AROMIST AIR FRESHENING SYSTEM

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  • AROMIST AIR FRESHENING SYSTEM (915412)
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  • Medicīniskās ierīces

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  • AROMIST AIR FRESHENING SYSTEM (915412)
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  • Klimata pārmaiņas:
  • Ecolab
  • Autorizācija numurs:
  • 915412
  • Pēdējā atjaunošana:
  • 12-03-2018

Pamatojums Zāļu Apraksta Izmaiņām

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

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IEDAĻA 1. VIELAS/ MAISĪJUMA UN UZŅĒMĒJSABIEDRĪBAS/ UZŅĒMUMA APZINĀŠANA

1.1 Produkta identifikators

Produkta nosaukums

AROMIST AIR FRESHENING SYSTEM

Produkta kods

915412

Vielas/maisījuma lietošanas

veids

Gaisa atsvaidzinātājs

Vielas tips

Maisījums

Tikai profesionāliem lietotājiem.

Informācija par produkta

atšķaidīšanu

Produkts tiek pārdots lietošanai gatavā stāvoklī.

1.2 Vielas vai maisījuma attiecīgi apzinātie lietojuma veidi un tādi, ko neiesaka izmantot

Apzināti lietošanas veidi

Gaisa atsvaidzinātāja pielietošana

Ieteicamie lietošanas

ierobežojumi

Tikai rūpnieciskai un profesionālai lietošanai.

1.3 Informācija par drošības datu lapas piegādātāju

Uzņēmums

KAY BVBA

Havenlaan 4, Ravenshout Bed. 4 210

B-3980 Tessenderlo, Beļģija

+32 13 67 06 91 (Beļģija)

BE_KAY_CS@ecolab.com

1.4 Tālruņa numurs, kur zvanīt ārkārtas situācijās

Tālruņa numurs, kur zvanīt

ārkārtas situācijās

+32 13 67 06 91 (Beļģija)

Saindēšanās informācijas

centra tālruņa numurs

67042473

Sastādīšanas/pārskatīšanas

datums

22.05.2015

Versija

IEDAĻA 2. BĪSTAMĪBAS APZINĀŠANA

2.1 Vielas vai maisījuma klasificēšana

Klasifikācija (REGULA (EK) Nr. 1272/2008)

Uzliesmojoši aerosoli, 2. kategorija

H223

Gāzes zem spiediena

H280

Acu kairinājums, 2. kategorija

H319

Toksiska ietekme uz īpašu mērķorgānu - vienreizēja

iedarbība, 3. kategorija, Centrālā nervu sistēma

H336

Klasifikācija (67/548/EEK, 1999/45/EK)

DROŠĪBAS DATU LAPA

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F; Uzliesmojošs

Xi; KAIRINOŠS

Šajā punktā minēto vielas iedarbības raksturojumu (R frāžu) pilno tekstu skatīt 16. punktā.

Pilnu bīstamības apzīmējumu tekstu, kas minēti šajā pozīcijā, skatīt 16. pozīcijā.

2.2 Etiķetes elementi

Marķēšana (REGULA (EK) Nr. 1272/2008)

Bīstamības piktogrammas

Signālvārds

Uzmanību

Bīstamības apzīmējumi

H223

Uzliesmojošs aerosols.

H280

Satur gāzi zem spiediena; karstumā var

eksplodēt.

H319

Izraisa nopietnu acu kairinājumu.

H336

Var izraisīt miegainību vai reiboņus.

Piesardzības apzīmējumi

P102

Sargāt no bērniem.

Novēršana:

P210

Nelietot vietās, kur ir sastopams

karstums/dzirksteles/atklāta uguns/karstas

virsmas. - Nesmēķēt.

P211

Neizsmidzināt uz atklātas uguns vai citiem

aizdegšanās avotiem.

P251

Tvertne zem spiediena: nedurt vai nededzināt,

arī pēc izlietošanas.

Glabāšana:

P410 + P412

Aizsargāt no saules gaismas. Nepakļaut

temperatūrai, kas pārsniedz 50 °C/ 122 °F.

Bīstamās sastāvdaļas, kuras jānorāda etiķetē:

difluoroethane

2.3 Citi apdraudējumi

Nekas nav zināms.

IEDAĻA 3. SASTĀVS/INFORMĀCIJA PAR SASTĀVDAĻĀM

3.2 Maisījumi

Bīstamās sastāvdaļas

Ķīmiskais

nosaukums

CAS Nr.

EC Nr.

REACH Nr.

Klasifikācija

(67/548/EEK)

Klasifikācija

(REGULA (EK) Nr.

1272/2008)

Koncentrācija [%]

difluoroethane

75-37-6

200-866-1

Toksiska ietekme uz īpašu

mērķorgānu - vienreizēja

iedarbība 3. kategorija; H336

>= 30 - < 50

DROŠĪBAS DATU LAPA

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propan-2-ol

67-63-0

200-661-7

01-2119457558-25

F-Xi; R11-R36-

Uzliesmojoši šķidrumi 2.

kategorija; H225

Acu kairinājums 2. kategorija;

H319

Toksiska ietekme uz īpašu

mērķorgānu - vienreizēja

iedarbība 3. kategorija; H336

>= 25 - < 30

distillates

(petroleum),

hydrotreated light A

complex combination

of hydrocarbons

obtained by treating

a petroleum fract

64742-47-8

265-149-8

Xn; R65

Uzliesmojoši šķidrumi 3.

kategorija; H226

Bīstamība ieelpojot 1.

kategorija; H304

>= 25 - < 30

Smaržvielas

Xi; R36

Nopietns acu

bojājums/kairinājums 2.

kategorija; H319

>= 3 - < 5

Šajā punktā minēto vielas iedarbības raksturojumu (R frāžu) pilno tekstu skatīt 16. punktā.

Pilnu bīstamības apzīmējumu tekstu, kas minēti šajā pozīcijā, skatīt 16. pozīcijā.

IEDAĻA 4. PIRMĀS PALĪDZĪBAS PASĀKUMI

4.1 Pirmās palīdzības pasākumu apraksts

Ja nokļūst acīs

Skalot nekavējoties ar lielu daudzumu ūdens, arī zem acu

plakstiņiem, vismaz 15 minūtes. Izņemiet kontaktlēcas, ja tās ir

ievietotas un to ir viegli izdarīt. Turpiniet skalot. Griezties pie

mediciniskā personāla.

Ja nokļūst uz ādas

Skalot ar lielu daudzumu ūdens.

Ja norīts

Izskalot muti. Griezties pie mediķa, ja parādās simptomi.

Ja ieelpots

Nogādāt svaigā gaisā. Simptomātiska ārstēšana. Griezties pie

mediķa, ja parādās simptomi.

4.2 Svarīgākie simptomi un ietekme - akūta un aizkavēta

Lai iepazītos ar detalizētāku informāciju par simptomiem un ietekmi uz veselību, skat. 11. nodaļu.

4.3 Norāde par nepieciešamo neatliekamo medicīnisko palīdzību un īpašu aprūpi

Ārstēšana

Simptomātiska ārstēšana.

IEDAĻA 5. UGUNSDZĒSĪBAS PASĀKUMI

5.1 Ugunsdzēsības līdzekļi

Piemēroti ugunsdzēsības

līdzekļi:

Izmantot ugunsdzēšanas pasākumus, kas ir piemēroti vietējiem

apstākļiem un apkārtesošajai videi.

Nepiemēroti ugunsdzēsības

līdzekļi

Augsta spiediena ūdens strūkla

DROŠĪBAS DATU LAPA

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5.2 Īpaša vielas vai maisījuma izraisīta bīstamība

Īpaša bīstamība

ugunsdzēšanas laikā

Tvertne zem spiediena: karstumā var eksplodēt.

Uzliesmojoši aerosoli

Bīstamie degšanas produkti

Sadalīšanās produkti var saturēt sekojošus savienojumus:

Oglekļa oksīdi

Slāpekļa oksīdi (NOx)

Sēra oksīdi

Fosfora oksīdi

5.3 Ieteikumi ugunsdzēsējiem

Īpašas ugunsdzēsēju

aizsargierīces

: Lietot personālo aizsardzības aprīkojumu.

Papildinformācija

: Ar ugunsgrēka paliekām un piesārņoto uguns nodzēšanā lietoto

ūdeni utilizēt saskaņā ar vietējo normatīvo aktu prasībām.

Ugunsgrēka un/vai sprādziena gadījumā neieelpot dūmus.

IEDAĻA 6. PASĀKUMI NEJAUŠAS NOPLŪDES GADĪJUMOS

6.1 Individuālās drošības pasākumi, aizsardzības līdzekļi un procedūras ārkārtas situācijām

Padomi personālam, kas nav

glābēji

Nodrošināt, ka satīrīšanu vada vienīgi apmācīts personāls.

Aizsardzības pasākumi uzskaitīti 7. un 8. punktos.

Padomi glābējiem

Ja noplūdušo produktu savākšanas laikā ir nepieciešams speciāls

apģērbs, iepazīties ar visu 8. nodaļā aprakstīto informāciju par

piemērotiem un nepiemērotiem materiāliem.

6.2 Vides drošības pasākumi

Vides drošības pasākumi

Nepieļaut saskaršanos ar augsni, virszemes vai grunts ūdeņiem.

6.3 Ierobežošanas un savākšanas paņēmieni un materiāli

Savākšanas metodes

Apstādināt noplūdi, ja to var izdarīt drošā veidā.Apturēt un savākt

nopilējumu ar nedegošu absorbenta materiālu (piemēram, smiltīm,

zemi, diatomītu, vermikulītu) un ievietot konteinerā utilizācijai

atbilstoši vietējiem / nacionālajiem noteikumiem (skat. 13.

punktu).Atlikumus noskalot ar ūdeni.Ja izlijis lielāks produkta

daudzums, ap to izveidot aizsargvalni vai kā citādi to norobežot,

lai būtu garantija, ka produkts nevar ieplūst tekošos ūdeņos.

6.4 Atsauce uz citām iedaļām

Skatīt 1. nodaļu par kontaktinformāciju avārijas situācijās.

Personālajai aizsardzībai skat. 8. punktu.

Papildus informācijas iegūšanai par atkritumu iznīcināšanu, skatīt 13. nodaļu.

IEDAĻA 7. LIETOŠANA UN GLABĀŠANA

7.1 Piesardzība drošai lietošanai

Ieteikumi drošām darbībām

Nepieļaut nokļūšanu uz ādas un acīs. Nepārdurt. Saturs zem

spiediena. Neieelpot putekļus/ tvaikus/ gāzi/ dūmus/ izgarojumus/

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smidzinājumu. Pēc izmantošanas rokas kārtīgi nomazgāt. Lietot

tikai ar piemērotu ventilāciju.

Higiēnas pasākumi

Rīkoties atbilstoši labai rūpnieciskās higiēnas un drošības praksei.

Pirms atkārtotas lietošanas novilkt un izmazgāt piesārņoto

apģērbu. Pēc izmantošanas seju, rokas un jebkuru iedarbībai

pakļautu ādu kārtīgi nomazgāt.

7.2 Drošas glabāšanas apstākļi, tostarp visu veidu nesaderība

Prasības uzglabāšanas

vietām un konteineriem

Glabāt vēsā, labi vēdināmā vietā. Sargāt no bērniem. Tvertni

stingri noslēgt. Uzglabāt piemērotos, marķētos konteineros.

Uzglabāšanas temperatūra

-30 °C līdz 50 °C

7.3 Konkrēts(-i) gala lietošanas veids(-i)

Specifisks(i) lietošanas

veids(i)

Gaisa atsvaidzinātāja pielietošana

IEDAĻA 8. IEDARBĪBAS PĀRVALDĪBA/ INDIVIDUĀLĀ AIZSARDZĪBA

8.1 Pārvaldības parametri

Pieļaujamās ekspozīcijas ierobežojums darba vietā

CAS Nr.

Sastāvdaļas

Vērtības veids

(Ekspozīcijas veids)

Pārvaldības

parametri

Precizējums

Bāze

67-63-0

propan-2-ol

AER 8 st

350 mg/m3

2007-05-18

AER īslaicīgā

600 mg/m3

2007-05-18

DNEL

propan-2-ol

Gala lietošana: Darba ņēmēji

Iedarbības ceļi: Dermāli

Potenciālā ietekme uz veselību: Ilgtermiņa - sistēmiskie efekti

Vērtība: 888 mg/cm2

Gala lietošana: Darba ņēmēji

Iedarbības ceļi: Ieelpošana

Potenciālā ietekme uz veselību: Ilgtermiņa - sistēmiskie efekti

Vērtība: 500 mg/m3

Gala lietošana: Patērētāji

Iedarbības ceļi: Dermāli

Potenciālā ietekme uz veselību: Ilgtermiņa - sistēmiskie efekti

Vērtība: 319 mg/cm2

Gala lietošana: Patērētāji

Iedarbības ceļi: Ieelpošana

Potenciālā ietekme uz veselību: Ilgtermiņa - sistēmiskie efekti

Vērtība: 89 mg/m3

Gala lietošana: Patērētāji

Iedarbības ceļi: Norīšana

Potenciālā ietekme uz veselību: Ilgtermiņa - sistēmiskie efekti

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Vērtība: 26 ppm

PNEC

propan-2-ol

Saldūdens

Vērtība: 140.9 mg/l

Jūras ūdens

Vērtība: 140.9 mg/l

Neregulāra lietošana/izplūšana

Vērtība: 140.9 mg/l

Saldūdens

Vērtība: 552 mg/kg

Jūras sediments

Vērtība: 552 mg/kg

Augsne

Vērtība: 28 mg/kg

Notekūdeņu attīrīšanas iekārtas

Vērtība: 2251 mg/l

Orāli

Vērtība: 160 mg/kg

8.2 Iedarbības pārvaldība

Piemērota inženierkontrole

Inženiertehniskie pasākumi

Efektīva vilkmes ventilācijas sistēma Gaisa koncentrācijas uzturēt

zem aroda ekspozīcijas standartiem.

Individuālie aizsardzības pasākumi

Higiēnas pasākumi

Rīkoties atbilstoši labai rūpnieciskās higiēnas un drošības praksei.

Pirms atkārtotas lietošanas novilkt un izmazgāt piesārņoto

apģērbu. Pēc izmantošanas seju, rokas un jebkuru iedarbībai

pakļautu ādu kārtīgi nomazgāt.

Acu / sejas aizsardzība (EN

166)

Nav nepieciešami īpaši aizsarglīdzekļi.

Roku aizsardzība (EN 374)

Nav nepieciešami īpaši aizsarglīdzekļi.

Ādas un ķermeņa

aizsardzība (EN 14605)

Nav nepieciešami īpaši aizsarglīdzekļi.

Elpošanas aizsardzība (EN

143, 14387)

Nekas nav nepieciešams, ja produkta koncentrācija gaisā tiek

uzturēta zemāka par ekspozīcijas robežvērtību, kas publicēta

sadaļā "Informācija par ekspozīcijas robežvērtībām". Lietot

sertificētus elpošanas ceļu aizsardzības līdzekļus, kas atbilst ES

prasībām (89/656/EEK, 89/686/EEK), vai tiem līdzvērtīgus, ja nav

izslēgta vai pietiekošā mērā ierobežota ieelpošanas riska

varbūtība, lietojot tehniskus kolektīvās aizsardzības līdzekļus vai

atbilstošus darba organizācijas pasākumus, metodes vai

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procedūras.

Vides riska pārvaldība

Vispārīgi ieteikumi

: Apsvērt norobežojuma nodrošināšanu apkārt uzglabāšanas

tvertnēm.

IEDAĻA 9. FIZIKĀLĀS UN ĶĪMISKĀS ĪPAŠĪBAS

9.1 Informācija par pamata fizikālajām un ķīmiskajām īpašībām

Izskats

: Aerosols.

Krāsa

: tīrs, dzeltens

Smarža

: Smaržas, smaržvielas

Nav piemērojams

Uzliesmošanas temperatūra

Nav piemērojams, Uztur degšanu

Smaržas slieksnis

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Kušanas/sasalšanas

temperatūra

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Viršanas punkts un viršanas

temperatūras diapazons

> 35 °C

Iztvaikošanas ātrums

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Uzliesmojamība (cietām

vielām, gāzēm)

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Augšējā

sprādzienbīstamības robeža

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Apakšējā

sprādzienbīstamības robeža

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Tvaika spiediens

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Relatīvais tvaiku blīvums

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Relatīvais blīvums

0.7982 - 0.8505

Šķīdība ūdenī

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Šķīdība citos šķīdinātājos

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Sadalījuma koeficients: n-

oktanols/ūdens

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Pašaizdegšanās

temperatūra

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Termiskā sadalīšanās

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Viskozitāte, kinemātiskā

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Sprādzienbīstamība

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Oksidēšanas īpašības

Viela vai maisījums nav klasificēts kā oksidējošs.

9.2 Cita informācija

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

IEDAĻA 10. STABILITĀTE UN REAĢĒTSPĒJA

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10.1 Reaģētspēja

Nav zināma bīstama reakcija normālos lietošanas apstākļos.

10.2 Ķīmiskā stabilitāte

Stabils normālos apstākļos.

10.3 Bīstamu reakciju iespējamība

Nav zināma bīstama reakcija normālos lietošanas apstākļos.

10.4 Apstākļi, no kuriem jāvairās

Nekas nav zināms.

10.5 Nesaderīgi materiāli

Nekas nav zināms.

10.6 Bīstami sadalīšanās produkti

Sadalīšanās produkti var saturēt sekojošus savienojumus:

Oglekļa oksīdi

Slāpekļa oksīdi (NOx)

Sēra oksīdi

Fosfora oksīdi

IEDAĻA 11. TOKSIKOLOĢISKĀ INFORMĀCIJA

11.1 Informācija par toksikoloģisko ietekmi

Informācija par

iespējamajiem iedarbības

veidiem

Nokļūšana acīs

Nokļūšana uz ādas

Toksicitāte

Akūta perorāla toksicitāte

: Nav pieejami dati par šo produktu.

Akūta ieelpas toksicitāte

: Nav pieejami dati par šo produktu.

Akūta dermāla toksicitāte

: Nav pieejami dati par šo produktu.

Kodīgums/kairinājums ādai

: Nav pieejami dati par šo produktu.

Nopietns acu

bojājums/kairinājums

: Viegls acu kairinājums

Elpceļu vai ādas

sensibilizācija

: Nav pieejami dati par šo produktu.

Kancerogēnums

: Nav pieejami dati par šo produktu.

Reproduktīvā iedarbība

: Nav pieejami dati par šo produktu.

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Mikroorganismu šūnu

mutācija

: Nav pieejami dati par šo produktu.

Teratogenitāte

: Nav pieejami dati par šo produktu.

Toksiskas ietekmes uz īpašu

mērķorgānu vienreizēja

iedarbība

: Nav pieejami dati par šo produktu.

Toksiskas ietekmes uz īpašu

mērķorgānu atkārtota

iedarbība

: Nav pieejami dati par šo produktu.

Aspirācijas toksicitāte

: Nav pieejami dati par šo produktu.

Sastāvdaļas

Akūta perorāla toksicitāte

: propan-2-ol

LD50 Žurka: 5,840 mg/kg

distillates (petroleum), hydrotreated light A complex combination

of hydrocarbons obtained by treating a petroleum fract

LD50 Žurka: > 5,000 mg/kg

Sastāvdaļas

Akūta ieelpas toksicitāte

: difluoroethane

4 h LC50 Žurka: > 437,500 mg/l

propan-2-ol

4 h LC50 Žurka: > 30 mg/l

Sastāvdaļas

Akūta dermāla toksicitāte

: propan-2-ol

LD50 Trusis: 12,870 mg/kg

Iespējamā iedarbība uz veselību

Acis

Izraisa nopietnu acu kairinājumu.

Āda

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Uzņemšana norijot

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Ieelpošana

Ieelpošana var izraisīt ietekmi un centrālo nervu sistēmu.

Hroniskā iedarbība

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Pieredze saistībā ar iedarbību uz cilvēkiem

Nokļūšana acīs

Apsārtums, Sāpes, Kairinājums

Nokļūšana uz ādas

nenozīmīgs kairinājums

Norīšana

Simptomi nav zināmi vai nav paredzami.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

10 / 14

Ieelpošana

Reibonis, Miegainība

IEDAĻA 12. EKOLOĢISKĀ INFORMĀCIJA

12.1 Ekotoksiskums

Iedarbība uz vidi

Šim produktam nav zināmu ekotoksikoloģisko efektu.

Produkts

Toksiskums attiecībā uz

zivīm

: Dati nav pieejami

Toksiskums attiecībā uz

dafnijām un citiem ūdens

bezmugurkaulniekiem.

: Dati nav pieejami

Tokiskums attiecībā uz

aļģēm

: Dati nav pieejami

Sastāvdaļas

Toksiskums attiecībā uz

zivīm

: propan-2-ol

96 h LC50 Pimephales promelas (Grundulis): 9,640 mg/l

distillates (petroleum), hydrotreated light A complex combination

of hydrocarbons obtained by treating a petroleum fract

96 h LC50: > 1,000 mg/l

Sastāvdaļas

Toksiskums attiecībā uz

dafnijām un citiem ūdens

bezmugurkaulniekiem.

: propan-2-ol

LC50 Daphnia magna (Dafnija (ūdensblusa)): > 10,000 mg/l

distillates (petroleum), hydrotreated light A complex combination

of hydrocarbons obtained by treating a petroleum fract

72 h EC50: > 1,000 mg/l

Sastāvdaļas

Tokiskums attiecībā uz

aļģēm

: distillates (petroleum), hydrotreated light A complex combination

of hydrocarbons obtained by treating a petroleum fract

48 h EC50: > 1,000 mg/l

12.2 Noturība un spēja noārdīties

Produkts

Dati nav pieejami

Sastāvdaļas

Bionoārdīšanās

difluoroethane

Rezultāts: Bionoārdāma

propan-2-ol

Rezultāts: Viegli bionoārdāms.

distillates (petroleum), hydrotreated light A complex combination

of hydrocarbons obtained by treating a petroleum fract

Rezultāts: Viegli bionoārdāms.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

11 / 14

Smaržvielas

Rezultāts: Dati nav pieejami

12.3 Bioakumulācijas potenciāls

Dati nav pieejami

12.4 Mobilitāte augsnē

Dati nav pieejami

12.5 PBT un vPvB ekspertīzes rezultāti

Produkts

Novērtējums

Šī viela/maisījums 0,1% vai lielākā daudzumā nesatur

sastāvdaļas, kuras uzskata par noturīgām, bioakumulatīvām un

toksiskām (PBT), vai par ļoti noturīgām un ļoti bioakumulatīvām

(vPvB).

12.6 Citas nelabvēlīgas ietekmes

Dati nav pieejami

IEDAĻA 13. APSVĒRUMI, KAS SAISTĪTI AR APSAIMNIEKOŠANU

Utilizēt atbilstoši Eiropas atkritumu un bīstamo atkritumu direktīvām.Atkritumu kodu piešķir

lietotājs, ieteicams apspriežoties ar atkritumu savākšanas iestādēm.

13.1 Atkritumu apstrādes metodes

Produkts

: Kur vien iespējams, utilizācijas vai sadedzināšanas vietā

ieteicama pārstrāde. Ja pārstrāde nav realizējama, utilizēt

atbilstoši vietējiem noteikumiem. Atkritumus utilizēt apstiprinātā

atkritumu pārstrādes iekārtā.

Piesārņotais iepakojums

: Utilizēt tāpat kā nelietotu produktu. Tukšos konteinerus nogādāt

apstiprinātā atkritumu novietnē pārstrādei vai iznīcināšanai.

Tukšos konteinerus neizmantot atkārtoti. Likvidējiet atbilstoši

vietējiem, valsts un federālajiem noteikumiem.

Eiropas Atkritumu

klasifikators

: 200129* - mazgāšanas līdzekļi, kas satur bīstamas vielas

IEDAĻA 14. INFORMĀCIJA PAR TRANSPORTĒŠANU

Kravas / preču nosūtītājs un (vai) ekspeditors ir atbildīgs par to, ka tiek nodrošināta iepakojuma,

marķējuma un apzīmējumu atbilstība izvēlētajam transporta veidam.

Sauszemes transports

(ADR/ADN/RID)

14.1 ANO numurs

1950

14.2 ANO sūtīšanas

nosaukums

AEROSOLI

14.3 Transportēšanas

bīstamības klase(-es)

14.5 Vides apdraudējumi

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

12 / 14

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

Gaisa transports (IATA)

14.1 ANO numurs

1950

14.2 ANO sūtīšanas

nosaukums

Aerosol, flammable

14.3 Transportēšanas

bīstamības klase(-es)

14.5 Vides apdraudējumi

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

Jūras transports

(IMDG/IMO)

14.1 ANO numurs

1950

14.2 ANO sūtīšanas

nosaukums

Aerosol, flammable

14.3 Transportēšanas

bīstamības klase(-es)

14.5 Vides apdraudējumi

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

14.7 Transportēšana bez

taras atbilstoši MARPOL

73/78 II pielikumam un IBC

kodeksam.

Nav piemērojams

IEDAĻA 15. INFORMĀCIJA PAR REGULĒJUMU

15.1 Drošības, veselības joma un vides noteikumi/ normatīvie akti, kas īpaši attiecas uz vielām

un maisījumiem

Vietējie normatīvie akti

Pievērst uzmanību jauniešu darba aizsardzības direktīvai 94/33/EEK.

Citi noteikumi

"Visiem produktiem:

LR KM 12.03.2002. noteikumi Nr.107 “Ķīmisko vielu un ķīmisko

produktu klasificēšanas, iepakošanas un marķēšanas kārtība”

Eiropas Parlamenta un Padomes regula 1907/2006 (REACH)

LR MK noteikumi 15.05.2007. nr.325 „Darb

15.2 Ķīmiskās drošības novērtējums

Šis produkts satur vielas, kam vēl ir nepieciešams ķīmiskās drošības novērtējums.

IEDAĻA 16. CITA INFORMĀCIJA

R frāžu pilns teksts

Viegli uzliesmojošs.

Kairina acis.

Kaitīgs - norijot var izraisīt plaušu bojājumu.

Tvaiki var radīt miegainību un reiboni.

H paziņojumu pilns teksts

H225

Viegli uzliesmojošs šķidrums un tvaiki.

H226

Uzliesmojošs šķidrums un tvaiki.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

13 / 14

H304

Var izraisīt nāvi, ja norij vai iekļūst elpceļos.

H319

Izraisa nopietnu acu kairinājumu.

H336

Var izraisīt miegainību vai reiboņus.

Citu saīsinājumu pilns teksts

Sagatavoja

Regulatory Affairs

Cipari, kas ir minēti MDDL, ir izteikti sekojošā formātā: 1,000,000 = 1 miljons un 1,000 = 1

tūkstotis. 0.1 = 1 desmitā un 0.001 = 1 tūkstošā daļa

PĀRSKATĪTĀ INFORMĀCIJA: Nozīmīgas izmaiņas šī pārskatītā izdevuma informācijā par

likumdošanu vai veselības aizsardzību ir norādītas ar joslu DDL kreisās puses malā.

Informācija, kas sniegta šajā drošības datu lapā, ir pareiza, ņemot vērā visas mums pieejamās

zināšanas, informāciju un pārliecību tās publicēšanas datumā. Sniegtā informācija ir paredzēta

tikai kā vadlīnijas drošām darbībām, lietošanai, apstrādei, uzglab

PIELIKUMS: IEDARBĪBAS SCENĀRIJI

DPD+ metodika, vielas

:

Sekojošās vielas ir galvenās vielas, kas ietekmē maisījuma iedarbības scenāriju saskaņā ar DPD+

metodiku:

Veids

Viela

CAS Nr.

EINECS Nr.

Norīšana

distillates (petroleum), hydrotreated

light A complex combination of

hydrocarbons obtained by treating a

petroleum fract

64742-47-8

265-149-8

Ieelpošana

difluoroethane

75-37-6

200-866-1

Dermāli

Nav vadošā viela

Acis

propan-2-ol

67-63-0

200-661-7

ūdens vide

Nav vadošā viela

Fizikālās īpašības, DPD+ metodika, vielas:

Viela

Tvaika spiediens

Šķīdība ūdenī

Pow

Molārā masa

distillates (petroleum),

hydrotreated light A

complex combination of

hydrocarbons obtained by

treating a petroleum fract

20 Pa

propan-2-ol

6,020 Pa

60.10 g/mol

Lai aprēķinātu, vai jūsu pakārtotie darbību apstākļi un riska pārvaldības pasākuimi ir droši,

lūdzu aprēķiniet savu riska faktoru zemāk redzamajā tīmekļa vietnē:

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

AROMIST AIR FRESHENING SYSTEM

915412

14 / 14

www.ecetoc.org/tra

Iedarbības scenārija īss

nosaukums

Gaisa atsvaidzinātāja pielietošana

Pielietojuma deskriptori

Galvenās lietotāju grupas

Profesionālie lietojumi. Visi sabiedrībai pieejamie pakalpojumi

(pārvalde, izglītība, izklaide, pakal-pojumi, amatnieku darbs)

Galējā lietojuma nozares

SU22: Profesionālie lietojumi. Visi sabiedrībai pieejamie

pakalpojumi (pārvalde, izglītība, izklaide, pakal-pojumi, amatnieku

darbs)

Procesa kategorijas

PROC11: Smidzināšana tādām vajadzībām, kasnav rūpnieciskas

Produktu kategorijas

PC35: Mazgāšanas un tīrīšanas līdzekļi (tostarp līdzekļi, kas satur

šķīdinātājus)

Izdalīšanās vidē kategorijas

ERC8a: Apstrādes palīgvielu lieto-jums lielos apmēros telpās

atvērtās sistēmās

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

8-11-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

7-11-2018

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm Recalls "Margie" Cheese Due to Listeria Monocytogenes

Sprout Creek Farm of Poughkeepsie, New York is recalling 132 wheels of "Margie" cheese, because it has the potential to be contaminated with Listeria monocytogenes. Listeria monocytogenes is 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

2-11-2018

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company Recalls Roasted and Salted in Shell Pistachios Because of Possible Health Risk

Barcelona Nut Company of Baltimore, Maryland is recalling 239 cases of roasted and salted in shell pistachios, because it has the potential to be contaminated with Salmonella, an organism that 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.

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

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

30-10-2018

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP  75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

Sciegen Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Irbesartan Tablets, USP 75 Mg, 150 Mg, and 300 Mg Due to The Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in The Active Pharmaceutical Ingredient (API)

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a...

FDA - U.S. Food and Drug Administration

30-10-2018

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables

J&J Snack Foods Handheld Corp. of Holly Ridge, NC is voluntarily recalling two lots of Fit & Active Southwest Veggie Stuffed Sandwiches due to potential contamination with Listeria monocytogenes and Salmonella. Salmonella is an organism that 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

30-10-2018

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Training courses on “Steering an Expert Knowledge Elicitation” and “Use of the Expert Knowledge Elicitation Guidance in Risk Assessments for EFSA Management” and “Conduct of the Sheffield protocol for an Expert Knowledge Elicitation”

Published on: Mon, 29 Oct 2018 00:00:00 +0100 This report presents the results from an exploratory study in 2016 on clear communication of scientific assessment results. It had a specific focus on the communication of scientific uncertainties in EFSA scientific opinions. Qualitative methods were applied to the design and communication of an opinion summary and uncertainty statements related to that opinion, and to collect evidence on how different stakeholder groups responded to them. The study tested t...

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance due to the Detection of Trace Amounts of NDEA (NNitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

FDA - U.S. Food and Drug Administration

24-10-2018

U-Pol Inc. recalls Automotive Repair and Refinish Products

U-Pol Inc. recalls Automotive Repair and Refinish Products

Health Canada has established that these products do not meet the mandatory warning labelling requirements for consumer use, as required under Canadian law. They are correctly labelled for workplace professional users, but the products lack the symbols and warnings required for consumer chemicals.

Health Canada

23-10-2018

Zeagle recalls Sport Buoyancy Control Device Inflators

Zeagle recalls Sport Buoyancy Control Device Inflators

There exists a possibility that buttons on the Zeagle Sport BCD inflators may break or fracture leading to a rapid loss of air or auto inflation of the BCD, posing a potential drowning hazard.

Health Canada

19-10-2018

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. Expands Recall of Ice Cream Products Because of Possible Health Risk

Working Cow Homemade, Inc. of St. Petersburg, FL is expanding its voluntary recall to include all ice cream manufactured from August 29, 2017 – October 11, 2018, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nause...

FDA - U.S. Food and Drug Administration

18-10-2018

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

Flushmate recalls Flushmate II 501-B Pressure-Assisted Flushing Systems

The Flushmate II 501-B system can burst at or near the vessel weld seam releasing stored pressure. This pressure can lift the tank lid and shatter the tank, posing impact and laceration hazards to consumers and property damage.

Health Canada

18-10-2018

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Ryerson Canada and Vista Railings Systems Inc. recall Various ProBuilt Aluminum Deck Railing Posts

Certain ProBuilt Aluminum Posts have an issue with the screws that affix the base plate to the post which may cause the post to separate from the base plate when forces over 334 pounds are applied horizontally to the top side of the post. As a result, the posts do not fully comply with local building code requirements and may pose a fall hazard.

Health Canada

18-10-2018

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Training courses in systematic reviews or in specific steps of systematic review for EFSA Risk Assessment

Published on: Wed, 17 Oct 2018 00:00:00 +0200 The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. Th...

Europe - EFSA - European Food Safety Authority Publications

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

9-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines

FDA issued a new series of guidance documents that will advance the development of generic transdermal and topical delivery systems

FDA - U.S. Food and Drug Administration

6-10-2018

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Gourmet to Go Voluntarily Recalls Signature Shaved Country Ham Rolls Due to Possible Health Risk

Ladyfingers Caterers is voluntarily recalling its Signature Shaved Country Ham Rolls as a result of the Johnston County Hams recall. The rolls were made with ham produced by Johnston County Hams, which recently initiated a recall of its ham products due to possible contamination with Listeria monocytogenes. Listeria monocytogenes can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer onl...

FDA - U.S. Food and Drug Administration

5-10-2018

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Consumer Alert: Sprout Creek Farm “Margie” Cheese Batch Recalled

Today the New York State Department of Agriculture and Markets alerted consumers to a pasteurization problem with one of Sprout Creek Farm's pasteurized cow's milk cheeses, "Margie," made on 8/28/2018. Sprout Creek Farm is located in Poughkeepsie, NY. The reason for the recall is the air temperature at the start and end of the pasteurization process is required to be above 150deg F per the Grade "A" Pasteurized Milk Ordinance; the batch in question did not meet that standard. The recall pertains only to...

FDA - U.S. Food and Drug Administration

5-10-2018

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade, Inc. Recalls Product Because of Possible Health Risk

Working Cow Homemade Ice Cream, Inc. of St. Petersburg, FL is conducting a voluntary recall of No Sugar Added Vanilla and No Sugar Added Chocolate ice cream manufactured in three-gallon tubs during the month of May 2018. The recall is being conducted due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only...

FDA - U.S. Food and Drug Administration

27-9-2018

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

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

During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation is voluntarily recalling all of its products produced at the Keaau facility between Sept. 6 - 21, 2018 due to a potential contamination of Escherichia coli (E. coli). The recall was initiated due to E. coli being detected in the well water and distribution system that supplies the firm's operations. No illnesses related to the water have been reported to the state.

FDA - U.S. Food and Drug Administration

20-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

14-9-2018

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Development of an automated multienzymatic biosensor for risk assessment of pesticide contamination in water and food

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The goal of this research is to better address the problems related to the widespread presence of pesticides in the environment. Despite the unquestionable utility of the pesticides against various pests in the agricultural field, most pesticides and the corresponding pesticide residues are toxic to the environment and hazardous to human health. The recent literature on organophosphate compounds emphasises a clear correlation between their use and the occurr...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The currently applied approaches, procedures and tools used for the identification of emerging risks vary greatly among Member States of the EU. EFSA established a structured approach for emerging risk identification that mainly consists of systematically searching, collecting, collating and analysing information and data. In addition, EFSA concluded that new methodologies and tools are needed to facilitate efficient and transparent sharing of data, knowledg...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Risk assessment of substances used in food supplements: the example of the botanical Gymnema sylvestre

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Botanicals and preparations derived from these are among the substances frequently added to foods and food supplements, yet the safety of many botanicals has not been systematically assessed. In the context of the EU‐FORA fellowship programme, the fellow performed an assessment on the safety of the botanical Gymnema sylvestre, in accordance with EFSA's guidance on the assessment of safety of botanicals. Although preparations of G. sylvestre are marketed as f...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Novel foods: a risk profile for the house cricket (Acheta domesticus)

Published on: Tue, 28 Aug 2018 00:00:00 +0200 Novel foods could represent a sustainable alternative to traditional farming and conventional foodstuffs. Starting in 2018, Regulation (EU) 2283/2015 entered into force, laying down provisions for the approval of novel foods in Europe, including insects. This Approved Regulation establishes the requirements that enable Food Business Operators to bring new foods into the EU market, while ensuring high levels of food safety for European consumers. The present ...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Hawthorne Hydroponics LLC recalls Ideal-Air 175 pint Industrial Grade Humidifiers

Hawthorne Hydroponics LLC recalls Ideal-Air 175 pint Industrial Grade Humidifiers

The humidifiers can overheat while in use, posing a risk of fire and electrical shock.

Health Canada

1-9-2018

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Multiple “Dr. King’s” homeopathic and “Natural Pet” veterinary products recalled due to potential microbial contamination

Health Canada is advising consumers and pet owners not to use homeopathic and veterinary products made by King Bio Inc. and labeled as "Dr. King's," "Dr King's Natural Pet" or "Natural Pet." These products may pose a health risk to people and pets, especially children, pregnant women and those with compromised immune systems, because of potential microbial contamination. According to the United States Food and Drug Administration, high levels of microbial contamination were identified at the manufacturin...

Health Canada

30-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 During the project seven standard operating procedures (SOP) were developed for the four data domains (zoonoses, chemical contaminant, pesticide residues and veterinary medical products residues). The SOPs describe 1) How the national governance of risk assessment data is organised, 2) how data are collected and validated before delivering to EFSA covering all four domains, 3) How data is transferred to EFSA, 4) how to respond to EFSA request for clarificati...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

24-8-2018

Imagine recalls Buckyballs magnet sets

Imagine recalls Buckyballs magnet sets

Health Canada has determined that these magnet sets are a danger to human health and safety because they contain small powerful magnets which can be easily swallowed or inhaled by children. Unlike other small objects that would be more likely to pass normally through the digestive system if swallowed, when more than one small powerful magnet is swallowed, the magnets can attract one another while travelling through the digestive system. The magnets can then pinch together and create a blockage and slowly...

Health Canada

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

22-8-2018

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industr...

FDA - U.S. Food and Drug Administration

21-8-2018

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk

Lipari Foods, LLC has issued a voluntary recall of Premo Brand turkey and cheese wedge sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal...

FDA - U.S. Food and Drug Administration

21-8-2018

Confer Plastics, Inc. recalls Curve Pool Step Systems

Confer Plastics, Inc. recalls Curve Pool Step Systems

Children’s limbs can be entrapped in the side openings, posing a drowning hazard.

Health Canada

18-8-2018

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan / Amlodipine / HCTZ Tablets

Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probabl...

FDA - U.S. Food and Drug Administration

17-8-2018

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke

FDA has reviewed the final results from the post-approval study conducted by SynCardia Systems, LLC. for their Temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). These final results indicate a higher mortality rate and higher stroke rate for patients initially supported with the C2 Driver System compared to patients initially supported with the previous generation driver, the Circulatory Support System (CSS) Console.

FDA - U.S. Food and Drug Administration

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

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

8-8-2018

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves treatment for two rare types of non-Hodgkin lymphoma

FDA approves new drug for the treatment of adults with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy

FDA - U.S. Food and Drug Administration

28-7-2018

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes

Lipari Foods, LLC has issued a voluntary recall of Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches produced and packaged by sister company JLM due to potential contamination of Listeria monocytogenes. Listeria monocytogenes is an organism, which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness,...

FDA - U.S. Food and Drug Administration

26-7-2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Medical Devices Safety Update Volume 6, Number 4, July 2018

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Therapeutic Goods Administration - Australia

24-7-2018

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

FDA - U.S. Food and Drug Administration

18-7-2018

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

Intragastric balloon systems

Intragastric balloon systems

Safety information for Intragastric Balloon Systems

Therapeutic Goods Administration - Australia

17-7-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of Valsartan and Valsartan Hydrochlorothiazide Tablets

Teva Pharmaceuticals USA today confirmed a voluntary recall to the consumer / user level of 29 lots of single and 51 lots of combination valsartan medicines distributed under the Actavis label in the U.S. due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical. The impurity detected in the API is N- nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking wat...

FDA - U.S. Food and Drug Administration

19-10-2018

New Safety Communication. @US_FDA   is sharing Updated Information To Reduce Potential Cardiac Surgery   Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More:  https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

New Safety Communication. @US_FDA is sharing Updated Information To Reduce Potential Cardiac Surgery Infection Risks Associated With the LivaNova 3T Heater-Cooler Systems. Read More: https://go.usa.gov/xPnNW  #FDA #MedicalDevice

FDA - U.S. Food and Drug Administration

17-8-2018

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System.  https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

#FDA issues letter to healthcare providers on the final post-approval study results & risks associated with #SynCardia TAH-t: C2 Driver System. https://go.usa.gov/xUeYd  #MedicalDevices

FDA - U.S. Food and Drug Administration

12-8-2018

IMDRF consultation: Unique Device Identification system

IMDRF consultation: Unique Device Identification system

The IMDRF is seeking comments on a proposed guidance document and two information documents

Therapeutic Goods Administration - Australia

10-8-2018

Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle  https://go.usa.gov/xUHbw  #fda #medicaldevice

Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle https://go.usa.gov/xUHbw  #fda #medicaldevice

Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle https://go.usa.gov/xUHbw  #fda #medicaldevice

FDA - U.S. Food and Drug Administration

6-8-2018

Scientific guideline:  ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

Scientific guideline: ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version, draft: consultation open

This new multidisciplinary guideline is proposed to address biopharmaceutics classification system (BCS)-based biowaivers. BCS-based biowaivers may be applicable to BCS Class I and III drugs, however BCS-based biowaivers for these two classes are not recognized worldwide. This means that pharmaceutical companies have to follow different approaches in the different regions. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide rec...

Europe - EMA - European Medicines Agency

30-7-2018

Special Access Scheme online system

Special Access Scheme online system

Introduction of the Special Access Scheme online system

Therapeutic Goods Administration - Australia

22-7-2018

NEST will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. But it requires addressing variations in data standards and ensuring systems talk to each other

NEST will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. But it requires addressing variations in data standards and ensuring systems talk to each other

NEST will facilitate timely detection of potential safety risks that wouldn’t otherwise be identified as quickly, or at all. But it requires addressing variations in data standards and ensuring systems talk to each other

FDA - U.S. Food and Drug Administration

22-7-2018

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claimspic.twitter.com/m2UaZ6gEaV

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claimspic.twitter.com/m2UaZ6gEaV

We'll establish a robust medical device patient safety net by continuing our work on NEST, or the National Evaluation System for health Technology. NEST links data from registries, EHRs and billing claims pic.twitter.com/m2UaZ6gEaV

FDA - U.S. Food and Drug Administration