Redigo Pro 170 FS

Primær information

  • Handelsnavn:
  • Redigo Pro 170 FS Flydende bejdse
  • Lægemiddelform:
  • Flydende bejdse
  • Sammensætning:
  • 20 g/l tebuconazol; 150 g/l prothioconazol
  • Brugt til:
  • Planter
  • Medicin typen:
  • agrokemiske

Dokumenter

  • for den brede offentlighed:
  • 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.

Lokation

  • Fås i:
  • Redigo Pro 170 FS Flydende bejdse
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • SEGES Landbrug & Fødevarer
  • Autorisation status:
  • Markedsført
  • Autorisationsnummer:
  • Ingen afstandskrav.
  • Sidste ændring:
  • 23-07-2018

Produktresumé

Bayer CropScience

SIKKERHEDSDATABLAD

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

REDIGO PRO FS170 1X1000L IBC DK

1/11

Udgave 4 / DK

Revisionsdato: 19.10.2015

102000016050

Udskrevet den: 19.10.2015

PUNKT 1: IDENTIFIKATION AF STOFFET/BLANDINGEN OG AF

SELSKABET/VIRKSOMHEDEN

1.1 Produktidentifikator

Handelsnavn

REDIGO PRO FS170 1X1000L IBC DK

Produktkode (UVP)

79301081, 84427497

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

frarådes

Anvendelse

Bejdsning, Svampemiddel

1.3 Nærmere oplysninger om leverandøren af sikkerhedsdatabladet

Leverandør

Bayer A/S, Bayer CropScience

Arne Jacobsens Allé 13

2300 København S

Danmark

Telefon

(+45) 45 23 50 00

Telefax

(+45) 45 23 52 60

Ansvarlig afdeling

E-mail: MSDS.Nordic@bayer.com

1.4 Nødtelefon

Nødtelefon

(+45) 45 23 50 00 (døgnet rundt)

PUNKT 2: FAREIDENTIFIKATION

2.1 Klassificering af stoffet eller blandingen

Klassificering i henhold til Miljøstyrelsens godkendelsestekst

Reproduktionstoksicitet: Kategori 2

H361d

Mistænkt for at skade det ufødte barn.

Kronisk toksicitet for vandmiljøet: Kategori 1

H410

Meget giftig med langvarige virkninger for vandlevende organismer.

2.2 Mærkningselementer

Mærkning i henhold til Miljøstyrelsens godkendelsestekst

Mærkningspligtig.

Signalord: Advarsel

Faresætninger

H361d

Mistænkt for at skade det ufødte barn.

H410

Meget giftig med langvarige virkninger for vandlevende organismer.

EUH401

Brugsanvisningen skal følges for ikke at bringe menneskers sundhed og miljøet i fare.

Sikkerhedssætninger

Bayer CropScience

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

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102000016050

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P101

Hvis der er brug for lægehjælp, medbring da beholderen eller etiketten.

P102

Opbevares utilgængeligt for børn.

P273

Undgå udledning til miljøet.

P280

Bær beskyttelseshandsker/beskyttelsestøj.

P281

Anvend de påkrævede personlige værnemidler.

P308 + P313

VED eksponering eller mistanke om eksponering: Søg lægehjælp.

P391

Udslip opsamles.

P405

Opbevares under lås.

P501

Indholdet/beholderen bortskaffes i overensstemmelse med kommunale regler for

affaldshåndtering.

2.3 Andre farer

Ingen andre kendte farer.

PUNKT 3: SAMMENSÆTNING AF/OPLYSNING OM INDHOLDSSTOFFER

3.2 Blandinger

Kemisk karakterisering

Suspensionspræparat til bejdsning (FS)

Prothioconazole 150g/l, Tebuconazole 20g/l

Farlige komponenter

Faresætninger i henhold til Forordning (EF) nr. 1272/2008

Navn

CAS-Nr. /

EF-Nr. /

REACH Reg. No.

Klassificering

Konc. [%]

Forordning (EF) Nr.

1272/2008

Tebuconazol

107534-96-3

403-640-2

Repr. 2, H361d

Acute Tox. 4, H302

Aquatic Acute 1, H400

Aquatic Chronic 1, H410

1,71

Prothioconazol

178928-70-6

Aquatic Acute 1, H400

Aquatic Chronic 1, H410

12,8

Sulfonsyre, C13-17-sec-

alkan, natriumsalt

85711-69-9

288-330-3

Acute Tox. 4, H302

Eye Dam. 1, H318

Skin Irrit. 2, H315

> 1 – < 25

Polyarylphenylether

sulfat, ammoniumsalt

119432-41-6

Aquatic Chronic 3, H412

> 1 – < 20

Glycerol

56-81-5

200-289-5

Ikke klassificeret

> 1

1,2-Benzisothiazol-3(2H)-

on

2634-33-5

220-120-9

Acute Tox. 4, H302

Skin Irrit. 2, H315

Eye Dam. 1, H318

Aquatic Acute 1, H400

Skin Sens. 1, H317

> 0,005 – <

0,05

5-Chlor-2-methyl-2H-

isothiazol-3-on [EF-nr.

247-500-7], blanding (3:1)

med 2-methyl-2H-

isothiazol-3-on [EF-nr.

220-239-6]

55965-84-9

Skin Corr. 1B, H314

Aquatic Chronic 1, H410

Aquatic Acute 1, H400

Skin Sens. 1, H317

Acute Tox. 3, H301

Acute Tox. 3, H331

> 0,0002 – <

0,0015

Bayer CropScience

SIKKERHEDSDATABLAD

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

REDIGO PRO FS170 1X1000L IBC DK

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Revisionsdato: 19.10.2015

102000016050

Udskrevet den: 19.10.2015

Acute Tox. 3, H311

Yderligere oplysninger

Tebuconazol

107534-96-3

M-faktor: 1 (acute), 10 (chronic)

Prothioconazol

178928-70-6

M-faktor: 10 (acute)

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

PUNKT 4: FØRSTEHJÆLPSFORANSTALTNINGER

4.1 Beskrivelse af førstehjælpsforanstaltninger

Generelt råd

Forlad det farlige område. Forurenet tøj tages straks af og fjernes til et

sikkert sted. Den tilskadekomne placeres og transporteres i en stabil

stilling (liggende på siden).

Indånding

Søg frisk luft. Hold patienten varm og i ro. Ring omgående til læge eller

giftinformationen.

Hudkontakt

Vaskes med rigeligt vand og sæbe, hvis tilgængeligt med

polyethylenglykol 400 efterfulgt af vand. Søg læge ved vedvarende

symptomer.

Øjenkontakt

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

minutter. Fjern evt. kontaktlinser efter de første fem minutter, og

fortsæt derefter med at skylle øjnene. Søg læge hvis irritation opstår

og vedvarer.

Indtagelse

Fremprovoker IKKE opkastning. Ring omgående til læge eller

giftinformationen. Skyl munden.

4.2 Vigtigste symptomer og virkninger, både akutte og forsinkede

Symptomer

Ingen kendte eller forventede symptomer.

4.3 Angivelse af om øjeblikkelig lægehjælp og særlig behandling er nødvendig

Behandling

Behandles symptomatisk. En maveskylning er normalt ikke nødvendig.

Hvis en større mængde er blevet indtaget (mere end en mundfuld)

gives aktivt kul og natriumsulfat. Der er ingen specifik modgift.

PUNKT 5: BRANDBEKÆMPELSE

5.1 Slukningsmidler

Egnede

Brug vandspray, alkoholbestandigt skum, pulver eller kuldioxid.

Uegnede

Kraftig vandstråle

Bayer CropScience

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

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5.2 Særlige farer i

forbindelse med stoffet

eller blandingen

Ved brand kan følgende frigøres:, Hydrogencyanid (blåsyre),

Kulmonoxid (CO), Nitrogenoxider (NOx)

5.3 Anvisninger for brandmandskab

Særlige personlige

værnemidler, der skal

bæres af

brandmandskabet

Indånd ikke dampe i tilfælde af brand og/eller eksplosion. I tilfælde af

brand: brug luftforsynet åndedrætsværn.

Andre informationer

Minimer udslippet af kontamineret slukningsmiddel. Tillad ikke

brandslukningsvæske at løbe i kloakafløb og vandløb.

PUNKT 6: FORHOLDSREGLER OVER FOR UDSLIP VED UHELD

6.1 Personlige sikkerhedsforanstaltninger, personlige værnemidler og nødprocedurer

Forholdsregler

Undgå kontakt med spildt produkt eller kontaminerede overflader.

Brug personligt beskyttelsesudstyr.

6.2 Miljøbeskyttelses-

foranstaltninger

Må ikke komme i overfladevand, kloakanlæg og grundvand.

6.3 Metoder og udstyr til inddæmning og oprensning

Metoder til oprydning

Forurenede genstande og gulve rengøres grundigt efter

miljøforskrifterne. Opsug med inaktivt absorberende materiale (f.eks.

sand, silicagel, syre bindemiddel, universal bindemiddel, savsmuld).

Opbevares i egnede og lukkede affaldsbeholdere.

6.4 Henvisning til andre

punkter

Informationer til en mere sikker håndtering, se punkt 7.

Informationer til personlig beskyttelsesudstyr, se punkt 8.

Informationer til bortskaffelse af affald, se punkt 13.

PUNKT 7: HÅNDTERING OG OPBEVARING

7.1 Forholdsregler for sikker håndtering

Råd om sikker håndtering

Må kun bruges i områder med passende udsugning til rådighed.

Hygiejniske foranstaltninger

Undgå kontakt med hud, øjne og tøj. Opbevar arbejdstøjet separat.

Vask hænder før pauser og straks efter håndtering af produktet. Fjern

snavset tøj straks og rengør disse grundigt inden efterfølgende brug.

Arbejdstøj, der ikke kan rengøres skal bortskaffet (brændes).

7.2 Betingelser for sikker opbevaring, herunder eventuel uforenelighed

Krav til lager og beholdere

Opbevar beholderne tæt lukket på et tørt, køligt og velventileret sted.

Opbevar i original beholder. Opbevares på et sted kun tilgængeligt for

autoriserede personer.

Bayer CropScience

SIKKERHEDSDATABLAD

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

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Revisionsdato: 19.10.2015

102000016050

Udskrevet den: 19.10.2015

Anvisninger ved samlagring

Må ikke komme i forbindelse med levnedsmidler, drikkevarer og

foderstoffer.

7.3 Særlige anvendelser

Refereres til etiket og/eller brochure.

PUNKT 8: EKSPONERINGSKONTROL/PERSONLIGE VÆRNEMIDLER

8.1 Kontrolparametre

Komponenter

CAS-Nr.

Kontrolparametre

Opdater

Basis

Tebuconazol

107534-96-3

0,2 mg/m³

(TWA)

OES BCS*

Prothioconazol

178928-70-6

1,4 mg/m³

(SK-ABS)

OES BCS*

*OES BCS: Intern eksponeringsgrænseværdi Bayer CropScience (Occupational Exposure Standard)

8.2 Eksponeringskontrol

Personlige værnemidler - Slutbruger

Generelt råd

I henhold til Arbejdstilsynets vejledning anbefales det at anvende

nedenstående værnemidler.

Før anvendelse; læs venligst brugsanvisningen for sikker

anvendelse.

Åndedrætsværn

Fuldmaske med kombinationsfilter A2/P3

Beskyttelse af hænder

Ved håndtering af produktet, skal CE mærket (eller lign.) nitril

gummi handsker anvendes (min. tykkelse 0,40 mm). Ved

udvendig forureningen skal handskerne vaskes grundigt. Ved

perforering, indvendig forurening eller hvis handskerne udvendig

ikke kan vaskes tilfredsstillende, skal handskerne bortkastes.

Hænderne skal, efter enhver håndtering af produktet, altid vaskes

grundigt. Vask hændene ofte og altid før der spises, drikkes,

ryges og inden toiletbesøg.

Hud- og krops-beskyttelse

Beskyttelsesdragt

Gummistøvler

PUNKT 9: FYSISK-KEMISKE EGENSKABER

9.1 Oplysninger om grundlæggende fysiske og kemiske egenskaber

Form

suspension

Farve

rød

Lugt

karakteristisk

pH-værdi

5,0 - 7,0 ved 100 % (23 °C)

Flammepunkt

>93 °C

Ikke relevant; vandopløsning

Selvantændelsestemperatur

490 °C

Massefylde

ca. 1,17 g/cm³ ved 20 °C

Bayer CropScience

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Fordelingskoefficient: n-

oktanol/vand

Tebuconazol: log Pow: 3,7

Prothioconazol: log Pow: 3,82 ved 20 °C

Oxiderende egenskaber

Oxiderende egenskaber (vaesker)

Ingen oxideringsegenskaber

Eksplosivitet

Ikke eksplosiv

92/69/EEC, A.14 / OØSU 113

9.2 Andre oplysninger

Yderligere sikkerhedsrelaterede fysisk-kemisk data er ikke kendt.

PUNKT 10: STABILITET OG REAKTIVITET

10.1 Reaktivitet

Termisk spaltning

Stabil under normale forhold.

10.2 Kemisk stabilitet

Stabil under de anbefalede opbevaringsforhold.

10.3 Risiko for farlige

reaktioner

Ingen farlige reaktioner ved reglementeret lagring og håndtering.

10.4 Forhold, der skal

undgås

Ekstreme temperaturer og direkte sollys.

10.5 Materialer, der skal

undgås

Opbevares kun i den originale emballage.

10.6 Farlige

nedbrydningsprodukter

Der forventes ingen nedbrydningsprodukter under normale

anvendelsesforhold.

PUNKT 11: TOKSIKOLOGISKE OPLYSNINGER

11.1 Oplysninger om toksikologiske virkninger

Akut oral toksicitet

LD50 (rotte) > 2.000 mg/kg

Akut toksicitet ved

indånding

Ved hensigtsmæssig og tilsigtet anvendelse dannes ikke respirable

aerosoler.

Akut dermal toksicitet

LD50 (rotte) > 2.000 mg/kg

Hudirritation

Ingen hudirritation (kanin)

Øjenirritation

Ingen øjenirritation (kanin)

Sensibilisering

Ikke sensibiliserende. (mus)

OECD test Guideline 429, assay på lokale lymfeknuder (LLNA)

Bedømmelse af toksicitet ved gentagen dosering

Tebuconazol forårsagede ikke specifik målorgantoksicitet i dyreforsøg.

Prothioconazol forårsagede ikke specifik målorgantoksicitet i dyreforsøg.

Bedømmelse af mutagenicitet

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Tebuconazol var ikke mutagent eller genotoksisk i en serie af in vitro og in vivo forsøg.

Prothioconazol var ikke mutagent eller genotoksisk baseret på den samlede vægt af evidens i en serie

af in vitro og in vivo test.

Bedømmelse af carcinogenicitet

Tebuconazol gav øget forekomst af tumorer i lever af mus ved høj dosis. Virkningsmekanismen for

dannelsen af tumorer anses ikke for at være relevant for mennesker.

Prothioconazol var ikke kræftfremkaldende hos rotter og mus ved permanent fodring.

Bedømmelse af toksicitet for forplantningsevnen

Tebuconazol forårsagede reproduktionstoksicitet i et 2-generations studie i rotter, ved et dosis niveau,

som var toksisk for moder dyret. Reproduktions toksiciteten observeret med Tebuconazol er relateret til

parental toksicitet.

Prothioconazol forårsagede reproduktionstoksicitet i et 2-generations studie i rotter, ved et dosis niveau,

som var toksisk for moder dyret. Reproduktions toksiciteten observeret med Prothioconazol er relateret

til parental toksicitet.

Bedømmelse af udviklingstoksicitet

Tebuconazol gav kun udviklingsmæssig toxicitet ved dosisniveauer der var giftig for moder dyret.

Tebuconazol forårsagede en øget forkomst af embryonal tab efter implantation, en øget forekomst af

ikke-specifikke misdannelser.

Prothioconazol gav kun udviklingsmæssig toxicitet ved dosisniveauer der var giftig for moder dyret. Den

udviklingsmæssige effekt set med Prothioconazol er relateret til maternel toksicitet.

PUNKT 12: MILJØOPLYSNINGER

12.1 Toksicitet

Toksicitet overfor fisk

LC50 (Oncorhynchus mykiss (Regnbueforel)) 4,4 mg/l

Ekspositionsvarighed: 96 h

Oplysningen refererer til det tekniske aktivstof tebuconazol.

LC50 (Oncorhynchus mykiss (Regnbueforel)) 1,83 mg/l

Ekspositionsvarighed: 96 h

De angivne værdier refererer til det tekniske aktivstof prothioconazol.

Gitighed overfor

vandlevende hvirvelløse dyr

EC50 (Daphnia magna (Stor dafnie)) 2,79 mg/l

Ekspositionsvarighed: 48 h

Oplysningen refererer til det tekniske aktivstof tebuconazol.

EC50 (Daphnia magna (Stor dafnie)) 1,3 mg/l

Ekspositionsvarighed: 48 h

De angivne værdier refererer til det tekniske aktivstof prothioconazol.

Kronisk toksicitet til

hvirvelløse vanddyr

NOEC (Daphnia (Dafnie)): 0,01 mg/l

Ekspositionsvarighed: 21 d

Oplysningen refererer til det tekniske aktivstof tebuconazol.

Giftighed overfor

vandplanter

EC50 (Raphidocelis subcapitata (ferskvandsgrønalge)) 3,8 mg/l

Vækstrate; Ekspositionsvarighed: 72 h

Oplysningen refererer til det tekniske aktivstof tebuconazol.

(Lemna gibba (Tyk andemad)) 0,237 mg/l

Vækstrate; Ekspositionsvarighed: 14 d

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Oplysningen refererer til det tekniske aktivstof tebuconazol.

EC50 (Raphidocelis subcapitata (ferskvandsgrønalge)) 2,18 mg/l

Vækstrate; Ekspositionsvarighed: 96 h

De angivne værdier refererer til det tekniske aktivstof prothioconazol.

EC50 (Skeletonema costatum) 0,046 mg/l

Vækstrate; Ekspositionsvarighed: 72 h

De angivne værdier refererer til det tekniske aktivstof prothioconazol.

12.2 Persistens og nedbrydelighed

Biologisk nedbrydelighed

Tebuconazol:

ikke fuldstændigt bionedbrydelig

Prothioconazol:

ikke fuldstændigt bionedbrydelig

Koc

Tebuconazol: Koc: 769

Prothioconazol: Koc: 1765; log Koc: < 3

12.3 Bioakkumuleringspotentiale

Bioakkumulering

Tebuconazol: Biokoncentrationsfaktor (BCF), 35 - 59

Bioophober ikke.

Prothioconazol: Biokoncentrationsfaktor (BCF), 19

Bioophober ikke.

12.4 Mobilitet i jord

Mobilitet i jord

Tebuconazol: Let mobilt i jord

Prothioconazol: Let mobilt i jord

12.5 Resultater af PBT- og vPvB-vurdering

PBT- og vPvB-vurdering

Tebuconazol: Dette stof anses ikke for at være persistent,

bioakkumulererend og toksisk (PBT). Dette stof anses ikke for at være

meget persistent og meget bioakkumulerend (vPvB).

Prothioconazol: Dette stof anses ikke for at være meget persistent og

meget bioakkumulerend (vPvB). Dette stof anses ikke for at være

persistent, bioakkumulererend og toksisk (PBT).

12.6 Andre negative virkninger

Yderligere økologisk

information

Der er ingen andre virkninger, som skal angives.

PUNKT 13: FORHOLD VEDRØRENDE BORTSKAFFELSE

13.1 Metoder til affaldsbehandling

Rester skal afleveres til den kommunale affaldsordning for farligt affald.

Tomme beholdere (palletanke) skal returneres til den af forhandleren

navngivne modtager.

Affaldskort nr.

02 01 08* Landbrugskemikalieaffald indeholdende farlige stoffer

PUNKT 14: TRANSPORTOPLYSNINGER

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ADR/RID/ADN

14.1 UN-nummer

3082

14.2 UN-forsendelsesbetegnelse

MILJØFARLIG VÆSKE, N.O.S.

(TEBUCONAZOLE, PROTHIOCONAZOLE SOLUTION)

14.3 Transportfareklasse( r )

14.4 Emballagegruppe

14.5 Miljøfarligt mærke

Farenr.

Tunnel Code

Denne klassificering er i princippet ikke gældende for transport af tank container på indre vandveje.

Der henvises til producenten for yderligere information.

IMDG

14.1 UN-nummer

3082

14.2 UN-forsendelsesbetegnelse

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,

N.O.S.

(TEBUCONAZOLE, PROTHIOCONAZOLE SOLUTION)

14.3 Transportfareklasse( r )

14.4 Emballagegruppe

14.5 Marin forureningsfaktor (Marine

pollutant)

IATA

14.1 UN-nummer

3082

14.2 UN-forsendelsesbetegnelse

ENVIRONMENTALLY HAZARDOUS SUBSTANCE, LIQUID,

N.O.S.

(TEBUCONAZOLE, PROTHIOCONAZOLE SOLUTION )

14.3 Transportfareklasse( r )

9

14.4 Emballagegruppe

14.5 Miljøfarligt mærke

14.6 Særlige forsigtighedsregler for brugeren

Se sektion 6 til 8 i dette sikkerhedsdatablad.

14.7 Bulktransport i henhold til bilag II til MARPOL og IBC-koden

Ingen transport i bulk iht. IBC koden.

PUNKT 15: OPLYSNINGER OM REGULERING

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

sikkerhed, sundhed og miljø

Andre informationer

WHO-klassificering: III (Slightly hazardous)

Anvendelsesområde

Følg alle instruktionerne på etiketten.

Unge under 18 år må i.h.t. Arbejdsministeriets bekendtgørelse nr. 239 af 06.04.2005 med senere

ændringer ikke arbejde med eller udsættes for produktet.

Arbejdsmæssige restriktioner for gravide og kvinder der ammer

Bemærk! Der dannes et nedbrydningsprodukt (desthio-prothioconazol), som er fosterskadende (H360d;

Bayer CropScience

SIKKERHEDSDATABLAD

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

REDIGO PRO FS170 1X1000L IBC DK

10/11

Udgave 4 / DK

Revisionsdato: 19.10.2015

102000016050

Udskrevet den: 19.10.2015

kan skade det ufødte barn).

Overtrædelse af nedenstående særligt fremhævede forskrifter kan medføre straf:

Må kun anvendes til bekæmpelse af svampesygdomme i vinter- og vårbyg, vinter- og vårhvede, rug og

triticale ved bejdsning i lukkede industrielle anlæg.

Må endvidere anvendes til bekæmpelse af svampesygdomme i havre til eksport ved bejdsning i lukkede

industrielle anlæg.

Må ikke anvendes mod andre skadevoldere og ikke i højere doseringer end de i brugsanvisningen

nævnte.

Undgå forurening af vandmiljøet med produktet eller med beholdere, der har indeholdt produktet. Rens

ikke sprøjteudstyr nær overfladevand/ Undgå forurening via dræn fra gårdspladser og veje (SP1).

Må ikke tømmes i kloakafløb.

Det bejdsede korn skal umiddelbart efter bejdsningen emballeres i sække/poser og plomberes.

Det bejdsede korn er bejdset med Redigo Pro FS 170 som indeholder prothioconazol og tebuconazol.

Det bejdsede korn er farligt og må ikke anvendes til menneskeføde eller foder. Beholderen/emballagen

må ikke anvendes til brødkorn, andre levnedsmidler og foderstoffer. Kornet er bejdset med

prothioconazol og tebuconazol, og det bejdsede korn er meget giftigt for fugle. Ved såning skal det

bejdsede korn dækkes med jord. Ikke dækket korn skal opsamles.

Ovenstående indrammede angivelse skal være tydeligt anført på en etikette eller bindemærke, der

straks skal fastgøres på beholderen/emballagen på en sådan måde, at etiketten eller bindemærket

normalt vil blive siddende indtil indholdet er brugt

Må ikke opbevares sammen med fødevarer, drikkevarer og foderstoffer.

Gældende fra 26. november 2015: Dette plantebeskyttelsesmiddel må kun købes af professionelle og

anvendes erhvervsmæssigt og kræver gyldig autorisation."

15.2 Kemikaliesikkerhedsvurdering

En kemisk sikkerhedsvurdering kræves ikke.

PUNKT 16: ANDRE OPLYSNINGER

Tekst af faresætninger nævnt i punkt 3

H301

Giftig ved indtagelse.

H302

Farlig ved indtagelse.

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.

H361d

Mistænkt for at skade det ufødte barn.

H400

Meget giftig for vandlevende organismer.

H410

Meget giftig med langvarige virkninger for vandlevende organismer.

Bayer CropScience

SIKKERHEDSDATABLAD

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

REDIGO PRO FS170 1X1000L IBC DK

11/11

Udgave 4 / DK

Revisionsdato: 19.10.2015

102000016050

Udskrevet den: 19.10.2015

H412

Skadelig for vandlevende organismer, med langvarige virkninger.

Forkortelser og akronymer

Europæisk konvention angående international transport af farligt gods på indre

vandveje

Europæisk konvention angående international transport af farligt gods på vej

CAS-Nr.

Chemical Abstracts Service nummer

Konc.

Koncentration

EF-Nr.

European community nummer (EF-nummer)

Effektiv koncentration x %

EINECS

Den europæiske fortegnelse over markedsførte kemiske stoffer

ELINCS

Europæiske liste over anmeldte stoffer

Europæiske standarder

Europæiske Union

IATA

International Air Transport Association

International Code for the Construction and Equipment of Ships Carrying Dangerous

Chemicals in Bulk (IBC Code)

Inhiberingskoncentration x %

IMDG

International Maritime Dangerous Goods

Dødelig koncentration x %

Dødelig dosis x %

LOEC/LOEL

Lavest observerede effektkoncentration/ effektniveau

MARPOL

MARPOL: International Convention for the prevention of marine pollution from ships

N.O.S.

Not otherwise specified

NOEC/NOEL

Nuleffektkoncentration/ nuleffektniveau

OECD

Organisationen for Økonomisk Samarbejde og Udvikling

Europæisk konvention angående international transport af farligt gods med tog

Tidsvægtet gennemsnit

Forende Nationer (FN)

Verdenssundshedsorganisationen

Oplysningerne i dette sikkerhedsdatablad er i overensstemmelse med de retningslinjer, der er fastsat

af forordning (EF) nr. 1907/2006 og forordning (EU) nr. 2015/830 om ændring af forordning (EF) nr.

1907/2006 (og eventuelle senere ændringer). Dette datablad supplerer brugervejledningen, men

erstatter den ikke. Oplysningerne heri er baseret på den viden, der var tilgængelig om produktet på det

tidspunkt, den blev udfærdiget. Brugerne skal endvidere være opmærksomme på evt. risici ved brug af

produktet til andre formål end de tiltænkte. De krævede oplysninger er i overensstemmelse med

gældende EU-lovgivning. Evt. yderligere nationale krav skal desuden overholdes.

Grund til revision:

Følgende sektioner er revideret: Sektion 2: Fareidentifikation. Sektion

8: Eksponeringskontrol/Personlige værnemidler. Sektion 3:

Sammensætning af/ oplysning om indholdsstoffer. Punkt 10. Stabilitet

og reaktivitet. Sektion 16: Andre oplysninger.

Ændringer siden sidste version vil være fremhævet i margen. Denne version erstatter alle tidligere

versioner.

  • 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

20-10-2018

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β‐unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex‐2(trans)‐enal [FL‐no: 05.073], and for other two substances in the same subgroup, namely 2‐dodecenal [FL‐no: 05.03...

Europe - EFSA - European Food Safety Authority Publications

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

19-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

19-10-2018

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee Voluntarily Recalls Several Meat and Potato Products

Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling six of its meat and potato products across its eight-state region due to possible contamination with Salmonella and Listeria monocytogenes. The potential for contamination was discovered after Hy-Vee’s supplier, McCain Foods, announced it was recalling its caramelized mushrooms and fire-roasted tomatoes, which are ingredients that are used in six Hy-Vee products. To date, no illnesses have been reported in connection with these prod...

FDA - U.S. Food and Drug Administration

18-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

18-10-2018

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

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

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

Health Canada

18-10-2018

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

Mom Life Market recalls 10" & 16" Personalized Stuffed Plush Bunnies

The recalled products may contain phthalate levels that exceed the allowable levels.

Health Canada

18-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

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”

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

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

FDA - U.S. Food and Drug Administration

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

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

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

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

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

FDA - U.S. Food and Drug Administration

10-10-2018

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

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

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

Bazzini LLC Recalls Certain Pistachio Products Because of Possible Health Risk

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

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

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

FDA - U.S. Food and Drug Administration

9-10-2018

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

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

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

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

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

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