New Substances
New substances notification is an international
procedure, which is in use, for example, in the
In
The purpose of notifying a new substance is to
obtain information about an unknown chemical compound before releasing it to
the market for commercial use. In the notification information is given about
the substance’s health and environment hazards or other dangerous properties
such as flammability or explosivity. For each
substance, a risk assessment is prepared to estimate the potential health,
environmental or consumer risks arising from the dangerous properties of the
substance. This information helps to determine the conditions of acceptable use
of the substance. Moreover, using the information obtained from the
notification dossier, the substance can be classified according to its inherent
dangerous properties and packed safely with appropriate warning labels. The
dossier also forms a basis for drafting a correct safety data sheet,
which purpose is to give workers additional information about safe use and
handling of the substance.
The new substance notifications are submitted to
the competent authority, which in
Notifying a new substance
According to the paragraph 20 of the Chemicals Act
744/1989, amendment 1147/1994, a manufacturer or his representative has to
notify a new substance to STTV before it is placed on the market.
Substances, which are placed on the market within the European Community after
What substance should be notified?
A substance is subject to notification if:
·
It is placed on the EEA –market
(European Community member states +
·
It is not on the European Inventory
of Existing Commercial Chemical Substances and
·
It is not covered by one of the
exemptions granted (see Council Directive 92/32/EEC, art. 13).
Example:
a notification is not necessary for a substance manufactured in the EU if
exported and marketed solely in
Who is responsible for submitting
the notification?
A manufacturer operating within the EEA submits
the notification to the Competent Authority in the country where he is
manufacturing the new substance. If the new substance is manufactured outside
the EEA the notification is done in the country where the importer is located.
A manufacturer outside the EEA can name an importer in the EEA as his sole
representative whose location dictates the country of notification. A sole
representative may represent other importers within the EEA. This can be
indicated in the notification by submitting a list of companies, which the sole
representative represents.
What information needs to be
submitted?
The information to be provided depends upon the
amounts which will be marketed annually across EEA .
If the amount is less than 1000 kg/a a reduced notification
is submitted . When the yearly amount reaches
A full notification includes (list not
complete):
A technical dossier describing the intrinsic properties of the substance and supplying the information necessary for evaluating the foreseeable risks. It includes among others:
·
Identity of the substance (name,
formula, spectral data, impurities, etc.)
·
Information on the substance
(production, uses, precautionary and emergency measures, packaging, etc)
·
Appropriately conducted studies to
assess the physico-chemical properties of the
substance (melting/boiling point, vapour pressure, flammability, etc.)
·
Appropriately conducted studies to
assess the dangerous properties of the substance (toxicological and ecotoxicological studies)
·
Documentation on the possibility of
rendering the substance harmless (for industry, recycling, destruction, etc.)
·
Identity of the notifier
·
A proposal for classification and
labelling of the substance
·
For substances classified as
dangerous, a proposal for a safety data sheet
A more complete explanation of the necessary
studies can be found in the Annexes VII and VIII of the Council Directive
92/32/EEC.
Notifiers
of new substances will be required to pay a fee for the notifications. The fees
payable are noted in the Decree 498/2000 by the Ministry of Social Affairs and
Health.
Treatment of the notification
STTV will check the contents of the new
substance notification and that the submitted notification dossier complies
with the Regulations. STTV will ask the Finnish Environment Institute’s opinion
concerning the environmental effects of the substance.
On the receipt of a full notification, the
competent authority will, within 60 days inform the notifier
in writing whether the submitted information is considered sufficient. In case
of a reduced notification, the notifier will be
informed within 30 days.
In the case of a full notification,
the substance can be placed on the market 60 days after the day
when the notifier has received acknowledgement from
STTV that the notification complies with the Regulations. In the case of a reduced
notification, the time is 30 days. The "clock"
starts when STTV has informed the notifier that the
notification contains the required information.
If the notifier has
not received a response from the competent authority within the implied time,
the substance can be placed on the market 60 days (full notification) or 30
days (reduced notification) after the date of notification submission.
Contact persons:
Annette
Ekman
Tel: +358-9-3967 2771
Marko Kuittinen
Tel: +358-9-3967 2764
10.12.2003