A guidance document on frame formulations was released. The guidance describes how the concept of ‘frame formulations’ should be handled in practice.

Important considerations in the guidance document are:

• A frame formulation is a generic specification of a series of products for a given use and user type. The specification of the products is in terms of the active and non-active substances present and the allowable range of the concentrations at which each substance may be present in products that belong to the frame.

• Variations in concentration should not affect the level of risk or decrease efficacy.

• The assessment of the frame formulation will be conducted to assess the maximum risks to health and environment and the minimum level of efficacy over the whole potential range of composition of the frame formulation as specified.

• Pigments, dyes and perfumes can be replaced by alternatives, with the implication that the alternatives could be present at different concentrations.

• What is an acceptable concentration range will depend on the nature of the substance and its properties and how its concentration may affect the product overall. The allowable range will be smaller for components with hazardous properties as changing the concentration significantly will potentially impact on the risk level. The classification of any product within the frame formulation should normally be the same.

• One would expect other properties, such as the type of formulation, the instructions for use, not to be affected by the variations in concentration.

• A frame formulation has to be established in connection to an authorisation, either at the same time or later. In most cases it will however make more sense in practice to establish the frame formulation in the first instance, and then to assess individual products falling within the frame formulation for authorisation.

• The frame formulation is based on data owned by a company and may not be used by a competent authority for biocidal products in application procedures for the benefit of other applicants unless a respective letter of access has been submitted.

In future, there might be simplified procedures for frame formulations, cf. Commission proposal for a Regulation concerning the placing on the market and use of biocidal products (COM(2009)267).