SG 89/23
The EU has revised the Union List and group restriction of substances under Annex I to the Food Contact Plastics Regulation. The amendment will enter into force on August 1, 2023
On July 12, 2023, the European Union (EU) issued Commission Regulation (EU) 2023/1442 to amend Table 1 (Union List) and Table 2 (Group restriction of substances) falling under Annex I to Regulation (EU) 10/2011 on food contact plastics (Food Contact Plastics Regulation, consolidated version to September 2020).
The latest revision contains several important changes to Annex I of the Food Contact Plastics Regulation. It:
- Delists food contact material (FCM) substance nos. 96 (wood flour and fibers, untreated) and 121 (salicylic acid)
- Replaces nine FCM substance nos., including new specifications for DBP, BBP, DEHP and DINP (FCM nos. 157, 159, 283 and 728)
- Adds five new entries (FCM substance nos. 1078 and 1080-1083)
- Replaces three entries in group restriction of substances, including considerations of DIBP in group restriction no. 32. Per group restriction no. 32, DIBP is not in the Union List (Table 1) to Annex I of the Food Contact Plastics Regulation. It may co-occur with other phthalates as a consequence of its use as a polymerization aid and is included in group restrictions with the assigned FCM no. 1085.
- Inserts three new entries to group restriction of substances, including group restriction no. 36 where the sum of four phthalates (DBP, DIBP, BBP and DEHP) is expressed as DEHP equivalents using a defined formula.
Highlights of several changes for DBP, BBP, DEHP and DINP in the amendment and a comparison with those in Annex I to the Food Contact Plastics Regulation are summarized in Table 1.
| Substance (FCM No.) | Regulation (EU) 2023/1442 amending Annex I to Regulation (EU) 10/2011 | Annex I to Regulation (EU) 10/2011 |
|---|---|---|
| DBP (157) |
|
|
| BBP (159) |
|
|
| DEHP (283) |
|
|
| DINP (728) |
|
|
Table 1
The amendment will enter into force on August 1, 2023 (20th day following its publication in the Official Journal of the EU).
Food contact plastics complying with the Food Contact Plastics Regulation before the entry into force of this amendment, and which were placed on the market before February 1, 2025, may remain on the market until stocks are exhausted
Food contact plastics manufactured with salicylic acid or untreated wood flour or fibers from a specific wood species may continue to be first placed on the market after February 1, 2025, but subject to defined conditions, including the submission of an application for authorization before August 1, 2024.
Definitions
| Abbreviation | Phthalate | CAS Number |
|---|---|---|
| DBP | Phthalic acid, dibutyl ester | 84-74-2 |
| BBP | Phthalic acid, benzyl butyl ester | 85-68-7 |
| DEHP | Phthalic acid, bis(2-ethylhexyl) ester | 117-81-7 |
| DINP | Phthalic acid, diesters with primary, saturated C8-C10 branched alcohols, more than 60% C9 | 68515-48-0 28553-12-0 |
| DIBP | Diisobutyl phthalate | 84-69-5 |
Table 2
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