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The 6th amendment to the Plastics Regulation on food contact materials and articles

September, 2016

On 24 August 2016, the European Commission (EC) published Regulation (EU) No 2016/14161 in the Official Journal of the European Union (OJEU), amending and correcting Regulation (EU) No 10/20112 on plastic materials and articles intended to come into contact with food (‘The Plastics Regulation’).

Plastic materials and articles which have been lawfully placed on the market before 14 September 2016 may be placed on the market until 14 September 2017 and may remain on the market after that date until exhaustion of stocks.  The provisions on the specific migration limits for aluminum and for zinc and the assignments of food simulants fresh and peeled fruits and vegetables will apply on 14 September 2018.

Regulation (EU) No. 2016/1146 made the following changes to The Plastics Regulation:

  • Added specification and/or application for 6 FCM substances and added 10 substances to Table 1 of Annex I as approved substances. Table A below shows the list of substances.
  • Defined the meaning of "hot-fill".
  • Specified the amount of saponifiable matter in vegetable oil and assigned simulants for fresh fruits and vegetables. 
  • Deleted the provision establishing generic specific migration limit (SML) of 60 mg/kg, made clear that certain constituents should not migrate at detectable levels in the first migration and removed the option to express the migration from caps or closures in mg/dm2.
  • Set new SML for aluminum and zinc. Table B shows the amended SML compare to the SML stated in Regulation (EU) No. 10/2011.
  • Clarified the reference to which a written confirmation of compliance is required. 
  • Amended Annex V on Compliance testing
    • Allowed the use of actual processing conditions used in equipment as testing conditions.
    • Made clear the testing conditions cannot be adjusted to conditions less strict than the real conditions of use.
    • Set new test temperatures for specific migration by adding 200°C and 225°C for testing above 175°C. Table C shows the comparison between the amended test temperatures for specific migration to the test temperature stated in Regulation (EU) No. 10/2011.
    • Clarified the specific migration conditions for contact times above 30 days.
    • Provided the possibility of applying a single test for successive combinations of time and temperature for specific migration.
    • Specified substitute tests using 95% ethanol, isooctane and simulant E for conditions OM1 to OM6 are allowed.
    • Specified an alternative testing approach to test overall migration for repeated use in an oily medium, and
    • Included a prohibition on the application of the Fat Reduction Factor (FRF).

Table A. Approved substance that was added to Table 1 of Annex I

 FCM No Substance name
871  Dodecanoic acid, 12-amino-, polymer with ethene, 2,5-furandione, α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) and 1-propene
 1031  Furan-2,5-dicarboxylic acid
 1034  1,7-octadiene
 1045  Perfluoro{acetic acid, 2-[(5-methoxy-1,3-dioxolan-4-yl)oxy]}, ammonium salt
 1046  Zinc oxide, nanoparticles, coated with [3-(methacryloxy)propyl]trimethoxysilane (FCM No 788)
 1048  Ethylene glycol dipalmitate
 1050  Zinc oxide, nanoparticles, uncoated
 1051  N,N'-bis(2,2,6,6-tetramethyl-4-piperidinyl) isophthalamide
 1052  2,4,8,10-tetraoxaspiro[5.5] undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- ('SPG')

 Fatty acids, C16-18 saturated, esters with dipentaerythritol

Table B. Specific migration limit (SML) for aluminum and zinc.

 Previous SML (mg/kg) Amended SML (mg/kg) 
 Not regulated 1



Table C.  Test temperatures for specific migration.

 Previous Ammended
 Conditions of contact in worst foreseeable use Test conditions Worst foreseeable contact temperature  Contact temperature to be selected for testing 
 T > 175 °C Adjust the temperature to the real temperature at the interface with the food (*)  175 °C < T ≤ 200 °C 200 °C(*)
 T > 200 °C  225 °C(*)

[1] Regulation (EU) No 2016/1416
[2] Regulation (EU) No 10/2011


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