Information Bulletin. What is the Biocidal Products Directive and why should I need to know about it?

The Biocidal Products Directive 98/8/EC (BPD) came into force in May 2000. Its objectives are to:

Provide a mechanism to harmonise Biocidal Products and their Active Substances, allowing for products authorised in one European Member State to be recognized in others.

 

Provide a high level of protection for people, animals and the environment through the risk assessment of Biocidal Products, and ensure that products are sufficiently effective against their target species.

 

How does it work?

All biocidal Active Substances that were on the market in 2000 were identified and those where there was intent to leave on the market were notified as of interest. These notified substances have, over the intervening period, been subject to a review process during which data, called in in the form of dossiers, have been evaluated and Risk Assessments made.

 

Those Active Substances that are authorized for use will be listed in an Annex to the Directive, Annex 1.

 

Today, Biocidal Products can only contain notified Active Substances. Eventually, as these substances find there way onto Annex 1, Biocidal Products themselves will be subjected to similar evaluations and, once authorized, will also populate an Annex.

 

What is a Biocidal Product?

The BPD has clear definitions of what a Biocidal Product is. It applies to products that kill, make harmless, repel or control harmful organisms by chemical or biological means.

The BPD is wide ranging in scope and has therefore been broken down into discreet sections known as Product Types (PTs). There are 23 of these PTs. Some of the uses that make up these PTs are obvious – such as disinfection, preservation and water treatment. Others are less so, such as embalming and antifouling.

 

How does the BPD affect me and what do I need to do?

If you manufacture an Active Substance, then you have already submitted a dossier for each active substance, or had one submitted on your behalf. This dossier will have either been reviewed or will be in the process of review. Following successful review, your substances will appear on Annex 1.

 

If you are a formulator of active substances into Biocidal Products then this is a very active time for you. Active Substances have now been submitted for Authorisation and subsequent inclusion on Annex 1.

 

 I am a Formulator and the Active Substance that I use has been notified – what do I do?

As a Formulator you are now in a Transitional Phase, where your formulation is on the market containing substances that Authorisations have been applied for.

 .You need to:-

 

Determine whether your product is a Biocidal Product as described within the BPD.

  

Clarify with your supplier the status of the substance in question and that it has been included within the PT that you require – this is very important as most active substances have only be supported for a limited number of PTs.

  

Check if there is any existing legislation that applies to your product type and ensure that you are within compliance.

 

 Inform the national Poisons Information Service (NIPS) before placing the product on the market in the UK.

  

Check your liability for the general industry charge.

 

Comply with the Biocidal Product Regulations that relate to advertising.

 

What about when the Active Substance that I use has been placed on Annex1?

When the active substances in your product are placed on Annex 1 of the BPD then you will need to gain authorization or registration for your biocidal product if you intend to remain on the market. You will need this within 2 years of the active substance being formally placed on Annex 1.