Firstly, it is a legal requirement of the supplier of a New Substance to make a notification according to the Seventh Amendment of the Dangerous Substances Directive (92/32/EEC).
Secondly, the supplier of a New Substance is obliged to make sure that the there is information to enable risks to people, the public at large and the environment to be at a minimum. The review of the data included in a notification ensures that the substance is labelled for supply, and that there is sufficient information to take appropriate measures to reduce risks during use and disposal.
Finally, there are numerous benefits, both practical and financial, to prospective suppliers of chemicals upon a European wide scale. A substance that has been accepted for supply in any of the member states of the scheme is in principle treated as notified in all of them.
In the context of the Notification of New Substances regulations, a new substance is one that does not appear on the EINECS inventory. The one exception to this is for polymers. Polymers composed entirely of EINECS listed monomers are exempt from notification. (For further details concerning the Notification of Polymers go to: Notification of Polymers.
A notification is required when a new substance is placed on the market. This means supplying a substance or preparation, or making it available to another person within the European Union and includes importation.
The notification scheme has a system whereby the charge levied and the content of the test package is in proportion to the level of supply. This reduces both animal testing and the costs to notifiers, who may be in the early stages of marketing a substance. The notification levels are set out in the table below.
| Type of Notification | Annual Quantity | Cumulative Quantity |
|---|---|---|
| Level 2 (1000 t) | ≥ 1000 t | ≥ 5000 t |
| Level 1 (100 t) | ≥ 100 t | ≥ 500 t |
| Level 1 (10 t) | ≥ 10 t | ≥ 50 t |
| VII A | ≥ 1 t | ≥ 5 t |
| VII B | ≥ 100 kg and < 1 t | ≥ 500 kg |
| VII C | ≥ 10 kg and < 100 kg | < 500 kg |
Once supply has breached either the upper limit of the annual supply tonnage or the cumulative supply tonnage of the band, then the notification must be upgraded to the next level and provide the extra data. For more information on data requirements go to: Data Requirements for Each Level. There is no requirement for the notifier to pass through levels VIIC/VIIB/VIIA in turn. A notification can be made initially at any of these levels. For the higher tonnage bands (≥10 tonnes/annum) each level must be passed through sequentially and a VIIA data package must be in place.
A 'new substance' must be notified by whoever places the substance on the market.
The cost of notifying a substance is proportional to the notification level; i.e. a VIIA costs more than a VIIB, which costs more than a VIIC. These costs cover the appraisal of the notification package. An additional fee can be made for conducting the Risk Assessment. However, companies who provide an adequate Risk Assessment are not charged. At Levels 1 and 2, additional charges are made. For a full list of charges, go to: NONS Charges.
The charges do not cover the cost of testing and the responsibility for testing the substance lies with the notifier. These can be conducted by commercial test houses or within the company. All tests must be conducted to Good Laboratory Practice (GLP).
NOTIFICATION OF NEW SUBSTANCES
SUBMISSION OF DOSSIERS AND PAYMENT OF FEES
The following procedure must be followed when submitting notifications. HSE will not accept any responsibility for delays in processing notifications if the new procedure is not followed fully.
1. NOTIFICATION DOSSIERS
Dossiers must be submitted to:-
The Office Manager
Industrial Chemicals Unit (NONS)
Health & Safety Executive
Room 1.3 Redgrave Court
Merton Road
Bootle
Merseyside
L20 7HS
UK
Telephone number: 0151 951 3295
Fax number: 0151 951 4889
2. PAYMENT OF FEES
HSE will accept payment by one of two methods, cheque or payment via a Bankers Automated Clearance (BACS) system.
Cheques - should be submitted with the notification dossier.
BACS payments - should be credited to:-
Health and Safety Executive
Sort Code 40-12-26
A/c 41453505
HSBC Bank PLC
197 Stanley Road, Bootle
Merseyside L20 3DX
3. REMITTANCE ADVICE NOTES
Remittance advice notes must be submitted for all notifications paid for via a BACS system. They should be sent to:-
Miss Sue Thomas
Health and Safety Executive
FOS Cash and Sales
6.4 Redgrave Court
Merton Road
Bootle
Merseyside L20 7HS
IT IS ESSENTIAL THAT A REMITTANCE NOTE IS SUBMITTED AND CONTAINS FULL DETAILS OF THE SUBSTANCE(S) THAT IT RELATES TO.
4. FURTHER INFORMATION
If you require any further information or advice please contact the Office Manager at the address shown in 1 above