Regulatory News

EU Amends Plastic Food Contact Regulation (EU) 10/2011

Sep. 24 2020

The European Commission published Regulation (EU) 2020/1245 to amend Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. This amendment entered into force on September 23, 2020. The most significant changes of the regulation are listed as below. 

Major Changes:

1. Specific migration of metals (Annex II)
Additional of 10 metals with defined specific migration limits.

  Specific migration limit (SML)   (mg/kg food or food simulant)
Antimony 0.04
Arsenic Not Detectable  (Detection Limit = 0.01)
Cadmium Not Detectable  (Detection Limit = 0.002)
Chromium Not Detectable  (Detection Limit = 0.01, if pre-existing documentary evidence can proof Cr VI in the material is excluded during the entire production process, detection limit of 3.6 mg/kg can be applied)
Europium *0.05
Gadolinium *0.05
Lanthanum *0.05
Lead Not Detectable  (Detection Limit = 0.01)
Mercury Not Detectable  (Detection Limit = 0.01)
Terbium *0.05

*The lanthanide substances can be used provided that the sum of all lanthanide substances migrating to the food or food simulant does not exceed SML of 0.05 mg/kg and analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16. 

2.    Specific migration of Primary Aromatic Amines (Annex II)
Detection limits for Primary Aromatic Amine (PAA) is revised:
•    ≤ 0.002 mg/kg for each PAA listed under REACH Annex XVII Entry 43 (Appendix 8) and for which no migration limit is specified in Table 1 of Annex I
•    ≤ 0.01 mg/kg for the sum of PAAs not listed under REACH Annex XVII Entry 43 (Appendix 8) and for which no migration limit is specified in Annex I 

3.    Compliance Testing (Annex V)
•    Overall Migration Testing Condition 
•    New testing condition OM 0 (30 mins at 40˚C) is introduced for any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes)
•    Reflux condition is added as an option for OM 4
•    Specific Migration Testing for Repeated use materials and articles 
•    The migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration value for each time shall not be higher than the value in the preceding migration 

Transitional Period
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and which were first placed on the market before March 23, 2021 may continue to be placed on the market until September 23, 2022 and remain on the market until the exhaustion of stocks. 

Additional Information:
Commission Regulation (EU) 2020/1245: 

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