In March of 2023, the South American trade bloc MERCOSUR released a new draft regulation on the use of silicones in food contact materials (FCM). The proposed regulation includes positive lists and specific migration limits for metal salts. Comments will be accepted until May 12, 2023.
Major contents revealed by the regulation
Application scope | It applies to silicones used in materials, containers, coatings and equipment designed to come into contact with food, excluding coatings for cellulosic materials. |
General requirements | Silicone food contact materials, containers, coatings and equipment must be manufactured according to GMP, and using the positive list of substances in Parts I to V of this Regulation as well as complying with any specifications thereof. |
Positive list | The draft includes five positive lists, each with its specifications: (1) Silicone oils (fluids) and their respective emulsions (2) Silicone resins (3) Elastomeric silicones (silicone rubber) (4) Additives, fillers and additives for fillers (5) Monomers |
Specific migration limits for metal salts | Salts (including double salts and acid salts) of aluminum (Al), barium (Ba), cobalt (Co), copper (Cu), iron (Fe), lithium (Li) manganese (Mn), nickel (Ni) and zinc (Zn) of authorized acids, phenols or alcohols are authorized for use as additives, but they must not exceed the Total Specific Migration Limits ((T) SML)): 1 mg/kg (Al); 1 mg/kg (Ba); 0.05 mg/kg (Co); 5 mg/kg (Cu); 48 mg/kg (Fe); 0.6 mg/kg (Li); 0.6 mg/kg (Mn); 0.02 mg/kg (Ni); 5 mg/kg (Zn). |
Other limits | Volatile organic matter≤ 0.5% Extractable compounds≤ 0.5% Sum of primary aromatic amines, PAA≤ 0.01 mg/kg |
Potential hazards of silicones
Silicone is a chemical substance widely used as a food contact material, which can make plastics softer and more elastic, as well as improve the heat resistance of products.
However, silicone may also pose potential hazards to human health. Previous studies have shown that certain silicone materials may release harmful volatile organic compounds, such as silane and hydrosilanes, which may cause irritation and damage to the human body.
According to a survey released by European civil society groups in December 2022, 23% of the 44 silicone baking products tested had high chemical release levels (>30 mg/kg) or the amount of chemical release increased over time. Besides, 82% of the samples were found to contain lower levels of substances of concern.1 Another peer-reviewed study on 42 silicone food contact products purchased from the Chinese market found that 84% induced endocrine activity.2
Impact of the regulation
The release of this newly proposed regulation has attracted widespread attention. In the Southern Common Market, the regulation framework is similar to EU, which means member countries need to convert the MERCOSUR regulations/directives into regulations applicable to their own national conditions. Among the four member countries of Argentina, Brazil, Paraguay, and Uruguay, currently Argentina and Uruguay have notified the WTO about the upcoming change.
The new regulation aims to ensure the health and safety of consumers. Its implementation will reinforce the FCM supervision in the region. Enterprises with relevant businesses should closely monitor the progress of this new regulation to ensure the compliance of their products.
