Notification of Substances

The information required for a notification is the chemical identity, amount manufactured or imported, use, physico-chemical properties, ecotoxicity studies, available mutagenicity studies and animal toxicity, indir t long-term effects on humans and recommendations for disposal and labelling. The data requirements for the notification of new substances are based on the OECD MPD and arc very similar to those in the EC. The minimum information required is listed in Table 34.1. There are no official reduced data requirements for notification of substances to be supplied only in low amounts, although FOEFL will negotiate on a case-by-case basis for certain of the standard tests to be omitted, especially if the substance is to be used in special applications or has special disposal methods which minimise environmental contamination. Studies are to be conducted in compliance with GLP to OECD guidelines or their equivalent. 

The minimum base set for the notification of substances to be placed on the market in quantities of less than 100 kg but more than 10 kg per year per producer contains the following descriptions ... 

SI 1982/1357 The Notification of Installations Handling Hazardous Substances Regulations... 

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

Requirements for the notification of new substances, iiTespective of their potential for harm, before they can be placed on the market. Aim to ensure that a chemical placed on the market can be validly marketed m any EU state without duplicating authonzation. 

Shortly to be introduced is the need to obtain Hazardous Substances Consent under the Housing and Planning Act 1986 from the local authority for any site intended to hold 25 tons or more of LPG. This will be in addition to any requirement for planning consent and to the need to notify the HSE under the Notification of Installations Handling Hazardous Substances Regulations 1982. 

COP7 New substances Principles of good laboratory practice Notification of New Substances... 

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 ... 

Emergency notification of extremely hazardous substance release. A business that unintentionally releases a reportable quantity of an extremely hazardous substance must report that release to the state emergency planning commission and the local emergency planning commission. 

In the EU, the current chemical control measures, based on a network of legislation for hazard communication and safety assessment, are soon to be dramatically revised. To set the scene for this forthcoming fundamental change to chemical control in the EU, the key facets of the existing measures are described briefly i.e., notification of new chemical substances, the relatively-limited measures to evaluate existing substances and hazard communication. There have been problems with the current scheme, principally the disparity between the safety data on new and existing substances. 

Council Directive 92/32/EEC (392), the Seventh Amendment of the Dangerous Substances Directive (DSD) (391), Council Directive 67/548/EEC, requires pre-marketing notification of new chemical substances. Notification ensures that sufficient information is available on the hazardous properties of new substances for labelling and risk assessment (see Section 14) which will ensure the necessary control measures are in place (67). 

There are various exemptions and special cases for EU notification of new substances ... 

The Notification of New Substances scheme set out in Directive 92/32/EEC, which is designed to protect people and the environment from the possible harmful effects of new substances and to create a single market, is described. Methods for making notification easier, quicker and cheaper are considered. The determination of test requirements is discussed and the Read Across and Family Approach strategies for test reduction are outlined. 

Chemical manufacturers submitted 1,031 Premanufacture Notifications in 1980 and 1981. In the same time period, they submitted 290 notifications of commencement of commercial manufacture. In other words, only 28)1 of the substances for which Premanufacturing notices were filed in the past two years of compliance have become commercial. Specifically, for the reactive polymer segment, about 29% of the reported substances have become commercial. These percentages indicate that much of what has constituted the impacts of TSCA has been "protective" filing of notifications. The length and complexity of the process mandated by TSCA has led to unnecessary resource diversion. A more liberal definition of what constitutes a commercial event could have significantly increased the percentages and reduced this type of impact, at least since July, 1979. 

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