Brazil Establishes Strict Residual Limit for Ethylene Oxide in Food Additives

On August 23, 2023, Brazil's Health Regulatory Agency (ANVISA) published a proposal to amend Resolution RDC No 778, establishing the general principles, technological functions and conditions of use of food additives and technological adjuvants. ANVISA initiated a public consultation period to gather feedback and comments, and interested parties are encouraged to submit their comments and suggestions before October 13.

Proposed Amendment:

• Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
• Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
• Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
• Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
• Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
• Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
• Polyethylene glycol, INS 1209

Background:

On March 1, 2023, Brazil's ANVISA published Resolution RDC No 778 which covers the following contents:

• What are food additives and technological adjuvants?

• Food additives refer to substances intentionally added to food to maintain or improve its physical, chemical, biological, or sensory properties during manufacturing, processing, preparation, packaging, storage, transportation, etc., without providing any nutritional value.
• Technological adjuvants are materials or substances (excluding equipment and appliances) intentionally used in raw materials, ingredients, or food preparation processes to achieve certain objectives, which are not consumed as ingredients themselves but may unavoidably result in residues or derivatives in the final product.

• General principal for the use of food additives:

The following principles shall be met when food additives and technological adjuvants are used in food materials or articles:

1. Food additive or adjuvants safety;
2. Justification for the use of additives or adjuvants;
3. Maximum use level to be functionally effective.

References

The use of food additives or technological adjuvants shall depend on toxicological assessments to ensure its concentration within the acceptable daily intake(ADI). Toxicological assessments shall be made on sci-tech data including:

1. pharmacokinetic research describing absorption, distribution, metabolism and excretion;
2. toxicological research including genotoxicity, acute toxicity, repeated dose toxicity, (multi-generation) reproductive toxicity, developmental toxicity, chronic toxicity or carcinogenicity;

As to specific effects, additional researches are required, such as neurotoxicity, immunotoxicity, anaphylaxis, endocrine disorder and etc. 

Food additives or technological adjuvants shall comply with the specification, purity and composition as specified in at least one of the following references:

1. Joint FAO/WHO Expert Committee on Food Additives (JECFA)
2. Food Chemicals Codex (FCC).

Value standard

1. If relevant references do not specify individual limit standards for arsenic and lead contaminants, arsenic/lead must not exceed 1 mg/kg. For technological adjuvants not specified in references, specifications approved by the Brazilian National Health Surveillance Agency (ANVISA) should be adopted. 
2. When using two or more food additives with same function and specified maximum use levels, the total volume of these additives must not exceed the higher standard of an additive for authorized functions. 
3. If the same food additive is used to achieve two or more different technological functions with different maximum use levels, the volume of the additive must not exceed the higher limit among the authorized functions.