FCM - Stability rules for repeated use articles

12/11/2024,

Commission Regulation (EU) No10/2011 on plastic materials and articles intended to come into contact with food (CELEX 32011R0010)

[extracted from]

For materials or articles intended for repeated contact with food, migration testing must be conducted three times on a single sample, using a fresh portion of food simulant for each test. Compliance is then assessed based on the migration level in the third test and the stability of the material accross all three migration tests.
The sample will be considered non-compliant if any of the following criteria are met:

1. The migration level in the third test  (m3) exceeds the Specific Migration Limit (SML): m3 > SML.
2. An increasing trend in migration is observed across tests, demonstrated by any of the following conditions:
   m1<m2, m2<m3, or m1<m3

Here m1, m2, and m3 represent the migration levels measured in the first, second, and third tests, respectively.

Evaluation criteria

• IF (mj - mi )/[(u(mj) + u(mi)] > 1.64            THEN              mi < mj
• IF (m_i - SML)/[(u(m_i)] > 1.64                        THEN              mi > SML.

where i=[1, 2], j=[2, 3], and u(m)= m * CV_R 

Additionally, if any measured concentration (mi) is less than 0.2 * SML, it shall be considered equal to 0.2 * SML with the corresponding measurement uncertainty for these evaluations.

The relative standard measurement uncertainty is calculated as the reproducibility coefficient of variation (CVR), calculated using the modified Horwitz equation by Thompson (https://doi.org/10.1039/B000282H).

The CRV are calculated as follows:

• For concentrations C below 1.2 * 10^(-7) g/g (= 0.12 mg/kg or 120 ug/kg)
  CVR = 0.22 (22 %).
• For concentrations ranging from 1.2 10^(-7) and 0.138 g/g
  CVR = [ 2 ^ (1 - 0.5 * log C)] / 100

The Excel sheet below evaluates compliance based the SML and the concentration levels measured in the three consecutive migration tests (m1, m2, m3), with all values expressed either in µg/kg or mg/kg, depending on the selected unit.

Note: Microsoft does not allow to ‘copy & paste’ cells into the online spreadsheet.
All values must be entered manually, one at a time, into the designated yellow cell ONLY.
Please note that your inputs will not be saved; the spreadsheet will be reset (clearing all values) each time you leave or refresh this page.