Division Introduction
United Kingdom
The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.
It is desirable to have a plant protection product without contaminants, if possible. The level of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
Both production and product must be subject to a continuous quality control by the applicant. The quality criteria for the product shall be submitted.
For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.
Descriptions of methods must be provided and include details of equipment, materials and conditions used. The applicability of existing CIPAC methods must be reported.
As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.
For this Section the following applies:
| Impurities, metabolites, relevant metabolites, residues | As defined in Article 3 of Regulation (EC) No 1107/2009 |
|---|---|
| Relevant impurities | Impurities, as defined above, that are of concern for human or animal health and/or the environment |
On request the following samples must be provided:
- (i)
samples of the preparation;
- (ii)
samples of the micro-organism as manufactured;
- (iii)
analytical standards of the pure micro-organism;
- (iv)
analytical standards of relevant metabolites and all other components included in the residue definition;
- (v)
if available, samples of reference substances for the relevant impurities.