Publication Date : 2008
1,113 Visited Entry Date : 2013/04/13


Document type Report
Subject Regulatory & Legal Aspect
This Commission staff working document provides a description of elements of selected EU legislation that seems most relevant and likely to apply to nanotechnologies and nanomaterials. It served as a basis for the conclusions presented in the Commission Communication on Regulatory Aspects of Nanotechnologies.
It is not intended to provide a detailed and full description of all directives and regulations that might be applicable, but to highlight some main features, illustrating how provisions apply to nanomaterials. In further work based on the Commission’s Communication, it can be used in addition to detailed analyses of potential regulatory gaps have been or will be made available by various Member States.
This document also indicates research needs in the field of environment, health and safety, referred to in the Commission Communication.
Finally, this document summarizes main action undertaken to bridge the knowledge gap in relation to legislation and implementation, reference to which is made in the Communication.
1. Chemicals
1.1. REACH     
1.2. Existing Regulation     

2. Worker Protection

3. Products
3.1. Plant Protection Products     
3.2. Biocides     
3.3. New Approach Legislation     
3.4. Cosmetic Products     
3.5. Aerosol Dispensers     
3.6. Medicinal Products     
3.7. Cars     
3.8. Food Legislation     
3.8.1. General Food Law          
3.8.2. Novel Food          
3.8.3. Food contact materials          
3.8.4. Food additives          
3.8.5. Food supplements          
3.8.6. Feed legislation          
3.9. Consumer products not covered by specific regulation     

4. Environmental legislation
4.1. Integrated Pollution Prevention and Control (IPPC)     
4.2. Major-accidents, Seveso II Directive     
4.3. Water     
4.4. Waste     
4.5. Air quality      
4.6. Soil      
4.7. Environmental liability     

Research needed to support legislative work in the field of environment, health and safety

1. Measurement methods, reference materials and materials characterisation

2. Test methods for human health, safety and environment and reference materials

3. Exposure information throughout the life cycle of nanomaterials

4. Risk assessment methods

5. Risk Management

6. Networking and infrastructure aspects

Addressing the knowledge gap
1. International cooperation at the level of OECD
1.1. Testing Methods and Risk Assessment     
1.2. Information Sharing, Co-operation and Dissemination     

2. Standardisation at the international and European level
3. Eu scientific committees with regard to risk assessment
4. The European Food Safety Authority
5. Ethical considerations with regard to nanomedecine

6. Joint Research Centre of the European Commission

7. Study on socio-economic factors
8. Sixth and Seventh Framework Programmes for Research and Technological Development

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