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Uruguay Consults Over Draft Resolution for Food Contact Silicones

SafeGuardSHardgoodsMarch 24, 2023

SG 38/23

Uruguay has announced it intends to approve the Mercosur Technical Regulation on silicones for the manufacture of materials, containers, coatings and equipment in contact with food. Comments are accepted until May 12, 2023.

On March 13, 2023, Uruguay’s Ministry of Industry, Energy and Mining (Ministerio de Industria, Energía y Minería, MIEM) announced draft Resolution No. 06/22 on food contact silicone materials and articles.

Highlights of several important provisions in the draft resolution are summarized in Table 1. 

Section to Annex of Draft Resolution No. 06/22Highlights of Mercosur Technical Regulation on Silicones Intended for the Manufacture of Materials, Containers, Coatings and Equipment in Contact with Food
1 'Scope'
  • Silicones used in materials, containers, coatings and equipment intended to come into contact with food
  • Exempts coatings for cellulosic materials as these must comply with Mercosur Technical Regulation on cellulosic materials, containers and equipment
2 ‘General Provisions’
  • General safety requirements
  • Only to be manufactured using the positive list of substances in Parts I to V of this Regulation and complying with any specifications thereof
  • Colorants complying with Mercosur Technical Regulations on colorants in food contact plastics may be used
  • Salts (including double salts and acid salts) of ammonium, calcium, magnesium, potassium, lithium and sodium of authorized acids, phenols or alcohols are authorized for use as additives
  • 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 meet the following 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)
  • ≤ 0.5% volatile organic matter (VOM) using defined method in the Technical Regulation
  • ≤ 0.5% extractable compounds using defined method in the Technical Regulation
  • Negative for peroxides using defined method in the Technical Regulation
  • ≤ 0.01 mg/kg (sum of primary aromatic amines, PAA)
3 ‘Positive List’
  • Contains five parts, each with its positive list and specifications:
    • Part I ‘Silicone oils (fluids) and their respective emulsions’
    • Part II ‘Silicone resins’
    • Part III ‘Elastomeric silicones (silicone rubber)’
    • Part IV ‘Additives, fillers and additives for fillers’
    • Part V ‘Monomers’

Table 1

According to the announcement, comments will be accepted until May 12, 2023 (60 days from March 13, 2023)

SGS technical experts have extensive knowledge and testing experience in materials and articles in contact with food. They work to ensure that your products meet the appropriate regulations for food contact materials, paving the way for compliance. From overall migration tests to expert advice on emerging regulations, compliance issues and documentation review, SGS is the partner to trust. In the end, it’s only trusted because it’s tested. Discover more on our website. 

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