On 12 July 2023, the European Commission published amendment (EU) 2023/1442, the 16th revision of the EU food contact plastics regulation (EU) No 10/2011. The revision mainly withdraws the authorisations for "untreated wood flour and wood fibres" and "salicylic acid", tightens the requirements for phthalate plasticisers, amends the conditions of use of already authorised substances and adds new authorised substances. The amendment enters into force 20 days after publication in the Official Journal.

The main revisions are as follows:

(1) The authorisations for FCM substance No. 96 (untreated wood flour and wood fibres) and FCM substance No. 121 (salicylic acid) are withdrawn (leaving only FCM substance No. 1060, ground sunflower seed shells, as an authorised plant fibre substance).

(2) Requirements for phthalate plasticisers are tightened (the DAP migration limit stays at ND):

The DBP migration limit is reduced from 0.3 mg/kg to 0.12 mg/kg;

The BBP migration limit is reduced from 30 mg/kg to 6 mg/kg;

The DEHP migration limit is reduced from 1.5 mg/kg to 0.6 mg/kg;

The migration limit for DIDP and DINP (group 26 SML(T)) is reduced from 9 mg/kg to 1.8 mg/kg;

The sum of DBP, DIBP, BBP and DEHP forms group 36 SML(T), expressed as DEHP equivalents using the formula DBP x 5 + DIBP x 4 + BBP x 0.1 + DEHP x 1, with an SML(T) of 0.6 mg/kg;

Note: DINP must not be used in combination with FCM No. 157, 159, 283 or 1085, that is DBP, BBP, DEHP or DIBP.

(3) Triethanolamine (CAS No. 102-71-6) together with the dimer of FCM substance No. 1080 (triethanolamine sodium perchlorate salt, CAS No. 156157-97-0) forms group 37, with SML(T) of 0.05 mg/kg expressed as the sum of triethanolamine and its hydrochloride adduct.

(4) Perchloric acid and its salts together with the dimer of FCM substance No. 1080 (CAS No. 156157-97-0) form group 38, with SML(T) of 0.002 mg/kg expressed as perchlorate (and subject to the requirements of point 4 of Table 3 in Annex I to EU 10/2011).

(5) FCM substance No. 1081 (N,N-bis(2-hydroxyethyl)stearylamine partially esterified with saturated C16/C18 fatty acids) is added to group 7 SML(T), and FCM substance No. 1078 (trioctyl trimellitate, CAS No. 3319-31-1) and FCM substance No. 1085 (DIBP) are added to group 32 SML(T).

(6) A note 30 is added to Table 3 of Annex I on verifying the conformity of FCM substance No. 1081.

(7) In addition to the six points above, several other authorised substances have also been revised, such as antioxidant 1222 (CAS No. 976-56-7), PHBH (CAS No. 147398-31-0), and phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)] C10-16 alkyl esters (FCM No. 1076).

Transitional measures

(1) Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before this regulation took effect may remain on the market until stocks are exhausted, provided they are first placed on the market before 1 February 2025.

(2) Where a substance or product from an intermediate stage in the manufacture of plastic materials and articles, or a substance used to manufacture such products, materials or articles, complies with Regulation (EU) No 10/2011 as applicable before entry but does not comply with this regulation and is first placed on the market after 1 May 2024, the declaration of conformity for that substance or product shall state that it does not comply with the current rules and may only be used to manufacture plastic materials and articles placed on the market before 1 February 2025.

(3) Plastic materials and articles manufactured using salicylic acid (FCM No. 121) or untreated wood flour or fibres of specific wood species may continue to be first placed on the market after 1 February 2025, provided that:

an application for authorisation of that substance, or of untreated wood flour or fibres from specific wood species, was submitted to the competent authority under Article 9 of Regulation (EC) No 1935/2004 before 1 August 2024;

the substance, or untreated flour or fibres from specific wood species, is used to manufacture plastic materials and articles, and its use is limited to the intended conditions of use described in the application;

the information provided to the Authority under Article 9(1)(b) of Regulation (EC) No 1935/2004 includes a statement that the application is made under this paragraph; and

the Authority considers the application valid.