World Trade Organization announces a draft change in Food contact material regulation in Europe

On January 23, 2023, the World Trade Organization (WTO) published a draft regulation on their website regarding the European Union (EU) intention to revise Annex I to Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food. The amendment identifies changes to substance authorizations and addition of new substances and to address the authorization of substances either following applications by business operators, or to address existing substance authorizations based on mandates provided by the European Commission.

This new draft version of (EU) 10/2011 has several important points that should be considered by industry:

Two substances are to be revoked from the Union List.

  • The authorization of the substance “wood flour and fibers, untreated” (FCM No 96, “wood”) is to be revoked due to insufficient safety data when used with plastics.

  • The substance “salicylic acid” (FCM No 121) is to be revoked due to uncertainty over the conditions of use.

New revisions based on the existing substances are to be made.

  • Based on opinions of the Authority adopted in 2005, five substances from a group commonly known as ‘phthalates’, namely FCM No 157 (‘DBP’), FCM No 159 (‘BBP’), FCM No 283 (‘DEHP’), FCM No 728 (‘DINP’) and FCM No 729 (‘DIDP’), are authorised as additives for use as plasticisers and technical support agents in plastic FCM, subject to specific restrictions of use and migration limits.

FCM NoRegulation (EU) 10/2011 Annex I in forceDraft Regulation amending Annex I to Regulation (EU) 10/2011Interpretation
DBP (157)SML= 0.3 mg/kg
SML(T) group restriction number: 32
SML = 0.12 mg/kg
SML(T) group restriction number: 32 and 3
Decrease in SML from 0.3 mg/kg to 0.12 mg/kg and change in group restriction number
BBP (159)SML = 30.0 mg/kg
SML(T) group restriction number: 32
SML = 6.0 mg/kg
SML(T) group restriction number: 32 and 36
Decrease in SML  from 30.0 mg/kg to 6.0 mg/kg and change in group restriction number
DEHP (283)SML = 1.5 mg/kg
SML(T) group restriction number: 3
SML = 0.6 mg/kg
SML(T) group restriction number: 32 and 36
Decrease in SML from 1.5 mg/kg to 0.6 mg/kg and change in group restriction number
DINP (728)No informationProhibition of the use of DINP together with DBP, BBP and DEHP as well as with DIBPUsage restriction with other substances

  • Other than DBP, BBP and DEHP, the Authority also established a new group t-TDI, taking into account their relative potencies. The authority set the group t-TDI for DBP, BBP, DEHP and DINP at 50 micrograms per kilogram of bodyweight (µg/kg bw) expressed as DEHP equivalent strength.

  • The existing authorisation for the use level of diethyl[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl] phosphonate (FCM No 1007) in PET at 0.2 % w/w also to the manufacture of PEF is to be extended.

  • Commission Regulation (EU) 2019/1338 authorised the substance Poly((R)-3- hydroxybutyrate-co-(R)-3-hydroxyhexanoate) (‘PHBH’, FCM No 1059). Due to its melting point and usage conditions which reflects “hot-fill”, the usage should be clarified indicating a condition of use as that does not exceed the temperature conditions foreseen in the opinion.

  • The use of the substance ‘phosphorous acid, triphenyl ester, polymer with alpha-hydro-omegahydroxypoly[oxy(methyl-1,2-ethanediyl)], C10–16 alkyl esters’ (FCM No 1076) as an additive at up to 0.025% w/w in acrylonitrile-butadiene-styrene (ABS) copolymers is to be authorized if the migration limit in accordance with the opinion of the Authority as 0.05 mg/kg in repeated use in contact with aqueous, acidic, alcoholic and oil-in-water emulsion foods, for long-term storage at room temperature and below.

New Food Contact Materials (FCMs) added to the Union List (FCM 1078-1083)

  • It has not been demonstrated that the use of tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate ester (FCM No 1078, CAS number 3319-31-1), as an additive (plasticiser) in poly(vinyl chloride) (‘PVC’) in contact with ‘infant foods’ would meet the requirements of Article 3 of Regulation (EC) No 1935/2004. Therefore, the authorisation of this substance should be subject to a limit on its migration of 1 mg/kg food and a restriction that prevents its in contact with foods intended for infants.

  • It is appropriate to amend substances FCM No 793 and 822 accordingly, and to include the substance (triethanolamine-perchlorate, sodium salt) dimer (FCM No 1080) as an additive in the Union list of authorised substances, with the restriction that it should only be used in contact with foods included in the food category with reference number 01.01.A in table 2 of Annex III which represents water and the acidic aqueous foods considered by the Authority.

  • It is appropriate to authorise the use of N, N-bis(2- hydroxyethyl)stearylamine (FCM 1081) at up to 2% (w/w) for manufacturing plastic FCM intended to be in contact only with dry foods at room temperature, and it should be included in the group restriction laid down for the substances with FCM No 19 and 20.

  • It is appropriate to authorise the use of phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate (FCM No 1082) in the manufacture of polymethylmethacrylate up to 0.35% w/w and to lay down a migration limit according to the opinion of the Authority.

  • It is appropriate to authorise the use of benzophenone-3,3’,4,4’-tetracarboxylic dianhydride (‘BTDA’) (FCM No 1083) for the use in the manufacture of polyimides at up to 43% w/w polymer in contact with foods for which only simulants B and/or D2 are laid down in table 2 of Annex III to Regulation (EU) No 10/2011 at temperatures up to 250°C, and if this use is subject to a migration limit of 0.05 mg/kg food.

In order to allow operators to adapt to the changes to certain existing authorisations set out in this Regulation, according to the Proposal, it is appropriate to provide that plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the date of the entry into force of this Regulation, are allowed to be first placed on the market for a transition period of 18 months after the entry into force of this Regulation and remain on the market until the exhaustion of stocks.

Proposed date of adoption: 31 March 2023

Proposed date of publication: 3 April 2023

Proposed date of entry into force: 20 days after publication in the Official Journal of the European Union



Objective of WTO

“The overall objective of the WTO is to help its members use trade as a means to raise living standards, create jobs and improve people’s lives. The WTO operates the global system of trade rules and helps developing countries build their trade capacity. It also provides a forum for its members to negotiate trade agreements and to resolve the trade problems they face with each other. Inline with those Objectives, EU also informs WTO for the upcoming amendments and revisions in the Regulations in a timely manner.”

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