(b) specifications of the impurities of the active substance and the relevant methods of analysis developed internally by the applicant, except for impurities that may have adverse effects on animal health, human health, or the environment.
(b) specifikacije o nečistoćama u aktivnoj tvari te relevantne metode analize koje je podnositelj zahtjeva razvio interno, osim nečistoća koje mogu imati negativan učinak na zdravlje životinja, zdravlje ljudi ili okoliš.".