Regulatory Assessment

by Decernis
Increase Confidence in the Compliance of Your Products

Determining if a new product will be compliant or, as regulations evolve, maintaining the compliance of products already in market is complex and can slow down new product introduction. Regulatory personnel can spend countless hours working to identify the acceptable limits for different ingredients, reducing focus on more strategic objectives.

Our Regulatory Assessment solution simplifies meeting complex global regulations by analysing products or bills of materials against our trusted regulatory data to provide a colour-coded, compliance management dashboard that allows you quickly identify where your product is and isn’t compliant across more than 220 countries.

Regulatory Assessment supports regulatory professionals by providing:
  • Chemical, material, ingredient, and product-level compliance analysis
  • Analysis and comparison of global threshold requirements for additives and contaminants
  • Development of global declarations of compliance for a product, material, or ingredient
  • Access to information concerning global regulatory status and requirements
  • Upload your formulations and recipes and analyze their compliance
  • An archive of compliance data and material acceptance processes to support auditing and retain institutional memory
Modules available

The food additives module includes over 3,000 substances that can be added to human food as additives, flavours, vitamins or minerals. By choosing their functions and usages (food categories) in specific countries, a  red/amber/green matrix provides a visual overview of your compliance status across markets. Citations for the regulations related to the results matrix are provided, and users who subscribe to our Regulatory Library can click-though to open the document.

The Contaminants module contains thousands of pesticides as well as a myriad of veterinary drugs, mycotoxins, heavy metals, marine biotoxins and microbiologicals. The maximum residue levels regulated in specific commodities are easily found by substance or by commodity.

The standards of identity module contains the required ingredients and physiochemical measurements needed to meet the chocolate and ice cream standards around the world. A recipe built in the recipe management module is submitted to a standard category to make the ‘go’ or ‘no-go’ decision about whether the recipe meets the standard. If required ingredients are missing from a recipe, the missing substances report quickly shows what substances are needed.

The recipe management module provides allows you to either build a recipe on the fly or upload a recipe via a spreadsheet. You can also nest one recipe within another and then decide whether to submit each individual recipe for Additive or SOI analysis, or submit them together as one. When a recipe is submitted for Additive analysis, rules determine if the concentration levels of the additive ingredients meet their threshold levels both individually as well as in combination using molecular weight conversion factors when one substance is expressed as another.

This module allows you t to understand all contaminant requirements around the world for your products in a single search. Contaminants covered include:

  • Dioxins and PCBs
  • Filth
  • General
  • Guidance Documents
  • Heavy Metals
  • Hormonal Substances
  • Marine Biotoxins
  • Methods of Analysis
  • Microbiological Contaminants
  • Mycotoxins
  • Nitrates and Nitrites
  • Other Chemicals
  • Pesticide Residues
  • Veterinary Drug Residue