SKINMAN SOFT PROTECT

Galvenā informācija

  • Iepakojuma:
  • SKINMAN SOFT PROTECT
  • Izmantot priekš:
  • Cilvēki
  • Zāļu veids:
  • Medicīniskās ierīces

Dokumenti

Lokalizācija

  • Pieejams:
  • SKINMAN SOFT PROTECT
    Latvija
  • Valoda:
  • latviešu

Cita informācija

Statuss

  • Klimata pārmaiņas:
  • Ecolab
  • Autorizācija numurs:
  • 115167E
  • Pēdējā atjaunošana:
  • 12-03-2018

Pamatojums Zāļu Apraksta Izmaiņām

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

Skinman soft protect

115167E

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IEDAĻA 1. VIELAS/MAISĪJUMA UN UZŅĒMĒJSABIEDRĪBAS/UZŅĒMUMA IDENTIFICĒŠANA

1.1 Produkta identifikators

Produkta nosaukums

Skinman soft protect

Produkta kods

115167E

Vielas/maisījuma lietošanas

veids

Roku dezinficēšanas 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

ādas dezinfekcijas līdzeklis

Ieteicamie lietošanas

ierobežojumi

Tikai rūpnieciskai un profesionālai lietošanai.

1.3 Informācija par drošības datu lapas piegādātāju

Uzņēmums

ECOLAB SIA

Bauskas iela 58a-8

Rīga, Latvija LV-1004

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

08.06.2016

Versija

IEDAĻA 2. BĪSTAMĪBAS APZINĀŠANA

2.1 Vielas vai maisījuma klasificēšana

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

Uzliesmojoši šķidrumi, 2. kategorija

H225

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

F; VIEGLI UZLIESMOJOŠS

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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2.2 Etiķetes elementi

Marķēšana (REGULA (EK) Nr. 1272/2008)

Bīstamības piktogrammas

Signālvārds

Bīstami

Bīstamības apzīmējumi

H225

Viegli uzliesmojošs šķidrums un tvaiki.

Piesardzības apzīmējumi

Novēršana:

P210

Turēt pietiekamā attālumā no karstuma

avotiem, karstām virsmām, dzirkstelēm,

atklātas liesmas un citiem aizdegšanās

avotiem. Nesmēķēt.

2.3 Citi apdraudējumi

Nekas nav zināms.

IEDAĻA 3. SASTĀVS/INFORMĀCIJA PAR SASTĀVDAĻĀM

3.2 Maisījumi

Bīstamās sastāvdaļas

Ķīmiskais nosaukums

CAS Nr.

EC Nr.

REACH Nr.

KlasifikācijaREGULA (EK) Nr.

1272/2008

Koncentrācija

ethanol

64-17-5

200-578-6

01-2119457610-43

Uzliesmojoši šķidrumi 2. kategorija;

H225

>= 50 - <= 100

Myristyl Alcohol

112-72-1

204-000-3

01-2119485910-33

Hroniska toksicitāte ūdens videi 4.

kategorija; H413

Nopietns acu bojājums/kairinājums 2.

kategorija; H319

>= 1 - < 2.5

Darba vietā jāierobežo ekspozīcija ar šīm vielām :

butanone

78-93-3

201-159-0

01-2119457290-43

Uzliesmojoši šķidrumi 2. kategorija;

H225

Acu kairinājums 2. kategorija; H319

Toksiska ietekme uz īpašu mērķorgānu -

vienreizēja iedarbība 3. kategorija; H336

>= 0.5 - < 1

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 ar ūdeni.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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Ja nokļūst uz ādas

Griezties pie mediķa, ja parādās simptomi.

Ja norīts

Izskalot muti. Griezties pie mediķa, ja parādās simptomi.

Ja ieelpots

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

Augsta spiediena ūdens strūkla

5.2 Īpaša vielas vai maisījuma izraisīta bīstamība

Īpaša bīstamība

ugunsdzēšanas laikā

Ugunsbīstamība

Glabāt prom no siltuma un degšanas avotiem.

Atkārtots uzliesmojums iespējams pēc ievērojama laika.

Sargāties no tvaiku uzkrāšanās, veidojot sprādzienbīstamas

koncentrācijas. Tvaiki var savākties zemās vietās.

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

: Izmantot ūdens šalti neatvērto konteineru atdzesēšanai. 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

Aizvākt visus degšanas avotus. 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

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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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

Novērst visus uzliesmošanas avotus, ja to var izdarīt

droši.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

Sargāt no uguns, dzirkstelēm un karstām virsmām. Veikt

nepieciešamos pasākumus, lai izvairītos no statiskās elektrības

lādiņa (kas var izraisīt organisko tvaiku aizdegšanos). Atvērt mucu

uzmanīgi, jo saturs var būt zem spiediena.

Higiēnas pasākumi

Specifiski pasākumi nav identificēti.

7.2 Drošas glabāšanas apstākļi, tostarp visu veidu nesaderība

Prasības uzglabāšanas

vietām un konteineriem

Glabāt prom no siltuma un degšanas avotiem. Glabāt vēsā, labi

vēdināmā vietā. Neuzglabāt kopā ar oksidētājiem. Sargāt no

bērniem. Tvertni stingri noslēgt. Uzglabāt piemērotos, marķētos

konteineros.

Uzglabāšanas temperatūra

0 °C līdz 25 °C

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

Specifisks(i) lietošanas

veids(i)

ādas dezinfekcijas līdzeklis

IEDAĻA 8. IEDARBĪBAS PĀRVALDĪBA/ INDIVIDUĀLĀ AIZSARDZĪBA

8.1 Pārvaldības parametri

Pieļaujamās ekspozīcijas ierobežojums darba vietā

Sastāvdaļas

CAS Nr.

Vērtības veids

(Ekspozīcijas

veids)

Pārvaldības parametri

Bāze

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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ethanol

64-17-5

AER 8 st

1,000 mg/m3

Latvija. AER.

Ķīmisko vielu

arodekspozīcija

s robežvērtības

darba vidē

butanone

78-93-3

AER 8 st

67 ppm

200 mg/m3

Latvija. AER.

Ķīmisko vielu

arodekspozīcija

s robežvērtības

darba vidē

AER īslaicīgā

300 ppm

900 mg/m3

Latvija. AER.

Ķīmisko vielu

arodekspozīcija

s robežvērtības

darba vidē

8.2 Iedarbības pārvaldība

Piemērota inženierkontrole

Inženiertehniskie pasākumi

Būtu jāpietiek ar labu vispārīgo ventilāciju, lai kontrolētu kaitīgo

vielu koncentrāciju gaisā.

Individuālie aizsardzības pasākumi

Higiēnas pasākumi

Specifiski pasākumi nav identificēti.

Acu / sejas aizsardzība (EN

166)

Nav nepieciešami īpaši aizsarglīdzekļi.

Roku aizsardzība (EN 374)

Nav nepieciešami īpaši aizsarglīdzekļi.

Ādas un ķermeņa

aizsardzība (EN 14605)

Nav nepieciešami īpaši aizsarglīdzekļi.

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.

IEDAĻA 9. FIZIKĀLĀS UN ĶĪMISKĀS ĪPAŠĪBAS

9.1 Informācija par fizikālajām un ķīmiskajām pamatīpašībām

Izskats

: šķidrums

Krāsa

: Bezkrāsains

Smarža

: spirtam līdzīga

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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6.0 - 7.0, 100 %

Uzliesmošanas temperatūra

16 °C slēgtā traukā

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

Nav vajadzīgs un / vai nav noteikts par šo maisījumu

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

0.81 - 0.83

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

Stabils normālos apstākļos.

10.3 Bīstamu reakciju iespējamība

Nav zināma bīstama reakcija normālos lietošanas apstākļos.

10.4 Apstākļi, no kuriem jāvairās

Siltums, liesmas un dzirksteles.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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10.5 Nesaderīgi materiāli

Nekas nav zināms.

10.6 Bīstami noārdīšanās 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

Produkts

Akūta perorāla toksicitāte

: Nav pieejami dati par šo produktu.

Akūta ieelpas toksicitāte

: Nav pieejami dati par šo produktu.

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

iedarbība

: Nav pieejami dati par šo produktu.

Toksiskas ietekmes uz īpašu

mērķorgānu atkārtota

iedarbība

: Nav pieejami dati par šo produktu.

Aspirācijas toksicitāte

: Nav pieejami dati par šo produktu.

Sastāvdaļas

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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Akūta perorāla toksicitāte

: ethanol

LD50 Žurka: 10,470 mg/kg

Sastāvdaļas

Akūta ieelpas toksicitāte

: ethanol

4 h LC50 Žurka: 117 mg/l

Sastāvdaļas

Akūta dermāla toksicitāte

: ethanol

LD50 Trusis: > 15,800 mg/kg

Myristyl Alcohol

LD50 Trusis: > 8,000 mg/kg

Iespējamā iedarbība uz veselību

Acis

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Āda

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Uzņemšana norijot

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Ieelpošana

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Hroniskā iedarbība

Normālos lietošanas apstākļos veselības traucējumi nav zināmi

vai nav gaidāmi.

Pieredze saistībā ar iedarbību uz cilvēkiem

Nokļūšana acīs

Simptomi nav zināmi vai nav paredzami.

Nokļūšana uz ādas

Simptomi nav zināmi vai nav paredzami.

Norīšana

Simptomi nav zināmi vai nav paredzami.

Ieelpošana

Simptomi nav zināmi vai nav paredzami.

IEDAĻA 12. EKOLOĢISKĀ INFORMĀCIJA

12.1 Ekotoksiskums

Iedarbība uz vidi

Šim produktam nav zināmu ekotoksikoloģisko efektu.

Produkts

Toksiskums attiecībā uz

zivīm

: Dati nav pieejami

Toksiskums attiecībā uz

dafnijām un citiem ūdens

bezmugurkaulniekiem.

: Dati nav pieejami

Tokiskums attiecībā uz

: Dati nav pieejami

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

Skinman soft protect

115167E

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aļģēm

Sastāvdaļas

Toksiskums attiecībā uz

zivīm

: ethanol

96 h LC50 Pimephales promelas (Grundulis): > 100 mg/l

Myristyl Alcohol

96 h LC50 Zivs: > 1 mg/l

12.2 Noturība un spēja noārdīties

Produkts

Dati nav pieejami

Sastāvdaļas

Bionoārdīšanās

ethanol

Rezultāts: Viegli bionoārdāms.

Myristyl Alcohol

Rezultāts: Viegli bionoārdāms.

butanone

Rezultāts: Viegli bionoārdāms.

12.3 Bioakumulācijas potenciāls

Dati nav pieejami

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 SAISTĪBĀ 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

: Kur vien iespējams, utilizācijas vai sadedzināšanas vietā

ieteicama pārstrāde. Ja pārstrāde nav realizējama, utilizēt

atbilstoši vietējiem noteikumiem. Atkritumus utilizēt apstiprinātā

atkritumu pārstrādes iekārtā.

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

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115167E

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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.

Ieteikumi Atkritumu koda

izvēlei

: Organiskie atkritumi, kas satur bīstamas vielas. Ja šis produkts

tiek izmantots jebkādiem turpmākiem procesiem, gala lietotājam ir

jāpārklasificē un jāpiešķir vispiemērotākais no Eiropas Atkritumu

kataloga (European Waste Catalogue) kodiem. Lai saskaņā ar

Direktīvu (ES Direktīva 2008/98/EK) un vietējiem normatīvajiem

aktiem varētu pareizi identificēt atkritumus un noteikt to

apsaimniekošanas metodes, atkritumu radītāja atbildība ir noteikt

tā radīto materiālu toksiskumu un fizikālā īpašības.

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

1170

14.2 ANO sūtīšanas

nosaukums

ETANOLA ŠĶĪDUMS

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

1170

14.2 ANO sūtīšanas

nosaukums

Ethanol solution

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

1170

14.2 ANO sūtīšanas

nosaukums

ETHANOL SOLUTION

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

Nav piemērojams

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

Skinman soft protect

115167E

11 / 13

kodeksam.

IEDAĻA 15. INFORMĀCIJA PAR REGULĒJUMU

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

un maisījumiem

Vietējie normatīvie akti

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

Citi noteikumi

Visiem produktiem:

·Eiropas Parlamenta un Padomes regula 1907/2006 (REACH) LR

MK noteikumi 15.05.2007. nr.325 „Darba aizsardzības prasības

saskarē ar ķīmiskajām vielām darba vietās”

·EPP Regula (EK) Nr. 1272/2008 (2008. gada 16.decembris) par

vielu un maisījumu klasificēšanu, marķēšanu un iepakošanu.

·EPP Regula (EK) Nr. 648/2004, (2004 gada 31. marts) par

mazgāšanas līdzekļiem. - tikai mazgāšanas līdzekļiem

·EPP Regula (ES) Nr. 528/2012(2012. gada 22.maijs) par biocīdu

piedāvāšanu tirgū un lietošanu. - tikai biocīdiem

·LR 01.04.1998. likums “Ķīmisko vielu un ķīmisko produktu likums”

·MK 27.08.2013. noteikumi Nr.628 “Prasības attiecībā uz

darbībām ar biocīdiem”. - tikai biocīdiem

·MK 15.05.2007. noteikumi nr. 325 „Darba aizsardzības prasības

saskarē ar ķīmiskajām vielām darba vietās”.

·LR MK 19.04.2011. noteikumi Nr. 302 „Noteikumi par atkritumu

klasifikatoru un īpašībām, kuras padara atkritumus bīstamus”.

15.2 Ķīmiskās drošības novērtējums

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

IEDAĻA 16. CITA INFORMĀCIJA

H paziņojumu pilns teksts

H225

Viegli uzliesmojošs šķidrums un tvaiki.

H319

Izraisa nopietnu acu kairinājumu.

H336

Var izraisīt miegainību vai reiboņus.

H413

Var radīt ilgstošas kaitīgas sekas ūdens organismiem.

Citu saīsinājumu pilns teksts

Eiropas

līgums

bīstamo

kravu

starptautiskiem

pārvadājumiem

iekšzemes

ūdensceļiem; ADR - Eiropas līgums par bīstamo kravu starptautiskiem pārvadājumiem pa ceļiem;

AICS - Austrālijas Ķīmisko vielu saraksts; ASTM - Amerikas Materiālu testēšanas biedrība; bw -

Ķermeņa masa; CLP - Iepakojuma marķējuma klasifikācijas likums; EK Regula Nr. 1272/2008;

CMR - Kancerogēns, mutagēns vai reproduktivitātei toksisks; DIN - Vācijas Standartizācijas

Institūta standarts; DSL - Vietējais vielu saraksts (Kanāda); ECHA - Eiropas Ķimikāliju Aģentūra;

EC-Number - Eiropas Kopienas numurs; ECx - Ar x% atbildreakciju saistītā koncentrācija; ELx -

Ar x% atbildreakciju saistītais iekraušanas apjoms; EmS - Ārkārtas gadījuma grafiks; ENCS -

Esošās un jaunās ķīmiskās vielas (Japāna); ErCx - Ar x% pieauguma apjoma atbildreakciju

saistītā koncentrācija; GHS - Globāli harmonizēta sistēma; GLP - Laba laboratorijas prakse; IARC

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

Skinman soft protect

115167E

12 / 13

- Starptautiskā vēža izpētes aģentūra; IATA - Starptautiskā gaisa transporta asociācija; IBC -

Bīstamu ķīmisku lielkravu pārvadājošu kuģu būvniecības un aprīkojuma starptautiskais kodekss;

IC50

Puse

maksimālās

inhibējošās

koncentrācijas;

ICAO

Starptautiskā

civilās

aviācija

organizācija; IECSC - Ķīnas Esošo Ķīmisko vielu saraksts; IMDG - Starptautiskās jūras transporta

bīstamās kravas; IMO - Starptautiskā jūrniecības organizācija; ISHL - Rūpnieciskās drošības un

veselības likums (Japāna); ISO - Starptautiskā standartizācijas organizācija; KECI - Korejas

esošo ķimikāliju saraksts; LC50 - Letāla koncentrācija 50% no testa populācijas; LD50 - Letāla

deva 50% no testa populācijas (vidējā letālā deva); MARPOL - Starptautiskā konvencija par kuģu

izraisītā

piesārņojuma

novēršanu;

n.o.s.

norādīts

citādi;

NO(A)EC

novērota

(nelabvēlīgo)

blakusparādību

koncentrācija;

NO(A)EL

novērots

(nelabvēlīgo)

blakusparādību

līmenis;

NOELR

novērojamas

ietekmes

ielādes

līmeni;

NZIoC

Jaunzēlandes

Ķīmisko

vielu

saraksts;

OECD

Ekonomiskās

sadarbības

attīstības

organizācija; OPPTS - Ķīmiskās drošības un piesārņojuma novēršanas birojs; PBT - Noturīga,

bioakumulatīva un toksiska viela; PICCS - Filipīnu Ķimikāliju un ķīmisko vielu vielu saraksts;

(Q)SAR - (Kvantitatīvās) Strukturālās aktivitātes attiecības; REACH - Eiropas Parlamenta un

Padomes Regula (EK) Nr. 1907 / 2006 par, kas attiecas uz ķimikāliju reģistrēšanu, vērtēšanu,

licencēšanu un ierobežošanu; RID - Noteikumi, kas attiecas uz starptautiskajiem bīstamo kravu

pārvadājumiem pa dzelzceļu; SADT - Pašpaaugstinoša sadalīšanās temperatūra; SDS - Drošības

datu lapa; TCSI - Taivānas Ķīmisko vielu saraksts; TRGS - Bīstamu vielu tehniskie noreikumi;

TSCA - Toksisko vielu kontroles akts (Savienotās Valstis); UN - Apvienotās Nācijas; vPvB - Ļoti

noturīgs un ļoti bioakumulatīvs

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.

Šajā Drošības Datu Lapā dotā informācija publicēšanas brīdī saskaņā ar mūsu rīcībā esošajiem

datiem, informāciju un labticību, ir pareiza. Dotā informācija ir paredzēta tikai kā vadlīnijas drošai

rīcībai, lietošanai, apstrādei, glabāšanai, pārvadāšanai, utilizācijai un izlaidei, un tā nav uzskatāma

par garantiju vai kvalitātes specifikāciju. Informācija atbilst tikai specifiski izstrādātam materiālam

un nevar būt derīga, ja šis materiāls tiek izmantots kombinācijā ar jebkuriem citiem materiāliem,

vai jebkurā procesā, ja vien tas nav norādīts dotajā tekstā.

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

Nav vadošā viela

Ieelpošana

Nav vadošā viela

Dermāli

Nav vadošā viela

Acis

Myristyl Alcohol

112-72-1

204-000-3

ūdens vide

Nav vadošā viela

DROŠĪBAS DATU LAPA

saskaņā ar regulu (EK) Nr. 1907/2006

Skinman soft protect

115167E

13 / 13

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

ādas dezinfekcijas līdzeklis

Pielietojuma deskriptori

Galvenās lietotāju grupas

Profesionālie lietojumi. Visi sabiedrībai pieejamie pakalpojumi

(pārvalde, izglītība, izklaide, pakal-pojumi, amatnieku darbs)

Galējā lietojuma nozares

SU22: Profesionālie lietojumi. Visi sabiedrībai pieejamie

pakalpojumi (pārvalde, izglītība, izklaide, pakal-pojumi, amatnieku

darbs)

Procesa kategorijas

PROC10: Uzklāšana ar rullīti vai otu

PROC8a: Vielas vai produktu pārvietošana (iekraušana/

izkraušana) no/ uz rezervuāriem/ lieliem konteineriem šim

nolūkam neparedzētās telpās

Produktu kategorijas

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

šķīdinātājus)

Izdalīšanās vidē kategorijas

ERC8a: Apstrādes palīgvielu lieto-jums lielos apmēros telpās

atvērtās sistēmās

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

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

5-11-2018

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Products containing metam-sodium: ANSES announces the withdrawal of marketing authorisations

Plant protection products containing metam-sodium are used in market gardening and horticulture to disinfect the soil. Following the substance's approval at European level, ANSES reassessed the dossiers and notified the industrial companies concerned of its intention to withdraw all marketing authorisations for metam-sodium products. ANSES is also taking this opportunity to reiterate the importance of phytopharmacovigilance and the requirement for professionals to report any adverse effects on humans or ...

France - Agence Nationale du Médicament Vétérinaire

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

1-11-2018

Pest categorisation of Conotrachelus nenuphar

Pest categorisation of Conotrachelus nenuphar

Published on: Wed, 31 Oct 2018 00:00:00 +0100 The EFSA Panel on Plant Health performed a pest categorisation of Conotrachelus nenuphar (Herbst) (Coleoptera: Curculionidae), for the EU. C. nenuphar is a well‐defined species, recognised as a serious pest of stone and pome fruit in the USA and Canada where it also feeds on a range of other hosts including soft fruit (e.g. Ribes,Fragaria) and wild plants (e.g. Crataegus). Adults, which are not good flyers, feed on tender twigs, flower buds and leaves. Femal...

Europe - EFSA - European Food Safety Authority Publications

30-10-2018

Pest categorisation of Sternochetus mangiferae

Pest categorisation of Sternochetus mangiferae

Published on: Mon, 29 Oct 2018 00:00:00 +0100 The European Commission requested EFSA to conduct a pest categorisation of Sternochetus mangiferae (Coleoptera: Curculionidae), a monophagous pest weevil whose larvae exclusively feed on mango seeds, whereas adults feed on mango foliage. S. mangiferae is a species with reliable methods available for identification. It is regulated in the EU by Council Directive 2000/29/EC where it is listed in Annex IIB as a harmful organism whose introduction into EU Protec...

Europe - EFSA - European Food Safety Authority Publications

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

25-10-2018

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

BLL Enterprises Inc. recalls Fluid Film Rust & Corrosion Protection Aerosol

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

Health Canada

18-10-2018

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

Trump Administration Launches “Winning on Reducing Food Waste” Initiative

The U.S. Department of Agriculture (USDA), the U.S. Environmental Protection Agency (EPA), and the U.S. Food and Drug Administration (FDA) today announced the signing of a joint agency formal agreement under the "Winning on Reducing Food Waste" initiative.

FDA - U.S. Food and Drug Administration

17-10-2018

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Lumpy skin disease: scientific and technical assistance on control and surveillance activities

Published on: Tue, 16 Oct 2018 00:00:00 +0200 The duration of the vaccination campaign sufficient to eliminate lumpy skin disease (LSD) mainly depends on the vaccination effectiveness and coverage achieved. By using a spread epidemiological model, assuming a vaccination effectiveness of 65%, with 50% and 90% coverage, 3 and 4 years campaigns, respectively, are needed to eliminate LSD. When vaccination effectiveness is 80% to 95%, 2 years of vaccination at coverage of 90% is sufficient to eliminate LSD vir...

Europe - EFSA - European Food Safety Authority Publications

16-10-2018

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

FDA and DHS increase coordination of responses to medical device cybersecurity threats under new partnership; a part of the two agencies’ broader effort to protect patient safety

FDA and DHS announce partnership to address medical device cybersecurity threats

FDA - U.S. Food and Drug Administration

1-10-2018

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

FDA’s efforts to strengthen the agency’s medical device cybersecurity program as part of its mission to protect patients

FDA - U.S. Food and Drug Administration

21-9-2018

Scientific guideline:  Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

Scientific guideline: Guideline on determination of withdrawal periods for edible tissues - Revision 1, adopted

This document provides a standard approach to be used across the European Union in the analysis of residue depletion data for the purpose of establishing withdrawal periods for edible tissues. Emphasis has been put on a statistical approach. As the method of first choice, a linear regression technique is recommended. A computerised version of the method described is available: Updated application software: withdrawal time calculation for tissues. Read together with the explanatory note on updated applica...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

11-9-2018

Update of the Xylella spp. host plant database

Update of the Xylella spp. host plant database

Published on: Mon, 10 Sep 2018 00:00:00 +0200 Following a request from the European Commission, EFSA periodically updates the database on the host plants of Xylella spp. While previous editions of the database (2015 and 2016) dealt with the species Xylella fastidiosa only, this database version addresses the whole genus Xylella, including therefore both species X. fastidiosa and Xylella taiwanensis. The database now includes information on host plants of Xylella spp. retrieved from scientific literature...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Risk assessment of white willow (Salix alba) in food

Risk assessment of white willow (Salix alba) in food

Published on: Tue, 28 Aug 2018 00:00:00 +0200 This Technical Report contains a description of the activities within the work programme of the EU‐FORA Fellowship on the risk assessment of white willow in food. The bark of different varieties of willow has had a long history of medical use as a means to reduce fever and as a painkiller. Willow bark is also used in weight loss and sports performance food supplements. The labelling of these products usually does not mention any restrictions to the length of...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Assessment of occupational and dietary exposure to pesticide residues

Assessment of occupational and dietary exposure to pesticide residues

Published on: Mon, 27 Aug 2018 00:00:00 +0200 Plant protection products (PPPs) are pesticides containing at least one active substance that drives specific actions against pests (diseases). PPPs are regulated in the EU and cannot be placed on the market or used without prior authorisation. EFSA assesses the possible risks of the use of active substances to humans and environment. Member States decide whether or not to approve their use at EU level. Furthermore, Member States decide at national level on ...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Livestock Health and Food Chain Risk Assessment

Livestock Health and Food Chain Risk Assessment

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

Europe - EFSA - European Food Safety Authority Publications

4-9-2018

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

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

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

Europe - EFSA - European Food Safety Authority Publications

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

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

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Scientific Opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) effect models for regulatory risk assessment of pesticides for aquatic organisms

Published on: Thu, 23 Aug 2018 00:00:00 +0200 Following a request from EFSA, the Panel on Plant Protection Products and their Residues (PPR) developed an opinion on the state of the art of Toxicokinetic/Toxicodynamic (TKTD) models and their use in prospective environmental risk assessment (ERA) for pesticides and aquatic organisms. TKTD models are species‐ and compound‐specific and can be used to predict (sub)lethal effects of pesticides under untested (time‐variable) exposure conditions. Three differen...

Europe - EFSA - European Food Safety Authority Publications

7-8-2018

Dollarama recalls the Skip Ball toy

Dollarama recalls the Skip Ball toy

The Skip Ball toy may contain levels of phthalates that exceed the allowable limit. Studies suggest that certain phthalates, including DEHP, may cause reproductive and developmental abnormalities in young children when soft vinyl products containing phthalates are sucked or chewed for extended periods.

Health Canada

2-8-2018

The 2017 ANSES Annual Report is now available !

The 2017 ANSES Annual Report is now available !

At a time when its responsibilities are being extended, ANSES is consolidating its position as a protector of public health. With a field of action that covers all the risks to which the population may be exposed on a daily basis, the Agency confirms its scientific expertise capability and its mission to assess risks in situations of uncertainty.

France - Agence Nationale du Médicament Vétérinaire

23-7-2018

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues taking key actions on bulk drug substances used for compounding to advance the regulatory framework governing compounded drugs and to protect patients

FDA continues making progress on bulk drug substances for compounding

FDA - U.S. Food and Drug Administration

18-7-2018

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

&quot;Anti-pollution&quot; masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

10-7-2018

7 Tips for Cleaning Fruits, Vegetables

7 Tips for Cleaning Fruits, Vegetables

Fresh produce can become contaminated in many ways, but following these simple steps can help protect you and your family from foodborne illness.

FDA - U.S. Food and Drug Administration

10-7-2018

Ortovox Canada recalls Ortovox 3 Avalanche Transceivers

Ortovox Canada recalls Ortovox 3 Avalanche Transceivers

The recalled products may have a temporary disruption of the transmission function due to a software error. This may cause a delay in the search and rescue process of users.

Health Canada

4-7-2018

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Footwear and textile clothing: consumers need better protection from the risks of skin allergies and irritation

Cases of skin allergies and irritation related to clothing or footwear are regularly reported to the health authorities. Today ANSES is publishing the results of the expert appraisal it conducted to identify the chemicals likely to be found in these articles and possibly responsible for these cases. Further to this expert appraisal, the Agency is issuing recommendations on how to better protect consumers from the risks of skin allergies and irritation caused by the presence of these substances.

France - Agence Nationale du Médicament Vétérinaire

19-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

FDA releases draft guidance to help food manufacturers implement the Intentional Adulteration rule under the FDA Food Safety Modernization Act

FDA - U.S. Food and Drug Administration

19-6-2018

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Mine Safety Appliances Company LLC recalls MSA Nuevo Wrap Safety Glasses

Testing by the CSA Group has shown that glasses distributed between October 2017 and April 2018 do not comply with the side impact requirements of the safety standard for eye and face protectors. The affected safety glasses may not provide adequate protection against side impact, posing a risk of eye injury.

Health Canada

12-6-2018

A&I Products recalls Tractor Canopies

A&I Products recalls Tractor Canopies

The canopies do not meet design specifications and can cause the tractor’s Rollover Protective Structure (ROPS) to fail to protect the operator in a rollover accident, posing an injury hazard.

Health Canada

7-6-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

Statement from FDA Commissioner Scott Gottlieb, M.D., on 2017 National Youth Tobacco Survey results and ongoing FDA efforts to protect youth from the dangers of nicotine and tobacco products

FDA - U.S. Food and Drug Administration

6-6-2018

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

Philippe Reignault appointed Director of the Plant Health Laboratory and Director of Plant Health at ANSES

On 4 June, Philippe Reignault was appointed Director of the ANSES Plant Health Laboratory and will also take over from Charles Manceau as Director of Plant Health, with effect from July. Professor of Plant Biology and Diseases at the Littoral Côte d'Opale University since 2010 and Chair of ANSES's Expert Committee on Plant Health since 2012, he will now be responsible for overall coordination of ANSES's scientific work in plant health and protection.

France - Agence Nationale du Médicament Vétérinaire

30-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

Statement from FDA Commissioner Scott Gottlieb, M.D., on the signing of the Right to Try Act

FDA stands ready to implement the Right to Try Act in a way that achieves Congress’ intent to promote access and protect patients

FDA - U.S. Food and Drug Administration

30-5-2018

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

Risks and benefits of plant protection products containing neonicotinoids compared with their alternatives

In 2016, as part of the implementation of the Act "for the restoration of biodiversity, nature and landscapes” and as requested by the Ministries of Agriculture, Health and Ecology, ANSES initiated an assessment weighing up the risks and benefits of plant protection products containing neonicotinoids, compared with their chemical and non-chemical alternatives. Today, ANSES is publishing its final opinion. For most uses of plant protection products containing neonicotinoids, sufficiently effective and ope...

France - Agence Nationale du Médicament Vétérinaire

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

25-5-2018

Safe use of personal insect repellents

Safe use of personal insect repellents

While enjoying the warm summer weather, don't forget to protect yourself from pesky bugs that bite! Health Canada is reminding Canadians to use bug spray and other insect repellents safely to avoid mosquito and other bug bites.

Health Canada

25-5-2018

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

Link Product Solutions Limited recalls Summer Time TM Puffer Balls

These toys do not meet the Canadian safety requirements for toys. Some of the soft, stretchy parts of the toys can stretch to extreme lengths, posing a strangulation hazard to children.

Health Canada

22-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

The FDA is announcing three new efforts as part of a comprehensive set of actions to advance the FDA’s framework for sun protection products ahead of this coming summer

FDA - U.S. Food and Drug Administration

8-5-2018

What to Know When Buying or Using a Breast Pump

What to Know When Buying or Using a Breast Pump

Breast pumps are medical devices regulated by the U.S. Food and Drug Administration. They can be used to extract milk, maintain or increase a woman's milk supply, and relieve engorged breasts (among other indications). But, to protect mothers and their babies, there are important safety considerations to know before using one.

FDA - U.S. Food and Drug Administration

8-1-2018

Dose Matters: FDA's Guidance on Children's X-rays

Dose Matters: FDA's Guidance on Children's X-rays

FDA is committed to protecting the health of children by helping lower their exposure to radiation from X-ray exams.

FDA - U.S. Food and Drug Administration

21-10-2018

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the heal

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the heal

Whether it’s funding scientific research, examining policy approaches to vexing safety issues, or launching public education campaigns, you can be assured that this is a top commitment for us, and #FDA is fully engaged in promoting and protecting the health of the nation’s women pic.twitter.com/euQki9iqsL

FDA - U.S. Food and Drug Administration

1-10-2018

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients  http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2 pic.twitter.com/8w5m5itceW

My statement on the #FDA’s new efforts to strengthen the agency’s medical device cybersecurity program as part of our mission to protect patients http://go.usa.gov/xPBK2  pic.twitter.com/8w5m5itceW

FDA - U.S. Food and Drug Administration

27-9-2018

Read about how the FDA is seeking more resources in FY2019 to help  advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while  protecting patients. Click here:  https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.

Read about how the FDA is seeking more resources in FY2019 to help advance our #FDAPrecert model for #DigitalHealth-modernizing our regulatory approach to help innovate digital health technologies, while protecting patients. Click here: https://go.usa.gov/xPWZ3  #mobilehealth

FDA - U.S. Food and Drug Administration

26-9-2018

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health:  https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

#DYK that condoms are considered #MedicalDevices? Click the link to learn more about the #FDA’s role in regulating contraceptive devices to protect your sexual health: https://go.usa.gov/xPDQw 

FDA - U.S. Food and Drug Administration

26-9-2018

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide:  https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #M

The single-use internal condom (formerly the single-use female condom) is the only female-controlled barrier method intended to provide protection against pregnancy & STI transmission. Check out the FDA's birth control guide: https://go.usa.gov/xPDQw  #MedicalDevices

FDA - U.S. Food and Drug Administration

24-9-2018

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

Tomorrow, September 25th at 9:15 AM, join the #FDA for a session at #MedTechCon about our #DigitalHealth Software Precertification #FDAPrecert Pilot Program...

FDA - U.S. Food and Drug Administration

22-8-2018

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed.  https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4

This back-to-school season and every day, protect your child from infections that could lead to the life-threatening condition called sepsis. Remind your child to wash his or her hands and keep cuts clean and covered until healed. https://go.usa.gov/xUH4a  #GetAheadOfSepsis pic.twitter.com/7rut8Big03

FDA - U.S. Food and Drug Administration

7-8-2018

Research: Software as a Medical Device and Cyber Security for Medical Devices

Research: Software as a Medical Device and Cyber Security for Medical Devices

Opportunity to participate in CSIRO research to inform new Australian medical device industry guidance

Therapeutic Goods Administration - Australia

22-7-2018

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. ht

Even when Essure is no longer sold, the #FDA will remain vigilant in protecting patients who’ve already had this device implanted. We’ll continue to monitor adverse events and publicly communicate any new safety findings on this - and any other device. https://www.bloomberg.com/news/articles/2018-07-20/bayer-to-stop-selling-contraceptive-implant-after-threats-by-fda …

FDA - U.S. Food and Drug Administration

22-7-2018

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and addre

Medical device safety is a key #FDA priority. We’re committed to protecting U.S. patients by minimizing avoidable risks, assuring they have timely information to make well-informed decisions, and advancing devices that are safer, more effective, and address unmet medical need. pic.twitter.com/Dm73SQ213p

FDA - U.S. Food and Drug Administration

18-7-2018

Knowing what software is included in a device means users and manufacturers can better assess and remediate potential cybersecurity threats that may emerge. #FDA looks forward to participating in the SBOM workstream and engaging broader perspective from t

Knowing what software is included in a device means users and manufacturers can better assess and remediate potential cybersecurity threats that may emerge. #FDA looks forward to participating in the SBOM workstream and engaging broader perspective from t

Knowing what software is included in a device means users and manufacturers can better assess and remediate potential cybersecurity threats that may emerge. #FDA looks forward to participating in the SBOM workstream and engaging broader perspective from the community.

FDA - U.S. Food and Drug Administration

18-7-2018

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a me

HSCC announced today a new workstream, conducted under the Task Group, that will discuss and seek input on a software bill of materials (SBOM) for medical devices. SBOMs can ensure that users have better understanding of what software elements are in a medical device.

FDA - U.S. Food and Drug Administration

5-7-2018

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays.  https://go.usa.gov/xU4Ht pic.twitter.com/lGayQuxMQw

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays. https://go.usa.gov/xU4Ht pic.twitter.com/lGayQuxMQw

It’s summertime and that means more skin exposure to the sun. Be sure to check out the FDA’s skin safety page for tips and information on how to protect your skin from UV rays. https://go.usa.gov/xU4Ht  pic.twitter.com/lGayQuxMQw

FDA - U.S. Food and Drug Administration

28-6-2018

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonthpic.twitter.com/ZpJ0aas1N4

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonthpic.twitter.com/ZpJ0aas1N4

Here are three main practices for protecting yourself online: be sure your internet connection is secure, be careful what you download, and always be careful what you post! #InternetSafetyMonth pic.twitter.com/ZpJ0aas1N4

FDA - U.S. Food and Drug Administration

29-5-2018

FDA Open Docket now available for feedback on benefits and risks of software that are not devices-  https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA Open Docket now available for feedback on benefits and risks of software that are not devices- https://go.usa.gov/xQdfx  #MedicalDevice #21CenturyAct #DigitalHealth

FDA - U.S. Food and Drug Administration

25-5-2018

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media:  https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7 pic.twitter.com/hKJbKLnwni

CDC wants to see your #SunSafeSelfie! Photograph yourself with protections such as sunglasses, a hat, long-sleeves & sunscreen and share your pic on social media: https://goo.gl/jr1nP7  pic.twitter.com/hKJbKLnwni

FDA - U.S. Food and Drug Administration

21-5-2018

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay  https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw pic.twitter.com/GzY50eEVp9

RT this: 10 Ways to Keep Athletes Safe While in the Sun: COVER UP! Wear sun-protective clothing and hats. Don't forget: May 25 is #DontFryDay https://loom.ly/Gbg7XBw  pic.twitter.com/GzY50eEVp9

FDA - U.S. Food and Drug Administration

17-5-2018

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

#ThrowBackThursday: May 17, 1971- The Public Health Service Bureau of Radiological Health transferred to FDA. It’s Mission: Protect against unnecessary human exposure to radiation from electronic products in the home and industry. #OnThisDay #FDAHistory

FDA - U.S. Food and Drug Administration