This is a short introduction to the requirements to an application for authorisation of families of biocidal products
On this page the EPA will outline the possible contents of a product family under the BPR as well as how to describe the various elements in your application. There is a more detailed EU Guidance and a guidance video on YouTube. Links below will take you to these tools.
The BPR defines a product family (biocidal product family) as a group of biocidal products having:
(i) Similar uses;
(ii) The same active substances;
(iii) Similar composition with specified variations; and
(iv) Similar levels of risk and efficacy;
Similar uses comprise the users, target organisms and areas of use, as well as how, how often and how much of the product must be used.
Same active substances comprise the active substances used to give the product the necessary efficacy. These substances must be found in all products in the family. On proof that an active substance is present in such a small quantity that the efficacy of a product is not affected this active substance shall not be counted.
Similar composition with specified variations means that it must be defined how the single products within the family may vary relative to each other. For example the definition may show that the active substance is present in quantities between one and three per cent.
All products must be proved effective.
It is not a requirement that all products have the same form, for example liquids. A Product Family may comprise more formulations, e.g. liquids and gels, but it must still be proved that each product is efficient within the variation allowed for the family.
Similar levels of risk and efficacy shall not mean that all products must be classified alike. This also means that a concentrate and a ready-to-use product may be found in the same family - provided that the products are grouped within the family in Summary Product Characteristics documents (SPCs) according to risk and risk mitigation. All products in the family must be proved efficient.
Documentation for the application
The documentation needed in an application comes at three levels: For each family, for each group of products with equal properties and for each specific product.
The applicant must provide the necessary information at all three levels to give an overview of the uses applied for and the composition of the products.
The overall SPC shall define the outer limits for composition and use. One or more meta-SPCs shall group products with similar form, composition and use. For specific requirements to the meta-SPC see below.
Finally, an SPC for each product must be supplied, based upon the meta-SPC to which the product has been grouped.
For publication with authorised products the applicant shall produce an SPC summarizing the properties of the product. The form to be used may be found in the Register for Biocidal Products, R4BP. The applicant shall also produce a meta-SPC covering products with similar properties within the family.
Each meta-SPC shall facilitate the work of the authorizing Member State regarding the conditions on which products in the family can be authorised. This will also facilitate the addition of new products.
There are specific requirements to how use and details of the properties of the product may be grouped in a meta-SPC. For example must risk-mitigating provisions, including the use of protective equipment, be alike for the specific products in the meta-SPC. The classification of the products must also be the same.
One meta-SPC should only contain summaries for products with like formulations, thus in a family with products for udder hygiene gels should be covered by one meta-SPC and wipes in another because the concentration of the active substance may differ in the two types of products.
In the same way different meta-SPCs for each formulation must be produced if different safety equipment should be used, for example if gloves must be used for the gel but not the wipes. Also efficacy at the same concentration of active substance(s) may differ for specific uses and this would also require two or more meta-SPCs.
Requirements for first aid, storage or disposal may also necessitate the production of more meta-SPCs. For example the risk of getting the product in the eyes may be greater when using a spray than applying the product with a brush or a painting roll.
Two different meta-SPCs must be produced if the use of a concentrated product requires protection or residues must be disposed of in a specific way, whereas a ready-to-use formulation does not make such precautions necessary.
The EPA urges applicants considering Denmark as Receiving Member State for an application for national authorisation to contact the EPA before the application is submitted in order to agree on the composition of the product family and the corresponding meta-SPCs.
Where an active substance is deemed a candidate for substitution each use of products must undergo a comparative assessment. This might favour the grouping of products with same use and same active substance in a meta-SPC.
Each meta-SPC must contain at least one concrete product, but a meta-SPC with only one product may still comprise a limited variation of the concentration of the active substance, e.g. between one and three per cent active substance. This may facilitate the addition of more products at a later stage. The limitation must be within the lower limit for efficacy and the upper limit for the amount of active substance.
All target organisms must be evaluated in the meta-SPC. A product against flies is not necessarily efficient against wasps.
Letter of Access
Only one Letter of Access is necessary for each active substance in the family.
Guidance video on You Tube
ECHA's SPC Editor
Guidance document on families (link to follow)