To clarify difficulties discovered in the original legislation
The European Chemicals Agency (ECHA) has announced that new reforms and guidance for the European Union’s (EU) new biocidal products regulation clarify difficulties discovered in the original legislation.
One amending regulation (334/2014) includes a new definition of biocidal product families, which sub-categorises products by risk and efficacy. It also confirms that new biocide-treated articles can be sold in the EU if an application for approval of an active substance or product type used is made by 1 September, 2016.
Another change clarifies how formulators of biocides using different active ingredients are covered by the new regulation, which has been in force since September 2013.
The reforms also extend the mandatory sharing of data on active substances under review in certain cases to include information on the overall environmental impact of chemicals.
In addition there will be clear data protection periods for information submitted about biocidal products under the regulation’s simplified authorisation system. And ECHA’s secretariat will now have an expanded role in supporting member states’ control and enforcement.
Meanwhile, another Commission regulation covers biocide authorisations granted through 'mutual recognition'. This deals with products first authorised by an EU member state, rather than a central EU authorisation, where another EU government approves a biocidal product by recognising an initial national authorisation. The new rules say how companies should apply for a renewal of such authorisations and how they should be assessed a by regulators, setting grace periods for sales of stocks of these biocidal products of no authorisation renewal is made.
ECHA has also released guidance on efficacy assessments for preservatives and mixture toxicity assessments.