč

:

ODDELEK 4: Ukrepi za prvo pomoč

4.2 Najpomembnejši simptomi in učinki, akutni in zapozneli

Potencialno akutni vplivi na zdravje

Vdihavanje

:

Lahko sprošča pline, hlape ali prah, ki so zelo dražilni ali jedki za dihalni sistem.

Izpostavljenost produktom razkroja lahko ogrozi zdravje. Resne posledice, ki sledijo

izpostavitvi, so lahko pojavijo z zakasnitvijo.

Lahko povzroči opekline ust, žrela in želodca.

:

Zaužitje

Stik s kožo

:

Povzroča hude opekline.

Povzroča hude poškodbe oči.

:

Stik z očmi

Znaki/simptomi prekomerne izpostavljenosti

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

bolečina

solzenje

pordelost

Do ukrepanja ne bo prišlo, če ima za posledico osebno tveganje ali osebje ni

predhodno ustrezno šolano. Preden se jih odstrani, onesnažena oblačila temeljito

sprati z vodo ali nositi zaščitne rokavice.

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ODDELEK 4: Ukrepi za prvo pomoč

Opombe za zdravnika

Pri vdihavanju produktov razkroja v požaru so lahko simptomi zakasnjeni.

:

Posebno ravnanje

Stik s kožo

Zaužitje

Vdihavanje

Škodljivi simptomi lahko vključujejo naslednje:

draženje dihalnih poti

kašljanje

Škodljivi simptomi lahko vključujejo naslednje:

bolečine v želodcu

Škodljivi simptomi lahko vključujejo naslednje:

bolečina ali draženje

pordelost

lahko se pojavijo mehurji

:

:

:

4.3 Navedba kakršne koli takojšnje medicinske oskrbe in posebnega zdravljenja

Ni specifičnega zdravljenja.

:

V primeru požara, evakuirati območje. Do ukrepanja ne bo prišlo, če ima za

posledico osebno tveganje ali osebje ni predhodno ustrezno šolano.

Nevarni produkti

izgorevanja

Nevarnosti zaradi snovi ali

mešanice

Razkrojni produkti lahko vsebujejo naslednje snovi:

ogljikov dioksid

ogljikov monoksid

dušikovi oksidi

fosforjevi oksidi

kovinski oksid/oksidi

Pri požaru ali segrevanju, se tlak poveča in posoda lahko poči.

Gasilci morajo nositi primerno zaščitno opremo in samostojni dihalni aparat (SCBA)

z masko, ki pokriva celoten obraz in ima pozitiven tlak.

Navedba posebne

varovalne opreme za

gasilce

V primeru požara uporabiti razpršeno vodo (meglica), peno, suha gasilna sredstva

ali CO2.

5.1 Sredstva za gašenje

:

:

:

Ni znano.

Ustrezna sredstva za

gašenje

:

Neprimerna sredstva za

gašenje

:

ODDELEK 5: Protipožarni ukrepi

5.2 Posebne nevarnosti v zvezi s snovjo ali zmesjo

5.3 Nasvet za gasilce

Posebni previdnostni

ukrepi za gasilce

:

ODDELEK 6: Ukrepi ob nenamernih izpustih

6.1 Osebni varnostni ukrepi, zaščitna oprema in postopki v sili

Za osebje. ki ni nujno

:

Za reševalce

:

Do ukrepanja ne bo prišlo, če ima za posledico osebno tveganje ali osebje ni

predhodno ustrezno šolano. Preprečiti dostop odvečnim in nezaščitenim osebam.

Poskusite se izogniti stiku ali hoji preko razlitega materiala. Preprečiti vdihavanje

hlapov ali meglic. Zagotoviti zadostno prezračevanje. Če je prezračevanje

nezadostno, nositi ustrezno opremo za dihanje. Nositi ustrezno osebno zaščitno

opremo.

Če so pri rokovanju z razlitjem zahtevana specialna oblačila, upoštevati podatke o

primernih in neprimernih materialih v Oddelku 8. Glej tudi informacije pod "Za

neizučeno osebje".

Datum izdaje/Datum

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ODDELEK 6: Ukrepi ob nenamernih izpustih

6.2 Okoljevarstveni ukrepi

Zaustaviti razlitje, če to ne predstavlja tveganja. Odmakniti embalažo z mesta

razlitja. Bližnji izpust v obratni smeri vetra. Preprečiti iztekanje v kanalizacijo,

vodotoke, kleti ali zaprte prostore. Sperite razlitja v obrat za obdelavo odpadnih vod

ali ravnajte kot sledi. Zadržati in zbrati razlit material z nevnetljivimi absorpcijskimi

materiali, npr. peskom, prstjo, vermikulitom, diatomejsko zemljo, in namestiti v

embalažo za odstranjevanje v skladu s predpisi. Razlito snov se lahko nevtralizira z

natrijevim karbonatom, natrijevim hidrogenkarbonatom ali natrijevim hidroksidom.

Onesnažen absorpcijski material predstavlja enako nevarnost kot razliti proizvod.

Preprečiti, da bi se razlit oz. razsut tovor razširil; preprečiti stik s tlemi, vodotoki,

cestno kanalizacijo in odplakami. Če je prišlo do onesnaženja okolja (kanalizacije,

vodotokov, tal ali zraka), obvestiti pristojne službe.

Obsežno razlitje

:

Zaustaviti razlitje, če to ne predstavlja tveganja. Odmakniti embalažo z mesta

razlitja. Če je topno v vodi, razredčiti z vodo in pobrisati. Po drugi strani, oziroma če

ni topno v vodi, vsrkati z inertno suho snovjo in namestiti v ustrezno embalažo za

odstranjevanje odpadkov.

Majhno razlitje

:

6.3 Metode in materiali za zadrževanje in čiščenje

6.4 Sklicevanje na druge

oddelke

Glej Oddelek 1 za podatke o kontaktu za nujne primere.

Glej Oddelek 8 za podatke o ustrezni zaščitni opremi.

Glej Oddelek 13 za podatke o dodatni obdelavi odpadkov.

:

:

Skladiščiti med sledečima temperaturama: 0 do 40°C (32 do 104°F). Skladiščiti

skladno z lokalno zakonodajo. Skladiščiti v originalni embalaži, zaščiteno pred

direktno sončno svetlobo v suhem, hladnem in dobro prezračevanem prostoru,

ločeno od nezdružljivih snovi (glej Oddelek 10) ter hrane in pijače. Hraniti ločeno od

lugov. Do uporabe hraniti posodo tesno zaprto in zatesnjeno. Odprto embalažo

previdno zatesniti in držati v pokončnem položaju, da se prepreči iztekanje. Ne

hraniti v neoznačeni embalaži. S primernim ravnanjem preprečiti onesnaževanje

okolja.

ODDELEK 7: Ravnanje in skladiščenje

Informacije v tem oddelku vsebujejo splošne nasvete in napotke. Glede specifične uporabe je za podatke, ki so na voljo

v scenariju(ih) izpostavljenosti, potrebno upoštevati seznam identificiranih uporab v Oddelku 1.

7.1 Varnostni ukrepi za varno ravnanje

Zaščitni ukrepi

:

Nasvet glede splošne

poklicne higiene

:

7.2 Pogoji za varno

skladiščenje, vključno z

nezdružljivostjo

7.3 Posebne končne uporabe

Nositi ustrezno osebno zaščitno opremo. (Glej Oddelek 8) Preprečiti stik z očmi,

kožo ali oblačili. Preprečiti vdihavanje hlapov ali meglic. Ne zaužiti. Če snov pri

običajni uporabi predstavlja nevarnost za dihanje, se jo sme uporabljati le v primerno

prezračevanem prostoru ali ob uporabi ustreznega dihalnega aparata. Hraniti v

originalni embalaži ali odobrenem nadomestilu iz ustreznega materiala; kadar se ne

uporablja, mora biti tesno zaprto. Ne izpostavljati lugom.

Pred jedjo, pitjem ali kajenjem si je potrebno umiti roke in obraz. Glej Oddelek 8 za

dodatne podatke glede higienskih ukrepov.

:

Razred skladiščenja

:

Rešitve, specifične za

industrijsko panogo

:

Ni primerno dokler ni na razpolago scenarijev izpostavljenosti za surovine.

Ni primerno dokler ni na razpolago scenarijev izpostavljenosti za surovine.

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Varovanje rok

(EN 374)

Če se na osnovi ocene tveganja ugotovi, je potrebno uporabljati ustrezno nameščen

respirator s prečiščevanjem zraka ali respirator z dovodom zraka, ki je skladen z

odobrenim standardom. Izbira respiratorja naj temelji na znanih in pričakovanih

nivojih izpostavitve, nevarnosti proizvoda in delovnih omejitvah respiratorja.

Zelo priporočljivo : Rokavice - butilna guma , nitrilna guma ( čas prodiranja: 1 - 4 ure

) . 1-4 ur (prebojni čas): butilna guma , nitrilna guma

Zelo priporočljivo : Varovalna očala, ščitnik za obraz ali ostala zaščita za ves obraz.

Zaščita oči / obraza

(EN 166)

Zaščita dihal

(EN 143, 14387)

:

:

:

Varovanje kože

Osebno zaščitno opremo za telo je potrebno izbrati na podlagi vrste dela, ki se

izvaja, in tveganj, ki so prisotna. To opremo mora pred ravnanjem s tem proizvodom

odobriti strokovnjak.

:

Nadzor izpostavljenosti

okolja

:

Emisije iz prezračevanja ali delovne procesne opreme je potrebno preveriti, da se

zagotovi skladnost z zahtevami zakonodaje o varovanju okolja. V nekaterih

primerih bodo za znižanje emisij na sprejemljivo raven potrebne naprave za čiščenje

hlapov, filtri ali inženirske modifikacije na procesni opremi.

Ustrezen tehnično-

tehnološki nadzor

:

Če pri delu s proizvodom nastaja prah, dim, plin, hlapi ali meglica, je potrebno

delovni proces fizično omejiti, zagotoviti lokalno prezračevanje ali kako drugače

zagotoviti, da so izpostavitve delavcev nečistočam v zraku pod katerimikoli

priporočenimi ali predpisanimi mejnimi vrednostmi.

Po ravnanju s kemikalijami ter pred jedjo, kajenjem, uporabo stranišča in ob koncu

delovnega cikla, si temeljito umiti roke, podlakti in obraz. Primerno tehniko je

potrebno uporabiti za odstranitev potencialno onesnaženih oblačil. Oprati

onesnažena oblačila pred ponovno uporabo. Zagotoviti primerno bližino priprave za

izpiranje oči in prhe za nujne primere.

8.2 Nadzor izpostavljenosti

Higienski ukrepi

:

Za zmesi ni na razpolago DNEL vrednosti.

Predvidena koncentracija brez učinka (PNEC)

Za zmesi ni na razpolago PNEC vrednosti.

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

8.1 Parametri nadzora

Izpeljana raven učinka (DNEL)

Osebni zaščitni ukrepi

Zaščita telesa

(EN 14605)

:

Druga zaščita za kožo

Termične nevarnosti

:

Pred postopkom se mora na podlagi dela, ki se ga opravlja in z njim povezanih

tveganj, izbrati primerno obutev in morebitne dodatne ukrepe za zaščito kože, ki jih

odobri strokovnjak.

Ni primerno.

Ime ali trgovsko ime izdelka/snovi

Mejne vrednosti izpostavljenosti

Mejne vrednosti izpostavitve pri delu

Mejna vrednost za izpostavljenost ni znana.

ODDELEK 9: Fizikalne in kemijske lastnosti

Fizikalno stanje

Tekočina.

Brez vonja.

Vonj

Rjava.

Barva

Prag vonja

:

:

:

:

9.1 Podatki o osnovnih fizikalnih in kemijskih lastnostih

Izgled

Ni primerno in/ali ni določeno za zmesi.

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ODDELEK 9: Fizikalne in kemijske lastnosti

Tališče/ledišče

Začetno vrelišče in območje vrelišča

Parni tlak

Relativna gostota

Parna gostota

Topnost(i)

1.09 do 1.13

Lahko topno v naslednjih snoveh: hladni vodi in vroči vodi.

pH

Hitrost izparevanja

Temperatura samovžiga

Plamenišče

> 100°C

Proizvod ne pospešuje gorenja.

0.5 do 1.5 [Konc. (%w/w): 100%]

Razmerje oktanol/voda

Eksplozivne lastnosti

:

:

:

:

:

:

:

:

:

:

:

:

Brez.

Oksidativne lastnosti

:

9.2 Drugi podatki

Čas gorenja

Stopnja gorenja

:

:

Temperatura razkroja

:

Ni dodatnih podatkov.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno in/ali ni določeno za zmesi.

Ni primerno.

Ni primerno in/ali ni določeno za zmesi.

Viskoznost

:

Zgornje/spodnje meje vnetljivosti ali eksplozivnosti

:

Ni primerno in/ali ni določeno za zmesi.

Vnetljivost (trdno, plinasto)

:

Ni primerno in/ali ni določeno za zmesi.

10.6 Nevarni produkti

razgradnje

10.4 Pogoji, ki se jim je treba

izogniti

Ni specifičnih podatkov.

Pri normalnih pogojih skladiščenja in uporabe ne bi smelo prihajati do nevarnih

razkrojnih produktov.

Proizvod je stabilen.

10.2 Kemijska stabilnost

:

:

:

10.5 Nezdružljivi materiali

:

10.3 Možnost poteka

nevarnih reakcij

:

Pri normalnih pogojih skladiščenja in uporabe do nevarnih reakcij ne bo prihajalo.

ODDELEK 10: Obstojnost in reaktivnost

10.1 Reaktivnost

:

Konkretnih podatkov o preskusih v zvezi z reaktivnostjo tega izdelka ali njegovih

sestavin ni na razpolago.

Skrajno reaktivno ali nezdružljivo z naslednjimi snovmi: alkalijami.

Datum izdaje/Datum

revidirane izdaje

:

7/13

31 Oktober 2012

PREMIX P3-stabimix WR

Potencialno akutni vplivi na zdravje

Vdihavanje

:

Lahko sprošča pline, hlape ali prah, ki so zelo dražilni ali jedki za dihalni sistem.

Izpostavljenost produktom razkroja lahko ogrozi zdravje. Resne posledice, ki sledijo

izpostavitvi, so lahko pojavijo z zakasnitvijo.

Lahko povzroči opekline ust, žrela in želodca.

:

Zaužitje

Akutna strupenost

Etoksilati alkohola

LD50 Dermalno

Podgana

>2000 mg/kg

LD50 Oralno

Podgana

>2000 mg/kg

Alkilpoliglikozidi

LD50 Dermalno

Kunec

>2000 mg/kg

LD50 Oralno

Podgana

>5000 mg/kg

Kisline

LC50 Vdihavanje Prah in

meglice

Podgana

>1.979 mg/l

4 ur

LD50 Dermalno

Podgana

>4000 mg/kg

LD50 Oralno

Podgana

>6500 mg/kg

ATMP:

nitrilotrimetilentris(fosfonska

kislina) ali njena sol

LD50 Dermalno

Kunec

>6310 mg/kg

LD50 Oralno

Podgana

2910 mg/kg

HEDP: (1-

hidroksietiliden)bifosfonska

kislina ali njena sol

LD50 Dermalno

Kunec

>10000 mg/kg

LD50 Oralno

Podgana

3130 mg/kg

Ime ali trgovsko ime

izdelka/snovi

Rezultat

Vrste

Odmerek

Izpostavljenost

Rakotvornost

Mutagenost

Teratogenost

Strupenost za reprodukcijo

Dražilnost/Jedkost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Povzroča preobčutljivost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

ODDELEK 11: Toksikološki podatki

11.1 Podatki o toksikoloških učinkih

Ocene akutne strupenosti

Ni določeno za zmesi.

SPECIFIČNA STRUPENOST ZA CILJNE ORGANE (STOT) – ENKRATNA IZPOSTAVLJENOST

Toksičnost za specifični ciljni organ (ponavljajoča se izpostavljenost)

Nevarnost pri vdihu

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Informacija o verjetnih

načinih izpostavljenosti

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Datum izdaje/Datum

revidirane izdaje

:

8/13

31 Oktober 2012

PREMIX P3-stabimix WR

ODDELEK 11: Toksikološki podatki

Potencialno kronični vplivi na zdravje

Stik s kožo

:

Povzroča hude opekline.

Povzroča hude poškodbe oči.

:

Stik z očmi

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Splošno

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Rakotvornost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Mutagenost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Teratogenost

:

Učinek na razvoj

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Učinki na plodnost

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Simptomi, ki izvirajo iz fizikalnih, kemičnih in toksikoloških značilnosti

Stik s kožo

Zaužitje

Vdihavanje

Ni specifičnih podatkov.

Škodljivi simptomi lahko vključujejo naslednje:

bolečine v želodcu

Škodljivi simptomi lahko vključujejo naslednje:

bolečina ali draženje

pordelost

lahko se pojavijo mehurji

:

:

:

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

bolečina

solzenje

pordelost

Zapozneli in takojšnji učinki ter kronični učinki po kratkoročni in dolgoročni izpostavljenosti

Kratkotrajna izpostavljenost

Dolgotrajna izpostavljenost

Možni neposredni učinki

:

Možni zapozneli učinki

:

Možni neposredni učinki

:

Možni zapozneli učinki

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Drugi podatki

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

ODDELEK 12: Ekološki podatki

12.1 Strupenost

Etoksilati alkohola

Akutni LC50 5 mg/l

Ribe

96 ur

Alkilpoliglikozidi

Akutni EC50 18 mg/l

Vodne rastline

72 ur

Kisline

Akutni LC50 >1042 mg/l

Ribe

96 ur

Kronični NOEC 17.8 mg/l

Alge

72 ur

ATMP:

nitrilotrimetilentris(fosfonska

kislina) ali njena sol

Akutni LC50 160 mg/l

Ribe

96 ur

HEDP: (1-

hidroksietiliden)bifosfonska

kislina ali njena sol

Akutni LC50 368 mg/l

Ribe

96 ur

Ime ali trgovsko ime

izdelka/snovi

Vrste

Rezultat

Izpostavljenost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Datum izdaje/Datum

revidirane izdaje

:

9/13

31 Oktober 2012

PREMIX P3-stabimix WR

ODDELEK 12: Ekološki podatki

LogP

ow

BCF

Potencialno

12.3 Zmožnost kopičenja v organizmih

12.6 Drugi škodljivi učinki

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Ime ali trgovsko ime

izdelka/snovi

ATMP:

nitrilotrimetilentris(fosfonska

kislina) ali njena sol

-3.53

nizko

12.2 Obstojnost in razgradljivost

Zaključek/Povzetek

:

V proizvodu vsebovane površinsko aktivne snovi so biorazgradljive v skladu z

Uredbo o detergentih 648/2004/EC.

PBT

:

Ni primerno.

vPvB

:

Ni primerno.

12.4 Mobilnost v tleh

12.5 Rezultati ocene PBT in vPvB

:

Porazdelitveni koeficient

prst/voda (K

OC

)

:

Ni določeno za zmesi.

Mobilnost

:

Ni določeno za zmesi.

Evropski katalog odpadkov (EWC)

Nevarni odpadki

:

Kjerkoli je možno, se je potrebno izogniti nastajanju odpadkov, oziroma jih zmanjšati

na najmanjšo možno raven. Prazne posode ali podloge lahko zadržijo ostanke

proizvoda. Vsebina in embalaža morata biti varno odstranjeni. Znatnih količin

odpadnih ostankov proizvoda se ne sme spuščati v kanalizacijo, ampak jih je

potrebno obdelati v ustreznih čistilnih napravah. Preostanke in proizvode, ki se jih

ne da reciklirati, odstrani pooblaščeno podjetje za odstranjevanje odpadkov.

Odstranjevanje tega proizvoda, raztopin in kakršnih koli stranskih proizvodov mora

vedno potekati v skladu z zahtevami predpisov o zaščiti okolja in odstranjevanju

odpadkov oz. katerih koli drugih predpisov. Preprečiti, da bi se razlit oz. razsut tovor

razširil; preprečiti stik s tlemi, vodotoki, cestno kanalizacijo in odplakami.

:

Metode odstranjevanja

ODDELEK 13: Odstranjevanje

Informacije v tem oddelku vsebujejo splošne nasvete in napotke. Glede specifične uporabe je za podatke, ki so na voljo

v scenariju(ih) izpostavljenosti, potrebno upoštevati seznam identificiranih uporab v Oddelku 1.

13.1 Metode ravnanja z odpadki

Proizvod

Pakiranje

Šifra odpadka

Oznaka odpadka

Metode odstranjevanja

:

Posebni previdnostni

ukrepi

:

20 01 14*

kisline

Kjerkoli je možno, se je potrebno izogniti nastajanju odpadkov, oziroma jih zmanjšati

na najmanjšo možno raven. Odpadno embalažo je potrebno reciklirati.

Vsebina in embalaža morata biti varno odstranjeni. Z izpraznjeno posodo, ki ni bila

očiščena ali splaknjena, je potrebno previdno ravnati. Prazne posode ali podloge

lahko zadržijo ostanke proizvoda. Preprečiti, da bi se razlit oz. razsut tovor razširil;

preprečiti stik s tlemi, vodotoki, cestno kanalizacijo in odplakami.

Datum izdaje/Datum

revidirane izdaje

:

10/13

31 Oktober 2012

PREMIX P3-stabimix WR

Not regulated.

Ni predmet predpisov.

Ni predmet predpisov.

Not regulated.

ODDELEK 14: Podatki o prevozu

ADR/RID

IMDG

IATA

14.1 UN številka

14.2 UN Uradno

ime blaga

14.3 Razredi

nevarnosti

prevoza

14.4 Embalažna

skupina

ADN/ADNR

14.5 Okolju

nevarno

14.6 Posebni

previdnostni

ukrepi za

uporabnika

14.7 Prevoz v razsutem

stanju v skladu s Prilogo II k

MARPOL 73/78 in

Kodeksom IBC

:

Ni primerno.

Brez.

Brez.

None.

None.

Državni predpisi

Drugi predpisi EU

Ni primerno.

Priloga XVII - Omejitve

proizvodnje, dajanja v

promet in uporabe

nekaterih nevarnih snovi,

pripravkov in izdelkov

:

ODDELEK 15: Zakonsko predpisani podatki

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

Uredba ES (ES) št 1907/2006 (REACH)

Priloga XIV - Seznam snovi, ki so predmet avtorizacije

15.2 Ocena kemijske

varnosti

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

Snovi, ki vzbujajo zelo veliko zaskrbljenost

:

Nobene od sestavin ni na seznamu.

≥15 - <30% neionski tenzidi

<5% anionski tenzidi, fosfati

Navedba sestavin v skladu z Uredbo o detergentih 648/2004/EC:

Slovenija

Datum izdaje/Datum

revidirane izdaje

:

11/13

31 Oktober 2012

PREMIX P3-stabimix WR

31 Oktober 2012

Datum tiskanja

Datum izdaje/ Datum

revidirane izdaje

Verzija

Obvestilo bralcu

Datum prejšnje izdaje

:

:

:

:

Celotno besedilo okrajšanih

stavkov R

:

R35- Povzroča hude opekline.

R41- Nevarnost hudih poškodb oči.

R36- Draži oči.

R36/38- Draži oči in kožo.

C - Jedko

Xi - Dražilno

:

Celotno besedilo razvrstitev

[DSD/DPD]

Prikazuje informacijo, ki se je spremenila od prejšnje izdaje.

31 Oktober 2012

Ni prejšnje validacije

ODDELEK 16: Drugi podatki

Celotno besedilo okrajšanih

stavkov H

:

Okrajšave in akronimi

:

ADN/ADNR = Evropski sporazum o mednarodnem prevozu nevarnih snovi po

celinskih vodah/po Renu

ADR = Evropski sporazum o mednarodnem cestnem prevozu nevarnega blaga

ATE = ocena akutne strupenosti

BCF = biokoncentracijski faktor

CLP = Uredba (ES) št. 1272/2008 o razvrščanju, označevanju in pakiranju snovi ter

zmesi

DNEL = Izpeljana raven brez učinka

DPD = Direktiva Sveta EU [1999/45/EC] o razvrščanju, pakiranju in označevanju

nevarnih pripravkov

EC = evropska komisija

EUH = CLP - specifičen stavek nevarnosti

IATA = Mednarodno združenje letalskih prevoznikov

IBC = vsebnik IBC

IMDG = Mednarodni kodeks o prevozu nevarnega blaga po morju

LogPow = logaritem porazdelitvenega koeficienta oktanol/voda

MARPOL 73/78 = Mednarodna konvencija o preprečevanju onesnaževanja morja z

ladij, 1973, in njen Protokol iz leta 1978

OEL = mejna vrednost za poklicno izpostavljenost

PBT = Obstojen, bioakumulativen in strupen

PNEC = predvidena koncentracija brez učinka

REACH = Registracija, Evalvacija, Avtorizacija in omejevanje Kemikalij [Uredba (ES)

št. 1907/2006]

RID = Pravilnik o mednarodnem železniškem prevozu nevarnega blaga

REACH # = Registracijska številka REACH

vPvB = zelo obstojen in zelo bioakumulativen

Postopek, po katerem se je določilo razvrstitev po uredbi (ES) št. 1272/2008 [CLP/GHS]

Razvrstitev

Utemeljitev

Skin Corr. 1A, H314

Na osnovi testnih podatkov

Celotno besedilo razvrstitev

[CLP/GHS]

:

H290

Lahko je jedko za kovine.

H314

Povzroča hude opekline kože in poškodbe oči.

H315

Povzroča draženje kože.

H318

Povzroča hude poškodbe oči.

H319

Povzroča hudo draženje oči.

Eye Dam. 1, H318

HUDA POŠKODBA OČI/DRAŽENJE OČI - Kategorija 1

Eye Irrit. 2, H319

HUDA POŠKODBA OČI/DRAŽENJE OČI - Kategorija 2

Met. Corr. 1, H290

JEDKO ZA KOVINE - Kategorija 1

Skin Corr. 1A, H314

JEDKOST ZA KOŽO/DRAŽENJE KOŽE - Kategorija 1A

Skin Irrit. 2, H315

JEDKOST ZA KOŽO/DRAŽENJE KOŽE - Kategorija 2

Datum izdaje/Datum

revidirane izdaje

:

12/13

31 Oktober 2012

PREMIX P3-stabimix WR

ODDELEK 16: Drugi podatki

Za posredovane podatke verjamemo, da so pravilni glede na formulacijo uporabljeno za proizvodnjo izdelka v

državi porekla. V primeru, da se podatki, standardi ali zakonodaja spremenijo, kakor tudi pogoji uporabe ter

rokovanja, ki so izven našega nadzora, NE DAJEMO NOBENEGA JAMSTVA, IZRAŽENEGA ALI NAZNAČENEGA,

GLEDE CELOVITOSTI ALI NEOKRNJENE TOČNOSTI NAVEDENIH PODAKOV.

Datum izdaje/Datum

revidirane izdaje

:

13/13

31 Oktober 2012

15-11-2018

Assessment of genetically modified maize MZHG0JG for food and feed uses, import and processing under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐DE‐2016‐133)

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Published on: Wed, 14 Nov 2018 The scope of application EFSA‐GMO‐DE‐2016‐133 is for food and feed uses, import and processing of genetically modified (GM) maize MZHG0JG in the European Union. Maize MZHG0JG was developed to confer tolerance to the herbicidal active substances glyphosate and glufosinate‐ammonium. The molecular characterisation data and bioinformatic analyses do not identify issues requiring food/feed safety assessment. None of the identified differences in the agronomic/phenotypic and com...

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

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Minister Bruno Bruins ondertekent actieplan ambulancezorg

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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

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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 ...

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8-11-2018

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

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Europe - EFSA - European Food Safety Authority Publications

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

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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...

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31-10-2018

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

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

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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