General Plastics Italy DM21/03/73 Testing Procedure
Date：2026-01-09 09:37:34 Classification
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Italian regulation DM21/03/73 is one of the most important regulations in Italy concerning food contact materials. This regulation sets forth specific requirements for the safety, chemical composition, migration limits, physical properties, and hygiene standards of food contact materials.
I. Determination of Testing Items
Based on the material type and intended use, the following core items need to be completed:
1. Total Migration Test
Multi-media system: Covering 4 food simulants (corresponding to different food types)
| Simulant | Corresponding Food | Test Conditions
| 10% Ethanol | Alcoholic Beverages | 60℃ × 2 hours
| 3% Acetic Acid | Acidic Foods | 40℃ × 24 hours
| 95% Ethanol/Isooctane | High-Fat Foods | 20℃ × 10 days
Key Details: Temperature control accuracy must be ±0.5℃; use glass containers to avoid interference; after extraction, concentrate by rotary evaporation to constant weight (accuracy 0.1mg).
2. Primary Aromatic Amines (PAAs) Migration
Limits: Single and total ≤0.01 mg/kg
Detection Procedure:
① Extraction with 3% acetic acid (70℃×2h) → ② Dansyl chloride derivatization (60℃×30min) → ③ HPLC-FLD detection (excitation 254nm/emission 520nm).
3. Heavy Metal Migration and Content
Migration Test: Detection of 8 elements including Pb, Cd, and As (3% acetic acid, 100℃×2h, ICP-MS analysis)
Content Test: Colored plastics require additional testing for total heavy metals (microwave digestion followed by ICP-MS determination, e.g., Pb ≤90 mg/kg).
4. Color Migration (Colored Plastics Only)
Simulators: Water, 3% acetic acid, 10% ethanol, sunflower oil
Judgment Criteria: Color difference ΔE*ab ≤2.0, and no visible staining after wiping with a cotton swab.
II. Sample Preparation and Submission
1. Sample Requirements
Provide 3-5 complete samples (e.g., food containers must include lids), with a surface area ≥100cm², avoiding coated or printed areas (each must be tested separately).
Submit a material composition table (resin brand, additive names and amounts), indicating the type of food to be in contact with (e.g., acidic, oily).
2. Selection of Testing Institution
DEZEW Testing CNAS Registration No.: L8083
III. Laboratory Testing Procedure
1. Pretreatment
Sample cleaning (ultrasonic soaking in deionized water for 10 minutes) → Drying (60℃ oven for 2 hours) → Cutting into 1cm × 1cm samples.
2. Test Execution
Total Migration: Grouped by simulant type, soaked; extract concentrated by rotary evaporation/nitrogen blowing and weighed.
Special Migration: PAAs are analyzed using LC-MS/MS internal standard method (aniline-d5); heavy metals are analyzed using ICP-MS (He mode to eliminate interference).
Color migration: The color difference of the simulant after immersion was measured using a spectrophotometer (D65 light source/10° viewing angle).
3. Data Review
The relative deviation of parallel samples must be ≤10%, and the method blank value must be below the detection limit (e.g., PAAs detection limit 0.002 mg/kg).
IV. Report and Certification
1. Test Report Content
The report must include sample information, test standard (DM21/03/73 + EU 10/2011), simulant type, test results, and conformity assessment.
2. Certification Process
After the report is approved by the Italian Ministry of Health, a "DM21/03/73 Compliance" declaration can be applied for, typically valid for 2 years (retesting is required if the formulation or process changes).
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