European Chemicals Bureau - guide
01 May 2008by eub2 -- last modified 02 May 2008
On 29 April 2008, the European Chemicals Bureau (ECB) at the European Commission's Joint Research Centre celebrated 15 years of contributing to a high level of protection for workers, consumers and the environment through the identification of dangerous chemicals. The ECB has contributed substantially to the new chemicals regulation, REACH, which entered into force on 1st June 2007, which aims to improve human health and the environment while strengthening the competitiveness of the chemicals industry. The ECB officially hands over its experience to the newly created European Chemicals Agency (ECHA) in Helsinki on 1st June 2008.
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Established in 1993, and employing around 60 people in 2007, the European Chemicals Bureau has carried out the scientific and technical work needed to implement EU legislation related to chemicals.
Towards the Bureau: the beginnings
In 1990, the establishment of ECB arose 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 which prompted DG XI (now DG Environment) to seek further support from the JRC to implement the industrial chemicals legislation. As a result, the European Chemicals Bureau came into being in 1993.
The Bureau 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 life, contributing to providing occupational, consumer and environmental protection against toxic chemicals.
At that time, the areas of work of 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 (Regulation (EC) 793/93 and 1488/94)
- Export/Import control of dangerous chemicals (Regulation (EC) 2455/92 and subsequently Regulation (EC) 304/2003)
In due course, two new areas of responsibility were added to the tasks of the Bureau: the technical implementation of the Biocidal Products Directive in 1998, and computational toxicology in 2001. Finally, the new REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation gave ECB another important task: development of guidance documents and tools in support of the REACH 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, and helping reaching consensus, counting a network of 3000 participants.
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 Commission's proposals to update the list of dangerous substances for which harmonised classification and labelling have been agreed at 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 3400 entries, corresponding to around 7900 substances.
"Existing chemicals"
An important area of the ECB's work is 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 pre-marketing hazards for novel substances was introduced. The scheme required collection of notification dossiers for new chemicals, and conformity control and logging of their summaries (SNIFs) in the New Chemicals Database. The database currently registers about 8000 notifications, representing about 6000 substances. The ECB has managed the notification scheme since April 1995, and it ensures conformity control of all SNIF files. In total, it receives, processes and exports about 400-500 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 Commission 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 5500 export notifications.
Towards REACH and IUCLID 5
Following research by the ECB and discussions between the Commission, the European Parliament, and stakeholders, the Commission proposal for a new chemicals regulation was released in 2000, and the "REACH" regulation entered into force on 1st June 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.
The ECB has in the past five years worked towards implementing online management and archiving of relevant material for REACH. IUCLID (International Uniform Chemicals Information Database) 5 is the software tool used to gather data and prepare dossiers for the new European Chemicals Agency. It is a global standard application which was developed by the Commission in close cooperation with the chemicals industry and Member States. The application is available to download for free via the ECB website. At the beginning of 2008, the IUCLID website had 8400 registered users and the IUCLID 5 software had been downloaded around 6900 times from worldwide users.