|June 5, 2012|
Previously published on June 1, 2012
The new Biocidal Products Regulation (BPR) (PE-CONS 3/12), adopted by the Council of the European Union on 10 May 2012, and entering into force on 1 September 2013 contains several provisions for the forced substitution of hazardous biocides with so-called "lower risk" substances.
Under the BPR active substances displaying certain serious hazard characteristics (carcinogens, mutagens, reproductive toxicants, PBTs and vPvBs, and endocrine disruptors) generally will not be approved for use in biocidal products except in special cases where approval is: (1) justified because of negligible risk from exposure to the substance; (2) essential to prevent or control a serious danger to health or the environment; or (3) necessary to prevent disproportionate negative societal impact in comparison to risk. When deciding whether to grant a special exception the availability of alternatives is taken into account. Approvals under these special cases are limited to a maximum period of seven years.
For active substances that have a lesser, but still serious, hazard characteristic (i.e., respiratory sensitizers, persistent or bioaccumulative chemicals, etc.) approval is still possible, but such substances will be considered "candidates for substitution." A comparative assessment against alternatives is required in the case of biocidal products containing "candidates for substitution." Any approval is for a limited period and subject to restrictions to minimize risk.
The approval of a biocidal product containing an active substance that is a candidate for substitution will not be granted where the comparative assessment demonstrates that
(a) for the uses specified in the application, an alternative exists which presents a significantly lower overall risk, is sufficiently effective and presents no other significant economic or practical disadvantages; and
(b) pest resistance problems can be minimized.
A biocidal product containing an active substance that is a candidate for substitution may be authorized for a period of up to four years without a comparative assessment in exceptional cases where it is first necessary to acquire real-world experience on the use of the product in order to conduct the assessment.