PRE. STABIMIX WR

Primær information

  • Handelsnavn:
  • PRE. STABIMIX WR
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Medicinsk udstyr

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Lokation

  • Fås i:
  • PRE. STABIMIX WR
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Ecolab
  • Autorisationsnummer:
  • 113894E
  • Sidste ændring:
  • 12-03-2018

Produktresumé

PREMIX P3-stabimix WR

SIKKERHEDSDATABLAD

Produktnavn

PREMIX P3-stabimix WR

Er i overensstemmelse med forordning (EF) nr. 1907/2006 (REACH), Bilag II (453/2010) -

Europa

:

1.1 Produktidentifikator

1.3 Nærmere oplysninger om leverandøren af sikkerhedsdatabladet

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

Identificerede anvendelser

PUNKT 1: Identifikation af stoffet/blandingen og af selskabet/virksomheden

Produktkode

:

Anvendelse der frarådes

1.4 Nødtelefon

Nationale rådgivende organ/Giftinformation

Procesrengøringsmiddel; "Cleaning In Place" (CIP) proces

Ingen kendte.

Ecolab ApS

Høffdingsvej 36

2500 Valby

DANMARK

Tel +45 36 15 85 85

Fax +45 36 15 85 48

dk@ecolab.com

:

Producent/ Distributør/

Importør

:

Telefonnummer

82121212

113894E

Anvendelsesområde

:

Vedligeholdelsesprodukt

Produktet er kun til professionelt brug

Producent/ Distributør/ Importør

:

Telefonnummer

36 15 85 85

Version:

: 1

Klassificering

C; R35

Klassificeringen af dette produkt er udelukkende baseret på dets ekstreme pH værdi

(i overensstemmelse med gældende EU regler)

:

:

Sundhedsfarer for

mennesker

Alvorlig ætsningsfare.

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

Klassificering i henhold til Europa-Parlamentets og Rådets forordning (EF) 1272/2008 [CLP/GHS]

PUNKT 2: Fareidentifikation

2.1 Klassificering af stoffet eller blandingen

Produktdefinition

:

Blanding

Se den komplette tekst med R-sætninger eller faresætninger nævnt ovenfor i afsnit 16.

Klassificering ifølge Direktiv 1999/45/EC [DPD]

Produktet er klassificeret som farligt i henhold til Direktivet 1999/45/EF og det's senere tilpasninger.

2.2 Mærkningselementer

Skin Corr. 1A, H314

Klassificeringen af dette produkt er udelukkende baseret på dets ekstreme pH værdi (i overensstemmelse med

gældende EU regler)

Udgivelsesdato/Revisionsdato

:

1/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 2: Fareidentifikation

:

Andre farer, som ikke

indebærer klassificering

Farepiktogrammer

:

Signalord

:

Faresætninger

:

Forebyggelse

:

Sikkerhedssætninger

Reaktion

:

Farlig

P280 - Bær beskyttelseshandsker og øjenbeskyttelse/ansigtsbeskyttelse.

P303 + P361 + P353 - VED KONTAKT MED HUDEN (eller håret): Tilsmudset tøj

tages straks af. Skyl eller brus huden med vand.

P305 + P351 + P338 - VED KONTAKT MED ØJNENE: Skyl forsigtigt med vand i

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

skylning.

P310 - Ring omgående til en GIFTINFORMATION eller en læge.

2.3 Andre farer

Indeholder

:

Ikke relevant.

alkohol ethoxylater

Alkylpolyglycosider

Syrer

ATMP

HEDP

H314

Forårsager svære forbrændinger af huden og øjenskader.

PUNKT 3: Sammensætning af/oplysning om indholdsstoffer

Identifikatorer

67/548/EØF

Produkt/ingrediens

navn

Den komplette tekst

for de ovenfor

nævnte R-sætninger

vises i sektion 16.

%

Type

Regulativ (EC) nr.

1272/2008 [CLP]

Klassificering

Se den komplette tekst

med faresætningerne

nævnt ovenfor i Afsnit

16.

alkohol ethoxylater

CAS: 111905-53-4

10-20

Xi; R36/38

Skin Irrit. 2, H315

Eye Irrit. 2, H319

Alkylpolyglycosider

REACH #: 01-

2119488530-36

EF: 500-220-1

CAS: 68515-73-1

5-10

Xi; R41

Skin Irrit. 2, H315

Eye Dam. 1, H318

Syrer

REACH #: 01-

2119436643-39

EF: 253-733-5

CAS: 37971-36-1

5-10

Ikke klassificeret.

Met. Corr. 1, H290

Eye Irrit. 2, H319

ATMP

REACH #: 01-

2119487988-08

EF: 229-146-5

CAS: 6419-19-8

Xi; R36

Eye Irrit. 2, H319

HEDP

REACH #: 01-

2119510391-53

EF: 220-552-8

CAS: 2809-21-4

Xi; R41

Eye Dam. 1, H318

Blandinger

3.2

Udgivelsesdato/Revisionsdato

:

2/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 3: Sammensætning af/oplysning om indholdsstoffer

Grænseværdier er nævnt under afsnit 8, hvis de er tilgængelige.

Der er ingen supplerende indholdsstoffer tilstede, som efter leverandørens nuværende kendskab og i anvendte

koncentrationer, er klassificeret som sundhedsskadelige eller miljøfarlige og som derfor behøver nævnes i denne

sektion.

[1] Stoffet er klassificeret med en sundheds- eller miljøfare

[2] Stoffet har en af Arbejdstilsynet fastsat grænseværdi

[3] Stoffet opfylder kriterierne for PBT i henhold til Regulativ (EC) nr. 1907/2006, bilag XIII

[4] Stoffet opfylder kriterierne for vPvB i henhold til Regulativ (EC) nr. 1907/2006, bilag XIII

Type

Skyl munden med vand. Fjern eventuel tandprotese. Hvis materialet er indtaget, og

den tilskadekomne er ved bevidsthed, gives små mægder vand at drikke. Stop, hvis

den tilskadekomne bliver dårlig, da opkastning kan være farlig. Forsøg ikke at

fremkalde opkastning, medmindre lægelig rådgiver anbefaler det. Hvis opkastning

indtræffer, holdes hovedet lavt så der ikke kommer opkast i lungerne. Kemiske

ætsninger skal hurtigt behandles af en læge. Giv aldrig en bevidstløs person noget

gennem munden. Er personen bevidstløs, lægges personen i aflåst sideleje og der

søges straks lægehjælp. Oprethold åbne luftveje. Løsn stram beklædning som

f.eks. krave, slips, bælte eller bukse-/nederdelslinning. Flyt personen til et sted med

frisk luft og sørg for, at vedkommende hviler i en stilling, som letter vejrtrækningen.

Søg straks lægebehandling. Kontakt en giftinformationscentral eller læge.

Hudkontakt

Skyl straks øjne med store mængder vand, hvor øverste og nederste øjenlåg

lejlighedsvis løftes. Kontroller for og fjern evt. kontaktlinser. Bliv ved med at skylle i

mindst 10 minutter. Kemiske ætsninger skal hurtigt behandles af en læge. Søg

straks lægebehandling. Kontakt en giftinformationscentral eller læge.

Vask forurenet hud med sæbe og vand. Forurenet tøj og sko tages af. Bliv ved med

at skylle i mindst 10 minutter. Kemiske ætsninger skal hurtigt behandles af en læge.

Vask forurenet tøj, før det atter tages i brug. Rengør skoene grundigt, før de bruges

igen. Søg straks lægebehandling. Kontakt en giftinformationscentral eller læge.

4.1 Beskrivelse af førstehjælpsforanstaltninger

Flyt personen til et sted med frisk luft og sørg for, at vedkommende hviler i en stilling,

som letter vejrtrækningen. Hvis der ingen vejrtrækning er, hvis vejrtrækningen er

uregelmæssig eller åndedrættet ophører, så sørg for kunstigt åndedræt eller ilt af

uddannet personale. Er personen bevidstløs, lægges personen i aflåst sideleje og

der søges straks lægehjælp. Oprethold åbne luftveje. Løsn stram beklædning som

f.eks. krave, slips, bælte eller bukse-/nederdelslinning. Ved indånding af

nedbrydningsprodukter ved brand kan symptomerne være forsinkede. Søg straks

lægebehandling. Kontakt en giftinformationscentral eller læge.

Indtagelse

Indånding

Øjenkontakt

:

:

:

:

Beskyttelse af

førstehjælpere

:

PUNKT 4: Førstehjælpsforanstaltninger

4.2 Vigtigste symptomer og virkninger, både akutte og forsinkede

Potentielle akutte helbredspåvirkninger

Indånding

:

Kan afgive gasser, dampe eller støv, der er meget irriterende eller ætsende for

åndedrætssystemet. Udsættelse for nedbrydningsprodukter kan udgøre en

sundhedsfare. Der kan efter eksponering opstå forsinkede alvorlige virkninger.

Kan forårsage ætsningsskader i mund, hals og mave.

:

Indtagelse

Hudkontakt

:

Alvorlig ætsningsfare.

Forårsager alvorlig øjenskade.

:

Øjenkontakt

Tegn/symptomer på overeksponering

Der må ikke iværksættes handlinger man ikke er uddannet til eller som medfører

personlig risiko. Vask forurenet tøj grundigt med vand, før det tages af, ellers

anvend handsker.

Udgivelsesdato/Revisionsdato

:

3/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 4: Førstehjælpsforanstaltninger

Anmærkninger til lægen.

Ved indånding af nedbrydningsprodukter ved brand kan symptomerne være

forsinkede.

:

Særlige behandlinger

Hudkontakt

Indtagelse

Indånding

Væsentlige symptomer kan omfatte følgende:

irritation i luftvejene

hosten

Væsentlige symptomer kan omfatte følgende:

mavesmerter

Væsentlige symptomer kan omfatte følgende:

smerte eller irritation

rødmen

der kan forekomme blister

:

:

:

Øjenkontakt

:

Væsentlige symptomer kan omfatte følgende:

smerte

løber i vand

rødmen

4.3 Angivelse af om øjeblikkelig lægehjælp og særlig behandling er nødvendig

Ingen specifik behandling.

:

Isoler straks området ved at fjerne alle personer i nærheden af branden. Der må

ikke iværksættes handlinger man ikke er uddannet til eller som medfører personlig

risiko.

Farlige

forbrændingsprodukter

Risici ved stoffet eller

blandinger

Nedbrydningsprodukter kan omfatte de følgende materialer:

kuldioxid

kulmonoxid

nitrogenoxider

fosforoxider

metaloxid/-oxider

Trykket stiger i tilfælde af brand eller ved opvarmning, og beholderen kan briste.

Brandmænd bør bære passende beskyttelsesudstyr og selvforsynet, lufttilført

åndedrætsapparatur (SCBA) med fuld ansigtsmaske, som skal anvendes i positiv

tryktilstand.

Særlige personlige

værnemidler, som skal

bæres af brandmandskabet

Brug vandspray (tåge), skum, pulver eller CO

i tilfælde af brand.

5.1 Slukningsmidler

:

:

:

Ingen kendte.

Passende slukningsmidler

:

Upassende

slukningsmidler

:

PUNKT 5: Brandbekæmpelse

5.2 Særlige farer i forbindelse med stoffet eller blandingen

5.3 Anvisninger for brandmandskab

Særlige

sikkerhedsforanstaltninger

for brandmænd

:

PUNKT 6: Forholdsregler over for udslip ved uheld

6.1 Personlige sikkerhedsforanstaltninger, personlige værnemidler og nødprocedurer

For ikke-akut personale

:

Der må ikke iværksættes handlinger man ikke er uddannet til eller som medfører

personlig risiko. Hold unødvendigt og ubeskyttet personnel ude. Forsøg at undgå at

røre ved eller at gå gennem spildt materiale. Undgå indånding af dampe eller tåger.

Sørg for tilstrækkelig ventilation. Brug egnet åndedrætsværn ved utilstrækkelig

ventilationen. Anvend egnet, personligt beskyttelsesudstyr.

Udgivelsesdato/Revisionsdato

:

4/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 6: Forholdsregler over for udslip ved uheld

6.2

Miljøbeskyttelsesforanstaltninger

Stop utætheden, hvis det kan gøres uden risiko. Flyt beholdere væk fra

spildområdet. Gå udslippet imøde i medvind. Undgå udslip til kloakker, vandløb,

kældre eller lukkede områder. Vask spild ned i et anlæg til behandling af

udstrømmende spild eller gør følgende. Spild begrænses og opsamles med ikke-

brandbart absorberende materiale, f.eks. sand, jord, vemiculite, diatomejord og

placeres i beholder og bortskaffes i overensstemmelse med gældende regler. Det

spildte materiale kan neutraliseres med natriumkarbonat, natriumbikarbonat eller

natriumhydroxid. Forurenet opsugningsmateriale kan have samme farlige

egenskaber som det spildte produkt.

Undgå spredning af spildt materiale og afstrømning og kontakt med jord, vandveje,

afløb og kloakker. Underret myndighederne hvis produktet har medført

miljøforurening (kloakker, vandveje, jord og luft).

Stort udslip

:

Stop utætheden, hvis det kan gøres uden risiko. Flyt beholdere væk fra

spildområdet. Fortynd med vand og mop op hvis vandopløselig. Alternativt, eller

hvis uopløsligt i vand, absorber med et ikke brændbart tørstof og placer i en egnet

affaldsbeholder.

Lille udslip

:

6.3 Metoder og udstyr til inddæmning og oprensning

For beredskab i

nødsituationer

:

6.4 Henvisning til andre

punkter

Se Afsnit 1 for kontaktoplysninger i nødsituationer.

Se Afsnit 8 for oplysninger om passende, personligt beskyttelsesudstyr.

Se Afsnit 13 for yderligere oplysninger om affaldshåndtering.

Hvis særlig beklædning er påkrævet for at håndtere spildet, skal man være

opmærksom på alle oplysninger i punkt 8 om passende og upassende materialer.

Se også informationen under "For ikke-akut personale".

:

:

Opbevares ved følgende temperaturer: 0 til 40°C (32 til 104°F). Opbevares i

henhold til lokale regler. Opbevares i original emballage, beskyttet fra direkte sollys

på et tørt, køligt og vel-ventileret sted, væk fra uforenelige materialer (se sektion 10)

samt føde- og drikkevarer. Holdes væk fra alkalier. Hold beholderen tæt lukket og

forseglet, indtil den skal bruges. Åbnede beholdere skal lukkes omhyggeligt og

opbevares oprejst for at forebygge lækage. Må ikke opbevares i umærkede

beholdere. Skal indesluttes forsvarligt for at undgå miljøforurening.

PUNKT 7: Håndtering og opbevaring

Oplysningerne i dette punkt indeholder generelle råd og vejledning. Listen over identificerede anvendelser i punkt 1 bør

konsulteres for at få enhver oplysning relateret til specifik brug ved eksponeringsscenarier.

7.1 Forholdsregler for sikker håndtering

Beskyttelsesforanstaltninger

:

Råd om generel

arbejdsmæssig hygiejne

:

7.2 Betingelser for sikker

opbevaring, herunder

eventuel uforenelighed

7.3 Særlige anvendelser

Brug egnede personlige værnemidler (se sektion 8). Må ikke komme i kontakt med

øjne, hud eller beklædning. Undgå indånding af dampe eller tåger. Må ikke

indtages. Hvis materialet ved normal brug udgør en risiko for vejrtrækningen, må

det kun anvendes med tilstrækkelig ventilation eller brug af passende

åndedrætsværn. Opbevares i den originale beholder eller godkendt alternativ, der er

fremstillet af et tilsvarende materiale, hold den tæt lukket, når den ikke bruges.

Undgå kontakt med alkalier.

Brugere skal vaske hænder og ansigt, før de spiser, drikker eller ryger. Se også

punkt 8 for yderligere oplysninger om hygiejneforanstaltninger.

:

Anbefalinger

:

Specifikke løsninger til den

industrielle sektor

:

Ikke anvendelig før eksponeringsscenarier for stoffer bliver tilgængelige.

Ikke anvendelig før eksponeringsscenarier for stoffer bliver tilgængelige.

Udgivelsesdato/Revisionsdato

:

5/13

31 oktober 2012

PREMIX P3-stabimix WR

Beskyttelse af hænder

(EN 374)

Brug en korrekt tilpasset luftrensende eller luftforsynet gasmaske, som overholder

en godkendt standard, hvis en risikovurdering angiver, at det er nødvendigt. Valg af

respirator skal være baseret på kendte eller forventede eksponeringsniveauer, faren

ved produktet og sikre funktionsgrænser for den valgte respirator.

Stærkt anbefalet : Handsker - butylgummi , nitrilgummi ( Gennemtrængningstid: 1-4

timer ) . 1-4 timer (gennembrudstid): butylgummi , nitrilgummi

Stærkt anbefalet : Beskyttelsesbriller, ansigtsmaske eller anden ansigtsbeskyttelse.

Beskyttelse af øjne/ansigt

(EN 166)

Beskyttelse af

åndedrætsorganer

(EN 143, 14387)

:

:

:

Beskyttelse af hud

Personligt beskyttelsesudstyr til kroppen bør vælges på grundlag af den opgave, der

skal udføres, og de involverede risici og bør godkendes af en specialist, før dette

produkt håndteres.

:

Foranstaltninger til

begrænsning af

eksponering af miljøet

:

Emissioner fra udluftnings- eller arbejdsudstyr bør kontrolleres for at sikre, at de

opfylder de juridiske krav for miljøbeskyttelse. I visse tilfælde vil det være

nødvendigt med luftrensere, filtre eller andre tekniske modifikationer til udstyret for

at reducere emissionerne til acceptable niveauer.

Egnede ingeniørmæssige

kontrolfunktioner

:

Hvis anvendelsen danner støv, røg, gas, dampe eller tåge, skal der bruges

afskærmning af processerne, lokal udsugningsventilation eller andre tekniske

kontroller til at holde arbejdernes eksponering for luftbårne forureningsstoffer under

eventuelle anbefalede eller lovmæssige grænseværdier.

Vask hænder, underarme og ansigt grundigt efter håndtering af kemiske produkter,

før der spises, ryges eller benyttes toilet, og ved arbejdsperiodens afslutning. De

rette teknikker bør bruges til at fjerne beklædning, der muligvis er forurenet. Vask

forurenet tøj, før det atter tages i brug. Sørg for, at øjenvaskestationer og

nødbruser befinder sig tæt på arbejdsstationens beliggenhed.

8.2 Eksponeringskontrol

Hygiejniske

foranstaltninger

:

Ingen DNELs tilgængelig for blandingen.

Forventede effekt koncentrationer

Ingen PNECs tilgængelig for blandingen.

PUNKT 8: Eksponeringskontrol/personlige værnemidler

8.1 Kontrolparametre

Afledte effektniveauer

Individuelle beskyttelsesforanstaltninger

Beskyttelse af krop

(EN 14605)

:

Anden hudbeskyttelse

Termiske farer

:

Passende fodtøj og alle yderligere hudbeskyttelsesforanstaltninger bør vælges

baseret på opgaven, som skal udføres og de involverede risici, og bør godkendes af

en specialist før håndtering af dette produkt.

Ikke relevant.

Produkt/ingrediens navn

Grænseværdier for eksponering

Arbejdstilsynets grænseværdier

Ingen kendt grænseværdi.

PUNKT 9: Fysisk-kemiske egenskaber

Fysisk tilstandsform

Væske.

Lugtfri.

Lugt

pH

Brun.

Farve

0.5 til 1.5 [Konc. (% vægt / vægt): 100%]

Lugtgrænse

:

:

:

:

:

9.1 Oplysninger om grundlæggende fysiske og kemiske egenskaber

Udseende

Ikke anvendelig og/eller ikke bestemt for blandingen.

Udgivelsesdato/Revisionsdato

:

6/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 9: Fysisk-kemiske egenskaber

Smeltepunkt/frysepunkt

Begyndelseskogepunkt og

kogepunkts interval

Damptryk

Relativ massefylde

damp densitet

Opløselighed(er)

1.09 til 1.13

Opløses nemt i de følgende materialer: koldt vand og varmt vand.

Fordampningsgrad

Selvantændelsestemperatur

Flammepunkt

> 100°C

Produktet vil ikke nære en brand

Oktanol/vand

fordelingskoefficient

Eksplosionsegenskaber

:

:

:

:

:

:

:

:

:

:

:

Ingen.

Oxiderende egenskaber

:

9.2 Andre oplysninger

Forbrændingstid

Forbrændingshastighed

:

:

Nedbrydningstemperatur

:

Ingen yderligere oplysninger.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Ikke relevant.

Ikke anvendelig og/eller ikke bestemt for blandingen.

Viskositet

:

Øvre/nedre grænser for

antændelse eller eksplosion

:

Ikke anvendelig og/eller ikke bestemt for blandingen.

Brandbarhed (fast, luftart)

:

Ikke anvendelig og/eller ikke bestemt for blandingen.

10.6 Farlige

nedbrydningsprodukter

10.4 Forhold, der skal

undgås

Ingen specifikke data.

Ved normale opbevarings- og brugsbetingelser bør der ikke dannes farlige

nedbrydningsprodukter.

Produktet er stabilt.

10.2 Kemisk stabilitet

:

:

:

10.5 Materialer, der skal

undgås

:

10.3 Risiko for farlige

reaktioner

:

Under normale opbevarings- og anvendelsesforhold opstår der ingen farlige

reaktioner.

PUNKT 10: Stabilitet og reaktivitet

10.1 Reaktivitet

:

Ingen specifikke testdata relateret til reaktivitet er tilgængelige for dette produkt eller

dets indholdsstoffer.

Yderst reaktiv eller inkompatibel med følgende materialer: alkalier.

Udgivelsesdato/Revisionsdato

:

7/13

31 oktober 2012

PREMIX P3-stabimix WR

Potentielle akutte helbredspåvirkninger

Indånding

:

Kan afgive gasser, dampe eller støv, der er meget irriterende eller ætsende for

åndedrætssystemet. Udsættelse for nedbrydningsprodukter kan udgøre en

sundhedsfare. Der kan efter eksponering opstå forsinkede alvorlige virkninger.

Kan forårsage ætsningsskader i mund, hals og mave.

:

Indtagelse

Hudkontakt

:

Alvorlig ætsningsfare.

Forårsager alvorlig øjenskade.

:

Øjenkontakt

Akut giftighed

alkohol ethoxylater

LD50 Dermal

Rotte

>2000 mg/kg

LD50 Oral

Rotte

>2000 mg/kg

Alkylpolyglycosider

LD50 Dermal

Kanin

>2000 mg/kg

LD50 Oral

Rotte

>5000 mg/kg

Syrer

LC50 Indånding Støv og

spraytåger

Rotte

>1.979 mg/l

4 timer

LD50 Dermal

Rotte

>4000 mg/kg

LD50 Oral

Rotte

>6500 mg/kg

ATMP

LD50 Dermal

Kanin

>6310 mg/kg

LD50 Oral

Rotte

2910 mg/kg

HEDP

LD50 Dermal

Kanin

>10000 mg/kg

LD50 Oral

Rotte

3130 mg/kg

Produkt/ingrediens navn

Resultat

Arter

Dosis

Eksponering

Carcinogenicitet

Mutagenicitet

Teratogenicitet

Reproduktionstoksicitet

Symptomer, som vedrører de fysiske, kemiske og toksikologiske egenskaber

Indånding

Ingen specifikke data.

:

Irritation/ætsning

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Sensibiliserende stof

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

PUNKT 11: Toksikologiske oplysninger

11.1 Oplysninger om toksikologiske virkninger

Estimater for akut toksicitet

Ikke bestemt for blandingen.

Toksicitet for specifikt målorgan (enkel eksponering)

Toksicitet for specifikt målorgan (gentagen eksponering)

Udsugningsfare

Ingen kendte betydelige virkninger eller kritiske risici.

Ingen kendte betydelige virkninger eller kritiske risici.

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Oplysninger om mulige

eksponeringsbaner

:

Ingen kendte betydelige virkninger eller kritiske risici.

Udgivelsesdato/Revisionsdato

:

8/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 11: Toksikologiske oplysninger

Potentielle kroniske sundhedseffekter

Ingen kendte betydelige virkninger eller kritiske risici.

Generelt

:

Ingen kendte betydelige virkninger eller kritiske risici.

Carcinogenicitet

:

Ingen kendte betydelige virkninger eller kritiske risici.

Mutagenicitet

:

Ingen kendte betydelige virkninger eller kritiske risici.

Teratogenicitet

:

Udviklingseffekter

:

Ingen kendte betydelige virkninger eller kritiske risici.

Fertilitets effekter

:

Ingen kendte betydelige virkninger eller kritiske risici.

Hudkontakt

Indtagelse

Væsentlige symptomer kan omfatte følgende:

mavesmerter

Væsentlige symptomer kan omfatte følgende:

smerte eller irritation

rødmen

der kan forekomme blister

:

:

Øjenkontakt

:

Væsentlige symptomer kan omfatte følgende:

smerte

løber i vand

rødmen

Forsinkede og øjeblikkelige påvirkninger samt kroniske påvirkninger fra kort- og langvarig eksponering

Eksponering i kort tid

Eksponering i lang tid

Potentielle øjeblikkelige

effekter

:

Potentielle forsinkede

effekter

:

Potentielle øjeblikkelige

effekter

:

Potentielle forsinkede

effekter

:

Ingen kendte betydelige virkninger eller kritiske risici.

Ingen kendte betydelige virkninger eller kritiske risici.

Ingen kendte betydelige virkninger eller kritiske risici.

Ingen kendte betydelige virkninger eller kritiske risici.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Andre oplysninger

:

Ingen kendte betydelige virkninger eller kritiske risici.

PUNKT 12: Miljøoplysninger

LogP

ow

BCF

mulighed

12.3 Bioakkumuleringspotentiale

Produkt/ingrediens navn

ATMP

-3.53

12.1 Toksicitet

alkohol ethoxylater

Akut LC50 5 mg/l

Fisk

96 timer

Alkylpolyglycosider

Akut EC50 18 mg/l

Akvatiske planter

72 timer

Syrer

Akut LC50 >1042 mg/l

Fisk

96 timer

Kronisk NOEC 17.8 mg/l

Alger

72 timer

ATMP

Akut LC50 160 mg/l

Fisk

96 timer

HEDP

Akut LC50 368 mg/l

Fisk

96 timer

Produkt/ingrediens navn

Arter

Resultat

Eksponering

12.2 Persistens og nedbrydelighed

Konklusion/Sammendrag

:

Tensiderne i produktet er biologisk nedbrydelige iht. kravene i forordning nr.

648/2004 om vaske- og rengøringsmidler.

Konklusion/Sammendrag

:

Ingen kendte betydelige virkninger eller kritiske risici.

Udgivelsesdato/Revisionsdato

:

9/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 12: Miljøoplysninger

12.6 Andre negative

virkninger

Ingen kendte betydelige virkninger eller kritiske risici.

PBT

:

Ikke relevant.

vPvB

:

Ikke relevant.

12.4 Mobilitet i jord

12.5 Resultater af PBT- og vPvB-vurdering

:

Fordelingskoefficient for

jord/vand (K

OC

)

:

Ikke bestemt for blandingen.

Mobilitet

:

Ikke bestemt for blandingen.

Europæisk affaldskatalog (EWC)

Farligt Affald

:

Produktion af affald bør undgås eller minimeres hvor som helst, det er muligt.

Tomme beholdere eller den indvendige beklædning kan indeholde rester fra

produktet. Materialet og dets beholder skal bortskaffes på en sikker måde.

Betydelige mængder af produktrester bør ikke bortskaffes via kloakken, men skal

behandles i et passende anlæg til behandling af spildevand. Overskudsprodukt og

produkt, der ikke kan genbruges, bortskaffes via en godkendt affaldsordning.

Bortskaffelse af dette produkt, opløsninger og eventuelle biprodukter bør til enhver

tid overholde kravene i lovgivningen om miljøbeskyttelse og bortskaffelse af affald og

alle regionale og lokale myndigheders eventuelle krav. Undgå spredning af spildt

materiale og afstrømning og kontakt med jord, vandveje, afløb og kloakker.

:

Metoder for bortskaffelse

PUNKT 13: Forhold vedrørende bortskaffelse

Oplysningerne i dette punkt indeholder generelle råd og vejledning. Listen over identificerede anvendelser i punkt 1 bør

konsulteres for at få enhver oplysning relateret til specifik brug ved eksponeringsscenarier.

13.1 Metoder til affaldsbehandling

Produkt

Emballage

Affaldskode

Affaldsbetegnelse

Metoder for bortskaffelse

:

Særlige forholdsregler

:

20 01 14*

Syrer

Produktion af affald bør undgås eller minimeres hvor som helst, det er muligt.

Emballageaffald bør genbruges.

Materialet og dets beholder skal bortskaffes på en sikker måde. Der skal udvises

omhu ved håndtering af tomme beholdere, som ikke er blevet rengjorte eller

skyllede af. Tomme beholdere eller den indvendige beklædning kan indeholde

rester fra produktet. Undgå spredning af spildt materiale og afstrømning og kontakt

med jord, vandveje, afløb og kloakker.

Not regulated.

Ikke reguleret.

Ikke reguleret.

Not regulated.

PUNKT 14: Transportoplysninger

ADR/RID

IMDG

IATA

14.1 UN-nummer

14.2 UN-

forsendelsesbetegnelse

(UN proper

shipping name)

ADN/ADNR

Udgivelsesdato/Revisionsdato

:

10/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 14: Transportoplysninger

14.3

Transportfareklasse(r)

14.4

Emballagegruppe

14.5 Miljøfarer

14.6 Særlige

forsigtighedsregler

for brugeren

14.7 Bulktransport i henhold

til bilag II til MARPOL 73/78

og IBC-koden

Nej.

Nej.

:

Ikke relevant.

Ingen.

Ingen.

None.

None.

Nationale regler

Andre EU regler

Ikke relevant.

Bilag XVII -

Begrænsninger

vedrørende fremstilling,

markedsføring og

anvendelse af visse

farlige stoffer, kemiske

produkter og artikler

:

Danmark

PUNKT 15: Oplysninger om regulering

15.1 Særlige bestemmelser/særlig lovgivning for stoffet eller blandingen med hensyn til sikkerhed, sundhed og

miljø

EU-regulativ (EC) Nr. 1907/2006 (REACH)

Fortegnelse over stoffer, der kræver godkendelse

15.2

Kemikaliesikkerhedsvurdering

Produktet indeholder stoffer, for hvilke der fortsat kræves en kemisk

sikkerhedsvurdering.

Særligt problematiske stoffer

:

Ingen af bestanddelene er angivet.

≥15 - <30% nonioniske tensider

<5% anioniske tensider, fosfater

Indholdsdeklaration iht. forordning nr. 648/2004 om vaske- og rengøringsmidler:

Angiver oplysninger, der er ændret fra den tidligere udgave.

PUNKT 16: Andre oplysninger

Udgivelsesdato/Revisionsdato

:

11/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 16: Andre oplysninger

31 oktober 2012

Udskriftsdato

Udgivelsesdato/

Revisionsdato

Version:

Bemærkning til læseren

Dato for forrige udgave

:

:

:

:

R35- Alvorlig ætsningsfare.

R41- Risiko for alvorlig øjenskade.

R36- Irriterer øjnene.

R36/38- Irriterer øjnene og huden.

:

Komplet tekst af forkortede

R-sætninger

Komplet tekst af

klassificeringer [DSD/DPD]

:

C - Ætsende

Xi - Lokalirriterende

31 oktober 2012

Ingen tidligere validering

Komplet tekst af forkortede

faresætninger

:

Forkortelser og initialord

:

ADN/ADNR = Europæiske Bestemmelser vedrørende International Transport af

Farligt Gods ad Indre Vandveje

ADR = Europæisk Konvention om International Transport af Farligt Gods ad Vej

ATE = Vurdering af Akut Toksicitet

BCF = Biokoncentrationsfaktor

CLP = Lovgivning om Klassificering, Mærkning og Emballering af stoffer og

blandinger [Europa-Parlamentets og Rådets Forordning (EF) Nr. 1272/2008]

DNEL-værdi = Derived-No-Effect-Level

DPD = Direktivet om Farlige Præparater [1999/45/EC]

EC = Europa-Kommissionen

EUH sætning = CLP-specificeret faresætning

IATA = International Air Transport Association

IBC = Mellemstor Beholder til Bulkvarer

IMDG = Den Internationale Kode for Søtransport af Farligt Gods

LogPow = Logaritme af octanol/vand-fordelingskoefficienten

MARPOL 73/78 = Den Internationale Konvention om Forebyggelse af Forurening Fra

Skibe, 1973 som modificeret ved Protokollen af 1978. ("Marpol" = skibsforurening)

OEL = Grænseværdi

PBT = Persistent, Bioakkumulerende og Toksisk

PNEC-værdi = Predicted-No-Effect-Concentration

REACH = Lovgivning om Registrering, Vurdering, Godkendelse af samt

Begrænsninger for Kemikalier [Europa-Parlamentets og Rådets forordning (EF) nr.

1907/2006]

RID = Lovgivnngen om International Transport af Farligt Gods på Bane

REACH # = REACH Registreringsnummer

vPvB = Meget Persistente og Meget Bioakkumulerende

Procedure brugt til at tilvejebringe klassificeringen i henhold til Regulativ (EC) nr. 1272/2008 [CLP/GHS]

Klassificering

Begrundelse

Skin Corr. 1A, H314

På basis af testdata

Fulde tekst af

klassificeringer [CLP/GHS]

:

H290

Kan ætse metaller.

H314

Forårsager svære forbrændinger af huden og øjenskader.

H315

Forårsager hudirritation.

H318

Forårsager alvorlig øjenskade.

H319

Forårsager alvorlig øjenirritation.

Eye Dam. 1, H318

ALVORLIGE ØJENSKADER/ØJENIRRITATION -

Kategori 1

Eye Irrit. 2, H319

ALVORLIGE ØJENSKADER/ØJENIRRITATION -

Kategori 2

Met. Corr. 1, H290

METALÆTSENDE - Kategori 1

Skin Corr. 1A, H314

HUDÆTSNING/HUDIRRITATION - Kategori 1A

Skin Irrit. 2, H315

HUDÆTSNING/HUDIRRITATION - Kategori 2

Udgivelsesdato/Revisionsdato

:

12/13

31 oktober 2012

PREMIX P3-stabimix WR

PUNKT 16: Andre oplysninger

Ovennævnte oplysninger er efter vor bedste overbevisning korrekte i relation til den receptur, der har været

anvendt ved produkternes fremstilling i det pågældende land.

Udgivelsesdato/Revisionsdato

:

13/13

31 oktober 2012

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

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

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

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Peer review of the pesticide risk assessment of the active substance sodium hydrogen carbonate

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Austria for the pesticide active substance sodium hydrogen carbonate are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of sodium hyd...

Europe - EFSA - European Food Safety Authority Publications

18-9-2018

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Peer review of the pesticide risk assessment of the active substance beta‐cyfluthrin

Published on: Fri, 14 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Germany and co‐rapporteur Member State Hungary for the pesticide active substance beta‐cyfluthrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of b...

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Peer review of the pesticide risk assessment of the active substance azadirachtin (Margosa extract)

Published on: Thu, 13 Sep 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Germany, for the pesticide active substance azadirachtin are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the additional representative use of azadir...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Prizer-Painter Stove Works, Inc. recalls BlueStar and Big Chill Brand Gas Ranges and Wall Ovens

Use of the convection oven fan during pre-heating or broiling can cause accumulated gas to ignite, posing a burn hazard to consumers when oven door is opened.

Health Canada

11-9-2018

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Peer review of the pesticide risk assessment of the active substance alpha‐cypermethrin

Published on: Mon, 10 Sep 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Greece for the pesticide active substance alpha‐cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EUFORA fellowship programme ‘Livestock Health and Food Chain Risk Assessment’ was proposed by the Animal and Plant Health Agency (APHA), a British governmental institution responsible for safeguarding animal and plant health in the UK. The working programme, which was organised into four different modules, covered a wide range of aspects related to risk assessment including identification of emerging risks, risk prioritisation methods, scanning surveilla...

Europe - EFSA - European Food Safety Authority Publications

5-9-2018

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology

Published on: Tue, 04 Sep 2018 00:00:00 +0200 This technical report reflects the outcome of the mammalian toxicology experts meeting on general recurring issues noted during the EFSA peer reviews of pesticide active substances under Regulation (EC) No 1107/2009. The main issues identified were related to genotoxicity of products and principles of (Q)SAR and read‐across. General presentations on the different EFSA guidance and EFSA developmental activities related to human health risk assessment of pesti...

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Outcome of the consultation with Member States and EFSA on the basic substance application for milk for use in plant protection as fungicide

Published on: Mon, 03 Sep 2018 00:00:00 +0200 The European Food Safety Authority (EFSA) was asked by the European Commission to provide scientific assistance with respect to the evaluation of applications received by the European Commission concerning basic substances. In this context, EFSA's scientific views on the specific points raised during the commenting phase conducted with Member States and EFSA on the basic substance application for milk are presented. The context of the evaluation was that req...

Europe - EFSA - European Food Safety Authority Publications

31-8-2018

Peer review of the pesticide risk assessment of the active substance cypermethrin

Peer review of the pesticide risk assessment of the active substance cypermethrin

Published on: Thu, 30 Aug 2018 00:00:00 +0200 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Belgium and co‐rapporteur Member State Germany for the pesticide active substance cypermethrin are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of cype...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

Anthrax

Anthrax

Anthrax is a zoonosis (i.e. a disease common to humans and animals) that primarily affects herbivores. It is caused by Bacillus anthracis, a bacterium that is unusual in that it persists in soil for decades as spores. ANSES is the National Reference Laboratory for this disease. Here we provide a presentation of the disease and the role played by ANSES.

France - Agence Nationale du Médicament Vétérinaire

29-8-2018

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Modification of the existing maximum residue levels for prohexadione in various oilseeds

Published on: Mon, 27 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRL) for the active substance prohexadione in linseeds, poppy seeds, sunflower seeds, rape seeds, mustard seeds and gold of pleasure seeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for all oilseeds under consid...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Joint EFSA and ECDC 2018 workshop on preparedness for a multi‐national food safety/public health incident

Published on: Tue, 21 Aug 2018 00:00:00 +0200 Abstract In May 2018, EFSA and ECDC co‐facilitated a workshop on preparedness for a multi‐national food safety/public health incident. The workshop, hosted at AGES in Vienna, was conceived to closely align with EFSA's Strategy 2020 commitment to prepare for future risk assessment challenges. EFSA, ECDC, AGES and BfR worked together closely to develop a workshop and associated training materials to be delivered over a 2.5‐day agenda. The workshop was attended...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Modification of the existing maximum residue levels for fluoxastrobin in oilseeds

Published on: Mon, 13 Aug 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Arysta LifeSciences SAS submitted a request to the competent national authority in the United Kingdom to modify the existing maximum residue levels (MRL) for the active substance fluoxastrobin in certain oilseeds. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the oilseeds for which a modification was requested. Adequate analytical...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Evaluation of data concerning the necessity of bromoxynil as herbicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Published on: Mon, 13 Aug 2018 00:00:00 +0200 EFSA was requested by the European Commission to provide scientific assistance under Article 31 of Regulation (EC) No 178/2002 regarding the evaluation of data concerning the necessity of bromoxynil as a herbicide to control a serious danger to plant health which cannot be contained by other available means including non‐chemical methods, in accordance with Article 4(7) of Regulation (EC) No 1107/2009. In this context, EFSA organised a commenting phase with ...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Peer review of the pesticide risk assessment of the active substance carvone (substance evaluated d‐carvone)

Published on: Tue, 07 Aug 2018 00:00:00 +0200 The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, the Netherlands and co‐rapporteur Member State, Sweden, for the pesticide active substance carvone are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative use...

Europe - EFSA - European Food Safety Authority Publications

18-6-2018

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

340 miljoen voor thuiswonende ouderen: zelfstandig oud worden in vertrouwde omgeving

Ouderen willen het liefst in hun eigen vertrouwde omgeving zelfstandig oud worden en een fijn en zinvol leven leiden. Om dat beter mogelijk te maken presenteert minister De Jonge (VWS) vandaag het programma Langer Thuis. Het Kabinet investeert daar de komende jaren ruim 340 miljoen euro in. Het programma is vandaag door minister De Jonge en minister Ollongren (BZK) naar de Tweede Kamer gestuurd.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-6-2018

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Minister Bruins presenteert maatregelen om uitgavengroei geneesmiddelen te beheersen

Lagere maximumprijzen, scherper inkopen en beter kijken welke geneesmiddelen tegen welke prijs vergoed worden.  Dat zijn drie belangrijke onderwerpen in een nieuw pakket aan maatregelen van minister Bruno Bruins voor Medische Zorg. Doel is de uitgavengroei aan geneesmiddelen te beheersen.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

9-6-2018

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

The U.S. Food and Drug Administration, along with the Centers for Disease Control and Prevention (CDC) and state and local partners, are investigating a multistate outbreak of Salmonella Adelaide illnesses that may be linked to cut melons.

FDA - U.S. Food and Drug Administration

6-6-2018

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

National Network for the Monitoring and Prevention of Occupational Diseases: new data published on cancers of occupational origin

At the 35th French occupational medicine and health congress (CNMST) held in Marseille from 5 to 8 June 2018, ANSES presented for the very first time data on cancers of occupational origin collected by the National Network for Monitoring and Prevention of Occupational Diseases (RNV3P) coordinated by the Agency. These data are used to build up a comprehensive picture of the cancers associated with occupational exposure situations, in order toidentify the industry sectors and situations most at risk, with ...

France - Agence Nationale du Médicament Vétérinaire

25-4-2018

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction

The FDA is warning that the medicine lamotrigine (Lamictal) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. As a result, we are requiring a new warning about this risk be added to the prescribing information in the lamotrigine drug labels. The immun...

FDA - U.S. Food and Drug Administration

10-8-2017

Bravecto® may cause convulsions in dogs on rare occasions

Bravecto® may cause convulsions in dogs on rare occasions

The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.

Danish Medicines Agency

3-2-2015

New director at the DHMA

New director at the DHMA

On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.

Danish Medicines Agency

4-11-2011

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

Comments received on the reassessment of reimbursement status of strong analgesics (opioids)

The Danish Medicines Agency has received a number of comments for the Reimbursement Committee's discussion of reimbursement status of strong analgesics (opioids). These comments were presented to the Reimbursement Committee at its meeting on 27 September 2011. The Reimbursement Committee is currently processing a recommendation.

Danish Medicines Agency

10-9-2018

 Pre-authorisation guidance

Pre-authorisation guidance

Europe - EMA - European Medicines Agency

27-8-2018

Discontinuing pre-market evaluation of Herbal Component Names: Frequently asked questions (FAQs)

Discontinuing pre-market evaluation of Herbal Component Names: Frequently asked questions (FAQs)

Frequently asked questions to inform sponsors about discontinuing the pre-market evaluation of HCNs

Therapeutic Goods Administration - Australia

27-8-2018

Submissions received: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

Submissions received: Discontinuing pre-market evaluation of Herbal Component Names (HCNs)

Submissions received on the Discontinuing pre-market evaluation of Herbal Component Names (HCNs) consultation have been published

Therapeutic Goods Administration - Australia

23-8-2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

TGA presentations: Inaugural Industry Forum on Good Manufacturing Practice (GMP), 26 June 2018

MMDR implementation, SME Assist, GMP reforms, medicinal cannabis and international cooperation

Therapeutic Goods Administration - Australia

14-8-2018

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at  https://go.usa.gov/xUF39   #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kid

We are excited by all the feedback we received over the last two days during the Pediatric Medical Device Development meeting. All presentation materials will be available on the Pediatric Medical Device webpage at https://go.usa.gov/xUF39  #Devices4Kids #MedicalDevice pic.twitter.com/XGwlpgopGn

FDA - U.S. Food and Drug Administration

2-8-2018

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Wave life Sciences Ireland Limited)

EU/3/18/2051 (Active substance: Synthetic antisense oligonucleotide directed against human dystrophin pre-mRNA) - Orphan designation - Commission Decision (2018)5283 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/032/18

Europe -DG Health and Food Safety

2-8-2018

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Ionis USA Limited)

EU/3/18/2041 (Active substance: 2'-O-(2-methoxyethyl) antisense oligonucleotide targeting microtubule-associated protein tau pre-mRNA) - Orphan designation - Commission Decision (2018)5273 of Thu, 02 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/050/18

Europe -DG Health and Food Safety

31-7-2018

Scientific guideline:  Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

Scientific guideline: Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells, draft: consultation open

This guideline defines scientific principles and provides guidance for the development and evaluation of medicinal products containing genetically modified cells intended for use in humans and presented for marketing authorisation. Its focus is on the quality, nonclinical aspects and safety and efficacy requirements of genetically modified cells developed as medicinal products.

Europe - EMA - European Medicines Agency

12-7-2018

TGA presentations: The new Code - where are we at? 12 &amp; 13 June 2018

TGA presentations: The new Code - where are we at? 12 &amp; 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

6-7-2018

TGA presentation: National Medicines Symposium, 30 May 2018

TGA presentation: National Medicines Symposium, 30 May 2018

This presentation covers the revised requirements for advertisements for medicines containing Schedule 3 substances

Therapeutic Goods Administration - Australia

29-6-2018

TGA presentation: ARCS  webinar, 22 June 2018

TGA presentation: ARCS webinar, 22 June 2018

An overview of the expectations and best practices for structuring and formatting data in module 1.3 for submissions in the eCTD format using the Australian specifications version 3.1

Therapeutic Goods Administration - Australia

14-6-2018

Evaluation Plan Estimators

Evaluation Plan Estimators

Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example...

Therapeutic Goods Administration - Australia

1-6-2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

TGA presentation: Health Consumers Workshop - Medical Devices, 1 March 2018

Presentations for the medical devices health consumer workshop on consumer information for implantable medical devices.

Therapeutic Goods Administration - Australia

24-5-2018

TGA presentation: Update on the therapeutic goods advertising reforms

TGA presentation: Update on the therapeutic goods advertising reforms

Some important changes are being implemented

Therapeutic Goods Administration - Australia

2-5-2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

TGA presentation: Medicines Australia Regulatory Affairs Working Group, 18 April 2018

Update on TGA activities from the Scientific Evaluation Branch

Therapeutic Goods Administration - Australia