Chemicals Sixth Amendment

In addition to these general exclusions, neither TSCA nor the Sixth Amendment require PMN s for new mixtures or preparations, which generally are defined as combinations of substances that do not result from chemical reactions. However, both laws effectively require PMN s for the marketing of new mixtures that are new (in part) because they contain new substances.(11)... 

Because the Sixth Amendment itself exempts most of the chemicals that are subject to EPA s current rulemaking, In general the Commission does not need to commence any exemption activities analogous to EPA s efforts. Thus, the EEC s premarket program covers only those new polymers that contain 2% or more of a monomer(s). (Any new monomer iis subject to the notification requirements.) Further, because PMN s must be submitted only for new substances that are "placed on the [Community] market," the EEC s PMN requirements generally do not apply to the manufacture and use of intermediates (or of any other new substances, for that matter) by one company at one site.(13)... 

TSCA and the Sixth Amendment are quite different in many important respects, and it would require some fundamental changes to standardize them or even make them consistent. However, because they deal in part with the same general subject matter — Industry notification and government review of new chemicals — and because they may lead to trade barriers and the inefficient use of scarce technical and scientific resources, it is useful to consider how they might be brought closer in line with one another. "Harmonization" is a term commonly applied to such efforts. 

First, to the extent that TSCA and the Sixth Amendment do not have the same general scope and coverage, this necessarily will mean that companies in some cases will face regulation of their (new) chemicals and commercial activities in one country(ies), but not in another, and vice versa. Almost by definition, this will create certain artificial competitive advantages and disadvantages for companies, depending upon at which end they lie in the trade of those particular chemicals. 

It is important to note the meaning of two terms used in connection with TSCA and the Sixth Amendment, because they often have different interpretations under the two laws. "Hazard" generally is used in the Sixth Amendment (and in other EEC directives) to mean what U.S. scientists and regulators often call "risk" — i.e. an assessment or evaluation that considers both the effects and exposures that are associated with particular substances. In this country, the term "hazard" usually refers to the inherent toxicity or effects of a substance, or to the unsafe characteristics of particular chemicals or products. The latter meaning is the one used... 

EINECS European Inventory of Existing Commercial Chemical Substances. This is the inventory of existing substances required by Article 13(1) of the Sixth Amendment. 

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... 

EEC (1979/1981) Sixth amendment to Directive 67/548/EEC, Official Journal of the European Communities, L259 (15 October 1979), 10-28 and 81/437/EEC, Commission Decision of 11 May 1981 laying down the criteria in accordance with which information relating to the inventory of chemical substances is supplied by the Member States to the Commission, LI 67 (24 June 1981), 31-38. 

To complete a registration, applicants must submit a voluminous dossier with technical data, ranging from the name of the substance to its physico-chemical properties and a base set of toxicity and eco-toxicity test results. While notifiers of new substances under the Sixth Amendment to Directive 67/548/EEC submitted this dossier to NRAs, new and existing substance producers and importers alike are now expected to report directly to ECHA. This shift deprives Member States of an early opportunity to communicate with the registrant and, where indicated, stage an early formal or informal intervention.22... 

However, none of these statutes were so directly focused on the chemical industry as the 1976 Toxic Substances Control Act (TSCA) in the United States and the Sixth Amendment to the Dangerous Substances Directive enacted by the European Parliament in 1979. These statutes did not focus on the industry s wastes, pollution or occupational exposures as much as on the intrinsic hazards - the toxicity, chemical stability, and bioavailability - of the industry s chemical products as they were used in commerce. These laws were intended to provide government agencies with the authority to collect relevant health and safety data on chemical products, require testing where data were missing, and condition and restrict the use of chemical substances so as to reduce unreasonable risks to the public and environment. 

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. 

An original proposal for a Norwegian notification scheme for new chemical substances was based on the Sixth Amendment EC scheme of Council Directive 79/831/EEC [22], with corresponding notification requirements and EINECS to define... 

In particular, the Toxic Substances Control Act (US EPA, 1978) in the U SA and the Sixth Amendment to the Directive on Dangerous Substances (EEC Council Directive, 1979) in Europe require the development of a basic set of information before a new chemical substance may be marketed. The required data set dealt with several characteristics of the substance (chemical structure, use patterns, physico-chemical properties, analytical methods, etc.) and includes toxicological and ecotoxicological tests at different levels of complexity in relation to the amount of the substance produced and the results at the preliminary levels (see Table 1). 

In the European Union (EU), Registration, Evaluation, Autorisation and Restriction of Chemicals (REACH) resolves the dilemma faced under the TSCA to some degree because there is no distinction between new and existing chemicals. Simultaneously, significant new nomenclature issues will undoubtedly surface. Under the Sixth Amendment to the Dangerous Substances Directive, the European Inventory of Existing Chemical Substances (EINECS) was established as the inventory of chemical substances that were manufactured in or imported into the EU at the time that it was established. EINECS consisted of those chemicals being in commerce in the... 

The Sixth Amendment distinguished between chemicals existing at the time it was implemented and new chemicals placed on the market after that time as described below. 

Article 13 of the Sixth Amendment simply required the authorities to inventory existing chemicals. Over a decade later, the assessment of those existing chemicals began with the promulgation of the Existing Substances Regulation. 

New chemicals had to be tested under the Sixth Amendment to Directive 67/548/EEC. The Sixth Amendment required the manufacturer or importer to submit a dossier containing these data to the member nation-state in which manufacture occurred or into which the substance was imported, and further required the competent authorities in that country to share the information with other member nation-states. 

The Sixth Amendment left the details of implementation to Member States. The way in which each Member State implemented the Directive reflected the regulatory milieu and social values of each country [89]. West Germany passed the Chemicals Act of 1980, and France, the Law on the Control of Chemicals, for example. Thus the implementation of the Sixth Amendment reflected a patchwork of country-specific requirements. 

Between 1981 and 2007 manufacturers and importers notified the competent authorities of over 5,000 new substances, which were listed on the European List of Notified Chemical Substances (ELINCS). The Sixth Amendment left it to the competent authorities to utilize the testing data to assess the potential risks from these new chemical substances. 

Notification under the Sixth Amendment (and related risk assessments under the Seventh Amendment as described above for Navy Blue) continued until 1 June 2008. On that date the notification scheme was revoked and replaced by Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ELINCS then contained 8,433 notifications, representing 5,292 substances in total [91]. 

The preceding discussion of the Sixth Amendment and the Existing Substances Regulation explains how, of the 105,398 new and existing chemical substances, competent authorities assessed the potential risks from exposure to each of 5,433 substances and ultimately restricted approximately 900 substances under the Limitations Directive. It also illustrates some of the concerns with the legislation that led to calls for reform, and ultimately to the implementation of REACH. 

The Sixth Amendment to the Dangerous Substances Directive required testing of new chemical substances and the exchange of information on new chemicals between nation-states. It did not require the testing of the approximately 100,000 substances already existing in 1981. 

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