On 25 August 2016, the EU Official Journal published a new Regulation (EU) 2016/1416, amending and correcting regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
The amendment added a new element aluminum to Annex II-Restriction on materials and articles, and the migration limit for aluminum is 1 mg/kg food. Meanwhile, the migration limit for zinc is amended from 25 mg/kg food to 5 mg/kg food.
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Before amendment |
After amendment |
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Barium = 1 mg/kg. Cobalt = 0,05 mg/kg. Copper = 5 mg/kg. Iron = 48 mg/kg. Lithium = 0,6 mg/kg. Manganese = 0,6 mg/kg. Zinc = 25 mg/kg. |
Barium = 1 mg/kg. Cobalt = 0,05 mg/kg. Copper = 5 mg/kg. Iron = 48 mg/kg. Lithium = 0,6 mg/kg. Manganese = 0,6 mg/kg. Zinc = 5 mg/kg. Aluminum = 1 mg/kg. |
The amendment also metioned that if it is not technically feasible to perform the test in vegetable oil, migration shall be done using 95% ethanol and isooctane.
Moreover, to reflects the most recent findings of the EFSA and to remove any doubt as regards its correct application, the amendment corrected certain textual errors and ambiguities and amended certain particular substances that may be used in FCM or have been authorized previously.
This regulation shall enter into force on 13th September 2016. However, to provide business operators with sufficient time, plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, may be placed on the market until 14 September 2017 and may remain on the market until exhaustion of stocks.
The provisions on the specific migration limits for aluminium and for zinc shall apply from 14 September 2018.