New French Law for Food Contact Rubber and Pacifiers for Young Children

On August 11 2020, France publishes a new law-Arrêté du 5 August 2020-covering food contact rubber materials and articles and pacifiers for infants and young children. This new law repeals and replace Arrêté du 9 November 1994, and will enter into force on July 1, 2021. Rubber materials and articles placed on the market for the first time before July 1, 2021, complying with the regulations in force before that date, may remain on the market until exhaustion of stocks.

Multiple important changes are as below:
  • Clarification to the definition of rubber covers vulcanized thermoplastic elastomers, but not silicone elastomer;
  • Update the list of authorized substances for the manufacture of rubber materials and articles intended to come into contact with food and pacifiers for infants and young children;
  • Update the restriction and specifications of certain authorized substances, including specific migration limit(SML);
  • Update certain rules for verifying the conformity of rubber materials and articles, please see below table for more details.
  • New requirements for declaration of compliance(DoC).
Items New law
(Arrêté du 5 August 2020)
Old law
(Arrêté du 9 November 1994)
Overall migration 60mg/kg(for infants and young children used products, baby bottle teats, seals, valves and valve elements of which the S/V ratio is known)
10mg/dm2( for pacifiers, seals, valves and valve elements of which the S/V ratio is unknown, and other products)
10mg/dm2(60mg/kg for containers, lids, plugs and seals)
VOM ≤0.5% ±0.1% ≤0.5%
Formaldehyde migration Formaldehyde ≤3mg/kg
hexamethylenetetramine+Formaldehyde ≤15mg/kg
Formaldehyde ≤3mg/kg
Nitrosamine and nitrosatable substances bottle teats and pacifiers: N-Nitrosamine ≤10ug/kg, N-nitrosatable substances ≤100ug/kg; others: N-Nitrosamine ≤1ug/dm2, N-nitrosatable substance ≤10ug/dm2 Same
Aromatic amines Primary aromatic amines ≤0.01mg/kg
Primary and secondary aromatic amines ≤1mg/kg
Primary and secondary aromatic amines ≤1mg/kg
Peroxides Negative Same
Metals Migration(Ba, Cu, Al, Zn)
Residual content(Pb, Cd, Sb, Hg, As)
No requirement

These restrictions will enter into force on July 1, 2021, STQ remind you pay high attention on it and make sure your products meet the new requirements.