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EU Notification Scheme (New Substances) and New Chemicals Database ECB INFODAYS, Zagreb, 11-13 December 2006 Sharon Munn, European Commission DG JRC, European Chemicals Bureau.

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slide1

EU Notification Scheme (New Substances)

and New Chemicals Database

ECB INFODAYS, Zagreb, 11-13 December 2006

Sharon Munn, European Commission DG JRC,

European Chemicals Bureau

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide2

ECB principal role: Coordination of EU competent authorities: implementation of industrial chemicals legislation, eg:

    • Risk Assessment of HPV Existing Chemicals.
    • Notification scheme for New Chemicals.
    • Classification & Labelling of hazardous chemicals.
    • Legislative standardisation of Test Methods.
  • ECB is host to various databases on chemicals, in particular:
  • Annex I (Directive 67/548/EEC): Official EU C&L inventory.
  • IUCLID 4 database: Existing (EINECS) Chemicals.
  • New Chemicals Database: Notified (ELINCS) Chemicals.

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide3

Existing Chemicals – IUCLID 4 Database

  • Existing Substances: EU market, 1971 to 1981,
    • i.e., reported for EINECS inventory.
  • ECB Database: IUCLID 4, published on CD-ROM (dated year 2000),
    • data extract for ~2600 HPVCs (original industry data),
    • including substances prioritised for risk assessment.
  • Data Quality: Heterogenous (multiple sources, data ranges, etc.),
    • company reports, literature references, etc.,
    • not systematically reviewed by regulators.
  • Substances: Relatively common industrial chemicals.
  • IUCLID 4 as a data source:
    • Advantage: data access not restricted.
    • Disadvantage: data quality not guaranteed.

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide4

ECB New Chemicals Database (NCD)

  • New Substances: EU market since 18th Sept 1981,
    • i.e., not reported for EINECS inventory.
  • Notification scheme for new substances,
    • operative since 1983.
  • Managed via NCD: ~7000 notifications, >4500 substances.
  • Notifs registered as SNIF files: Summary info, including:

Origin, Use, Tonnage, ID, PhysChem., Tox., Eco-Tox., C&L.

In practice:

  • Notifier (manufacturer, importer): full dossier to CA in relevant MS,
    • incl. comprehensive test reports (on paper).
  • Notifier also prepares SNIF file (electronic summary),
    • checked by CA, forwarded to ECB, loaded into NCD.
  • ECB conformity check (incl. EC number): distributes file to all CAs.
  • 200-300 substances registered per year.

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide5

New Substance Notification

Industry

notification dossier

National

Competent Authority

ECB - Ispra

New Chemicals Database

Distribution to

25 Member States

+ Norway & Iceland

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide6

SNIF files registered in NCD

  • High Quality: conform to official methods & standards
    • (GLP, Annex V, OECD protocols).
  • Structured Format: independent of references, glossaries, etc.
    • (uniform reporting, units, etc.).
  • Regulator Review: approved by all CAs
    • (formal classification & labelling).
  • NCD as a data source
    • Advantage: data quality guaranteed.
    • Disadvantages:

Unpublished substance IDs confidential,

    • limited access (generally) to individually linked substance data,
      • property rights issue.
    • limited regulatory interest (public health/environmental conservation)
      • client-oriented market (with specific end-uses),
      • emerging technologies (with competitive replacement).

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide7

Full notification:  1 - 10 t/a or  50 t cumulative

Annex VII A: “Base-set”

Reduced notifications:

Annex VII C:  0.01 - 0.1 t/a or  0.5 t cumulative

Annex VII B:  0.1 - 1 t/a or  5 t cumulative

Level 1 (optional):  10 - 100 t/a or  50 t cumulative

Level 1 (compulsory):  100 - 1000 t/a or  500 t cumulative

Level 2:  1000 or  5000 t cumulative

Annex VIII

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide8

Eco-toxicological studies

according to volume

additional studies

birds

bioaccumulation

prolonged fish

earthworms

higher plants

Daphnia, 21-days

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

1000 t/a

bioaccumulation

prolonged fish

earthworms

higher plants

Daphnia, 21-days

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

10 / 100

algal growth

acute Daphnia

acute fish

bacterial inhibition

adsorption/desorption

biodegradation

1

none

0.01

biodegradation

0.1

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide17

Annual submission of notifications

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide18

Cummulative notifications per EU member state

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide19

Origin of notified substances

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide20

Industry sector distribution of notified substances

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide21

Functional use distribution of notified substances

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide22

Market tonnage distribution of notified substances

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide25

Directive 93/67/EEC defines principles for risk assessment

(human health and environment) of notified substances

Four conclusions:

(i)Substance is of no immediate concern

(ii) Substance is of concern, requiring further information at next threshold production volume

(iii) Substance is of concern, requiring further information immediately

(iv) Substance is of concern, requiring immediate risk reduction measures

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

slide28

Risk reduction measures:

  • Modifications to the classification and labelling
  • Modifications to the Safety Data Sheet according Directive 91/155/EEC
  • Modifications to the recommended methods and precautions or emergency measures
  • Advice to the relevant control authorities to consider appropriate measures
  • Voluntary agreement of the notifier to withdraw the substance from the market
  • Restrictions of marketing and use (Directive 76/769/EEC) total ban, ban with exemptions, restrictions for certain uses only

ECB INFODAYS, Zagreb, Croatia, 11-13 December 2006

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