Guidance

  • For C, resources for environmental risk assessment include, but are not limited to, those in the Resources section.
  • For E, as the number of organic ingredients for products sold in the United States in this product category that have been evaluated for biodegradability using standardized test methods, or accepted in silico models where appropriate, divided by the total number of organic ingredients for products sold in the United States in this product category, then multiply by 100.
  • Calculate F as the number of organic ingredients for products sold in the United States in this product category that achieve pass level criteria for ready or inherent biodegradability using standardized test methods, or accepted in silico models where appropriate divided by the total number of organic ingredients for products sold in the United States in this product category, then multiply by 100.
  • Calculate G as the number of ingredients for products sold in the United States in this product category that were evaluated for environmental fate and environmental risk that have been determined to be safe for the environment in this product's use scenario, dividing by the total number of ingredients for products sold in the United States in this product category, then multiply by 100.


Resources

European Chemicals Bureau - Technical Guidance Document on Risk Assessment:  This document outlines environmental chemical risk assessment methodologies for notified new substances.


EPA Ecological Risk Assessment:  This EPA website describes the phases necessary for effective ecological risk assessment which include planning and scoping, problem formulation, analysis, and risk characterization.


OECD Guidelines for Testing of Chemicals, Section 3 - Test No. 301:  Ready Biodegradability:  This OECD Test Guideline outlines the steps necessary to perform tests for ready biodegradability.


OECD Guidelines for the Testing of Chemicals, Section 3 - Test No. 302B:  Inherent Biodegradability:  Zahn-Wellens/EVPA Test.  This OECD Test guideline outlines the steps necessary to perform tests for inherent biodegradability.


Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b:  Endpoint specific guidance.  Version 4.0 - June 2017:  This guidance document provides valuable information regarding REACH regulatory requirements with emphasis on substance properties, exposure, uses, and risk management measures.


Definitions

Biodegradability:  A property of matter in which it is able to be decomposed by bacteria or other living organisms.


Environmental fate:  The fate of a chemical in the environment after its disposal by a consumer.


Risk assessment:  A systematic process to evaluate the potential risks associated with environmental release of individual ingredients or final formulations.