KLERCIDE WFI QUALITY WATER

Primær information

  • Handelsnavn:
  • KLERCIDE WFI QUALITY WATER
  • Brugt til:
  • Mennesker
  • Medicin typen:
  • Medicinsk udstyr

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:
  • KLERCIDE WFI QUALITY WATER
    Danmark
  • Sprog:
  • dansk

Andre oplysninger

Status

  • Kilde:
  • Ecolab
  • Autorisationsnummer:
  • 116151E
  • Sidste ændring:
  • 12-03-2018

Produktresumé: dosering, interaktioner, bivirkninger

SIKKERHEDSDATABLAD

i henhold til Forordning (EF) nr.

1907/2006

Klercide WFI Quality Water

116151E

1 / 10

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

1.1 Produktidentifikator

Produktnavn

Klercide WFI Quality Water

Produkt kode

116151E

Anvendelse af stoffet/det

kemiske produkt

Mellemprodukt

Stoftype

Blanding

Kun til erhversmæssig brug.

Information om fortyndning

Ingen information om fortyndning angivet.

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

frarådes

Identificerede anvendelser

Konserverings-/desinfektionsmiddel. Procesvand

Anbefalede begrænsninger i

brugen

Forbeholdt industriel og erhvervsmæssig brug.

1.3 Nærmere oplysninger om leverandøren af sikkerhedsdatabladet

Firma

Ecolab ApS

Høffdingsvej 36

2500 Valby, Danmark Tel +45 36 15 85 85

dk-customerservice@ecolab.com

1.4 Nødtelefon

Nødtelefon

36 15 85 85 (hverdage 8.00 - 16.00)

Giftinformationen tlf. nr.

82 12 12 12

Udstedelse-/revisionsdato

01.09.2014

Udgave

PUNKT 2. FAREIDENTIFIKATION

2.1 Klassificering af stoffet eller blandingen

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

Ikke et farligt stof eller blanding.

Klassificering (67/548/EØF, 1999/45/EF)

I henhold til EU-direktiver og dansk lov skal produktet ikke mærkes.

Se afsnit 16 for fuld ordlyd af R-sætninger nævnt i dette afsnit.

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

2.2 Mærkningselementer

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

2 / 10

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

Ikke et farligt stof eller blanding.

2.3 Andre farer

Ingen kendte.

PUNKT 3. SAMMENSÆTNING AF/ OPLYSNING OM INDHOLDSSTOFFER

3.2 Blandinger

Bemærkninger

Ingen farlige indholdsstoffer

PUNKT 4. FØRSTEHJÆLPSFORANSTALTNINGER

4.1 Beskrivelse af førstehjælpsforanstaltninger

I tilfælde af øjenkontakt

Skyl med vand.

I tilfælde af hudkontakt

Skyl med vand.

Ved indtagelse.

Skyl munden. Søg læge hvis symptomer opstår.

Hvis det indåndes

Søg læge hvis symptomer opstår.

4.2 Vigtigste symptomer og virkninger, både akutte og forsinkede

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

4.3 Angivelse af om øjeblikkelig lægehjælp og særlig behandling er nødvendig

Behandling

Ingen specifikke foranstaltninger identificeret.

PUNKT 5. BRANDBEKÆMPELSE

5.1 Slukningsmidler

Egnede slukningsmidler

Brandslukningsforanstaltningerne skal være hensigtsmæssige i

forhold til lokale omstændigheder og det omgivne miljø.

Uegnede slukningsmidler

Ingen kendte.

5.2 Særlige farer i forbindelse med stoffet eller blandingen

Specifikke farer ved

brandbekæmpelse

Ikke brandfarligt eller brændbart.

Farlige

forbrændingsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

Fosforholdige oxider

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

3 / 10

5.3 Anvisninger for brandmandskab

Særlige personlige

værnemidler, der skal bæres

af brandmandskabet

: Brug personligt beskyttelsesudstyr.

Yderligere oplysninger

: Brandrester og forurenet brandslukningsvand skal bortskaffes i

henhold til de lokale regler.

PUNKT 6. FORHOLDSREGLER OVER FOR UDSLIP VED UHELD

6.1 Personlige sikkerhedsforanstaltninger, personlige værnemidler og nødprocedurer

Rådgivning for ikke-

indsatspersonel

Der henvises til beskyttelsesforanstaltninger nævnt i afsnit 7 og 8.

Rådgivning for

indsatspersonel

Hvis særlig beklædning er påkrævet for at håndtere spildet, skal

man være opmærksom på alle oplysninger i punkt 8 om passende

og upassende materialer.

6.2 Miljøbeskyttelsesforanstaltninger

Miljøbeskyttelsesforanstaltnin

Ingen specielle miljømæssige forholdsregler kræves.

6.3 Metoder og udstyr til inddæmning og oprensning

Metoder til oprydning

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

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

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

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

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

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

6.4 Henvisning til andre punkter

Se Afsnit 1 for kontaktoplysninger i nødsituationer.

For personlig beskyttelse se punkt 8.

Se Afsnit 13 for yderligere oplysninger om affaldshåndtering.

PUNKT 7. HÅNDTERING OG OPBEVARING

7.1 Forholdsregler for sikker håndtering

Råd om sikker håndtering

Ingen speciel håndteringsvejledning påkrævet.

Hygiejniske foranstaltninger

Ingen specifikke foranstaltninger identificeret.

7.2 Betingelser for sikker opbevaring, herunder eventuel uforenelighed

Krav til lager og beholdere

Opbevares utilgængeligt for børn. Hold beholderen tæt lukket.

Opbevares i behørigt mærkede beholdere.

Opbevaringstemperatur

0 °C til 25 °C

7.3 Særlige anvendelser

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

4 / 10

Særlige anvendelser

Konserverings-/desinfektionsmiddel. Procesvand

PUNKT 8. EKSPONERINGSKONTROL/PERSONLIGE VÆRNEMIDLER

8.1 Kontrolparametre

Grænseværdier for erhvervsmæssig eksponering

Indeholder ingen stoffer med grænseværdi for erhvervsmæssig eksponering.

8.2 Eksponeringskontrol

Passende tekniske foranstaltninger

Tekniske foranstaltninger

God generel ventilation skulle være tilstrækkeligt til at kontrollere

arbejdernes udsættelse for luftbårne urenheder.

Individuelle beskyttelsesforanstaltninger

Hygiejniske foranstaltninger

Ingen specifikke foranstaltninger identificeret.

Beskyttelse af øjne / ansigt

(EN 166)

Intet specielt beskyttelsesudstyr nødvendigt.

Beskyttelse af hænder (EN

374)

Intet specielt beskyttelsesudstyr nødvendigt.

Beskyttelse af hud og krop

(EN 14605)

Intet specielt beskyttelsesudstyr nødvendigt.

Åndedrætsværn (EN 143,

14387)

En komponent i dette produkt kan nedbrydes så svovlbrinte (H2S)

produceres. H2S-koncentrationerne i produktes væskefase er <

0.1% (1000ppm). Koncentrationer i frirum over væsken kan

variere.

Foranstaltninger til begrænsning af eksponering af miljøet

Generelle anvisninger

: Overvej om det er nødvendig at lukke opbevaringsbeholderne

inde.

PUNKT 9. FYSISK- KEMISKE EGENSKABER

9.1 Oplysninger om grundlæggende fysiske og kemiske egenskaber

Udseende

: væske

Farve

: Farveløs

Lugt

: lugtfri

pH-værdi

7.0, 100 %

Flammepunkt

Ikke anvendelig

Lugttærskel

Ingen data tilgængelige

Smeltepunkt/frysepunkt

Ingen data tilgængelige

Begyndelseskogepunkt og

kogepunktsinterval

Ingen data tilgængelige

Fordampningshastighed

Ingen data tilgængelige

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

5 / 10

Antændelighed (fast stof,

luftart)

Ingen data tilgængelige

Højeste eksplosionsgrænse

Ingen data tilgængelige

Laveste eksplosionsgrænse

Ingen data tilgængelige

Damptryk

Ingen data tilgængelige

Relativ dampvægtfylde

Ingen data tilgængelige

Relativ massefylde

Vandopløselighed

opløselig

Opløselighed i andre

opløsningsmidler

Ingen data tilgængelige

Fordelingskoefficient: n-

oktanol/vand

Ingen data tilgængelige

Selvantændelsestemperatur

Ingen data tilgængelige

Termisk spaltning

Ingen data tilgængelige

Viskositet, kinematisk

Ingen data tilgængelige

Eksplosive egenskaber

Ingen data tilgængelige

Oxiderende egenskaber

Stoffet eller blandingen er ikke klassificeret som oxiderende.

9.2 Andre oplysninger

Ingen data tilgængelige

PUNKT 10. STABILITET OG REAKTIVITET

10.1 Reaktivitet

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.2 Kemisk stabilitet

Stabil under normale forhold.

10.3 Risiko for farlige reaktioner

Ingen farlige reaktioner kendt ved normalt brug under normale forhold.

10.4 Forhold, der skal undgås

Ingen kendte.

10.5 Materialer, der skal undgås

Ingen kendte.

10.6 Farlige nedbrydningsprodukter

Nedbrydningsprodukter kan omfatte de følgende materialer:

Carbonoxider

Nitrogenoxider (NOx)

Svovloxider

Fosforholdige oxider

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

6 / 10

PUNKT 11. TOKSIKOLOGISKE OPLYSNINGER

11.1 Oplysninger om toksikologiske virkninger

Oplysninger om sandsynlige

eksponeringsveje

Indånding, Øjenkontakt, Hudkontakt

Toksicitet

Akut oral toksicitet

: Der er ingen tilgængelige data på dette produkt.

Akut toksicitet ved indånding

: Der er ingen tilgængelige data på dette produkt.

Akut dermal toksicitet

: Der er ingen tilgængelige data på dette produkt.

Hudætsning/-irritation

: Der er ingen tilgængelige data på dette produkt.

Alvorlig

øjenskade/øjenirritation

: Der er ingen tilgængelige data på dette produkt.

Respiratorisk sensibilisering

eller hudsensibilisering

: Der er ingen tilgængelige data på dette produkt.

Kræftfremkaldende

egenskaber

: Der er ingen tilgængelige data på dette produkt.

Reproduktionsskadende

virkninger

: Der er ingen tilgængelige data på dette produkt.

Kimcellemutagenicitet

: Der er ingen tilgængelige data på dette produkt.

Fosterbeskadigelse

: Der er ingen tilgængelige data på dette produkt.

Enkel STOT-eksponering

: Der er ingen tilgængelige data på dette produkt.

Gentagne STOT-

eksponeringer

: Der er ingen tilgængelige data på dette produkt.

Aspiration giftighed

: Der er ingen tilgængelige data på dette produkt.

Potentielle sundhedspåvirkninger

Øjne

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indtagelse

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Indånding

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Langtidspåvirkning

Helbredsskader er ikke kendte eller forventede ved normalt brug.

Erfaringer med human eksponering

Øjenkontakt

Ingen kendte eller forventede symptomer.

Hudkontakt

Ingen kendte eller forventede symptomer.

Indtagelse

Ingen kendte eller forventede symptomer.

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

7 / 10

Indånding

Ingen kendte eller forventede symptomer.

PUNKT 12. MILJØOPLYSNINGER

12.1 Økotoksicitet

Miljøpåvirkninger

Dette produkt har ingen kendt økotoksikologisk effekt.

Produkt

Toksicitet overfor fisk

: Ingen data tilgængelige

Toksicitet for dafnier og

andre hvirvelløse vanddyr.

: Ingen data tilgængelige

Toksicitet overfor alger

: Ingen data tilgængelige

12.2 Persistens og nedbrydelighed

Ingen data tilgængelige

12.3 Bioakkumuleringspotentiale

Ingen data tilgængelige

12.4 Mobilitet i jord

Ingen data tilgængelige

12.5 Resultater af PBT- og vPvB-vurdering

Produkt

Vurdering

Dette stof/blanding indeholder ingen komponenter, der anses for

at være enten persistente, bioakkumulerende og toksiske (PBT)

eller meget persistente og meget bioakkumulerende (vPvB) ved

niveauer på 0,1% eller højere.

12.6 Andre negative virkninger

Ingen data tilgængelige

PUNKT 13. FORHOLD VEDRØRENDE BORTSKAFFELSE

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

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

bortskaffelse af affald.

13.1 Metoder til affaldsbehandling

Produkt

: Hvor det er muligt foretrækkes genanvendelse frem for

bortskaffelse eller forbrænding. Hvis genanvendelse ikke er

praktisk muligt, skal bortskaffelse ske i henhold til lokale

regulativer. Bortskaf affald til en godkendt

affaldsbortskaffelsesfacilitet.

Forurenet emballage

: Bortskaffes som ikke-forarbejdet produkt. Tomme beholdere skal

bringes til et godkendt affaldsdeponeringssted for genbrug eller

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

8 / 10

bortskaffelse. Tomme beholdere må ikke genbruges.

Europæisk Affalds Katalog

: 200130 - Detergenter, bortset fra affald henhørende under 20 01

PUNKT 14. TRANSPORTOPLYSNINGER

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

valgte transportform.

Vejtransport (ADR/ADN/RID)

14.1 UN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Lufttransport (IATA)

14.1 UN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

Søtransport (IMDG/IMO)

14.1 UN-nummer

Ikke farligt gods

14.2 UN-

forsendelsesbetegnelse (UN

proper shipping name)

Ikke farligt gods

14.3 Transportfareklasse( r )

Ikke farligt gods

14.4 Emballagegruppe

Ikke farligt gods

14.5 Miljøfarer

Ikke farligt gods

14.6 Særlige

forsigtighedsregler for

brugeren

Ikke farligt gods

14.7 Bulktransport i henhold

til bilag II til MARPOL 73/78

og IBC-koden

Ikke farligt gods

PUNKT 15. OPLYSNINGER OM REGULERING

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

sikkerhed, sundhed og miljø

National lovgivning

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

9 / 10

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

15.2 Kemikaliesikkerhedsvurdering

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

PUNKT 16. ANDRE OPLYSNINGER

Udarbejdet af

Regulatory Affairs

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

= 1 tiendedel og 0.001 = 1 tusindedel.

REVIDERET INFORMATION: Signifikante ændringer i den regulatoriske eller sundhedsmæssige

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

margin.

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

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

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

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

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

materialer eller forarbejdning, medmindre udtrykkeligt anført i teksten.

BILAG: EKSPONERINGSSCENARIER

DPD+-stoffer

:

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

til DPD+-regelen:

Måde for

optagelse

Stof

CAS-Nr.

EINECS-Nr.

Ikke afhængighedsstof, ikke forlig

For at beregne om anvendelsesforholdene og de nødvendige risikohåndteringsforanstaltninger

er sikre, venligst kalkuler risikofaktor på dette web site:

www.ecetoc.org/tra

Eksponeringsscenariets korte

titel

Konserverings-/desinfektionsmiddel. Procesvand

Use descriptors

Hovedbrugergrupper

Industrielle anvendelser: Anvendelser af stoffer som sådan eller i

kemiske produkter på industri-anlæg

Slutanvendelsessektor

SU3: Industrielle anvendelser: Anvendelser af stoffer som sådan

SIKKERHEDSDATABLAD

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

Klercide WFI Quality Water

116151E

10 / 10

eller i kemiske produkter på industri-anlæg

Proceskategorier

PROC4: Anvendelse i batch- eller anden proces (syntese) med

mulighed for eksponering

PROC8b: Overførsel af stof eller kemisk produkt (påfyldning/

tømning) fra/ til kar/ store beholdere på dedikerede anlæg

Produktkategorier

PC37: Vandbehandlingskemikalier

Miljøudledningskategorier

ERC4: Industriel anvendelse i pro-cesser og produkter af pro-

ceshjælpemidler, der ikke bliver en del af artikler

  • 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

14-12-2018

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Risk to human health related to the presence of perfluorooctane sulfonic acid and perfluorooctanoic acid in food

Published on: Thu, 13 Dec 2018 The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluorooctane sulfonic acid (PFOS) and perfluorooctanoic acid (PFOA) in food. Regarding PFOS and PFOA occurrence, the final data set available for dietary exposure assessment contained a total of 20,019 analytical results (PFOS n = 10,191 and PFOA n = 9,828). There were large differences between upper and lower bound exposure due to analytical methods with i...

Europe - EFSA - European Food Safety Authority Publications

14-12-2018

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Analysis of hunting statistics collection frameworks for wild boar across Europe and proposals for improving the harmonisation of data collection

Published on: Thu, 13 Dec 2018 Heterogeneities in the wild boar data collection frameworks across Europe were analysed using questionnaires to explore comparability of hunting data in the short term and propose a common framework for future collection. Fifty‐seven respondents representing 32 countries covering more than 95% of European territory participated to the questionnaire. The most frequently recorded information in the official statistics included the quantity of animals shot per hunting ground ...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Evaluation of the safety and efficacy of the organic acids lactic and acetic acids to reduce microbiological surface contamination on pork carcasses and pork cuts

Published on: Wed, 12 Dec 2018 Studies evaluating the safety and efficacy of lactic and acetic acids to reduce microbiological surface contamination on pork carcasses pre‐chill and pork meat cuts post‐chill were assessed. Lactic acid treatments consisted of 2–5% solutions at temperatures of up to 80°C applied to carcasses by spraying or up to 55°C applied on cuts by spraying or dipping. Acetic acid treatments consisted of 2–4% solutions at temperatures of up to 40°C applied on carcasses by spraying or o...

Europe - EFSA - European Food Safety Authority Publications

13-12-2018

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

The European Union summary report on trends and sources of zoonoses, zoonotic agents and food-borne outbreaks in 2017

Published on: Wed, 12 Dec 2018 This report of the European Food Safety Authority and the European Centre for Disease Prevention and Control presents the results of zoonoses monitoring activities carried out in 2017 in 37 European countries (28 Member States (MS) and nine non-MS). Campylobacteriosis was the commonest reported zoonosis and its EU trend for confirmed human cases increasing since 2008 stabilised during 2013–2017. The decreasing EU trend for confirmed human salmonellosis cases since 2008 end...

Europe - EFSA - European Food Safety Authority Publications

12-12-2018

Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada

Kimberly-Clark Announces Voluntary Recall of U by Kotex® Sleek® Tampons, Regular Absorbency,Throughout U.S. and Canada

Kimberly-Clark announced a voluntary product recall of its U by Kotex® Sleek® Tampons, Regular Absorbency, sold throughout the United States and Canada for a quality-related defect that could impact the performance of this product.

FDA - U.S. Food and Drug Administration

12-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice

FDA releases guidance with recommendations for drug manufacturers regarding good manufacturing practices and data integrity

FDA - U.S. Food and Drug Administration

10-12-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new efforts to assure the quality of compounded drugs

FDA releases guidance with recommendations for protecting patients from the risk of contaminated or substandard compounded products produced by outsourcing facilities.

FDA - U.S. Food and Drug Administration

7-12-2018

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Magnesium citrate malate as a source of magnesium added for nutritional purposes to food supplements

Published on: Thu, 06 Dec 2018 The present scientific opinion deals with the assessment of the bioavailability of magnesium, from the proposed nutrient source, magnesium citrate malate (MgCM), when added for nutritional purposes to food supplements. MgCM is a mixed salt consisting of magnesium cations and citrate and malate anions, and with a magnesium content of 12–15%. MgCM is proposed to be used in food supplements that are intended to provide up to 300–540 mg/day magnesium. The data provided demonst...

Europe - EFSA - European Food Safety Authority Publications

1-12-2018

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘RecyPET Hungária’, based on RecyPET Hungária technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 30 Nov 2018 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process RecyPET Hungária (EU register number RECYC0146). The input is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes originating from collected post‐consumer PET containers, containing no more than 5% of PET from non‐food applications. The flakes are dried and extruded. The output of the extrusion step is cut into pellets in an underwater...

Europe - EFSA - European Food Safety Authority Publications

30-11-2018

RedeCan recalls one lot of B.E.C. dried cannabis

RedeCan recalls one lot of B.E.C. dried cannabis

The affected product may contain mould. In certain individuals, exposure to mould can result in allergic symptoms such as sneezing, coughing, wheezing, runny nose or nasal congestion, and watery eyes or itchy eyes.

Health Canada

27-11-2018

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

Teva Pharmaceuticals has initiated a voluntary recall in the United States, to the patient level, of all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carc...

FDA - U.S. Food and Drug Administration

27-11-2018

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Database of processing techniques and processing factors compatible with the EFSA food classification and description system FoodEx 2 Objective 3: European database of processing factors for pesticides in food

Published on: Mon, 26 Nov 2018 EFSA is conducting pan‐European dietary exposure and risk assessments related to actual levels of pesticide residues in food commodities. These assessments use the pesticide occurrence data generated under the official monitoring programs of Member States, the consumption data from EFSA's comprehensive food consumption database and pesticide‐specific information such as processing factors. Currently no harmonised list of processing factors is available within Europe and wo...

Europe - EFSA - European Food Safety Authority Publications

27-11-2018

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

INNUENDO: A cross‐sectoral platform for the integration of genomics in the surveillance of food‐borne pathogens

Published on: Mon, 26 Nov 2018 Abstract In response to the EFSA call New approaches in identifying and characterizing microbial and chemical hazards, the project INNUENDO (https://sites.google.com/site/theinnuendoproject/) aimed to design an analytical platform and standard procedures for the use of whole‐genome sequencing in surveillance and outbreak investigation of food‐borne pathogens. The project firstly attempted to identify existing flaws and needs, and then to provide applicable cross‐sectorial ...

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

The EFSA‐funded collection of dietary and related data in the general population aged 10‐74 years in Greece

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

24-11-2018

Hazard identification and ranking for poultry at slaughter

Hazard identification and ranking for poultry at slaughter

Published on: Fri, 23 Nov 2018 The Hellenic Health Foundation received support from the European Food Safety Authority in order to organise a national nutrition survey according to the methodology described in the EFSA Guidance document and to collect food consumption and related information among 780 adolescents, adults and elderly residing permanently in Greece. The EFSA‐funded data collection was largely based on the protocol of a large scale Greek national nutrition and health survey, called HYDRIA....

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan Initiates Voluntary Nationwide Recall of 15 Lots of Valsartan Tablets, USP, Amlodipine and Valsartan Tablets, USP, and Valsartan and Hydrochlorothiazide Tablets, USP, Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Fou

Mylan N.V. (NASDAQ: MYL) today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall to the consumer level of select lots of Valsartan-containing products, including six lots of Amlodipine and Valsartan Tablets, USP (including the 5mg/160mg, 10mg/160mg, and 10mg/320mg strengths), seven lots of Valsartan Tablets, USP (including 40 mg, 80 mg, 160 mg, and 320 mg strengths), and two lots of Valsartan and Hydrochlorothiazide Tablets, USP 320mg/25mg strength. ...

FDA - U.S. Food and Drug Administration

21-11-2018

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Risk for animal and human health related to the presence of dioxins and dioxin-like PCBs in feed and food

Published on: Tue, 20 Nov 2018 The European Commission asked EFSA for a scientific opinion on the risks for animal and human health related to the presence of dioxins (PCDD/Fs) and DL‐PCBs in feed and food. The data from experimental animal and epidemiological studies were reviewed and it was decided to base the human risk assessment on effects observed in humans and to use animal data as supportive evidence. The critical effect was on semen quality, following pre‐ and postnatal exposure. The critical s...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Peer review of the pesticide risk assessment of the active substance (EZ)‐1,3‐dichloropropene

Published on: Mon, 19 Nov 2018 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance (EZ)‐1,3‐dichloropropene 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 uses of (EZ)‐1,3‐dichloropropene ...

Europe - EFSA - European Food Safety Authority Publications

17-11-2018

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

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

Published on: Fri, 16 Nov 2018 The applicant BASF Agro B.V. submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for picolinafen 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 validated analytical method for enforcement of the residue in dry/high starch‐, high water content‐, high acid content‐ and high oil content commodities ...

Europe - EFSA - European Food Safety Authority Publications

10-11-2018

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Outcome of the consultation with Member States and EFSA on the basic substance application for propolis extract (admissibility accepted when named water‐soluble extract of propolis) for use in plant protection as fungicide and bactericide

Published on: Fri, 09 Nov 2018 00:00:00 +0100 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 propolis extract are presented. The context of the evaluation ...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

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

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

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

FDA - U.S. Food and Drug Administration

6-11-2018

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Setting of import tolerances for haloxyfop‐P in linseed and rapeseed

Published on: Fri, 02 Nov 2018 00:00:00 +0100 In accordance with Article 6 of Regulation (EC) No 396/2005, the Australian Government Department of Agriculture and Water Resources submitted two requests to the competent national authority in Denmark to set import tolerances for the active substance haloxyfop‐P in linseed and rapeseed. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for linseed and rapeseed. Adequate analytical metho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos when used as a feed flavouring for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of a super critical carbon dioxide extract of Humulus lupulus L. flos (hop strobiles) when used as a sensory feed additive for all animal species. The additive is specified to containing 40% beta acids and less than 0.2% alpha acids. Known substances of conce...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

30-10-2018

Mountain Warehouse Limited recalls BPA-Free Printed Kids' Water Bottles

Mountain Warehouse Limited recalls BPA-Free Printed Kids' Water Bottles

If the spout of the water bottle becomes detached during use, a small ring can be exposed and both the spout and the ring may pose a choking hazard.

Health Canada

29-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

17-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

10-10-2018

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruins tekent Green Deal voor duurzame zorg

Minister Bruno Bruins voor Medische Zorg en Sport heeft vandaag de Green Deal ‘Duurzame zorg voor een gezonde toekomst’ getekend. Hiermee maken 132 partijen uit de zorg, overheid en bedrijfsleven afspraken om de zorg in Nederland duurzamer te maken. Inzet is het terugdringen van CO2-uitstoot, zuiniger gebruik van grondstoffen, minder medicijnresten in het water en een gezonde leefomgeving voor patiënt, cliënt en zorgmedewerkers.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

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

27-9-2018

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

Mauna Loa Macadamia Nut Corporation Voluntarily Recalls

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

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

20-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

14-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

13-9-2018

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination

BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. To date, there have been no reports of illness or...

FDA - U.S. Food and Drug Administration

13-9-2018

Use of next‐generation sequencing in microbial risk assessment

Use of next‐generation sequencing in microbial risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Despite the ever increase in rigorous control and monitoring measures to assure safe food along the entire farm‐to‐fork chain, the past decade has also witnessed an increase in microbial food alerts. Hence, research on food safety and quality remain of utmost importance. Complementary, and at least as important, is the necessity to be able to assess the potential microbial risks along the food chain. Risk assessment relies on sound scientific data. Unfortuna...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Natural Disaster Preparedness and Response (Drugs)

Natural Disaster Preparedness and Response (Drugs)

The FDA reminds consumers to have an emergency plan and to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves and their pets during and after severe storms (tornados, hurricanes, blizzards) and other events that can result in power outages, flooding, or road and business closures.

FDA - U.S. Food and Drug Administration

11-9-2018

Preparation of Dutch food consumption data for risk assessment

Preparation of Dutch food consumption data for risk assessment

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The availability of detailed and high‐quality food consumption data collected at an individual level is essential for assessing the exposure to potential risks in the food chain. During the years 2012–2016, the Dutch National Food Consumption Survey was conducted in the Netherlands as part of the EU Menu survey, following the EFSA 2009 guidance on ‘General principles for the collection of national food consumption data in the view of a pan‐European dietary s...

Europe - EFSA - European Food Safety Authority Publications

7-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

FDA announces revised draft memorandum of understanding between FDA and the states to help ensure the quality of and preserve access to compounded drugs

FDA - U.S. Food and Drug Administration

5-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.

FDA - U.S. Food and Drug Administration

30-8-2018

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

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

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

30-8-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Scientific Opinion about the Guidance of the Chemical Regulation Directorate (UK) on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessments

Published on: Mon, 27 Aug 2018 00:00:00 +0200 The EFSA Panel on Plant Protection Products and their Residues reviewed the guidance on how aged sorption studies for pesticides should be conducted, analysed and used in regulatory assessment. The inclusion of aged sorption is a higher tier in the groundwater leaching assessment. The Panel based its review on a test with three substances taken from a data set provided by the European Crop Protection Association. Particular points of attention were the quali...

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

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

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

Health Canada

22-8-2018

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk

Radagast Pet Food, Inc. of Portland, OR is expanding its voluntary recall to include an additional quantity of Rad Cat Raw Diet across all varieties with Best By dates of 10/19/18 through 12/3/19 because it has the potential to be contaminated with Listeria monocytogenes. Radagast Pet Food is conducting this voluntary recall out of an abundance of caution because of its strong commitment to food safety and quality.

FDA - U.S. Food and Drug Administration

22-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-8-2018

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Clean Republic recalls Hill Topper Electric Bike Motor Controllers

Water can enter the controller and cause it to accelerate unexpectedly posing a crash and injury hazard to the rider.

Health Canada

18-8-2018

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

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

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

FDA - U.S. Food and Drug Administration

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

13-11-2018

Health information for those affected by #WoolseyFire is available on our website at:  http://publichealth.lacounty.gov/media/FireSafety …
- Food safety
- Ash clean-up
- Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air qualitypic.twitter.com/8HC7NoLaXB

Health information for those affected by #WoolseyFire is available on our website at: http://publichealth.lacounty.gov/media/FireSafety … - Food safety - Ash clean-up - Smoke and air quality pic.twitter.com/8HC7NoLaXB

FDA - U.S. Food and Drug Administration

21-10-2018

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%,

The MQSA was intended to address mammography quality concerns and it’s been a huge success. Image quality has improved, radiation dose has declined and equipment violations have all but disappeared. Today the 5-year breast cancer survival rate is 95%-99%, up from 84% in 1995.

FDA - U.S. Food and Drug Administration

21-10-2018

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9

FDA - U.S. Food and Drug Administration

10-10-2018

As Hurricane #Michael nears land, take shelter & stay safe.

Follow weather updates on your phone or radio.

 In a tornado WARNING, go to an interior, windowless room.

 If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a clos

As Hurricane #Michael nears land, take shelter & stay safe. Follow weather updates on your phone or radio. In a tornado WARNING, go to an interior, windowless room. If water comes in, go to the highest floor that’s not flooded but do NOT enter a closed attic. pic.twitter.com/KD5WZ7gamP

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here:  https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.g

Federal Register Notice: #FDA Request for Nominations of Voting Members on a Public Advisory Committee; National Mammography Quality Assurance Advisory Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgW5  #MedicalDevice

FDA - U.S. Food and Drug Administration

7-9-2018

 2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

2018 Annual workshop of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA), European Medicines Agency, London, UK, From: 07-Jun-2018, To: 07-Jun-2018

Enpr-EMA will hold its tenth annual workshop on 7-8 June 2018 at EMA. The workshop brings relevant stakeholders together to discuss requirements, barriers and opportunities for the conduct of high-quality clinical studies in children. The overall theme of this year’s workshop will be a ‘holistic approach to paediatric research’. Highlights of this year’s workshop include: i) short perspectives of the various stakeholders involved in paediatric research (patient/young people advisory groups, research netw...

Europe - EMA - European Medicines Agency

6-9-2018

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program:  https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa 

#FDA is launching the Quality in 510(k) Review Program Pilot to help promote efficiency and consistency in the review of certain moderate-risk medical devices. Click the link to find out more information about this new program: https://go.usa.gov/xPxVa  #MedicalDevice pic.twitter.com/dOcFpbed9K

FDA - U.S. Food and Drug Administration

21-8-2018

Always use contact lens solution, not water, to clean and store your lenses!  #OnePairTakeCare  https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89 pic.twitter.com/Jm50z0UFVu

Always use contact lens solution, not water, to clean and store your lenses! #OnePairTakeCare https://go.usa.gov/xUs89  pic.twitter.com/Jm50z0UFVu

FDA - U.S. Food and Drug Administration

15-8-2018

Scientific guideline:  Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on quality of herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document intends to cover the general quality aspects of herbal medicinal products for human and veterinary use, including traditional herbal medicinal products for human use. It describes the special problems of herbal medicinal products and the differences between medicinal products containing chemically defined active substances.

Europe - EMA - European Medicines Agency

15-8-2018

Scientific guideline:  Draft guideline on specifications: test procedures and acceptance criteria for herbal  substances, herbal  preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

Scientific guideline: Draft guideline on specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Revision 3 , draft: consultation open

This document addresses specifications, i.e. those tests, procedures, and acceptance criteria used to assure the quality of the herbal substances/preparations and herbal medicinal products at release and during the shelf-life.

Europe - EMA - European Medicines Agency

15-8-2018

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/1994 (Active substance: Ivosidenib) - Transfer of orphan designation - Commission Decision (2018)5555 of Wed, 15 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/172/17/T/01

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