Everything you need to know about Biocidal Product Regulations
Biocidal product regulations is a piece of legislation that affects everyone in their daily life, which very few have heard of and even fewer are able to explain.
The EU Biocidal Products Regulation 528/2012 affects all substances that have, as their purpose or incidental effect, the killing of any form of life – from microscopic to mammoth. It covers disinfectants, pest control products and preservatives, whilst the team at GL Law have come across it in connection with less obviously “harmful” substances; copper and silver.
The history of the regulations
Before the Regulations were put in place, there was a European Directive on Biocidal Products (1998). The Directive had intended the gathering of information about all products on the EU market that contained biocides. The overarching goal was to reduce the duplication of testing, particularly on vertebrates, across Europe by national H&S agencies and for the creation of a Europe wide safety standard (the level playing field approach).
The Directive ran for nearly 15 years and under its auspices, a great deal of work was done to collect and assemble studies and to understand how biocides could be grouped by substance and product type (PT). This information was then used to draft the Regulations.
Biocidal product regulations
When the Directive gave way to the Regulations, the law makers behind this initiative bared their teeth. From 1 September 2015 they made it an offence to make a biocidal product available on the EU market unless it is either “Authorirsed” (something that can only happen once the Active substances within are approved) or the active substances in that product are part of the Review Program. Further, from 1 September 2015, the active substances must come from an approved substance supplier, names on a list maintained by the European Chemicals Agengy (ECHA). The next phase, which will start soon, is for each product to be subjected to authorisation.
As of 1 September 2013, if a manufacturer of Active Substances wants to place them on the EU market, for us in Biocidal Products, they must be listed on the ECHA list.
Private rights and public law
This is where the Regulations, from a lawyer’s perspective, get interesting. We are now watching as companies wake up to the realisation that their products, which they have been happily trading in the EU, are suddenly no longer legal. This is whilst companies, who have got their house in order, have been watching this legislation carefully, and suddenly find themselves talking to companies who missed the changes.
The cost of studies and the whole application process, including the assessment of those studies, is running into €millions – for each substance and for each PT within each substance. Unsurprisingly there is now an urgency on companies to recover costs wherever possible. The Regulations recognise that companies are going to have to come together and agree arrangements for sharing data in a commercial context but, other than where the studies concern vertebrates, the Regulations simply leave it to parties to agree matters amongst themselves – and we have seen a variety of different approaches to sharing.
With the usual caveat that we have not actually seen the legislation, the headlines and discussion around the Great Repeal Bill suggests to us that the Regulations will appear in UK form after Brexit. This is so that UK companies seeking to export to the EU that currently comply, will continue to do so after Brexit and that similarly EU companies that wish to export to the UK will similarly continue to be able to do so.
However, English regulatory authorities have a tendency to enforce the letter of the law where their European counterparts take a looser approach. English lawmakers can also be quite good at cutting through red tape so whilst the UK may start as a mirror image of the EU, we anticipate changes soon emerging meaning that we could soon see divergence and a need for separate consideration of each regime.
GL Law biocidal product regulation specialists
We have an expert team able to advice on this complex area of law – both private rights and public law – and would be happy to discuss further. For more information, please contact Paul Hardman, Director of Corporate & Commercial,or Melissa Toney, Head of Regulatory & Licensing. Call 0117 906 9400 or email firstname.lastname@example.org