HSE Press Release C040:02 - 29 August 2002
An amendment to the Notification of New Substances Regulations 1993 which will save companies an estimated £1.7million is to come into force on September 17.
Known as NONS 2002, the amendments introduce a reduced test package (RTP) for chemical intermediates with low exposure to workers and the environment. This allows notifiers the possibility of submitting an RTP to HSE for a new chemical that is solely manufactured and consumed in a chemical reaction under strictly controlled conditions.
The change to NONS should reduce the overall costs of notification for intermediates -chemicals that are solely manufactured and consumed in a chemical reaction under strictly controlled conditions. It may also produce savings in terms of animal testing and the time needed to launch new chemicals. The RTP is a minimum data set designed to produce a preliminary risk assessment for any chemical intermediate.
HSE will accept an RTP providing the chemical manufacturer provides a satisfactory technical dossier detailing the information necessary to evaluate the foreseeable risk for man and the environment. Additional tests and studies may be required for intermediates in higher volumes.
Bob Warner of HSE said:
"This is an important change to the Notification of New Substances Regulations because it eases the requirements for some notifiers without jeopardising protection. It should be welcomed by those who have a stake in the innovative capacity of the chemical industry. The change flows from an EU agreement originally proposed by the UK."
The Notification of New Substances (Amendment) Regulations 2002 (NONS 2002), S.I.2002/2176 can be obtained from the Stationery Office
1. NONS 93 (SI 1993/3050) implements part of the Dangerous Substances Directive (DSD) 67/548/EEC. This is a 'single market' EC directive which aims to protect people and the environment from the effects of dangerous chemicals. One of its requirements is for new chemicals to be tested before they are marketed and for the results of the tests to be notified to Competent Authorities across the EC.
2. Following the EC agreement (in the form of Commission Directive 2000/21/EC) a change to the list of exemptions was made in order to avoid duplicate notification requirements resulting from the introduction of the Biocidal Products Directive 98/8/EC. In order to implement in full the changes HSC produced new Regulations, known as The Notification of New Substances (Amendment) Regulations 2001, which came into force by 1 April 2001.
DSD has recently been updated by Annexes 7A, 7B, 8A and 8B of Directive 2001/59/EC (adapting to technical progress for the 28th time Council Directive 67/548/EEC). These changes concern a reduced test package (RTP) for a chemical intermediate supplied for and consumed during a manufacturing process to produce the final product. Member States agreed that substances supplied and consumed in a chemical process which is strictly controlled and minimises exposure to man and the environment through rigorous containment should qualify for a RTP.
All enquiries from journalists should be directed to the HSE Press Office
Social media
Javascript is required to use HSE website social media functionality.
Follow HSE on Twitter:
Follow @H_S_E