On 1 September 2013, the Biocidal Product Regulation (BPR, Reg. EU 528/2012) (1) entered into force repealing and replacing the Biocidal Product Directive 98/8/EC (2). The BPR introduces in Europe novel concepts which already impact the industry even more than Directive 98/8/EC. In the BPR, regulators have placed specific obligations for the suppliers of nanomaterials with biocidal properties. The provisions involve not only those who produce and deal with products containing nanomaterials, but also those who manufacture and sell active substances in their nano-form. Rules are therefore in place; however industry faces difficulties in fulfilling the requirements because there is still lack of scientific knowledge. As a consequence, allocating a budget for regulatory compliance is a complex exercise which companies should take into consideration to secure their product portfolio.

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Implications of the nanomaterial provisions of the BPR on industry

corresponding

GABRIELE DE PAOLI
Physical Chemistry and Analytical Methods Department
GAB Consulting GmbH
Heinrich-Fuchs-Str. 94, 69126 Heidelberg, Germany

Abstract

On 1 September 2013, the Biocidal Product Regulation (BPR, Reg. EU 528/2012) (1) entered into force repealing and replacing the Biocidal Product Directive 98/8/EC (2). The BPR introduces in Europe novel concepts which already impact the industry even more than Directive 98/8/EC. In the BPR, regulators have placed specific obligations for the suppliers of nanomaterials with biocidal properties. The provisions involve not only those who produce and deal with products containing nanomaterials, but also those who manufacture and sell active substances in their nano-form. Rules are therefore in place; however industry faces difficulties in fulfilling the requirements because there is still lack of scientific knowledge. As a consequence, allocating a budget for regulatory compliance is a complex exercise which companies should take into consideration to secure their product portfolio.


 

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