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The Revised Directive of the EU Food Contact Plastics Regulation (EU) No 10/2011 published Release Time:2023-07-14

On 17 July 2023, the European Union issued Directive (EU) 2023/1442 in its Official

Journal (OJ) to amend the Directive (EU) No 10/2011, amending Annex I as regards changes to substance authorisations and addition of new substances and the addition of new substances.The Regulation enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Major revisions

Table 1. Main content of EU plastics regulation

Scope of revision

Content of revision

Table 1.”Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids”

1. Delete two authorised substances:

FCM 96 wood flour and fibers, untreated

FCM 121 salicylic acid(CAS No 0000069-72-7)

2. Update 9 FCM material contents, mainly as follows:

l Addition of English name abbreviations, description of limits;

l Tightening of the specific migration limits (SML) and updating of cluster restriction requirements for DBP, BBP and DEHP (see the following comparison table A for details);

l Addition of restriction requirements for DINP (see the following comparison table A for details)

3. Five new authorized substances were added(FCM substance No 1078 to1083) (see the table B for details)

Table 2.”Group restriction of substances”

1. Update the applicable FCM substance numbering or restriction requirements for 3 entries.

l Addition of substance FCM 1081 to Group 7;

l Reduction of Group SML(T) limits for Group 26, The limit for the sum of substances was modified from 9mg/kg to 1.8mg/kg;

l Addition of FCM No 1078 and 1085 to Group 32 and new group limit description for FCM No 1085

2. Three entries are added:

One of them, No. 36, specifies the sum of four o-benzenes (DBP, BBP, DEHP and DIBP) in terms of DEHP, SML(T) 0.6mg/kg.

Table 3.”Notes on verification of compliance”

Add new entry 30


Table A. Table of amendments to limit values for specific o-benzene substances in the revised directive and comparison with the current Regulation (EU) 10/2011


Revised Directive (EU) 2023/1442

Current Regulation (EU) 10/2011

FCM 157


(CAS No 0000084-74-2)

SML: 0.12mg/kg

Group 32 SML(T): 60mg/kg

Group 36 SML(T): 0.6mg/kg

SML: 0.3mg/kg

Group 32 SML(T): 60mg/kg;

FCM 159


(CAS No 0000085-68-7)

SML: 6.0mg/kg

Group 32 SML(T): 60mg/kg

Group 36 SML(T): 0.6mg/kg

SML: 30.0mg/kg

Group 32 SML(T): 60mg/kg;

FCM 283


(CAS No 0000117-81-7)

SML: 0.6mg/kg

Group 32 SML(T): 60mg/kg

Group 36 SML(T): 0.6mg/kg

SML: 0.5mg/kg

Group 32 SML(T): 60mg/kg;

FCM 728


(CAS No 0068515-48-0/ 

CAS No0028553-12-0)

Group 26 SML(T): 1.8mg/kg

Group 32 SML(T):  60mg/kg

Not to be used in combination with FCM substances 157, 159, 283, or 1085.

Group 26 SML(T): 9mg/kg

Group 32 SML(T): 60mg/kg


Table B. Five new authorized substances were added(FCM substance No 1078 to1083)


Substance name

Restrictions and specifications

FCM No 1078

(CAS No 3319-31-1)



Only to be used as plasticiser to manufacture soft poly(vinyl chloride)Not to be used in contact with foods intended for infants

FCM No 1080

(CAS No 156157-97-0)

(triethanolamine e-perchlorate, sodium salt) dimer

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

FCM No 1081

N, N-bis(2-hydroxyethyl)st earylamine partially esterified with saturated C16/C18 fatty acids

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.

FCM No 1082

(CAS No 52628-03-2)

Phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate

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

FCM No 1083

(CAS No 2421-28-5)


tetracarboxylic dianhydride


Only to be used at up to 43% (w/w) as a comonomer 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.”


Transition period

To enable operators to adapt to the regulatory changes, a transition period of 18 months is allowed after the official entry into force of the regulation.

1) 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.;

2) In case a product from an intermediate stage of the manufacturing of plastic materials and articles or a substance intended for the manufacturing of such a product, material or article, which complies with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation and which is first placed on the market after 1 May 2024 does not comply with this Regulation, the declaration of compliance available for that substance or product shall indicate that it does not comply with the present rules, and that it can only be used in the manufacture of plastic materials and articles to be placed on the market before 1 February 2025;

3) Plastic materials and articles manufactured with salicylic acid (FCM No 121) or manufactured with untreated wood flour or fibres from a specific wood species may continue to be first placed on the market after 1 February 2025 provided that the following conditions are fulfilled:

a.an application for the authorisation of that substance or of that untreated wood flour or fibre from a specific wood species has been submitted to the competent authority in accordance with Article 9 of Regulation (EC) No 1935/2004 before 1 August 2024;

b.the use of that substance or of that untreated flour or fibre from a specific wood species to manufacture a plastic material and article, and the use thereof, is limited to the intended conditions of use described in the application;

c.the information provided to the Authority in accordance with Article 9(1)(b) of Regulation (EC) No 1935/2004 includes a statement that the application is an application in accordance with this paragraph;

d. the Authority has considered the application valid.

AGC recommendations

ØChina has the richest bamboo resource in the world, In addition to disposable bamboo and wood products, there are a large number of plastic tableware with the addition of authorised bamboo and wood fibres, such as dense amine-bamboo fibre tableware exported to the EU. The directive (EU) 2023/1442 to the EU Plastics Regulation proposes to remove FCM 96 untreated wood flour and wood fibre from the positive list of additives, which will have a greater impact and influence on the export of plant fibre plastic products from China. For plastic products made from plant fibres exported to the EU, after the revised regulation comes into force, the only additives authorised for use are "crushed sunflower seed hulls" (FCM No 1060), which should be used in accordance with the corresponding restrictions. Plastic food contact products containing other plant fibres such as corn starch and bamboo fibres will be rejected at the border and banned from the EU market.

ØThe directive (EU) 2023/1442 to the EU Plastics Regulation intends to tighten the requirements for the restriction of o-benzene substances. Food contact plastic manufacturers whose target markets are EU countries should pay attention to the use of plasticisers in the production process, especially for PU, PVC, PVDC and other plastic types that may use large amounts of plasticisers.


AGC reminds: Relevant enterprises should pay close attention to the information on changes in standards, carry out relevant production and operation activities in strict accordance with the new standards, and update the test reports of relevant products in a timely manner so that the products can meet the latest requirements and be sold smoothly.

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