Biocidal Product Regulation
21st August 2015
All you need to know about the EU Biocidal Product Regulation and how it may effect you.
What is a Biocidal Product?
A biocidal product is one which controls harmful or unwanted organisms through chemical or biological means. Common examples of such products are disinfectants, wood preservatives and insect repellents.
What is the Biocidal Product Regulation (BPR) (EU) No. 528/2012?
The Biocidal Product Regulation (BPR) replaced the Biocidal Product Directive from September 2013. Like the BPD, the BPR is concerned with how biocidal products are made available to the European market and how they should be used.
When will BPR affect distributors and users of Biocidal Products?
The 1st of September 2015 is the date from which all biocides for use in Europe should be from approved sources i.e. manufacturers who have authorisation or those who are still in the process of authorisation. This will cause some products to disappear, if the active components are not supported, and may lead to price changes as manufacturers are required to buy more expensive European grades of active ingredients.
Active and product authorisation is ongoing and will only affect Evans customers directly from 2016 – 2018.
We will keep customers informed of the details nearer the time.
What is the object of the BPR?
The BPR has two main objectives:
1. To harmonise the European market (for biocides) to enable all EU members to compete on a level playing field
2. To provide a high level of protection for the operator and the environment by ensuring all biocidal products are registered and risk assessed
What is the scope of BPR?
The scope is very wide and covers 22 different product types in 4 main groups:
Group One – Disinfectants and General Biocidal Products
This includes human hygiene products, food area and water disinfection and veterinary area disinfection products.
Group Two – Preservatives
This includes preservatives for cleaners, wood, paint, textiles, cutting fluid and cooling water.
Group Three – Pest Control
This includes insecticides, rodenticides and repellents.
Group Four – Other Biocidal Products
This includes antifouling paints and embalming fluids
Do biocidal products need to be authorised?
Yes, they do. Over the next five years, Evans Vanodine and other leading formulators will be producing dossiers on the products they want to market for submission to the appropriate member state.
How does the BPR authorisation system work?
Authoristaion is a 2 stage process. First the active substance is authorised followed by the relevant biocidal products. Assessment is by a Component Authority in one of the EU member states.
What is an active substance and a biocidal product?
An active substance is the biocide, either used on its own or in a formulation. When either is sold to the user market, they are then biocidal products.
If an active substance has not been assessed and authorised, can it be used in a biocidal product?
The simple answer is no. From the 1st of September 2015, companies such as Evans Vanodine can only manufacture biocidal products using active substances bought from suppliers on the Article 95 list of active substances and suppliers; this list contains authorised active substances and those still under assessment.
When does a biocidal product have to be authorised?
A biocidal product only has to be submitted for authorisation 18 months after the active substance has been approved. The authorisation process takes 12-18 months.
When will the active substances be approved?
Producers of active substances have submitted data on the quality, efficacy and safety of their substances, in relation to specific Product Type uses, for assessment at European level by a nominated member state. This process has been ongoing since 1998 and will continue for at least another 9 years.
Most of the actives authorised so far are for Wood treatment, Antifouling Paints and Rodenticides. The first of the Group one actives – iodine, is now due for product submission in September 2015.
Can anyone use biocides?
The BPR makes the distinction between ‘Professional’ and ‘Amateur’ users. Commercial or industrial use biocides are for professional use and must be used by those who have had the appropriate information, instruction and, most importantly, training.
Professional / Industrial biocidal products will be labelled "For professional use only" and should never be used by the general public considered to be amateur users. An amateur user does not require specific training, however, the information and instructions on the product label must be clear, concise and understandable by the end user.
How do you find out if a product is authorised?
In the future all authorised biocidal products will be found on a European BPR database.
What information will be on the label?
The label must contain the following:
1. The authorisation number.
2. The specific uses for which the product is authorised. eg “killing bacteria in the food industry”. The product must not be used for any other purpose
3. Information about who is allowed to use it, eg an amateur (general public) or a professional (industrial user)
4. Whether any protective clothing or equipment needs to be worn
5. Directions for use: frequency and type of use and the application method, and volume and the correct contact time
6. Direct or indirect side effects
7. How to dispose of the product or empty container
Before choosing a Biocidal Product, what should you consider?
The first consideration is, do you really need a biocide i.e. do you need a product to control / deter or kill harmful organisms?
If a biocidal product is necessary, ensure that:
- The active substance is authorised or under assessment.
- The product is suitable for the intended application i.e. is the product approved or being assessed for your specific application?
Is it expensive to have a Biocidal Product authorised?
Yes it is. 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.
Does this mean there will be fewer disinfectants available?
Most probably. Evans Vanodine and other companies will rationalise their disinfectant ranges, either due to lack of demand or lack of authorised active suppliers. The costs will have to be passed on but the market is very competitive, so we suspect the increase will be minimal.
What do Evans think of the BPR?
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 on labels and on literature.