P3-RISIL MAT

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  • P3-RISIL MAT
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  • P3-RISIL MAT
    Latvija
  • Valoda:
  • latviešu

Cita informācija

Statuss

  • Klimata pārmaiņas:
  • Ecolab
  • Autorizācija numurs:
  • 107960E
  • Pēdējā atjaunošana:
  • 12-03-2018

Pamatojums Zāļu Apraksta Izmaiņām

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

1 / 14

IEDAĻA 1. VIELAS/ MAISĪJUMA UN UZŅĒMĒJSABIEDRĪBAS/ UZŅĒMUMA APZINĀŠANA

1.1 Produkta identifikators

Produkta nosaukums

P3-risil MAT

Produkta kods

107960E

Vielas/maisījuma lietošanas

veids

Tīrīšanas līdzeklis

Vielas tips

Maisījums

Tikai profesionāliem lietotājiem.

Informācija par produkta

atšķaidīšanu

Nav sniegta informācija par atšķaidīšanu.

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

Apzināti lietošanas veidi

Iekārtu tīrīšanas līdzeklis; Centralizētais tīrīsanas process (CIP)

Ieteicamie lietošanas

ierobežojumi

Tikai rūpnieciskai un profesionālai lietošanai.

1.3 Informācija par drošības datu lapas piegādātāju

Uzņēmums

SIA „ECOLAB”

Rītausmas iela 11b

Rīga, Latvija LV-1058

67063770

aiga.teihmane@ecolab.com

1.4 Tālruņa numurs, kur zvanīt ārkārtas situācijās

Tālruņa numurs, kur zvanīt

ārkārtas situācijās

67063770

Saindēšanās informācijas

centra tālruņa numurs

67042473

Sastādīšanas/pārskatīšanas

datums

28.08.2015

Versija

IEDAĻA 2. BĪSTAMĪBAS APZINĀŠANA

2.1 Vielas vai maisījuma klasificēšana

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

Materiāli, Kas Ir Kodīgi Metāliem, 1. kategorija

H290

Kodīgums ādai, 1B kategorija

H314

Hroniska toksicitāte ūdens videi, 3. kategorija

H412

Šis produkts tiek klasificēts vienīgi tādēļ, ka tam ir ekstremāla pH vērtība (saskaņā ar spēkā esošo

Eiropas likumdošanu).

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

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

C; KODĪGS

Šis produkts tiek klasificēts vienīgi tādēļ, ka tam ir ekstremāla

pH vērtība (saskaņā ar spēkā esošo Eiropas likumdošanu).

R52/53

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

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

2.2 Etiķetes elementi

Marķēšana (REGULA (EK) Nr. 1272/2008)

Bīstamības piktogrammas

Signālvārds

Bīstami

Bīstamības apzīmējumi

H290

Var kodīgi iedarboties uz metāliem.

H314

Izraisa smagus ādas apdegumus un acu

bojājumus.

H412

Kaitīgs ūdens organismiem ar ilgstošām

sekām.

Piesardzības apzīmējumi

Novēršana:

P273

Izvairīties no izplatīšanas apkārtējā vidē.

P280

Izmantot aizsargcimdus/ acu aizsargus/ sejas

aizsargus.

Rīcība:

P303 + P361 + P353

SASKARĒ AR ĀDU (vai matiem):

nekavējoties novilkt visu piesārņoto apģērbu.

Noskalot ādu ar ūdeni/dušā.

P305 + P351 + P338

SASKARĒ AR ACĪM: uzmanīgi izskalot ar

ūdeni vairākas minūtes. Izņemt kontaktlēcas, ja

tās ir ievietotas un ja to ir viegli izdarīt. Turpināt

skalot.

P310

Nekavējoties sazinieties ar SAINDĒŠANĀS

INFORMĀCIJAS CENTRU/ārstu.

Bīstamās sastāvdaļas, kuras jānorāda etiķetē:

sodium hydroxide

Alkilamīna etoksilāti

2.3 Citi apdraudējumi

Nekas nav zināms.

IEDAĻA 3. SASTĀVS/INFORMĀCIJA PAR SASTĀVDAĻĀM

3.2 Maisījumi

Bīstamās sastāvdaļas

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

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Ķīmiskais

nosaukums

CAS Nr.

EC Nr.

REACH Nr.

Klasifikācija

(67/548/EEK)

Klasifikācija

(REGULA (EK) Nr.

1272/2008)

Koncentrācija [%]

Taukspirta

etoksilāti=/<15en un

=/<5eo

68439-51-0

Xi; R41-R38

Ādas kairinājums 2.

kategorija; H315

Nopietni acu bojājumi 1.

kategorija; H318

>= 5 - < 10

ziepes

1984-06-1

217-850-5

Xi-Xn; R36-

R38-R20

Akūta toksicitāte 4. kategorija;

H332

Ādas kairinājums 2.

kategorija; H315

Acu kairinājums 2. kategorija;

H319

>= 3 - < 5

sodium hydroxide

1310-73-2

215-185-5

01-2119457892-27

C; R35

Kodīgums ādai 1A kategorija;

H314

Materiāli, Kas Ir Kodīgi

Metāliem 1. kategorija; H290

>= 2.5 - < 5

Alkilamīna etoksilāti

61791-14-8

500-152-2

Xn-Xi-N; R22-

R38-R41-

R51/53

Akūta toksicitāte 4. kategorija;

H302

Ādas kairinājums 2.

kategorija; H315

Nopietni acu bojājumi 1.

kategorija; H318

Hroniska toksicitāte ūdens

videi 2. kategorija; H411

>= 3 - < 5

Alkilamīns

61788-46-3

262-977-1

01-2119473798-17

Xn-C-N; R22-

R35-R41-R50

Akūta toksicitāte 4. kategorija;

H302

Kodīgums ādai 1A kategorija;

H314

Nopietni acu bojājumi 1.

kategorija; H318

Akūta toksicitāte ūdens videi

1. kategorija; H400

>= 0.1 - < 0.25

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

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

IEDAĻA 4. PIRMĀS PALĪDZĪBAS PASĀKUMI

4.1 Pirmās palīdzības pasākumu apraksts

Ja nokļūst acīs

Skalot nekavējoties ar lielu daudzumu ūdens, arī zem acu

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

ievietotas un to ir viegli izdarīt. Turpiniet skalot. Nekavējoties

sazināties ar ārstu.

Ja nokļūst uz ādas

Nekavējoties nomazgāt ar lielu daudzumu ūdens vismaz 15

minūtes. Izmantot maigas ziepes, ja iespējams. Izmazgāt

piesārņoto apģērbu pirms atkārtotas izmantošanas. Rūpīgi notīrīt

apavus pirms atkārtotas lietošanas. Nekavējoties sazināties ar

ārstu.

Ja norīts

Skalot muti ar ūdeni. NEizraisīt vemšanu. Nekad personai

bezsamaņā nedot neko caur muti. Nekavējoties sazināties ar

ārstu.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

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Ja ieelpots

Nogādāt svaigā gaisā. Simptomātiska ārstēšana. Griezties pie

mediķa, ja parādās simptomi.

4.2 Svarīgākie simptomi un ietekme - akūta un aizkavēta

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

4.3 Norāde par nepieciešamo neatliekamo medicīnisko palīdzību un īpašu aprūpi

Ārstēšana

Simptomātiska ārstēšana.

IEDAĻA 5. UGUNSDZĒSĪBAS PASĀKUMI

5.1 Ugunsdzēsības līdzekļi

Piemēroti ugunsdzēsības

līdzekļi:

Izmantot ugunsdzēšanas pasākumus, kas ir piemēroti vietējiem

apstākļiem un apkārtesošajai videi.

Nepiemēroti ugunsdzēsības

līdzekļi

Nekas nav zināms.

5.2 Īpaša vielas vai maisījuma izraisīta bīstamība

Īpaša bīstamība

ugunsdzēšanas laikā

Nav uzliesmojošs vai degošs.

Bīstamie degšanas produkti

Sadalīšanās produkti var saturēt sekojošus savienojumus:

Oglekļa oksīdi

Slāpekļa oksīdi (NOx)

Sēra oksīdi

Fosfora oksīdi

5.3 Ieteikumi ugunsdzēsējiem

Īpašas ugunsdzēsēju

aizsargierīces

: Lietot personālo aizsardzības aprīkojumu.

Papildinformācija

: Ar ugunsgrēka paliekām un piesārņoto uguns nodzēšanā lietoto

ūdeni utilizēt saskaņā ar vietējo normatīvo aktu prasībām.

Ugunsgrēka un/vai sprādziena gadījumā neieelpot dūmus.

IEDAĻA 6. PASĀKUMI NEJAUŠAS NOPLŪDES GADĪJUMOS

6.1 Individuālās drošības pasākumi, aizsardzības līdzekļi un procedūras ārkārtas situācijām

Padomi personālam, kas nav

glābēji

Nodrošināt adekvātu ventilāciju. Izsargāt cilvēkus no

izšļakstījuma/noplūdes vietas un no vēja pārnestā piesārņojuma.

Izvairīties no ieelpošanas, norīšanas un saskares ar ādu un acīm.

Kad strādājošie saskaras ar koncentrācijām, kas lielākas par

ekspozīcijas robežvērtībām, viņiem ir jāizmanto piemēroti

sertificēti respiratori. Nodrošināt, ka satīrīšanu vada vienīgi

apmācīts personāls. Aizsardzības pasākumi uzskaitīti 7. un 8.

punktos.

Padomi glābējiem

Ja noplūdušo produktu savākšanas laikā ir nepieciešams speciāls

apģērbs, iepazīties ar visu 8. nodaļā aprakstīto informāciju par

DROŠĪBAS DATU LAPA

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piemērotiem un nepiemērotiem materiāliem.

6.2 Vides drošības pasākumi

Vides drošības pasākumi

Nepieļaut saskaršanos ar augsni, virszemes vai grunts ūdeņiem.

6.3 Ierobežošanas un savākšanas paņēmieni un materiāli

Savākšanas metodes

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

nopilējumu ar nedegošu absorbenta materiālu (piemēram, smiltīm,

zemi, diatomītu, vermikulītu) un ievietot konteinerā utilizācijai

atbilstoši vietējiem / nacionālajiem noteikumiem (skat. 13.

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

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

lai būtu garantija, ka produkts nevar ieplūst tekošos ūdeņos.

6.4 Atsauce uz citām iedaļām

Skatīt 1. nodaļu par kontaktinformāciju avārijas situācijās.

Personālajai aizsardzībai skat. 8. punktu.

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

IEDAĻA 7. LIETOŠANA UN GLABĀŠANA

7.1 Piesardzība drošai lietošanai

Ieteikumi drošām darbībām

Nenorīt. Nepieļaut nokļūšanu acīs, uz ādas vai uz drēbēm.

Neieelpot putekļus/ tvaikus/ gāzi/ dūmus/ izgarojumus/

smidzinājumu. Lietot tikai ar piemērotu ventilāciju. Pēc

izmantošanas rokas kārtīgi nomazgāt.

Higiēnas pasākumi

Rīkoties atbilstoši labai rūpnieciskās higiēnas un drošības praksei.

Pirms atkārtotas lietošanas novilkt un izmazgāt piesārņoto

apģērbu. Pēc izmantošanas seju, rokas un jebkuru iedarbībai

pakļautu ādu kārtīgi nomazgāt. Nodrošināt piemērotu aprīkojumu,

lai saskares vai šļakatu veidošanās riska gadījumā varētu veikt

ātru acu un ķermeņa samērcēšanu vai skalošanu.

7.2 Drošas glabāšanas apstākļi, tostarp visu veidu nesaderība

Prasības uzglabāšanas

vietām un konteineriem

Neuzglabāt skābju tuvumā. Sargāt no bērniem. Tvertni stingri

noslēgt. Uzglabāt piemērotos, marķētos konteineros.

Uzglabāšanas temperatūra

0 °C līdz 40 °C

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

Specifisks(i) lietošanas

veids(i)

Iekārtu tīrīšanas līdzeklis; Centralizētais tīrīsanas process (CIP)

IEDAĻA 8. IEDARBĪBAS PĀRVALDĪBA/ INDIVIDUĀLĀ AIZSARDZĪBA

8.1 Pārvaldības parametri

Pieļaujamās ekspozīcijas ierobežojums darba vietā

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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CAS Nr.

Sastāvdaļas

Vērtības veids

(Ekspozīcijas veids)

Pārvaldības

parametri

Precizējums

Bāze

1310-73-2

sodium

hydroxide

AER 8 st

0.5 mg/m3

2007-05-18

DNEL

nātrija hidroksīds

Gala lietošana: Darba ņēmēji

Iedarbības ceļi: Ieelpošana

Potenciālā ietekme uz veselību: Ilgtermiņa - lokālie efekti

Vērtība: 1 mg/m3

Gala lietošana: Patērētāji

Iedarbības ceļi: Ieelpošana

Potenciālā ietekme uz veselību: Ilgtermiņa - lokālie efekti

Vērtība: 1 mg/m3

8.2 Iedarbības pārvaldība

Piemērota inženierkontrole

Inženiertehniskie pasākumi

Efektīva vilkmes ventilācijas sistēma. Gaisa koncentrācijas uzturēt

zem aroda ekspozīcijas standartiem.

Individuālie aizsardzības pasākumi

Higiēnas pasākumi

Rīkoties atbilstoši labai rūpnieciskās higiēnas un drošības praksei.

Pirms atkārtotas lietošanas novilkt un izmazgāt piesārņoto

apģērbu. Pēc izmantošanas seju, rokas un jebkuru iedarbībai

pakļautu ādu kārtīgi nomazgāt. Nodrošināt piemērotu aprīkojumu,

lai saskares vai šļakatu veidošanās riska gadījumā varētu veikt

ātru acu un ķermeņa samērcēšanu vai skalošanu.

Acu / sejas aizsardzība (EN

166)

Aizsargbrilles

Sejas aizsargekrāns

Roku aizsardzība (EN 374)

Uzvilkt sekojošus individuālos aizsarglīdzekļus:

Nitrilgumija

butilgumija

Necaurlaidīgi cimdi

Cimdus novilkt un aizvietot, ja ir jebkāda bojājuma vai ķīmiskas

iekļūšanas pazīme.

Ādas un ķermeņa

aizsardzība (EN 14605)

Personāla aizsargaprīkojums, kas sastāv no: piemērotiem

aizsargcimdiem, drošības aizsargbrillēm un aizsargtērpa

Elpošanas aizsardzība (EN

143, 14387)

Nekas nav nepieciešams, ja produkta koncentrācija gaisā tiek

uzturēta zemāka par ekspozīcijas robežvērtību, kas publicēta

sadaļā "Informācija par ekspozīcijas robežvērtībām". Lietot

sertificētus elpošanas ceļu aizsardzības līdzekļus, kas atbilst ES

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

izslēgta vai pietiekošā mērā ierobežota ieelpošanas riska

varbūtība, lietojot tehniskus kolektīvās aizsardzības līdzekļus vai

atbilstošus darba organizācijas pasākumus, metodes vai

procedūras.

Vides riska pārvaldība

Vispārīgi ieteikumi

: Apsvērt norobežojuma nodrošināšanu apkārt uzglabāšanas

tvertnēm.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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IEDAĻA 9. FIZIKĀLĀS UN ĶĪMISKĀS ĪPAŠĪBAS

9.1 Informācija par pamata fizikālajām un ķīmiskajām īpašībām

Izskats

: šķidrums

Krāsa

: tumši brūns

Smarža

: aromātiska

13.5 - 14.0, 100 %

Uzliesmošanas temperatūra

Nav piemērojams

Smaržas slieksnis

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Kušanas/sasalšanas

temperatūra

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Viršanas punkts un viršanas

temperatūras diapazons

100 °C

Iztvaikošanas ātrums

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Uzliesmojamība (cietām

vielām, gāzēm)

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Augšējā

sprādzienbīstamības robeža

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Apakšējā

sprādzienbīstamības robeža

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Tvaika spiediens

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Relatīvais tvaiku blīvums

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Relatīvais blīvums

1.11 - 1.15

Šķīdība ūdenī

šķīstošs

Šķīdība citos šķīdinātājos

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Sadalījuma koeficients: n-

oktanols/ūdens

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Pašaizdegšanās

temperatūra

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Termiskā sadalīšanās

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Viskozitāte, kinemātiskā

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Sprādzienbīstamība

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

Oksidēšanas īpašības

Viela vai maisījums nav klasificēts kā oksidējošs.

9.2 Cita informācija

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

IEDAĻA 10. STABILITĀTE UN REAĢĒTSPĒJA

10.1 Reaģētspēja

Nav zināma bīstama reakcija normālos lietošanas apstākļos.

10.2 Ķīmiskā stabilitāte

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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Stabils normālos apstākļos.

10.3 Bīstamu reakciju iespējamība

Nav zināma bīstama reakcija normālos lietošanas apstākļos.

10.4 Apstākļi, no kuriem jāvairās

Nekas nav zināms.

10.5 Nesaderīgi materiāli

Skābes

10.6 Bīstami sadalīšanās produkti

Sadalīšanās produkti var saturēt sekojošus savienojumus:

Oglekļa oksīdi

Slāpekļa oksīdi (NOx)

Sēra oksīdi

Fosfora oksīdi

IEDAĻA 11. TOKSIKOLOĢISKĀ INFORMĀCIJA

11.1 Informācija par toksikoloģisko ietekmi

Informācija par

iespējamajiem iedarbības

veidiem

Ieelpošana, Nokļūšana acīs, Nokļūšana uz ādas

Toksicitāte

Akūta perorāla toksicitāte

: Akūtās toksicitātes novērtējums : > 2,000 mg/kg

Akūta ieelpas toksicitāte

: 4 h Akūtās toksicitātes novērtējums : > 5 mg/l

Akūta dermāla toksicitāte

: Nav pieejami dati par šo produktu.

Kodīgums/kairinājums ādai

: Nav pieejami dati par šo produktu.

Nopietns acu

bojājums/kairinājums

: Nav pieejami dati par šo produktu.

Elpceļu vai ādas

sensibilizācija

: Nav pieejami dati par šo produktu.

Kancerogēnums

: Nav pieejami dati par šo produktu.

Reproduktīvā iedarbība

: Nav pieejami dati par šo produktu.

Mikroorganismu šūnu

mutācija

: Nav pieejami dati par šo produktu.

Teratogenitāte

: Nav pieejami dati par šo produktu.

Toksiskas ietekmes uz īpašu

mērķorgānu vienreizēja

: Nav pieejami dati par šo produktu.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

9 / 14

iedarbība

Toksiskas ietekmes uz īpašu

mērķorgānu atkārtota

iedarbība

: Nav pieejami dati par šo produktu.

Aspirācijas toksicitāte

: Nav pieejami dati par šo produktu.

Sastāvdaļas

Akūta perorāla toksicitāte

: Taukspirta etoksilāti=/<15en un =/<5eo

LD50 Žurka: > 2,000 mg/kg

ziepes

LD50 Žurka: > 2,000 mg/kg

Alkilamīna etoksilāti

LD50 Žurka: 500 mg/kg

Alkilamīns

LD50 Žurka: 1,300 mg/kg

Sastāvdaļas

Akūta ieelpas toksicitāte

: ziepes

4 h LC50 Žurka: > 4.6 mg/l

Sastāvdaļas

Akūta dermāla toksicitāte

: Taukspirta etoksilāti=/<15en un =/<5eo

LD50 Trusis: 2,290 mg/kg

ziepes

LD50 Trusis: > 5,000 mg/kg

Alkilamīna etoksilāti

LD50 Trusis: > 2,000 mg/kg

Iespējamā iedarbība uz veselību

Acis

Izraisa nopietnus acu bojājumus.

Āda

Rada smagus ādas apdegumus.

Uzņemšana norijot

Izraisa gremošanas sistēmas apdegumus.

Ieelpošana

Var izraisīt deguna, rīkles un plaušu kairinājumu.

Hroniskā iedarbība

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Pieredze saistībā ar iedarbību uz cilvēkiem

Nokļūšana acīs

Apsārtums, Sāpes, Korozija

Nokļūšana uz ādas

Apsārtums, Sāpes, Korozija

Norīšana

Korozija, Sāpes vēderā

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

10 / 14

Ieelpošana

Respiratorais kairinājums, Klepus

IEDAĻA 12. EKOLOĢISKĀ INFORMĀCIJA

12.1 Ekotoksiskums

Iedarbība uz vidi

Kaitīgs ūdens organismiem ar ilgstošām sekām.

Produkts

Toksiskums attiecībā uz

zivīm

: Dati nav pieejami

Toksiskums attiecībā uz

dafnijām un citiem ūdens

bezmugurkaulniekiem.

: Dati nav pieejami

Tokiskums attiecībā uz

aļģēm

: Dati nav pieejami

Sastāvdaļas

Toksiskums attiecībā uz

zivīm

: Taukspirta etoksilāti=/<15en un =/<5eo

96 h LC50: > 1 mg/l

ziepes

96 h LC50: 22 mg/l

Sastāvdaļas

Toksiskums attiecībā uz

dafnijām un citiem ūdens

bezmugurkaulniekiem.

: sodium hydroxide

48 h EC50: 40 mg/l

Alkilamīna etoksilāti

96 h LC50 Daphnia (Dafnijas): 8 mg/l

12.2 Noturība un spēja noārdīties

Produkts

Bionoārdīšanās

: Produkta sastāvā ietilpstošās virsmaktīvās vielas biodegradējas

atbilstoši prasībām, kas noteiktas regulā 648/2004/EK par

mazgāšanas līdzekļiem.

Sastāvdaļas

Bionoārdīšanās

Taukspirta etoksilāti=/<15en un =/<5eo

Rezultāts: Viegli bionoārdāms.

ziepes

Rezultāts: Viegli bionoārdāms.

sodium hydroxide

Rezultāts: Nav piemērojams - neorganiska

Alkilamīna etoksilāti

Rezultāts: Slikti pakļaujas bioloģiskajai noārdīšanai

12.3 Bioakumulācijas potenciāls

Dati nav pieejami

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

11 / 14

12.4 Mobilitāte augsnē

Dati nav pieejami

12.5 PBT un vPvB ekspertīzes rezultāti

Produkts

Novērtējums

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

sastāvdaļas, kuras uzskata par noturīgām, bioakumulatīvām un

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

(vPvB).

12.6 Citas nelabvēlīgas ietekmes

Dati nav pieejami

IEDAĻA 13. APSVĒRUMI, KAS SAISTĪTI AR APSAIMNIEKOŠANU

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

lietotājs, ieteicams apspriežoties ar atkritumu savākšanas iestādēm.

13.1 Atkritumu apstrādes metodes

Produkts

: Produkts nedrīkst nokļūt kanalizācijā, ūdenstilpēs vai augsnē. Kur

vien iespējams, utilizācijas vai sadedzināšanas vietā ieteicama

pārstrāde. Ja pārstrāde nav realizējama, utilizēt atbilstoši vietējiem

noteikumiem. Atkritumus utilizēt apstiprinātā atkritumu pārstrādes

iekārtā.

Piesārņotais iepakojums

: Utilizēt tāpat kā nelietotu produktu. Tukšos konteinerus nogādāt

apstiprinātā atkritumu novietnē pārstrādei vai iznīcināšanai.

Tukšos konteinerus neizmantot atkārtoti. Likvidējiet atbilstoši

vietējiem, valsts un federālajiem noteikumiem.

Eiropas Atkritumu

klasifikators

: 200115* - sārmi

IEDAĻA 14. INFORMĀCIJA PAR TRANSPORTĒŠANU

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

marķējuma un apzīmējumu atbilstība izvēlētajam transporta veidam.

Sauszemes transports

(ADR/ADN/RID)

14.1 ANO numurs

3267

14.2 ANO sūtīšanas

nosaukums

KOROZĪVS ŠĶIDRUMS, BĀZISKS, ORGANISKS, C.N.P.

(sodium hydroxide, Alcohol ethoxylate)

14.3 Transportēšanas

bīstamības klase(-es)

14.4 Iepakojuma grupa

14.5 Vides apdraudējumi

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

Gaisa transports (IATA)

14.1 ANO numurs

3267

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

12 / 14

14.2 ANO sūtīšanas

nosaukums

Corrosive liquid, basic, organic, n.o.s.

(sodium hydroxide, Alcohol ethoxylate)

14.3 Transportēšanas

bīstamības klase(-es)

14.4 Iepakojuma grupa

14.5 Vides apdraudējumi

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

Jūras transports

(IMDG/IMO)

14.1 ANO numurs

3267

14.2 ANO sūtīšanas

nosaukums

CORROSIVE LIQUID, BASIC, ORGANIC, N.O.S.

(sodium hydroxide, Alcohol ethoxylate)

14.3 Transportēšanas

bīstamības klase(-es)

14.4 Iepakojuma grupa

14.5 Vides apdraudējumi

14.6 Īpaši piesardzības

pasākumi lietotājiem

Nekas

14.7 Transportēšana bez

taras atbilstoši MARPOL

73/78 II pielikumam un IBC

kodeksam.

Nav piemērojams

IEDAĻA 15. INFORMĀCIJA PAR REGULĒJUMU

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

un maisījumiem

saskaņā ar detergentu regulu

EK 648/2004

5 % un vairāk bet mazāk nekā 15 %: Nejonu virsmaktīvajām

vielām

mazāk par 5 %: Fosfonātiem, Ziepēm

Vietējie normatīvie akti

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

Citi noteikumi

"Visiem produktiem:

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

produktu klasificēšanas, iepakošanas un marķēšanas kārtība”

Eiropas Parlamenta un Padomes regula 1907/2006 (REACH)

LR MK noteikumi 15.05.2007. nr.325 „Darb

15.2 Ķīmiskās drošības novērtējums

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

IEDAĻA 16. CITA INFORMĀCIJA

R frāžu pilns teksts

Kaitīgs ieelpojot

Kaitīgs norijot.

Rada smagus apdegumus.

Kairina acis.

Kairina ādu.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

13 / 14

Nopietnu bojājumu draudi acīm.

Ļoti toksisks ūdens organismiem.

R51/53

Toksisks ūdens organismiem, var radīt ilglaicīgu negatīvu ietekmi ūdens

vidē.

H paziņojumu pilns teksts

H290

Var kodīgi iedarboties uz metāliem.

H302

Kaitīgs, ja norij.

H314

Izraisa smagus ādas apdegumus un acu bojājumus.

H315

Kairina ādu.

H318

Izraisa nopietnus acu bojājumus.

H319

Izraisa nopietnu acu kairinājumu.

H332

Kaitīgs ieelpojot.

H400

Ļoti toksisks ūdens organismiem.

H411

Toksisks ūdens organismiem ar ilgstošām sekām.

Citu saīsinājumu pilns teksts

Sagatavoja

Regulatory Affairs

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

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

PĀRSKATĪTĀ INFORMĀCIJA: Nozīmīgas izmaiņas šī pārskatītā izdevuma informācijā par

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

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

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

tikai kā vadlīnijas drošām darbībām, lietošanai, apstrādei, uzglab

PIELIKUMS: IEDARBĪBAS SCENĀRIJI

DPD+ metodika, vielas

:

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

metodiku:

Veids

Viela

CAS Nr.

EINECS Nr.

Norīšana

sodium hydroxide

1310-73-2

215-185-5

Ieelpošana

sodium hydroxide

1310-73-2

215-185-5

Dermāli

sodium hydroxide

1310-73-2

215-185-5

Acis

sodium hydroxide

1310-73-2

215-185-5

ūdens vide

Alkilamīns

61788-46-3

262-977-1

Fizikālās īpašības, DPD+ metodika, vielas:

Viela

Tvaika spiediens

Šķīdība ūdenī

Pow

Molārā masa

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

P3-risil MAT

107960E

14 / 14

sodium hydroxide

1 g/ml

40 g/mol

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

lūdzu aprēķiniet savu riska faktoru zemāk redzamajā tīmekļa vietnē:

www.ecetoc.org/tra

Iedarbības scenārija īss

nosaukums

Iekārtu tīrīšanas līdzeklis; Centralizētais tīrīsanas process

(CIP)

Pielietojuma deskriptori

Galvenās lietotāju grupas

Rūpnieciskie lietojumi. Atsevišķu vielu izmantošana vai to

izmantošana preparātos rūpniecības uzņēmumos

Galējā lietojuma nozares

SU3: Rūpnieciskie lietojumi. Atsevišķu vielu izmantošana vai to

izmantošana preparātos rūpniecības uzņēmumos

Procesa kategorijas

PROC1: Lietošana slēgtā procesā, iedarbības iespējamības nav

PROC8b: Vielas vai produktu pārvietošana (iekraušana/

izkraušana) no/ uz rezervuāriem/ lieliem konteineriem šim

nolūkam paredzētās telpās

Produktu kategorijas

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

šķīdinātājus)

Izdalīšanās vidē kategorijas

ERC4: Apstrādes palīgvielu rūp-nieciska izmantošana pro-cesos

un produktos, kuri nekļūs par izstrādājumu sastāvdaļu

14-11-2018

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

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

Published on: Tue, 13 Nov 2018 The applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in France to evaluate the confirmatory data that were identified in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005 as not available. The data gap which was related to information on freezer storage conditions for the residue trials reported on potatoes, tomatoes and cucurbits with edible and inedible peel was considered satisfactorily addressed...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Peer review of the pesticide risk assessment of the active substance napropamide‐M

Published on: Mon, 12 Nov 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State the United Kingdom for the pesticide active substance napropamide‐M 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 napropamid...

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

The importance of vector abundance and seasonality

The importance of vector abundance and seasonality

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

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release

Vaccine lot release information updated on 3/3/2010.

FDA - U.S. Food and Drug Administration

7-11-2018

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information

Vita Health Products is voluntarily recalling several store-brand (Care, Exact, Life, and Pharmasave) over-the-counter drugs used for pain or sinus relief because of a labelling issue. Consumers may be unable to peel open the wrap-around label on the bottle to access the warning statements, or the label may not peel off completely, which may make it difficult to read some of the important safety information.

Health Canada

6-11-2018

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Evaluation of confirmatory data following the Article 12 MRL review for kresoxim‐methyl

Published on: Fri, 02 Nov 2018 00:00:00 +0100 The applicant BASF SE submitted a request to the competent national authority in Belgium to evaluate the confirmatory data that were identified for kresoxim‐methyl 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 confirmatory data requirement, a new study on the storage stability of kresoxim‐methyl residues in animal matrices was submitted. The data gap was considered ...

Europe - EFSA - European Food Safety Authority Publications

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Italy and co‐rapporteur Member State Bulgaria for the pesticide active substance dimethoate 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 dimetho...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Updated review of the existing maximum residue levels for imazalil according to Article 12 of Regulation (EC) No 396/2005 following new toxicological information

Published on: Tue, 30 Oct 2018 00:00:00 +0100 In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide an update of the reasoned opinion on the review of existing maximum residue levels (MRLs) for imazalil published on 5 September 2017, taking into account the additional information provided on the toxicity of the metabolites R014821, FK‐772 and FK‐284. EFSA did not derive MRL proposals from the post‐harvest uses reported on citrus fru...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Guidance on the scientific requirements for health claims related to muscle function and physical performance

Published on: Tue, 30 Oct 2018 00:00:00 +0100 EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

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

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

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The conclusions of EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State the United Kingdom and co‐rapporteur Member State Germany for the pesticide active substance methiocarb 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

31-10-2018

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Safety and efficacy of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri CNCM I‐4323/NCIMB 40788 as a silage additive for all animal species

Published on: Tue, 30 Oct 2018 00:00:00 +0100 Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFS...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

29-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

Food allergies have touched the lives of most of us. Thousands of Americans experience life-threatening, food-related reactions each year, and an estimated 20 people die from them annually. In some cases, such reactions occur despite a careful reading of packaged food labels by conscientious consumers. To me, that’s unacceptable. The FDA is committed to advancing our efforts to help ensure that Americans have access to the information they need about common allergens in packaged foods.

FDA - U.S. Food and Drug Administration

26-10-2018

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Multi-country outbreak of Listeria monocytogenes sequence type 8 infections linked to consumption of salmon products

Published on: Thu, 25 Oct 2018 00:00:00 +0200 A multi-country outbreak of 12 listeriosis cases caused by Listeria monocytogenes sequence type (ST) 8 has been identified through whole genome sequencing (WGS) analysis in three EU/EEA countries: Denmark (6 cases), Germany (5) and France (1). Four of these cases have died due to or with the disease. It is likely that the extent of this outbreak has been underestimated since the outbreak was identified through sequencing and only a subset of the EU/EEA count...

Europe - EFSA - European Food Safety Authority Publications

25-10-2018

Nutrition Facts Label Reboot: A Tale of Two Labels

Nutrition Facts Label Reboot: A Tale of Two Labels

The Nutrition Facts Label (NFL) on packages consumers look at when they’re buying groceries or preparing a meal has undergone a makeover. The U.S. Food and Drug Administration (FDA) has changed it to reflect updated scientific findings and help consumers make better-informed choices about the foods their families eat. Until the deadlines, consumers may see two different versions on the products they buy: the original label they’ve been using, as well as the new label. The Consumer Update will emphasize...

FDA - U.S. Food and Drug Administration

25-10-2018

Safety of zinc chelate of methionine sulfate for the target species

Safety of zinc chelate of methionine sulfate for the target species

Published on: Wed, 24 Oct 2018 00:00:00 +0200 Zinc chelate of methionine sulfate is intended to be used as a nutritional additive (functional group: compounds of trace elements). The additive is zinc chelated with methionine in a molar ratio 1:1. It is intended to supply zinc as a nutritional additive to all animal species/categories. In 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of zinc chelate of methionine su...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Information Update - Staying Safe on Halloween

Information Update - Staying Safe on Halloween

Costume and decoration safety

Health Canada

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

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

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

Published on: Fri, 19 Oct 2018 00:00:00 +0200 The applicant BASF SE submitted a request to the competent national authority in Germany to evaluate the confirmatory data that were identified for dimethomorph in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. The submitted residue data on raspberries were satisfactorily addressing the data gaps on raspberries and blackberries. Considering the new information provided, it is appropri...

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

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum

Published on: Mon, 15 Oct 2018 00:00:00 +0200 Following a request from the European Commission, the EFSA Panel on Plant Health performed a pest categorisation of Cronartium harknessii, Cronartium kurilense and Cronartium sahoanum, which are well‐defined and distinguishable tree fungal pathogens of the family Cronartiaceae. In 2018, these species were moved from the genus Endocronartium to the genus Cronartium. These pathogens are not known to be present in the EU and are regulated in Council Directive 2...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

11-10-2018

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

Published on: Wed, 10 Oct 2018 00:00:00 +0200 The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was n...

Europe - EFSA - European Food Safety Authority Publications

4-10-2018

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

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

Published on: Wed, 03 Oct 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 Italy and co‐rapporteur Member State Ireland for the pesticide active substance ethoprophos 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 ethopro...

Europe - EFSA - European Food Safety Authority Publications

2-10-2018

Garderie Dépôt recalls Dream on Me Portable Cribs

Garderie Dépôt recalls Dream on Me Portable Cribs

The distance between the top surface of the lowest fixed side and the top surface of the mattress support is lower than what is required by law, posing a fall hazard.

Health Canada

2-10-2018

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for cyflufenamid according to Article 12 of Regulation (EC) No 396/2005

Published on: Mon, 01 Oct 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance cyflufenamid. To assess the occurrence of cyflufenamid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (in...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

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

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

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

FDA - U.S. Food and Drug Administration

28-9-2018

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Peer review of the pesticide risk assessment of the active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623)

Published on: Thu, 27 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, France, for the pesticide active substance ABE‐IT 56 (components of lysate of Saccharomyces cerevisiae strain DDSF623) 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...

Europe - EFSA - European Food Safety Authority Publications

27-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

Statement from FDA Commissioner Scott Gottlieb, M.D., on modernizing standards of identity and the use of dairy names for plant-based substitutes

FDA issues a request for information to solicit feedback on how consumers are using plant-based substitutes for milk, cheese and other dairy foods.

FDA - U.S. Food and Drug Administration

27-9-2018

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for tembotrione according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 26 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and European author...

Europe - EFSA - European Food Safety Authority Publications

26-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety

FDA - U.S. Food and Drug Administration

22-9-2018

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Risk assessment of new sequencing information on genetically modified carnation FLO‐40689‐6

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for...

Europe - EFSA - European Food Safety Authority Publications

22-9-2018

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Risk assessment of new sequencing information for genetically modified soybean BPS‐CV127‐9

Published on: Fri, 21 Sep 2018 00:00:00 +0200 The GMO Panel has previously assessed genetically modified (GM) soybean BPS‐CV127‐9. This soybean was found to be as safe and nutritious as its conventional counterpart and commercial soybean varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses. On 16 February 2018, European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for GM soy...

Europe - EFSA - European Food Safety Authority Publications

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

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

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

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Review of the existing maximum residue levels for fluquinconazole according to Article 12 of Regulation (EC) No 396/2005

Published on: Wed, 12 Sep 2018 00:00:00 +0200 According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance fluquinconazole. Considering the information provided by Member States, neither EU uses nor import tolerances are currently authorised for fluquinconazole within the European Union. Furthermore, no MRLs are established by the Codex Alimentarius Commission (codex maximum residue ...

Europe - EFSA - European Food Safety Authority Publications

12-9-2018

Application of data science in risk assessment and early warning

Application of data science in risk assessment and early warning

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

Europe - EFSA - European Food Safety Authority Publications

13-11-2018

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on  http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealthpic.twitter.com/1DCieYB33v

Check out the #PEAC2018 agenda, webcast information, and meeting materials for Thursday’s Patient Engagement Advisory Committee meeting on http://FDA.gov : https://go.usa.gov/xPf9n  #DigitalHealth pic.twitter.com/1DCieYB33v

FDA - U.S. Food and Drug Administration

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

13-11-2018

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Celgene Europe B.V.)

EU/3/17/1863 (Active substance: Autologous T lymphocyte-enriched population of cells transduced with a lentiviral vector encoding a chimeric antigen receptor targeting human B cell maturation antigen with 4-1BB and CD3-zeta intracellular signalling domains) - Transfer of orphan designation - Commission Decision (2018)7574 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/270/16/02

Europe -DG Health and Food Safety

2-11-2018

Check out @US_FDA's information on Direct-to-Consumer Tests:  https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

Check out @US_FDA's information on Direct-to-Consumer Tests: https://go.usa.gov/xPVPu  #MedicalDevice #FDA

FDA - U.S. Food and Drug Administration

30-10-2018

#DYK: Mammograms are still the best tool for breast cancer screening.  Check out @US_FDA’s information on the importance of choosing a certified mammography facility:  https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/YaG

#DYK: Mammograms are still the best tool for breast cancer screening. Check out @US_FDA’s information on the importance of choosing a certified mammography facility: https://go.usa.gov/xPPpT  #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/YaGqeGgrTH

FDA - U.S. Food and Drug Administration

26-10-2018

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options:  https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonthpic.twitter.com/aZBjgCGsB

Men can also be diagnosed with breast cancer. Check out the @US_FDA’s information regarding breast cancer in men, available treatments and counseling options: https://go.usa.gov/xPPpx  ) #MedicalDevice #BreastCancerAwarenessMonth pic.twitter.com/aZBjgCGsB1

FDA - U.S. Food and Drug Administration

21-10-2018

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects

Transparency is one way to encourage greater inclusion. Check out our Drug Trials Snapshots - information about who participated in clinical trials supporting a drug’s approval and whether there are any demographic differences in benefits or side effects https://go.usa.gov/xPnVQ . pic.twitter.com/MyoBPe0IGg

FDA - U.S. Food and Drug Administration

19-10-2018

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

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

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

FDA - U.S. Food and Drug Administration

30-9-2018

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied.  Selected applications will be announced in November. For more information about the challenge, click the link:   https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk pic.twi

Today is the last day to submit applications to the #FDAInnovationChallenge. Thanks to all who have applied. Selected applications will be announced in November. For more information about the challenge, click the link: https://go.usa.gov/xP4Nk  pic.twitter.com/pFJZ39oGJC

FDA - U.S. Food and Drug Administration

24-9-2018

For more information about the #FDA’s effort to address the epidemic of  #opioid addiction, click the link to find out more about the  #FDAInnovationChallenge:  https://go.usa.gov/xPja7  The last day to submit  applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018.https:/

For more information about the #FDA’s effort to address the epidemic of #opioid addiction, click the link to find out more about the #FDAInnovationChallenge: https://go.usa.gov/xPja7  The last day to submit applications is September 30th, 2018. https://twitter.com/NIDAnews/status/1032719474934382593 …

FDA - U.S. Food and Drug Administration

21-9-2018

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like  activity trackers, social media, and patient registries to better  understand their needs.  Click the link for more information about the upcoming meeting:  https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https:/

This year's #PEAC2018 Topic: How the FDA can use patient-generated data from sources like activity trackers, social media, and patient registries to better understand their needs. Click the link for more information about the upcoming meeting: https://bit.ly/2MUNqhU 

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

Scientific guideline: Reflection paper on the use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health, draft: consultation open

The objective of this document is to review available information on the use of aminopenicillins and their beta-lactamase inhibitor combinations in veterinary medicines in the EU, their effect on the emergence of antimicrobial resistance (AMR) and the potential impact of resistance on human and animal health. The document provides information for the risk profiling, as recommended by the Antimicrobial Advice ad hoc Expert Group (AMEG) of the EMA.

Europe - EMA - European Medicines Agency

17-9-2018

Visit our webpage for more information:  https://go.usa.gov/xP4Nk pic.twitter.com/juX1wEGMBk

Visit our webpage for more information: https://go.usa.gov/xP4Nk pic.twitter.com/juX1wEGMBk

Visit our webpage for more information: https://go.usa.gov/xP4Nk  pic.twitter.com/juX1wEGMBk

FDA - U.S. Food and Drug Administration

17-9-2018

 European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

European Medicines Agency (EMA) Human Scientific Committees' Working Parties with Patients’ and Consumers’ Organisations (PCWP) and with Healthcare Professionals’ Organisations (HCPWP), European Medicines Agency, London, UK, From: 25-Sep-2018, To: 25-Sep

This joint Patients' and Consumers' Working Party (PCWP) and Healthcare Professionals' Working Party (HCPWP) meeting will include results of the 2017 EMA perception survey. EMA regulatory science to 2025 will be discussed together with updates on Good Pharmacovigilance Practices (GVP). The Topic Group on Digital media and health will feedback to the working parties’ members. Participants will also receive an update on ongoing work on electronic product information and on availability of authorised med...

Europe - EMA - European Medicines Agency

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

14-9-2018

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here:  https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

Federal Register Notice: Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee. Nominations are due by October 9, 2018. For more information, click here: https://go.usa.gov/xPgWa  #MedicalDevice

FDA - U.S. Food and Drug Administration

14-9-2018

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://

Federal Register Notice: #FDA Request for Nominations for Voting Members on a Public Advisory Committee; Technical Electronic Product Radiation Safety Standards Committee. Nominations are due by November 5, 2018. For more information, click here: https://go.usa.gov/xPgDd 

FDA - U.S. Food and Drug Administration

12-9-2018

Agenda:  Agenda - Risk management plan information day

Agenda: Agenda - Risk management plan information day

Europe - EMA - European Medicines Agency

12-9-2018

 Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

Risk management plan information day, European Medicines Agency, London, UK, From: 25-Oct-2018, To: 25-Oct-2018

This information day will update participants on the Agency’s medicine risk management activities and provide advice to marketing authorisation holders and applicants on drafting a risk management plan (RMP) in view of the full implementation of the second revision of the RMP template after the transitional period has elapsed. It will also provide an opportunity for an exchange of experiences with this template between regulators and industry. A dedicated session will discuss the streamlining of safety s...

Europe - EMA - European Medicines Agency