March 25, 2013 by Iain Wilson
Seminar on Product Authorisation under the Biocidal Products Directive (BPD) 98/8/EC; Chemicals Regulation Directorate (CRD) of the HSE
Becky Marks and I attended a training course run by the Chemicals Regulation Directorate of the HSE titled ‘Seminar on product authorisation under the Biocidal Products Directive (BPD) 98/8/EC’ with the aim of gaining a greater understanding of the many changes to biocides legislation that are currently taking place.
The main aims of the seminar were to;
- Cover the transitional arrangements from the Control of Pesticide Regulation (COPR) to the Biocidal Products Regulations (BPR) 2001 and to give an overview of the UK product authorisation process
- Allow for CRD to detail their experiences with product authorisation and how to avoid common problems
- Detail issues emerging from the Product Authorisation and Mutual Facilitation Group (PA&MRFG)
- Give a forward look at the Biocides Regulation (EU) 528/2012
The transitional arrangements from the COPR to the BPR, including details of which products qualify for Certificates of Exemption and when these need to be applied for, were covered as this is a pressing issue for a number of the attendees. This then naturally fed into the UK product authorisation process. There are a number of types of product authorisation under BPR, including Full Product Authorisation, Provisional Authorisation, Product Amendments, Process Orientated Research and Development (PORD)/Experimental Authorisation and Mutual recognition. The UK authorisation process has these different classes of Product Authorisation to allow for changes to existing products, registration of new active substances (not previously covered under the COPR) and R&D on existing active substances under the current biocides regulations.
CRD detailed their experience with product authorisation, which highlighted the most common problems they have identified in authorisation dossiers. These include:
- Gaps in the data supplied – there are far more requirements under BPD than COPR
- Reliance on Annex I inclusion data – Data may be incomplete for the purposes of product authorisation, for example efficacy needs to be assessed as efficacy in the formulated product
- Read across dossiers – Robust read across justification is required
- Updated guidance – Dossiers need to be compliant with the most recent guidance available at the time of submission
The seminar also took a forward look at the new European Regulation on Biocides (528/2012). The regulation has been introduced in response to issues with the current BPD (98/8/EC), such as long delays, high compliance costs and the large number of active substances and products being withdrawn from market. Some of the main differences between the new regulation and the current BPD are:
- Active substances will now be ‘approved’ and placed onto a new list
- European Union authorisation will allow a single authorisation for products with similar conditions of use throughout the EU for certain Biocidal products.
- Authorisation can be given for a ‘product family’ and cover all products within that family. This also means changes to dyes, perfume or pigments within existing ranges do not need to be notified
- Simplified authorisation will be available for some products to encourage use of products with a more favourable environmental or human and animal health profile
As well as providing an overview of the status of the various pieces of biocides legislation, a walk-through of the HSE website and other useful links was conducted by members of the biocides help desk (Biocides law, Biocidal products requirements, CIRCABC. This was particularly useful, as the CIRCA website is not particularly user friendly! The seminar also provided information about the issues emerging from the PA&MRFG group, in an informative session presented by Dr. Ros Hanway, the UK’s representative in the group. This covered how the group works and some of the forthcoming position papers that are expected to be released by the group.
wca continue to actively monitor developments in the area of biocides legislation to ensure that wca is up to date in this sector and to enhance the service that we can provide. For example, Chris Moore and Iain Wilson will be attending a biocides webinar hosted by Chemical Watch at the end of March detailing the impact of Biocidal regulation.