BPR - new obligations and in situ production
The Biocidal Products Regulation EU/528/2012 (BPR) entered into force on 1st September 2013 and replaced the previous Biocidal Product Directive (BPD). The BPR introduced some changes relevant to the Euro Chlor Biocides Registration Group and the chlorine, sodium hypochlorite and calcium hypochlorite dossiers.
In situ-generated active substances
In situ-generated biocidal active substances have now been brought explicitly within the scope of the regulation. This directly affects producers of in situ-generated active chlorine.
The practicalities related to in-situ generated active substances under the BPR (for example data requirements for precursors and active substance combinations) have been agreed on by the European Commission and the Member States. More information can be found on the website of DG Environment, and concerned parties are advised to follow developments on the European level.
Data Sharing under the BPR
The BPR lays out new obligations for data-sharing of existing dossiers. This is described in Chapter XIV (Data Protection and Data-Sharing) and Article 95 (Transitional measures concerning access to the active substance dossier) of the regulation.
Under the BPR, data sharing is now mandatory for all (eco)toxicological and environmental fate and behaviour data for exisiting active subtances.
Furthermore, as of 1 September 2013, any company that supplies active substance(s) on the Union market on its own or in biocidal products shall, for every active substance that they manufacture or import for use in biocidal products, submit to ECHA either an active substance dossier or a letter of access to such a dossier.
Article 95 establishes a procedure by which suppliers of an active substance who are not currently participants in the active substance review prgramme (so-called “alternative suppliers”) can be included in the list, and subsequently allowed to start or continue to place their active subtsance on the market in the EU. This article also directly addresses alternative suppliers who already today place active substances on the market (known as "free riders"), those suppliers who now find themselves within the scope of the new regulation, or alternative suppliers who intend to start placing active substances on the market at any given time after 1 September 2013.
ECHA shall make publicly available the list of persons that have made such a submission, which shall also contain the names of persons who are participants in the BPR review programme for existing active substances. As participants in the review programe, the members of the Euro Chlor Biocides Registration Group appear on the list of suppliers for chlorine, sodium hypochlorite and calcium hypochlorite.
As of 1st September 2015, all formulators placing biocidal products on the market within the EU must ensure that their active substance is obtained from a source that is listed on the published list of active substance suppliers.
Letters of Access
Euro Chlor (a not-for-profit entity) provides letters of access to the active substance dossier for those active substance suppliers who now need to obtain access to the chlorine, sodium hypochlorite or calcium hypochlorite dossier in order to be placed on the ECHA list of approved active substance suppliers.
Letters of access to the active subtance dossier for the purposes of product authorisation will be provided directly by the members of the Euro Chlor Registration Group to their own customers. Companies intending to submit product authorization dossiers should therefore contact their active substance suppliers for a letter of access. Applications for biocidal product authorization cannot be submitted until a decision on the approval of the active substance has been taken. An exact date for the approval decision cannot be anticipated yet. We predict, after the BPC meeting in December 2016 that if the dossiers are correct, a final opinion will be due in January 2017. This would mean that for PTs 1-5, an expected Active substance approval date of January 2019, with preparation to conduct product registration occurring in the 18 months leading upto this. N.B. Euro Chlor are not involved in any product registration activities and these dates are approximate, provided for information only and should not be relied upon for business decision making.
For all further information: call Richy Mariner on +32 2 436 9508 or contact us via our contact form.