SGS : EU Consults Over Proposal to Revise Food Contact Plastics Regulation

SG 13/23

The EU has informed the WTO of its intention to revise its regulation on food contact plastics. The revisions are proposed to enter into force in Q2 of 2023.

On January 23, 2023, the World Trade Organization (WTO) announced a draft regulation from the European Union (EU) on its intention to revise Annex I to Regulation (EU) 10/2011 in relation to Tables 1 (Union list/positive list) and 2 (Group restriction of substances) for food contact plastics. The draft regulation, attached to WTO document number 23-0494, contains several important changes to Annex I of Regulation (EU) 10/2011. It:

• Revokes the authorizations for food contact material (FCM) substance nos. 96 (wood flour and fibers, untreated) and 121 (salicylic acid) on the Union list. 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 18 months after the date of entry into force of the amendment but subject to authorization and other conditions
• Replaces nine FCM substance nos., including strengthened specific migration limits (SML) for DBP (2.5-fold), BBP (5-fold) and DEHP (2.5-fold) and new requirements for the restriction of group substances (total SML)
• Adds five new entries (FCM substance nos. 1078 to 1083)
• Replaces three entries in group restriction of substances, including the consideration of DIBP in group restriction no. 32. According to group restriction no. 32, DIBP (FCM no. 1085) is not listed as an authorized substance in Table 1 to Annex I of Regulation (EU) 10/2011. It may co-occur with other phthalates as a consequence of its use as an aid to polymerization and is included in group restrictions with the assignment FCM no 1085
• Adds three new entries to group restriction of substances, including group restriction no. 36 where the sum of four phthalates (DBP, BBP, DEHP and DIBP) is expressed as DEHP equivalents

Highlights of several changes for DBP, BBP, DEHP and DINP in the draft regulation and a comparison with those in Annex I to Regulation (EU) 10/2011 are summarized in Table 1.

Substance (FCM substance no.)	Draft Regulation amending Annex I to Regulation (EU) 10/2011	Annex I to Regulation (EU) 10/2011 (consolidated to September 2020)
DBP (157)	0.12 mg/kg (specific migration limit, SML) Total SML Group Restriction No = 32 and 36	0.3 mg/kg (specific migration limit, SML) Total SML Group Restriction No = 32
BBP (159)	6.0 mg/kg (SML) Total SML Group Restriction No = 32 and 36	30.0 mg/kg (SML) Total SML Group Restriction No = 32
DEHP (283)	0.6 mg/kg for SML Total SML Group Restriction No = 32 and 36	1.5 mg/kg for SML Total SML Group Restriction No = 32
DINP (728)	Not to be used in combination with FCM substances 157, 159, 283 or 1085

Table 1

According to the proposal, food contact plastics complying with the food contact plastics regulation before the entry of this amendment, and which were first placed on the market before 18 months after the of entry into force of this amendment, may remain on the market until stocks are exhausted.

According to the WTO document and the draft regulation, it is proposed that the draft regulation is:

• Adopted on March 31, 2023
• Published on April 3, 2023
• Brought into force 20 days after its publication in the Official Journal of the EU

Abbreviations

Abbreviation	Phthalate	CAS
DBP	Phthalic acid, dibutyl ester	84-74-2
BBP	Phthalic acid, benzyl butyl ester	85-68-7
DEHP	Phthalic acid, bis(2-ethylhexyl) ester	17-81-7
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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