European dangerous substances directive

The 28 Adaptation to Technical Progress in relation to the European Dangerous Substances Directive (67/548/EEC), has now classified CIT/MIT in any preparation equal to or greater than 15 parts per million to be a sensitiser. Since many formulations will require more than 15 ppm of CIT/MIT, it will make it more difficult to use this chemistry (and not put hazard labels arising from CIT/MIT use) and achieve technical success. 

In the European Union, coal-derived complex chemical substances, ie, those contained in the European Inventory of Existing Commercial Chemical Substances, have been classified for carcinogenicity in the twenty-first adaptation to technical progress of the European Commission (EC) Dangerous Substances Directive 1994 67/548/EEC (57). The EC Regulation 793/93 requires data sets to be submitted by producers or importers to the... 

The European Community s Dangerous Substances Directive, DSD (67/548/EEC), was originally adopted in 1967. It regulates the classification, packaging and labelling of dangerous substances. Up until Spring 1992, six amendments have been adopted. A proposed seventh amendment appeared in February 1990, but it was not until April 1992 that it was finally adopted. The major differences between the requirements of the current directive and those which will apply once the seventh amendment is implemented are outlined. 

In 1979 the sixth amendment to the dangerous substances directive (79/831/ EEC) introduced a notification system for new substances and made provision for the publication of an inventory of existing substances, the latter being those substances on the European market by 18 September 1981. The European Inventory of Existing Commercial Substances (EINECS) was published in 1990 and lists 100,106 substances (SLIM, 1999). A decade later some 30,000 or so of these substances were thought to be marketed in volumes of above 1 tonne per year, these accounting for more than 99 per cent of the total volume of all substances on the EU market (CEC, 2001, p6). 

The types of harm that chemicals have the capacity to cause (in other words their hazards) are qualitatively different and not commensurate with each other. At one extreme are effects that require reasonably high concentrations of the substance, are immediate and localized (for example flammability, explosivity, corrosiveness and acute toxicity). The causal relationship between a particular chemical exposure and such effects is usually obvious, or at least easy to demonstrate. Those affected generally include those who deal directly with the chemical and it is often possible to handle and store the chemical in such a way that harm is avoided. The existing European Union (EU) regulatory system, dating from the 1967 dangerous substances directive (Council Directive 67/548/EEC) was clearly set up with... 

Over a period of 20 years, CESIO [1] has conducted reviews of the toxicological data available on marketed surfactants in order to provide guidance to its member companies on classification and labelling in accordance with European legislation and, initially, the requirements of Annex VI of the Fifth Adaptation to Technical Progress [2] of the Dangerous Substances Directive. The first review was carried out in 1984 [3] and the second several years later, being completed in 1990 [4]. Recommendations were made based on data available at that time on acute oral toxicity, skin and eye irritation and skin sensitisation studies. 

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. 

Key European Directive Release Controls Dangerous Substances Directive (76/464/EEC) and amendments (1997) The Directive establishes a system for controlling releases of dangerous substances to water through the setting of environmental quality standards for certain substances included in a list of daughter directives. 

As we mentioned in the previous chapter, its approach used a codification system (Risk Phrases) that was based on toxicological evidence of harm arising from exposure to substances. Criteria for codification were set out in Annex VI to the Dangerous Substances Directive (67/548/EEC) as amended by its Seventh Amendment (92/32/EEC). Annex I to the Dangerous Substances Directive included risk phrases (R-phrases) for all substances with an agreed hazard classification in the EU. This information was reproduced in the UK in the Approved Classification and Labelling Guide (Third Ed.) whilst specific substances and their R-phrases were listed in the Approved Supply List. If any substance supplied to a workplace within the European Community was not listed in Annex I to the Directive, the supplier was required to consider whether a hazard classification was appropriate and if so, based on the classification criteria, apply the appropriate R-phrases as well as other information. 

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... 

Substances have to be checked to determine whether they are listed in annex I of the Dangerous Substance Directive 67/54 /EEC [4-1]. Classification and labeling are obligatory and are not allowed to change. If new information becomes available which could change the classification and labeling, the European Chemical Bureau (ECB) has to be immediately provided with all the important data (for details see Section 4.4). 

The formulation of water quality standards is an extremely sensitive area of pollution control. It is one in which there is a tendency for political decisions to hold almost as much weight as scientific judgements. The approach to standard setting varies from one country to another and this has led to innumerable problems, particularly when international co-operation is required. This is well illustrated by the years of argument and discussion which have arisen in an attempt to reach agreement over the European Economic Communities (EEC) Dangerous Substances Directive and the Directive on Quality of Water for Human Consumption. 

The proposed restriction on 1,4-dichlorobenzene (1,4-DCB) illustrates the process. Concerns over the potential toxicity of this compound first surfaced under the Dangerous Substances Directive. The European Commission subsequently assessed the risks from exposure to 1,4-EXZB under the Existing Substances Regulation, beginning in the mid-1990s. 

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