Existing chemicals regulation

In the 1980s, increased concern regarding the effects of chemicals led to an amendment to the European Commission classification and labelling Directive 67/548 that requires risk assessments of substances on the EU market. Previously, classification and labelling were based on existing data sets available to a company or in the literature, or voluntary testing of chemicals by companies. 

By 2006, only 72 existing substances had completed the risk assessment process under Regulation 793/93 compared with about 4,300 that have been notified with test data as new substances [47]. This does not imply that these substances are not regulated or that no data are available. Companies are required to classify all chemicals on the market based on available data [169]. This includes reviewing references available in academic articles and epidemiological studies. To assist companies in this task, an international chemical database was set up by the OECD that is frequently updated by regulators and companies across the world [166]. 

No official Limited data Base set Level 1 Level 2 

28 Base-set level testing is the minimum data set that the current Existing Substances Regulation 793/93/EEC requires to carry out an assessment of risk to human health and the environment for a substance. Regulation 793/93/EEC will be replaced by REACH. 

The combined cost of conforming to regulatory requirements can result in significant expenditure for companies producing, supplying or using any substance classified as dangerous . 

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The EU Existing Chemicals Regulation (ECR) (390) applied to all EU manufacturers or importers of existing chemical substances listed in EINECS. Each manufacturer or importer had to report the administrative and technical information and the available data on hazardous properties for substances supplied at above 1000 tonnes per annum dining the period 23 March 1990 to 23 March 1994. Only administrative and technical information had to be reported for substances supplied at 10 to 1,000 tonnes per annum The information has been collated into a EU database, and anon-confidential version is available called the International Uniform Chemicals Information Database (a.4). 

ECR Existing Chemicals Regulation PBT Persistent, bioaccumulative and toxic... 

The SCHER Opinion was considered, but the risk assessment was not changed and finalized under the old existing chemicals regulation before June 1, 2008, when this regulation was superseded by REACH. For TCPP, TDCP, TCEP, and V-6, SCHER is not finished. 

While the level of data on existing substances and the application of substitution provide contentious topics for public debate, a major failure of existing chemicals regulation is the poor use and communication of existing hazard information. Surprisingly, this gains relatively little attention from politicians, media, research or the public. 

EUCLID is operated by the European Chemicals Bureau which, in turn is part of the EC Joint Research Centre s Environmental Institute. This newly-established database will receive, process and store all the data submitted by industry in accordance with existing Chemicals Regulations. The Bureau will use data in EUCLID to harmonise procedures for priority setting and risk assessment of existing chemicals. From 1994 the Bureau will also... 

The program was codified under the EU Existing Chemicals Regulation, which covered all European Inventory of Existing Chemical Substances (ElNECS)-listed existing substances manufactured or imported at >10 t/annum. The available test data have been reported for 1408 substances supplied at >1000 t/annum. Of these, only 110 have been selected so far for complete testing and risk assessment. 

The LD q for sodium bromide taken orally by rats is 3.5 g/kg body weight, and the TD q orally in rats is 720 mg/kg (8). RTECS Hsts data on reproductive effects in male and female rats. Sodium bromide is Hsted in the TSCA Inventory, the Canadian Domestic Substances Hst (DSL), the European Inventory of Existing Commercial Chemical Substances (EINECS), the Japanese Existing and New Chemical Substances (ENCS), and the Korean Existing Chemicals Hst (ECL). It is not regulated by the U.S. Department of Transportation. 

An overview is provided of ongoing risk assessments on halogenated phosphate ester flame retardants in Europe. On the basis of the so-called second and fourth Priority lists on Existing Chemicals (Council Regulation No793/93) three chlorinated phosphate ester flame retardants are selected. The selection is based on their hazard profile, volume and use pattern. The three substances involved are TCPP, TDCP and TCEP (Antiblaze V6 from Albemarle is also involved but, due to confidentiality, is not discussed. An outline is provided from a European point of view on topics such as methodology of risk analyses, data-gaps and worst case approach, industry involvement, downstream participation and possible impact of final report on industry. 2 refs. 

Under the Existing Substances Regulation, which was passed in 1993, individual member states are allocated substances for which they are responsible for the risk assessment. To date, three priority fists for assessment have been drawn up, which cover just over 100 chemicals. Following the conclusion of four risk assessments, the European Commission has recently issued a recommendation on the results on the risk evaluation and on the risk reduction strategies for the following substances 2-(2-butoxyethoxy) ethanol 2-,(-methoxyethoxy) ethanol alkanes, C10-13, chloro and benzene, C 10-13-alkyl derivatives. For two of the substances, 2-(2-butoxyethoxy) ethanol and 2-(2-methoxyethoxy) ethanol it is concluded that there is a need for specific measures to limit the risks to workers... 

Second, EPA could issue rules under S 8(a) to require periodic reports concerning the commercial development of certain new substances once they enter production. Unlike SNUR s, S 8(a) requirements would not prevent companies from continuing their production and marketing activities. Rather, EPA would review information contained in the 8(a) reports, and then could pursue control actions under its other TSCA authorities for regulating existing chemicals (i.e. 4 test rules, or 6(a) "unreasonable risk" regulat ions). 

The goal of the Toxic Substances Control Act (TSCA) is to provide authority to regulate chemical substances which present an unreasonable risk of injury to health or the environment. An important feature of TSCA requires the administrator of the Environmental Protection Agency (EPA) to examine such data on existing chemicals and, when it is insufficient, to direct industry to conduct tests. 

The preventive nature of the Act, under which new as well as existing chemicals may be subject to regulation. 

Regulation of New As Well As Existing Chemicals. An evaluation of TSCA s impact would differ from that of most environmental statutes in that the former purports to regulate new as well as existing chemicals. The objective of the premanufacturing notification (PMN) system under section 5 is to permit EPA to make a reasoned evaluation of new chemicals ... 

Measurement or estimation of health impacts under TSCA would be premature, since relatively little has been done to regulate new or existing chemicals that could result in health benefits. The principal exception to this generalization is the ban on aerosol uses of CFCs, whose chronic effects on human health derive from their environmental impact rather than direct biological toxicity. Compared with other environmental laws, such as the Clean Air Act, the regulatory accomplishments of TSCA are somewhat insubstantial. 

The TSCA chemical substances inventory is a comprehensive list of the names of all existing chemical substances, and currently contains over 70,000 existing chemicals. Information in the inventory is updated every four years. A facility must submit a premanufacture notice (PMN) prior to manufacturing or importation for any chemical substances not on the list and not excluded by the TSCA. Examples of regulated chemicals include lubricants, paints, inks, fuels, plastics, and solvents. 

The cost of TSCA administration is high. Hundreds of people are now employed in the Office of Toxic Substances. Direct public and private costs total millions of dollars and there may be other indirect costs that cannot be estimated. Certainly some things could be done to get more for our money. The PMN system could be modified to spend less time on low-risk chemicals. The ability to regulate existing chemicals should be increased. Voluntary compliance by industry should be stressed because it is cheaper and more efficient, but this must obviously be backed up by the possibility of regulatory action by the government. 

The Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) regulations came into force on June 1, 2007. At that time, it was estimated that there were approximately 100,000 existing chemicals, of which approximately 30,000 were marketed in volumes at or above 1 tonne per year. For these 30,000 substances, a registration dossier must be submitted. The registration requirements depend on the tonnage thresholds, as follows ... 

EC (1996) Technical guidance document in support of the Commission directive 93/67EEC on risk assessment for new notified substances and Commission regulation 1488/94 EEC on risk assessment for existing chemicals. Brussels, European Commission. 

Assessments of risks are, of course, only as good as the information on which they are based. For new substances, information had to be supplied before a chemical could be marketed. This was not the case for existing substances. Under the Existing Substances Regulation (Regulation (EEC) 793/93) manufacturers or importers of more than 10 tonnes per year of a substance listed in the inventory had to supply information on that substance to the European Commission, and as the amount they manufacture or import increased so did the data requirements. Manufacturers and importers had to make all reasonable efforts to obtain data... 

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