ProductNo0ficaon’according’to’’ Ar0cle’45’Classificaon ......14/11/2019...

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14/11/2019 Product No0fica0on according to Ar0cle 45 Classifica0on Labelling and Packaging in Ireland Dr Edel Duggan Clinical Director, Na0onal Poisons Informa0on Centre Ireland

Transcript of ProductNo0ficaon’according’to’’ Ar0cle’45’Classificaon ......14/11/2019...

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Product  No0fica0on  according  to    Ar0cle  45  Classifica0on  Labelling  

and  Packaging  in  Ireland    

 Dr  Edel  Duggan    Clinical  Director,    

Na0onal  Poisons  Informa0on  Centre  Ireland    

 

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Outline  

•  Ar0cle  45  CLP  in  Ireland:  Na0onal  Poisons  Informa0on  Centre;  who  we  are,  what  we  do.    

 •  Current  Product  No0fica0on  Process    •  The  Journey  towards  Jan  2021-­‐    Key  resources      •  Challenges      •  Future  Product  No0fica0on  Process      

 

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Ar#cle  45  EU  Regula#on  1272/2008    

“Member  states  shall  appoint  a  body  or  bodies  responsible  for  receiving  informa0on  relevant,  in  par0cular,  for  formula0ng  preventa0ve  and  cura0ve  measures,  in  par0cular  in  the  event  of  emergency  health  response,  from  importers  and  downstream  users  placing  mixtures  on  the  market.      

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Chemicals  Act  2008    Amendment  2010  

“(3)  The  following  are  competent  authori0es  in  the  state  for  the  purposes  of  the  CLP  regula0on:      

 (a)  the  Authority,    

 (b)  the  minister  for  Agriculture,  Fisheries  and    Food,  in  respect  of  pes0cides  

   (c)  Beaumont  Hospital  Board,  for  the  purpose    only  of  Ar0cle  45  of  that  Regula0on.”  

 

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•  Health  and  Safety  Authority:    Competent  Authority  

•  Representa0on  at  EU,  ECHA,  OECD,  and  UN      •  Liaise  with  Industry      •  Enforcement  role    

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Beaumont  Hospital    

 • Large  academic  hospital      • Serves  290,000  people      • Designated  Cancer  Centre    • Na0onal  Referral:  Neurosurgery,  Renal  Transplant,  Cochlear  implanta0on.    

• Na#onal  Poisons  Informa#on  Centre  

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Na#onal  Poisons  Informa#on  Centre  •  >10,000  calls/yr      • 4.5  WTE  Poison  Informa0on  Officers    Secretary,  Manager  &  Director  (PT)    • Provide  informa0on  to  assist  in  the  management  of  poisoning    • 8am    -­‐  10pm  members  of  public  &  health  care  professionals      • 10pm-­‐8am:    Na0onal  Poison  Informa0on  Service  in  UK    

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Enquiries  concerning  Household  Chemicals      

2608   2312  2844  

2324  2992   2738  

0  

500  

1000  

1500  

2000  

2500  

3000  

3500  

No  of  agents     No  of  cases   No  of  agents     No  of  cases   No  of  agents     No  of  cases  

2016   2017   2018  

Household    

Household  products:  76%  of  calls  -­‐  0-­‐9yrs    Industrial  products    58%  of  calls  –  0-­‐9yrs      

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Household  &  Industrial  calls    

0%  

5%  

10%  

15%  

20%  

25%  

30%  

2012   2013   2014   2015   2016   2017   2018  

Household  

Household  

%  of  total  no  of  cases    

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Home    About      Public      Professionals    Industry    News      Links      Contact  us    

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Current  No#fica#on  Process  in  Ireland    

Telephone/email  query  to  NPIC  

www.poisons.ie  

Download  and  return  [email protected]  1.  Product  Registra0on  Form    

 2.  Agreement  and  Indemnity  form  

Product  informa0on  forms  uploaded  manually  onto    

Document  Management  System  

Company  invoiced    NPIC  number  on  product  

Industry  

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Document  Management  System  

289  company  folders:    39,000  products  on  the  DMS    

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DMS  log-­‐in  screen  

Hospital  Document  Management  system      NPIC  folder:  only  accessible  by  NPIC  staff        User  Administrator    Searchable  Database  (limited)    Cumbersome  and  resource  intensive  to  upload  documents      

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Product  No0fica0ons  to  the  NPIC  

0  

500  

1000  

1500  

2000  

2500  

3000  

2015   2016   2017   2018   2019  

No  of  produ

cts  

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Ar#cle  45:  The  journey  so  far  

Ø  2008:      1  Whole  Time  Equivalent  (WTE);      2019:    5  members  2  WTE  

 Ø   EAPCCT-­‐  Representa0on  PC  Ac0vi0es/European  

Regulatory  WG  -­‐2012    

Ø  European  Commission  mee0ngs:  Harmonisa0on  of  PC  informa0on  –  2013  

Ø  Webinar:  provide  guidance  on  Annex  VIII  to  CLP.    Ø   ECHA  Poisons  Centre  database  consulta0on  process    

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Ø  Par0cipated  in:      a)  “Study  on  harmonisa0on  of  informa0on  to  be  submimed  to  Poison  

centres,  according  to  ar0cle  45  (4)  of  the  regula0on  (E)  No  1272/2008  (CLP  regula0on).”  –  undertaken  for  the  EC  by  Amec  Foster  Wheeler  and  the  Na0onal  Chemical  Emergency  Centre  UK.    

 b)  “Study  on  workability  issues  concerning  the  implementa0on  of  Annex  VIII  

of  Regula0on  EC  No  1272/2008  on  harmonised  informa0on  rela0ng  to  emergency  health  response  and  preventa0ve  measures”.  Undertaken  by  EC  by  Wood.    

 

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The  op0ons  

Appointed  bodies  build  or  adapt  their  own  

databases      

Centralised  No0fica0on  Portal  (ECHA)  

Industry    

Version  1  April  2018  

Version  2  Nov  2019  

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NPIC  and  Ar0cle  45  CLP    

Informa#on  Technology    

Security    

 Resources  

Informa0on  Technology  Harmonised  informa0on:    XML  format  defined  by  Annex  VIII  of  the  CLP  regula0on    

 Op0ons  :    

–  Local  IT  Depart:        2015  (developing  in-­‐house  IT  plaoorm)    

             Na0onal      (2016  proposals  mandate  HSE:  Office  of    the  Chief  Informa0on  officer)    

 –  European:      ECHA  Poisons  Central  No0fica0on  portal    

 

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ECHA  Poisons  Central  No0fica0on  Portal  

 

Version  1   Version  2   Future  addi#ons  

Industry    ê

ECHA

ê

Dispatch  to  

Appointed  Bodies      

Industry    ê

ECHA

éê

Appointed Bodies

eDelivery Searchable Database

Industry    ê

ECHA

éê  

Appointed  Bodies    

?  Extra  func0ons    

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ECHA  Version  1    

•  Applied  for  version  1:  April  2019      •  ?  Unsure  if  it  was  a  requirement  for  Version  2  (available  Oct/Nov  2019  -­‐  0ght  deadline)    

•  Unable  to  download  no0fica0ons  to  xml  format      •  Short  0me  frame  (weeks)    

Informa#on  Technology  

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     Security  

Ø ECHA  security  requirements      Ø Legal  Representa0ve:  Declara0on  of  Commitment  (security  aspects)      

 Ø User  Administrator:  NPIC  manager      

Ø Security  Officers  Network:  IT  Department  (Data  Protec0on  Officer)  

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Security  Requirements  ü Many  in  place  due  to  hospital  environment      ü  Automa0c  locking  of  computer  screens    ü  Accountability  of  who  is  using/accessing  the  system    ü  Risk  of  malware  infec0on  mi0gated      ü  Access  from  untrusted  networks  controlled.    ✕ Two  factor  user  authen0ca0on  system  in  place    

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 Resources  

Ar0cle  45    

Educa0onal  

Organisa0onal  

Rela0onal        

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Poison  Informa0on  Officers  (PIO):    role  of  user  administrator  (UA),    annual  audits,    reports  to  the  EC  and  awareness  ac0vity.      No0fica0ons  expected  to  ñ  3  fold  (30k  –  100k)*  with  mandatory  repor0ng    Es0mated  at  least  3%  of  products  audited  per  year  (3k):  3  WTE    Requested  funding  for  1  poison  informa0on  officer  and  1  clerical  officer    Staffing  requirements  to  be  resized  with  data  aser  implementa0on  of  CLP    

*  Guess0mate  as  unknown  how  many  hazardous  products  are  placed  on  Irish  market  per  year      

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 Resources  

Funding       Human        

Ar0cle  45    

Rela0onal  

lnfrastructure        

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Organisa0onal    •  Clinical  Governance  Structure      •  Policies  and  Procedures  

•  Data  Protec0on:  Confiden0ality      •  Security  aspects    •  Educa0onal/Training      

Beaumont  Hospital    

NPIC  

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 Resources  

Funding       Human        

Ar0cle  45    

Educa0onal  

Organisa0onal  

Rela0onal        

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Rela#onal  

•  Pre  Jan  2021  –  Informa0on  on  website:  update      –  Par0cipate  in  Workshops      –  Service  Level  Agreement  with  

HSA  re  enforcement      –  ECHA  requirements  ?  SLA    

NPIC    

HSA    Industry    

•  Post  Jan  2021    

–  Rela0onship  with  Industry      –  Audi0ng  (security/  

no0fica0ons)      –  Toxicosurveillance      

ECHA    

EC    

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Liasing  with  Industry      Website:  Produc0on  No0fica0ons,    FAQ,  links  to  ECHA  website.      Communica0on  once  no0fica0ons  are  central?      Fee  charged  to  companies:    NPIC  number  on  their  products    Enforcement    

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Challenges    Ø  Brexit:  NPIS  (UK)  answers  calls  from  Ireland  at  night    

§  ECHA  portal    §  Jurisdica0on  

 Ø  Emerging  from  a  recession:  Finanical  constraints  

   §  Poison  Centre:  remit  Department  of  Health:    §  Chemicals  Act:  remit  of  Department  of  Business,  Enterprise  and  Innova0on    

Ø  Enforcement:  NPIC  has  no  prior  experience.        

Ø  No  direct  link  our  calls  database  to  the  ECHA  database      Ø  Charge  fee  for  using  the  NPIC  number  (no  increase  since  it  was  

introduced)      

 

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Advantages    

•  NPIC:  Poison  Centre  &  Appointed  body  for  Ar0cle  45  

•  Hospital  campus  with  IT  Department/Security    

•  Close  0es  with  the  HSA,  EAPCCT,  other  poison  centres    •  Low  level  of  staff  turnover    •  Play  a  role  in  Toxicosurveillance    

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Future  No#fica#on  Process  in  Ireland    

NPIC  Industry  Invoiced  NPIC  number  on  

product    

Industry  

HSA  

Enforcement  

Audi0ng:  Request  further  Informa0on    

Non  Compliance  

ECHA  PCN  portal  

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Summary  

•  ECHA  searchable  database  Version  2  (IT  Department)      •  Addi0onal  func0ons:  Invoicing  

•  Security  requirements:  Internal  &  External  Audi0ng      •  Enforcement      •  Strenghten  rela0ons  with  stakeholders      •  Funding    

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Go  raibh  maith  agat!                    Acknowledgements:  Staff  of  Na0onal  Poisons  Informa0on  Centre:  Elaine  Donohoe,  Patricia  Casey,  John  Herbert,  Niamh  English,  Nicola  Cassidy,  Fergal  O’Connor,  Sinead  Doyle.    


Internet Jouranl - 14-45(2)

Internet Jouranl - 14-45(2)

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Carcinogens&–&&&&&&&&&&& WhatShould&You&Know& … Blanc.pdf3/10/16 5 IARC&Carcinogen&Classificaon& through&Volume&115& Cancer’in’Experimental’Animals’ Sufficient Limited&

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15:21 ZOOM Cloud Meetings a App 99% (PMI) 4.0 Today 14:45 ... · Meetings a App 99% (PMI) 4.0 Today 14:45 4.0 92K 47%' ZOOM Cloud Meetings zoom.us 100M* 14:45 470/06 13:14 50%' 3

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Wowbug’( Meli%obia)digitata)’classificaon’staff.4j.lane.edu/~ruzicka/Cal_Young/lifescience/Organisms/Wowbug... · Wowbug’(Meli%obia)digitata)’classificaon’ Taxonomic)

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UVACS$4501$+$001$/$6501$–007 $ Yanjun&Qi&/&UVA&CS ... · 10/20/14 2 Where&are&we&?&!&& Three&major&sec,ons&for&classificaon • We can divide the large variety of classification

The Department of Pulmonary Learn from renowned …...APFT case studies 35m Dr Neerja Shastri LUNCH BREAK (14:15-14:45) SESSION 5 – HANDS ON WORKSTATIONS (14:45-16:45) Station-1

The Department of Pulmonary Learn from renowned …...APFT case studies 35m Dr Neerja Shastri LUNCH BREAK (14:15-14:45) SESSION 5 – HANDS ON WORKSTATIONS (14:45-16:45) Station-1

90th GO 45 14

90th GO 45 14

Industrial Policy - UTLBC Diu & Daman · 2018. 9. 13. · 2.1 Objecve 12 2.2 Vision 12 2.3 Mission 12 2.4 Policy Objecves 13 2.5 Policy Targets 13 2.6 Thrust Areas 14 2.7 Classificaon

Industrial Policy - UTLBC Diu & Daman · 2018. 9. 13. · 2.1 Objecve 12 2.2 Vision 12 2.3 Mission 12 2.4 Policy Objecves 13 2.5 Policy Targets 13 2.6 Thrust Areas 14 2.7 Classificaon

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Meetingbooklet - th.fhi-berlin.mpg.de...2Program MondayAugust26thDay1:Data-drivenmaterialsdiscovery 12:00-14:30 Registration 14:30-14:45 TheOrganizers Introductoryremarks 14:45-15:45

Meetingbooklet - th.fhi-berlin.mpg.de...2Program MondayAugust26thDay1:Data-drivenmaterialsdiscovery 12:00-14:30 Registration 14:30-14:45 TheOrganizers Introductoryremarks 14:45-15:45

PlantEvolu+on&and&Classificaon& - Weebly

PlantEvolu+on&and&Classificaon& - Weebly

ARTICLE 45-14 CONSUMER PRIVACY CHAPTER 45-14-01 …

ARTICLE 45-14 CONSUMER PRIVACY CHAPTER 45-14-01 …

Volume 45 Issue 23 [04/14/2011]

Volume 45 Issue 23 [04/14/2011]

BrainDaysIntroduction 14:00-14:45 The rest of the brain 16:30-17:15 Limbic System 14:00-14:45 16:30-17:15 Circuits functional neuroanatomy Telencephalon.

BrainDaysIntroduction 14:00-14:45 The rest of the brain 16:30-17:15 Limbic System 14:00-14:45 16:30-17:15 Circuits functional neuroanatomy Telencephalon.

Saurabh Gupta - From Captions to Visual Concepts and Back · 2018-11-22 · PHR AP NN VB$ JJ DT PRP$ IN$ Oth$ All$ All$ Classificaon+ (AlexNet) 39 28 37 37 26 32 25 36 27 Classificaon(VGG)+

Saurabh Gupta - From Captions to Visual Concepts and Back · 2018-11-22 · PHR AP NN VB$ JJ DT PRP$ IN$ Oth$ All$ All$ Classificaon+ (AlexNet) 39 28 37 37 26 32 25 36 27 Classificaon(VGG)+

Detroit AutoFocus Vol 14 Issue 45

Detroit AutoFocus Vol 14 Issue 45

Bruno 14 10 45

Bruno 14 10 45

KIDS № 14 (45)

KIDS № 14 (45)

Vol 45 Issue 14

Vol 45 Issue 14