Notification of New Substances

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. 

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 ... 

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. 

At the same time, however, development of a new apphcation or new formulation of preparations on the basis of the available inventory of substances are important examples of innovation with a high added value in the chemical industry. In this irrstance many SMEs are active in developing new recipes or in adapting existing ones to specific customer reqrrirements. This means that the abihty to be irmovative in the domain of chemicals cannot be illustrated solely by the number of newly registered substances. Or to say it in another way sim-plify ing notification of New Substances is not the sole and maybe not even the essential factor for the ability to be irmovative. 

In the EU and several other countries the legislation regulates the notification of new substances, classification, packaging, labeling and possible prohibition of dangerous substances, the safety of the work place, and the use of chemicals for more sensitive purposes, such as in foodstuffs, drugs, cosmetics, and consumer goods. 

Mixtures or solutions composed of two or more substances The making available of the substance to third parties Notification of New Substances European Inventory of Existing Chemical Substances European List of Notified Chemical Substances Premanufacturing notification (USA)... 

Enacting part of the UK competent authority, on behalf of DEFRA and together with the Health and Safety Executive (HSE), for the notification of new substances and undertaking environmental risk assessments on existing substances. 

Manufacture and use of chemicals is nowadays tightly regulated around the globe and not limited to the industrialized countries. Prior to marketing every producer or importer has to comply with a general chemical regulation that asks either for a notification of new substances and/or products or compliance with existing chemicals inventories, e.g., in EU [8], the USA [9], Japan [10], Canada [11], Australia... 

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). 

Since its original introduction, amendments have expanded and updated the provisions of the Directive. Procedures for notification of new substances were introduced with the 6th Amendment to the Directive in 1979. In order to define new substances , it was necessary to establish an inventory of chemicals then on the Community market. EINECS, the European Inventory of Existing Commercial Substances, was compiled as of 18th September 1981. New chemicals, notified within the European Community after that date, are added to the European List of Notified (New) Chemical Substances (ELINCS). 

Council Directive 79/831/EEC [22] (which is the Sixth Amendment of Council Directive 67/348/EEC) requires pre-marketing notification of new substances, and classification, packaging and labelling according to the degree of hazard. Thus sufficient information on new substances is available to enable the hazard to be assessed and any necessary control measures to be taken. The EC notification scheme has been updated by Council Directive 92/32/EEC [12] (ie, the Seventh Amendment of Council Directive 67/548/EEC), which is to be brought into force by 31 October 1993, and hence the revised scheme is discussed. 

A harmonised system of limited notification of new substances for supply in the EC at below 1 tonne a has rqrlaced the Sixth Amendment system of national Limited Announcements . As with a Base Set notification for supply of a substance in the EC at 1 tonne a and above, a limited notification permits the notifier to supply the substance in all EC Member States without multiple regulatory submissions. The studies required for limited notification depend on whether the substance is to be supplied at a 100 kg a (or 500 kg cumulative) threshold, as shown in Table 34.6. The waiting pmod is 30 d after submission of satisfactory documents, or 15 d after official acceptance of the limited notification by the authorities if no additional information is required. 

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. 

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