EUROPEAN COMMISSION 16th AMENDMENT TO PLASTIC FOOD CONTACT REGULATION (EU) 10/2011

Jul. 18 2023

The European Commission published Regulation (EU) 2023/1442 to amend Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. This amendment entered into force on August 1, 2023. The most significant changes of the regulation are listed as below.

Major Changes on authorization according to Annex I to Regulation (EU) No 10/2011:

Deletion

Entry 96	Wood flour and fibers, untreated
Entry 121	Salicylic acid	(CAS No 69-72-7)

Plastic materials and articles manufactured with salicylic acid (Entry 121) or manufactured with untreated wood flour or fibres from a specific wood species (entry 96) may continue to be first placed on the market after 1 Feb 2025 provided that certain conditions are fulfilled, including the submission of an application for authorization before 1 Aug 2024.

Revision

Entry 157	DBP	(CAS No 84-74-2)
Entry 159	BBP	(CAS No 85-68-7)
Entry 283	DEHP	(CAS No 117-81-7)
Entry 728	DINP	(CAS No 68515-48-0, CAS No 28553-12-0)
Entry 729	DIDP	(CAS No 68515-49-1, CAS No 26761-40-0)

Authorization of phthalic acids have the following changes:

Entry	substance	(eu) no 10/2011 up to 15th amendment	(eu) no 10/2011 up to 15th amendment	16th amendment (eu) 2023/1442	16th amendment (eu) 2023/1442
		SML [mg/kg]	SML(T) [mg/kg]	SML [mg/kg]	SML(T) [mg/kg]
157	DBP	0.3	60 (Group 32)	0.12	60 (Group 32) 0.6 (Group 36)
159	BBP	30	60 (Group 32)	6	60 (Group 32) 0.6 (Group 36)
283	DEHP	1.5	60 (Group 32)	0.6	60 (Group 32) 0.6 (Group 36)
1085	DIBP (*not authorized)	/	/	/	60 (Group 32) 0.6 (Group 36)
728	DINP	/	60 (Group 32) 9 (Group 26)	/	60 (Group 32) 1.8 (Group 26)
729	DIDP	/	60 (Group 32) 9 (Group 26)	/	60 (Group 32) 1.8 (Group 26)

*DIBP is not listed as an authorized substance but it may co-occur with other phthalates.

Below substances have authorization scope and restriction changed, or have SML changed to SML(T) together with other substances:

Entry 793	Triethanolamine	(CAS No 102-71-6)
Entry 822	Perchloric acid, salts	(CAS No 14797-73-0 as perchlorate)
Entry 1007	Diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate	(CAS No 976-56-7)
Entry 1059	Poly((R)-3-hydroxybutyrate-co-(R)-3-hydroxyhexanoate)	(CAS No 147398-31-0)
Entry 1076	Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters	(CAS No 1227937-46-3)

Addition

Entry 1078	Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate	(CAS No 3319-31-1)
Entry 1080	(Triethanolamine-perchlorate, sodium salt) dimer	(CAS No 156157-97-0)
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	(CAS No 52628-03-2)
Entry 1083	Benzophenone-3,3',4,4'-tetracarboxylic dianhydride (‘BTDA’)	(CAS No 2421-28-5)

Transition Measures

Plastic materials and articles complying with the Regulation as applicable before the entry into force of this Regulation, which were first placed on the market before 1 Feb 2025 may remain on the market until the exhaustion of stocks.

Additional Information:
Commission Regulation (EU) 2023/1442:
https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32023R1442

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