Brazil Proposes Regulations in Food Additives

Brazil's health regulatory agency, ANVISA recently announced a proposal to amend Resolution RDC 778/2023, which governs food additives and adjuvants in food technology. This proposed resolution seeks to establish a maximum tolerable residual limit for ethylene oxide in food additives, aiming to enhance consumer protection.

Ethylene Oxide Regulation

The proposed amendment to RDC 778/2023 introduces a crucial regulation concerning ethylene oxide levels in food additives. Specifically, it sets a maximum tolerable residual limit of 0.01 mg/kg for ethylene oxide in food additives. Ethylene oxide is a chemical used in various industrial processes, and its presence in food additives must be carefully controlled to ensure consumer safety.

Exceptions for Certain Food Additives

While the proposed regulation imposes strict limits on ethylene oxide, it includes exceptions for specific food additives. These exceptions apply to food additives that comply with the identity, purity, and composition specifications established by JECFA (Joint FAO/WHO Expert Committee on Food Additives) or FCC (Food Chemicals Codex). The listed food additives exempt from the maximum tolerable residual limit are as follows:

1. Polyoxyethylene (20) sorbitan monolaurate, polysorbate 20, INS 432
2. Polyoxyethylene (20) sorbitan monooleate, polysorbate 80, INS 433
3. Polyoxyethylene (20) sorbitan monopalmitate, polysorbate 40, INS 434
4. Polyoxyethylene (20) sorbitan monostearate, polysorbate 60, INS 435
5. Polyoxyethylene triestearate (20) sorbitan, polysorbate 65, INS 436
6. Grafted copolymer of polyvinyl alcohol (PVA) and polyethylene glycol (PEG), INS 1209
7. Polyethylene glycol, INS 1209

These additives, when meeting the specified criteria, will not be subject to the ethylene oxide limit, ensuring that they continue to be safe for consumption.

Public Consultation

ANVISA has initiated a public consultation period to gather feedback and comments from stakeholders and the general public. Interested parties are encouraged to submit their comments and suggestions regarding this proposed regulation within 45 days of the issuance of the public notice, which was posted on August 23, 2023. 

Ensuring Food Safety

The proposed regulation of ethylene oxide in food additives underscores ANVISA's dedication to ensuring the safety and quality of food products in Brazil. By setting a clear limit and providing exceptions for additives meeting stringent criteria, ANVISA aims to protect consumers from potential health risks associated with ethylene oxide exposure.

This important regulatory change reflects ANVISA's ongoing efforts to adapt and enhance food safety standards, aligning with international best practices while considering the unique needs of the Brazilian population. To submit your comments and engage in the public consultation process, visit ANVISA's official website.