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European Parliament drafts ‘Nanomaterials’ into Biocide Recast

Published: Wednesday 17 February 2010

The Committee on the Environment, Public Health and Food Safety (ENVI) of the European Parliament has written its ‘Draft Report on the proposal for a regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products’ (COM(2009/0076(COD)) – C7 0036 – 2009/0076(COD)) (Rapporteur: Christa Klaß), suggesting several amendments that specifcally mention ‘nanomaterials’:

Amendment 8; Proposal for a regulation: Recital 61 a (new)

(61a) The use of nanomaterials in biocidal products may increase with the further development of technology. In order 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 at international level. The Union should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly. At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the Scientific Committee for Consumer Safety (SCCS) should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials. The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.

 

Amendment 22; Proposal for a regulation: Article 3 - paragraph 1 - point u a (new)

          (ua) 'nanomaterial' means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain at least one of the following properties that are characteristic to the nanoscale:
          (i) properties related to the large specific surface area of the materials considered;
          (ii) specific physico-chemical properties that are different from those of the non-nanoform of the same material.
 

Amendment 44; Proposal for a regulation: Article 16 - paragraph 1 - point d a (new)

          (da) when using nanomaterials in biocidal products, the risk to the environment and to health has been reviewed separately.
Justification: Nanomaterials have different characteristics to the same substances in a non-nanomaterial form. The risks posed by biocides with nanomaterials must therefore be investigated separately.
 

Explanatory Statement:

Regarding the Environment: The authorisation rules laid down in the regulation should also make allowance for the further technical development of active substances, for example nanomaterials, the use of which is increasingly widespread. In order to guarantee a high standard of protection for the future as well as legal certainty for producers, therefore, the rapporteur considers that a uniform definition of nanomaterials should be formulated and that the text of the regulation should be regularly updated in the light of technical developments.
 

Follow these link to download the full Draft Report, or to access the relevant Procedure File.

 

Tags: European Commission, European Parliament, European Council, biocide, regulation, nanomaterial definition