on july 12, 2023, the european commission published regulation (eu) no 2023/1442, amending the eu food contact plastic materials regulation (eu) no 10/2011. the regulation has come into effect on august 1, 2023.
key amendments
- removal of two additives
untreated wood flour/wood fiber (fcm no 96) and salicylic acid (fcm no 121) are removed from the list of permitted additives.
- update on phthalate migration limits and requirements
the phthalate migration limit requirements have been revised as follows:
1. substance: dbp (fcm no 157)
after revision | sml: 0.12 mg/kg ↓ |
before revision | sml: 0.3 mg/kg |
2. substance: bbp (fcm no 159)
after revision | 6.0 mg/kg ↓ |
before revision | 30.0 mg/kg |
3. substance: dehp (fcm no 283)
after revision | 0.6 mg/kg ↓ |
before revision | 1.5 mg/kg |
4. substance: dinp (fcm no 728)
after revision | group 26 sml(t): 1.8 mg/kg group 32 sml(t): 60 mg/kg dinp shall not be used simultaneously with dbp, bbp, dehp, dibp |
before revision | group 26 sml(t): 9.0 mg/kg group 32 sml(t): 60 mg/kg |
5. substance group: group 36 (dbp bbp dehp dibp)
after revision | sml(t): 0.6 mg/kg (migration results based on dehp) |
before revision | / |
note: sml refers to specific migration limit, sml(t) refers to the total migration limit for a specific substance group.
- other entries modifications
- several substances, such as triethanolamine (fcm no 793), perchlorates (fcm no 822), antioxidant 1222 (fcm no 1007), and phbh (fcm no 1059), have been revised.
- five new authorized substances are added (fcm no 1078, fcm no 1080-1083).
- one substance is added to group 7, and two substances are added to group 32. the sml(t) of group 26 is adjusted. new migration limit total and related requirements for groups 36 to 38 regarding phthalates, triethanolamine, and perchlorates are added.
transitional measures
food contact plastic materials and articles placed on the market for the first time before february 1, 2025, and compliant with the old regulation, are allowed to continue to be placed on the market until stocks are exhausted.
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