Notification of New Chemical Substances

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. 

The core of the new EU scheme to control chemicals is REACH Registration, Evaluation and Authorisation of Chemicals (32, 93). REACH will place a duty on companies that manufacture, import and use chemicals in the EU to assess the risks arising from their use, which will often require safety testing, and manage any risks identified. 

The REACH scheme has been controversial, with many suggested changes and improvements, but it now seems certain that it will come into force the best estimate is sometime in 2007 (63,118). Industry has been concerned about the practicalities of the scheme, for example it will often be difficult to find out the necessary but commercially sensitive details of downstream use. Industry is also concerned about the costs of compliance, not only for testing, but also in-house management and administration and scientific and regulatory advice and consultancy. Nevertheless, some of the earlier impact assessments probably over-estimated the costs, because 

2 Current EU Chemical Control Legislation for New and Existing Chemicals 

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). 

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Notification of new chemical substances in the USA under the Toxic Substances Control Act (TSCA) [13] differs from other notification schemes based on the OECD MPD, in that a Premanufacture Notice (PMN) can be submitted inoMparating only the existing data on the substance. However, the EPA can require studies to be conducted if necessary for adequate evaluation of the safety of the substance. 

The Austrian Chemicals Law of 1987, which does not apply to H oducts regulated by other legislation, requires notification of new chemical substances, and regulations implementing this were issued in 1989. The notification system is similar to the former Sixth Amendment EC scheme of Council Directive 79/831/EEC. [22]. In due course the Austrian notification scheme will in principle become harmonized with the updated Seventh Amendment EC scheme of Council Directive 92/32/EEC [12], because Austria is one of the 6 EFTA countries participating in the agreement with the EC to form the EEA. 

There is no scheme for notification of new chemical substances, and no fcxmal registration requirements for wood preservatives, surface biocides and anti-fouling paints, although some of these chemicals may be banned w have their use restricted on an ad hoc basis. 

Studies for notification of new chemical substances are to be conducted to OECD guidelines or their equivalent. They must be conducted by a laboratory whose practices are consistent with the principles of OECD GLP, and Canadian GLP is to be developed. Pre-notification consultations with Environment Canada may be useful, to establish whether specific existing non-standard or non-GLP studies are acceptable, if surrogate data (/e, SAR, QSAR or other calculation methods) would be adequate instead of actual tests, or if requests for waivers for specific data requirements will be likely to be accepted. 

Chemical regulations in Switzerland are the responsibility of two institutions the Swiss Federal Office of Public Health, Bundesamt fiir Gesundheitswesen (BAG), and the Swiss Agency for the Environment, Forests and Landscape, BUWAL (Bundesamt fur Umwelt, Wald und Landschaft). Although the requirements for the notification of new chemical substances are very similar to those of the EU, there are some specific features [34]. Any manufacturer or importer of a chemical substance has to perform an environmental compatibility assessment as part of a self-control according to the Ordinance on Substances [35]. This is not just for notified substances it includes all products. 

The European Inventory of Existing Commercial Chemical Substances (EINECS) consists of substances on the market in the European Community between 1971 and 1981.19 These substances may be imported or manufactured without further notification. The list of 100,106 substances was published in 1990, and the contents are fixed. All chemicals that will be marketed after the September 18,1981 are not placed on the EINECS. These chemicals have to be notified before they will be placed on the market according to the sixth Amendment of Directive 67/548/EEC, Directive 79/831/EEC. Once assessed, these new chemicals are listed on the European List of New Chemical Substances (ELINCS).20 These substances must be notified by each new importer/manufacturer (although sometimes reduced notification packages may be accepted if the substance has already... 

The MPD is tecommended by the OECD for adequate hazard assessment of new chemical substances. Full notification for supply in the EC at 1 tonne a (or S tonnes cumulative) under the Seventh Amendment Council Directive 92/32/EEC [12], Note that a screening test for toxicity to reproduction will ako be required as part of the Base Set when a snitaUe method has been developed. 

Manufacturers and importers of new chemical substances are required to follow premanufacture notification procedures before manufacturing or importing those new chemicals. ... 

A major responsibility of the Office of Pollution Prevention and Toxics is the implementation of the Toxic Substances Control Act (TSCA) (7). Central to TSCA is section 5, which requires manufacturers to submit premanufacture notifications (PMNs) to EPA before they begin manufacture of new chemical substances. Under section 5, EPA may limit or ban the production of a new chemical substance that may present an unreasonable risk to human health or the environment. 

Premanufacture Notification (PMN) 40 CFR 720 Premanufacture notification (PMN) for chemical not on TSCA Inventory Requires notification of EPA before manufacture or import of new chemical substance... 

The Provisions provided for the authorities to review each dossier for administrative and technical content and then to approve or reject the notification. The technical assessment followed the protocol in Guidance for the Hazard Assessment of New Chemical Substances (HJ/T 154-2004), which reportedly resulted in a new chemical being classified according to four health hazard levels (low to extremely high) and five environmental hazard levels (nonhazardous to extremely high), with each evaluation based on the toxicity of the substance and potential exposure. Technical reviewers made four types of recommendations based on this assessment ... 

The MEP accepted 217 Normal Notifications for new chemicals under the Provisions on Environmental Administration of New Chemical Substances between 2004 and 2010, and 148 Typical Notifications under the Provisions from 2011 to 2013 in addition, nearly 11,000 Simple Notifications have been accepted between 2011 and 2013. 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

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. 

The Toxic Substances Control Act (TSCA) refers to "new chemicals" as those not on the TSCA Inventory of Chemical Substances which lists about 55,000 existing commercial chemicals. All new chemicals must enter EPA s premanufacture notification program (PMN) for review before manufacture. This program is the most complete record of development of new chemicals by U.S. industry over the past 2 1/2 years. To date over 1,000 notices have been submitted, many including confidential business information (CBI). Despite the CBI, it is possible to summarize EPA s experience with new chemical substances and to evaluate the PMN program and its impact on product innovation. That is essentially the aim of this paper. 

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. 

Premanufacture Notification - The Toxics Act requires chemical manufacturers to give EPA 90 days notice before commencing commercial production on any new chemical substance. Through premanufacture notification, the Agency is charged with the responsibility of regulating unreasonable risks from these new chemicals before they occur. 

SARs have been used for decades by medicinal chemists in the design of highly efficacious drug substances [47] and by the US Environmental Protection Agency (EPA) for assessing the toxicity of new, untested commercial chemicals prior to commercialization [i.e., chemicals submitted to the EPA in the form of Premanufacture Notifications (PMNs)] [48]. However, despite the structure-activity data available for many classes of commercial chemical substances, the use of SARs has been given much less attention by chemists as a rational approach for designing new, less toxic, commercial chemical substances. 

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. 

The Chemical Substances Control Law was established in 1973 in order to introduce a prior examination system of chemical substances in Japan ahead of any other countries in the world. Subsequently, the United States established the Toxic Substances Control Act (TSCA) in 1977 to introduce a prior examination system similar to that of Japan. The EEC also introduced in 1979 a notification system for new chemical substances by the Directive 79/831/EEC, the 6th amendment to the Directive 67/548/EEC on Dangerous Substances , and the Directive came into force in all Member States on 18 September 1981. 

Such a new substance is subjected to a biodegradation test before notification. If the substance is biodegradable, it is notified to the competent authority (the Ministry of Economy, Trade and Industry) with the test results and necessary documents without carrying out additional safety evaluation. If there is no problem, the substance is registered as a new chemical substance approximately 3 months after notification. There is neither a duty to report the manufactured and/or imported amount of the substance nor regulation on the use, etc. of the substance and, therefore, it can be freely manufactured, imported or used as a non-regulated substance. 

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