There may be various sources of an active substance. A source is linked to a production location of a given producer. Even if the production method is changed at a given location, the profile of an active substance may also change and this is then referred to as a new 'source'.
During the approval of an active substance, a reference specification is determined based on the first approved source(s) (in other words a minimum level of purity and maximum content of impurities). This/these initially examined source(s) are referred to as the reference source(s). For an application for a new source, or for modifications to existing sources, the specification of the new source is always compared with the reference specification. This is referred to as the equivalence assessment. A new source is declared to be equivalent and authorised if it does not have more harmful effects than the reference source (cfr. art. 29, 1, (b) of Regulation (EC) 1107/2009).
Application for an equivalence assessment
The following data need to be submitted:
- 1 copy (electronic and hard copy) of the study reports and the doc. J (confidential summary)
- an electronic copy of the assessment report template, completed with due observance of the following instructions:
- new specificationsfor an active substance of the same producer (modification of the analytical method(s), production location, etc.): complete the template with a comparison between old and new specifications in Tier I and, where appropriate, a proposal for toxicological and ecotoxicological assessment in Tier II.
- new source (new producer): complete the template with the specifications and analytical methods of the new source (Tier I partially completed). If necessary, more information and/or data can be requested in order to facilitate an assessment in Tier II (toxicology and ecotoxicology).
Generally, the RMS will carry out the equivalence assessment, but in principle any Member State can perform it. The conclusion is subject to an EU peer review. The terms for this assessment are laid down by art. 38 of Regulation (EC) 1107/2009 and are clarified in the EU guidance document SANCO/10597/2003.
Use of an equivalent source
In order to be able to use a new, equivalent source in a plant protection product in Belgium, an application for an official approval must be submitted. For the equivalence assessment, reference can be made to the assessment which was carried out by the RMS and which was subjected to a peer review. It is important that the application is submitted in good time in Belgium, along with the supporting data, in order to allow participation in the peer review.
Use of multiple equivalent sources of the same active substance
An authorisation holder may replace one source with an alternative source of the same active substance without notification, on condition that:
- the authorisation holder has already submitted an application for the use of the alternative source for the plant protection products in question
- both sources are approved and authorised in Belgium.
In all other cases, an application must be submitted to be able to use an alternative source.