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The Biocidal Product Regulation…what's that?

10 May 2019

Matt Wood, technical manager at Mirius, provides an update of The Biocidal Product Regulation and its impact on the cleaning industry

The story of the Biocidal Product Regulation (BPR) is a long one, which, as you scratch the surface, starts to feel like a shaggy dog story and eventually a tall story. You really don’t need to know the details so I’ll spare you them and cut to the quick…the ‘so what’ of the BPR.

First a bit of background

Biocides is the term used to capture a whole range of chemicals products which are used to ‘affect’ living organisms. That ‘affect’ can mean to ‘deter’ or ‘remove’ but most often we use it to mean ‘kill’. Within the cleaning and hygiene sector biocides is the term applied to disinfectants, sanitisers and pesticides. (I’ll call them biocides from hereon in).

The BPR…so what

How will the BPR impact on the cleaning and hygiene industry?

  • The number of manufacturers able to continue manufacturing biocides is likely to fall significantly
  • The number of ‘active substances’ (i.e. chemicals on which biocides can be based) has fallen dramatically
  • The variety of biocidal products available to the market will fall
  • As the BPR kicks in for each active substance there will be a 24-month moratorium on launching new products 
  • Innovations in disinfection will dry up or stop all together

How the BPR works (or maybe doesn’t)

The BPR makes it a legal requirement to obtain formal permission (a product authorisation) before a biocidal product can be placed on the market. 

So whether you’re buying a branded disinfectant or have your own private label disinfectants or sanitisers – this will impact on you: After a certain date (see below) disinfectants must be authorised. It will be illegal to sell a biocidal product that has not been authorised. 

To understand the so what of the BPR there are some terms you need to know:

  • Active Substance the specific chemicals which are used to formulate biocides and which must be approved (authorised) for use in biocides
  • Inclusion Date the date on which a given active substance becomes formally authorised
  • Dossier A complex and very expensive data required for a biocide (or family of biocides) to gain formal authorisation. The dossier must comprise:
    • Efficacy (does it work)
    • Physical chemistry (is it stable)
    • Toxicology (is it safe)
    • Environmental Risk Assessment (is it safe for the environment) 

Typical costs for a Biocidal Product Dossier will be £150,000 (yes, really!).

  • Evaluation Period the time that the authorities have to evaluate and approved (authorise) a biocidal product. During this period no one is allowed to launch any new products based on that active substance. Basically it’s a 24 month moratorium. 

Really? When?

When the BPR was first proposed we all said ‘this is stupid – it’ll never happen'. But we were only half right – it is stupid. But it is happening.

On 1st January 2019 sodium hypochlorite (bleach) was formally authorised. Manufacturers wanting to continue marketing products based on hypochlorite had to submit their product dossiers before this date. 

We have now entered a 2-year moratorium on the launch of any new bleach based disinfectants. 

If you have an own label product based on hypochlorite by a contract manufacturer (assuming they have submitted their dossier and included your trade name in their dossier) you cannot transfer supply of that product to another supplier until their dossier has been authorised. 

What’s next?

The BIG one – the one the industry is holding its breath for is benzalkonium chloride (BKC).

BKC is the active substance used in the vast majority of disinfectants and sanitisers. We’re months away from finding out the date when this will be included in the list. When that happens your suppliers will have two years to create and submit biocidal product dossiers.

So it’s worth asking your supplier what their plans are to ensure they remain on the market after the BPR bites.