brekelmans by 5iC78p6

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									Notification of product information to Poisons Centres
     The road to harmonisation at the EU level


                                Pieter Brekelmans
                         National Poisons Information Centre
               National Institute for Public Health and the Environment
                                    The Netherlands


 Workshop on the Harmonisation of Information for Poisons Centres - CLP Article 45(4)
 CLP - Regulation on Classification, Labelling and Packaging of Substances and Mixtures
                               Brussels 24 November 2010

                 European Association of Poisons Centres and Clinical Toxicologists
      Why are we here?



  The appointed bodies shall have at their disposal
             all the information required
     from the importers and downstream users
              responsible for marketing
to carry out the tasks for which they are responsible

       (CLP Regulation (EC) No 1272/2008, article 45/3)




         European Association of Poisons Centres and Clinical Toxicologists
        Tasks of Poisons Centres

Example: Dutch Poisons Centre
                                                                  Anti-rain sprays cause
                                                                      030-274 Cannabis:
                                                                  Strong Dutch 8888
                                                                      Annual incidents
                                                                    Chemical reports
• 24/7 information/advice on acute                                www.vergiftigingen.info
                                                                  serious lung damage
                                                                  soft drug or hard drug?
  poisonings (public / professionals)
  www.vergiftigingen.info

• 24/7 medical advise in large incidents
                                                                  Dangerous preparations
• Annual reports / ad hoc reports
                                                                   Radiation incidents anis
                                                                 Teaonly for professionals
                                                                 NL: with ‘decoration’
• Trend watching, analysis                                       causes hallucinations

• Research
 (fundamental, patients/volunteers)                                    Risk analysis
                                                                   of acute poisonings
• Product notification                                             on a secure website
                                                              Since 2007

            European Association of Poisons Centres and Clinical Toxicologists
        Tasks of Poisons Centres

Example: Dutch Poisons Centre
• 24/7 information/advice on acute                                      030-274 8888
  poisonings (public / professionals)
  www.vergiftigingen.info

• 24/7 medical advise in large incidents

• Annual reports / ad hoc reports

• Trend watching, analysis

• Research
 (fundamental, patients/volunteers)

• Product notification

            European Association of Poisons Centres and Clinical Toxicologists
     Product notification importance


Hazardous product                                       Company



Information request                                                           Poisons Centre
- product name                           Product information:
- quantity                               The (hazardous) substances
- weight of patient                      Their concentrations


Physician / Public                       Substance information:
                                         Dose-effect-relationship
                                         - seriousness: L/M/S
Adequate                                 - symptoms
information / advice                     - diagnostics
on treatment                             - therapy

         European Association of Poisons Centres and Clinical Toxicologists
        Product notification aspects



                           Quality of information




                             Product information
Natl. legislation                                                     Format of information
                             Product notification




                                                           DPD 88/379/EC, article 12
                                 EU legislation            DPD 1999/45/EC, article 17


                             by CLP Regulation (EC) No 1272/2008, article 45

            European Association of Poisons Centres and Clinical Toxicologists
          Dangerous Preparations Directive

 Art. 12 . Bodies responsible for receiving information relating to health

Member States shall appoint the body or bodies responsible for receiving
information, including chemical composition, relating to preparations placed on
the market and considered dangerous on the basis of their health effects or on
the basis of their physico-chemical effects.
Member States shall take the necessary steps to ensure that the appointed
bodies provide all the requisite guarantees for maintaining the confidentiality of
the information received. Such information may only be used to meet any
medical demand by formulating preventive and curative measures, in particular
in case of emergency.

Member States shall ensure that the information is not used for other
purposes.

Member States shall ensure that the appointed bodies have at their disposal all
the information required from the manufacturers or persons responsible for
marketing to carry out the tasks for which they are responsible.


               European Association of Poisons Centres and Clinical Toxicologists
            Different requirements on composition
            Different requirements on ingredient concentration
            Different procedures

            Different forms

            Different electronic formats




            CAUSE:




European Association of Poisons Centres and Clinical Toxicologists
         Report conclusions

Harmonisation of product notification in the EU
Step 1 – Reach consensus on required product information
=> EAPCCT guideline (1989!) is still a good compromise


Step 2 – Establish common (electronic) format
=> SDS format as basis, but with additional info


Step 3 – Implementation in EU legislation
=> Implementation in CLP Regulation



   REGULATION (EC) No 1272/2008 on                  Classification, Labelling and Packa

             European Association of Poisons Centres and Clinical Toxicologists
         CLP regulation

EC No 1272/2008, article 45, paragraph 4
By 20 January 2012 the Commission shall carry out a review to assess
the possibility of harmonising the information referred to in paragraph
1, including establishing a format for the submission of information by
importers and downstream users to appointed bodies. On the basis of
this review, and following consultation with relevant stakeholders such
as the European Association of Poison Centres and Clinical
Toxicologists (EAPCCT), the Commission may adopt a Regulation
adding an Annex to this Regulation




             European Association of Poisons Centres and Clinical Toxicologists
          EAPCCT working group

European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues
Dr Herbert Desel, chair (Göttingen, EAPCCT Board)
Dr Hugo Kupferschmidt (Zürich, EAPCCT past-President)


Poisons Information Centres representatives from:


Netherlands               Italy                            Norway
Germany                   Ireland                          Sweden
Belgium                   Switzerland                      Denmark
France                    Spain                            Estonia



               European Association of Poisons Centres and Clinical Toxicologists
         EAPCCT working group

European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues

Current activities:
- Harmonisation of Product Notification: CLP 45(4) review by COM
  (Uta Jensen)
  lead: Ronald de Groot (NL)

- Cosmetic Products Notification Portal            (CPNP) working group
   (Aurelien Perez)
   lead: Herbert Desel (DE)
   Ad hoc WG on IT issues                           lead: Pieter Brekelmans (NL)
   Ad hoc WG on Categorisation                      lead: Andreas Stürer (DE)
   Ad hoc WG on Frame Formulations                  lead: Martine Mostin (BE)


             European Association of Poisons Centres and Clinical Toxicologists
        CLP 45(4) review

By DG Enterprise & Industry
Lead by Dr. Uta Jensen-Korte
- Sept 18th 2009             Introductory meeting
- March 17th 2010            1st meeting of COM and PIC representatives
- May 28th 2010              2nd meeting of COM, PIC and some GA
                             representatives

- June 17th 2010             Caracal meeting (EC)

- Aug 2010                   3rd meeting with PIC representatives

- Sept 2010                  endorsed draft of EAPCCT 2010 guidelines

- Nov 24th 2010              Workshop with all stakeholder representatives

              European Association of Poisons Centres and Clinical Toxicologists
          CLP 45(4) review

Schedule
1a) Poisons Information Centres (PIC) should reach consensus on:
   • Essential information for medical purposes, esp.
     required quality of the composition              EAPCCT guidelines 2010
   • Unique product (information) identifiers
   • Product categorisation
   • Format: SDS + additional information in XML, PDF or both
1b) Consultation with all stakeholders, e.g. industry, governmental authorities
   • Workshop 24th november 2010
   • Report summarising the state of the project

1c) Determine with stakeholders the required information quality

2) Determine with stakeholders the required information format

3) Implementation in an Annex to the CLP Regulation
               European Association of Poisons Centres and Clinical Toxicologists
         EAPCCT 2010 guidelines

Presentation by Ronald de Groot
EAPCCT guideline 1989: composition

All constituents should be mentioned

Actual concentrations of any
very toxic (T+), toxic (T) or corrosive (C)
constituents

Concentrations of all other constituents
can be given in % concentration bands:

0 to 1%          20 to 30%
1 to 5%          30 to 50%
5 to 10%         50 to 75%
10 to 20%        over 75%

              European Association of Poisons Centres and Clinical Toxicologists
         EAPCCT 2010 guidelines

Presentation by Ronald de Groot




Signal words: danger / warning




               European Association of Poisons Centres and Clinical Toxicologists
         EAPCCT 2010 guidelines

Presentation by Ronald de Groot


 COMPANY INFORMATION                                   CLASSIFICATION
 - Company placing the mixture on the market           - Classification
 - Company submitting the mixture information          - Label elements
 - Contact Point(s) in case of emergency
                                                       PACKAGING
 IDENTIFICATION OF THE MIXTURE                         - Type(s)
 - Mixture identifiers                                 - Size(s)
 - Product Identification Element                      - Labels

 COMPOSITION                                           PHYSICAL/CHEMICAL CHARATERISTICS
 - Substances in the mixture                           - Physical state
 - Substance concentrations                            - pH
 - Reformulation                                       - Total reserve acidity/alkalinity

 CATEGORISATION                                        TOXICOLOGY
 - Product Category
 - Consumer / Professional use                         OTHER INFORMATION




               European Association of Poisons Centres and Clinical Toxicologists
          Product (information) identification



Product Information                                                            Product Label


  Product Name                                                               Product Name
  Product Formula




Product Name                                                         Product Name
Product Formula




                  European Association of Poisons Centres and Clinical Toxicologists
          Product identification

Presentation by Axel Hahn

Product Information                                                            Product Label


  Product Name                                                               Product Name
  Product Formula                                                       Product Identification Element



Product Name                                                         Product Name
Product Formula                                                  Product Identification Element




                  European Association of Poisons Centres and Clinical Toxicologists
          Product versioning

Presentation by Herbert Desel

Product Information                                                            Product Label

  Product Formula Id
  Product Name                                                               Product Name
  Product Formula


Product Formula Id
Product Name                                                         Product Name
Product Formula




                  European Association of Poisons Centres and Clinical Toxicologists
         Product categorisation

Presentation by Andreas Stürer

● Use of a harmonised product categorisation system

● E.g. for better comparison of exposure data of products in certain
  categories between European Poisons Centres

● E.g. to better combine exposure data of European Poisons Centres
  into one european annual report




             European Association of Poisons Centres and Clinical Toxicologists
        Product information format



                  SDS                                 Add. Info

                                         PC requirements




For companies:
• Convenient to use the Safety Data Sheet as part of the product
information
For Poison Centres:
• Not enough information on the SDS to perform an adequate risk
assessment
• Additional information needed

            European Association of Poisons Centres and Clinical Toxicologists
         Product information format

Presentation by Cristophe Dupriez

                   SDS                                 Add. Info

                                          PC requirements

                                        PC electronic dataset

Format requirements:
• No notification of one SDS file and one file with additional information
• But notification of a SDS file and a PC electronic dataset
    (containing most data of the Poisons Centres requirements)
• Electronic notification of the required dataset to PICs allows easy
electronic data import, validation, presentation, statistical analysis, …
• Use of XML, PDF and/or techniques/tools
             European Association of Poisons Centres and Clinical Toxicologists
         Cosmetic Products Notification Portal

Cosmetic products Regulation (EC) No 1223/2009
Paragraph 1
Prior to placing the cosmetic product on the market the responsible
  person shall submit, by electronic means, the following information
  to the Commission: (a list of requirements follows)

Paragraph 5
The Commission shall, without delay, make the information referred to
  in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3
  available electronically to all competent authorities.

Paragraph 6
The Commission shall, without delay, make the information referred to
  in paragraphs 1, 2 and 3 available electronically to poison centres or
  similar bodies, where such centres or bodies have been established
  by Member States.


             European Association of Poisons Centres and Clinical Toxicologists
      Cosmetic Products Notification Portal

Prototyping                                                                                                             CA 1



                                                                                                                        CA 2

                                                                        Submit
                                                                                                         Search,
                                                                         data
                                                                                                         Browse,
                                                                                                         Downloa
                                                                                                            d           CA n

                                                                                           CPNP
                                                                                                                   Competent Authorities




                                                                                                                        PC 1



                                                                                                                        PC 2
                                                                                  ACK
                                                                                 Message
                                                                                           Centralized   Search,
                                                                                            Database     Browse,
                                                                                                         Downloa
                                                                                                            d           PC n



                                           Distributors / Responsible Persons                 EC                      Poison Centers




         European Association of Poisons Centres and Clinical Toxicologists
         Cosmetic Products Notification Portal

Development by DG SANCO
Lead by Dr. Aurelien Perez
- June 29th 2009            1st meeting of COM, Colipa, Ind, GA, PICs
- Sept 18th 2009            2nd meeting of COM, Colipa, Ind, GA, PICs

                            =>ad hoc WG IT-related issues (3 meetings)
                            =>ad hoc WG categorisation (2 meetings)
                            =>ad hoc WG Frame formulations (3 meetings)

- Jan 2011                  3rd meeting of COM, Colipa, Ind, GA, PICs

- 2011                      Four iterations of constructing and testing

- Jan 2012                  CPNP in production

             European Association of Poisons Centres and Clinical Toxicologists
         Cosmetic Products Notification Portal

European Association of Poisons Centres and Clinical Toxicologists
WG on Poisons Centres Activities / European Regulatory Issues

Current activities:
- Harmonisation of Product Notification: CLP 45(4) survey by COM
  (Uta Jensen)
  lead: Ronald de Groot (NL)

- Cosmetic Products Notification Portal            (CPNP) working group
   (Aurelien Perez)
   lead: Herbert Desel (DE)
   Ad hoc WG on IT issues                           lead: Pieter Brekelmans (NL)
   Ad hoc WG on Categorisation                      lead: Andreas Stürer (DE)
   Ad hoc WG on Frame Formulations                  lead: Martine Mostin (BE)


             European Association of Poisons Centres and Clinical Toxicologists
          CLP 45(4) review: future

Schedule
1a) Poisons Information Centres (PIC) should reach consensus on:
   • Essential information for medical purposes, esp.
     required quality of the composition              EAPCCT guidelines 2010
   • Unique product (information) identifiers
   • Product categorisation
   • Format: SDS + additional information in XML, PDF or both
1b) Consultation with all stakeholders, e.g. industry, governmental authorities
   • Workshop 24th november 2010
   • Report summarising the state of the project

1c) Determine with stakeholders the required information quality

2) Determine with stakeholders the required information format

3) Implementation in an Annex to the CLP Regulation
               European Association of Poisons Centres and Clinical Toxicologists
            Future (a Dutch perspective)

Past situation                       Preparationsdatabase


             PIF
                                                               Dangerous Preparations Directive
 PINDA     Datafiles                                           (88/379 art.12; 1999/45 art. 17)
                                                               Biocides Directive (98/8 art. 23)



                       T, T+, C
            SDS



Sysdecos   KOS files                                           Cosmetics Directive (76/768)




            SDS                                                SDS Directive
                                                               (91/155; 2001/58)
           ProdInfo


                       European Association of Poisons Centres and Clinical Toxicologists
         Future (a Dutch perspective)

Present situation

Complete composition                https://www.productnotificatie.nl/
(no thresholds)

Exact concentrations
(all ingredients)
or
Exact concentrations
(T, T+, C, Xi, Xn ingr.)
Well specified ranges
(other ingredients)
or
Well specified ranges
(all ingredients)                    SDS.pdf + Composition.pdf

             European Association of Poisons Centres and Clinical Toxicologists
             Future (a Dutch perspective)

Present situation Preparationsdatabase
             PIF                                               Dangerous Preparations Directive
 PINDA     Datafiles                                           (88/379 art.12; 1999/45 art. 17)

            comp.
                       pdf                                     Biocides Directive (98/8 art. 23)
                       pdf
             SDS




            SDS


Sysdecos   KOS files                                           Cosmetics Directive (76/768)




            SDS                                                SDS Directive
                                                               (91/155; 2001/58)
           ProdInfo

                       European Association of Poisons Centres and Clinical Toxicologists
            Future (a Dutch perspective)

Present situation Preparationsdatabase

                                                               Dangerous Preparations Directive
                                                               (88/379 art.12; 1999/45 art. 17)

            comp.
                       pdf                                     Biocides Directive (98/8 art. 23)
                       pdf
             SDS




Sysdecos   KOS files                                           Cosmetics Directive (76/768)




                       European Association of Poisons Centres and Clinical Toxicologists
        Future (a Dutch perspective)

Future situation                  Mixtures database




       comp.
                   CLP.XML                                 CLP Regulation
                   pdf                                     (1272/2008)
         SDS
                                                           Notification of hazardous mixtures
                                                           incl. biocides
                                                           incl. plant protection products

                   CosmProd.XML
CPNP   datafiles
                                                           Cosmetics Regulation
                                                           (1223/2009)




                   European Association of Poisons Centres and Clinical Toxicologists
       Future (a Dutch perspective)

Future situation                  Mixtures database




                                                            Have good quality product
                                                            information available right at the
                  EUProdNot.XML                             doorstep of the poisons information
      datafiles                                             centre

                                                            Make use of one format/standard
                                                            for exchange of product information
                                                            within the EU for all products




                  European Association of Poisons Centres and Clinical Toxicologists
‘All for one, one for all’




   European Association of Poisons Centres and Clinical Toxicologists

								
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