FCM - Compliance
The consolidated Commission Regulation (EU) No 10/2011 (23.09.2020) on plastic materials and articles intended to come into contact with food, states under section 2.1.6 "Repeated use of materials and articles":
- If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration in the second test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.
- Compliance of the material or article shall than be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.
- However, if there is conclusive scientific proof that the level of the migration decreases in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.
- Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation if in the first test a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) is detected.
These clauses are summarised in the flowchart, where "numbers" refer to the four regulatory paragraphs.
The following spreadsheet allows to assess compliance.
You have to introduce (i) SML; (ii) LOD; (iii) the three migration concentrations.
The app will calculate the LOQ and the uncettainties for the three migrated mass fractions.
Then check how many "red" coloured cells appear, indicating non-compliance.
The uncertainty functon used applies to mass fraction below 50 mg/kg.
You have to type in all values one-by-one in the yellow cell ONLY (no copy/paste possible).
Your values will not be saved. The spreadsheet will be reset (= all introduced values deleted) each time you refresh the page.