New styrene migration limits under consideration

Farm to Fork strategy shines a light on the importance of food contact materials on the food industry chain and security of consumers. Based on this European strategy the EC has been proposing gradual changes to several regulations including:

• The Regulation (EU) 2022/1616 on recycled plastic materials and articles intended to come into contact with foods
• and the Regulation (EU)10/2011 on plastic materials which come in contact with food.

Future legislative changes for Food Contact Materials

For the specific case of the 10/2011, as they have been done, these changes present themselves as new amendments to the current regulation. This legislation counts 15 amendments already. According to the several meetings of the European Commission’s Working Group for Food Contact Materials (WG-FCM) they are preparing at least 4 more amendments.

Specific migration limit to styrene

One of these changes is the application of a specific migration limit to styrene. The polystyrene homopolymers and styrenic copolymers are made into a variety of materials and articles that are intended for either single use (e.g. food packaging) or repeated use (e.g. durable articles). These materials and articles are in turn used in contact with many different categories of food. Examples are:

• high impact polystyrene (HIPS) containers for dairy products, such as yoghurt;
• sheets and films for dairy products, take away foods, cutlery and tableware made of styrene-butadiene copolymer (SBC) thermoplastics and blended with general purpose polystyrene (GPPS);
• reusable kitchenware and cutlery, made of GPPS, HIPS, ABS or SAN;
• disposable plates and containers for hot foods like soups, e.g. for catering, HIPS;
• disposable wares for hot solid foods, made of foamed GPPS;
• cups for hot beverages, like coffee or tea, made from GPPS or expanded polystyrene (EPS);
• trays for packaging meat, poultry, cheese, fruits and vegetables, made of expanded (EPS) or extruded polystyrene (XPS);
• cold boxes for fisheries, food or beer, of EPS;
• kitchen appliances and machine parts thereof, of ABS;
• unsaturated polyester/epoxy vinylester/styrene polymers for food containers (vats, other large vessels) in industrial applications;
• can coatings for food and beverages;
• sealants, e.g. styrene-butadiene rubber (SBR) for can ends;
• polymer dispersions/lattices (e.g. styrene butadiene or styrene acrylate copolymers) used for coatings of paper and board, adhesives, overprint varnishes etc.;
• styrene as a solvent, cross-linking agent and reactive diluent in the production of glass-reinforced plastics.

The conditions for the use of styrene polymers range typically from low temperature (refrigeration) for periods of days to few weeks, e.g. packaged fish, meat and dairy products, to elevated temperatures for short periods of time, e.g. vending cups for hot drinks or fast food take aways⁵.

At the 32nd meeting of the WG-FCM in October 2022, the group received feedback from the European Commission (EC) concerning the safety of styrene in FCMs¹. The Commission provided feedback on their intention to follow up the assessment made by EFSA³ and to set a specific migration limit (SML)”. At the following WG-FCMs meeting in December 2022, EFSA representatives presented the styrene draft received from the EC. At this point everything indicated that the proposal to apply an SML to styrene would be included in the 18th amendment of the 10/2011 regulation. The precautionary measures that were presented were the following:

• Using the guidance value of 20 ppb determined by the World Health Organization for drinking water2, the basis of Tolerable Daily Intake (TDI)3 calculated by the European Food Safety Agency and a 10% allocation factor. And assuming that the exposure from food is half that from drinking water we can assume that a precautionary limit of 40ppb should be achievable in many materials.

Furthermore, the handout given at this meeting states that the testing should be done in food. At the 8th meeting of the EFSA’s FCM network, DG SANTE stated that testing the migration into food is possible but very challenging, especially since there are no defined standards4. So it will also be accepted as an estimation from the residual concentration of styrene monomer in the plastic, assuming 100% migration.

Recently, in February of 2023, at the 34th meeting of the group the handout given stated that the measures are the same but they will not be applied with the 18th amendment, only in the 19th. This gives companies more time to adjust to the new legislation.

However, the meeting documents which were made public stated that: “This presentation is intended to facilitate discussion and understanding of the matters presented. It does not necessarily represent a final position and does not commit the European Commission. The European Commission accepts no responsibility for the accuracy of any data or information contained in this presentation, which may be under validation or preliminary assessment. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law.” Therefore, whilst they should not be taken as a final decision, they give us a good perspective of what is coming next in the Food Contact Materials world.

In conclusion, the market should prepare itself for a change in legislation that will include a SML to the styrene monomer in a near future. Currently at AIMPLAS, with the use of chromatographic methods, we can reach the required limits of quantification for residual content of styrene.

At our company, we act as consultants to help businesses comply with the different regulations and protocols in the field of plastics. Do not hesitate to contact us if you have any doubt regarding the analysis we offer or the applicable legislation.

Ana Vasconcelos Azevedo

Food Contact & Chromatography

1. FCM_M34_minutes (8-9_02_2023).docx (europa.eu)
2. Styrene in Drinking-water
3. EFSA
4. SCIENTIFIC PANEL ON
   FOOD CONTACT MATERIALS, ENZYMES AND PROCESSING AIDS
5. Assessment of the impact of the IARC Monograph