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On November 23, 2011, the European Union (EU) Council's committee of the permanent representatives of each member state (COREPER) approved the compromise agreement on the proposed EU biocidal products regulation that would repeal and replace the biocidal products Directive 98/8/EC. Under the compromise reached by the EU Council and the European Parliament (EP), biocides would be reviewed regularly, with approvals or renewals valid for a maximum of ten years, and less for 'problematic' substances. The proposed legislation states that there is 'scientific uncertainty' about the safety of nanomaterials, and 'to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.' The proposed legislation calls on the European Commission (EC) to 'regularly review the provisions on nanomaterials in the light of scientific progress.'
The proposed legislation incorporates the EC's recent recommendation on the definition of a nanomaterial, stating:
'nanomaterial' means a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm;
Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
For the purposes of the definition of nanomaterial, 'particle', 'agglomerate' and 'aggregate' are defined as follows:
'particle' means a minute piece of matter with defined physical boundaries;
'agglomerate' means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components; [and]
'aggregate' means a particle comprising of strongly bound or fused particles.
The EC would have the authority to determine, at the request of a member state, whether a substance is a nanomaterial. It would also have the authority to adopt delegated acts to adapt the definition of nanomaterial 'in view of technical and scientific progress and taking into account the Commission Recommendation.' Under the proposed legislation, where nanomaterials are used in a product, the risk to the environment and to health must be assessed separately. Labels would be required to include the name of all nanomaterials contained in biocidal products, followed by the word 'nano' in brackets. Every five years, member states would be required to submit to the EC a report on the implementation of the biocides regulation in their respective territories. The report must address several topics, including information on the use of nanomaterials in biocidal products and the potential risks.
Both the EU Council and the EP must approve the proposed legislation. The EP is scheduled to vote on the proposed legislation in January 2012.
About The Acta Group, L.L.C. and The Acta Group EU, Ltd
Consulting firms established to control the spiraling costs and inefficiencies encountered by clients seeking approvals to market chemicals, biocides, products of biotechnology and nanotechnology, and medical device products. The Acta Group and The Acta Group EU, Ltd manage products from concept to approval, utilizing the skills and experience of professionals who have worked in the specific product areas in government and industry.
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