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 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.
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 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.
New Substance Notification
Industry
notification dossier
National
Competent Authority
ECB - Ispra
New Chemicals Database
Distribution to
25 Member States
+ Norway & Iceland
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).
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
Eco-toxicological studies
according to volume
none
0.01
biodegradatio
n
0.1
bioaccumulation
prolonged fish
earthworms
higher plants
Daphnia, 21-days
algal growth
algal growth
acute Daphnia
acute Daphnia
acute fish
acute fish
bacterial inhibition
bacterial inhibition
adsorption/desorption adsorption/desorption
biodegradation
biodegradation
additional studies
birds
bioaccumulation
prolonged fish
earthworms
higher plants
Daphnia, 21-days
algal growth
acute Daphnia
acute fish
bacterial inhibition
adsorption/desorption
biodegradation
1
1000
10 / 100
t/a
Annual submission of notifications
Cummulative notifications per EU member state
Origin of notified substances
Industry sector distribution of notified substances
Functional use distribution of notified substances
Market tonnage distribution of notified substances
Classification status of New Substances registered in
NCD (Sept 2004): all notification levels (Total: 3920)
1200
31%
classified
n.c.
2720
69%
Progress/Status of Classified New Substances registered in
NCD (Sept 2004)
[Annex VIIA & VIII notifications (>1 t/a) only (Total 2020)]
Classified in
NCD (awaiting
discussion) 540
(27%)
In discussion
(including ~30
CMRs recently
prioritised from
NCD screening)
80 (4%)
Official C&L
(Annex I entries)
1055 (52%)
Proposed for
30th ATP
(including 16
CMRs) 345
(17%)
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
Cumulative Risk Assessments
since adoption of 7th amendment
1000
900
800
700
600
500
400
300
200
100
0
932
Notifications
Risk Assessments
665
256
305335
224
172 171 153
159
89
83
44 32 21 51 75
UK DE FR NL
IT
BE
IE
6
45 24 21 15
6
3
0
2
ES SE AT NO
FI
81
DK PT
Overall conclusion of the risk assessment
conclusion iii)
14%
conclusion ii)
20%
conclusion iv)
10%
Risk reduction
conclusion i)
56%
No concern
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