Otherwise products generating unregistered and unassessed ‘in situ’ biocides will have to be withdrawn from sale
Suppliers of biocidal products have been told by the European Chemicals Agency (ECHA) to re-review their products regarding their biocidal impact, in case combinations of chemicals within a preparation create a new biocide during and after use.
The ECHA has released new guidance on so-called ‘in situ generated active substances’, saying companies yet to declare such chemicals for assessment can do so by 1 September 2016. If not, products generating unregistered and unassessed ‘in situ’ biocides will have to be withdrawn from sale. That said, suppliers and cleanroom managers have an additional year over the existing 1 September 2015 deadline for lodging other biocides for assessment under the EU’s biocidal products regulation (Regulation EU 528/2012).
The ECHA explained: 'While many in situ generated active substances are included in the Review Programme, the submission of data on the precursors has not been consistent (e.g. data on several precursors were provided in a single dossier), and consequently precursors have not been consistently evaluated.'
The Agency gave examples, such as, active bromine generated from sodium bromide and sodium hypochlorite; and hydrogen peroxide generated from sodium percarbonate by dissolution in water.
Some of these combinations and chemical reactions are already known to the ECHA and are included in its biocidal product review programme, but some are not. These now need to be referred to the Agency for companies in order 'to keep their biocidal products on the market'.
A new system has been drafted by the Commission to make sure these ‘in situ’ biocides are examined properly, with assessments considering the precursor substances and the resulting biocide created during use.
The reform comes as the ECHA has warned that some companies have had difficulties managing their biocidal product authorisations 'since their assets have erroneously expired and ‘disappeared’ from the [registry for biocidal products] R4BP 3 system preventing the companies from updating any information'.
The Agency has asked competent authorities that grant authorisations for biocidal products 'to urgently send information to the agency on the expired assets for authorisation that are still valid', to prevent related products from being banned from the market from 1 September this year.