PRO SHINE SPECIAL

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  • Handelsnavn:
  • PRO SHINE SPECIAL
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Medicinsk udstyr

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Lokation

  • Fås i:
  • PRO SHINE SPECIAL
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Ecolab
  • Autorisationsnummer:
  • 111104E
  • Sidste ændring:
  • 12-03-2018

Produktresumé

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i henhold til Forordning (EF) nr.

1907/2006

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PUNKT 1. IDENTIFIKATION AF STOFFET/ BLANDINGEN OG AF SELSKABET/ VIRKSOMHEDEN

1.1 Produktidentifikator

Produktnavn

Pro shine special

Produkt kode

111104E

Anvendelse af stoffet/det

kemiske produkt

Møbelpolish

Stoftype

Blanding

Kun til erhvervsmæssig brug.

Information om fortyndning

Ingen information om fortyndning angivet.

1.2 Relevante identificerede anvendelser for stoffet eller blandingen samt anvendelser, der

frarådes

Identificerede anvendelser

Møbelpolish; Manuel proces

Anbefalede begrænsninger i

brugen

Forbeholdt industriel og erhvervsmæssig brug.

1.3 Nærmere oplysninger om leverandøren af sikkerhedsdatabladet

Firma

Ecolab ApS

Høffdingsvej 36

2500 Valby, Danmark Tel +45 36 15 85 85

dk-customerservice@ecolab.com

1.4 Nødtelefon

Nødtelefon

+4578746855

+32-(0)3-575-5555 Transeuropæisk

Giftinformationen tlf. nr.

82 12 12 12

Udstedelse-/revisionsdato

13.07.2017

Udgave

PUNKT 2. FAREIDENTIFIKATION

2.1 Klassificering af stoffet eller blandingen

Klassificering (FORORDNING (EF) Nr. 1272/2008)

Øjenirritation, Kategori 2

H319

2.2 Mærkningselementer

Etikettering (FORORDNING (EF) Nr. 1272/2008)

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Farepiktogrammer

Signalord

Advarsel

Faresætninger

H319

Forårsager alvorlig øjenirritation.

Sikkerhedssætninger

Forebyggelse:

P280

Bær øjenbeskyttelse/ ansigtsbeskyttelse.

Tillægsmærkning:

Særlig mærkning af visse

blandinger

Indeholder: Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-

methyl-2H-isothiazol-3-on (3:1) Kan udløse

allergisk reaktion.

2.3 Andre farer

Ingen kendte.

PUNKT 3. SAMMENSÆTNING AF/ OPLYSNING OM INDHOLDSSTOFFER

3.2 Blandinger

Farlige komponenter

Kemisk betegnelse

CAS-Nr.

EF-Nr.

REACH No.

KlassificeringFORORDNING (EF) Nr.

1272/2008

Koncentration

Hvid mineralolie

(petroleum)

8042-47-5

232-455-8

01-2119487078-27

Aspirationsfare Kategori 1; H304

>= 10 - < 20

Alkoholer, C13-15,

forgrenede og lineære,

ethoxylerede

157627-86-6

Akut toksicitet Kategori 4; H302

Hudirritation Kategori 2; H315

Alvorlig øjenskade Kategori 1; H318

Akut toksicitet for vandmiljøet Kategori 1;

H400

>= 1 - < 2.5

Blanding: 5-chlor-2-

methyl-2H-isothiazol-3-on

med 2-methyl-2H-

isothiazol-3-on (3:1)

55965-84-9

05-2117814284-47

Akut toksicitet Kategori 3; H301

Akut toksicitet Kategori 3; H331

Akut toksicitet Kategori 3; H311

Hudætsning Kategori 1B; H314

Hudsensibilisering Kategori 1; H317

Akut toksicitet for vandmiljøet Kategori 1;

H400

Kronisk toksicitet for vandmiljøet.

Kategori 1; H410

< 0.0015

For den fuldstændige tekst af faresætningerne nævnt i dette punkt, se punkt 16.

PUNKT 4. FØRSTEHJÆLPSFORANSTALTNINGER

4.1 Beskrivelse af førstehjælpsforanstaltninger

I tilfælde af øjenkontakt

Skyl straks med rigeligt vand, også under øjenlågene i mindst 15

minutter. Fjern eventuelle kontaktlinser, hvis dette kan gøres let.

Fortsæt skylning. Søg lægehjælp.

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I tilfælde af hudkontakt

Skyl med rigeligt vand.

Ved indtagelse.

Skyl munden. Søg læge hvis symptomer opstår.

Hvis det indåndes

Søg læge hvis symptomer opstår.

4.2 Vigtigste symptomer og virkninger, både akutte og forsinkede

I afsnit 11 findes mere detaljerede oplysninger om helbredspåvirkninger og symptomer.

4.3 Angivelse af om øjeblikkelig lægehjælp og særlig behandling er nødvendig

Behandling

Behandles symptomatisk.

PUNKT 5. BRANDBEKÆMPELSE

5.1 Slukningsmidler

Egnede slukningsmidler

Brandslukningsforanstaltningerne skal være hensigtsmæssige i

forhold til lokale omstændigheder og det omgivne miljø.

Uegnede slukningsmidler

Ingen kendte.

5.2 Særlige farer i forbindelse med stoffet eller blandingen

Specifikke farer ved

brandbekæmpelse

Ikke brandfarligt eller brændbart.

Farlige

forbrændingsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

Fosforholdige oxider

5.3 Anvisninger for brandmandskab

Særlige personlige

værnemidler, der skal bæres

af brandmandskabet

: Brug personligt beskyttelsesudstyr.

Yderligere oplysninger

: Brandrester og forurenet brandslukningsvand skal bortskaffes i

henhold til de lokale regler. Indånd ikke dampe i tilfælde af brand

og/eller eksplosion.

PUNKT 6. FORHOLDSREGLER OVER FOR UDSLIP VED UHELD

6.1 Personlige sikkerhedsforanstaltninger, personlige værnemidler og nødprocedurer

Rådgivning for ikke-

indsatspersonel

Sørg for, at rengøring kun udføres at uddannet personale. Der

henvises til beskyttelsesforanstaltninger nævnt i afsnit 7 og 8.

Rådgivning for

indsatspersonel

Hvis særlig beklædning er påkrævet for at håndtere spildet, skal

man være opmærksom på alle oplysninger i punkt 8 om passende

og upassende materialer.

6.2 Miljøbeskyttelsesforanstaltninger

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Miljøbeskyttelsesforanstaltnin

Tillad ikke kontakt med jord, overflade- eller grundvand.

6.3 Metoder og udstyr til inddæmning og oprensning

Metoder til oprydning

Stands lækagen, hvis dette er sikkert. Opbevar og opsaml spild

med ikke brændbart absorberende materiale, (f. eks. sand, jord,

moler el. vermikulit) og placer det i affaldsbeholdere i henhold til

de lokale myndigheders forskrifter (se afsnit 13).Skyl rester væk

med vand. Ved store spild, inddæm det spildte materiale eller

saml det op på anden vis, for at sikre at spild ikke når vandveje.

6.4 Henvisning til andre punkter

Se Afsnit 1 for kontaktoplysninger i nødsituationer.

For personlig beskyttelse se punkt 8.

Se Afsnit 13 for yderligere oplysninger om affaldshåndtering.

PUNKT 7. HÅNDTERING OG OPBEVARING

7.1 Forholdsregler for sikker håndtering

Råd om sikker håndtering

Undgå kontakt med huden og øjnene. Brug kun med tilstrækkelig

ventilation. Vask hænder grundigt efter brug.

Hygiejniske foranstaltninger

Skal håndteres i overensstemmelse med god erhvervshygiejne og

sikkerhedsforanstaltninger. Fjern forurenet tøj og vask før

genbrug. Vask ansigt, hænder og alt udsat hud grundigt efter

brug.

7.2 Betingelser for sikker opbevaring, herunder eventuel uforenelighed

Krav til lager og beholdere

Opbevares utilgængeligt for børn. Hold beholderen tæt lukket.

Opbevares i behørigt mærkede beholdere.

Opbevaringstemperatur

0 °C til 30 °C

7.3 Særlige anvendelser

Særlige anvendelser

Møbelpolish; Manuel proces

PUNKT 8. EKSPONERINGSKONTROL/PERSONLIGE VÆRNEMIDLER

8.1 Kontrolparametre

Grænseværdier for erhvervsmæssig eksponering

Komponenter

CAS-Nr.

Ventil type

(Påvirkningsform)

Kontrolparametre

Basis

Hvid mineralolie

(petroleum)

8042-47-5

GV (tåge og

partikler)

1 mg/m3

DK OEL

8.2 Eksponeringskontrol

Passende tekniske foranstaltninger

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Tekniske foranstaltninger

God generel ventilation skulle være tilstrækkeligt til at kontrollere

arbejdernes udsættelse for luftbårne urenheder.

Individuelle beskyttelsesforanstaltninger

Hygiejniske foranstaltninger

Skal håndteres i overensstemmelse med god erhvervshygiejne og

sikkerhedsforanstaltninger. Fjern forurenet tøj og vask før

genbrug. Vask ansigt, hænder og alt udsat hud grundigt efter

brug.

Beskyttelse af øjne / ansigt

(EN 166)

Sikkerhedsbriller med sideskærme

Beskyttelse af hænder (EN

374)

Intet specielt beskyttelsesudstyr nødvendigt.

Beskyttelse af hud og krop

(EN 14605)

Intet specielt beskyttelsesudstyr nødvendigt.

Åndedrætsværn (EN 143,

14387)

Ingen påkrævet, hvis luftbårne koncentrationer holdes under de

oplyste grænseværdier for eksponering. Brug certificerede

åndedrætsværn der opfylder EU-krav (89/656 / EØF, 89/686 /

EØF) eller tilsvarende, når respiratoriske risici ikke kan undgås

eller i tilstrækkelig grad begrænses ved kollektive tekniske

beskyttelsesforanstaltninger eller ved foranstaltninger, metoder

eller procedurer i tilrettelæggelse af arbejdet.

Foranstaltninger til begrænsning af eksponering af miljøet

Generelle anvisninger

: Overvej om det er nødvendig at lukke opbevaringsbeholderne

inde.

PUNKT 9. FYSISKE OG KEMISKE EGENSKABER

9.1 Oplysninger om grundlæggende fysiske og kemiske egenskaber

Udseende

: Emulsion.

Farve

: hvid

Lugt

: Parfumer, duftstoffer

pH-værdi

7.5 - 8.5, 100 %

Flammepunkt

Ikke anvendelig

Lugttærskel

Ikke anvendelig og/eller ikke bestemt for blandingen

Smeltepunkt/frysepunkt

Ikke anvendelig og/eller ikke bestemt for blandingen

Begyndelseskogepunkt og

kogepunktsinterval

Ikke anvendelig og/eller ikke bestemt for blandingen

Fordampningshastighed

Ikke anvendelig og/eller ikke bestemt for blandingen

Antændelighed (fast stof,

luftart)

Ikke anvendelig og/eller ikke bestemt for blandingen

Højeste eksplosionsgrænse

Ikke anvendelig og/eller ikke bestemt for blandingen

Laveste eksplosionsgrænse

Ikke anvendelig og/eller ikke bestemt for blandingen

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Damptryk

Ikke anvendelig og/eller ikke bestemt for blandingen

Relativ dampvægtfylde

Ikke anvendelig og/eller ikke bestemt for blandingen

Relativ massefylde

0.95 - 1.0

Vandopløselighed

opløselig

Opløselighed i andre

opløsningsmidler

Ikke anvendelig og/eller ikke bestemt for blandingen

Fordelingskoefficient: n-

oktanol/vand

Ikke anvendelig og/eller ikke bestemt for blandingen

Selvantændelsestemperatur

Ikke anvendelig og/eller ikke bestemt for blandingen

Termisk spaltning

Ikke anvendelig og/eller ikke bestemt for blandingen

Viskositet, kinematisk

300.000 mm2/s (40 °C)

Eksplosive egenskaber

Ikke anvendelig og/eller ikke bestemt for blandingen

Oxiderende egenskaber

Stoffet eller blandingen er ikke klassificeret som oxiderende.

9.2 Andre oplysninger

Ikke anvendelig og/eller ikke bestemt for blandingen

PUNKT 10. STABILITET OG REAKTIVITET

10.1 Reaktivitet

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.2 Kemisk stabilitet

Stabil under normale forhold.

10.3 Risiko for farlige reaktioner

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.4 Forhold, der skal undgås

Ingen kendte.

10.5 Materialer, der skal undgås

Ingen kendte.

10.6 Farlige nedbrydningsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

Fosforholdige oxider

PUNKT 11. TOKSIKOLOGISKE OPLYSNINGER

11.1 Oplysninger om toksikologiske virkninger

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Oplysninger om sandsynlige

eksponeringsveje

Indånding, Øjenkontakt, Hudkontakt

Produkt

Akut oral toksicitet

: Estimat for akut toksicitet : > 2,000 mg/kg

Akut toksicitet ved indånding

: Der er ingen tilgængelige data på dette produkt.

Akut dermal toksicitet

: Der er ingen tilgængelige data på dette produkt.

Hudætsning/-irritation

: Der er ingen tilgængelige data på dette produkt.

Alvorlig

øjenskade/øjenirritation

: Svag øjenirritation

Respiratorisk sensibilisering

eller hudsensibilisering

: Der er ingen tilgængelige data på dette produkt.

Kræftfremkaldende

egenskaber

: Der er ingen tilgængelige data på dette produkt.

Reproduktionsskadende

virkninger

: Der er ingen tilgængelige data på dette produkt.

Kimcellemutagenicitet

: Der er ingen tilgængelige data på dette produkt.

Fosterbeskadigelse

: Der er ingen tilgængelige data på dette produkt.

Enkel STOT-eksponering

: Der er ingen tilgængelige data på dette produkt.

Gentagne STOT-

eksponeringer

: Der er ingen tilgængelige data på dette produkt.

Aspiration giftighed

: Der er ingen tilgængelige data på dette produkt.

Komponenter

Akut oral toksicitet

: Hvid mineralolie (petroleum)

LD50 Rotte: 5,000 mg/kg

Alkoholer, C13-15, forgrenede og lineære, ethoxylerede

LD50 Rotte: 1,250 mg/kg

Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

LD50 Rotte: 457 mg/kg

Komponenter

Akut toksicitet ved indånding

: Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

4 h LC50 Rotte: 0.33 mg/l

Komponenter

Akut dermal toksicitet

: Alkoholer, C13-15, forgrenede og lineære, ethoxylerede

LD50 Rotte: > 2,000 mg/kg

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Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

LD50 Kanin: 660 mg/kg

Potentielle sundhedspåvirkninger

Øjne

Forårsager alvorlig øjenirritation.

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indtagelse

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indånding

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Langtidspåvirkning

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Erfaringer med human eksponering

Øjenkontakt

Rødme, Smerte, Irritation

Hudkontakt

Ingen kendte eller forventede symptomer.

Indtagelse

Ingen kendte eller forventede symptomer.

Indånding

Ingen kendte eller forventede symptomer.

PUNKT 12. MILJØOPLYSNINGER

12.1 Økotoksicitet

Miljøpåvirkninger

Dette produkt har ingen kendt økotoksikologisk effekt.

Produkt

Toksicitet overfor fisk

: Ingen data tilgængelige

Toksicitet for dafnier og

andre hvirvelløse vanddyr.

: Ingen data tilgængelige

Toksicitet overfor alger

: Ingen data tilgængelige

Komponenter

Toksicitet overfor fisk

: Hvid mineralolie (petroleum)

96 h LC50 Oncorhynchus mykiss (Regnbueforel): > 100 mg/l

Komponenter

Toksicitet for dafnier og

andre hvirvelløse vanddyr.

: Alkoholer, C13-15, forgrenede og lineære, ethoxylerede

48 h EC50 Daphnia magna (Stor dafnie): 0.317 mg/l

Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

48 h EC50 Daphnia (Dafnie): 0.16 mg/l

12.2 Persistens og nedbrydelighed

Produkt

Ingen data tilgængelige

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Komponenter

Biologisk nedbrydelighed

Hvid mineralolie (petroleum)

Resultat: Bionedbrydelig

Alkoholer, C13-15, forgrenede og lineære, ethoxylerede

Resultat: Let bionedbrydeligt.

Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

Resultat: Let bionedbrydeligt.

12.3 Bioakkumuleringspotentiale

Ingen data tilgængelige

12.4 Mobilitet i jord

Ingen data tilgængelige

12.5 Resultater af PBT- og vPvB-vurdering

Produkt

Vurdering

Dette stof/blanding indeholder ingen komponenter, der anses for

at være enten persistente, bioakkumulerende og toksiske (PBT)

eller meget persistente og meget bioakkumulerende (vPvB) ved

niveauer på 0.1% eller højere.

12.6 Andre negative virkninger

Ingen data tilgængelige

PUNKT 13. BORTSKAFFELSE

Bortskaffes i overensstemmelse med EU-direktiverne om affald og farligt affald.Affaldskoder skal

fastsættes af bruger, at fortrække i samarbejde med de myndigheder der er ansvarlig for

bortskaffelse af affald.

13.1 Metoder til affaldsbehandling

Produkt

: Hvor det er muligt foretrækkes genanvendelse frem for

bortskaffelse eller forbrænding. Hvis genanvendelse ikke er

praktisk muligt, skal bortskaffelse ske i henhold til lokale

regulativer. Bortskaf affald til en godkendt

affaldsbortskaffelsesfacilitet.

Forurenet emballage

: Bortskaffes som ikke-forarbejdet produkt. Tomme beholdere skal

bringes til et godkendt affaldsdeponeringssted for genbrug eller

bortskaffelse. Tomme beholdere må ikke genbruges. Bortskaffes i

overensstemmelse med lokale, regionale og nationale

bestemmelser.

Vejledning til valg af

affaldskoder

: Organisk affald indeholdende farlige stoffer. Hvis dette produkt

anvendes i yderligere processer, skal den endelige bruger

omdefinere og tildele den mest hensigtsmæssige Europæiske

Affaldskatalogkode (EAK). Det påhviler den der producerer

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affaldet at bestemme toksicitet og fysiske egenskaber af

materialet som genereres for at identificere affaldet korrekt og

bestemme bortskaffelsemetoder af affaldet i overensstemmelse

med gældende europæisk (EU direktiv 2008/98 / EF) og lokale

bestemmelser.

PUNKT 14. TRANSPORTOPLYSNINGER

Afsenderen har ansvar for, at emballager, etikettering og mærkning er i overensstemmelse med den

valgte transportform.

Vejtransport (ADR/ADN/RID)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Lufttransport (IATA)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Søtransport (IMDG/IMO)

14.1 FN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

14.7 Bulktransport i henhold

til bilag II til MARPOL 73/78

og IBC-koden

Ikke farligt gods

PUNKT 15. OPLYSNINGER OM REGULERING

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15.1 Særlige bestemmelser/særlig lovgivning for stoffet eller blandingen med hensyn til

sikkerhed, sundhed og miljø

iht. Detergent Forordningen

EU 648/2004

5 % eller derover men under 15 %: Alifatiske kulbrinter

under 5 %: Nonioniske overfladeaktive stoffer, Polycarboxylater

Andre bestanddele: Parfume

Konserveringsmidler:

Blanding: 5-chlor-2-methyl-2H-isothiazol-3-on med 2-methyl-2H-

isothiazol-3-on (3:1)

Allergener:

Hexylcinnamaldehyd

National lovgivning

Vær opmærksom på Dir 94/33/EF til beskyttelse af unge mennesker på arbejde.

Produktregister nummer

2293979

15.2 Kemikaliesikkerhedsvurdering

Produktet indeholder stoffer, for hvilke der fortsat kræves en kemisk sikkerhedsvurdering.

PUNKT 16. ANDRE OPLYSNINGER

Procedure anvendt til at bestemme klassificeringen i henhold til

FORORDNING (EF) Nr. 1272/2008

Klassifikation

Begrundelse

Øjenirritation 2, H319

Beregningsmetode

Fuld tekst af H-sætninger

H301

Giftig ved indtagelse.

H302

Farlig ved indtagelse.

H304

Kan være livsfarligt, hvis det indtages og kommer i luftvejene.

H311

Giftig ved hudkontakt.

H314

Forårsager svære forbrændinger af huden og øjenskader.

H315

Forårsager hudirritation.

H317

Kan forårsage allergisk hudreaktion.

H318

Forårsager alvorlig øjenskade.

H331

Giftig ved indånding.

H400

Meget giftig for vandlevende organismer.

H410

Meget giftig med langvarige virkninger for vandlevende organismer.

Fuld tekst af andre forkortelser

ADN - Europæisk konvention om international transport af farligt gods ad indre vandveje; ADR -

Europæisk konvention om international transport af farligt gods ad vej; AICS

- Australiens

fortegnelse over kemiske stoffer; ASTM - Det amerikanske forbund for testning af materialer,

ASTM; bw - Kropsvægt; CLP - CLP-forordningen om klassificering, mærkning og emballering;

Forordning (EF) Nr. 1272/2008; CMR - Kræftfremkaldende, mutagent eller reproduktionstoksisk

stof; DIN - Standard fra det tyske standardiseringsinstitut; DSL - Liste over indenlandske stoffer

(Canada);

ECHA

europæiske

kemikalieagentur;

EC-Number

EU-nummer;

Koncentration forbundet med x % respons; ELx - Belastningsgrad forbundet med x % respons;

EmS - Nødplan; ENCS - Eksisterende og nye kemiske stoffer (Japan); ErCx - Koncentration

forbundet med x % vækstrate respons; GHS - Det globale harmoniserede system; GLP - God

SIKKERHEDSDATABLAD

i henhold til Forordning (EF) nr. 1907/2006

Pro shine special

111104E

12 / 13

laboratoriepraksis;

IARC

Internationale

Agentur

Kræftforskning;

IATA

Internationale Luftfartssammenslutning, IATA; IBC - Den internationale kode for konstruktion og

udrustning af skibe, som fører farlige kemikalier i bulk; IC50 - Halv maksimal inhiberende

koncentration; ICAO - Organisationen for International Civil Luftfart, ICAO; IECSC - Fortegnelse

over eksisterende kemikalier i Kina; IMDG - Det internationale regelsæt for søtransport af farligt

gods; IMO - Den Internationale Søfartsorganisation; ISHL - Lov om industriel sikkerhed og

sundhed (Japan); ISO - International standardiseringsorganisation; KECI - Koreas fortegnelse

over eksisterende kemikalier; LC50 - Dødelig koncentration for 50 % af en testpopulation; LD50 -

Dødelig dosis for 50 % af en testpopulation (gennemsnitlig dødelig dosis); MARPOL - Den

internationale konvention om forebyggelse af forurening fra skibe; n.o.s. - Andet ikke angivet;

NO(A)EC - Koncentration for ingen observeret (negativ) virkning; NO(A)EL - Niveau for ingen

observeret (negativ) virkning; NOELR - Belastningsgrad for ingen observeret virkning; NZIoC -

New Zealands fortegnelse over kemikalier; OECD - Organisationen for Økonomisk Samarbejde

og Udvikling; OPPTS - Afdelingen for kemisk sikkerhed og forebyggelse af forurening; PBT -

Persistent, bioakkumulativt og giftigt stof; PICCS - Fillippinernes fortegnelse over kemikalier og

kemiske stoffer; (Q)SAR - (Kvantitativt) forhold mellem struktur og aktivitet; REACH - Europa-

parlamentets og Rådets forordning (EF) nr. 1272/2008 om registrering, vurdering og godkendelse

af samt begrænsninger for kemikalier; RID - Reglement for international befordring af farligt gods

med jernbane; SADT - Selvaccelererende dekompositionstemperatur; SDS - Sikkerhedsdatablad;

TCSI - Taiwans fortegnelse over kemiske stoffer; TRGS - Teknisk forskrift for farlige stoffer; TSCA

- Lov om kontrol af giftige stoffer (USA); UN - Forenede Nationer; vPvB - Meget persistent og

meget bioakkumulativ

Udarbejdet af

Regulatory Affairs

Tal angives i sikkerhedsdatabladet i følgende form: 1,000,000 = 1 million og 1,000 = 1 tusind. 0.1

= 1 tiendedel og 0.001 = 1 tusindedel.

REVIDERET INFORMATION: Signifikante ændringer i den regulatoriske eller sundhedsmæssige

information af denne revision er angivet med en lodret streg i sikkerhedsdatabladets venstre

margin.

Informationerne i dette Arbejdshygiejniske Datablad er efter vor bedste viden, oplysninger og

overbevisning korrekte på datoen, hvor det er trykt. Informationerne tjener kun som vejledning til

sikker håndtering, brug, forarbejdning, lagring, transport, disponering og frigivelse og kan ikke

betragtes som en garanti eller kvalitetsangivelse. Informationerne vedrører kun det udtrykkeligt

angivne materiale og er ikke gældende for dette materiale anvendt i kombination med andre

materialer eller forarbejdning, medmindre udtrykkeligt anført i teksten.

BILAG: EKSPONERINGSSCENARIER

DPD+-stoffer

:

Følgende stoffer er de vigtigste stoffer der bidrager til blandingens eksponeringsscenarie i henhold

til DPD+-regelen:

Måde for

optagelse

Stof

CAS-Nr.

EINECS-Nr.

Indtagelse

Hvid mineralolie (petroleum)

8042-47-5

232-455-8

Indånding

Ikke afhængighedsstof

Alkoholer, C13-15, forgrenede og

lineære, ethoxylerede

157627-86-6

SIKKERHEDSDATABLAD

i henhold til Forordning (EF) nr. 1907/2006

Pro shine special

111104E

13 / 13

Øjne

Alkoholer, C13-15, forgrenede og

lineære, ethoxylerede

157627-86-6

vandmiljø

Alkoholer, C13-15, forgrenede og

lineære, ethoxylerede

157627-86-6

Fysikaliske egenskaber DPD+-stoffer:

Stof

Damptryk

Vandopløselighe

d

Pow

Molar masse

Hvid mineralolie

(petroleum)

0.01 HPa

For at beregne om anvendelsesforholdene og de nødvendige risikohåndteringsforanstaltninger

er sikre, venligst kalkuler risikofaktor på dette web site:

www.ecetoc.org/tra

Eksponeringsscenariets korte

titel

Møbelpolish; Manuel proces

Use descriptors

Hovedbrugergrupper

Faglige anvendelser: Det offentlige område (administration,

uddannelse, forlystelser, tjeneste-ydelser, håndværkere)

Slutanvendelsessektor

SU22: Faglige anvendelser: Det offentlige område (administration,

uddannelse, forlystelser, tjeneste-ydelser, håndværkere)

Proceskategorier

PROC10: Påføring med rulle eller pensel

Produktkategorier

PC31: Polermidler og voksblandinger

Miljøudledningskategorier

ERC8a: Udbredt indendørs anvendelse af proceshjælpemidler i

åbne systemer

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



  • Dokumenter på andre sprog er tilgængelige her

18-10-2018

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

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

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Europe - EFSA - European Food Safety Authority Publications

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

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery Recalls Fred Meyer Bakery Angel Food Cake Bar Due to Undeclared Allergens

Clackamas Bakery has recalled Fred Meyer Bakery Angel Food Cake Bar (12 oz.) sold in its retail stores because the product may contain milk and soy not listed on the label. Clackamas Bakery initiated the recall when it was discovered that the Fred Meyer Bakery Angel Food Cake Bar label had been incorrectly applied to packages of cornbread.

FDA - U.S. Food and Drug Administration

16-10-2018

Brexit: Two-year implementation period for name and address changes

Brexit: Two-year implementation period for name and address changes

During an implementation period of maximum two years, it will be permitted to sell released packs on which a UK marketing authorisation holder or a representative is indicted as well as packs on which an EEA marketing authorisation holder or a representative is indicated for the concerned D.Sp.No. (Danish speciality number).

Danish Medicines Agency

16-10-2018

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Evaluation of confirmatory data following the Article 12 MRL review for teflubenzuron

Published on: Mon, 15 Oct 2018 00:00:00 +0200 The applicant BASF Agro BV submitted a request to the competent national authority in United Kingdom to evaluate the confirmatory data that were identified for teflubenzuron in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new metabolism study on leafy crops, a study investigating the nature of residues under standard hydrolytic conditions and a validated ...

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”

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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

15-10-2018

Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA’s new steps to modernize drug development, improve efficiency and promote innovation of targeted therapies

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FDA issues two guidance documents to provide drug developers greater clarity and direction as they pursue the next generation of therapies and treatments for patients.

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15-10-2018

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Toy Land Company recalls Boom Boom ChemsSlime andPutty

Health Canada has determined that the slime and putty products do not meet the Canadian toy safety requirements related to boric acid content.

Health Canada

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

12-10-2018

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Voluntary Recall of Limited Amounts of Nuts & Vanilla Protein Plant Shake

Forager Project is recalling three dates of Nuts and Vanilla – Organic Plant Protein Shake because the product contains almond flour which is not declared on the label.

FDA - U.S. Food and Drug Administration

11-10-2018

Cooper Lighting LLC Recalls All-Pro and Defiant Solar/Battery Powered Light Fixtures

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The batteries in the solar-powered light fixtures can overheat and cause the light fixture's housing to melt, posing a fire hazard.

Health Canada

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

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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.

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10-10-2018

Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination

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Eight and Company LLC, d/b/a Sprayology is voluntarily recalling all lots within expiry from 10/18-7/22 of its aqueous-based homeopathic product line for human use. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination.

FDA - U.S. Food and Drug Administration

10-10-2018

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

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BazziniI LLC of Allentown, PA out of an abundance of caution, is recalling 4,000 pounds of Roasted and Salted Colossal Natural, Super Colossal Natural and Rams Head Natural in Shell Pistachios received from one of its suppliers because it has the potential to be contaminated with Salmonella. NO OTHER BAZZINI PISTACHIOS OR BAZZINI PRODUCTS ARE IMPACTED OR PART OF THIS RECALL. The recall is being initiated voluntarily and no illnesses have been reported to date.

FDA - U.S. Food and Drug Administration

9-10-2018

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

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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

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

Essity Professional Hygiene North America LLC recalls Tork Foam Soap Extra Mild SKU

The recalled product is potentially contaminated with the bacteria Burkholderia cepacia. B. cepacia is found in soil and water and poses little medical risk to healthy people.

Health Canada

6-10-2018

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

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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

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FDA - U.S. Food and Drug Administration

5-10-2018

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Callie's Charleston Biscuits Issues Voluntary Product Recall for Country Ham Biscuits and Cocktail Ham Biscuits Produced Using Johnston County Hams

Johnston County Hams, Inc. issued a voluntary recall on October 3, 2018 for approximately 89,096 pounds of ready-to-eat ham products due to possible contamination with Listeria monocytogenes. In response, Callie's Charleston Biscuits, LLC is issuing a voluntary product recall for two products that may contain the potentially affected Johnston County Hams.

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

4-10-2018

Silver Star Brands, Inc. Issues Voluntary Nationwide Recall of Human and Animal Drug Products Due to Microbial Contamination

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Silver Star Brands, Inc., is initiating a voluntary recall of six products for humans (including four Native Remedies® and two Healthful Naturals™) and two PetAlive® products for pets for a total of eight products with lot numbers, see table below, to the consumer level. The products have been tested and found to contain microbial contamination.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Shengan Natural Model contains hidden drug ingredient

Public Notification: Shengan Natural Model contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Shengan Natural Model, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: USA for Women contains hidden drug ingredient

Public Notification: USA for Women contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use USA for Women, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: In Shape contains hidden drug ingredient

Public Notification: In Shape contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use In Shape, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: ProSolution contains hidden drug ingredient

Public Notification: ProSolution contains hidden drug ingredient

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Pro Solution, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: FX75000 contains hidden drug ingredient

Public Notification: FX75000 contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use FX75000, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

Public Notification: Baschi Quick Slimming Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Baschi Quick Slimming Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: V-Max contains hidden drug ingredient

Public Notification: V-Max contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use V-Max, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Strong Horses contains hidden drug ingredient

Public Notification: Strong Horses contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Strong Horses, a product promoted for sexual enhancement. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

Public Notification: Green Lean Body Capsule contains hidden drug ingredients

The Food and Drug Administration is advising consumers not to purchase or use Green Lean Body Capsule, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

1-10-2018

Public Notification: Like Slim Coffee contains hidden drug ingredient

Public Notification: Like Slim Coffee contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use Like Slim Coffee, a product promoted for weight loss. This product was identified during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

28-9-2018

Drug agency from China visits Denmark

Drug agency from China visits Denmark

A delegation from the Centre for Drug Evaluation under the China National Medical Products Administration visited the Danish Medicines Agency this week to discuss clinical trials and drug monitoring, among other things. The meeting at the Danish Medicines Agency is part of a Danish-Chinese collaboration under the auspices of the China-Denmark Food and Drug Regulatory Cooperation Centre, which was established with the signing of a collaboration agreement in May of last year, and which aims to strengthen r...

Danish Medicines Agency

27-9-2018

General Finishes Recalls Outdoor Oil

General Finishes Recalls Outdoor Oil

The recalled products do not have the proper consumer chemical hazard packaging and labelling required by the consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

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

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

25-9-2018

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Voluntary Recall on Harris Teeter Low Fat Cookies & Cream Frozen Yogurt Due to Undeclared Peanut Product

Harris Teeter is notifying shoppers of a voluntarily recall of Harris Teeter Low Fat Frozen Yogurt Cookies & Cream 1.5 qt laminated cartons, UPC 0 72036 98182 0, with all SELL BY DATES up to 07/30/19 due to undeclared peanut product.

FDA - U.S. Food and Drug Administration

2-10-2018

Zavesca (Janssen-Cilag International NV)

Zavesca (Janssen-Cilag International NV)

Zavesca (Active substance: Miglustat) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5472 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000435/T/0063

Europe -DG Health and Food Safety

2-10-2018

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Pfizer Europe MA EEIG)

Dynastat (Active substance: Parecoxib ) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6471 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/000381/T/0073

Europe -DG Health and Food Safety

2-10-2018

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Pfizer Europe MA EEIG)

Retacrit (Active substance: epoetin zeta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6481 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/872/T/86

Europe -DG Health and Food Safety

2-10-2018

HALAVEN (Eisai GmbH)

HALAVEN (Eisai GmbH)

HALAVEN (Active substance: eribulin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6457 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2084/T/46

Europe -DG Health and Food Safety

2-10-2018

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Samsung Bioepis UK Limited)

Imraldi (Active substance: adalimumab) - Centralised - 2-Monthly update - Commission Decision (2018)6458 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4279/IB/14

Europe -DG Health and Food Safety

2-10-2018

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Pfizer Healthcare Ireland)

Nexium Control (Active substance: esomeprazole) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6474 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/002618/T/0023

Europe -DG Health and Food Safety

1-10-2018

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Pharmsure Veterinary Products Europe Ltd)

MS-H vaccine (Active substance: Mycoplasma synoviae Strain MS-H live attenuated thermosensitive) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6404 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/161/T/11

Europe -DG Health and Food Safety

1-10-2018

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Eli Lilly Nederland B.V.)

Verzenios (Active substance: abemaciclib) - Centralised - Authorisation - Commission Decision (2018)6405 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4302

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Celgene Europe B.V.)

EU/3/05/328 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6434 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/056/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Celgene Europe B.V.)

EU/3/05/279 (Active substance: (E)-(1S,4S,10S,21R)-7-[(Z)-ethylidene]-4,21-diisopropyl-2-oxa-12,13-dithia-5,8,20,23- tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone) - Transfer of orphan designation - Commission Decision (2018)6433 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/001/05/T/03

Europe -DG Health and Food Safety

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

1-10-2018

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Mylan S.A.S.)

Gefitinib Mylan (Active substance: gefitinib) - Centralised - Authorisation - Commission Decision (2018)6406 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4826

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety

26-9-2018

Comfortis (Elanco GmbH)

Comfortis (Elanco GmbH)

Comfortis (Active substance: Spinosad) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6323 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2233/T/18

Europe -DG Health and Food Safety

26-9-2018

Kexxtone (Elanco GmbH)

Kexxtone (Elanco GmbH)

Kexxtone (Active substance: Monensin sodium) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6324 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2235/T/10

Europe -DG Health and Food Safety

25-9-2018

Udenyca (ERA Consulting GmbH)

Udenyca (ERA Consulting GmbH)

Udenyca (Active substance: pegfilgrastim) - Centralised - Authorisation - Commission Decision (2018)6290 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/004413/0000

Europe -DG Health and Food Safety

25-9-2018

Inovelon (Eisai GmbH)

Inovelon (Eisai GmbH)

Inovelon (Active substance: Rufinamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6283 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/660/T/48

Europe -DG Health and Food Safety

25-9-2018

Zonegran (Eisai GmbH)

Zonegran (Eisai GmbH)

Zonegran (Active substance: zonisamide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6285 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/577/T/90

Europe -DG Health and Food Safety

25-9-2018

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (RAD Neurim Pharmaceuticals EEC Limited)

Slenyto (Active substance: melatonin) - Centralised - Authorisation - Commission Decision (2018)6223 of Tue, 25 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4425

Europe -DG Health and Food Safety