European Union has issued the Commission Regulation (EU) 2023/1442 to amend Commission Regulation (EU) No 10/2011 (on plastic materials and articles intended to come into contact with food) on 12 July, 2023.

The amendment amends table 1 (Union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids) and table 2 (Group restriction of substances) of Annex I of EU No 10/2011.  Below shows highlights of the amendment:

  1. Remove entry 96 (wood flour and fibers, untreated) and entry 121 (salicylic acid) from table 1;
  2. Add new substances:
    1. entry 1078 (tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate)
    2. entry 1080 ((triethanolamine- perchlorate, sodium salt) dimer)
    3. entry 1081 (N, N-bis (2-hydroxyethyl) stearylamine partially esterified with saturated C16/C18 fatty acids)
    4. entry 1082 (Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate)
    5. entry 1083 (Benzophenone-3,3′,4,4′- tetracarboxylic dianhydride (‘BTDA’))
  3. Revise limits of several phthalates

Table 1 (Union list)

PhthalatesEU No 10/2011EU 2023/1442 amendment
DBP (Entry 157) SML < 0.3 mg/kgSML <0.12 mg/kg
BBP (Entry 159) SML <30 mg/kgSML <6 mg/kg
DEHP (Entry 283)SML <1.5 mg/kgSML <0.6 mg/kg
DINP (Entry 728) Not to be used in combination with
food contact material substances DBP, BBP, DEHP, or DIBP

Table 2 (group restriction)
PhthalatesEU No 10/2011EU 2023/1442 amendment
Group restriction of DINP
and DIDP (Entry 26)
SML <9 mg/kgSML <1.8 mg/kg
Group restriction of substances
includes phthalates (Entry 32)
20 substances 22 substances
(Add tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate and DIBP)
Group restriction of
DEHP equivalent (Entry 36)
SML of DBP*5 + DIBP*4 + BBP*0,1 + DEHP*1
shall be <0.6 mg/kg
Remark: SML denotes specific migration limit