The South American trade bloc MERCOSUR published a draft regulation for the use of silicones in food contact materials. Stakeholders can comment on the draft until May 12, 2023.  

The new regulation includes total specific migration limits for nine metal salts, limits primary aromatic amines (PAAs) to <= 0.01 mg/kg, adds a standard for volatile organics, and includes a positive list of substances allowed for use in silicone FCMs. The positive list is divided into five parts, each part with its own specifications for: (i) silicone oils (fluids) and their respective emulsions; (ii) silicone resins; (iii) elastomeric silicones (silicone rubber); (iv) additives, fillers and additives for fillers; and (v) monomers. 

Assuming no major revisions come to the proposal, MERCOSUR regulations work similarly to European Union directives, in that member nations will still have to individually ratify the new standard. The bloc consists of Argentina, Brazil, Paraguay, and Uruguay. Both Argentina and Uruguay have already sent notifications to the World Trade Organization of the impending change.  

In December 2022, European civil society groups published findings that 23% of 44 silicone baking products tested released chemical constituents in high (>30 mg/kg) or increasing amounts over time, and 82% contained substances of concern at lower levels (FPF reported). A peer-reviewed study of 42 silicone food contact articles purchased off the Chinese market found 84% induced endocrine activity (FPF reported).  

 

References 

MERCOSUR (March 2023). “MERCOSUR Technical regulation on silicones intended for the elaboration of materials , containers, coatings and equipment in contact with food.” Government of Uruguay. (pdf, in Spanish). 

Government of Uruguay (March 13, 2023). “Public consultation on the Mercosur Technical Regulation (RTM).”  

Government of Argentina (March 24, 2023). “World Trade Organization Notification.” WTO 

Government of Uruguay (March 20, 2023). “World Trade Organization Notification.” WTO 

Read more 

InfoAlimentario (March 27, 2023). “Argentina – Draft of MERCOSUR technical regulation on silicones for the manufacture of materials, containers coatings and equipment in contact with foodstuffs.”  

SGS (March 23, 2023). “Uruguay consults over draft resolution for food contact silicones.” 

Cailey Gleeson (March 22, 2023). “Mercosur seeks input on draft regulation on silicone in FCMs.” Chemical Watch 

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