European Chemicals Bureau Phases Out of Service

May 2, 2008 // Published as a news service by IHS

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The European Chemicals Bureau (ECB) recently celebrated 15 years of service, at the same time preparing to hand over operations to the newly created European Chemicals Agency (ECHA) on June 1, 2008.

Established in 1993 and employing around 60 people in 2007, the ECB has long carried out the scientific and technical work needed to implement European Union (EU) legislation related to chemicals.

The ECB has helped provide a high level of protection for workers, consumers and the environment through the identification of hazardous chemicals.

It has also contributed substantially to the new Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation, which entered into force on June 1, 2007. REACH aims to improve human health and the environment while strengthening the competitiveness of the chemicals industry.

The beginnings of the ECB
In 1990, the idea of the ECB began from the development of the European Inventory of Existing Commercial Substances, commonly known as the EINECS database. It was the success of the EINECS project that prompted what is now the EU's Environment Directorate-General to seek further support from the European Commission (EC) Joint Research Centre to implement the industrial chemicals legislation. As a result, the European Chemicals Bureau came into being in 1993.

The ECB in full operation
During the late 1990s, the ECB assumed an increasingly important role in the assessment and control of the risks posed by chemical substances. It has helped EU citizens in their daily lives, helping provide occupational, consumer and environmental protection against toxic chemicals.

During the 1990s, works areas for the ECB included:

• Classification and labelling of dangerous substances (directive 67/548/EEC).
• Testing methods (directive 67/548/EEC).
• Notification of new substances (directive 67/548/EEC) and their risk assessment (directive 93/67/EEC).
• Data collection and risk assessment of existing substances (EC regulation 793/93 and 1488/94).
• Export/import control of dangerous chemicals (EC regulation 2455/92 and subsequently EC regulation 304/2003).

In due course, two new areas of responsibility were added to the tasks of the ECB: the technical implementation of the biocidal products directive in 1998 and computational toxicology in 2001. The 2007 REACH legislation gave ECB another important task: development of guidance documents and tools in support of the new regulation.

In full operation, the ECB coordinated the activities in its main areas, chairing more than 400 meetings with member states' competent authorities and other stakeholders, helping them reach consensus.

Classification and labelling
Classification is an important means to identify the intrinsic properties of dangerous chemicals and the subsequent measures for control. It is directly linked to labelling, which is one of the key ways to communicate information on hazards. The ECB's work has been essential to the scientific and technical preparation of the EC's proposals to update the list of dangerous substances for which harmonised classification and labelling have been agreed upon at the European Community level, as well as updating the classification criteria.

The official inventory of classification and labelling for hazardous substances with toxicological and eco-toxicological potential currently lists about 3,400 entries, corresponding to around 7,900 substances.

Existing chemicals
An important area of the ECB's work has been data collection, priority setting, risk assessment and risk reduction for chemicals on the market before 1981 (known as "existing chemicals"). Substances on a priority list are required to undergo an in-depth risk assessment. To assist risk assessment, a guide was developed in consultation with industry and stakeholders. This document is complemented by the EUSES (European Union System for Evaluation of Substances) decision support software.

New substances
With the directive on the notification of "new substances," i.e., chemical substances introduced to the EU industrial market after September 1981, a new notification scheme assessing premarketing hazards for novel substances was introduced. The scheme required collection of notification dossiers for new chemicals, and conformity control and logging of their summaries in the new chemicals database.

The database currently registers about 8,000 notifications, representing about 6,000 substances. The ECB has managed the notification scheme since April 1995, and it ensures conformity control of files. In total, it receives, processes and exports about 400 to 500 notifications per year.

Coordination of standard testing methods
Another significant area of work is coordination of standard testing methods in which the ECB acts as the central input source for the EC in the OECD Test Guideline Programme. The list of standard test methods, which comprises detailed protocols for physico-chemical properties, toxicity and eco-toxicity, today includes almost 100 methods.

Import and export information exchange of dangerous chemicals
The EDEXIM database listing notifications on the international trade of dangerous chemicals within the EU member states, third countries and the United Nations contains details on 400 import and 5,500 export notifications.

Towards REACH and IUCLID 5
Following research by the ECB and discussions between the EC, the European Parliament and stakeholders, the EC proposal for a new chemicals regulation was released in 2000, and the REACH regulation entered into force on June 1, 2007. It provides for a coherent legislation, replacing about 40 pieces of existing legal text.

The overall objective of REACH is to improve human health and the environment, while strengthening the competitiveness of the chemicals industry. It also aims to improve communication and risk management in the entire chemical supply chain, and to replace particularly dangerous chemical substances with safer alternatives. In the past five years, the ECB has worked towards implementing online management and archiving of relevant material for REACH.

International Uniform Chemicals Information Database (IUCLID) 5 is the software tool used to gather data and prepare dossiers for the new European Chemicals Agency. It is a global standard application that was developed by the EC in close cooperation with the chemicals industry and member states. The application is available to download for free via the ECB web site. At the beginning of 2008, the IUCLID web site had 8,400 registered users and the IUCLID 5 software had been downloaded around 6,900 times from worldwide users.

Further information
For more information, see the ECB web site, the IUCLID web site and the ECHA web site.

Source: European Commission.