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Chemical substances, risk assessment

Objective

Specific Objectives

New chemicals policy: In September 2001, the fact-finding stage in for the new chemicals policy as suggested in the White Paper started. To support DG ENV and DG ENTR, the ECB will participate in different working groups on Classification and labelling including the voluntary industry list, substances in products, the information to the supply chain, testing, evaluation and registration of chemicals, the risk assessment and finally restriction and authorisation. On request, the ECB will prepare thought starters and documents on technical details as well as documents on the experience with the current scheme.

In a later stage in 2002 and 2003, the ECB will support the drafting of the future legislation on dangerous substances.

Specific Objectives and Deliverables in 2002:

The ECB will maintain the activities within the different Directives and Regulations on dangerous substances. It should be noted that most of the tasks of the ECB are permanent and therefore not subject to changes, e.g. the notification process as the core unit between 15 Member States and Norway on approx. 350 new substances per year. The following list tables only the changes or additional activities within the tasks.

Classification and Labelling: Final discussion on and establishment of lists of approx. 400 substances of classified and labelled substances for the 29th and 30th Adaptation to the technical process of Annex I of the Directive 67/548/EEC and establishment of the consolidated version of Annex VI of the Directive.

New Chemicals: Preparation of a list of 2496 substances to be published as the 6th ELINCS list on new chemicals.

Testing Methods: Final discussion and establishment of +/- 11 Testing methods on physico-chemical, toxicological and ecotoxicological properties for the 29th and 30th Adaptation to the technical progress (see above).

Existing substances: further increase of the number of risk assessment reports on dangerous substances to be agreed and to be published on the WEB. Further tasks: The incorporation of the rules of the revised Technical Guidance Documents (TGD) into the EUSES programme and the creation of UICLID CD-ROM 2002 (the 3rd version of the IUCLID CD-ROM).

Biocides: Check and storage in a database of approx. 550 notifications on biocidal substances between March and summer 2002. Handling of approx. 10 000 identifications on biocidal substances (information on placing on the market). Creation of a legal list of active biocidal substances, creation of a legal list of notified existing active biocidal substances.
Planned Deliverables

All deliverables go to DG ENV and DG ENTR.

Summary of deliverables made by: 31/12/2001
The following list highlights only changes / improvements beside the permanent work:

Publication of the 28th ATP including testing methods, Classification and Labelling of new and existing substances (DG ENV responsible, ECB for the technical/scientific part), publication of the 5th ELINCS list, finalisation of numerous risk assessment reports on existing substances, finalisation of the negotiations on the update of several Technical Guidance Documents, publication of numerous National Profiles on the WEB within the Capacity Building network programme in co-operation with UN organisations, first version of a IUCLID - biocides database established;
Distribution of an updated version of the New Chemicals Database (NCD) to the Authorities of the Member States.

Output Indicators and Impact

The impact on the chemical industry and importers of chemicals is fundamental, as they have to follow the legislation, which is to be decided by Council but based on the technical work of the ECB.
Summary of the project

JRC will carry out the scientific and technical part of the Commission's duties related to the implementation and updating of directives and regulations concerning dangerous chemicals, biocides, plant protection products and related environmental effects, and the export notification process. Work will involve proposals for the classification and labelling of dangerous substances, the notification process of new substances, proposals for risk assessment and the publication of ELINCS (list of new substances). The project will manage ring tests and validation studies for new testing methods and will represent the Commission at the OECD meetings for testing methods; new methods for efficacy testing of active substances (biocides) will be developed and the physico-chemicals, toxicological and ecotoxicological properties of biocides will be studies with a view to prepare a priority list for risk assessment. As regards existing substances the emphasis will continue on the international harmonisation of data collection, criteria for priority setting and new risk assessment methodologies.

Rationale

The Unit carries out the technical and scientific part of the duties of the European Commission mainly related to the Directive 67/548/EEC, 93/69/EEC, 96/56/EC and 97/57/EC (dangerous Substances) and 98/8/EC (Biocides) and the Regulations 2455/92, 793/93 and 484/94.

Funding Scheme

JRC - Joint Research Centre research

Coordinator

Institute for Health and Consumer Protection
Address

Ispra
Italy