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The European Union plans to amend the plastic FCM regulations, adding five new substance restrictions, with a transition period of 18 months


Time:

2023-02-23

The European Union plans to amend the plastic FCM regulations, adding five new substance restrictions, with a transition period of 18 months

On January 23, 2023, the WTO announced the amendment notification of Regulation No. 10/2011 on plastic materials and articles in contact with food submitted by the EU, involving the change of substance authorization and the addition of new substances.

The European Food Safety Agency (EFSA) has issued further scientific opinions on new substances that can be used in food contact materials (FCM) and the use of authorized substances. At the request of the European Commission, EFSA reviewed the 451 substances listed in Annex I of Regulation EU 10/2011 and established a specific migration limit (SML). Of these, 284 substances need to be re-evaluated to determine whether specific migration limits are required.

The final public review date of the document is March 24, 2023.

The proposed adoption date is March 31, 2023.

The main amendments to Annex I of the Regulation are as follows, adding restriction requirements for five substances

CAS NO. Substance name Limit
3319-31-1 tris(2-ethylhexyl) benzene-1,2,4- tricarboxylate It is only used as a plasticizer for the manufacture of soft PVC and shall not be in contact with baby food
156157-97-0 (triethanolamine e-perchlorate, sodium salt) dimer Rigid PVC used only for contact with food in the food category with reference number 01.01. A in Table 2 of Annex III
– N, N-bis(2- hydroxyethyl)st earylamine partially esterified with saturated C16/C18 fatty acids It is only allowed to use the proportion of no more than 2% (w/w) in the plastic materials and articles used by food operators to package dry food.
52628-03-2 Phosphoric acid, mixed esters with 2- hydroxyethyl methacrylate It is only allowed to be used in the manufacture of polymethylmethacrylate at a proportion not exceeding 0,35% (w/w). The migration limit is expressed as the sum of monoester, diester and triester of phosphoric acid and monoester, diester, triester and tetraester of diphosphate.
2421-28-5 Benzophenone3,3′,4,4’- tetracarboxylic dianhydride (′BTDA′) Only 43% (w/w) of co-monomer is allowed to be used in the production of polyimide in contact with food.

 

In order to enable operators to adapt to changes in regulations, an 18-month transition period is allowed after the regulations come into force. After the end of the 18-month transition period, plastic materials and products that do not meet the requirements for food contact shall not be put on the EU market.

 

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