EU – Amendment to Plastic Food Contact Regulation (EU) 10/2011 Approved

Vol. 1187 | 09 Sep 2020

The European Commission has published Regulation (EU) 2020/1245 to amend Regulation (EU) No 10/2011 on plastic food contact materials and articles. The amendment will enter into force on 23 September 2020.

The most significant changes are the new specific migration requirements (Annex II) and testing rules (Annex V):

Specific Migration (Annex II)

1. Metals
   The specific migration limits of metals in Annex II are rearranged into a table. The new limits are shown below:

   	Specific migration limit (mg/kg food or food simulant)
   Antimony	0.04
   Arsenic	Not detectable (Limit of detection 0.01)
   Cadmium	Not detectable (Limit of detection 0.002)
   Chromium	Not detectable (Limit of detection: 3.6 mg/kg if there is proof to exclude the presence of chromium (VI), 0.01 mg/kg for other cases)
   Europium	0.05*
   Gadolinium	0.05*
   Lanthanum	0.05*
   Lead	Not detectable (Limit of detection 0.01)
   Mercury	Not detectable (Limit of detection 0.01)
   Terbium	0.05*

   * For lanthanide substances (europium, gadolinium, lanthanum and terbium),

   • The sum of all lanthanide substances migrating to food or food simulant shall not exceed 0.05 mg/kg.
   • There shall be analytical evidence using a well described methodology demonstrating the lanthanide substance(s) used are present in dissociated ionic form in the food or food simulant. The evidence shall form part of the supporting documentation referred to in Article 16.
2. Primary Aromatic Amines
   The detection limits for primary aromatic amines (PAAs) are amended as follows:
   1. ≤ 0.002 mg/kg for each PAA listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation (EC) No 1907/2006, and no migration limit is specified in Table 1 of Annex I
   2. ≤ 0.01 mg/kg for the sum of PAAs not listed in entry 43 to Appendix 8 of Annex XVII to REACH Regulation, and no migration limit is specified in Annex I

Compliance Testing (Annex V)

1. For repeated-use materials and articles, the regulation requires the specific migration between subsequent tests does not increase.
2. For overall migration testing conditions,
   1. OM0 (new): 30 minutes at 40°C for materials use only at cold or ambient temperatures for 30 minutes or less
   2. OM4: reflux condition is available as an option when testing at 100°C is technically difficult
3. Testing rules for food processing equipment and appliances are added.

In addition to these changes to the requirements for Specific Migration, minor changes have also been made to the Union List of Authorised Substances and Declaration of Compliance.

Transitional Arrangements

Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before 23 September 2020, and which were first placed on the market before 23 March 2021, may continue to be placed on the market until 23 September 2022, and remain on the market until all stock has been sold.

For additional information please contact:

Laureen Leung
laureen.leung@intertek.com 
+852 3760 6361