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:
- Remove entry 96 (wood flour and fibers, untreated) and entry 121 (salicylic acid) from table 1;
- Add new substances:
- entry 1078 (tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate)
- entry 1080 ((triethanolamine- perchlorate, sodium salt) dimer)
- entry 1081 (N, N-bis (2-hydroxyethyl) stearylamine partially esterified with saturated C16/C18 fatty acids)
- entry 1082 (Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate)
- entry 1083 (Benzophenone-3,3′,4,4′- tetracarboxylic dianhydride (‘BTDA’))
- Revise limits of several phthalates
Table 1 (Union list)
| Phthalates | EU No 10/2011 | EU 2023/1442 amendment |
| DBP (Entry 157) | SML < 0.3 mg/kg | SML <0.12 mg/kg |
| BBP (Entry 159) | SML <30 mg/kg | SML <6 mg/kg |
| DEHP (Entry 283) | SML <1.5 mg/kg | SML <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)
| Phthalates | EU No 10/2011 | EU 2023/1442 amendment |
| Group restriction of DINP and DIDP (Entry 26) | SML <9 mg/kg | SML <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 |
