Is Your Biocide Legal? - Biocide Directive
It is possible that more than half of the water treatment biocides on the market in the UK are illegal – does that surprise you? … it certainly surprised us!
The legislation around biocides has changed significantly and the companies producing and selling biocides have, in a lot of cases, have failed to keep up.
On the 1st of September 2015 it became illegal to sell biocides that included Active Substances that were not listed on ECHA's Article 95 list.
Our estimate is also backed up by the findings of a recent inspection in Denmark, that found that 50% of Danish pest control companies are selling biocides that are not legal in the EU.
Users of biocides need to understand this regulation and also need to ensure that the biocides that the use are legal. Unfortunately there isn't a simple database saying what products are and are not legal, instead there is a duty on the user to check that -
- The Active Substance is registered
- The Active Substance Supplier is registered
- The type of use is registered.
This article explains the basics of the legislation and how to check that your biocides are legal.
Are the biocides that you use legal?
As mentioned above, from 1st September 2015, it became illegal to sell biocidal products in the EU unless the Active Substance (the biocide component) was approved or included in the EU biocide approval process. This means that the Active Substance and the specific Active Substance Supplier must be included on something called the ECHA Article 95 list, or that the biocide is subject to an exclusion (a very limited number and none that are used for water treatment).
The Article 95 list also covers chemicals that are produced in-situ such as chlorine dioxide, or our biocide, Innowatech Anolyte.
It is worth noting that for any Active Substance it is not enough that the chemical is included, it must also include the specific supplier of the Active Substance.
What does this mean to me?
Some definitions may help to gain an understanding of this complicated piece of legislation –
What are biocides and biocidal products?
"Any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.
Any substance or mixture generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical means.
A treated article that has a primary biocidal function shall be considered a biocidal product.”
Basically, this covers just about any product that is used as a biocide in water treatment.
What is an active substance?
“The active substance or mix in a formulation that confers the efficacy of a product."
This can be complicated. When a product contains more than one active substance the biocidal product/biocidal family cannot be authorised until all of the Active Substances in it and all of the Active Substance Suppliers
are included on the Article 95 list.
In addition, for chlorine / hypochlorous acid based products, if the pH of the product is below pH5 then the biocide is deemed by ECHA to comprise of both elemental chlorine and hypochlorite and both active substances will require an Active Substance approval.
Who is a substance supplier?
“A person established in the EU who manufacturers or imports a relevant substance, on its own or in biocidal products (Article 95(1), second sub-paragraph of the BPR).”
It is worth noting that an EU-based entity has to be the registered supplier. Entities from outside the EU cannot undertake this role and must have an EU supplier listed on the ECHA Article 95 list for their product.
The Biocide Regulations Process
The active substance supplier needs to have submitted a chemical dossier for review to the European Chemical Agency (ECHA) or the National authority dealing with biocide regulation by 1st September 2015. The dossier will be reviewed for completeness and the Active Substance and the Active Substance Supplier will be listed in the ECHA Article 95 list.
The ECHA Article 95 list covers biocidal chemicals and also in-situ processes that generate biocides. Examples of in-situ processes include electrolysis for the production of sodium hypochlorite or chlorine dioxide, in can also cover the precursor chemicals and the active substance that is produced.
It should be noted that the inclusion of in-situ generated products was a late addition to the legislation and that, at present, only three chlorine dioxide systems appear in the Article 95 list. A guidance note issued by ECHA has suggested that a six-month period of grace (to 1st March 2016) may be applicable for the providers of in-situ generated biocides, though this does not appear to have formally been included into legislative guidance.
The Active Substances and the Suppliers then have to be approved for certain uses – for water treatment this is Category 5, for surface disinfection it is Category 2. The Active Substance can only be used for the approved uses
i.e. an active Substance that is approved for Category 2 but not for Category 5 cannot be used for water treatment. In total there are 22 categories.
Once an Active Substance from a specific Active Substance Supplier has been listed on the Article 95 list for a specific Product Type, it can be sold for that use within the EU, if the Active Substance from the specific supplier is not listed it is illegal to sell it.
What Products can be sold?
Before a biocidal product can be sold for a specified use the product supplier should ensure that the Active Substance from the specific Supplier and for the specific use is either -
1) Approved for that Product Type,
2) Is under review for that Product Type, or
3) Is exempt from the regulation and is listed in Annex I of the EU BPR.
If the Active Substance, the Active Substance Supplier
and the specific use type
are not covered by points 1-3 above, then the product can not be legally sold in the EU.
A second phase of the legislation covers biocidal products. If it can be demonstrated that the product contains a registered Active Substance then the biocidal product also needs to be registered. This will require a letter of access from the Active Substance Supplier demonstrating that they are the supplier and allowing reliance upon the Active Substance technical dossier.
If you are providing an unamended Active Substance then it must be traceable back to the original Active Substance and the Active Substance Supplier.
When a product contains more than one Active Substance the biocidal product/biocidal family cannot be authorised until all of the Active Substances in it are in the Article 95 list.
How Do I Ensure Compliance With The Biocides Directive?
Firstly, be aware that if you have read this far you may well know more than your biocide supplier! If you want to read up further there is plenty of information on the HSE and ECHA websites.
Secondly, be aware that
there is no definitive list of approved biocides yet, that will come in the second phase.
It is therefore important to check that the Active Substances, Active Substance Suppliers and product uses are included in the ECHA Article 95 list. To do this we suggest that -
- You identify the biocides that you use or the chemical precursors that are used for in-situ biocide generation.
- You review the supplier MSDS sheets and note the ingredients of the biocide.
- You request a list of the Active Substances in the biocidal product (and do a common sense review of these),
- You request details of the the Active Substance Suppliers and details of their inclusion on the ECHA Article 95 list.
- You can then check the Active Substance and details of the ECHA Article 95 registration and ensure that the biocide is legal.
If your supplier is unable to provide these details then it is possible that the biocide that is being supplied is not legal for use in the EU and that you should look for an alternative product that is legal. It is also worth noting that biocides regulation is not the same as REACH regulation and that REACH is not a replacement for an entry on the ECHA Article 95 list.
If you would like any assistance with the above please feel free to call or email us.
Please feel free to share this article with others that may find it of interest.
We would love to show you how the Aquadron can benefit you and your business Click here to arrange a call back. And show you our ECHA Article 95 listing (Innowatech Anolyte) for biocide use types 1-5!