On July 12, 2023, the European Union published the 16th amendment (EU) 2023/1442 to the Regulation (EU) No 10/2011 on plastic food contact materials and articles. This amendment includes routine updates to the Union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids (positive list), as well as strengthened control measures for ortho-phthalates, including lower limits and additional group restrictions. The amendment will come into effect on August 1, 2023, 20 days after its publication.
Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, which were first placed on the market before 1 February 2025 may remain on the market until the exhaustion of stocks.
They key updates are:
1.Untreated wood flour and fibers (FCM No.96) and salicylic acid (FCM No.121) are deleted from the Positive list；
2.The limitation on phthalates has been stricter, please see table below for details（The newly added portions are highlighted in red for easy identification.）：
| Substance (FCM No.) | Regulation (EU) 2023/1442 amending Annex I to Regulation (EU) 10/2011(SML) |
Annex I to Regulation (EU) 10/2011(SML) |
| DBP (157) | 0.12 mg/kg | 0.3 mg/kg |
| BBP (159) | 6 mg/kg | 30 mg/kg |
| DEHP (283) | 0.6 mg/kg | 1.5 mg/kg |
| DINP (728)+DIDP (729) | 1.8 mg/kg | 9 mg/kg |
| Group 32 (8, 72, 73,138,140,157, 159,207,242, 283,532,670,728, 729,775,783, 797,798,810,815,1078,1085) |
SML(T) 60 | SML(T) 60 |
| Group 36 (157,159,283,1085) |
SML(T) 0.6 mg/kg [以DEHP 计] (DBP*5+DIBP*4+ BBP*0,1+DEHP*1) |
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| Note: 1. tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate (FCM No.1078) --Only to be used as plasticizer to manufacture soft poly (vinyl chloride); not to be used in contact with foods intended for infants. 2. Replaces three entries in group restriction of substances, including considerations of DIBP in group restriction no. 32. Per group restriction no. 32, DIBP is not in the Union List (Table 1) to Annex I of the Food Contact Plastics Regulation. It may co-occur with other phthalates as a consequence of its use as a polymerization aid and is included in group restrictions with the assigned FCM no. 1085. 3. DINP (FCM No.728) -- Not to be used in combination with FCM substances 157, 159, 283, or 1085. |
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3.The positive list has been revised to include five non-ortho-phthalate substances and two group restrictions：
Five Substance：
Two Group restrictions：
4.Following five substances and two group restrictions have been added to the positive list：
Five Substance：
| FCM No. | CAS No. | Substance Name | Limit （SML/SML（T）） |
Restrictions and specifications |
| 1078 | 3319-31-1 | tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate | SML：1mg/kg Group 32 SML（T）：60mg/kg |
Only to be used as plasticizer to manufacture soft poly (vinyl chloride); not to be used in contact with foods intended for infants. |
| 1080 | 156157-97-0 | triethanolamine-perchlorate, sodium salt) dimer | Group 37 SML（T）：0.05mg/kg Group 38 SML（T）：0.002mg/kg |
Only to be used in rigid poly (vinyl chloride) in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III. |
| 1081 | - | N, N-bis (2-hydroxyethyl) stearylamine partially esterified with satura-ted C16/C18 fatty acids | Group 7 SML（T）：1.2mg/kg | Only to be used at up to 2 % (w/w) in plastic materials and articles intended for the packaging by food business operators of dry foods for which simulant E is assigned in table 2 of Annex III. |
| 1082 | 52628-03-2 | Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate | SML：0.05mg/kg | Only to be used at up to 0,35 % (w/w) to manufacture polymethylmethacrylate. SML expressed as the sum of the mono-, di-and triesters of phosphoric acid and the mono-, di-, tri- and tetraesters of diphosphoric acid. |
| 1083 | 2421-28-5 | Benzophenone-3,3',4,4'- tetracarboxylic dianhydride | SML：0.05mg/kg | Only to be used at up to 43 % (w/w) as a co-monomer in the production of polyimides for use in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III at temperatures up to 250 °C.' |
Two Group restrictions：
5.The following entry is added in Table 3：
| Number | Instructions for verifying compliance |
| （30） | There is a risk that migration limits may be exceeded; migration increases with the thickness of the plastic in which the substance is contained, and with a decreasing polarity of the polymer and a decreasing degree of esterification of the substance itself’ |
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