Comprehensive Analysis of Scientific Data and Safety Guidelines for PLA and PBAT

PLA (polylactic acid) and PBAT (polybutylene adipate/terephthalate), as preferred biodegradable raw materials, are widely used in many food packaging, daily necessities, and environmentally friendly products. However, many consumers are extremely concerned about the safety of these materials when using them. Some even worry about the release of harmful substances during use. This article will comprehensively analyze the safety of these two materials based on authoritative international research results, industry standards, and product application data to help you make a scientific and safe choice.

I. Safety Assessment of PLA

PLA (polylactic acid) is a biodegradable material made from plants such as corn and sugarcane, and has passed food contact safety certifications from the US FDA and the EU EFSA. Research has verified that PLA does not release toxic substances under normal use conditions and can naturally degrade into lactic acid and metabolize into water and carbon dioxide, with no cumulative toxicity. However, it is important to avoid use at temperatures exceeding 60°C to prevent changes in material properties. Choosing PLA products with authoritative certifications ensures safety and reliability.

1. Raw Material Source and Production Process

PLA is mainly made from renewable plant resources such as corn and sugarcane. Lactic acid is produced through microbial fermentation and then polymerized into a high-molecular-weight material. Its production process has the following safety characteristics:

(1) The raw materials are food-grade agricultural products, free of petroleum-based harmful substances;

(2) No phthalates, bisphenol A, or other environmental hormones are added during the polymerization process;

(3) The product is certified by the US FDA and EU EFSA as food contact materials;

2. Toxicological Research Conclusions

(1) Acute and Chronic Toxicity Tests: In animal experiments, no organ damage, immunotoxicity, or carcinogenic reactions were found in PLA;

(2) Metabolic Pathway: PLA can be gradually degraded into lactic acid in the human body, participating in the tricarboxylic acid cycle, and ultimately converted into water and carbon dioxide for excretion;

(3) High Temperature Safety Threshold: PLA is structurally stable at ≤60℃; above this temperature, hydrolysis may be accelerated, but the degradation product is still lactic acid, with no toxic gas release.

3. PLA Usage Precautions

(1) Avoid using PLA products to hold boiling water or high-temperature food (e.g., microwave heating);

(2) Long-term contact with strong acids, strong alkalis, or high-oil substances is not recommended;

(3) Choose products marked with “food grade” or “FDA certified”;

II. Safety Analysis of PBAT

PBAT, as a petroleum-based biodegradable material, has passed multiple international authoritative certifications for its safety. Under standardized production conditions, PBAT does not contain harmful plasticizers or heavy metal residues, meeting food contact material standards. Experimental studies have shown that its chemical properties are stable in normal temperature environments and it does not release toxic substances.

Products certified by FDA, REACH, etc., can be completely degraded into water, carbon dioxide, and biomass under industrial composting conditions, with no negative impact on human health or the ecological environment. It is recommended to choose compliant products with complete certification marks.

1. Chemical Stability and Biocompatibility of PBAT

PBAT is polymerized from petroleum-based monomers, but the ester bonds in its molecular structure can be enzymatically degraded by microorganisms in a composting environment. Key safety features include:

(1) Chemically stable at room temperature, without releasing volatile organic compounds;

(2) Compliant with EU REACH regulations, not listed in the list of substances of very high concern;

(3) Meets food packaging standards by passing migration tests (e.g., total migration < 10 mg/dm²);

2. Safety verification by authoritative institutions

(1) FDA certification: Permitted for use in food contact films, packaging bags, etc.;

(2) German LFGB testing: Passes multiple safety screenings including sensory testing and heavy metal leaching;

(3) Meets Chinese GB 4806.7-2016 “Plastic Materials for Food Contact” standard;

3. Potential risk management

PBAT’s safety hazards mainly stem from process control during production:

(1) Strict monitoring of residual monomer (e.g., adipic acid, 1,4-butanediol) content is required;

(2) Adding masterbatches or additives containing heavy metals such as lead and cadmium is prohibited;

(3) Priority should be given to purchasing products with ISO certification. Products certified under the ISO 13485 Medical Device Management System;

III. Key Factors Affecting the Safety of PBAT/PLA Materials

The core factors affecting the safety of PLA/PBAT lie in the purity of raw materials, production processes, and usage conditions. Raw materials must meet food-grade standards (e.g., PLA derived from non-GMO crops), and the production process should strictly control catalyst residues and harmful additives (such as heavy metals and plasticizers).

The material’s operating temperature (PLA is recommended to be below 60℃, PBAT below 80℃) and the type of substances it comes into contact with (e.g., strong acids, oils) also directly affect the material’s stability and safety. Choosing products with international certifications such as FDA and REACH can maximize safety during use.

1. Production Process and Quality Control

(1) Material Purity: Industrial-grade PLA/PBAT may have residual catalyst; food-grade standards require a purity >99.5%;

(2) Additive Compliance: Environmentally friendly plasticizers (such as citrate esters) and natural pigments (such as titanium dioxide) must be used;

2. Usage Scenarios and Conditions

(1) Operating Temperature: PLA should be used at a temperature <60℃, and PBAT at a temperature <80℃;

(2) Contact Substances: Avoid prolonged storage of liquids with an ethanol concentration >50%;

(3) UV Exposure: Long-term outdoor use may accelerate aging; it is recommended to choose models with added UV-resistant additives;

3. Certification System Guarantee

(1) Biodegradability Certification: ASTM D6400, EN 13432;

(2) Food Safety Certification: FDA 21 CFR, EU 10/2011;

(3) Quality Management System: ISO 9001 and BRCGS Packaging Material Certifications;

IV. Recommendations for Special Populations

For infants, pregnant women, and those with sensitive skin, it is recommended to prioritize products made of pure PLA material. Its raw materials are derived from natural crops, and no chemical plasticizers are added during the production process, making it safer. Before use, a short boiling water sterilization process can be performed (PLA products should not exceed 2 minutes). Before first use, those with sensitive skin should test a small area on their arm and choose products without dyes or fragrances to reduce the risk of allergies. Daily storage should avoid high temperatures and strong light to ensure material stability.

V. Frequently Asked Questions

1. Q: Will hot water in a PLA cup produce plasticizers?

A: No. PLA can be processed without plasticizers. High temperatures only accelerate its hydrolysis into lactic acid, but may cause the cup to deform. It is recommended to use it at a temperature ≤60℃.

2. Q: Is PBAT cling film safe for contact with oils?

A: FDA-certified PBAT film meets the total migration standards for oily food packaging. However, it is still recommended to avoid directly wrapping hot, oily foods (such as freshly fried chicken).

3. Q: Does the lactic acid released from biodegradable materials irritate the skin?

A: Lactic acid is a component of the skin’s natural moisturizing factor. Low concentrations of lactic acid in composting environments are quickly metabolized by microorganisms and are non-irritating.

VI. Conclusion: Scientific Choices, Safe and Environmentally Friendly

Choosing PLA and PBAT products that meet international standards is based on rigorous scientific safety decisions. These materials have passed toxicological testing by globally recognized authoritative institutions, strictly avoiding harmful substances found in traditional plastics during production and use, translating environmental commitments into practical protection for health. Every responsible choice is a practice of sustainable development—protecting the health of your family and nourishing the future of the planet. Let us use scientific understanding to guide green living, ensuring that environmental protection and peace of mind truly go hand in hand.