Reproduction/Developmental Toxicity Screening Test of the Smoke Flavouring Primary Products in accordance with OECD Test Guideline (TG) 421

Certain ingredients that fall under food improvement agents need authorisation which requires safety assessment by European Food Safety Authority (EFSA). Examples of these ingredients are flavouring substances (such as acetaldehyde, limonene), enzymes, food additives, smoke flavourings and other flavourings. EFSA dictates the studies that must be conducted and reported in applications for approval.  

The EFSA Scientific Guidance, Section 3, specifically requires additional animal based toxicological studies be carried out as adequate human data are unlikely to be available. For smoke flavourings, we are required to follow this guidance document. 

This testing applies ONLY for our three primary products that are currently authorised in the EU. This testing is currently unavoidable for authorisation of these ingredients in the EU, or the ingredients will be prohibited for use. Please see Kerry Group’s Animal Welfare statement by clicking here.  

We have completed a Reproduction/Developmental Toxicity Screening Test of the Smoke Flavouring Primary Products in accordance with OECD Test Guideline (TG) 421 for purposes of dose-range finding and screening for potential effects. Our findings suggest very low potential for reproductive or developmental toxicity for the smoke flavourings. The links below are for the full OECD 421 studies and the summaries made available to EFSA. 

SF-OO2

• SF 002 OECD 421 Final Report
• EFSA summary SF-002

SF-005

• SF 005 OECD 421 Final Report 
• EFSA summary SF-005

SF-006

• SF-006 OECD 421 Final Report  
• EFSA summary SF-006

United States 

Smoke flavourings do not require FEMA GRAS approval. However, most other flavouring ingredients do. When required, results of toxicological studies must be provided to get FEMA GRAS approval. This article outlines which authorities require which toxicological studies to perform the required safety assessments. Kerry is not required in the US to perform this testing on our smoke flavourings and so we do not. 

 ISO Standard 

The International Organization for Standardization has developed ISO 23662.2021 Definitions and technical criteria for foods and food ingredients suitable for vegetarians or vegans and for labelling and claims. This standard recognizes that animal testing remains unavoidable “when required by public authorities’ regulatory procedures” and animal testing required for regulatory compliance does not invalidate vegan and vegetarian claims. 

 Advocacy for the replacement of animal based toxicological studies 

Alternatives to animal testing (collectively termed NAMs) have the potential to replace current practices. However, regulatory acceptance has not yet been established.  

EFSA has committed to principles of minimising the use of animal testing with their ‘3rs’ approach – replacement, reduction, and refinement of animal testing – per EU Directive 2010/63/EU. However, this commitment is lagging behind the legislation for the approval of food additives that continue to require substantial animal tests.   

As new scientific methods become available, we encourage our partners to join us in advocating for the approval of standards which replace the animal testing currently required with your industry associations and governmental bodies.