Do you supply disinfectants, preservatives, insecticides or other products designed to control harmful organisms? Or do you use these to protect your formulations or products? If the answer to either of these questions is a 'yes', then the new Biocidal Products Regulation will affect you.
The EU Biocidal Products Regulation (BPR) entered into force on 1 September 2013 and from that date it placed duties on manufacturers and importers of substances, formulators, importers of mixtures, producers and importers of articles and end users. These duties are summarised below:
Manufacturers or importers of substances
If the substance has an action on or against harmful organisms and is placed on the market for use in a biocidal product the manufacturer or importer must ensure that the active substance is approved for use in the biocidal product-type in which it is to be incorporated*, for example those who manufacture ethanol which is supplied to be used in disinfectants. The manufacturer or importer must also ensure they are included on the list of active substance suppliers for that active substance/product-type combination.
If the substance itself does not have an action on or against harmful organisms, but has been treated with a biocidal product, for example an in-can preservative, then it is in fact a mixture and is regarded as a ‘treated article’. The active substance within the biocidal product used for the treatment must be approved under the BPR for the product-type in which it was used*. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.
Formulators of mixtures
If the mixture has a biocidal function - i.e. it is placed on the market with a purpose of protecting humans, animals, materials or articles against harmful organisms through the action of the active substance it contains - an authorisation must be obtained. One of the requirements for the granting of an authorisation is that the active substance has been approved for the product-type in which it is contained*. For example, if supplying an anti-microbial hand soap, the active substance contained (e.g. ethanol) must be approved for product-type 1 (human hygiene bioicdal products). The formulator must also ensure that the supplier of the active substance is included on the list of approved active substance suppliers, or otherwise be included himself.
If the mixture itself does not have a biocidal function, but it has been treated with or intentionally incorporates a biocidal product in order to exert a protective effect on the mixture itself, for example an in-can preservative, then the mixture is a ‘treated article’. The active substance within the biocidal product must be approved under the BPR for the product-type in which it was used*. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.
Importers of mixtures
If the mixture has a biocidal function – i.e. it is placed on the market with a purpose of protecting humans, animals, materials or articles against harmful organisms through the action of the active substance it contains – an authorisation must be obtained. One of the requirements for the granting of an authorisation is that the active substance has been approved for the product type in which it is contained*. For example, if supplying an anti-microbial hand soap, the active substance within it, e.g. ethanol, must be approved for product-type 1 (human hygiene biocidal products). The importer must also ensure that they are included on the list of active substance suppliers for that active substance/product-type combination.
If the mixture itself does not have a biocidal function, but it has been treated with or intentionally incorporates a bioicdal product such as an in-can preservative prior to or following import, then the mixture is a 'treated article'. The active substance within the biocidal product must be approved under the BPR for the product type in which it was used*, even if the treatement took place outside the EU. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.
Producers or importers of articles
If the primary function of the article is biocidal – that is, it is placed on the market with the primary purpose of protecting humans, animals, materials or articles by means other than solely physical or mechanical action – an authorisation must be obtained. One of the requirements for the granting this authorisation is that the substance which provides this biocidal function is approved under the BPR for the product-type in which it is used*. For example, if an insecticide-soaked mosquito net is placed on the market, the active substance (e.g. pyrethrin) must be approved for product-type 18 (insecticides, acaricides and products to control other arthropods).
If the article does not have a primary biocidal function but it has been treated with or incorporate a biocidal product; for example wooden garden furniture treated with a preservative, then the active substance within that biocidal product must be approved under the BPR for the product-type in which it was used*. Specific labelling related to this treatment may be required, depending on the claims made by the supplier and on the conditions of approval of the active substance.
End users
End users may not use a bioicdal product that has not been authorised under the BPR*, and must use it in accordance with any provisions stated in the authorisation.
*Please note, approvals for active substance-product type combinations are currently being reviewed and transitional arrangements are in place to allow the continued supply of biocidal products until an approval decision is made. More information on these arrangements is available when you sign up for our FREE Silver subscription.
Further support
If you think some of the duties above may apply to you and want to know more, we run workshops which will give you an introduction to the BPR, as well as REACH or CLP – check out the training section of the website to find out more. Alternatively we can deliver bespoke training tailored to provide what you and your colleagues need to know about the Biocidal Products Regulation in your own workplace.
If you are unsure how the obligations described fit in with duties you already have under the REACH and CLP Regulations, take a look at our guidance document on the three pieces of legislation below:
REACHReady guidance
Ask for help if you think you need further information about your compliance with the BPR – REACHReady’s Gold subscribers get swift advice through our helpdesk and support through additional information on the Gold website. Why not contact us for more information?