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KLERREVEAL RED UV GLOW POWDER

VARNOSTNI LIST

Ime proizvoda

KLERREVEAL RED UV GLOW POWDER

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

Intermediat (polproizvod).

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

114554E

Uporaba proizvoda

:

Barvilo

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

Ni razvrščeno.

:

:

Ostale nevarnosti, ki

nimajo vpliva na

razvrstitev

Pri rokovanju in/ali predelavi te snovi lahko nastaja prah, ki lahko povzroči mehansko

draženje oči, kože, nosu in grla. Oblaki drobnega prahu lahko tvorijo eksplozivne

mešanice z zrakom.

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

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

2.2 Elementi etikete

Standardna obvestila S

(Stavki S)

Ni primerno.

Izdelek skladno z zakonodajo EU ni razvrščen.

Standardna opozorila R

(Stavki R)

:

:

2.3 Druge nevarnosti

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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

[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.

Zmesi

3.2

Usta sprati z vodo. Ne sprožiti bruhanja, razen po navodilih zdravniškega osebja.

Če se pojavijo simptomi, poiskati zdravniško pomoč.

Stik s kožo

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

ima ponesrečenec kontaktne leče in jih odstraniti . Če se pojavi draženje, poiskati

zdravniško pomoč.

Onesnažen predel kože izprati z obilo vode. Odstraniti onesnažena oblačila in

obutev. Če se pojavijo simptomi, poiskati zdravniško pomoč.

4.1 Opis ukrepov za prvo pomoč

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

dihanje. Če se pojavijo simptomi, poiskati zdravniško pomoč.

Opombe za zdravnika

Zdraviti simptomatično. Pri zaužitju ali vdihavanju večjih količin, takoj poklicati

specialista za ravnanje v primeru zastrupitev.

Zaužitje

Vdihavanje

Stik z očmi

:

:

:

:

:

Posebno ravnanje

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

:

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje nosa, grla in oči.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

:

Zaužitje

Stik s kožo

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje oči.

:

Stik z očmi

Znaki/simptomi prekomerne izpostavljenosti

Stik s kožo

Zaužitje

Vdihavanje

Škodljivi simptomi lahko vključujejo naslednje:

draženje dihalnih poti

kašljanje

Ni specifičnih podatkov.

Ni specifičnih podatkov.

:

:

:

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

draženje

pordelost

4.3 Navedba kakršne koli takojšnje medicinske oskrbe in posebnega zdravljenja

Ni specifičnega zdravljenja.

:

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

predhodno ustrezno šolano.

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

posledico osebno tveganje ali osebje ni predhodno ustrezno šolano. Odstraniti

embalažo iz območja gorenja, če je to možno storiti brez tveganja. Uporabite vodno

prho, da ohranite embalažo, ki je izpostavljena ognju, hladno.

Nevarni produkti

izgorevanja

Nevarnosti zaradi snovi ali

mešanice

Ni specifičnih podatkov.

Oblaki drobnega prahu lahko tvorijo eksplozivne mešanice z zrakom.

Gasilci morajo nositi ustrezno zaščitno opremo.

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

:

6.2 Okoljevarstveni ukrepi

Preprečiti iztekanje v kanalizacijo, vodotoke, kleti ali zaprte prostore. Posesati ali

pomesti material in ga preložiti v primerno označeno embalažo za odpadke.

Uporabljati orodje, ki ne povzroča isker in opremo, ki ne povzroča gorenja.

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

:

Odmakniti embalažo z mesta razlitja. Posesati ali pomesti material in ga preložiti v

primerno označeno embalažo za odpadke. Uporabljati orodje, ki ne povzroča isker

in opremo, ki ne povzroča gorenja.

Majhno razlitje

:

6.3 Metode in materiali za zadrževanje in čiščenje

ODDELEK 6: Ukrepi ob nenamernih izpustih

6.1 Osebni varnostni ukrepi, zaščitna oprema in postopki v sili

Za osebje. ki ni nujno

:

Za reševalce

:

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.

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

predhodno ustrezno šolano. Evakuirati okolico. Preprečiti dostop odvečnim in

nezaščitenim osebam. Ne dotikajte se ali ne hodite po razlitem oz. razsutem

proizvodu. Izključiti vse vire vžiga. V območju nevarnosti je prepovedano svetiti z

odprtim ognjem, zažigati in kaditi. Preprečiti vdihovanje prahu. 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 Oddelek 8 za dodatne podatke

glede higienskih ukrepov.

:

:

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Skladiščiti med sledečima temperaturama: 0 do 25°C (32 do 77°F). Skladiščiti

skladno z lokalno zakonodajo. Hraniti na ločenem in odobrenem mestu. 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. Odstraniti vse vire vžiga. Hraniti ločeno od oksidativnih snovi. 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 vdihovanje

prahu. Pri rokovanju preprečiti nastajanje prahu in kakršnokoli izpostavljenost virom

vžiga (iskra ali ogenj). Preprečiti kopičenje prahu. Uporabljati le ob primernem

prezračevanju. Če je prezračevanje nezadostno, nositi ustrezno opremo za dihanje.

Električna oprema in osvetlitev naj bosta zaščiteni glede na ustrezen standard, da se

prepreči stik prahu z vročimi površinami, iskrenjem ali drugimi viri vžiga. Preprečiti

elektrostatično razelektritev. Da se izognemo požaru ali eksploziji med transportom,

pred prenosom izničimo statično elektriko z ozemljitvijo in povezavo sodov ter

opreme.

V prostorih, kjer se s proizvodom rokuje, se ga shranjuje ali predeluje, je

prepovedano jesti, piti in kaditi. Pred jedjo, pitjem ali kajenjem si je potrebno umiti

roke in obraz. Pred vstopom v prostore, kjer se uživa hrana, odstraniti

kontaminirana oblačila in zaščitno opremo. Glej Oddelek 8 za dodatne podatke

glede higienskih ukrepov.

:

Razred skladiščenja

:

Rešitve, specifične za

industrijsko panogo

:

Ni primerno.

Ni primerno.

8.2 Nadzor izpostavljenosti

DNEL vrednosti ni na razpolago.

Predvidena koncentracija brez učinka (PNEC)

PNEC vrednosti ni na razpolago

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

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.

8.1 Parametri nadzora

Izpeljana raven učinka (DNEL)

Ime ali trgovsko ime izdelka/snovi

Mejne vrednosti izpostavljenosti

Mejne vrednosti izpostavitve pri delu

Mejna vrednost za izpostavljenost ni znana.

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ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

Varovanje rok

(EN 374)

V običajnih in predvidenih pogojih uporabe respirator ni potreben.

Ni posebnih priporočil.

Če delovni pogoji povzročajo visoke koncentracije prahu, je potrebno uporabljati

zaščitna očala proti prahu.

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

:

Uporabljati le ob primernem prezračevanju. 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. Tehnične kontrolne merilne naprave morajo ohranjati koncentracije

plina, par ali prahu pod katerokoli spodnjo mejo eksplozivnosti. Uporabite

eksplozijsko varno ventilacijsko opremo.

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.

Higienski ukrepi

:

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.

ODDELEK 9: Fizikalne in kemijske lastnosti

Fizikalno stanje

Tališče/ledišče

Začetno vrelišče in območje vrelišča

Parni tlak

Trdna snov. [Prašek.]

Brez vonja.

Vonj

pH

Bela.

Barva

Hitrost izparevanja

Plamenišče

> 100°C

Ni razpoložljivo.

Prag vonja

:

:

:

:

:

:

:

:

:

:

9.1 Podatki o osnovnih fizikalnih in kemijskih lastnostih

Izgled

Čas gorenja

Stopnja gorenja

:

:

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.

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.

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ODDELEK 9: Fizikalne in kemijske lastnosti

Relativna gostota

Parna gostota

Topnost(i)

Netopno v naslednjih snoveh: hladni vodi.

Temperatura samovžiga

Razmerje oktanol/voda

Eksplozivne lastnosti

:

:

:

:

:

:

Brez.

Oksidativne lastnosti

:

9.2 Drugi podatki

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.

Ni primerno in/ali ni določeno za zmesi.

Viskoznost

:

10.6 Nevarni produkti

razgradnje

10.4 Pogoji, ki se jim je treba

izogniti

Pri rokovanju preprečiti nastajanje prahu in kakršnokoli izpostavljenost virom vžiga

(iskra ali ogenj). Preprečiti elektrostatično razelektritev. Da se izognemo požaru ali

eksploziji med transportom, pred prenosom izničimo statično elektriko z ozemljitvijo

in povezavo sodov ter opreme. Preprečiti kopičenje prahu.

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

razkrojnih produktov.

Proizvod je stabilen.

10.2 Kemijska stabilnost

:

:

:

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.

10.5 Nezdružljivi materiali

:

Ni specifičnih podatkov.

Akutna strupenost

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

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.

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ODDELEK 11: Toksikološki podatki

Potencialno kronični vplivi na zdravje

Potencialno akutni vplivi na zdravje

Vdihavanje

:

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje nosa, grla in oči.

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

:

Zaužitje

Stik s kožo

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Izpostavljenost koncentracijam v zraku, ki so nad zakonskimi ali priporočenimi

mejnimi vrednostmi, ima lahko za posledico draženje oči.

:

Stik z očmi

Ponavljajoče ali dolgotrajno vdihovanje prahu lahko privede kroničnega draženja

dihal.

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

Škodljivi simptomi lahko vključujejo naslednje:

draženje dihalnih poti

kašljanje

Ni specifičnih podatkov.

Ni specifičnih podatkov.

:

:

:

Stik z očmi

:

Škodljivi simptomi lahko vključujejo naslednje:

draženje

pordelost

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

Kratkotrajna izpostavljenost

Dolgotrajna izpostavljenost

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Informacija o verjetnih

načinih izpostavljenosti

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

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

12.2 Obstojnost in razgradljivost

Zaključek/Povzetek

:

Ekološka ocena proizvoda temelji na podatkih o sestavinah in/ali podobnih snoveh.

Vsota organskih komponent, ki jih proizvod vsebuje, doseže v testu lahke

razgradljivosti vrednosti >60% BPK/KPK ali sproščanje CO2 oz. > 70% DOC

znižanje v testih razgradljivosti. Dosežene so mejne vrednosti za razvrščanje lahke

razgradljivosti /readily degradable (npr. OECD 301).

Zaključek/Povzetek

:

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

Datum izdaje/Datum

revidirane izdaje

:

7/10

13 Januar 2012

KLERREVEAL RED UV GLOW POWDER

ODDELEK 12: Ekološki podatki

12.3 Zmožnost kopičenja v organizmih

12.6 Drugi škodljivi učinki

Ni znanih značilnih učinkov ali kritičnih nevarnosti.

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.

Zaključek/Povzetek

:

Ni določeno za zmesi.

Evropski katalog odpadkov (EWC)

Glede na trenutno znanje dobavitelja, ta izdelek ni nevaren odpadek v skladu z

določili v EU direktivi 91/689/EC.

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 30

čistila, ki niso zajeta v 20 01 29

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. 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.

ODDELEK 14: Podatki o prevozu

Datum izdaje/Datum

revidirane izdaje

:

8/10

13 Januar 2012

KLERREVEAL RED UV GLOW POWDER

ODDELEK 14: Podatki o prevozu

Not regulated.

Ni predmet predpisov.

Ni predmet predpisov.

Not regulated.

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 za

proizvodnjo, dajanje v

promet in uporabo

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.

Slovenija

Razred skladiščenja

:

Datum izdaje/Datum

revidirane izdaje

:

9/10

13 Januar 2012

KLERREVEAL RED UV GLOW POWDER

1/13/2012.

Datum tiskanja

Datum izdaje/ Datum

revidirane izdaje

Verzija

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.

Obvestilo bralcu

Datum prejšnje izdaje

:

:

:

:

Celotno besedilo okrajšanih

stavkov R

:

Ni primerno.

Ni primerno.

:

Celotno besedilo razvrstitev

[DSD/DPD]

Prikazuje informacijo, ki se je spremenila od prejšnje izdaje.

1/13/2012.

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

Celotno besedilo razvrstitev

[CLP/GHS]

:

Ni primerno.

Ni primerno.

Datum izdaje/Datum

revidirane izdaje

:

10/10

13 Januar 2012

20-11-2018

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Modification of the existing maximum residue levels and setting of import tolerances for pyraclostrobin in various crops

Published on: Mon, 19 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted two requests to the competent national authority in Germany. The first one, to modify the existing maximum residue levels (MRL) for the active substance pyraclostrobin in various crops and to set import tolerances for sugar canes and American persimmons; the second one to set import tolerances for pineapples and passion fruits/maracujas. The data submitted in support of the request...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Safety and efficacy of Monimax® (monensin sodium and nicarbazin) for chickens for fattening and chickens reared for laying

Published on: Wed, 14 Nov 2018 The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for chickens for fattening and chickens reared for laying at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. This conclusion is extended to chickens reared for laying. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC)...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices

Sirob Imports, Inc. Issues Recall Due to Elevated Lead in Spices

Sirob Imports, Inc of Lindenhurst, NY is recalling, Corrado, Orlando Imports, Nouri’s Syrian Bakery, Mediterranean Specialty Foods Brand and Butera Fruit Market Curry Powder because it contains elevated levels of lead.

FDA - U.S. Food and Drug Administration

18-10-2018

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 201 Revision 2 (FGE.201Rev2): 2‐alkylated, aliphatic, acyclic alpha,beta‐unsaturated aldehydes and precursors, with or without additional double‐bonds, from chemical subgroup 1.1.2 of FGE.19

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to consider in this revision 2 of Flavouring Group Evaluation 201, the additional data on genotoxicity submitted by the Industry on two substances, 2‐methylpent‐2‐enal [FL‐no: 05.090] and 2 methylcrotonaldehyde [FL‐no: 05.095], from subgroup 1.1.2 of FGE.19. In FGE.201Rev1, the Panel concluded that further data were required in order to clarify the genotoxic poten...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Assessment of low pathogenic avian influenza virus transmission via raw poultry meat and raw table eggs

Published on: Mon, 15 Oct 2018 00:00:00 +0200 A rapid qualitative assessment has been done by performing a theoretical analysis on the transmission of low pathogenic avian influenza (LPAI) via fresh meat from poultry reared or kept in captivity for the production of meat (raw poultry meat) or raw table eggs. A predetermined transmission pathway followed a number of steps from a commercial or non‐commercial poultry establishment within the EU exposed to LPAI virus (LPAIV) to the onward virus transmission...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

Tanning booths: ANSES issues a reminder of the proven risk of skin cancer

The health risks associated with exposure to artificial UV radiation from tanning booths have been well established for many years now. ANSES points out that recent data on the subject support previous assessments: there is a proven cancer risk associated with UV radiation from artificial tanning equipment. The Agency therefore recommends that the public authorities take the necessary steps to prevent people from being exposed to artificial UV radiation from tanning booths used for cosmetic purposes.

France - Agence Nationale du Médicament Vétérinaire

1-10-2018

Vabilo na Festival za trtje življenjsko obdobje, Cankarjev dom, Ljubljana, od 1. do 3. oktobra 2018

Vabilo na Festival za trtje življenjsko obdobje, Cankarjev dom, Ljubljana, od 1. do 3. oktobra 2018

Od 1. do 3. oktobra poteka Festival za tretje življenjsko obdobje, edinstvena prireditev za starejše...

Ministrstvo za zdravje

25-9-2018

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks from Anna Abram as prepared for delivery to the 2018 Intergovermental Meeting on Drug Compounding

Remarks by FDA’s Anna Abram to the 2018 Intergovermental Meeting on Drug Compounding

FDA - U.S. Food and Drug Administration

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

Natural Disaster Preparedness and Response (Drugs)

The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures.

FDA - U.S. Food and Drug Administration

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

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Outcome of the public consultation on a draft protocol for the Scientific Opinion on dietary sugars

Published on: Fri, 10 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on a draft protocol for the Scientific Opinion on free sugars from all dietary sources, prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel), supported by the ad‐hoc Working Group on Sugars. The draft protocol was endorsed by the Panel for public consultation at its plenary meeti...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Update of the tolerable upper intake level for vitamin D for infants

Update of the tolerable upper intake level for vitamin D for infants

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the draft Scientific Opinion on the update of the tolerable upper intake level for vitamin D for infants. This draft Scientific Opinion was prepared by the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) and endorsed by the Panel for public consultation by written procedure on 9 April 20...

Europe - EFSA - European Food Safety Authority Publications

16-8-2018

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life Recalls Kratom Because Of Possible Health Risk

Zakah Life, LLC of Ankeny, Iowa, is recalling the following Kratom products (Super Green Maeng Da Premium Kratom powder, Powerful Red Vein Bali Premium Kratom powder, Super Green Maeng Da Premium Kratom capsules, and Powerful Red Vein Bali Premium Kratom capsules) with expiration dates prior to 01/01/2023 because they have the potential of being contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weak...

FDA - U.S. Food and Drug Administration

14-8-2018

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

Neo-Image Candlelight Ltd recalls Thermoglow Stem Wick Chafing fuel & Thermoglow Methanol Gel Chafing Fuel

The recalled products do not have proper hazard labelling as required by the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act. Improper labelling could result in unintentional exposure to these products and lead to serious illness, injury or death.

Health Canada

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

10-8-2018

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement: Unitary Products Group of York International Corp. recalls Coleman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

7-8-2018

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

Recall Re-Announcement:Unitary Products Group of York International Corp. recallsColeman, Coleman Evcon and Red T brand furnaces

The furnaces can overheat causing the heat exchanger to crack, burn-through and in extreme cases cause furnace wrapper burn-through. This can lead to heating and possible burning of the drywall and other combustibles adjacent to the furnace, which poses a risk of significant property damage, personal injury or death.

Health Canada

25-7-2018

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

AMPI Recalls Limited Amount of Dry Whey Powder Because of Possible Health Risk

Associated Milk Producers Inc. (AMPI) of New Ulm, Minn., is recalling dry whey powder packaged in 50-pound and 25-kg bags that were produced at the cooperative’s Blair, Wis., dry whey plant from May 1-5, 2018; May 24-29, 2018; June 2-5, 2018; and June 7-14, 2018 due to the potential to be contaminated with Salmonella. This is a precautionary recall. All products shipped to the marketplace tested negative for Salmonella.

FDA - U.S. Food and Drug Administration

24-7-2018

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm® Announces Voluntary Recall of Four Varieties of Goldfish® Crackers

Pepperidge Farm has been notified by one of its ingredient suppliers that whey powder in a seasoning that is applied to four varieties of crackers has been the subject of a recall by the whey powder manufacturer due to the potential presence of Salmonella. Pepperidge Farm initiated an investigation and, out of an abundance of caution, is voluntarily recalling four varieties of Goldfish crackers. The products were distributed throughout the United States. No illnesses have been reported. ...

FDA - U.S. Food and Drug Administration

23-7-2018

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

Flowers Foods Issues Voluntary Recall on Mrs. Freshley’s and Other Brands of Swiss Rolls and Captain John Derst’s Old Fashioned Bread

As a precautionary measure, Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling Swiss Rolls sold under the brand names Mrs. Freshley’s, Food Lion, H-E-B, Baker’s Treat, Market Square, and Great Value, distributed nationwide, and Captain John Derst’s Old Fashioned Bread distributed in Alabama, Florida, Georgia, North Carolina, and South Carolina, due to the potential presence of Salmonella in an ingredient, whey powder. The ingredient recall was initiated by a third-party whey powder manufacturer and...

FDA - U.S. Food and Drug Administration

23-7-2018

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC Conducts Voluntary Recall of Certain Ritz Cracker Sandwiches and Ritz Bits Product in the U.S., including Puerto Rico & U.S. Virgin Islands Due to Possible Health Risk

Mondelēz Global LLC announced today a voluntary recall in the United States, including Puerto Rico & the U.S. Virgin Islands, of certain Ritz Cracker Sandwiches and Ritz Bits product. These products contain whey powder as an ingredient, which the whey powder supplier has recalled due to the potential presence of Salmonella.

FDA - U.S. Food and Drug Administration

18-7-2018

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan

FDA releases Biosimilars Action Plan to address competition and affordability for biologics and biosimilar products.

FDA - U.S. Food and Drug Administration

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

11-7-2018

Ministrica za zdravje na srečanju ministrov za zdravje držav članic Zdravstvene mreže JV Evrope in partnerskih držav ter partnerskih organizacij Zdravstvene mreže JV Evrope

Ministrica za zdravje na srečanju ministrov za zdravje držav članic Zdravstvene mreže JV Evrope in partnerskih držav ter partnerskih organizacij Zdravstvene mreže JV Evrope

Ministrica za zdravje se je kot vabljena predstavnica partnerske države Zdravstvene mreže...

Ministrstvo za zdravje

2-7-2018

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies Issues Voluntary Nationwide Recall of Certain Kratom Powder Capsule

Blissful Remedies., is voluntarily recalling only Lot No.: 112710 with expiration 03/2019 found embedded on the top of package of kratom ( mitragyn a speciosa) powder products, it manufactured, processed, packed, and/or held, between “March 1, 2018” to “April 30, 2018” to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing to have salmonella contamination. Blissful Remedies has not received reports of adverse events related to this recall. ...

FDA - U.S. Food and Drug Administration

27-6-2018

ITW Canada recalls Red Head Trubolt wedge anchors

ITW Canada recalls Red Head Trubolt wedge anchors

The affected product does not meet the requirements for use in cracked concrete andseismic applications, which may lead to incidents or injuries to consumers.

Health Canada

22-6-2018

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination

The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines

FDA - U.S. Food and Drug Administration

21-6-2018

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., Voluntarily Recalls Kratom Products Due to Potential Salmonella Contamination

Gaia Ethnobotanical, LLC., is voluntarily recalling all kratom (mitragyna speciosa) powder products, with Lot No.: 0102031800 it manufactured, processed, packed, and/or held, between March 18, 2018 to March 30, 2018 to the consumer level. The products have been found by the U.S. Food and Drug Administration (“FDA”) via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordanc...

FDA - U.S. Food and Drug Administration

15-6-2018

Na ministrstvu za zdravje potekal sestanek z vodstvom UKC Ljubljana in Nacionalnega inštituta za otroške srčne bolezni

Na ministrstvu za zdravje potekal sestanek z vodstvom UKC Ljubljana in Nacionalnega inštituta za otroške srčne bolezni

Na ministrstvu za zdravje je danes potekal sestanek predstavnikov ministrstva za zdravje, vodstva...

Ministrstvo za zdravje

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

6-6-2018

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram, remarks prepared for testimony before a subcommittee of the U.S. House Committee on Energy and Commerce on the Pandemic and All-Hazards Preparedness Act

FDA’s Anna Abram’s testimony for U.S. House Committee on Energy and Commerce Subcommittee on Health on the Pandemic and All-Hazards Preparedness Act

FDA - U.S. Food and Drug Administration

30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

Statement from FDA Commissioner Scott Gottlieb, M.D., on federal preparedness and FDA’s response efforts to the Ebola virus outbreak in the Democratic Republic of Congo

FDA committed to helping the people of the Democratic Republic of Congo effectively confront and end the current Ebola virus outbreak

FDA - U.S. Food and Drug Administration

8-5-2018

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter

Ampicillin and Sulbactam for Injection USP, 3 g/Single-Dose Vials by AuroMedics Pharma: Recall - Exposure to particulate may result in local site reaction, thromboembolic events and systemic immune response.

FDA - U.S. Food and Drug Administration

4-5-2018

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals Recalls Red Suma, Green Suma, Green Hulu 2, And Red Hulu 2 Kratom Supplements Because Of Possible Salmonella Health Risk

Badger Botanicals, LLC of Springville, Utah is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2 kratom dietary supplements sold directly to consumers via the company website from January 1st, 2018 to April l 12th, 2018 in pouches of 250g, because it has the potential to be contaminated with Salmonella.

FDA - U.S. Food and Drug Administration

4-5-2018

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC Recalls Dragon Label Kratom Because Of Possible Salmonella Contamination

Maya Distribution, LLC of South Salt Lake City, Utah is voluntarily recalling Dragon Kratom labeled bottles and sealed packages of encapsulated and raw powder product because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 

FDA - U.S. Food and Drug Administration

1-5-2018

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Do You Vape? See These Tips on How to Keep E-Liquids Away from Children

Accidentally touching or drinking e-liquids can be dangerous and even deadly for young children. So it’s important to handle and store these products carefully, to teach children to stay away from these products, and to be prepared for emergencies. Consider these tips.

FDA - U.S. Food and Drug Administration

25-4-2018

Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder

Labrada Nutrition Issues Allergy Alert on Undeclared Egg in "Leanpro8" Protein Powder

Labrada Nutrition of Houston, TX, is recalling specific lots of its "LeanPro8" Protein Powder because they may contain undeclared egg protein. People who have allergies to egg protein run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

24-4-2018

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget

Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA’s Fiscal Year 2019 budget

FDA Commissioner Scott Gottlieb, M.D. remarks to a U.S. Senate Subcommittee on Appropriations on the FDA’s Fiscal Year 2019 budget

FDA - U.S. Food and Drug Administration

19-4-2018

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination

Viable Solutions of Nampa, ID has initiated a recall of certain Kratom-containing powder products, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result...

FDA - U.S. Food and Drug Administration

9-4-2018

Na ministrstvu za zdravje predstavili nov način razpisovanja specializacij

Na ministrstvu za zdravje predstavili nov način razpisovanja specializacij

Spoštovani mladi zdravniki in predstavniki izvajalcev zdravstvene dejavnosti v mreži javne...

Ministrstvo za zdravje

6-4-2018

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

"Organic Traditions Shatavari Powder" sold at Choices Markets Yaletown in Vancouver, B.C., contaminated with Salmonella

Health Canada is advising Canadians that one lot of “Organic Traditions Shatavari Powder” is being voluntarily recalled by Advantage Health Matters Inc. Company testing found Salmonella bacteria contamination, which may pose serious health risks. According to Advantage Health Matters Inc., 13 units from the affected lot were distributed. Of the 13 units, only 2 packages, sold at Choices Markets Yaletown (1202 Richards Street) in Vancouver, B.C., have not been recovered.

Health Canada

28-3-2018

Public Notification: Red Zone Xtreme 3000 contains hidden drug ingredient

Public Notification: Red Zone Xtreme 3000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Red Zone Xtreme 3000, a product promoted and sold for sexual enhancement on various websites, including www.ebay.com, and possibly in some retail stores.

FDA - U.S. Food and Drug Administration

8-1-2018

Ministrica za zdravje na slovesni prireditvi Ona ali On - Dejanje leta 2017, Gospodarstvenik leta 2017 in Podjetnik leta 2017

Ministrica za zdravje na slovesni prireditvi Ona ali On - Dejanje leta 2017, Gospodarstvenik leta 2017 in Podjetnik leta 2017

Ministrica za zdravje Milojka Kolar Celarc se je v soboto udeležila tradicionalne slovesne...

Ministrstvo za zdravje

6-1-2018

Ministrica za zdravje na prireditvi Dejanje leta 2017

Ministrica za zdravje na prireditvi Dejanje leta 2017

Ministrica za zdravje Milojka Kolar Celarc se bo v soboto, 6. 1. 2018, ob 19. uri,...

Ministrstvo za zdravje

15-12-2017

Skupno javno naročilo za zdravila predvidoma uspešno zaključeno v januarju 2018

Skupno javno naročilo za zdravila predvidoma uspešno zaključeno v januarju 2018

Ministrstvo za zdravje v sodelovanju z Ministrstvom za javno upravo uspešno izvaja postopek skupnega...

Ministrstvo za zdravje

26-6-2015

Guide to individual case safety reporting

Guide to individual case safety reporting

We have prepared a guide to companies on the electronic reporting of adverse drug reactions (ADR) to the Danish Health and Medicines Authority.

Danish Medicines Agency

29-7-2014

Good laboratory practice in non-clinical trials

Good laboratory practice in non-clinical trials

Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.

Danish Medicines Agency

7-7-2014

Monitoring of medicines for births

Monitoring of medicines for births

The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.

Danish Medicines Agency

8-4-2014

Medicinal use of cannabis

Medicinal use of cannabis

The Danish Health and Medicines Authority has prepared a memo about the Danish experiences with and rules applicable to medicinal use of cannabis.

Danish Medicines Agency

27-5-2008

Danish Medicines Agency warns against the weight-loss product Therma Power

Danish Medicines Agency warns against the weight-loss product Therma Power

The Danish Medicines Agency strongly warns against Therma Power Red and similar products with the same content and characteristics. Therma Power Red contains ephedrine and is illegal in Denmark.

Danish Medicines Agency

14-11-2018

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe:  http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonthpic.twitter.com/DpNpz8NCDe

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonthpic.twitter.com/DpNpz8NCDe

Caring for a loved one? Be prepared for any situation. 4 tips to help you keep you loved one safe: http://www.fda.gov/caregivertips  #NationalFamilyCaregiversMonth pic.twitter.com/DpNpz8NCDe

FDA - U.S. Food and Drug Administration

30-10-2018

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

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

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

Europe -DG Health and Food Safety

19-10-2018

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray.  http://go.usa.gov/35cbh  #NationalMammographyDay

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray. http://go.usa.gov/35cbh  #NationalMammographyDay

#DYK: you shouldn’t wear deodorant, lotion or powder on the day of your mammogram. It may show up on the x-ray. http://go.usa.gov/35cbh  #NationalMammographyDay

FDA - U.S. Food and Drug Administration

21-9-2018

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity

#DYK #hurricane season is active through November. Be prepared & stay informed of #MedicalDevice safety. Click the link to find a useful planning booklet from the #FDA that can help u prepare & handle power outages for medical devices that use electricity: https://go.usa.gov/xPbYt 

FDA - U.S. Food and Drug Administration

17-9-2018

Scientific guideline:  Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

Scientific guideline: Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1, draft: consultation open

The Guideline on the investigation of medicinal products in the term and preterm neonates was prepared during the period from 2007 to 2009 and came into effect in 2010 (EMEA/536810/2008). Considerable experience of assessing PIP applications covering neonatal age subset has been gained since then and it has become apparent that some essential questions arise repeatedly during the assessment of Paediatric Investigation Plans (PIP) applications for products intended to be investigated and used in neonates....

Europe - EMA - European Medicines Agency

5-7-2018

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays.  https://go.usa.gov/xU4Ht pic.twitter.com/lGayQuxMQw

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays. https://go.usa.gov/xU4Ht pic.twitter.com/lGayQuxMQw

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays. https://go.usa.gov/xU4Ht  pic.twitter.com/lGayQuxMQw

FDA - U.S. Food and Drug Administration

25-5-2018

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices  https://go.usa.gov/xQyEz pic.twitter.com/z6OFXyYitD

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices https://go.usa.gov/xQyEz pic.twitter.com/z6OFXyYitD

Today is #DontFryFriday. Stay informed about skin safety. Check out the FDA’s information on UV radiation and tanning devices https://go.usa.gov/xQyEz  pic.twitter.com/z6OFXyYitD

FDA - U.S. Food and Drug Administration

22-5-2018

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancerpic.twitter.com/mNsFqKTfFk

Pls RT: 10 Ways to Keep Athletes Safe While in the Sun: AVOID THE SUN BETWEEN 10 AM-4 PM when UV rays are strongest! Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  #skincancer pic.twitter.com/mNsFqKTfFk

FDA - U.S. Food and Drug Administration

16-5-2018

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Active substance: Tobramycin (inhalation powder)) - Transfer of orphan designation - Commission Decision (2018)3031 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/072/02/T/02

Europe -DG Health and Food Safety