Bruxelles, 1 December 2003
Today, at the Commission's Joint Research Centre (JRC) in Ispra, Italy, EU Research Commissioner Philippe Busquin was joined by top European chemical experts to examine the scientific basis for the New Chemicals Policy of the EU and the JRC's work on the existing and proposed EU Chemicals Legislation.
The seminar was jointly organised with the Italian Presidency of the EU. Sound science and technical guidance are essential to effectively pave the way for the implementation of the new system for the Registration, Evaluation and Authorisation of Chemicals (REACH) (1) . This will allow Europe to gather the necessary knowledge on the toxicity of chemicals and their impact on human health and the environment, while introducing new and cost-effective testing methods. Ongoing EU research activities aim to reduce the need for animal testing of chemicals across Europe. They are phased in via effective partnerships with industry and national authorities. The cost of the implementation of REACH could be reduced by as much as €900 million through alternative methods, including in vitro tests and computer models of hazard assessment.
"The new EU chemicals policy aims to provide an effective instrument to policy-makers for making well-informed choices regarding the safe use of chemicals," said European Research Commissioner, Philippe Busquin. "We must make sure that REACH will actually provide the tools for the cost-effective protection of human health and the environment, while maintaining and even boosting the European industry's competitiveness. EU research will play a key role in this process, both in terms of chemical substances' innovation and in terms of finding appropriate modern alternative methods to time-consuming, expensive animal tests for the evaluation of chemicals' safety."
Networking scientific excellence
The Commission invited some of the world's leading experts in the assessment of chemicals to attend the workshop in Ispra. On this occasion, Commissioner Busquin and the President of the Region of Lombardy, Mr. Roberto Formigoni, were present at the signature of a Co-operation Agreement between Regione Lombardia and the JRC covering areas such as environment and health (2) .
REACH and EU research
The purpose of this new legislation is to better protect human health and the environment by reducing the risks related to chemicals. At the same time, it enhances the competitiveness and innovative capability of the EU chemicals industry. As a single EU regulatory system, it replaces over 40 EU directives and regulations and allows industry to market their products with a high quality image.
The proposed REACH system foresees the application of alternative methods to the testing of chemicals produced or imported in quantities above one tonne. The Commission advocates the use of non-animal testing methods, such as: (1) refined exposure information, (2) computer models, and (3) cell culture tests. These new risk assessment strategies are essential for the implementation of REACH and have the potential to significantly reduce the costs associated with it.
JRC support to the implementation of REACH
The JRC will help develop necessary guidance documents, software tools and infrastructure to support the implementation of REACH. Its expertise is based in particular on the support it has provided to Council Regulation EEC 793/93 (3) on data collection, priority setting and risk assessment of chemical substances.
The JRC has given technical and scientific input in the definition of the legislation since 2000. Its main contribution focused on the rules for handling substances of high concern such as persistent, biocumulative and toxic chemicals (PBTs) very persistent and very biocumulative ones (vPvB), and intermediates.
It has also been responsible for the development, introduction and adaptation to technical progress of harmonized testing methods of Annex V to Directive 67/548/EEC (4) for the determination of the intrinsic properties of chemical substances. These allow for the characterization of potential hazards for people and the environment. In the context of the implementation of REACH, it will contribute to the building of strategic partnerships between industry and authorities, thus enabling the transfer of responsibility from the authorities (under the current legislation) to industry (under REACH).
The European Chemicals Agency
Having carefully examined every aspect, the Commission concluded that the establishment of a separate Agency is essential for effective implementation of the proposed REACH system. The Commission is paving the way for proper enforcement of the legislation over the transition period leading to the creation of the new agency. To this end, the European Chemicals Bureau in the JRC will continue to give its scientific and technical support
More chemical experts needed
The need for sound science underpinning the implementation of REACH provides major new opportunities for European researchers. Of course, the need for more chemical testing once the REACH system is up and running will also increase the need for properly trained scientists in these methods. Young researchers now have the chance to respond to this career opportunity. Training in alternative methods can be further promoted by making the most of the JRC's in-house expertise and worldwide network.
For further information please visit:
European Centre for the Evaluation of Alternative Methods (ECVAM)
ECVAM Scientific Information Service
The European Chemical Bureau
Institute for Health and Consumer Protection
ANNEX
Background
The Commission proposed the REACH system to reduce risks to human health and the environment through broader identification of chemicals and increased testing. One of the prime objectives of REACH is to tackle the lack of publicly available data on the toxicity of chemicals. This hampers the advance of research and innovation. Under the new legislative framework, companies will be required to register all substances produced or imported in volumes above 1 tonne per year per manufacturer or importer.
The lack of proper data on chemicals raises the need for extensive testing, which, by using traditional risk assessment methods, could lead to an increase in animal testing. Alternative testing strategies therefore need to be developed. These include more sophisticated information on exposure, computer models, and in-vitro methods.
As chemicals represent a key industrial sector, the Italian Presidency of the EU has given priority to discussions on new chemicals legislation in the European Council, and it has included in this debate scientific and technical activities, such as the 1 December seminar in Ispra. This Seminar will help improve our knowledge of the various scientific and technical issues underpinning the new chemical legislation. This includes new analytical methods; the development of alternative methods to animal testing; and the development of public information systems to inform citizens about the properties and uses of existing substances.
Response to the research needs under the proposed REACH legislation
The JRC identifies an increasing use of computer-based estimation techniques, such as "(quantitative) structure-activity relationships" (Q)SARS (5) , for chemical safety assessment. Europe is presently lagging behind other countries such as the US and Canada that have extensively used these "in silico" methods for regulatory purposes. It is anticipated that these models will likely play an important role in the assessment of chemicals produced or imported in quantities between 1 and 10 tonnes, for which only minimal animal testing is foreseen.
Considerable savings (of the order of €900 million) could be made on direct testing costs, if (Q)SARS are applied (6) . The JRC recommends that current activities must be intensified in the coming years in the EU and the OECD, as well as in research and industry, on the development, validation and adoption of estimation techniques such as (Q)SAR methodologies and in vitro tests, if Europe is to meet the needs imposed by the REACH system.
Response to REACH - Exposure Assessment
The JRC has established close links with industry to work towards gathering data on human exposure to chemicals. This also allows for a more accurate evaluation of the overall risk for European citizens when exposed to chemicals from various sources (ingestion, inhalation, and skin contact).
Response to REACH - Validation of Alternative Methods
The JRC is developing estimation techniques that are useful for regulatory purposes, such as (Q)SARS. This involves the work of both the European Chemicals Bureau (ECB), the current focal point for collecting information on new and existing chemicals and the European Centre for the Validation of Alternative Methods (ECVAM). As part of the JRC the ECB and ECVAM are the cornerstones in the safety evaluation of chemicals at European level. In relation to the implementation of REACH, the JRC anticipates that about 50 (Q)SARs will need to be carefully assessed for their validity by 2006.
ECVAM was established in 1991. Since then, validation of alternative methods has been refined. 16 independent statements on the validity of alternatives have been published. Three of the methods have become OECD (Organisation for Economic Co-operation and Development) guidelines already. These are in vitro replacement methods (2 tests for skin corrosivity and 1 test for phototoxicity), which had undergone the full cycle of evaluation / pre-validation / validation, underlining the fact that the "in vivo" methods can be successfully replaced by validated "in vitro" methods. In response to REACH, ECVAM has focused on key areas directly targeting those animal tests that need to be replaced, and by involving regulators in the validation process already at an early stage. In several networks with academic partners, regulators and industry, the regulatory testing demands shall be met via the development of novel integrated testing strategies.
The large number of tests that will have to be conducted once the REACH system is implemented will require trained scientists in these methods. Therefore, ECVAM is implementing a new approach towards providing training for validated methods by e-learning, which will be conducted with web-based training tools.
The JRC has also enhanced efforts to make data on the safety of chemicals more readily accessible to the public. It has recently established the European Chemical Substances Information System (ESIS, http://ecb.jrc.it/ esis ), which, for the first time, offers a single search tool on chemicals and the legislation under which they are presently covered.
(1) Commission Proposal from 29 October 2003COM (2003) 644 final: Proposal for the Registration, Evalu a tion and Authorization and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) on Persistent Organic Pollutants.
(2) See JRC press release on 1.12.2003
(3) Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. Official journal NO. L 084, 05/04/1993 P. 0001 - 0075
(4) Council Directive 67/548/EEC of June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official journal NO. 196, 16/08/1967 P. 0001 - 0005
(5) A (Q)SAR is a mathematical model that relates a quantitative measure of chemical structure (e.g. a phy s icochemical property) to a physical property or to a biological effect .
(6) Pedersen, F.; de Bruin, J.; Munn, S.; Van Leeuwen, C.: "Assessment of Additional Testing Needs under REACH ", EUR Report 20863 EN, 2003