WHAT ARE THE BIOCIDAL PRODUCTS REGULATIONS (528/2012/EU) (BPR) ALL ABOUT?
Disclaimer – This is not intended to be a legal interpretation of the BPR. If you are on this site and reading this text, the chances are that your organisation needs either to manufacture, formulate or import a biocidal active substance or product to supply or use in the territory of the BPR.
Tarn-Pure is a founding member of the Biocidal Copper Task Force and the Silver Task Force. This means that we are permitted to “first place” on the market copper and silver for use in biocidal applications covered by the Product Types we support. (For further information please read the definitions of the Product Types and the current “Article 95” List published by ECHA, using the links that appear at the end of this explanation).
The following paragraphs are presented to provide you with a brief but non-legal and non- technical overview of the road which has led to the creation of this new regulatory environment. This paper is intended as a guide that will allow you to make such further enquiries as you deem necessary to ensure that your business is compliant with the BPR.
HISTORY OF THE BPR
In the late 1980s the European Commission decided that it was necessary to harmonise the standards and regulate the conditions for the supply and use of biocides across all of the EU Member States. The ultimate objective was to ensure that all biocides placed on the market in the EU were fit for purpose and safe for use.
This process resulted in the publication of the EU Biocidal Products Directive in February 1998 which created the Biocides Review Programme. The European Commission allocated the conduct of these Biocides Reviews across all of the Member State Competent Authorities (MSCA). The task of performing the Review of Copper was assigned to the French body AFSSET (now ANSES). Silver was assigned to KemI – the Swedish Chemicals Agency. Industry then formed Task Forces, or consortia, to share the cost of these Review programmes.
As this process commenced the European Parliament drafted primary legislation to supersede the Directive and, in March 2012, approved the Biocidal Products Regulations (528/2012/EU) (the “BPR”).
This legislation regulates the terms under which a party may place biocides on the market in the territory covered by the BPR, which has now grown to include the 28 Member States of the EU plus Iceland, Liechtenstein, Norway and Switzerland.
THE PURPOSE OF THE BPR
The essence of the BPR is to ensure that only commercial organisations that have contributed to the cost of the relevant Biocide Review may place the biocidal active substance or product on to the market.
Clause 2 of Article 95 of the BPR states “As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance included in the [Article 95 List] shall not be made available on the market unless either the substance supplier or the product supplier is included in the [Article 95 List] for the product-type(s) to which the product belongs.”
Any business wishing to be included in the Article 95 list must submit an application to the European Chemicals Agency (ECHA) in which it must identify how it complies with the relevant regulations.
Article 95 Clause 1, paragraph 2, states, inter alia: “A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, [or] containing [….] that relevant substance (‘the product supplier’), may at any time submit to the Agency either a complete substance dossier for that relevant substance [or] a letter of access to a complete substance dossier…”
In order to submit a “complete substance dossier” in your own right you must be able to lawfully reference all of the data required to be contained within the dossier that has been deemed necessary by the Review body (the evaluating Competent Authority, or “eCA”).
In order to mitigate the costs of many parties conducting unnecessary duplicate studies the members of the Task Forces (the Review Programme Participants, or “RPP”s) negotiate, agree and pay compensation to the owners of all of the confidential studies that are required by the eCA for the purpose of conducting the relevant Review.
To achieve the desired outcome while retaining confidentiality of the data, the data owners submit the data to the eCA and the RPPs receive, through their Task Force, Letters of Access from the owners granting permission to reference this confidential data for the purpose of conducting the Review.
It is important to understand that the RPPs do not receive copies of the studies, have no rights to sell these studies or their contents and cannot pass on, assign or otherwise transfer access to these studies to any party unless this is done within the terms of their internal Task Force agreement.
In the case of Copper and Silver there are essentially two ways that your organisation may secure sufficient rights to data citation to be able to secure inclusion in the Article 95 List:
i. By joining the relevant Task Force.
The Task Forces themselves own the complete substance dossier citation rights and membership of the relevant Task Force in and of itself confers RPP status and the right to Article 95 inclusion.
ii. By purchasing a Letter of Access from the relevant Task Force
The secretariats of each Task Force are the only parties permitted to issue to any applicant a Letter of Access to the data used to compile the “complete substance dossier” on behalf of the membership of the Task Force in question.
If you are interested in your party being included on the Article 95 List for copper or silver please write to the relevant bodies for further information as under:
The EU Biocidal Copper Task Force
℅ Regulatory Compliance Limited
Attn. Carol Mackie
6 Dryden Road
Loanhead EH20 9TY
Tel: + 44 131 448 1085/6
The EU BPR Silver Task Force
℅ Field Fisher Waterhouse LLP
Attn. Koen van Maldegem
l’Arsenal, Boulevard Louis Schmidt 29
Tel: + 32 2 742 70 70
There is a lot of confusion over the issue of Letters of Access, as it is possible to obtain another type of Letter of Access, or “LoA”, which does not grant rights to the complete substance dossier.
This “secondary” LoA may be issued by RPPs to their direct customers to provide their direct customers with the right to cite any data to which the RPP has title for the purpose of obtaining Product Authorisation.
A more detailed explanation of Letters of Access is published in another paper in this series.
Product Authorisation is the final stage of the process of approving and regulating biocides and is also dealt with in a separate paper on this web site.
The view or download Regulation 528/2012/EU please click here
To view or download the table of Biocides Product Types please visit the ECHA web site here
To view or download the most up to date Article 95 List please click here