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Publication 15th Amendment

Publication Commission Regulation (EU) 2020/1245

On 2 September 2020, the 15th amendment to EU 10/2011 was officially published as ‘Commission Regulation (EU) 2020/1245 amending Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food’. This amendment shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

We have studied the amendment for you and created an overview of the most important topics:

New and changed substances on Annex 1

FCM CAS Substance Change
1075 hexadecyltrimethylammonium bromide new
1076 1227937-46-3 C10-16 alkyl esters new
1077 fluoride-modified alumina new
236 0000108-45-2 1,3 phenylenediamine Detection limit from 0,01 mg/kg to 0,002 mg/kg (note 28)
398 001309-64-4 Antimony trioxide SML antimony replaced to Annex 2 table 1

Extension to Annex 2

  • Number of metals on Annex 2 increased from 9 to 18
  • Detection limit of primary aromatic amines (PAA) decreased to 0,002 mg/kg: PAA from Entry 43 of Appendix 8 of Annex XVII (REACH Regulation 1907/2006).
  • Addition to Annex IV of the Declaration of Compliance: The obligation for producers of intermediate products to communicate substances of Annex 2 and substances for which genotoxicity cannot be excluded.

New overall migration test
A new overall migration test was introduced: OM0, 30 min at 40 °C. This OMT is for short term contact (<30 minutes) for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).

We are working hard to implement this amendment in FOCOS to help our users analyze and manage the impact of the changes on their products and DoCs.
Expect an update of FOCOS in the coming weeks. You will be updated accordingly.

For any further questions, please contact us!