Existing substances

Existing substances are substances deemed to be on the EU Market between 1 January 1971 and 18 September 1981 and listed in EINECS, the European INventory of Existing Commercial Chemical Substances (EU 2006j, ECB 2006). The substances placed on the market for the first time after this target date are new (Section 2.4.1.5). 

EINECS is a closed list containing 100,106 entries and counts for about 99% of the chemicals volume on the market. EINECS include chemical substances produced from natural products by chemical modifications or purification, such as metals, minerals, cement, refined oil, and gas substances produced from animals and plants active substances of pesticides, medicaments, fertilizers, and cosmetic products food additives a few natural polymers and some waste and by-products. They can be mixtures of different chemicals occurring namrally or as an unintentional result of the production process. 

Existing substances do not include Synthetic polymers (which are registered in EINECS under their building block monomers) medical, cosmetic, and pesticide preparations as intentional mixtures food feedstuffs alloys, such as stainless steel (but individual components of alloys are included) and most naturally occurring raw materials, including coal and most ores. 

Chemical substances are treated differently in the Community, depending on when they were introduced on the market. In contrast to new substances (Section 2.4.1.5), there are at present no routine testing requirements for existing substances. 

According to the ESR (EEC 1993a), evaluation and control of the risks posed by existing substances is carried out in four steps (i) data collection, (ii) priority setting, (iii) risk assessment, and (iv) risk reduction. 

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The Standard-Setting Process. Settiag USP-NF standards is a continuing, and by no means unilateral, process. The Committee of Revision not only develops monographs for new substances but also continually reviews the monographs, specifications, and testing methods for existing substances. Results are pubHshed in one or more supplements each year. A complete review is done every five years and a revision is pubHshed. 

EEC on the placing of plant protection products on the market 793/93 Regulation on the evaluation of existing substances... 

Technical Guidance Document in Support of the Commission Directive 93/67/EEC on Risk. Assessment for New Notified Substances and the Commission Regulation (EC) 1488/94 on Risk Assessment for Existing Substances, European Commission, 1996. 

Promotes pollution prevention, the use of safer chemicals through regulatory and vohmtaiy efforts, risk reduction so as to minimize exposure to existing substances such as lead, asbestos, dioxin, and polychlorinated biphenyls, promotes the public understanding of risks by providing understandable, accessible and complete information on chemical risks. 

Whilst, in general terms, industry is in agreement with the objectives of the White Paper there is disagreement over implementation. The main concerns of industry centre on the cost, timescale and increased use of animals for the testing of existing substances, many of which have been used for 30 years or more without any obvious problems. Satisfactory resolution of the issues could have a significant impact on the future direction of the European chemical industry. 

Priority Lists, Risk Assessment process and tracking system in relation to Council Regulation (EEC) 793/93 also known as Existing Substances Regulation (ESR). 

Health Canada Proposal for Priority Setting for Existing Substances on the Domestic Substances List under the Canadian Environmental Protection Act, 1999 Greatest Potential for Human Exposure. This report describes a proposed priority setting process of existing substances in Canada. A stakeholder meeting was convened to discuss the Complex Exposure Model (comET). 

Most of the provisions of the Toxic Substances Control Act (TSCA) of 1976 (PL 94-469) rely in some way on risk assessment of chemicals. Under the reporting requirements of the statute, any manufacturer, processor, or distributor of a chemical for commercial purposes must inform the EPA immediately after discovering any information which "reasonably supports the conclusion" that a chemical substance or mixture "presents a substantial risk of injury to health or to the environment" unless the EPA Administrator has been adequately informed already. EPA is mandated to establish regulations for testing new or existing substances when it is determined that there is not enough health or environmental information, that testing is necessary to develop such information and that the chemical or mixture "may present an unreasonable risk of injury to health or the environment."... 

The European Union System for the Evaluation of Substances (EUSES) [8] is the software provided by European Chemical Bureau (ECB) to implement the EU Technical Guidance Documents on Risk Assessment for new notified substances, existing substances, and biocides [3]. The development of EUSES 2.1 was commissioned by the European Commission to the National Institute of Public Health and the Environment (RIVM) of the Netherlands. The work was supervised by an EU working group comprised of representatives of the JRC-European Chemicals Bureau, EU Member States, and the European chemical industry. 

Institute for Health and Consumer Protection (2003) Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC on risk assessment for new notified substances Commission Regulation (EC) No 1488/94 on risk assessment for existing substances Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market... 

For regional scale, EUSES, a European Union multimedia environmental model for risk assessment of new and existing substances was applied considering the region where the e-waste recycling sites are. 

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. 

On 13 February 2001 the European Commission adopted the much-discussed White Paper Strategy for a Future Chemicals Policy (a. 10). The current EU chemical control measures were considered to result in too great a disparity between new and existing substances, with the high cost of new substance notification stifling innovation. Furthermore, although existing substances account for >99% by volume of chemicals in commerce, they were considered to be relatively poorly assessed and controlled in comparison with new substances. 

Phase-in for existing substances (from date Regulation in force) ... 

The first step is to identify existing substances, or particular uses of substances, that require authorisation, then to decide on deadlines for authorisation and any uses exempted from authorisation. As additional very high concern substances are identified, largely from testing for registration and evaluation, they will be fed into the authorisation system. 

In practice there will often be old studies or published papers that can provide adequate information to assess the properties of phase in existing substances. The US Environmental Protection Agency (EPA) has issued useful guidance on searching for literature data (a. 15). 

A CSR is a risk assessment, following the general provisions of Annex I of the proposed REACH Regulation, with extra guidance in Annex IB for substances that are components of preparations. These general principles correspond with the current EU practice for notified new substances and priority existing substances, as described more fully in Section 14. The ECA will develop software to help registrants prepare the CSR. It is essential to have input from downstream users to prepare the risk assessment for the CSR, which... 

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... 

Details of the regulation are given including systematic data reporting and establishment of lists of priority substances, risk evaluation, list of existing substances produced or imported within the Community in quantities exceeding 1,000 tonnes per year, and list of substances exempt from the provisions of Articles 3 and 4. 

Aside from the actions already initiated by EPA under Section 6 to restrict exposures to polychlorinated biphenyls and to chlorofluorocarbons in certain uses, no other actions have been taken against specific chemical substances, nor has an imminent hazard been identified for appropriate action. Less than a dozen proposed orders have been issued under Section 5(e) requesting further information to assess the risks of as many new substances. Perhaps 80 informal requests for further information on such substances have been made and satisfied voluntarily. Testing programs for a substantial number of existing substances have been started and more are planned. In addition, of course, the monumental task of creating an inventory of some 55,000 existing chemicals was completed. 

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

There are considerable resources being devoted to the testing of existing substances throughout the world. This testing is being concentrated on those substances which would be expected to pose risk to health or the environment. 

A conflict clearly exists between permanent confidentiality, available under the system of U.S. laws, and the eventual disclosure of identities of specialized chemical substances which had heretofore been undisclosed, but which are now affected by EINECS or by EEC s premarketing notification system. The rules are different the assumptions regarding disclosure are different. Perhaps the best solution a lawyer could offer is that member states should be willing to adjudicate individual cases of specific confidentiality needs. Inventories of existing substances are rules, adopted prospectively to announce to the world both the existence of a material and its regulatory status. Those rules can operate to accommodate both public and private needs. 

We have a U.S. sytem which could satisfactorily resolve the conflict. I propose that we take the approach of permitting confidentiality claims for the identity of an existing substance, if they can be justified to the national authority, such as a ministry of the environment, which will consider whether confidentiality reasons are sufficient to merit excepting that item from inventory requirements. 

This chapter uses the formal EU risk assessment methodology laid down in the European Commission Regulation (1488/94) and follows closely the principles of the technical Guidance Document [1] of the Existing Substances Regulation (793/93). 

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