France has published a new Order on rubber materials and articles intended to come into contact with foodstuffs and pacifiers for infants and young children. This new legislation will become effective on July 1, 2021.
On August 11, 2020, France published Order of August 5, 2020 to regulate food contact rubber materials and articles, as well as pacifiers for young children (‘new Order’). This new Order replaces and repeals the Order of November 9, 1994 (consolidated version to June 2020 for reference) relating to rubber materials and articles in contact with foodstuffs, food products and drinks.
The new law contains, several important changes. It:
Clarifies the definition of rubber covers and vulcanized thermoplastic elastomers, but not silicone elastomers
Updates the lists 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
Updates the restrictions and specifications for these authorized substances due to new scientific information, including specific migration limits (SMLs)
Updates certain rules for verifying the conformity of rubber materials and articles
Adds a completely new requirement for declaration of compliance (Doc)
Expresses overall migration limits (OMLs) and their requirements in one of two specifications:
≤ 10 mg/dm² for 1) all articles 2) pacifiers for infants and young children and 3) gaskets, valves and valve elements where the ratio between the surface in contact with food and the volume is not known or specified
≤ 60 mg/kg for 1) food contact materials and articles for infants and young children 2) bottle nipples (teats) and 3) gaskets, valves and valve elements where the ratio between the surface in contact with food and the volume is known or specified
The new Order will become effective on July 1, 2021.
Safeguards, 25 August 2020