SGS RSTS Publications

Learn about the latest industry news and trends here.

RSTS LOGO
Data source SGS RSTS-EE
  • 4953
2023-07-24

EU Revises (EU) 10/2011 on Food Contact Plastics

On July 12, 2023, the European Union (EU) issued Commission Regulation (EU) 2023/1442 to amend Table 1 (Union List) 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.
     
Table 1. 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
Substance FCM No. / CAS No. Regulation (EU) 2023/1442 amending Annex I to Regulation (EU) 10/2011 Annex I to Regulation (EU) 10/2011
DBP 157 / 84-74-2
  • 0.12 mg/kg (specific migration limit, SML)
  • 0.3 mg/kg (specific migration limit, SML)
BBP 159 / 85-68-7
  • 6.0 mg/kg (SML)
  • 30.0 mg/kg (SML)
DEHP 283 / 68515-48-0 & 28553-12-0
  • 0.6 mg/kg (SML)
  • 1.5 mg/kg (SML)
DINP 728 / 84-69-5
  • Not to be used in combination with FCM substances 157, 159, 283 or 1085
  • Total SML = 9 mg/kg (sum of DINP and DIDP, group restriction no. 26)
Group restriction No 36 (DBP+BBP+DEHP+DIBP
  • 0.6 mg/kg (SML)
  • Sum express as DEHP equivalents
/

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.


Food Contact Materials (FCM) services from SGS ensure compliance with requirements for sale and distribution in global markets.

Please contact our Customer Service Team for more information!

Most Popular Article

Keyword

Contact Us

QRCode