Notification of New Substances Regulations

HS(G)117 Making sense of NONS - a guide to the Notification of New Substances Regulations 1993... 

Where necessary the manufacturer must carry out, or arrange for, safety testing. Many countries operate mandatory premanufacturing and premarketing notification schemes of which safety testing is the cornerstone. Within the European Community under Directive 67/548/EEC and its sixth amendment 79/831/EEC, Competent Authorities must be notified before new substances are supplied in the marketplace. In the UK this Directive is enacted by the Notification of New Substances Regulations 1993 (NONS). Exempt are ... 

In 1979, a directive (79/831/EEC EEC, 1979) established for what was then the European Community (EC) a notification scheme for new substances, which are defined as chemicals not on the EC market between January 1971 and September 1981. Before placing a new substance on the market, the manufacturer or importer must notify it in the appropriate member state. Notification involves, among other things, provision of a technical dossier describing various toxicological tests conducted using the substance, and a classification proposal based on the hazards identified by those tests. In the UK, the directive is implemented by the Notification of New Substances Regulations 1993 (HSE, 1993). 

Principles of good laboratory practice Notification of New Substances Regulations (1982) (in support of SI 1982 No.1496)... 

COP 22 Classification and labelling of substances dangerous for supply. Notification of New Substances Regulations 1982. Classification, Packaging and Labelling of Dangerous Substances Regulations 1984. (1988)... 

Where no hazard data are available for a new substance and it is not possible to estimate its characteristics from substances of similar molecular structure, that substance must be treated as toxic until proved otherwise. Before new substances are put on the market, they must be notified under the Notification of New Substances Regulations 1993 (NONS) with its supporting guide and some may need to be notified under the Chemical Weapons Act 1996 °. The purpose of NONS is to ensure that adequate technical information is available on new substances before they are put on the market so that suitable precautionary measures can be developed to protect employees, the public and the environment from possible ill effects. NONS support an EU-wide system of notification of new substances. 

To most practitioners who work in the day to day issues of environmental control these uncertainties are irrelevant. The decision on what constitutes an acceptable level of control for a particular substance or agent has already been made by national or international bodies. The daily task in practice is to manage the consequences. However, for some areas of activity the fact of data uncertainty is of very real concern. In the chemical business, for example, researchers develop new chemicals which have to be tested to demonstrate the point at which toxic effects occiu (most chemicals are toxic at some dose rate). Once a toxic effect is observed the precautionary principle can be applied so that environmental concentrations are 10 times to 100 times below the known effect level. This becomes the predicted no-effect concentration (PNEC). The more toxic a chemical appears, the more sensitive the species upon which the tests are performed before the precautionary principle is applied. The Notification of New Substances Regulations, dealt with in another chapter, enshrines this process in law. 

Notification of New Substances Regulations 1993 822,869 Offices, Shops and Railway Premises Act 1963 37 Offshore (Electricity and Noise) Regulations 1997 746 Offshore Safety Act 1992 56... 

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