Interpretation of the New Regulation: Five Key Changes in EN13432-2024

The new EN13432 standard, which is scheduled for formal implementation by the European Commission in June 2024, introduces a series of more stringent requirements specifically targeting PLA/PBAT materials. According to statistics released by TÜV Süd, the certification pass rate in the first month following the standard’s implementation was only 58%, representing a significant 24-percentage-point decrease compared to the previous standard. This dramatic drop underscores the challenges manufacturers face in adapting to the new requirements.

The main changes introduced in the 2024 version of the standard include:

1. Extended test cycle: The required testing period has been doubled from 90 days to 180 days, with the actual time consumed from start to finish typically extending to about 8 months due to administrative and logistical factors.

2. Tighter heavy metal limits: The maximum allowable lead content has been reduced from 50mg/kg to 20mg/kg, reflecting growing concerns about the environmental and health impacts of heavy metal contamination.

3. New ecotoxicity test: A novel requirement mandates that the survival rate of earthworms exposed to the material must be at least 90%, ensuring that the degradation products are not harmful to soil organisms.

4. Microplastic testing: Adopt the “sieving-infrared detection method” in accordance with ISO 19748 standard (test temperature: 58±2℃, test time: 28 days).Ecotoxicity test: Refer to OECD Test Guideline 207 (Earthworm Acute Toxicity Test), with a test period of 14 days and a required survival rate of ≥90%.

5. Label standardization: Products must now clearly indicate their composting suitability with standardized labels stating either “industrial composting only” or “home composting,” providing crucial information to consumers and waste management facilities.Supplement the core differences between the two standards to meet the needs of enterprises exporting to both Europe and North America, as shown in the table below:

   	EN13432 (EU)	ASTM D6400 (North America)
   Testing Cycle	180 days	180 days (can be shortened to 90 days for some products)
   Heavy Metal Limit	Pb ≤ 20mg/kg	Pb ≤ 100mg/kg
   Microplastic Requirement	Mandatory (<5mm particles ≤ 0.1% of total mass)	No mandatory requirement
   Application Scope	All biodegradable plastics	Mainly for compostable plastics

Technical Response: Material Modification Four-Step Method

To address these new challenges, industry consultants have developed a comprehensive four-step technical response plan for material modification that companies can implement:

Step 1: Formulation Optimization

 

For PLA materials:

• Incorporate 1-3% of a high-performance chain extender (such as ADR-4468) to significantly enhance molecular weight and improve melt strength.
• Adopt a recommended compounding ratio of PLA/PBAT = 70/30. This specific ratio has been shown to increase throughput rates to approximately 82%, improving production efficiency while maintaining material performance.

Step 2: Key Points for Process Adjustment

Process Parameter	Old Standard	New Standard (for EN13432 Compliance)
Extrusion Temperature	155-165℃	145-155℃ (to prevent thermal degradation)
Drying Time	4-6 hours	8-10 hours (to reduce moisture content to ≤0.05%)
Die Pressure	18-22 MPa	15-18 MPa (to improve product uniformity)

 

Step 3: Additives Selection

Essential additives:

• Anti-hydrolysis agent: (e.g., Stabaxol P200) to protect the material from degradation caused by moisture during processing and storage.
• Calcium Carbonate Nanoparticles: (5-8% by weight) to enhance the disintegration process in composting environments without compromising mechanical strength.

Prohibited agents:

• Lead/cadmium-containing color masterbatches: Strictly forbidden due to the new heavy metal limits, compliance with which is essential for maintaining access to the EU market.
• Talc with particle size >5μm: Larger talc particles can impede disintegration and may contribute to microplastic formation, thus their use is discouraged.

Certification Strategy: Reduce Time and Cost

Certification Process Illustration (2024 New Version)

The updated certification process now follows this timeline:

1. Weeks 1-2: Complete pre-testing of heavy metals in existing formulas (Recommended institution: TÜV local laboratory)

2. Weeks 3-4: Select a certification body and submit pre-consultation (Required documents: MSDS, process flow chart)

3. Weeks 5-8 (Diagnosis Phase): Analyze formula defects and finalize optimization directions

4. Weeks 9-18 (Improvement Phase): Debug process parameters and conduct small-batch trial production

5. Weeks 19-26 (Certification Phase): Submit samples to the certification body and track test progress

Cost Control Tips

1. Combination certification: Utilize packaged testing services for similar biodegradable products to achieve approximately 30% cost savings compared to testing each product individually.Combined certification cost formula: Combined certification cost = Single product testing fee × Number of products × 70%Example: For 3 similar products with a single testing fee of $10,000 per product, the combined certification cost is $10,000 × 3 × 70% = $21,000, saving $9,000 compared to separate testing ($30,000).

2. Pre-screening service: Conduct initial heavy metal and microplastic screening before the full certification process ($800 per test), allowing for early identification and remediation of potential issues, thus avoiding costly delays for PBAT firms.

3. Green channel: Consider using TÜV’s “fast track” service, which, although requiring an expedited fee of $5000, can significantly reduce the overall certification timeline, helping to maintain market responsiveness and global competitiveness.

Enterprise Practical Case Library

Successful Case A: A PLA Lunch Box Company

• Problem Identified: The initial disintegration test resulted in a rate of only 83%, falling short of the new 90% requirement for biodegradable products.
• Implemented Solution:
  • Added 3% citrate plasticizer to improve the material’s flexibility and facilitate the disintegration process of the biodegradable lunch box.
  • Adjusted the product thickness from 0.4mm to 0.3mm, reducing the mass that needs to be broken down without compromising functionality.
• Measured Result: The second test successfully reached a disintegration rate of 96%, with the entire process taking 4 months from start to finish. This rapid adaptation is a testament to how companies can quickly respond to regulatory changes to protect their global competitiveness.

Failure Case B: A PBAT Mulch Film Manufacturer

• Key Lesson Learned: The company neglected the newly introduced earthworm ecotoxicity test, resulting in a survival rate of only 72%, well below the required 90% for biodegradable materials.
• Quantified Loss: The oversight led to a retesting cost of $18,000, in addition to substantial order postponement penalties, highlighting the importance of understanding all new requirements for PBAT firms to avoid financial damage and protect their global competitiveness..

PLA/PBAT vs. Emerging Materials

Material Type	Certification Difficulty	Cost (USD/ton)	Production Flexibility	Technical Maturity
PLA/PBAT	Medium	2100-2500	High (suitable for large-scale production)	Mature
PHA	High	3500-4200	Low (global capacity ≈ 100,000 tons/year, only 5% of PLA/PBAT)	Moderate
Cellulose-based	Medium-High	2800-3200	Medium (depends on agricultural waste raw material supply)	Moderate

 

Day 1-30: Diagnostic Phase

• Conduct comprehensive pre-testing of all existing formulations of biodegradable materials, with a specific focus on heavy metal content and disintegration rate performance.
• Research and select an appropriate certification body, with strong recommendations for established leaders like TÜV or SGS, to ensure a smooth certification process.

Day 31-90: Improvement Phase

• Implement adjustments to process parameters based on the technical recommendations outlined in the four-step method above, optimizing the production of biodegradable products.
• Prepare multiple small-scale trial samples (at least 3 separate batches) to evaluate different formulation and process adjustments, a key step for PBAT firms seeking to innovate while ensuring compliance.

Day 91-180: Certification Phase

• Submit a complete and thorough set of application documents for the biodegradable products, including detailed MSDS (Material Safety Data Sheets) and comprehensive process descriptions.
• Begin simultaneous preparation of new version packaging designs that comply with the new labeling standardization requirements, ensuring all market-facing elements reflect the company’s commitment to quality and sustainability, which are vital for maintaining global competitiveness.

Expert Warning

Dr. Schmidt, Technical Director of the International Society for Biodegradable Materials (ISBM), has issued a stark warning: “It is expected that 25-30% of SMEs (Small and Medium-sized Enterprises) will exit the EU market in 2025 due to their inability to meet the new standards.” This prediction underscores the critical juncture facing PBAT firms in the biodegradable materials sector. He strongly advises companies to take immediate action and specifically highlights the following three “life-saving” tips to preserve their global competitiveness:

1. Formulation backup: Develop and validate at least two standardized formulations of biodegradable materials to provide flexibility and a safety net in case one fails certification.

2. Certification front-loading: Initiate the certification process at least 8 months in advance to accommodate the extended testing cycles and potential delays, a strategic move for PBAT firms to avoid missing market opportunities.

3. Proactive customer communication: Engage with customers early to explain the inevitable changes in lead times caused by the new, more complex regulations for biodegradable products, managing expectations and strengthening business relationships, which is essential for long-term global competitiveness.

Data Sources:

• TÜV Süd Certification Report (June 2024)
• ISBM Industry White Paper (Q2 2024)
• European Bioplastics Association Market Research (May 2024)