Important milestone in Biocide Product Regulations
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. Euro Chlor stands ready to further support this process and is monitoring developments at the ECHA Biocides Stakeholder Day (http://echa.europa.eu/news-and-events/news-alerts) which brings together commission experts, member state authorities and industry to discuss the current situation. The event can be monitored by using the Twitter hashtag (#BiocidesDay).
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 will also dramatically transform the biocidal industry, since it will have far-reaching effects on 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 This regulation repealed and replaced the Biocidal Products Directive 98/8/EC (BPD), and introduces a range of changes.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 BPR describes biocides as chemical preparations containing one or more active substances that are intended to control harmful organisms by either chemical or biological means. 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 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.
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.
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.
See the Draft competent authority reports on circa.europa.eu
Currently we are updating the dossiers according to requests from the Technical Meetings. Once the final competent authority report has been produced by the RMS, the substances will be discussed at ECHA’s Biocidal Products Committee before a decision is taken on approval as a biocidal active substance.
The dossiers submitted in 2008 (PTs 11 + 12) are currently undergoing evaluation by the RMS.
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
Last Update: 08/2015