Biocidal Products Regulation
6 April 2016
All you need to know about the EU Biocidal Products Regulation and how it may affect you.
Over the next few years, users may start to see some disinfectants on the market disappear. This will be due in part to the EU Biocidal Products Regulation, which first came into force in 2012, but is now starting to have an effect on the industry.
A biocidal product is a substance which controls harmful or unwanted organisms through chemical or biological means. Common examples are disinfectants, wood preservatives and insect repellents. The Biocidal Product Regulation (BPR) governs how these biocidal products are made available to the European market and how they should be used.
The BPR has two main objectives, firstly to harmonise the European biocidal market to enable all EU members to compete on a level playing field and secondly to provide a high level of protection for the operator and the environment by ensuring all biocidal products are assessed for risk and efficacy.
The registration process is split into two stages; firstly, the active substances (raw materials) are registered and secondly the biocidal products which contain those actives (ie a bactericidal disinfectant). The active and the biocidal product must both be registered for a specific use, known as a Product Type, and it must not be used for any other purpose. For example, a product registered as a disinfectant for washroom surfaces must not be used as a disinfectant for kitchen surfaces. Under BPR there are 22 different Product Types, ranging from human hygiene products to antifouling paints; Evans Vanodine has products under 5 of these Types.
As of 1st of September 2015, all biocidal active substances must be purchased from a supplier who is part of the active assessment process and whose products appear on the Article 95 list of approved suppliers for EU biocidal actives. Evans Vanodine, and other similar companies, can now only manufacture disinfectants, for sale in the European market, by using an approved active substance which is included on the Article 95 list.
Over the next few years, as products are authorised, the product label will change to show:
- The authorisation number
- The type of organism killed – eg bacteria, fungi, viruses
- The specific areas of approved use (the product must not be used for any other purpose)
- Requirements for Personal Protective Equipment for each stage of use
- Detailed directions for use, with dilution rates, application types and contact times
- Product disposal instructions
- Professional and / or amateur use
As an extra safeguard for the users of biocidal products, the BPR makes the distinction between ‘Professional’ and ‘Amateur’ users. Commercial or industrial use biocides will be labelled "For professional use only" and should only be used by those who have had the appropriate information, instruction and, most importantly, training.
Authorising biocidal products is an expensive process. The costs involved have not been finalised, but, including the laboratory work and authorisation fee, we estimate that each biocidal product will cost approximately £40,000 - £50,000 to bring to market. Due to the high costs involved, and possibly due to the lack of authorised active substances, companies may well rationalise their disinfectant ranges and no doubt many will disappear from the market. These costs will have to be passed on but as the market is very competitive, we suspect the increase will be minimal.
Despite the extra work and cost, we believe that it is very important to have safeguards in place to ensure biocidal products can be used without causing harm to people, the environment or wildlife. We also believe the BPR will help eliminate false claims made by some companies on labels and on literature, in particular with regards to bactericidal properties.
You can find out more about BPR via the HSE website http://www.hse.gov.uk/biocides/eu-bpr/ or you can contact Evans Vanodine.