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Release Time:2023-02-15 On 23 January 2023, the World Trade Organization (WTO) published notification No. 23-0494. in which the EU submitted a draft of the 16th amendment to the EU Food Contact Plastics Regulation (EU) No 10/2011, concerning changes to the authorization of substances in Appendix I and the addition of new substances. According to WTO notification documents, the deadline for public comment on the draft amendment is 24 March 2023 and the proposed date for publication in the Official Journal of the European Union is 3 April 2023, with the official entry into force expected from 23 April 2023.
Major revisions
Table 1. Main content of amendments to the draft 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 draft amendment and comparison with the current Regulation (EU) 10/2011
Substances | Draft amendment to Regulation (EU) 10/2011 | Current Regulation (EU) 10/2011 |
FCM 157 DBP (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 BBP (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 DEHP (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 DINP (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)
Substances | Substance name | Restrictions and specifications |
FCM No 1078 (CAS No 3319-31-1) | tris(2-ethylhexyl)benzene-1,2,4- tricarboxylate | 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) | Benzophenone-3,3’,4,4’- tetracarboxylic dianhydride (‘BTDA’) | 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 onthe market before [enter date 18 months after the date of entry into force of this Regulation] 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 [enter date 9 months after the date of entry into force of this Regulation] 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 [enter date 18 months after the date of entry into force of this Regulation];
3) Plastic food contact plastics made from FCM 96 untreated wood flour and wood fibre or FCM 121 salicylic acid: may continue to be placed on the market for a period of 18 months after the entry into force of the amendment, provided that the requirements for authorised declaration to the competent authority under Article 9 of Regulation (EC) No 1935/2004 are met within 12 months of the formal entry into force of this amendment Act.
AGC recommendations
China 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 draft amendment 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.
The draft amendment 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.
The link to the WTO notification 23-0494
Notification file:
https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/G/SPS/NEU611.pdf&Open=True
Annex 1:https://members.wto.org/crnattachments/2023/SPS/EEC/23_0600_00_e.pdf
Annex 2:https://members.wto.org/crnattachments/2023/SPS/EEC/23_0600_01_e.pdf
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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