EU Amends Annex I to Regulation (EU) No 10/2011

By Luca Foltran, subject matter expert on food contact materials, UL Solutions

The European Commission (EC) has issued Commission Regulation (EU) 2023/1442, amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food. The amendment makes changes to substance authorizations and includes the addition of new substances.

This amends some specific migration limits (SMLs) and some restrictions and specifications for substances already listed in the EU list.

Plastic materials and articles complying with Regulation (EU) No 10/2011 that were first placed on the market before Feb. 1, 2025, may remain on the market until the exhaustion of stocks.

Annex I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation:

• Delists substance nos. 96 (wood flour and fibers, untreated) and 121 (salicylic acid)
• Includes 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.

Producers of plastic food contact articles and suppliers of raw materials shall evaluate their products for compliance with the new amendment of European Regulation 10/2011.

With deep expertise in the food contact materials industry, UL Solutions offers a comprehensive portfolio of services for retailers, private labels and manufacturers who need to evaluate their products for compliance with safety and quality requirements. UL Solutions also supports the launch of innovative and quality articles that comply with target markets to protect your final consumers.

Reference

Commission Regulation (EU) 2023/1442 of 11 July 2023 amending Annex I to Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food, as regards changes to substance authorisations and addition of new substances