Biocidal chlorine-based products
The Biocidal Products Regulation EU/528/2012 (BPR) seeks to establish a high level of protection for humans and the environment, and to eliminate barriers to trade by harmonizing the processes involved in placing biocidal products on the European market. But it also dramatically transforms the biocidal industry, as it has implications for those who produce, distribute and use active substances.
The BPR was adopted on the 22nd of May 2012, and entered into force on the 1st of September 2013. This regulation repealed and replaced the Biocidal Products Directive 98/8/EC (BPD), and introduces a range of changes. The European Chemicals Agency (ECHA) has taken over administrative duties under the European biocides legislation and more detailed information can be found on the ECHA website.
The classification of biocides is broken down into 22 Product Types (i.e. application categories), with several comprising different subgroups.
Under the BPR, the system of product authorisation requires two regulatory steps before a biocidal product can be marketed. The first step is the approval of the active substance and the second step is the authorization of individual formulated biocidal products. Each step requires a dossier per product type that contains information on its biocidal efficacy, toxicological and ecotoxicological properties, etc. Read more information on the submitted product types page. Euro Chlor is only involved in the registration of active substances on behalf of it's members.
Furthermore, under the BPR, all companies that manufacture or import biocidal active substances have an obligation to submit to ECHA either an active substance dossier or a letter of access to such a dossier for each active substance they supply on the Union Market. ECHA is required to publically publish a list of approved active substance suppliers consisting of the names of the persons that have made this submission. This list can be consulted at the ECHA website.
As of 01 September 2015, Euro Chlor members are on the Article 95 list of approved biocidal active substance suppliers. This process has been going since 2004 and the active substance dossiers, which Euro Chlor supports for sodium hypochlorite, calcium hypochlorite and chlorine, are now under review.
For PT1-5, all three of our actives had their opinions approved as of 17 January 2017 and product registration work can begin. Assessment reports can be found on the ECHA website as of March 2017. The decision to approve active chlorine from chlorine, sodium hypochlorite and calcium hypochlorite was published in January 2017. The opinion to approve these actives concerns the active substance released into water (e.g. for swimming pools) and lists example conditions which were used to assess the safety of the active substance. These conditions are the maximum values used in the risk assessment and operators and product applicants can disinfect within appropriate ranges that they select, apply for and prove to be safe and efficacious. To summarise, recommended use concentrations form part of the product approval and not the active.
Any Euro Chlor members who produce or import chlorine, sodium hypochlorite or calcium hypochlorite for biocidal purposes and have not already complied with this aspect of the regulation should contact Richy Mariner (direct tel. +32 2 676 73 61) for more information on their duties under the regulation.
Progress thus far
The dossiers submitted in 2007 (for PTs 1-5) have passed through their inital evaluation period and have been subject to review by the Technical Meetings in 2012 and 2016.
See the Draft competent authority reports on circa.europa.eu
Currently we are updating the dossiers for PT11 and 12 as well as closing out the remaining Member State issues according to requests from the Working Group Technical Meetings. The final competent authority report has been produced by the RMS and the substances (in PT1-5) were discussed at ECHA’s Biocidal Products Committee (December 2016). A decision was taken on approval as a biocidal active substance in the disinfectant PTs and approval was granted. Publication of the implementing regulation for PT1-5 for the three biocides occurred on 15 July 2017 and as such the final active substance approval date is 01 January 2019.
The dossiers submitted in 2008 (PTs 11 + 12) are currently undergoing evaluation by the RMS, we anticipate that this will be up for evaluation in 2021/2022.
For more information on the current status of the dossier evaluations please consult the substance-specific links below:
More information on the currently approved active substances is available on the ECHA website.
More information about the active substance review programme and the Biocidal Products Regulation can be found on the ECHA website at http://echa.europa.eu/regulations/biocidal-products-regulation