The latest update to the European Union’s guidelines for plastic materials used in food-contact applications, Annex I to Regulation (EU) 10/2011, due to take effect on 1 August 2023, foresees a number of regulatory changes for mainstream packaging applications as well as niche uses.

At the same time, Brussels is opening the door for new products to be regulated in the next amendment, as food contact plastics commercially introduced before 1 February 2025 generally may remain in circulation, subject to defined conditions, until stocks have been exhausted.

In principle, plastics made with salicylic acid or untreated wood flour may remain on the market if a request for authorisation is submitted before 1 August 2024.

However, there could be restrictions. The European Commission said it is, for now, withdrawing its authorisation of materials made with salicylic acid as no companies have provided the European Food Safety Authority (EFSA, Parma, Italy; www.efsa.europa.eu) with details of their production, and the authority has no information on where such products are used.

Some of the new provisions in the updated Union List (Table 1) to Annex I, are likely to affect only a few niche players in the plastics processing sector, but the replacement of nine FCM-relevant substances, including new specifications for DIBP, BBP, DEHP and DINP (FCM nos. 157, 159, 283 and 728) and the addition of five new substances (nos. 1078 and 1080-103) to group restrictions potentially could have a broader impact on the market generally.

In one significant change to group restriction no. 36, the sum of four phthalates (DBP, DIBP, BBP and DEHP) in the future is to be expressed as DEHP equivalents using a defined formula. As DIBP – which is not authorised as an additive for plastic FCM, but may be present in smaller amounts as an impurity – may co-occur with other phthalates as a consequence of its use as a polymerisation aid and in other market applications, EFSA said it had included the substance in group restrictions under FCM no. 1085.

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The authority noted that DIBP “substantially adds to the overall exposure and risk to consumers from phthalates” and that such exposure together with its potential effects should also be taken into account.

The revised EU rules have been three years in the making.

Following a request by the European Commission, EFSA in 2020 among other things began reviewing the 451 substances listed in the 2011 amendment, for which no specific migration limit (SML) had been set. Deciding that 284 among them needed to be re-evaluated, it divided them into three priority groups for potential regulatory changes.

In the roughly 10 ensuing years since the last amendment, EFSA has published other scientific opinions on new substances that may be used in new food contact materials (FCM) as well as on the use of already authorised substances. As part of this, the authority said it had identified certain ambiguities related to applications and has taken into account the degree of scientific and technical progress.

While most plastics FCMs evaluated for the 2023 amendment were plasticisers, the food safety researchers left other products out of their review, determining, for instance, that PS feedstock styrene (FCM No 193) was already subject to a re-evaluation, while information submitted by producers indicated that lauric acid, vinyl ester (FCM No 43) is a low priority.