Is Your Biocide Legal? - Biocide Directive - Update 2017:

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! That was our findings 12 months ago ... and not much has changed.

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.

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.

The full article explains the basics of the legislation and how to check that your biocides are legal and can be found on our website www.aquadron.co.uk

Are the Biocides you use legal?

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.

Use of biocidal products affected by the 1 September 2015 deadline

Article 95 (as amended) of the EU BPR states that a biocidal product “shall not be made available on the market” if the product or active supplier isn’t included in the Article 95 list. However, Article 95 (as amended) of the EU BPR does not prohibit use of stocks of products that had already been supplied before 1 September 2015. The original text of Article 95 of the EU BPR did prohibit the use of biocidal products affected by 1 September 2015 deadline but this prohibition was removed when the requirements of Article 95 where updated via Regulation (EU) No 334/2014 which entered into force on 25 April 2014 . Therefore, use of the biocidal products can continue after 1 September 2015.

Therefore, after 1 September 2015 use of biocidal products affected by the 1 September 2015 deadline can continue until an approval decision (positive or negative) is taken for active substance(s) in the product, at which point the relevant phase out periods in Article 89(2), 3(b) and 4(b) of EU BPR (as amended) will apply. If the biocidal product has approval under COPR the conditions of approval relating to storage and use continue to apply during this time and until the end of the Article 89 phase out period.

The full article is on the Blog page of our website and can be found here.

If you would like any assistance with the above please feel free to call or email us. Full contact details are on the website.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 and show you our ECHA Article 95 listing for biocide use types 1-5!