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  • 12-03-2018

Glavnih Značilnosti Zdravila

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ODDELEK 1: Identifikacija snovi/zmesi in družbe/podjetja

1.1 Identifikator izdelka

Ime proizvoda

Into action plus

Koda proizvoda

100237E

Uporaba snovi/zmesi

Čistilo za sanitarije

Vrsta snovi

Zmes

Samo za poklicne uporabnike.

Podatki o redčenju izdelka

0.025 % - 0.1 %

1.2 Pomembne identificirane uporabe snovi ali zmesi in odsvetovane uporabe

Identifikacija uporabe

Čistilo za sanitarije. Ročni postopek: razprševanje in brisanje

Čistilo za sanitarije. Ročni postopek

Priporočene omejitve

uporabe

Samo za industrijsko in profesionalno uporabo.

1.3 Podrobnosti o dobavitelju varnostnega lista

Družba

Ecolab d.o.o.

Vajngerlova ulica 4

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

narocila@ecolab.com

1.4 Telefonska številka za nujne primere

Telefonska številka za nujne

primere

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

Telefonska številka Centra

za zastrupitve

Datum sestavitve/Revizije

12.10.2015

Verzija

ODDELEK 2: Ugotovitev nevarnosti

2.1 Razvrstitev snovi ali zmesi

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

Proizvod - ORIGINALNA VSEBINA

Jedkost za kožo, Kategorija 1.A

H314

Proizvod - DELOVNA RAZTOPINA

Ni nevarna snov ali zmes.

Razvrstitev (67/548/EGS, 1999/45/ES)

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Proizvod - ORIGINALNA VSEBINA

C; JEDKO

Razvrstitev proizvoda temelji na toksikološki oceni.

Proizvod - DELOVNA RAZTOPINA

Ni treba, da je proizvod označen v skladu z direktivami ES ali odgovarjajočimi nacionalnimi zakoni.

Popolno besedilo stavkov 'R' omenjenih v tem Poglavju, je v Poglavju 16.

Za celotno besedilo H-izjav, omenjeno v tem poglavju, glej 16. poglavje.

2.2 Elementi etikete

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

Proizvod - ORIGINALNA VSEBINA

Piktogrami za nevarnost

Opozorilna beseda

Nevarno

Opozorila o nevarnosti

H314

Povzroča hude opekline kože in poškodbe oči.

Obvestila o nevarnosti

Preprečevanje:

P280

Nositi zaščitne rokavice/ zaščitno obleko/

zaščito za oči/ zaščito za obraz.

Ukrepanje:

P303 + P361 + P353

PRI STIKU S KOŽO (ali lasmi): Takoj sleči

vsa kontaminirana oblačila. Izprati kožo z

vodo/prho.

P305 + P351 + P338

PRI STIKU Z OČMI: previdno izpirajte 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/zdravnika.

Nevarne komponente, ki morajo biti naštete na nalepki/etiketi:

Amidosulfonska kislina

Proizvod - DELOVNA RAZTOPINA

Ni nevarna snov ali zmes.

2.3 Druge nevarnosti

Proizvod - ORIGINALNA VSEBINA

Ne mešati z belilom ali kakim drugim sredstvom, ki vsebuje klor – lahko pride do sproščanja klora.

ODDELEK 3: Sestava/podatki o sestavinah

3.2 Zmesi

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Proizvod - ORIGINALNA VSEBINA

Nevarne sestavine

Kemijsko ime

Št. CAS

ES-št.

Št. REACH

Razvrstitev

(67/548/EGS)

Razvrstitev

(UREDBA (ES) št.

1272/2008)

Koncentracija:

Amidosulfonska

kislina

5329-14-6

226-218-8

Xi; R36/38-

R52/53

Draženje kože Kategorija 2;

H315

Draženje oči Kategorija 2;

H319

Kronična strupenost za vodno

okolje Kategorija 3; H412

>= 10 - < 20

Fatty alcohol

ethoxylates > 5EO

Xn-Xi; R22-

Akutna strupenost Kategorija

4; H302

Huda poškodba oči Kategorija

1; H318

>= 10 - < 20

Citronska kislina

5949-29-1

201-069-1

01-2119457026-42

Xi; R36

Draženje oči Kategorija 2;

H319

>= 1 - < 2.5

Proizvod - DELOVNA RAZTOPINA

Opombe

Ni nevarnih sestavin

Popolno besedilo stavkov 'R' omenjenih v tem Poglavju, je v Poglavju 16.

Za celotno besedilo H-izjav, omenjeno v tem poglavju, glej 16. poglavje.

ODDELEK 4: Ukrepi za prvo pomoč

4.1 Opis ukrepov za prvo pomoč

Proizvod - ORIGINALNA VSEBINA

Pri stiku z očmi

Takoj začeti izpirati z obilo vode, tudi pod očesnim vekam,

najmanj 15 minut. Odstranite kontaktne leče, če jih imate in če to

lahko storite brez težav. Nadaljujte z izpiranjem. Takoj pokličite

zdravnika.

Pri stiku s kožo

Takoj umivajte/izpirajte z obilo vode vsaj 15 minut. Po možnosti

uporabljati blago milo. Operite kontaminirana oblačila pred

ponovno uporabo. Pred uporabo temeljito očistiti obutev. Takoj

pokličite zdravnika.

Pri zaužitju

Izprati usta z vodo. NE izzivati bruhanja. Nikoli ne dajajte

nezavestni osebi nicesar peroralno (v usta). Takoj pokličite

zdravnika.

Pri vdihavanju

Potrebna je odstranitev na svež zrak. Simptomatsko zdravljenje.

Če se pojavijo simptomi, poiskati zdravniško pomoč.

Proizvod - DELOVNA RAZTOPINA

Pri stiku z očmi

Izprati z obilo vode.

Pri stiku s kožo

Izprati z obilo vode.

Pri zaužitju

Splaknite usta. Če se pojavijo simptomi, poiskati zdravniško

pomoč.

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Pri vdihavanju

Če se pojavijo simptomi, poiskati zdravniško pomoč.

4.2 Najpomembnejši simptomi in učinki, akutni in zapozneli

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

4.3 Navedba kakršnekoli takojšnje medicinske oskrbe in posebnega zdravljenja

Oskrba

Simptomatsko zdravljenje.

ODDELEK 5: Protipožarni ukrepi

Proizvod - ORIGINALNA VSEBINA

5.1 Sredstva za gašenje

Ustrezna sredstva za

gašenje:

Uporabljajte gasilne ukrepe, ki so primerni lokalnim okoliščinam in

bližnjemu okolju.

Neustrezna sredstva za

gašenje

Nobena znana.

5.2 Posebne nevarnosti v zvezi s snovjo ali zmesjo

Specifične nevarnosti med

gašenjem

Ni vnetljivo ali gorljivo.

Nevarni proizvodi izgorevanja

Razkrojni produkti lahko vsebujejo naslednje snovi:

Ogljikova oksida

Dušikovi oksidi (NOx)

Žveplovi oksidi

Fosforovi oksidi

5.3 Nasvet za gasilce

Posebne varovalne opreme

za gasilce

: Uporabljajte osebno varovalno opremo.

Dodatne informacije

: Ostanke po požaru in kontaminirano vodo za gašenje požara je

treba varno odstraniti v skladu z lokalnimi uredbami. Pri požaru

in/ali eksploziji ne vdihavajte dima.

ODDELEK 6: Ukrepi ob nenamernih izpustih

6.1 Osebni varnostni ukrepi, zaščitna oprema in postopki v sili

Proizvod - ORIGINALNA VSEBINA

Nasvet za neizučeno osebje

Zagotovite zadostno prezračevanje. Preprečite ljudem dostop do

izpusta/razliva in v protivetrni smeri od izpusta/razliva. Izogibati se

vdihavanju, zaužitju ter stiku s kožo in očmi. Če so delavci

izpostavljeni koncentracijam nad dovoljenimi mejnimi vrednostmi,

morajo uporabljati ustrezno obrazno masko. Zagotovite, da

cišcenje izvaja samo usposobljeno osebje. Informirajte se o

varnostnih ukrepih, naštetih v poglavjih 7 in 8.

Nasvet za reševalce

Če so pri rokovanju z razlitjem zahtevana specialna oblačila,

upoštevati podatke o primernih in neprimernih materialih v

Oddelku 8.

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Proizvod - DELOVNA RAZTOPINA

Nasvet za neizučeno osebje

Informirajte se o varnostnih ukrepih, naštetih v poglavjih 7 in 8.

Nasvet za reševalce

Če so pri rokovanju z razlitjem zahtevana specialna oblačila,

upoštevati podatke o primernih in neprimernih materialih v

Oddelku 8.

6.2 Okoljevarstveni ukrepi

Proizvod - ORIGINALNA VSEBINA

Okoljevarstveni ukrepi

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

Proizvod - DELOVNA RAZTOPINA

Okoljevarstveni ukrepi

Niso potrebni posebni okoljevarstveni ukrepi.

6.3 Metode in materiali za zadrževanje in čiščenje

Proizvod - ORIGINALNA VSEBINA

Metode čiščenja

Zaustaviti puščanje, če je varno.Zajezite in zadržite izlitje z

negorljivim absorpcijskim materialom (npr. peskom, zemljo,

diatomejsko zemljo, vermikulitom) in dajte v vsebnik za

odstranjevanje v skladu z lokalnimi/nacionalnimi predpisi (glejte

poglavje 13).Splakniti sledi z vodo.Pri večjih razlitjih zajeziti ali

drugače zadržati razlito snov in s tem zagotoviti, da ne doseže

vodotokov.

Proizvod - DELOVNA RAZTOPINA

Metode čiščenja

Zaustaviti puščanje, če je varno.Zajezite in zadržite izlitje z

negorljivim absorpcijskim materialom (npr. peskom, zemljo,

diatomejsko zemljo, vermikulitom) in dajte v vsebnik za

odstranjevanje v skladu z lokalnimi/nacionalnimi predpisi (glejte

poglavje 13).Splakniti sledi z vodo.Pri večjih razlitjih zajeziti ali

drugače zadržati razlito snov in s tem zagotoviti, da ne doseže

vodotokov.

6.4 Sklicevanje na druge oddelke

Glej Oddelek 1 za podatke o kontaktu za nujne primere.

Za osebno zaščito glejte poglavje 8.

Glej Oddelek 13 za podatke o dodatni obdelavi odpadkov.

ODDELEK 7: Ravnanje in skladiščenje

7.1 Varnostni ukrepi za varno ravnanje

Proizvod - ORIGINALNA VSEBINA

Navodilo za varno rokovanje

Ne zaužiti. Preprečiti stik z očmi, kožo ali oblačili. Ne vdihavati

prahu/ dima/ plina/ meglice/ hlapov/ razpršila. Uporabljati samo ob

ustreznem prezračevanju. Po uporabi temeljito umiti roke. Ne

mešati z belilom ali kakim drugim sredstvom, ki vsebuje klor –

lahko pride do sproščanja klora.

Higienski ukrepi

Ravnajte v skladu z dobro industrijsko higiensko in varnostno

prakso. Odstranite in operite kontaminirana oblačila pred ponovno

uporabo. Po uporabi temeljito umiti obraz, roke in izpostavljeno

kožo. V primeru nevarnosti, kjer bi lahko prišlo do stika ali

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brizganja, zagotoviti ustrezne prostore in pripomočke za hitro

polivanje ali izpiranje oči in telesa.

Proizvod - DELOVNA RAZTOPINA

Navodilo za varno rokovanje

Umiti roke po rokovanju. Za osebno zaščito glejte poglavje 8.

Higienski ukrepi

Roke si umivajte pred odmori in takoj po rokovanju s proizvodom.

7.2 Pogoji za varno skladiščenje, vključno z nezdružljivostjo

Proizvod - ORIGINALNA VSEBINA

Zahteve glede skladiščnih

prostorov in vsebnikov

Hraniti ločeno od močnih baz. Hraniti zunaj dosega otrok. Hraniti v

tesno zaprti posodi. Hraniti v posodah z ustreznimi nalepkami.

Temperatura pri skladiščenju

-5 °C do 40 °C

Proizvod - DELOVNA RAZTOPINA

Zahteve glede skladiščnih

prostorov in vsebnikov

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

posodah z ustreznimi nalepkami.

7.3 Posebne končne uporabe

Proizvod - ORIGINALNA VSEBINA

Posebni način(-i) uporabe

Čistilo za sanitarije. Ročni postopek: razprševanje in brisanje

Čistilo za sanitarije. Ročni postopek

ODDELEK 8: Nadzor izpostavljenosti/osebna zaščita

8.1 Parametri nadzora

Proizvod - ORIGINALNA VSEBINA

Ne vsebuje sestavin z mejnimi vrednostmi za poklicno izpostavljenost.

8.2 Nadzor izpostavljenosti

Proizvod - ORIGINALNA VSEBINA

Ustrezni inženirski mehanizmi

Tehnični ukrepi

Učinkovit izpušni prezračevalni sistem. Ohranjati vrednosti

koncentracij v zraku znotraj standardov za poklicno

izpostavljenost.

Individualni zaščitni ukrepi

Higienski ukrepi

Ravnajte v skladu z dobro industrijsko higiensko in varnostno

prakso. Odstranite in operite kontaminirana oblačila pred ponovno

uporabo. Po uporabi temeljito umiti obraz, roke in izpostavljeno

kožo. V primeru nevarnosti, kjer bi lahko prišlo do stika ali

brizganja, zagotoviti ustrezne prostore in pripomočke za hitro

polivanje ali izpiranje oči in telesa.

Zaščita za oči / obraz (EN

166)

Varovalna očala

Obrazni ščitnik

Zaščita rok (EN 374)

Priporočena preventivna zaščita kože

Rokavice

Nitrilni kavčuk

butilni kavčuk

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Prebojni čas: 1 - 4 ure

Posvetujte se s proizvajalcem OZO glede ustrezne debeline

rokavic (odvisno od vrste rokavic in glede na njihovo predvideno

uporabo).

Če se pojavijo kakršni koli znaki razkroja rokavic ali prodora

kemikalij skozi rokavice, je treba le-te odstraniti in jih zamenjati z

novimi.

Zaščita kože in telesa (EN

14605)

Osebna zaščitna oprema, vsebujoč: prilegajoče se zaščitne

rokavice, zaščitna očala in zaščitno obleko

Zaščita dihal (EN 143,

14387)

Ni potrebna posebna varovalna oprema.

Proizvod - DELOVNA RAZTOPINA

Ustrezni inženirski mehanizmi

Tehnični ukrepi

Dobro splošno prezračevanje naj bi zadoščalo za uravnavanje

izpostavitve delavcev nečistočam v zraku.

Individualni zaščitni ukrepi

Higienski ukrepi

Roke si umivajte pred odmori in takoj po rokovanju s proizvodom.

Zaščita za oči / obraz (EN

166)

Ni potrebna posebna varovalna oprema.

Zaščita rok (EN 374)

Ni potrebna posebna varovalna oprema.

Zaščita kože in telesa (EN

14605)

Ni potrebna posebna varovalna oprema.

Zaščita dihal (EN 143,

14387)

Ni potrebna posebna varovalna oprema.

Nadzor izpostavljenosti okolja

Splošna navodila

: Upoštevati dolocilo o ograjevanju okoli posod za shranjevanje.

ODDELEK 9: Fizikalne in kemijske lastnosti

9.1 Podatki o osnovnih fizikalnih in kemijskih lastnostih

Proizvod - ORIGINALNA

VSEBINA

Proizvod - DELOVNA

RAZTOPINA

Videz

: tekočina

tekočina

Barva

: rožnata

Brezbarven

Vonj

: Parfumi, dišave

zelo nežen

0.9 - 1.1, 100 %

6.2 - 6.9

Plamenišče

Se ne upošteva., Ne pospešuje gorenja.

Mejne vrednosti vonja

Ni primerno in/ali ni določeno za zmesi

Tališče/ledišče

Ni primerno in/ali ni določeno za zmesi

Začetno vrelišče in območje

Ni primerno in/ali ni določeno za zmesi

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vrelišča

Hitrost izparevanja

Ni primerno in/ali ni določeno za zmesi

Vnetljivost (trdno, plinasto)

Ni primerno in/ali ni določeno za zmesi

Zgornja meja eksplozivnosti

Ni primerno in/ali ni določeno za zmesi

Spodnja meja eksplozivnosti

Ni primerno in/ali ni določeno za zmesi

Parni tlak

Ni primerno in/ali ni določeno za zmesi

Relativna gostota par/hlapov

Ni primerno in/ali ni določeno za zmesi

Relativna gostota

1.0 - 1.3

Topnost v vodi

topnost v maščobah

Topnost v drugih topilih

Ni primerno in/ali ni določeno za zmesi

Porazdelitveni koeficient: n-

oktanol/voda

Ni primerno in/ali ni določeno za zmesi

Temperatura samovžiga

Ni primerno in/ali ni določeno za zmesi

Toplotni razpad/razgradnja

Ni primerno in/ali ni določeno za zmesi

Viskoznost, kinematična

Ni primerno in/ali ni določeno za zmesi

Eksplozivne lastnosti

Ni primerno in/ali ni določeno za zmesi

Oksidativne lastnosti

Snov ali zmes ni označena kot oksidativna.

9.2 Drugi podatki

Ni primerno in/ali ni določeno za zmesi

ODDELEK 10: Obstojnost in reaktivnost

Proizvod - ORIGINALNA VSEBINA

10.1 Reaktivnost

Nevarne reakcije pri normalni uporabi niso znane.

10.2 Kemijska stabilnost

Stabilno pri normalnih pogojih.

10.3 Možnost poteka nevarnih reakcij

Ne mešati z belilom ali kakim drugim sredstvom, ki vsebuje klor – lahko pride do sproščanja klora.

10.4 Pogoji, ki se jim je treba izogniti

Nobena znana.

10.5 Nezdružljivi materiali

Baze

10.6 Nevarni produkti razgradnje

Razkrojni produkti lahko vsebujejo naslednje snovi:

Ogljikova oksida

Dušikovi oksidi (NOx)

Žveplovi oksidi

Fosforovi oksidi

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ODDELEK 11: Toksikološki podatki

11.1 Podatki o toksikoloških učinkih

Proizvod - ORIGINALNA VSEBINA

Podatki o možnih načinih

izpostavljenosti

Vdihavanje, Stik z očmi, Stik s kožo

Strupenost

Akutna oralna toksičnost

: Ocena akutne strupenosti : > 2,000 mg/kg

Akutna toksičnost pri

vdihavanju

: Za ta proizvod ni na voljo podatkov.

Akutna dermalna strupenost

: Za ta proizvod ni na voljo podatkov.

Jedkost za kožo/draženje

kože

: Za ta proizvod ni na voljo podatkov.

Resne okvare oči/draženje

: Za ta proizvod ni na voljo podatkov.

Preobčutljivost pri vdihavanju

in preobčutljivost kože

: Za ta proizvod ni na voljo podatkov.

Rakotvornost

: Za ta proizvod ni na voljo podatkov.

Učinki na razplojevanje

: Za ta proizvod ni na voljo podatkov.

Mutagenost za zarodne

celice

: Za ta proizvod ni na voljo podatkov.

Teratogenost

: Za ta proizvod ni na voljo podatkov.

STOT - enkratna

izpostavljenost

: Za ta proizvod ni na voljo podatkov.

STOT - ponavljajoča se

izpostavljenost

: Za ta proizvod ni na voljo podatkov.

Toksičnost pri vdihavanju

: Za ta proizvod ni na voljo podatkov.

Sestavine

Akutna oralna toksičnost

: Amidosulfonska kislina

LD50 Podgana: 3,160 mg/kg

Citronska kislina

LD50 Podgana: 11,700 mg/kg

Sestavine

Akutna dermalna strupenost

: Amidosulfonska kislina

LD50 Podgana: > 2,000 mg/kg

Citronska kislina

LD50 Podgana: > 2,000 mg/kg

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Možni učinki na zdravje

Proizvod - ORIGINALNA VSEBINA

Oči

Povzroča hude poškodbe oči.

Koža

Povzroča težke opekline kože.

Zaužitje

Povzroča opekline prebavnega trakta.

Vdihavanje

Lahko povzroči draženje nosu, grla in pljuč.

Kronična izpostavljenost

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Proizvod - DELOVNA RAZTOPINA

Oči

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Koža

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Zaužitje

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Vdihavanje

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Kronična izpostavljenost

Pri normalni rabi ni znano ali pričakovano, da bi škodovalo

zdravju.

Izkušnje z izpostavljenostjo človeka

Proizvod - ORIGINALNA VSEBINA

Stik z očmi

Rdečina, Bolečina, Razjede

Stik s kožo

Rdečina, Bolečina, Razjede

Zaužitje

Razjede, Želodčna bolečina

Vdihavanje

Razdraženost dihal, Kašelj

Proizvod - DELOVNA RAZTOPINA

Stik z očmi

Ni znanih ali pričakovanih simptomov.

Stik s kožo

Ni znanih ali pričakovanih simptomov.

Zaužitje

Ni znanih ali pričakovanih simptomov.

Vdihavanje

Ni znanih ali pričakovanih simptomov.

ODDELEK 12: Ekološki podatki

Proizvod - ORIGINALNA VSEBINA

12.1 Ekotoksičnost

Učinki na okolje

Ta proizvod nima znanih strupenih učinkov na okolje.

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Proizvod

Strupenost za ribe

: Ni razpoložljivih podatkov

Strupenost za vodno bolho in

druge vodne vretenčarje.

: Ni razpoložljivih podatkov

Strupenost za alge

: Ni razpoložljivih podatkov

Sestavine

Strupenost za ribe

: Citronska kislina

96 h LC50 Ribe: > 100 mg/l

Sestavine

Strupenost za alge

: Amidosulfonska kislina

72 h EC50: 48 mg/l

12.2 Obstojnost in razgradljivost

Proizvod

Biorazgradljivost

: V proizvodu vsebovane površinsko aktivne snovi so

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

Sestavine

Biorazgradljivost

Amidosulfonska kislina

Rezultat: Se ne upošteva - anorgansko

Fatty alcohol ethoxylates > 5EO

Rezultat: Biološko razgradljivo

Citronska kislina

Rezultat: Zlahka biorazgradljivo.

12.3 Zmožnost kopičenja v organizmih

Ni razpoložljivih podatkov

12.4 Mobilnost v tleh

Ni razpoložljivih podatkov

12.5 Rezultati ocene PBT in vPvB

Proizvod

Ocena

Snov/mešanica ne vsebuje komponent, ki so obstojne,

bioakumulacijske in strupene (PBT) ali izredno obstojne in zelo

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

12.6 Drugi škodljivi učinki

Ni razpoložljivih podatkov

ODDELEK 13: Odstranjevanje

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

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

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13.1 Metode ravnanja z odpadki

Proizvod - ORIGINALNA VSEBINA

Proizvod

: Kjer je mogoče, ima recikliranje prednost pred odlaganjem ali

sežiganjem. Če recikliranje ni izvedljivo, odstranite v skladu z

lokalnimi uredbami. Odpad odlagajte v odobrenih objektih za

odlaganje odpada.

Kontaminirana

embalaža/pakiranje

: Odstranite kot nerabljen proizvod. Prazne posode je treba

dostaviti pooblaščeni osebi za ravnanje z odpadki na recikliranje

ali odlaganje. Prazni vsebniki niso za ponovno uporabo.

Odstranjevati v skladu s krajevnimi, državnimi in zveznimi

predpisi.

Evropski katalog odpadkov

: 200114* - kisline

Proizvod - DELOVNA RAZTOPINA

Proizvod

: Razredčen proizvod lahko splaknete v kanalizacijo.

Kontaminirana

embalaža/pakiranje

: Odstranjevati v skladu s krajevnimi, državnimi in zveznimi

predpisi.

ODDELEK 14: Podatki o prevozu

Proizvod - ORIGINALNA VSEBINA

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

označevanje nevarnosti skladni z izbranim načinom prevoza.

Transport po kopnem (ADR/ADN/RID)

14.1 Številka ZN

3264

14.2 Pravilno odpremno ime

ANORGANSKA TEKOČINA, JEDKA, KISLA, N.D.N.

(sulphamic acid)

14.3 Razredi nevarnosti

prevoza

14.4 Skupina embalaže

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Nobeden

Zračni transport (IATA)

14.1 Številka ZN

3264

14.2 Pravilno odpremno ime

Corrosive liquid, acidic, inorganic, n.o.s.

(sulphamic acid)

14.3 Razredi nevarnosti

prevoza

14.4 Skupina embalaže

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Nobeden

Pomorski transport

(IMDG/IMO)

14.1 Številka ZN

3264

14.2 Pravilno odpremno ime

CORROSIVE LIQUID, ACIDIC, INORGANIC, N.O.S.

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(sulphamic acid)

14.3 Razredi nevarnosti

prevoza

14.4 Skupina embalaže

14.5 Nevarnosti za okolje

14.6 Posebni previdnostni

ukrepi za uporabnika

Nobeden

14.7 Prevoz v razsutem

stanju v skladu s Prilogo II k

MARPOL 73/78 in Kodeksom

IBC

Se ne upošteva.

Proizvod - DELOVNA RAZTOPINA

Ni namenjeno za prevoz.

ODDELEK 15: Zakonsko predpisani podatki

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

v skladu z Uredbo o

detergentih ES 648/2004

5 % ali več vendar manj kot 15 %: Neionske površinsko aktivne

snovi

Nacionalni predpis

Upoštevajte Direktivo 94/33/ES za varnost in zdravje pri delu mladoletnih oseb.

Razred skladiščenja

Drugi predpisi

Zakon o kemikalijah

Pravilnik o tehničnih in organizacijskih ukrepih za skladiščenje

nevarnih kemikalij

Pravilnik o varovanju delavcev pred tveganji zaradi

izpostavljenosti kemičnim snovem pri delu

Pravilnik o varovanju delavcev pred tveganji zaradi

izpostavljenosti rakotvornim ali mutagenim snovem

Pravilnik o osebni varovalni opremi, ki jo delavci uporabljajo pri

delu

Pravilnik o varovanju zdravja pri delu otrok, mladostnikov in

mladih oseb

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

pred kratkim rodile ter doječih delavk

Zakon o varstvu okolja

Uredba o odpadkih

Uredba o ravnanju z embalažo in odpadno embalažo

Zakon o prevozu nevarnega blaga

15.2 Ocena kemijske varnosti

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

ODDELEK 16: Drugi podatki

Celotno besedilo R-stavkov

Zdravju škodljivo pri zaužitju.

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Draži oči.

R36/38

Draži oči in kožo.

Nevarnost hudih poškodb oči.

R52/53

Škodljivo za vodne organizme, lahko povzroči dolgotrajne škodljive

učinke na vodno okolje.

Celotno besedilo H-stavkov

H302

Zdravju škodljivo pri zaužitju.

H315

Povzroča draženje kože

H318

Povzroča hude poškodbe oči.

H319

Povzroča hudo draženje oči.

H412

Škodljivo za vodne organizme, z dolgotrajnimi učinki.

Celotno besedilo drugih okrajšav

Zdravju škodljivo pri zaužitju.

Draži oči.

R36/38

Draži oči in kožo.

Nevarnost hudih poškodb oči.

R52/53

Škodljivo za vodne organizme, lahko povzroči dolgotrajne

škodljive učinke na vodno okolje.

(Q)SAR - (Kvantitativno) razmerje med strukturo in aktivnostjo; ADN - Evropski sporazum o

mednarodnem

prevozu

nevarnih

snovi

celinskih

vodah;

Evropski

sporazum

mednarodnem prevozu nevarnih snovi po cesti; ASTM

- Ameriško združenje za testiranje

materialov; bw - Telesna teža; CLP - Uredba o razvrščanju, označevanju in pakiranju; Uredba

(ES) št. 1272/2008; DIN - Standard nemškega inštituta za standardizacijo; ECHA - Evropska

agencija za kemikalije; EC-Number - Evropska številka Skupnosti; ECx - Koncentracija, povezana

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

Koncentracija, povezana z x% odzivom stopnje rasti; GHS - Globalno usklajeni sistem; IARC -

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

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

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

civilnega letalstva; IMDG - Mednarodni kodeks za prevoz nevarnih snovi po morju; IMO -

Mednarodna pomorska organizacija; ISO - Mednarodna organizacija za standardizacijo; LC50 -

Smrtna koncentracija za 50% testirane populacije; LD50 - Smrtni odmerek za 50% testirane

populacije

(srednji

smrtni

odmerek);

MARPOL

Mednarodna

konvencija

preprečevanju

onesnaževanja morja z ladij; n.o.s. - Nikjer drugje navedeno; NO(A)EC - Koncentracija brez

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

Stopnja obremenitve brez opaznega učinka; OECD - Organizacija za gospodarsko sodelovanje in

razvoj; OPPTS - Urad za kemijsko varnost in preprečevanje onesnaževanja; PBT - Snov, ki je

obstojna, se kopiči v organizmih in je strupena; REACH - Uredba (ES) št. 1907/2006 Evropskega

parlamenta in Sveta o registriranju, vrednotenju, potrjevanju in omejevanju kemikalij; RID -

Pravilniki o mednarodnem železniškem prevozu nevarnega blaga; SADT - Samopospešujoča

temperatura razgradnje; SDS - Varnostni list; TRGS - Tehnično pravilo za nevarne snovi; UN -

Združeni narodi; vPvB - Zelo obstojno in se zelo lahko kopiči v organizmih; DSL - Seznam

domačih snovi (Kanada); KECI - Korejski seznam obstoječih kemikalij; TSCA - Zakon o nadzoru

strupenih

snovi

(ZDA);

AICS

Avstralski

popis

kemičnih

snovi;

IECSC

Kitajski

seznam

obstoječih kemičnih snovi; ENCS - Obstoječe in nove kemične snovi (Japonska); ISHL - Zakon o

varnosti in zdravju pri delu (Japonska); PICCS - Filipinski seznam kemikalij in kemičnih snovi;

NZIoC

Novozelandski

popis

kemikalij;

TCSI

Tajvanski

popis

kemičnih

snovi;

Karcinogena, mutagena strupena snov ali snov, strupena za razmnoževanje; GLP

- Dobra

laboratorijska praksa

Dodatne informacije

Pripravil

Regulatory Affairs

Številke navedene v varnostnem listu so podana v obliki: 1,000, 000=1 milijon in 1,000=1 tisoč. 0.1

VARNOSTNI LIST

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= 1 deseti in 0.001 = 1 tisoči.

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

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

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

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

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

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

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

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

tekstu.

PRILOGA: SCENARIJI IZPOSTAVLJENOSTI

Snovi po DPD+:

:

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

metodologijo DPD+:

Pot

Snov

Št. CAS

Št. EINECS

Zaužitje

Fatty alcohol ethoxylates > 5EO

Vdihavanje

Ni snovi v sledeh

Kožno

Amidosulfonska kislina

5329-14-6

226-218-8

Oči

Fatty alcohol ethoxylates > 5EO

vodno okolje

Amidosulfonska kislina

5329-14-6

226-218-8

Fizikalne lastnosti snovi po DPD+:

Snov

Parni tlak

Topnost v vodi

Pow

Molska masa

Amidosulfonska kislina

0.0078 hPa

181.4 g/l

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

prosimo, izračunajte faktor tveganja na spodaj navedeni spletni strani:

www.ecetoc.org/tra

Kratek naslov scenarija

izpostavljenosti

Čistilo za sanitarije. Ročni postopek

Deskriptorji uporabe

Glavne skupine uporabnikov

Poklicne uporabe: javna uporaba (uprava, izobraževanje,

razvedrilo, storitve, obrt)

Sektorji končne uporabe

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

razvedrilo, storitve, obrt)

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Skupine postopkov

PROC10: Nanašanje z valjčkom ali čopičem

PROC8a: Prenos snovi ali pripravka (polnjenje/ praznjenje) iz/ v

posode/ velike vsebnike na nenamenskih napravah

Kategorije izdelka

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

topil)

Kategorije sproščanja v

okolje

ERC8a: Močno razpršena notranja uporaba procesnih

pripomočkov v odprtih sistemih

Kratek naslov scenarija

izpostavljenosti

Čistilo za sanitarije. Ročni postopek: razprševanje in brisanje

Deskriptorji uporabe

Glavne skupine uporabnikov

Poklicne uporabe: javna uporaba (uprava, izobraževanje,

razvedrilo, storitve, obrt)

Sektorji končne uporabe

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

razvedrilo, storitve, obrt)

Skupine postopkov

PROC10: Nanašanje z valjčkom ali čopičem

PROC11: Neindustrijsko brizganje

PROC8a: Prenos snovi ali pripravka (polnjenje/ praznjenje) iz/ v

posode/ velike vsebnike na nenamenskih napravah

Kategorije izdelka

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

topil)

Kategorije sproščanja v

okolje

ERC8a: Močno razpršena notranja uporaba procesnih

pripomočkov v odprtih sistemih

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

19-11-2018

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises Issues Allergy Alert on Undeclared Milk Allergen in Unflavored Egg White Protein

Jay Robb Enterprises is recalling Jay Robb Unflavored Egg White Protein Product, manufactured by Agropur MSI, LLC of La Crosse, Wisconsin, because it may contain undeclared milk allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

17-11-2018

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Safety evaluation of the food enzyme endo‐1,4‐β‐xylanase from a genetically modified Aspergillus oryzae (strain NZYM‐FA)

Published on: Fri, 16 Nov 2018 The food enzyme is an endo‐1,4‐β‐xylanase (EC 3.2.1.8) produced with a genetically modified strain of Aspergillus oryzae by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. This xylanase is intended to be used in baking and cereal‐based processes. Based on the proposed maximum use levels, dietary exposure to the food enzyme–total organic solids (TOS) was e...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries Issues Allergy Alert on Undeclared Milk in 7.5 Oz Amaretto Rainier Chocolate Cherries Pouches

Chukar Cherries of Prosser, WA is recalling 7.5oz Amaretto Rainier Chocolate Cherries because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

16-11-2018

Setting of an import tolerance for pyraclostrobin in rice

Setting of an import tolerance for pyraclostrobin in rice

Published on: Thu, 15 Nov 2018 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in Germany to set an import tolerance for the active substance pyraclostrobin in rice. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for rice. Based on the risk assessment results, EFSA concluded that the short‐term intake of residues resulting from the use of p...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Assessment of genetically modified LLCotton25 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐010)

Published on: Wed, 14 Nov 2018 Following the submission of application EFSA‐GMO‐RX‐010 under Regulation (EC) No 1829/2003 from Bayer, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the herbicide‐tolerant genetically modified LLCotton25, for food and feed uses, import and processing, excluding cultivation within the EU. The d...

Europe - EFSA - European Food Safety Authority Publications

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)

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)

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...

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

15-11-2018

Safety 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

15-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-11-2018

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC ISSUES ALLERGY ALERT ON UNDECLARED Tree Nut – Walnut in The Purveyors Kitchen - Pumpkin Pesto Tapenade

Nor Cal Food Solutions, LLC of Auburn, CA is announcing a recall of 567 cases of Pumpkin Pesto Tapenade, manufactured by Purveyors Kitchen, because it contains an undeclared tree nut (walnut). People who have an allergy or severe sensitivity to tree nuts (walnuts) run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

14-11-2018

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerts doctors, patients about risk of complications when certain implanted pumps are used to deliver pain medications not approved for use with the devices

FDA alerted health care providers and patients about the serious complications that can occur when using medications not approved for use with implanted pumps that deliver medication into the spinal fluid to treat or manage pain.

FDA - U.S. Food and Drug Administration

13-11-2018

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

Oscor Inc. Issues Recall Product Expansion of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

On September 26, 2018 Oscor notified customers of a recall for certain lots (Recall No. 1035166- 09/07/2018-01-R) of TB Unshrouded Bipolar Pacing Leads. As part of the recall correction activities, Oscor is retrieving any remaining inventory out in the field. The recall scope is being expanded to include expired inventory for devices distributed between December 21, 2011 to May 17, 2018. The recall expansion is to ensure proper disposition of expired units. The FDA has been notified and is aware Oscor In...

FDA - U.S. Food and Drug Administration

13-11-2018

Questions on antimicrobial resistance

Questions on antimicrobial resistance

Antimicrobial resistance is a major public health issue in France: resistance to antibiotics calls into question the efficacy of treatments for infections occurring in humans and animals alike. At its annual symposium on this issue, ANSES will be presenting the result of its two reports on national trends in resistance in animals (Resapath report) and sales of veterinary antimicrobials.

France - Agence Nationale du Médicament Vétérinaire

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Recall of Bittersweet & Feve Chocolate Bars Due to High Levels of Milk Allergens

Today, Recchiuti Confections (San Francisco, CA) discovered two batches of their Bittersweet Chocolate Bar and two batches of their Feve Chocolate Bar contain high levels of milk protein after FDA sampling. No illnesses have been reported to date. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The chocolate bars can be enjoyed if you do not have milk allergies or sensitivities. Recchiuti Confections is...

FDA - U.S. Food and Drug Administration

8-11-2018

Manage Your Asthma: Know Your Triggers and Treatment Options

Manage Your Asthma: Know Your Triggers and Treatment Options

You can manage your asthma by taking medications approved by the FDA. Before going to the pharmacy, get a proper diagnosis from a doctor and together develop an asthma action plan.

FDA - U.S. Food and Drug Administration

8-11-2018

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans Food Markets, Inc. Issues Allergy Alert on Undeclared Milk in Wegmans Pumpkin Loaf, 11 oz., and Wegmans Placek Coffee Cake, 11 oz. and 22 oz.

Wegmans has initiated a voluntary recall of the following products because they may contain milk not declared on the label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

1-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

30-10-2018

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

FDA’s Plant & Animal Biotechnology Innovation Action Plan ensures the safety of plant and animal products of biotechnology while avoiding unnecessary barriers to future innovation. Key elements: Veterinary Innovation Program, public webinar on genome editing in animals & release of future guidance.

FDA - U.S. Food and Drug Administration

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Aleurocanthus spp.

Pest categorisation of Aleurocanthus spp.

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Aleurocanthus spp., a well‐defined insect genus of the whitefly family Aleyrodidae (Arthropoda: Hemiptera). Difficulties within the taxonomy of the genus give doubt about the ability to accurately identify some members to species level. Nevertheless, the genus is thought to currently include about ninety species mainly reported from tropical and subtropical areas. The genus is listed in Council Dir...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars

Maribel’s Sweets Inc. of Brooklyn, NY is recalling its 2.82oz MarieBelle Japanese Matcha Japanese Green Tea and White Chocolate Bar, container code 101619, Cacao Market by MarieBelle Rosemary Truffle Salt 60% Dark Chocolate Bar, all container codes, and the Cacao Market by MarieBelle Orange Peels 60% Dark Chocolate Bar, all container codes, because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if...

FDA - U.S. Food and Drug Administration

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

25-10-2018

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company In. Issues Allergy Alert on Undeclared Peanuts in "Chocolate Whoopie Pie"

Shirley’s Cookie Company Inc. of Claysburg, PA, is recalling its 16 ounce packages of "Chocolate Whoopie Pie" because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

23-10-2018

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market Issues Allergy Alert on Undeclared Soy in Hot & Sour Broth

New Seasons Market is recalling 193 jars of New Seasons Market Hot & Sour Broth because it contains undeclared soy. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-10-2018

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Soy in Cedar’s Chickpea Salad 8 oz.

Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling Cedar’s Chickpea Salad 8 oz. because it may contain undeclared edamame (soy). People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-10-2018

Dollarama recalls Craft Dough toys

Dollarama recalls Craft Dough toys

The craft dough toy is mislabelled and incorrectly states that it is gluten free. Consumers who are sensitive or allergic to gluten may have an adverse reaction when using the toy.

Health Canada

18-10-2018

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Stewart’s Shops Issues Allergy Alert on Undeclared Milk in Cranberry Apple Refresher

Saratoga Springs, NY - Stewart’s Shops Corp. is recalling units of Stewart’s Shops brand Cranberry Apple Refresher 16 fluid oz. because the product may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 2,300 units of affected product were distributed in upstate New York and Southern Vermont.

FDA - U.S. Food and Drug Administration

18-10-2018

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Unauthorized "Surfaz-SN Triple Action Cream" seized from Mississauga store may pose serious health risks

Health Canada seized “Surfaz-SN Triple Action Cream”—an unauthorized skin cream promoted for antifungal, antibacterial and anti-inflammatory use—because it is labelled to contain prescription drugs (betamethasone dipropionate and neomycin sulphate). The product was seized from Kaf African Caribbean Market (2642 Liruma Road, Unit 2A) in Mississauga, Ontario.

Health Canada

18-10-2018

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. East Trading Corp. Issues Alert on Undeclared Sulfites In Fruits Du Sud Golden Seedless Raisins

P. EAST TRADING CORP. of Bronx, NY is recalling Fruits Du Sud Golden Seedless Raisins (Lot No. FDS T499/18) 30 lbs Box, because they contain undeclared SULFITES. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

FDA - U.S. Food and Drug Administration

17-10-2018

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy

SLR Food Distribution Inc. Issues Alert on Undeclared Sulfites in Sugar Melon Candy

SLR Food Distribution Inc. of New Hyde Park, NY is recalling its 7.04oz package of SUGAR MELON CANDY / WAX GOURD because it contains undeclared sulfites. Consumers who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. Issues Allergy Alert on Undeclared Sulfites in Source Day Natural Treasures Dried Liquorice Slice

New Nan Fong Hong Trading Inc. is recalling its 16 oz (454g) packages of Source Day Natural Treasures Dried Liquorice Slice because they contain undeclared sulfites. Consumers who are allergic to sulfite allergens run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. Announces Voluntary Recall of a Limited Quantity of S&W Brand White Beans Due to the Presence of Undeclared (Sulfites)

Faribault Foods, Inc. of Faribault, MN is recalling its 15 ounce S&W White Beans because it contains undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

17-10-2018

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Applicability of in silico tools for the prediction of dermal absorption for pesticides

Published on: Tue, 16 Oct 2018 00:00:00 +0200 Based on the “Human in vitro dermal absorption datasets” published as supporting information to the revised EFSA Guidance on Dermal Absorption, in silico models for prediction of absorption across the skin have been evaluated. For this evaluation, a systematic literature search and review was performed, identifying 288 publications describing mathematical models for prediction of dermal absorption. Eleven models potentially relevant to the regulatory assessm...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Stagonosporopsis andigena

Pest categorisation of Stagonosporopsis andigena

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

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

Pest categorisation of Thecaphora solani

Pest categorisation of Thecaphora solani

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The Panel on Plant Health performed a pest categorisation of the fungus Thecaphora solani, the causal agent of smut of potato, for the EU. The identity of the pest is well established and reliable methods exist for its detection and identification. T. solaniis present in Bolivia, Chile, Colombia, Ecuador, Mexico, Panama, Peru and Venezuela. The pathogen is not known to occur in the EU and is listed in Annex IAI of Directive 2000/29/EC, meaning its introducti...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Pest categorisation of Melampsora farlowii

Pest categorisation of Melampsora farlowii

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Melampsora farlowii, a well‐defined and distinguishable fungus of the family Melampsoraceae. M. farlowii is the causal agent of a leaf and twig rust of hemlocks (Tsuga spp.) in eastern North America. The pathogen is regulated in Council Directive 2000/29/EC (Annex IAI) as a harmful organism whose introduction into the EU is banned. M. farlowii ...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc Issues Allergy Alert on Undeclared Egg Product In “Vegetable Fried Rice”

Feel Good Foods Inc. of Brooklyn, NY is recalling six lots of “Vegetable Fried Rice” frozen meals, UPC 00899039002129 because they may contain undeclared egg. People who have allergies to egg run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

15-10-2018

Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”

Apollo Food International Inc Issues Allergy Alert on Undeclared Eggs In “Mini Roll”

Apollo Food International Inc. of Long Island City, NY, is recalling its 2.469 ounce packages of “Mini Roll” food treats because they may contain undeclared eggs. Consumers who are allergic to eggs may run the risk of serious or life-threatening allergic reactions if they consume this product.

FDA - U.S. Food and Drug Administration

12-10-2018

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA advances investigation into whether more than 40 e-cigarette products are being illegally marketed and outside agency's compliance policy

FDA - U.S. Food and Drug Administration

11-10-2018

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Wild boar in focus: Review of existing models on spatial distribution and density of wild boar and proposal for next steps

Published on: Wed, 10 Oct 2018 00:00:00 +0200 This report provides a review of existing models for predicting the spatial distribution and abundance of wild boar at various scales (global, continental, national and regional) in order to inform the development of a new model to produce estimates of wild boar abundance at European level. The review identifies and discusses a range of models based on a wide variety of data types, corresponding to those targeted by the data collection model set by ENETwild,...

Europe - EFSA - European Food Safety Authority Publications

10-10-2018

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC Issues a Voluntary Nationwide Recall of the Regen Series ® Product, Manufactured by Genetech, Inc.

Liveyon, LLC (“Liveyon”) is a distributor of stem cell products manufactured by Genetech, Inc. (“Genetech”), a laboratory located in San Diego, CA. Liveyon marketed and distributed these products under the trade name ReGen Series®. Liveyon has voluntarily recalled all ReGen Series® products due to reported possible adverse reactions.

FDA - U.S. Food and Drug Administration

10-10-2018

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Voluntary Recall Issued for Sweet Me Creamery Brookie Dough Ice Cream that may Contain an Undeclared Peanut Allergen

Kemps of St. Paul, Minn., is voluntarily recalling Sweet Me Creamery Brookie Dough ice cream, individual pints and pint four-packs, because it may contain an undeclared peanut allergen. Individuals who have an allergy or severe sensitivity to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

9-10-2018

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Ukrop’s Homestyle Foods, LLC Announces Recalls Because of Possible Health Risk

Johnston County Hams’ country ham was recalled due to its potential for contamination with Listeria monocytogenes; therefore, Ukrop’s made the decision that any products that contained country ham or came into contact with equipment used to process the country ham are being recalled due to the potential to be contaminated with Listeria monocytogenes.

FDA - U.S. Food and Drug Administration

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

2-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency actions to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions

FDA issues revised guidance to allow for a more efficient approach to 505(q) petitions and focus more resources on scientific reviews.

FDA - U.S. Food and Drug Administration

26-9-2018

Boy Story LLC recalls Action Dolls

Boy Story LLC recalls Action Dolls

The joints on the vinyl dolls can break, creating broken pieces that pose a choking hazard to young children.

Health Canada

25-9-2018

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Allergy Alert Issued in Whole Foods Market Stores Nationwide for Undeclared Milk in 365 Everyday Value White Corn Tortilla Chips

Whole Foods Market is voluntarily recalling 365 Everyday Value White Corn Tortilla Chips because the product may contain undeclared milk that was not listed on the product label. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product

FDA - U.S. Food and Drug Administration

21-9-2018

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs Issues Allergy Alert on Undeclared Milk and Soy in MyoWhey

Purus Labs, Inc of Plano, Texas is recalling MyoWhey Chocolate Cookie Crunch, because it may contain undeclared milk and soy. This only effects products with Lot number PL: 0100518 Exp: 04/2020. People who have an allergy or severe sensitivity to milk and soy run the risk of serious or life-threatening allergic reaction if they consume these products.

FDA - U.S. Food and Drug Administration

19-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of <i>Cyclospora</i>

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of <i>Cyclospora</i>

he safety of the American food supply is one of the U.S. Food and Drug Administration’s highest priorities. A key part of our work in this space focuses on implementing the principles and measures of the FDA Food Safety Modernization Act (FSMA). The actions directed by FSMA are designed to prevent foodborne illness and food safety problems from happening.

FDA - U.S. Food and Drug Administration

14-11-2018

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or   manage pain:  https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/x

The @US_FDA issues a safety communication cautioning doctors & patients of the risks associated w/ using medications that are not approved for use w/ implanted pumps that are delivered into the spinal fluid to treat or manage pain: https://go.usa.gov/xPfuw  #FDA #MedicalDevice pic.twitter.com/kgDSx2PQzn

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

14-9-2018

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here:  http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

#FDA MQSA: Mammography Facility Adverse Event and Action Report - September 13, 2018: Lakes Radiology II, Inc. Read the report here: http://go.usa.gov/xPgTB  #MedicalDevice

FDA - U.S. Food and Drug Administration